Commission Implementing Regulation (EU) 2017/2470
law://eu/reg/2017/2470/anx_1__grp_1@2026-11-13law://eu/reg/2017/2470/anx_1__grp_1@2026-11-13| Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements | Data Protection | |
|---|---|---|---|---|---|
| N-Acetyl-D-neuraminic acid | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘N-acetyl-D-neuraminic acid’Food supplements containing N-acetyl-D-neuraminic acid shall bear a statement that the food supplement should not be given to infants, young children and children under 10 years of age where they consume breast milk or other foods with added N-acetyl-D-neuraminic acid within the same twenty four hour period. | ||
| Infant and follow-on formulae as defined by Regulation (EU) No 609/2013note | 0,05 g/L of reconstituted formula | ||||
| Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 | 0,05 g/kg for solid foods | ||||
| Foods for special medical purposes for infants and young children as defined by Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than the maximum levels specified for the category mentioned in the table corresponding to the products. | ||||
| Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013 | 0,2 g/L (drinks)1,7 g/kg (bars) | ||||
| Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014note | 1,25 g/kg | ||||
| Unflavoured pasteurised and sterilised (including UHT) milk-based products | 0,05 g/L | ||||
| Unflavoured fermented milk-based products, heat treated after fermentation, flavoured fermented milk products including heat-treated products | 0,05 g/L (beverages)0,4 g/kg (solids) | ||||
| Dairy analogues, including beverage whiteners | 0,05 g/L (beverages)0,25 g/kg (solids) | ||||
| Cereal bars | 0,5 g/kg | ||||
| Table top sweeteners | 8,3 g/kg | ||||
| Fruit and vegetable-based drinks | 0,05 g/L | ||||
| Flavoured drinks | 0,05 g/L | ||||
| Speciality coffee, tea, herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions | 0,2 g/kg | ||||
| Food Supplements as defined in Directive 2002/46/ECnote | 300 mg/day for general population older than 10 years55 mg/day for infants130 mg/day for young children250 mg/day for children between 3 to 10 years of age | ||||
| Acheta domesticus (house cricket) partially defatted powder | Specified food category | Maximum levels (g/100 g)(marketed as such or reconstituted according to the instructions) | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Acheta domesticus (house cricket) partially defatted powder.2. The labelling of the foodstuffs containing Acheta domesticus (house cricket) partially defatted powder shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, molluscs, and products thereof, and to dust mites. This statement shall appear in close proximity to the list of ingredients. | Authorised on 24.1.2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Cricket One Co. Ltd’, 383/3/51 Quang Trung street, Ward 10, Go Vap district, Ho Chi Minh City, Vietnam.During the period of data protection, the novel food Acheta domesticus (house cricket) partially defatted powder is authorised for placing on the market within the Union only by ‘Cricket One Co. Ltd’, unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283, or with the agreement of ‘Cricket One Co. Ltd’.End date of the data protection: 24.1.2028. | |
| Multigrain bread and rolls; crackers and breadsticks | 2 | ||||
| Cereal bars | 3 | ||||
| Pre-mixes for baked products (dry) | 3 | ||||
| Biscuits | 1,5 | ||||
| Pasta-based products (dry) | 0,25 | ||||
| Stuffed pasta-based products (dry) | 3 | ||||
| Sauces | 1 | ||||
| Processed potato products, legume- and vegetable-based dishes, pizza, pasta-based dishes | 1 | ||||
| Whey powder | 3 | ||||
| Meat analogues | 5 | ||||
| Soups and soup concentrates or powders | 1 | ||||
| Maize flour based snacks | 4 | ||||
| Beer-like beverages | 0,1 | ||||
| Chocolate confectionary | 2 | ||||
| Nuts and oilseeds | 2 | ||||
| Snacks other than chips | 5 | ||||
| Meat preparations | 2 | ||||
| Adansonia digitata (Baobab) dried fruit pulp | Not specified | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Baobab fruit pulp’ | |||
| Frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm) | Specified food category | Maximum levels (g/100g) | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Frozen/paste Alphitobius diaperinus larvae (lesser mealworm) or Dried/powder Alphitobius diaperinus larvae (lesser mealworm) depending on the form used.2. The labelling of food supplements containing the novel food shall bear a statement that those food supplements should not be consumed by persons under 18 years of age.3. The labelling of the foodstuffs containing frozen, paste, dried or powder forms of Alphitobius diaperinus larvae (lesser mealworm) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, and products thereof, and to dust mites. This statement shall appear in close proximity to the list of ingredients. | Authorised on 26.1.2023. This inclusion is based on proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Ynsect NL B.V, Harderwijkerweg 141B, 3852 AB Ermelo, the Netherlands.During the period of data protection, the novel food is authorised for placing on the market within the Union only by Ynsect NL B.V., unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283, or with the agreement of Ynsect NL B.V.End date of the data protection: 26.1.2028. | |
| Cereal bars | 25 (Dried form)25 (Powder form) | ||||
| Bread and rolls | 20 (Powder form) | ||||
| Processed and breakfast cereals | 10 (Dried form)10 (Powder form) | ||||
| Porridge | 15 (Powder form) | ||||
| Pre-mixes (dry) for baked products | 10 (Powder form) | ||||
| Dried pasta-based products | 10 (Powder form) | ||||
| Stuffed pasta-based products | 28 (Frozen or paste form)10 (Powder form) | ||||
| Whey powder | 35 (Powder form) | ||||
| Soups | 15 (Powder form) | ||||
| Cereal-, pasta-based dishes | 5 (Powder form) | ||||
| Pizza-based dishes | 5 (Dried form)5 (Powder form) | ||||
| Noodles | 10 (Powder form) | ||||
| Snacks other than chips | 10 (Dried form)10 (Powder form) | ||||
| Chips/crisps | 10 (Powder form) | ||||
| Crackers and bread sticks | 10 (Powder form) | ||||
| Peanut butter | 15 (Powder form) | ||||
| Ready-to-eat savoury based sandwich | 20 (Powder form) | ||||
| Meat preparations | 14 (Frozen or paste form)5 (Powder form) | ||||
| Meat analogues | 40 (Frozen or paste form)15 (Powder form) | ||||
| Milk and dairy analogues | 10 (Powder form) | ||||
| Chocolate confectionary | 5 (Powder form) | ||||
| Food supplements as defined in Directive 2002/46/EC for the adult population | 4 g/day (Powder form) | ||||
| Ajuga reptans extract from cell cultures | Specified food category | Maximum levels | |||
| Food Supplements as defined in Directive 2002/46/EC | In line with normal use in food supplements of a similar extract of the flowering aerial parts of Ajuga reptans | ||||
| Akkermansia muciniphila (pasteurised) | Specified food category | Maximum levels | |||
| Foods for special medical purposes as defined under Regulation (EU) No 609/2013, excluding foods for special medical purposes intended for infants, children younger than 12 years of age, pregnant and lactating women | In accordance with the particular nutritional requirements of the persons for whom the products are intended, but no higher than:2,1 × 1010 cells/day for the general population older than 12 years of age,3,0 × 1010 cells/day for the general population older than 14 years of age.3,4 × 1010 cells/day for the adult population | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘pasteurised Akkermansia muciniphila’.The labelling of food supplements containing pasteurised Akkermansia muciniphila shall bear a statement that those food supplements should not be consumed by:a) pregnant and lactating women;b) by infants and children under 12 years of age / infants, children and adolescents under 14 years of age/ infants, children and adolescents under 18 years of age depending on the age groups the food supplement is intended for. | Authorised on 1 March 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/ 2283. Applicant: the Akkermansia Company SA., rue Granbonpré, 11, Bâtiment H, 1435 Mont-Saint-Guibert. Belgium. During the period of data protection, the novel food pasteurised Akkermansia muciniphila is authorised for placing on the market within the Union only by the Akkermansia Company SA, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of the Akkermansia Company SA. End date of the data protection: 1 March 2027. | ||
| Food supplements as defined in Directive 2002/46/EC, excluding infants and children younger than 12 years of age, pregnant and lactating women | 2,1 × 1010 cells/day for the general population older than 12 years of age,3,0 × 1010 cells/day for the general population older than 14 years of age.3,4 × 1010 cells/day for the adult population | ||||
| L-Alanyl-L-Glutamine | Specified food category | Maximum levels | |||
| Food Supplements as defined in Directive 2002/46/EC | |||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 excluding foods for infants and young children | |||||
| Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen | |||||
| Algal oil from the microalgae Ulkenia sp. | Specified food category | Maximum levels of DHA | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the micro-algae Ulkenia sp.’ | ||
| Bakery products (breads, rolls and sweet biscuits) | 200 mg/100 g | ||||
| Cereal bars | 500 mg/100 g | ||||
| Non-alcoholic beverages (including milk based beverages) | 60 mg/100 ml | ||||
| Allanblackia seed oil | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Allanblackia seed oil’ | ||
| Yellow fat spreads and cream based spreads | 30 g/100 g | ||||
| Mixtures of vegetable oils (*) and milk (falling under the food category: Dairy analogues, including beverage whiteners) | 30 g/100 g | ||||
| (*)Except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/2013. | |||||
| Aloe macroclada Baker leaf extract | Specified food category | Maximum levels | |||
| Food Supplements as defined in Directive 2002/46/EC | In line with normal use in food supplements of the similar gel derived from Aloe vera (L.) Burm. | ||||
| Juice of the stems of the Angelica keiskei plant (‘Ashitaba stem juice’) | Specified food category | Maximum levels (expressed on the juice) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ashitaba (Angelica keiskei) stem juice’.The labelling of food supplements containing the juice of the stems of the Angelica keiskei plant (Ashitaba stem juice) shall bear a statement that they should be consumed by adults only, excluding pregnant and lactating women. | Authorised on 20 August 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Japan Bio Science Laboratory (JBSL)-USA, Inc.’, 1547 Palos Verdes Mall No 131, Walnut Creek, California 94597, United States of America.During the period of data protection, the novel food juice of the stems of the Angelica keiskei plant (‘Ashitaba stem juice’) is authorised for placing on the market within the Union only by ‘Japan Bio Science Laboratory (JBSL)-USA, Inc.’ unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘Japan Bio Science Laboratory (JBSL)-USA, Inc.’.End date of the data protection: 20 August 2029 | |
| Food Supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and lactating women | 137 mg/day | ||||
| Antarctic Krill oil from Euphausia superba | Specified food category | Maximum levels of combined DHA and EPA | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lipid extract from the crustacean Antarctic Krill (Euphausia superba)’ | ||
| Dairy products except milk-based drinks | 200 mg/100 g or for cheese products 600 mg/100 g | ||||
| Dairy analogues except drinks | 200 mg/100 g or for analogues to cheese products 600 mg/100 g | ||||
| Non-alcoholic beveragesMilk-based drinksDairy analogue drinks | 80 mg/100 ml | ||||
| Spreadable fat and dressings | 600 mg/100 g | ||||
| Cooking fats | 360 mg/100 ml | ||||
| Breakfast cereals | 500 mg/100 g | ||||
| Bakery products (breads, rolls and sweet biscuits) | 200 mg/100 g | ||||
| Nutrition bars/cereal bars | 500 mg/100 g | ||||
| Food Supplements as defined in Directive 2002/46/EC | 3000 mg/day for the general population450 mg/day for pregnant and lactating women | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 250 mg/meal | ||||
| Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013 | 200 mg/100 ml | ||||
| Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen | |||||
| Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 | |||||
| Antarctic Krill oil rich in phospholipids from Euphausia superba | Specified food category | Maximum levels of combined DHA and EPA | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lipid extract from the crustacean Antarctic Krill (Euphausia superba)’ | ||
| Dairy products except milk-based drinks | 200 mg/100 g or for cheese products 600 mg/100 g | ||||
| Dairy analogues except drinks | 200 mg/100 g or for analogues to cheese products 600 mg/100 g | ||||
| Non-alcoholic beveragesMilk-based drinksDairy analogue drinks | 80 mg/100 ml | ||||
| Spreadable fat and dressings | 600 mg/100 g | ||||
| Cooking fats | 360 mg/100 ml | ||||
| Breakfast cereals | 500 mg/100 g | ||||
| Bakery products (breads, rolls and sweet biscuits) | 200 mg/100 g | ||||
| Nutrition bars/cereal bars | 500 mg/100 g | ||||
| Food Supplements as defined in Directive 2002/46/EC | 3000 mg/day for the general population450 mg/day for pregnant and lactating women | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 250 mg/meal | ||||
| Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013 | 200 mg/100 ml | ||||
| Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen | |||||
| Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 | |||||
| Antrodia camphorata mycelia powder | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of food supplements containing it shall be Antrodia camphorata mycelia powder.2. The labelling of the food supplements containing Antrodia camphorata mycelia powder shall bear a statement that this food supplement should not be consumed by infants, children, and adolescents younger than 14 years of age. | ||
| Food supplements as defined in Directive 2002/46/EC, excluding infants, children, and adolescents younger than 14 years of age | 990 mg/day | ||||
| Aqueous ethanolic extract of Labisia pumila | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be aqueous ethanolic extract of Labisia pumila.2. The labelling of food supplements containing the novel food shall bear a statement that they should only be consumed by persons above 18 years of age excluding pregnant and lactating women. | Authorised on 6 June 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Medika Natura Sdn. Bhd., No. 44B Jalan Bola Tampar 13/14 Section 13, 40100 Shah Alam Selangor, Malaysia. During the period of data protection, the novel food aqueous ethanolic extract of Labisia pumila is authorised for placing on the market within the Union only by Medika Natura Sdn. Bhd., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Medika Natura Sdn. Bhd.End date of the date protection: 6 June 2028. | |
| Food supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and lactating women | 350 mg/day | ||||
| Apple fruit cell culture biomass | Specified food category | Maximum levels | |||
| Food supplements as defined in Directive 2002/46/EC for the adult population | 0,15 mg/day | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be apple fruit cell culture biomass.2. The labelling of food supplements containing the novel food shall bear a statement that they should only be consumed by persons above 18 years of age. | |||
| Arachidonic acid-rich oil from the fungus Mortierella alpina | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from Mortierella alpina’ or ‘Mortierella alpina oil’ | ||
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Foods for special medical purposes for infants as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Argan oil from Argania spinosa | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Argan oil’ and if used as seasoning ‘Vegetable oil only for seasoning’ shall be mentioned on the label | ||
| As seasonings | Not specified | ||||
| Food Supplements as defined in Directive 2002/46/EC | In line with normal food use of vegetable oils | ||||
| Astaxanthin-rich oleoresin from Haematococcus pluvialis algae | Specified food category | Maximum levels of astaxanthin | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Astaxanthin rich oleoresin from Haematococcus pluvialis algae’The labelling of food supplements containing Astaxanthin rich oleoresin from Haematococcus pluvialis algae shall bear a statement that they should not be consumed:(a) if other food supplements containing astaxanthin esters are consumed on the same day(b) by infants and young children under 3 years of age(c) by infants and children under 10 years of age(d) by infants, children and adolescents under 14 years of age. | ||
| Food supplements as defined in Directive 2002/46/EC excluding infants and young children | 2,3 mg astaxanthin per day for children 3 to less than 10 years of age | ||||
| 5,7 mg astaxanthin per day for adolescents 10 to less than 14 years of age | |||||
| 8 mg astaxanthin per day for general population older than 14 years of age | |||||
| Partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Partially hydrolysed protein from barley and rice’.In accordance with Article 21 of Regulation (EU) No 1169/2011. | Authorised on 10 January 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Evergrain LLC, 3205 S. 9th St, St. Louis, Missouri, 63118 USA. During the period of data protection, the novel food partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) is authorised for placing on the market within the Union only by Evergrain LLC, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Evergrain LLC.End date of the date protection: 10 January 2029. | |
| Fried or extruded cereal, seed or root-based products | 5 g/100 g | ||||
| Confectionery including chocolate | 5 g/100 g | ||||
| Breakfast cereals | 5 g/100 g | ||||
| Pastas and rice (or other cereal)-based dishes | 8 g/100 g | ||||
| Soups (dry mixture) | 50 g/100 g | ||||
| Soups (ready-to-eat) | 5 g/100 g | ||||
| Sauces | 10 g/100 g | ||||
| Dried sauce preparation | 50 g/100 g | ||||
| Meat analogues | 15 g/100 g | ||||
| Cereal bars | 30 g/100 g | ||||
| Butter and margarine/oil blends | 10 g/100 g | ||||
| Milk analogues based ice creams | 10 g/100 g | ||||
| Milk analogues | 5 g/100 ml | ||||
| Nut/seeds paste/emulsion | 15 g/100 g | ||||
| Energy drinks | 8 g/100 ml | ||||
| Soft drinks marketed in relation to physical exercise | 5 g/100 ml | ||||
| Cola type drinks | 5 g/100 g | ||||
| Powdered drink bases | 90 g/100 g | ||||
| Beverages based on fruit and/or vegetable juices | 5 g/100 ml | ||||
| Cream, cheese and yoghurt (non-soy) analogues | 10 g/100 g | ||||
| Hummus | 10 g/100 g | ||||
| Alcohol-free beer | 5 g/100 ml | ||||
| Meal replacement for weight control | 30 g/100 g | ||||
| Basil seeds (Ocimum basilicum) | Specified food category | Maximum levels | |||
| Fruit juice and fruit/vegetable blend beverages | 3 g/200 ml for addition of whole basil seeds (Ocimum basilicum) | ||||
| Beta-glucan from Euglena gracilis microalgae | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘beta-glucan from Euglena gracilis microalgae’. | Authorised on 30 April 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Kemin Foods L.C., 1900 Scott Avenue Des Moines, IA 50317, United States. During the period of data protection, the novel food beta-glucan from Euglena gracilis microalgae is authorised for placing on the market within the Union only by Kemin Foods L.C., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Kemin Foods L.C.End date of the date protection 30 April 2029. | |
| Cereal bars | 670 mg/100 g | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 | 600 mg/day | ||||
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 100 mg/day for children from 3 to 9 years of age150 mg/day for children from 10 to 17 years of age200 mg/day for adults | 1.The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘beta-glucan from Euglena gracilis microalgae’.2.The labelling of food supplements containing the novel food shall bear a statement that they should only be consumed by persons above 3 years of age/above 9 years of age/adults, depending on the age group the product is intended for | |||
| Betaine | Specified food category | Maximum levelsnote | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘betaine’.The labelling of foods containing betaine shall bear a statement that the foods should not be used if food supplements containing betaine are consumed the same day. | Authorised on 22 August 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: DuPont Nutrition Biosciences ApS, Langebrogade 1 Copenhagen K, DK-1411, Denmark. During the period of data protection, the novel food betaine is authorised for placing on the market within the Union only by DuPont Nutrition Biosciences ApS unless a subsequent applicantobtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of DuPont Nutrition Biosciences ApS,End date of the data protection: 22 August 2024. | |
| Drink powders, isotonic and energy drinks intended for sportsmen | 60 mg/100 g | ||||
| Protein and cereal bars intended for sportsmen | 500 mg/100 g | ||||
| Meal replacements intended for sportsmen | 20 mg/100 g | ||||
| Total diet replacement for weight control as defined under Regulation (EU) No 609/2013 | 500 mg/100 g (bar)136 mg/100 g (soup)188 mg/100 g (porridge)60 mg/100 g (beverages) | ||||
| Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 for adults | 400 mg/day | ||||
| Fermented black bean extract | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fermented black bean (Soya) extract’’ or ‘Fermented Soya extract’ | ||
| Food Supplements as defined in Directive 2002/46/EC | 4,5 g/day | ||||
| Bovine lactoferrin | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’ | ||
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 (ready to drink) | 100 mg/100 ml | ||||
| Foods on dairy basis intended for young children (ready to eat/drink) | 200 mg/100 g | ||||
| Processed cereal food (solid) | 670 mg/100 g | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | Depending on the needs of the individual up to 3 g/day | ||||
| Beverages based on milk | 200 mg/100 g | ||||
| Powdered drink mixes based on milk (ready to drink) | 330 mg/100 g | ||||
| Beverages based on fermented milk (including yoghurt drinks) | 50 mg/100 g | ||||
| Non-alcoholic drinks | 120 mg/100 g | ||||
| Products based on yoghurt | 80 mg/100 g | ||||
| Products based on cheese | 2000 mg/100 g | ||||
| Ice cream | 130 mg/100 g | ||||
| Cakes and pastries | 1000 mg/100 g | ||||
| Candies | 750 mg/100 g | ||||
| Chewing gum | 3000 mg/100 g | ||||
| Bovine milk basic whey protein isolate | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Milk whey protein isolate’.Food supplements containing bovine milk basic whey protein isolate shall bear the following statement:‘This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen (*) years’(*)Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Armor Protéines S.A.S. End date of the data protection: 20 November 2023. | |
| Infant formulae as defined in Regulation (EU) No 609/2013 | 30 mg/100 g (powder) | ||||
| 3,9 mg/100 mL (reconstituted) | |||||
| Follow-on formulae as defined in Regulation (EU) No 609/2013 | 30 mg/100 g (powder) | ||||
| 4,2 mg/100 mL (reconstituted) | |||||
| Total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013 | 300 mg/day | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | 30 mg/100 g (powder formula for infants during the first months of life until the introduction of appropriate complementary feeding) | ||||
| 3,9 mg/100 mL (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding) | |||||
| 30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced) | |||||
| 4,2 mg/100 mL (reconstituted formula for infants when appropriate complementary feeding is introduced) | |||||
| 58 mg/day for young children | |||||
| 380 mg/day for children and adolescents from 3 to 18 years of age | |||||
| 610 mg/day for adults | |||||
| Food supplements as defined in Directive 2002/46/EC | 25 mg/day for infants | ||||
| 58 mg/day for young children | |||||
| 250 mg/day for children and adolescents from 3 to 18 years of age | |||||
| 610 mg/day for adults | |||||
| Bovine milk beta-lactoglobulin (β-lactoglobulin) | Specified food category | Maximum levels (g NF/100 ml) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘bovine milk beta-lactoglobulin’ or ‘bovine milk β-lactoglobulin’. | Authorised on 11 January 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Arla Foods Ingredients Group P/S, Sønderhøj 10-12, 8260 Viby J, Denmark. During the period of data protection, the novel food beta-lactoglobulin (β-lactoglobulin) is authorised for placing on the market within the Union only by Arla Foods Ingredients Group P/S unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Arla Foods Ingredients Group P/S.End date of the data protection: 11 January 2028. | |
| Soft drinks marketed in relation to physical exercise | 25 | ||||
| Whey powder (reconstituted) | 8 | ||||
| Milk based drinks and similar products | 12 | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 intended for the general population older than 3 years of age, excluding pregnant and lactating women | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Bovine milk osteopontin | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Bovine milk Osteopontin’. | Authorised on 26 March 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Arla Foods Ingredients Group P/S., Sønderhøj 10-12 8260 Viby J Denmark. During the period of data protection, the novel food Bovine milk osteopontin is authorised for placing on the market within the Union only by Arla Foods Ingredients Group P/S., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Arla Foods Ingredients Group P/S.End date of the data protection: 26 March 2028. | |
| Infant formula as defined in Regulation (EU) No 609/2013note | 151 mg/L in the final product ready for use,marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined in Regulation (EU) No 609/2013note | 151 mg/L in the final product ready for use,marketed as such or reconstituted as instructed by the manufacturer | ||||
| Milk-based drinks intended for young children | 151 mg/L in the final product ready for use,marketed as such or reconstituted as instructed by the manufacturer | ||||
| Buglossoides arvensis seed oil | Specified food category | Maximum levels of stearidonic acid (STA) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined Buglossoides oil’ | ||
| Dairy products and analogues | 250 mg/100 g | ||||
| 75 mg/100 g for drinks | |||||
| Cheese and cheese products | 750 mg/100 g | ||||
| Butter and other fat and oil emulsions including spreads (not for cooking or frying purposes) | 750 mg/100 g | ||||
| Breakfast cereals | 625 mg/100 g | ||||
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 500 mg/day | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013, excluding foods for special medical purposes intended for infants and young children | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 250 mg/meal | ||||
| Calanus finmarchicus oil | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be oil from Calanus finmarchicus (crustacean).2. The labelling of food supplements containing Calanus finmarchicus oil shall bear a statement that those food supplements should not be consumed: (a)if other food supplements containing astaxanthin esters are consumed on the same day;(b)by infants and children younger than 3 years / children under 10 years of age / children and adolescents under 14 years of age depending on the age groups the food supplement is intended for. | ||
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 0,9 g/day (≤ 2,25 mg astaxanthin per day) for the general population under 10 years of age, excluding infants and young children2,2 g/day (≤ 5,5 mg astaxanthin per day) for the general population between 10 to 14 years of age3,1 g/day (≤7,75 mg astaxanthin per day) for the general population older than 14 years of age | ||||
| Calcium fructoborate | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be calcium fructoborate.2. The labelling of food supplements containing calcium fructoborate shall bear a statement that those food supplements should not be consumed by population under 18 years of age and by pregnant and lactating women. | Authorised on 23 December 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: VDF FutureCeuticals, Inc., 300 West 6th Street Momence, Illinois 60954, the United States.During the period of data protection, the novel food calcium fructoborate is authorised for placing on the market within the Union only by VDF FutureCeuticals, Inc., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of VDF FutureCeuticals, Inc.End date of the date protection: 23 December 2026 | |
| Food supplements as defined in Directive 2002/46/EC for the adult population, excluding food supplements for pregnant and lactating women | 220 mg/day | ||||
| Calcium L-Methylfolate | Specified food category | Maximum levels (expressed as folic acid) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Calcium L-Methylfolate’. | ||
| Foods for special medical purposes and total diet replacement for weight control as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Infant formulae and follow-on formula as defined by Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Food supplements as defined in Directive 2002/46/EC | In accordance with Directive 2002/46/EC | ||||
| Food fortified in accordance with Regulation (EC) No 1925/2006 | In accordance with Regulation (EC) No 1925/2006 | ||||
| Calcidiol monohydrate | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be calcidiol (calcifediol) monohydrate (vitamin D).2. The labelling of food supplements containing the novel food shall bear a statement that they should not be consumed by infants and children under 3 years of age/children under 11 years of age, depending on the age group the product is intended for. | Authorised on 1 May 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: DSM Nutritional Products Ltd., Wurmisweg 576, 4303 Kaiseraugst, Switzerland. During the period of data protection, the novel food calcidiol monohydrate is authorised for placing on the market within the Union only by DSM Nutritional Products Ltd., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of DSM Nutritional Products Ltd.End date of the date protection: 1 May 2029. | |
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 10 μg/day for children from 11 years of age and adults5 μg/day for children from 3 to 10 years of age | ||||
| Dried nuts of Canarium ovatum Engl. | Specified food category | Maximum levels | 1.The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘nuts of Canarium ovatum’ and/or ‘pilinuts’ and/or ‘pili (Canarium ovatum) nuts’.2.The labelling of the foodstuffs containing dried nuts of Canarium ovatum Engl. shall bear a statement that the dried nuts of Canarium ovatum Engl. may cause allergic reactions to consumers with known allergies to cashew and walnut. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredients, in close proximity to the name of the food. | ||
| Not specified | |||||
| Canarium indicum L. dried nuts (Kenari) (Traditional food from a third country) | Specified food category | Maximum levels (g/100 g) | 1. The designation of the traditional food on the labelling of the foodstuffs containing it shall be dried kenari (Canarium indicum) nuts.2. The labelling of the foodstuffs containing dried nuts of Canarium indicum L. shall bear a statement that the nuts may cause allergic reactions to consumers with known allergies to hazel, cashew and pistachio. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredient, in close proximity to the name of the food. | ||
| Not specified | |||||
| Cellobiose | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be cellobiose.2. The labelling of food supplements containing cellobiose shall bear a statement that those food supplements should not be consumed by infants and young children. | Authorised on 1 June 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: SAVANNA Ingredients GmbH, Dürener Straße 67, 50189 Elsdorf, Germany. During the period of data protection, the novel food cellobiose is authorised for placing on the market within the Union only by SAVANNA Ingredients GmbH, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of SAVANNA Ingredients GmbH.End date of the data protection: 1 June 2028. | |
| Food supplements as defined in Directive 2002/46/EC for the general population, excluding infants and young children | 3 g/day | ||||
| Dried, canned-tinned, raw cured (or seasoned), cooked cured (or seasoned) meat | 2 g/100 g | ||||
| Fresh raw, preserved or partly preserved sausages | 2 g/100 g | ||||
| Meat based spreadable-textured specialties | 2 g/100 g | ||||
| Liver based spreadable-textured specialties | 2 g/100 g | ||||
| Savoury sauce dry preparation | 40 g/100 g | ||||
| Table-top sweeteners in powder form | 60 g/100 g | ||||
| Table-top sweeteners in tablets | 60 g/100 g | ||||
| Cetylated fatty acids | Specified food category | Maximum levels | 1.The designation of the novel food on the labelling of the food supplements containing it shall be ‘cetylated fatty acids preparation’.2.The labelling of food supplements containing the novel food shall bear a statement that those food supplements should not be consumed by persons under 18 years of age. | Authorised on 3 March 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Pharmanutra S.p.A., Via Delle Lenze 216/b, 56122 Pisa, Italy. During the period of data protection, the novel food cetylated fatty acids is authorised for placing on the market within the Union only by Pharmanutra S.p.A., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Pharmanutra S.p.A.End date of the date protection: 3 March 2027 | |
| Food supplements as defined in Directive 2002/46/EC for the adult population | 1,6 g/day | ||||
| Chewing gum base (monomethoxypolyethylene glycol) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Gum base (including 1,3-butadiene, 2-methyl-homopolymer, maleated, esters with polyethylene glycol mono-Me ether)’ or ‘Gum base (including CAS No: 1246080-53-4)’ | ||
| Chewing gum | 8 % | ||||
| Chewing gum base (Methyl vinyl ether-maleic anhydride copolymer) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Gum base (including methyl vinyl ether-maleic anhydride copolymer)’ or ‘Gum base (including CAS No 9011-16-9)’ | ||
| Chewing gum | 2 % | ||||
| Chia oil from Salvia hispanica | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chia oil (Salvia hispanica)’ | ||
| Fats and oils | 10 % | ||||
| Pure chia oil | 2 g/day | ||||
| Food Supplements as defined in Directive 2002/46/EC | 2 g/day | ||||
| Chia seeds (Salvia hispanica) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chia seeds (Salvia hispanica)’ | ||
| Bread products | 5 % (whole or ground chia seeds) | ||||
| Baked products | 10 % whole chia seeds | ||||
| Breakfast cereals | 10 % whole chia seeds | ||||
| Sterilised ready to eat meals based on cereal grains, pseudocereal grains and/or pulses | 5 % whole chia seeds | ||||
| Fruit, nut and seed mixes | |||||
| Chia seeds as such | |||||
| Confectionery (including chocolate and chocolate products), excluding chewing gums | |||||
| Dairy products (including yoghurt) and analogues | |||||
| Edible ices | |||||
| Fruit and vegetables products (including fruit spreads, compotes with/without cereals, fruit-preparations to underlay or to be mixed with dairy products, fruit desserts, mixed fruits with coconut milk for a twin pot) | |||||
| Non-alcoholic beverages (including fruit juice and fruit/vegetable blend beverages) | |||||
| Puddings that do not require heat treatment at or above 120 °C in their manufacture, processing or preparation | |||||
| Chitin-glucan from Aspergillus niger | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitin-glucan from Aspergillus niger’ | ||
| Food Supplements as defined in Directive 2002/46/EC | 5 g/day | ||||
| Chitin-glucan complex from Fomes fomentarius | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitin-glucan from Fomes fomentarius’ | ||
| Food Supplements as defined in Directive 2002/46/EC | 5 g/day | ||||
| Chitosan extract from fungi (Agaricus bisporus; Aspergillus niger) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitosan extract from Agaricus bisporus’ or ‘Chitosan extract from Aspergillus niger’ | ||
| Food Supplements as defined in Directive 2002/46/EC | In line with normal use in food supplements of chitosan from crustaceans | ||||
| Chondroitin sulphate | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chondroitin sulphate derived from microbial fermentation and sulphation’ | ||
| Food supplements as defined in Directive 2002/46/EC for adult population, excluding pregnant and lactating women | 1200 mg/day | ||||
| Chromium Picolinate | Specified food category | Maximum levels of total chromium | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chromium Picolinate’ | ||
| Foods covered by Regulation (EU) No 609/2013 | 250 μg/day | ||||
| Foods fortified in accordance with Regulation (EC) No 1925/2006note | |||||
| Chromium-containing yeast (Yarrowia lipolytica) biomass | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘chromium-containing yeast (Yarrowia lipolytica) biomass’The labelling of food supplements containing chromium-containing yeast (Yarrowia lipolytica) biomass shall bear a statement that the food supplements should not be consumed by infants and young children (children under 3 years of age)/children from 3 to 9 years of agenote. | ||
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 2 g/day for children from 3 to 9 years of age, resulting in 46 μg of chromium per day4 g/day for children from 10 years of age, adolescents and adults, resulting in 92 μg of chromium per day | ||||
| Cistus incanus L. Pandalis herb | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Cistus incanus L. Pandalis herb’ | ||
| Herbal infusions | Intended daily intake: 3 g herbs/day (2 cups/day) | ||||
| Citicoline | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Citicoline2. The labelling of foods containing citicoline shall bear a statement that the product is not intended to be consumed by children | ||
| Food Supplements as defined in Directive 2002/46/EC | 500 mg/day | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | 250 mg per serving and a maximum daily consumption level of 1000 mg | ||||
| Clostridium butyricum | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Clostridium butyricum MIYAIRI 588 (CBM 588)’ or ‘Clostridium butyricum (CBM 588)’ | ||
| Food Supplements as defined in Directive 2002/46/EC | 1,35 × 108 CFU/day | ||||
| Clostridium butyricum TO-A | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Clostridium butyricum TO-A.2. The labelling of food supplements containing Clostridium butyricum TO-A shall bear a statement that the food supplements should not be consumed by: a)pregnant and lactating womenb)infants and children under 3 years of agec)infants and children under 10 years of aged)infants and children under 14 years of agee)infants, children and adolescents under 18 years of agedepending on the age group the food supplements is intended for. | Authorised on 27 November 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: TOA Biopharma Co. Ltd., 2-1-11, Sasazuka, Shibuya, Tokyo, Japan.During the period of data protection, the novel food Clostridium butyricum TO-A is authorised for placing on the market within the Union only by TOA Biopharma Co. Ltd., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of TOA Biopharma Co. Ltd.End date of the data protection: 27 November 2030 | |
| Food supplements as defined in Directive 2002/46/EC, excluding infants and young children, and pregnant and lactating women | 1,0 × 108 CFU/day for children from 3 to < 10 years2,0 × 108 CFU/day for adolescents from 10 to < 14 years2,8 × 108 CFU/day for adolescents from 14 to < 18 years3,2 × 108 CFU/day for adults, excluding pregnant and lactating women | ||||
| Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner dried cherry pulp and its infusion (Traditional food from a third country) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘coffee cherry pulp’ and/or ‘cascara (coffee cherry pulp)’, and/or ‘coffee cherry pulp infusion’ and/or ‘coffee cherry pulp dried infusion’.If the product containing the novel food contains more than 150 mg/l of caffeine (as such or after reconstitution), it shall be labelled with the following indication: ‘High caffeine content. Not recommended for children or pregnant or breast-feeding women’ in the same field of vision as the name of the food, followed by the caffeine content expressed in mg per 100 ml.Typical infusion preparations are prepared with up to 6 g of coffee cherry pulp per 100 ml of hot water (> 75 °C). For the coffee cherry pulp placed on the market as such for the preparation of infusions, instructions shall be given to the consumer on the preparation. | ||
| Coffee cherry pulp from Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner for the preparation of infusions | |||||
| Coffee, coffee and chicory extracts, instant coffee, tea, herbal- and fruit-infusions, coffee substitutes, coffee mixes and instant mixes for hot beverages (and their flavoured counterparts). | |||||
| Flavoured and unflavoured non-alcoholic ready-to-drink beverages | |||||
| D-ribose | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘D-ribose’.The labelling of foods containing D-ribose shall bear a statement that the foods should not be used if food supplements containing D-ribose are consumed the same day. | Authorised on 16 April 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Bioenergy Life Science, Inc., 13840 Johnson St. NE, Minneapolis, Minnesota, 55304, USA. During the period of data protection, the novel food D-ribose is authorised for placing on the market within the Union only by Bioenergy Life Science, Inc. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Bioenergy Life Science, Inc.End date of the data protection: 16 April 2024 (5 years). | |
| Cereal bars | 0,20 g/100 g | ||||
| Fine bakery wares | 0,31 g/100 g | ||||
| Chocolate confectionery (excluding chocolate bars) | 0,17 g/100 g | ||||
| Milk-based drinks (excluding malts and shakes) | 0,08 g/100 g | ||||
| Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen, isotonic and energy drinks | 0,80 g/100 g | ||||
| Bars intended to meet the expenditure of intense muscular effort especially for sportsmen | 3,3 g/100 g | ||||
| Meal replacement for weight control (as drinks)' | 0,13 g/100 g | ||||
| Meal replacement for weight control (as bars) | 3,30 g/100 g | ||||
| Confectionery | 0,20 g/100 g | ||||
| Tea and infusions (in powder form to be reconstituted) | 0,23 g/100 g | ||||
| Extract of defatted cocoa powder | Specified food category | Maximum levels | Consumers shall be instructed not to consume more than 600 mg polyphenols corresponding to 1,1 g of extract of defatted cocoa powder per day | ||
| Nutrition bars | 1 g/day and 300 mg polyphenols corresponding to not more than 550 mg of extract of defatted cocoa powder in one portion of food (or food supplement) | ||||
| Milk based beverages | |||||
| Any other foods (including food supplements as defined in Directive 2002/46/EC) which have become established vehicles for functional ingredients and which are typically positioned for consumption by health conscious adults | |||||
| Low fat cocoa extract | Specified food category | Maximum levels | Consumers shall be instructed not to consume more than 600 mg of cocoa flavanols per day | ||
| Foods including food supplements as defined in Directive 2002/46/EC | 730 mg per serving and around 1,2 g/day | ||||
| Coriander seed oil from Coriandrum sativum | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Coriander seed oil’ | ||
| Food Supplements as defined in Directive 2002/46/EC | 600 mg/day | ||||
| Cranberry extract powder | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘cranberry extract powder’ | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Ocean Spray Cranberries Inc. One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA.During the period of data protection the novel food, cranberry extract powder, is authorised for placing on the market within the Union only by Ocean Spray Cranberries Inc. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Ocean Spray Cranberries Inc.End date of the data protection: 20 November 2023. | |
| Food Supplements as defined in Directive 2002/46/EC for the adult population | 350 mg/day | ||||
| Crataegus pinnatifida dried fruit | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Crataegus pinnatifida dried fruit’ | ||
| Herbal infusions | In line with normal food use of Crataegus laevigata | ||||
| Jams and jellies in accordance with Directive 2001/113/ECnote | |||||
| Compotes | |||||
| α-cyclodextrin | Not specified | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Alpha-cyclodextrin’ or ‘α-cyclodextrin’ | |||
| γ-cyclodextrin | Not specified | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Gamma-Cyclodextrin’ or ‘γ-Cyclodextrin’ | |||
| Cyperus esculentus (tiger nut) oil | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Cyperus esculentus (tiger nut) oil’. | ||
| Cyperus esculentus (tiger nut) oil as such | |||||
| Pasta-based products | 30 mL/100 g | ||||
| Bread and rolls | 30 mL/100 g | ||||
| Snacks other than chips (crackers) | 30 mL/100 g | ||||
| Salad dressing | 50 mL/100 g | ||||
| Fats as defined in Appendix II of Annex VII of Regulation (EU) No 1308/2013 of the European Parliament and of the Councilnote | 80 mL/100 g | ||||
| Fine bakery wares | 30 mL/100 g | ||||
| Milk-based products (*) | 60 mL/100 g | ||||
| (*)When used in milk-based products Cyperus esculentus (tiger nut) oil may not replace in whole or in part any milk constituent. | |||||
| Decorticated grains of Digitaria exilis (Kippist) Stapf(Traditional food from a third country) | Not specified | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘decorticated fonio (Digitaria exilis) grains’ | |||
| Dextran preparation produced by Leuconostoc mesenteroides | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Dextran’ | ||
| Bakery products | 5 % | ||||
| Diacylglycerol oil of plant origin | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Diacylglycerol oil of plant origin (at least 80 % diacylglycerols)’ | ||
| Cooking oils | |||||
| Fat spreads | |||||
| Salad dressings | |||||
| Mayonnaise | |||||
| Meal replacement for weight control (as drinks) | |||||
| Bakery products | |||||
| Yoghurt type products | |||||
| Dihydrocapsiate (DHC) | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Dihydrocapsiate2. Food supplements containing synthetic dihydrocapsiate will be labelled as not intended for children up to 4.5 years | ||
| Cereal bars | 9 mg/100 g | ||||
| Biscuits, cookies and crackers | 9 mg/100 g | ||||
| Rice based snacks | 12 mg/100 g | ||||
| Carbonated drinks, dilutable drinks, fruit juice based beverages | 1,5 mg/100 ml | ||||
| Vegetable drinks | 2 mg/100 ml | ||||
| Coffee based drinks, tea based drinks | 1,5 mg/100 ml | ||||
| Flavoured water — still | 1 mg/100 ml | ||||
| Precooked oatmeal cereal | 2,5 mg/100 g | ||||
| Other cereals | 4,5 mg/100 g | ||||
| Ice cream, dairy desserts | 4 mg/100 g | ||||
| Pudding mixes (ready to eat) | 2 mg/100 g | ||||
| Products based on yoghurt | 2 mg/100 g | ||||
| Chocolate confectionery | 7,5 mg/100 g | ||||
| Hard candy | 27 mg/100 g | ||||
| Sugar-free gum | 115 mg/100 g | ||||
| Whitener/creamer | 40 mg/100 g | ||||
| Sweeteners | 200 mg/100 g | ||||
| Soup (ready to eat) | 1,1 mg/100 g | ||||
| Salad dressing | 16 mg/100 g | ||||
| Vegetable protein | 5 mg/100 g | ||||
| Ready to eat meals | 3 mg/meal | ||||
| Meal replacements for weight control | 3 mg/meal | ||||
| Meal replacement for weight control (as drinks) | 1 mg/100 ml | ||||
| Food Supplements as defined in Directive 2002/46/EC | 3 mg/single intake9 mg/day | ||||
| Non-alcoholic powdered drink mixes | 14,5 mg/kg equivalent to 1,5 mg/100 ml | ||||
| Roasted seeds of Dipteryx alata Vogel (baru) (traditional food from a third country) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘roasted nuts of Dipteryx alata’ or ‘roasted baru (Dipteryx alata) nuts’ | ||
| Not specified | |||||
| Dried Euglena gracilis | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried biomass of Euglena gracilis algae’.The labelling of food supplements containing dried Euglena gracilis shall bear a statement that those food supplements should not be consumed by infants/children under 3 years of age/children under 10 years of age/children and adolescents under 18 years of agenote. | Authorised on 23 December 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Kemin Foods L.C., 2100 Maury Street Des Moines, IA 50317, USA.During the period of data protection, the novel food is authorised for placing on the market within the Union only by Kemin Foods L.C. unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Kemin Foods L.C.End date of the data protection: 23 December 2025. | |
| Breakfast cereal bars, granola bars and protein bars | 630 mg/100 g | ||||
| Yoghurt | 150 mg/100 g | ||||
| Yoghurt Beverages | 95 mg/100 g | ||||
| Fruit and vegetable juices, nectars, fruit/vegetable blend beverages | 120 mg/100 g | ||||
| Fruit-Flavoured Drinks | 40 mg/100 g | ||||
| Meal replacement beverages | 75 mg/100 g | ||||
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants | 100 mg/day for young children150 mg/day for children from 3 to 9 years of age225 mg/day for children from 10 years of age and adolescents (to 17 years of age)375 mg/day for adults | ||||
| Total diet replacement for weight control as defined by Regulation (EU) No 609/2013 | 190 mg/meal | ||||
| Dried aerial parts of Hoodia parviflora | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried aerial parts of Hoodia parviflora’ | Authorised on 3 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Desert Labs, Ltd Kibbutz Yotvata, 88820 Israel.During the period of data protection the novel food dried aerial parts of Hoodia parviflora is authorised for placing on the market within the Union only by Desert Labs, Ltd unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Desert Labs, Ltd.End date of the data protection: 3 September 2023. | |
| Food Supplements as defined in Directive 2002/46/EC for adult population | 9,4 mg/day | ||||
| Dried extract of Lippia citriodora from cell cultures | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried extract of Lippia citriodora from cell cultures HTN®Vb’ | ||
| Food Supplements as defined in Directive 2002/46/EC | In line with normal use in food supplements of a similar extract from the leaves of Lippia citriodora | ||||
| Echinacea angustifolia extract from cell cultures | Specified food category | Maximum levels | |||
| Food Supplements as defined in Directive 2002/46/EC | In line with normal use in food supplements of a similar extract from the root of Echinacea angustifolia | ||||
| Echinacea purpurea extract from cell cultures | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried extract of Echinacea purpurea from cell cultures EchiPure-PC™’ | ||
| Food Supplements as defined in Directive 2002/46/EC | In line with normal use in food supplements of a similar extract from florets within the flower head of Echinacea purpurea | ||||
| Echium plantagineum oil | Specified food category | Maximum levels of stearidonic acid (STA) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined echium oil’ | ||
| Milk-based products and drinkable yoghurt products delivered in a single dose | 250 mg/100 g; 75 mg/100 g for drinks | ||||
| Cheese preparations | 750 mg/100 g | ||||
| Spreadable fat and dressings | 750 mg/100 g | ||||
| Breakfast cereals | 625 mg/100 g | ||||
| Food supplements as defined in Directive 2002/46/EC | 500 mg/day | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 250 mg/meal | ||||
| Ecklonia cava phlorotannins | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ecklonia cava Phlorotannins’.Food supplements containing Ecklonia cava phlorotannins shall bear the following statement:(a) This food supplement should not be consumed by children/adolescents under the age of twelve/fourteen/eighteen(*) years.(b) This food supplement should not be consumed by persons with thyroid disease or by persons who are aware of or have been identified as being at risk of developing thyroid disease.(c) This food supplement should not be consumed if other food supplements containing iodine are also consumed.(*)Depending on the age group the food supplement is intended for. | ||
| Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 12 years | 163 mg/day for adolescents from 12 to 14 years of age230 mg/day for adolescents above 14 years of age263 mg/day for adults | ||||
| Egg membrane hydrolysate | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘egg membrane hydrolysate’. | Authorised on 25 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Biova, LLC., 5800 Merle Hay Rd, Suite 14 PO Box 394 Johnston 50131, Iowa USA. During the period of data protection the novel food egg membrane hydrolysate is authorised for placing on the market within the Union only by Biova, LLC. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Biova, LLC.End date of the data protection: 25 November 2023 | |
| Food Supplements as defined in Directive 2002/46/EC intended for the general adult population | 450 mg/day | ||||
| Egg membrane hydrolysate (enzymatically produced) | Specified food category | Maximum levels | The designation of the novel food on the labelling of food supplements containing it shall be ‘egg membrane hydrolysate’.The labelling of food supplements containing ‘egg membrane hydrolysate’ shall bear a statement that they should not be consumed by persons under 18 years of age, pregnant and lactating women. | Authorised on 23 July 2026. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Eggnovo SL’, Av. de los Tilos no 5, 31132 Villatuerta, Navarra, Spain.During the period of data protection, the novel food egg membrane hydrolysate (enzymatically produced) is authorised for placing on the market within the Union only by ‘Eggnovo SL’ unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘Eggnovo SL’.End date of the data protection: 23 July 2031. | |
| Food supplements as defined in Directive 2002/46/EC, for the general adult population, excluding pregnant and lactating women. | 500 mg/day | ||||
| Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis) | Specified food category | Maximum levels | The labelling shall bear a statement that consumers should not consume more than 300 mg of extract per day | ||
| Foods including food supplements as defined in Directive 2002/46/EC | 150 mg of extract in one portion of food or food supplement | ||||
| L-ergothioneine | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘L-ergothioneine’ | ||
| Alcohol-free beverages | 0,025 g/kg | ||||
| Milk-based drinks | 0,025 g/kg | ||||
| ‘Fresh’ milk products(*) | 0,040 g/kg | ||||
| Cereal bars | 0,2 g/kg | ||||
| Chocolate confectionery | 0,25 g/kg | ||||
| Food supplements as defined in Directive 2002/46/EC | 30 mg/day for general population (excluding pregnant and lactating women)20 mg/day for children older than 3 years | ||||
| (*)When used in milk products L-ergothioneine may not replace in whole or in part, any milk constituent | |||||
| Inulin-propionate ester | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘inulin-propionate ester’. | Authorised on 30 June 2026. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Imperial College Hammersmith Campus, DuCane Road, London W12 0NN, United Kingdom.During the period of data protection, the novel food inulin-propionate ester is authorised for placing on the market within the Union only by Imperial College Hammersmith Campus, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Imperial College Hammersmith Campus.End date of the data protection: 30 June 2031 | |
| Cereal bars | 17 g/100 g | ||||
| Fruit smoothies | 3 g/100 ml | ||||
| Roasted and popped kernels from the seeds of Euryale ferox Salisb. (makhana) (Traditional food from a third country) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘roasted seeds of Euryale ferox’ or ‘makhana (Euryale ferox) roasted seeds’ | ||
| Processed nuts | |||||
| Extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)’.The labelling of food supplements containing the extract of mixture of the three herbal roots shall bear a statement in close proximity to the list of ingredients indicating that it should not be consumed by individuals with known celery allergy. | ||
| Food supplements as defined in Directive 2002/46/EC for adult population | 175 mg/day | ||||
| Ferric Sodium EDTA | Specified food category | Maximum levels (expressed as anhydrous EDTA) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ferric Sodium EDTA’ | ||
| Food supplements as defined in Directive 2002/46/EC | 18 mg/day for children75 mg/day for adults | ||||
| Foods covered by Regulation (EU) No 609/2013 | 12 mg/100 g | ||||
| Foods fortified in accordance with Regulation (EC) No 1925/2006 | |||||
| Ferrous ammonium phosphate | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ferrous ammonium phosphate’ | ||
| Food supplements as defined in Directive 2002/46/EC | To be used in compliance with Directive 2002/46/EC, Regulation (EU) No 609/2013 and/or Regulation (EC) No 1925/2006 | ||||
| Foods covered by Regulation (EU) No 609/2013 | |||||
| Foods fortified in accordance with Regulation (EC) No 1925/2006 | |||||
| Fish peptides from Sardinops sagax | Specified food category | Maximum levels fish peptide product | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish (Sardinops sagax) peptides’ | ||
| Foods based on yoghurt, yoghurt drinks, fermented milk products, and powdered milk | 0,48 g/100 g (ready to eat/drink) | ||||
| Flavoured water, and vegetable-based drinks | 0,3 g/100 g (ready to drink) | ||||
| Breakfast cereals | 2 g/100 g | ||||
| Soups, stews and soup powders | 0,3 g/100 g (ready to eat) | ||||
| Flavonoids from Glycyrrhiza glabra | Specified food category | Maximum levels of flavonoids from Glycyrrhiza glabra | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Flavonoids from Glycyrrhiza glabra L.2. The labelling of the foods where the product was added as a novel food ingredient shall bear a statement that: (a)the product should not be consumed by pregnant and breast feeding women, children and young adolescents; and(b)people taking prescription drugs should only consume the product under medical supervision;(c)a maximum of 120 mg of flavonoids per day should be consumed.3. The amount of flavonoids in the final food shall be indicated on the labelling of the food containing it. | Beverages containing flavonoids shall be presented to the final consumer as single portions. | |
| Beverages based on milk | 120 mg/day | ||||
| Beverages based on yoghurt | |||||
| Beverages based on fruit or vegetables | |||||
| Food Supplements as defined in Directive 2002/46/EC | 120 mg/day | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 | 120 mg/day | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | 120 mg/day | ||||
| Fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. (Traditional food from a third country) | Not specified | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘cocoa (Theobroma cacao L.) pulp’, ‘cocoa (Theobroma cacao L.) pulp juice’ or ‘cocoa (Theobroma cacao L.) concentrated pulp juice’ depending on the form used. | |||
| Fucoidan extract from the seaweed Fucus vesiculosus | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fucoidan extract from seaweed Fucus vesiculosus’. | ||
| Foods including food supplements as defined in Directive 2002/46/EC for the general population | 250 mg/day | ||||
| Fucoidan extract from the seaweed Undaria pinnatifida | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fucoidan extract from seaweed Undaria pinnatifida’ | ||
| Foods including food supplements as defined in Directive 2002/46/EC for the general population | 250 mg/day | ||||
| 2′-Fucosyllactose | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be 2′-Fucosyllactose.2. The labelling of food supplements containing 2′-Fucosyllactose shall bear a statement that the supplements should not be used if other foods with added 2′-fucosyllactose are consumed the same day.3. The labelling of food supplements containing 2′-Fucosyllactose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added 2′-fucosyllactose are consumed the same day. | ||
| Unflavoured pasteurised and sterilised (including UHT) milk-based products | 1,2 g/l | ||||
| Unflavoured fermented milk-based products | 1,2 g/l for beverages | ||||
| 19,2 g/kg for products other than beverages | |||||
| Flavoured fermented milk-based products including heat-treated products | 1,2 g/l for beverages | ||||
| 19,2 g/kg for products other than beverages | |||||
| Dairy analogues, including beverage whiteners | 1,2 g/l for beverages | ||||
| 12 g/kg for products other than beverages | |||||
| 400 g/kg for whitener | |||||
| Cereal bars | 12 g/kg | ||||
| Table-top sweeteners | 200 g/kg | ||||
| Infant formula as defined in Regulation (EU) No 609/2013 | 3,0 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined in Regulation (EU) No 609/2013 | 3,64 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 | 12 g/kg for products other than beverages | ||||
| 1,2 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer | |||||
| Milk based drinks and similar products intended for young children | 1,2 g/l for milk-based drinks and similar products in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 | 4,8 g/l for drinks | ||||
| 40 g/kg for bars | |||||
| Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No 828/2014 | 60 g/kg | ||||
| Flavoured drinks | 1,2 g/l | ||||
| Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products | 9,6 g/l – the maximum level refers to the products ready to use | ||||
| Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants | 3,0 g/day for general population | ||||
| 1,2 g/day for young children | |||||
| 2'-Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’)(microbial source) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘2'-Fucosyllactose/Difucosyllactose mixture’.The labelling of food supplements containing the 2'-Fucosyllactose/Difucosyllactose mixture shall bear a statement that they should not be used if breast milk or other foods containing added 2'-Fucosyllactose and/or Difucosyllactose are consumed the same day. | Authorised on 19.12.2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 2'-Fucosyllactose/Difucosyllactose mixture is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.End date of the data protection: 19.12.2024. | |
| Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products | 2,0 g/L | ||||
| Unflavoured fermented milk-based products | 2,0 g/L (beverages)20 g/kg (products other than beverages) | ||||
| Flavoured fermented milk-based products including heat-treated products | 2,0 g/L (beverages)20 g/kg (products other than beverages) | ||||
| Beverages (flavoured drinks) | 2,0 g/L | ||||
| Cereal bars | 20 g/kg | ||||
| Infant formula as defined under Regulation (EU) No 609/2013 | 1,6 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 1,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013 | 1,2 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer10 g/kg for products other than beverages | ||||
| Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013 | 4,0 g/L (beverages)40 g/kg (products other than beverages) | ||||
| Food for special medical purposes as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food Supplements as defined in Directive 2002/46/EC intended for the general population excluding infants | 4,0 g/day | ||||
| Milk-based drinks and similar products intended for young children | 1,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| 3-Fucosyllactose (3-FL)(microbial source) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘3-Fucosyllactose’.The labelling of food supplements containing 3-Fucosyllactose (3-FL) shall bear a statement that they should not be consumed:a) if foods containing added 3-Fucosyllactose are consumed on the same day;b) by infants and children under 3 years of age. | Authorised on 12 December 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: DuPont Nutrition & Biosciences ApS Langebrogade 1, 1001 Copenhagen K, Denmark. During the period of data protection, the novel food 3-Fucosyllactose is authorised for placing on the market within the Union only by DuPont Nutrition & Biosciences ApS, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of DuPont Nutrition & Biosciences ApS.End date of the data protection: 12 December 2026. | |
| Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products | 0,85 g/L | ||||
| Unflavoured and flavoured fermented milk-based products including heat-treated products | 0,5 g/L (beverages) | ||||
| 5,0 g/kg (products other than beverages) | |||||
| Dairy analogues | 0,85 g/L (beverages) | ||||
| 8,5 g/kg (products other than beverages) | |||||
| Flavoured drinks, energy and sports drinks | 1,0 g/L | ||||
| Cereal bars | 30,0 g/kg | ||||
| Infant formula as defined under Regulation (EU) No 609/2013 | 0,85 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 0,85 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Milk-based drinks and similar products intended for young children | 0,85 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013 | 0,3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| 3,0 g/kg for products other than beverages | |||||
| Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013 | 2,0 g/L (beverages) | ||||
| 30,0 g/kg (products other than beverages) | |||||
| Foods for special medical purposes as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food Supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 5,0 g/day | ||||
| 3-Fucosyllactose (‘3-FL’) (produced by a derivative strain of E. coli BL21 (DE3)) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘3-fucosyllactose’.The labelling of food supplements containing 3-Fucosyllactose (3-FL) shall bear a statement that(a) they should not be consumed by children under 3 years of age;(b) they should not be used if other foods containing added 3-Fucosyllactose are consumed on the same day. | Authorised on 25 January 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: ‘Chr. Hansen A/S’, Bøge Allé 10-12, 2970 Hørsholm, Denmark. During the period of data protection, the novel food 3-Fucosyllactose is authorised for placing on the market within the Union only by Chr. Hansen A/S unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘Chr. Hansen A/S’. End date of the data protection 25 January 2028. | |
| Infant formula as defined under Regulation (EU) No 609/2013 | 1,75 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 1,75 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No 609/2013 | 1,20 g/l or 1,20 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Milk based drinks and similar products intended for young children | 1,20 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than 1,75 g/l or 1,75 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. | ||||
| Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food Supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children | 4 g/day | ||||
| 3-Fucosyllactose (‘3-FL’) (produced by derivative strain of E. coli K-12 DH1) | Specified food category | Maximum levels (expressed as 3-Fucosyllactose) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘3-Fucosyllactose’.The labelling of food supplements containing 3-Fucosyllactose (3-FL) shall bear a statement that(a) they should not be consumed by children under 3 years of age;(b) they should not be used if other foods containing added 3-Fucosyllactose are consumed on the same day. | Authorised on 12 November 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Glycom A/S’, Kogle Allé 4, 2970 Hørsholm, Denmark. During the period of data protection, the novel food 3-Fucosyllactose produced by derivative strain of E. coli K-12 DH1 is authorised for placing on the market within the Union only by Glycom A/S unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘Glycom A/S’.End date of the data protection: 12 November 2028. | |
| Infant formula as defined under Regulation (EU) No 609/2013 | 1,75 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 1,75 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products | 2,0 g/L | ||||
| Unflavoured fermented milk-based products | 2,0 g/L (beverages) | ||||
| 4,0 g/kg (products other than beverages) | |||||
| Flavoured fermented milk-based products including heat-treated products | 2,0 g/L (beverages) | ||||
| 12,0 g/kg (products other than beverages) | |||||
| Cereal bars | 25,0 g/kg | ||||
| Milk based drinks and similar products | 2,0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| 12,0 g/kg (products other than beverages) | |||||
| Beverages (flavoured drinks, excluding drinks with a pH less than 5) | 1,25 g/L | ||||
| Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013 | 2,0 g/L (beverages) | ||||
| 25,0 g/kg (products other than beverages) | |||||
| Foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended but, in any case, not higher 1,75 g/L or 1,75 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. | ||||
| Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children | In accordance with the particular nutritional requirements of the persons for whom the products are intended but, in any case, not higher 4,0 g/L or 4,0 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. | ||||
| Food Supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children | 4,0 g/day | ||||
| Galacto-oligosaccharide | Specified food category | Maximum levels (expressed as ratio kg galacto-oligosaccharide/kg or L final food unless expressed as maximum per day) | |||
| Food supplements as defined in Directive 2002/46/EC | 0,333 | ||||
| Food supplements as defined in Directive 2002/46/EC, excluding infants and young children | 0,450 (corresponding to 5,4 g galacto-oligosaccharide/serving; maximum 3 servings/day up to a maximum of 16,2 g/day) | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013, excluding infants and young children | In accordance with the particular nutritional requirements of the persons for whom the products are intended but not more than 0,128 (corresponding to a maximum of 8,25 g galacto-oligosaccharide/day) | ||||
| Milk | 0,020 | ||||
| Milk-based drinks | 0,030 | ||||
| Flavoured milk-based drinks | 0,025 | ||||
| Dairy analogue drinks | 0,020 | ||||
| Yoghurt | 0,033 | ||||
| Dairy-based desserts | 0,043 | ||||
| Fruit drinks except products defined in Part I of Annex I to Directive 2001/112/EC | 0,021 | ||||
| Meal replacement for weight control (as drinks) | 0,020 | ||||
| Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 | Juice: 0,025Yogurt drink: 0,024Dessert: 0,027Snack: 0,143Cereals: 0,027 | ||||
| Food intended for infants and young children, food for special medical purposes as defined by Regulation (EU) No 609/2013 | ‘infant meal as drink’ or ‘infant meal’: 0,012 | ||||
| Energy drinks | 0,021 | ||||
| Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen | 0,013 | ||||
| Fruit pie filling | 0,059 | ||||
| Fruit preparations, except products defined in Part I of Annex I to Directive 2001/112/EC and in Part I of Annex I to Directive 2001/113/EC | 0,125 | ||||
| Fruit or vegetable juice concentrate except products defined in Part I of Annex I to Directive 2001/112/EC | 0,02 | ||||
| Processed and breakfast cereals, including cereal bars | 0,125 | ||||
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | 0,008 | ||||
| Cheese and processed cheese | 0,1 | ||||
| Butter and spreadable fats | 0,1 | ||||
| Syrups and powdered drink bases for the preparation of flavoured drinks, and for sweetening purposes | 0,250 | ||||
| Dairy and chocolate confectionery | 0,05 | ||||
| Chocolate-coated confectionery | 0,025 | ||||
| Other confectionery products, including chewing gum but excluding dairy and chocolate confectionery and chocolate-coated confectionery | 0,1 | ||||
| Beverages | Cola-type drinks: 0,018Flavoured drinks: 0,02 | ||||
| Whey based powder | 0,250 | ||||
| Protein products, excluding dairy analogues | 0,125 | ||||
| Coffee-based drinks | 0,018 | ||||
| Powder cocoa beverage preparations | 0,1 | ||||
| Cocoa-based beverages | 0,02 | ||||
| Liquid drink bases, including concentrates and home-made preparations | 0,1 | ||||
| Glucosamine HCl | Specified food category | Maximum levels | |||
| Food Supplements as defined in Directive 2002/46/EC | In line with normal food use of glucosamine from shell fish | ||||
| Foods covered by Regulation (EU) No 609/2013 | |||||
| Meal replacement for weight control | |||||
| Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen | |||||
| Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 | |||||
| Glucosamine sulphate KCl | Specified food category | Maximum levels | |||
| Food Supplements as defined in Directive 2002/46/EC | In line with normal food use of glucosamine from shell fish | ||||
| Glucosamine sulphate NaCl | Specified food category | Maximum levels | |||
| Food Supplements as defined in Directive 2002/46/EC | In line with normal food use of glucosamine from shell fish | ||||
| Glucosyl hesperidin | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Glucosyl hesperidin.2. The labelling of food supplements containing the novel food shall bear a statement that the novel food should not be consumed by infants and young children/children under 10 years of age (*)(*)depending on the age groups the food supplement is intended for. | Authorised on 20 February 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Nagase Viita Co., Ltd, Nihon-Seimei Okayama Bldg., II Shinkan, 1-1-3 Shimoishii, Kita-ku, Okayama, 700-0907, Japan.During the period of data protection, the novel food glucosyl hesperidin is authorised for placing on the market within the Union only by Nagase Viita Co., Ltd, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Nagase Viita Co., Ltd.End date of the data protection: 20 February 2030 | |
| Soft drinks marketed in relation to physical exercise | 525 mg/L | ||||
| Energy drinks | 525 mg/L | ||||
| Food supplements as defined in Directive 2002/46/EC for the general population, excluding infants and young children | 115 mg/day for children between 3 to 10 years of age200 mg/day for general population older than 10 years of age | ||||
| Guar Gum | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Guar Gum.2. A specific mention of the possible risks of digestive discomfort linked to the exposure of children aged under 8 to guar gum must be visible on the label of any foodstuffs containing it. For example, Excessive consumption of these products may cause digestive discomfort, especially for children under 8 years of age.3. In the case of products with two compartments containing dairy and cereal products respectively, the instructions for use must clearly specify the need to mix the cereal and the dairy product before consumption, in order to take into account the potential risk of gastro-intestinal obstruction. | ||
| Fresh dairy products such as yogurts, fermented milks, fresh cheeses and other dairy-based desserts. | 1,5 g/100 g | ||||
| Fruit or vegetable-based liquid foodstuffs (of the ‘smoothie’ variety) | 1,8 g/100 g | ||||
| Fruit or vegetable-based compotes | 3,25 g/100 g | ||||
| Cereals accompanied by a dairy product, in packaging containing two compartments | 10 g/100 g in the cerealsNone in the accompanying dairy product1 g/100 g in the product when ready to eat | ||||
| Heat-treated milk products fermented with Bacteroides xylanisolvens | Specified food category | Maximum levels | |||
| Fermented milk products (in liquid, semi-liquid and spray-dried powder forms) | |||||
| Hydroxytyrosol | Specified food category | Maximum levels | The designation of the novel food on the labelling of the food products containing it shall be ‘hydroxytyrosol’.The labelling of the food products containing hydroxytyrosol shall bear the following statements:(a) This food product should not be consumed by children under the age of three years, pregnant women, and lactating women;(b) This food product should not be used for cooking, baking or frying’ | ||
| Fish and vegetable oils, (except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/2013note), placed as such on the market | 0,215 g/kg | ||||
| Spreadable fats as defined in Part VII of Annex VII of Regulation (EU) No 1308/2013, placed as such on the market | 0,175 g/kg | ||||
| Ice Structuring Protein type III HPLC 12 | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ice Structuring Protein’ | ||
| Edible ices | 0,01 % | ||||
| Aqueous extracts of dried leaves of Ilex guayusa | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Extracts of dried leaves of Ilex guayusa’ | ||
| Herbal infusions | In line with normal use in herbal infusions and food supplements of a similar aqueous extract of dried leaves of Ilex paraguariensis | ||||
| Food Supplements as defined in Directive 2002/46/EC | |||||
| Infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner(Traditional food from a third country) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Infusion from coffee leaves’ or ‘Dried infusion from coffee leaves’, depending on the form to be marketed. | ||
| Infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner placed on the market as such | |||||
| Flavoured and unflavoured non-alcoholic ready-to-drink beveragesnote | |||||
| Coffee, coffee and chicory extracts, instant coffee, tea, herbal- and fruit-infusions, coffee substitutes, coffee mixes and instant mixes for beverages (and their flavoured counterparts)note | |||||
| Iron hydroxide adipate tartrate | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘iron hydroxide adipate tartrate (nano)’.The labelling of food supplements containing iron hydroxide adipate tartrate shall bear a statement that they should not be consumed by children and adolescents under the age of 18/children under 4 years of age (*)(*)Depending on the age group the food supplement is intended for. | Authorised on 28.8.2022. This inclusion is based on proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Nemysis Limited, Suite 4.01 Ormond Building 31-36 Ormond Quay Upper Arran Quay Dublin 7, D07 F6DC, Dublin, Ireland. During the period of data protection, the novel food iron hydroxide adipate tartrate is authorised for placing on the market within the Union only by Nemysis Limited, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Nemysis Limited.End date of the data protection: 28.8.2027. | |
| Food supplements as defined in Directive 2002/46/EC for the adult population | ≤ 100 mg/day (≤ 30 mg Fe/day) | ||||
| Food supplements as defined in Directive 2002/46/EC for children and adolescents under 18 years of age, excluding children under 4 years of age | ≤ 50 mg/day (≤ 14 mg Fe/day) | ||||
| Iron milk caseinate | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘iron milk caseinate’.The labelling of food supplements containing iron milk caseinate shall bear a statement that(a) they should not be consumed by children under 3 years of age;(b) they should not be consumed if other foods containing iron milk caseinate and/or if other foods with added iron are consumed the same day. | Authorised on 4 June 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Société des Produits Nestlé S.A.’, Avenue Nestlé 55, 1800 Vevey, Switzerland. During the period of data protection, the iron milk caseinate is authorised for placing on the market within the Union only by ‘Société des Produits Nestlé S.A.’ unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘Société des Produits Nestlé S.A.’.End date of the data protection: 4 June 2028. | |
| Milk and dairy powder products | 500 mg/100 g (≤ 10 mg Fe/100 g) | ||||
| Soft-drinks marketed in relation to physical exercise | 85 mg/100 g (≤ 1,7 mg Fe/100 g) | ||||
| Powder cocoa beverage preparations | 400 mg/100 g (≤ 8 mg Fe/100 g) | ||||
| Powder or liquid malt-based coffee substitutes | 1050 mg/100 g (≤ 21 mg Fe/100 g) | ||||
| Cereal bars | 350 mg/100 g (≤ 7 mg Fe/100 g) | ||||
| Noodles other than glass noodles | 75 mg/100 g (≤ 1,5 mg Fe/100 g) | ||||
| Stock cubes or granulates (bouillon base) | 4750 mg/100 g (≤ 95 mg Fe/100 g) | ||||
| Single meal replacements for weight control | 120 mg/100 g (≤ 2,4 mg Fe/100 g) | ||||
| Total diet replacement for weight control as defined under Regulation (EU) No 609/2013 | 235 mg/meal (≤ 4,7 mg Fe/meal) or 700 mg/day (≤ 14,0 mg/Fe/day) | ||||
| Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food supplements as defined in Directive 2002/46/EC, for the adult population | 700 mg/day (≤ 14 mg Fe/day) | ||||
| Food supplements as defined in Directive 2002/46/EC, for children and adolescents under 18 years of age, excluding infants and young children | 350 mg/day (≤ 7 mg Fe/day) | ||||
| Isomalto-oligosaccharide | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Isomaltooligosaccharide.2. Foods containing the novel ingredient must be labelled as a source of glucose. | ||
| Energy-Reduced Soft Drinks | 6,5 % | ||||
| Energy Drinks | 5,0 % | ||||
| Foods intended to meet the expenditure of intense muscular efforts, especially for sportsmen (including isotonic drinks) | 6,5 % | ||||
| Fruit Juices | 5 % | ||||
| Processed Vegetables and Vegetable Juices | 5 % | ||||
| Other Soft Drinks | 5 % | ||||
| Cereals Bars | 10 % | ||||
| Cookies, Biscuits | 20 % | ||||
| Breakfast Cereal Bars | 25 % | ||||
| Hard Candies | 97 % | ||||
| Soft Candies/Chocolate Bars | 25 % | ||||
| Meal replacement for weight control (as bars or milk based) | 20 % | ||||
| Isomalto-oligosaccharide | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be isomalto-oligosaccharide.2. The designation of the novel food on the labelling shall be accompanied by indication that the isomalto-oligosaccharide is a source of glucose.3. The labelling of food supplements containing isomalto-oligosaccharide shall bear a statement that they should not be consumed by children under 10 years of age. | Authorised on 11 February 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: BioNeutra North America Inc., 9608 25 Avenue NW, Edmonton, Alberta T6N 1J4, Canada. During the period of data protection, the novel food isomalto-oligosaccharide is authorised for placing on the market within the Union only by BioNeutra North America Inc., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of BioNeutra North America Inc.End date of the data protection: 11 February 2030. | |
| Ice cream, dairy desserts | 8 % | ||||
| Instant coffee and tea | 10 % | ||||
| Table-top sweeteners | 100 % | ||||
| Cakes, muffins and pies | 20 % | ||||
| Pastries | 15 % | ||||
| Breakfast cereals | 10 % | ||||
| Savoury sauces, gravies and condiments | 10 % | ||||
| Gelatines and puddings | 15 % | ||||
| Fruit pie fillings | 15 % | ||||
| Fruit spreads (except products defined in Part I of Annex I to Directive 2001/113/EC) | 50 % | ||||
| Yoghurts | 2,5 % | ||||
| Milk-based drinks | 5 % | ||||
| Cereal-, fruit- or vegetable-based snacks | 5 % | ||||
| Sweet sauces, toppings and syrups | 50 % | ||||
| Food supplements as defined in Directive 2002/46/EC, for the general population, excluding children, under the age of 10 years | 10 g/day | ||||
| Isomaltulose | Not specified | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Isomaltulose.2. The designation of the novel food on the labelling shall be accompanied by indication that the Isomaltulose is a source of glucose and fructose. | |||
| Isomaltulose powder | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be isomaltulose powder.2. The designation of the novel food on the labelling shall be accompanied by indication that the Isomaltulose is a source of glucose and fructose. | ||
| All foods, excluding foods and drinks intended specifically for infants and young children | |||||
| Jatropha curcas L. (edible variety) kernels | Specified food category | Maximum levels (g/100 g) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘kernels from edible Jatropha curcas L.’ | Authorised on 12 July 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘JatroSolutions GmbH’, Echterdinger Strasse 30, 70599 Stuttgart, Germany.During the period of data protection, the novel food kernels from the edible variety of Jatropha curcas L. is authorised for placing on the market within the Union only by ‘JatroSolutions GmbH’, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘JatroSolutions GmbH’.End date of the data protection: 12 July 2027. | |
| Kernels as such, or processed whole kernels to be consumed as snack (e.g. roasted, candied, salted or similar), including mixes with other nuts, seeds, and/or dried fruits | |||||
| Cereal bars | 5 | ||||
| Breakfast cereals | 5 | ||||
| Dried fruits | 5 | ||||
| Cereal bars | 30 | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘kernels from edible Jatropha curcas L.’ | Authorised on 14 July 2026. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Chuta Nut GmbH, Hans-Lorenser-Str. 20, 89079 Ulm, Germany.During the period of data protection, the novel food Jatropha curcas L. (edible variety) kernels, under the extended conditions of use, is authorised for placing on the market within the Union only by Chuta Nut GmbH, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Chuta Nut GmbH.End date of the data protection: 14 July 2031. | ||
| Breakfast cereals | 30 | ||||
| Dried fruits | 30 | ||||
| Nuts/seeds paste/emulsion | |||||
| Dried nuts/seeds flour/powder | |||||
| Lactitol | Specified food category | Maximum levels | The designation of the novel food on the labelling of the food supplements containing it shall be ‘Lactitol’ | ||
| Food supplements as defined in Directive 2002/46/EC intended for the adult population | 20 g/day | ||||
| Lacto-N-fucopentaose I and 2'-Fucosyllactose (‘LNFP-I and 2'-FL’) mixture (produced using a derivative strain of E. coli K-12 DH1) | Specified food category | Maximum levels(expressed as Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture’.The labelling of food supplements containing Lacto-N-fucopentaose I and 2'-Fucosyllactose (‘LNFP-I and 2'-FL’) mixture produced by a derivative strain of E. coli K-12 DH1 shall bear a statement that:(a) they should not be consumed by children under 3 years of age;(b) they should not be used, if other foods containing added Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture and/or foods containing added 2'-Fucosyllactose are consumed on the same day. | Authorised on 19.8.2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Glycom A/S’, Kogle Allé 4, 2970 Hørsholm, Denmark. During the period of data protection, the novel food Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture produced using a derivative strain of E. coli K-12 DH1 is authorised for placing on the market within the Union only by Glycom A/S unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘Glycom A/S’.End date of the data protection: 19.8.2029. | |
| Infant formula as defined under Regulation (EU) No 609/2013 | 2,0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 2,0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products | 1,5 g/L | ||||
| Unflavoured fermented milk-based products | 1,5 g/L (beverages) | ||||
| 3,0 g/kg (products other than beverages) | |||||
| Flavoured fermented milk-based products including heat-treated products | 1,5 g/L (beverages) | ||||
| 15,0 g/kg (products other than beverages) | |||||
| Milk based drinks and similar products | 1,5 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Food for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended but in any case not higher than the maximum levels specified for the proposed food categories or higher than 2,0 g/L or 2,0 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Food for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children | In accordance with the particular nutritional requirements of the persons for whom the products are intended but in any case not higher than the maximum levels specified for the proposed food categories or higher than 4,5 g/day in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013 | 3,0 g/L (beverages) | ||||
| 4,5 g/kg (products other than beverages) | |||||
| Beverages (flavoured drinks, excluding drinks with a pH less than 5) | 1,5 g/kg | ||||
| Cereal bars | 15,0 g/kg | ||||
| Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 | 1,5 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| 9,1 g/kg for products other than beverages | |||||
| Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children | 4,5 g/day | ||||
| Lacto-N-neotetraose | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be lacto-N-neotetraose.2. The labelling of food supplements containing lacto-N-neotetraose shall bear a statement that the supplements should not be used if other foods with added lacto-N-neotetraose are consumed the same day.3. The labelling of food supplements containing lacto-N-neotetraose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added lacto-N-neotetraose are consumed the same day. | ||
| Unflavoured pasteurised and sterilised (including UHT) milk-based products | 0,6 g/l | ||||
| Unflavoured fermented milk-based products | 0,6 g/l for beverages | ||||
| 9,6 g/kg for products other than beverages | |||||
| Flavoured fermented milk-based products including heat-treated products | 0,6 g/l for beverages | ||||
| 9,6 g/kg for products other than beverages | |||||
| Dairy analogues, including beverage whiteners | 0,6 g/l for beverages | ||||
| 6 g/kg for products other than beverages | |||||
| 200 g/kg for whitener | |||||
| Cereal bars | 6 g/kg | ||||
| Table-top sweeteners | 100 g/kg | ||||
| Infant formula as defined under Regulation (EU) No 609/2013 | 0,6 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 0,6 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based foods and baby foods for infants and young children as defined under Regulation (EU) No 609/2013 | 6 g/kg for products other than beverages | ||||
| 0,6 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer | |||||
| Milk based drinks and similar products intended for young children | 0,6 g/l for milk-based drinks and similar products in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Foods for special medical purposes as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 | 2,4 g/l for drinks | ||||
| 20 g/kg for bars | |||||
| Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 | 30 g/kg | ||||
| Flavoured drinks | 0,6 g/l | ||||
| Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products | 4,8 g/l – the maximum level refers to the products ready to use | ||||
| Food Supplements as defined in Directive 2002/46/EC, for the general population, excluding infants | 1,5 g/day for general population0,6 g/day for young children | ||||
| Lacto-N-tetraose (‘LNT’)(microbial source) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘lacto-N-tetraose’.The labelling of food supplements containing lacto-N-tetraose shall bear a statement that they should not be used if breast milk or other foods containing added lacto-N-tetraose are consumed the same day. | Authorised on 23.4.2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food lacto-N-tetraose is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.End date of the data protection: 23.4.2025. | |
| Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products | 1,0 g/l | ||||
| Unflavoured fermented milk-based products | 1,0 g/l (beverages)10 g/kg (products other than beverages) | ||||
| Flavoured fermented milk-based products including heat-treated products | 1,0 g/l (beverages)10 g/kg (products other than beverages) | ||||
| Beverages (flavoured drinks) | 1,0 g/l | ||||
| Cereal bars | 10 g/kg | ||||
| Infant formula as defined under Regulation (EU) No 609/2013 | 0,8 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 0,6 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based food, baby food for infants and young children as defined under Regulation (EU) No 609/2013 | 0,6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer5 g/kg for products other than beverages | ||||
| Milk based drinks and similar products intended for young children | 0,6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer5 g/kg for products other than beverages | ||||
| Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013 | 2,0 g/l (beverages)20 g/kg (products other than beverages) | ||||
| Food for special medical purposes as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food Supplements as defined in Directive 2002/46/EC, excluding infants | 2,0 g/day for young children, children, adolescents, and adults | ||||
| Lacto-N-tetraose (‘LNT’)(produced by derivative strains of E. coli BL21(DE3)) | Specified food category | Maximum levels (expressed as lacto-N-tetraose) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘lacto-N-tetraose’.The labelling of food supplements containing lacto-N-tetraose (LNT) shall bear a statement that(a) they should not be consumed by children under 3 years of age;(b) they should not be used if other foods containing added lacto-N-tetraose are consumed the same day. | Authorised on 24.1.2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Chr. Hansen A/S’, Boege Allé 10-12, 2970 Hoersholm, Denmark. During the period of data protection, the novel food Lacto-N-tetraose is authorised for placing on the market within the Union only by ‘Chr. Hansen A/S’ unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘Chr. Hansen A/S’.End date of the data protection: 24.1.2028. | |
| Infant formula as defined under Regulation (EU) No 609/2013 | 1,82 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 1,82 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based foods and baby foods for infants and young children as defined under Regulation (EU) No 609/2013 | 1,82 g/L or 1,82 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Milk based drinks and similar products intended for young children | 1,82 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than 1,82 g/L or 1,82 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. | ||||
| Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children | 4,6 g/day | ||||
| Lacto-N-tetraose (‘LNT’)(produced by a derivative strain of Escherichia coli K-12 MG1655) | Specified food category | Maximum levels (expressed as lacto-N-tetraose) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘lacto-N-tetraose’.The labelling of food supplements containing lacto-N-tetraose (LNT) shall bear a statement that(a) they should not be consumed by children under 3 years of age;(b) they should not be used if other foods containing added lacto-N-tetraose are consumed the same day. | Authorised on 16 March 2026. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Inbiose N.V.’, Technologiepark 82, bus 41, 9052 Zwijnaarde, Belgium. During the period of data protection, the novel food Lacto-N-tetraose is authorised for placing on the market within the Union only by ‘Inbiose N.V.’ unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘Inbiose N.V.’.End date of the data protection: 16 March 2031. | |
| Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products | 1,0 g/L | ||||
| Unflavoured fermented milk-based products | 1,0 g/L (beverages)10 g/kg (products other than beverages) | ||||
| Flavoured fermented milk-based products including heat-treated products | 1,0 g/L (beverages)10 g/kg (products other than beverages) | ||||
| Beverages (flavoured drinks) | 1,0 g/L | ||||
| Cereal bars | 10 g/kg | ||||
| Infant formula as defined under Regulation (EU) No 609/2013 | 0,8 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 0,6 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based foods and baby foods for infants and young children as defined under Regulation (EU) No 609/2013 | 0,6 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer5 g/kg for products other than beverages | ||||
| Milk based drinks and similar products | 0,6 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer5 g/kg for products other than beverages | ||||
| Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013 | 2,0 g/L (beverages)20 g/kg (products other than beverages) | ||||
| Foods for special medical purposes as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children | 2,0 g/day for the general population above 3 years | ||||
| Lonicera caerulea L. berries (haskap)(Traditional food from a third country) | Not specified | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘haskap (Lonicera caerulea) berries’ | |||
| Lucerne leaf extract from Medicago sativa | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lucerne (Medicago sativa) protein’ or ‘Alfalfa (Medicago sativa) protein’. | ||
| Food supplements as defined in Directive 2002/46/EC | 10 g/day | ||||
| Lycopene | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’ | ||
| Fruit/vegetable juice-based drinks (including concentrates) | 2,5 mg/100 g | ||||
| Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen | 2,5 mg/100 g | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 8 mg/meal | ||||
| Breakfast cereals | 5 mg/100 g | ||||
| Fats and dressings | 10 mg/100 g | ||||
| Soups other than tomato soups | 1 mg/100 g | ||||
| Bread (including crispy breads) | 3 mg/100 g | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food supplements as defined in Directive 2002/46/EC | 15 mg/day | ||||
| Lycopene from Blakeslea trispora | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’ | ||
| Fruit/vegetable juice-based drinks (including concentrates) | 2,5 mg/100 g | ||||
| Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen | 2,5 mg/100 g | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 8 mg/meal | ||||
| Breakfast cereals | 5 mg/100 g | ||||
| Fats and dressings | 10 mg/100 g | ||||
| Soups other than tomato soups | 1 mg/100 g | ||||
| Bread (including crispy breads) | 3 mg/100 g | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food supplements as defined in Directive 2002/46/EC | 15 mg/day | ||||
| Lycopene from tomatoes | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’ | ||
| Fruit/vegetable juice-based drinks (including concentrates) | 2,5 mg/100 g | ||||
| Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen | 2,5 mg/100 g | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 8 mg/meal | ||||
| Breakfast cereals | 5 mg/100 g | ||||
| Fats and dressings | 10 mg/100 g | ||||
| Soups other than tomato soups | 1 mg/100 g | ||||
| Bread (including crispy breads) | 3 mg/100 g | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food supplements as defined in Directive 2002/46/EC | 15 mg/day | ||||
| Lycopene oleoresin from tomatoes | Specified food category | Maximum levels of lycopene | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene oleoresin from tomatoes’ | ||
| Fruit/vegetable juice-based drinks (including concentrates) | 2,5 mg/100 g | ||||
| Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen | 2,5 mg/100 g | ||||
| Total diet replacement for weight control covered by Regulation (EU) No 609/2013 and meal replacements for weight control | 8 mg/meal | ||||
| Breakfast cereals | 5 mg/100 g | ||||
| Fats and dressings | 10 mg/100 g | ||||
| Soups other than tomato soups | 1 mg/100 g | ||||
| Bread (including crispy breads) | 3 mg/100 g | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Yellow tomato extract | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be yellow tomato extract.2. The labelling of food supplements containing yellow tomato extract shall bear a statement that the food supplements should be consumed by adults only. | Authorised on 30 November 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Lycored Ltd, P.O Box 320, Beer Sheva 8410202, Israel.During the period of data protection, the novel food yellow tomato extract is authorised for placing on the market within the Union only by Lycored Ltd, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Lycored Ltd.End date of the date protection: 30 November 2030 | |
| Food supplements as defined in Directive 2002/46/EC for the adult population | 100 mg/day | ||||
| Hen egg white lysozyme hydrolysate | Specified food category | Maximum levels | The designation of the novel food on the labelling of food supplements containing it shall be ‘Hen egg white lysozyme hydrolysate’. | ||
| Food supplements as defined in Directive 2002/46/EC intended for adult population | 1000 mg/day | ||||
| Magnesium citrate malate | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Magnesium citrate malate’ | ||
| Food Supplements as defined in Directive 2002/46/EC | |||||
| Magnesium L-threonate | Specified food category | Maximum levels of Mg | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Magnesium L-threonate.2. The labelling of food supplements containing magnesium L-threonate shall bear a statement that the food supplements should be consumed by adults only, excluding pregnant and lactating women. | Authorised on 7 November 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: AIDP Inc., 19535 East Walnut Drive South City of Industry, CA 91748, the United States. During the period of data protection, the novel food magnesium L-threonate is authorised for placing on the market within the Union only by AIDP Inc., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of AIDP Inc.End date of the date protection: 7 November 2029 | |
| Food supplements as defined in Directive 2002/46/EC for adults, excluding pregnant and lactating women | 250 mg/day | ||||
| Magnolia Bark Extract | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Magnolia Bark Extract’ | ||
| Mints (confectionary products) | 0,2 % for breath freshening purposes. Based on a 0,2 % maximum incorporation level and a maximum gum/mint size of 1,5 g each, each gum or mint serving will contain no more than 3 mg of magnolia bark extract. | ||||
| Chewing gum | |||||
| Maize-germ oil high in unsaponifiable matter | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Maize-germ oil extract’ | ||
| Food Supplements as defined in Directive 2002/46/EC | 2 g/day | ||||
| Chewing gum | 2 % | ||||
| Methylcellulose | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Methylcellulose’ | Methylcellulose is not to be used in foods specially prepared for young children | |
| Edible ices | 2 % | ||||
| Flavoured drinks | |||||
| Flavoured or unflavoured fermented milk products | |||||
| Cold desserts (dairy, fat, fruit, cereal, egg-based products) | |||||
| Fruit preparations (pulps, purees or compotes) | |||||
| Soups and broths | |||||
| 1-Methylnicotinamide chloride | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘1- Methylnicotinamide chloride’.Food supplements containing 1-Methylnicotinamide shall bear the following statement:This food supplement should be consumed by adults only excluding pregnant and lactating women | Authorised on 2 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Pharmena SA, Wolczanska 178, 90 530 Lodz, Poland. During the period of data protection the novel food 1-methylnicotinamide chloride is authorised for placing on the market within the Union only by Pharmena S.A. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Pharmena S.A.End date of the data protection: 2 September 2023 | |
| Food Supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women | 58 mg/day | ||||
| (6S)-5-methyltetrahydrofolic acid, glucosamine salt | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘(6S)-5-methyltetrahydrofolic acid, glucosamine salt’ or ‘5MTHF-glucosamine’ | ||
| Food Supplements as defined in Directive 2002/46/EC as a source of folate | |||||
| Monomethylsilanetriol (Organic Silicon) | Specified food category | Maximum levels of silicon | The designation of the novel food on the labelling of the food supplements containing it shall be ‘Organic silicon (monomethylsilanetriol)’ | ||
| Food Supplements as defined in Directive 2002/46/EC for adult population (in liquid form) | 10,40 mg/day | ||||
| Monosodium salt of L-5-methyltetrahydrofolic acid | Specified food category | Maximum levels(expressed as folic acid) | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Monosodium salt of L-5-methyltetrahydrofolic acid (folic acid).2. The labelling of food supplements containing monosodium salt of L-5-methyltetrahydrofolic acid shall bear a statement that the food supplements should not be consumed by infants and young children (children under 3 years of age) | Authorised on 30 April 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Merck & Cie KmG, Im Laternenacker 5, 8200 Schaffhausen, Switzerland. During the period of data protection, the novel food monosodium salt of L-5-methyltetrahydrofolic acid is authorised for placing on the market within the Union only by Merck & Cie KmG, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Merck & Cie KmG.End date of the date protection: 30 April 2029. | |
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | In accordance with Directive 2002/46/EC | ||||
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Food fortified in accordance with Regulation (EC) No 1925/2006 | In accordance with Regulation (EC) No 1925/2006 | ||||
| Mung bean (Vigna radiata) protein | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘mung bean protein from Vigna radiata’. | Authorised on 15 May 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Eat Just, Inc., 2000 Folsom Street San Francisco, CA 94110 USA. During the period of data protection, the novel mung bean protein is authorised for placing on the market within the Union only by Eat Just, Inc., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Eat Just, Inc.End date of the date protection: 15 May 2027. | |
| Protein products | 20 g/100 g | ||||
| Mycelial extract from Shiitake mushroom (Lentinula edodes) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘extract from the mushroom Lentinula edodes’ or ‘extract from Shiitake mushroom’ | ||
| Bread products | 2 ml/100 g | ||||
| Soft drinks | 0,5 ml/100 ml | ||||
| Ready prepared meals | 2,5 ml per meal | ||||
| Foods based on yoghurt | 1,5 ml/100 ml | ||||
| Food supplements as defined in Directive 2002/46/EC | 2,5 ml per day dose | ||||
| Nicotinamide riboside chloride | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘nicotinamide riboside chloride’. | Authorised on 20 February 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ChromaDex Inc., 10900 Wilshire Boulevard Suite 600, Los Angeles, CA 90024 USA. During the period of data protection, the novel food is authorised for placing on the market within the Union only by ChromaDex Inc. unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ChromaDex Inc.End date of the data protection: 20 February 2025. | |
| Food supplements as defined in Directive 2002/46/EC | 300 mg/day for the adult population, excluding pregnant and lactating women230 mg/day for pregnant and lactating women | ||||
| Foods for special medical purposes as defined by Regulation (EU) No 609/2013 for the adult population, excluding pregnant and lactating women | In accordance with the particular nutritional requirements of the persons for whom the products are intended | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be nicotinamide riboside chloride2. The labelling of foodstuffs containing the novel food shall bear a statement that those foods should only be consumed by persons above 18 years of age excluding pregnant and lactating women. | |||
| Total diet replacement for weight control as defined by Regulation (EU) No 609/2013 for the adult population, excluding pregnant and lactating women | 500 mg/day | ||||
| Meal replacements for the adult population, excluding pregnant and lactating women | 150 mg/meal (maximum 2 meals/day up to a maximum of 300 mg/day) | ||||
| Noni fruit juice (Morinda citrifolia) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Noni juice’ or ‘Juice of Morinda citrifolia’ | ||
| Pasteurised fruit and fruit nectar based drinks | 30 ml with one serving (up to 100 % noni juice)or20 ml twice a day, not more than 40 ml per day | ||||
| Noni fruit juice powder (Morinda citrifolia) | Food supplements as defined in Directive 2002/46/EC | 6,6 g/day (equivalent to 30 ml of noni juice) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Noni juice powder’ or ‘Juice powder of Morinda citrifolia’ | ||
| Noni fruit puree and concentrate (Morinda citrifolia) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be:For fruit puree:‘Morinda citrifolia fruit puree’ or ‘Noni fruit puree’For fruit concentrate:‘Morinda citrifolia fruit concentrate’ or ‘Noni fruit concentrate’ | ||
| Fruit puree | |||||
| Candy/confectionery | 45 g/100 g | ||||
| Cereal bars | 53 g/100 g | ||||
| Powdered nutritional drink mixes (dry weight) | 53 g/100 g | ||||
| Carbonated beverages | 11 g/100 g | ||||
| Ice cream & sorbet | 31 g/100 g | ||||
| Yoghurt | 12 g/100 g | ||||
| Biscuits | 53 g/100 g | ||||
| Buns, cakes and pastries | 53 g/100 g | ||||
| Breakfast cereals (wholegrain) | 88 g/100 g | ||||
| Jams and jellies in accordance with Directive 2001/113/EC | 133 g/100 gBased on pre-processing quantity to produce final 100 g product | ||||
| Sweet spreads, fillings and icings | 31 g/100 g | ||||
| Savoury sauces, pickles, gravies and condiments | 88 g/100 g | ||||
| Food Supplements as defined in Directive 2002/46/EC | 26 g/day | ||||
| Fruit concentrate | |||||
| Candy/Confectionery | 10 g/100 g | ||||
| Cereal bars | 12 g/100 g | ||||
| Powdered nutritional drink mixes (dry weight) | 12 g/100 g | ||||
| Carbonated beverages | 3 g/100 g | ||||
| Ice cream & sorbet | 7 g/100 g | ||||
| Yoghurt | 3 g/100 g | ||||
| Biscuits | 12 g/100 g | ||||
| Buns, cakes and pastries | 12 g/100 g | ||||
| Breakfast cereals (wholegrain) | 20 g/100 g | ||||
| Jams and jellies in accordance with Directive 2001/113/EC | 30 g/100 g | ||||
| Sweet spreads, fillings and icings | 7 g/100 g | ||||
| Savoury sauces, pickles, gravies and condiments | 20 g/100 g | ||||
| Food Supplements as defined in Directive 2002/46/EC | 6 g/day | ||||
| Noni leaves (Morinda citrifolia) | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Noni leaves or leaves of Morinda citrifolia.2. Instructions shall be given to the consumer that a cup of infusion should not be prepared with more than 1 g of dried and roasted leaves of Morinda citrifolia. | ||
| For the preparation of infusions | A cup of infusion to be consumed shall not be prepared with more than 1 g of dried and roasted leaves of Morinda citrifolia | ||||
| Noni fruit powder (Morinda citrifolia) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Morinda citrifolia fruit powder’ or ‘Noni fruit powder’ | ||
| Food Supplements as defined in Directive 2002/46/EC | 2,4 g per/day | ||||
| Odontella aurita microalgae | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Odontella aurita microalgae’ | ||
| Flavoured pasta | 1,5 % | ||||
| Fish soups | 1 % | ||||
| Marine terrines | 0,5 % | ||||
| Broth preparations | 1 % | ||||
| Crackers | 1,5 % | ||||
| Frozen breaded fish | 1,5 % | ||||
| Oil enriched with phytosterols/phytostanols | Specified food category | Maximum levels of phytosterols/ phytostanols | In accordance with Annex III.5 to Regulation (EU) No 1169/2011 | ||
| Spreadable fats as defined in Annex VII, Part VII and Appendix II, points B and C of Regulation (EU) No 1308/2013, and excluding cooking and frying fats and spreads based on butter or other animal fat | 1. The products containing the novel food ingredient shall be presented in such a manner that they can be easily divided into portions that contain either a maximum of 3 g (in case of one portion per day) or a maximum of 1 g (in case of three portions per day) of added phytosterols/phytostanols.2. The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.3. Salad dressings, mayonnaise and spicy sauces shall be packed as single portions. | ||||
| Milk based products, such as products based on semi-skimmed and skimmed milk products, possibly with the addition of fruits and/or cereals, products based on fermented milk such as yoghurt and cheese based products (fat content ≤ 12 g per 100 g), where possibly the milk fat has been reduced and the fat or protein has been partly or fully replaced by vegetable fat or protein | |||||
| Soya drinks | |||||
| Salad dressings, mayonnaise and spicy sauces | |||||
| Oil extracted from squids | Specified food category | Maximum levels of DHA and EPA combined | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’. | ||
| Dairy products except milk-based beverages | 200 mg/100 g or for cheese products 600 mg/100 g | ||||
| Dairy analogues except drinks | 200 mg/100 g or for analogues to cheese products 600 mg/100 g | ||||
| Spreadable fat and dressings | 600 mg/100 g | ||||
| Breakfast cereals | 500 mg/100 g | ||||
| Bakery products (breads and bread rolls) | 200 mg/100 g | ||||
| Cereal bars | 500 mg/100 g | ||||
| Non-alcoholic beverages (including milk-based beverages) | 60 mg/100 ml | ||||
| Food Supplements as defined in Directive 2002/46/EC | 3000 mg/day for general population450 mg/day for pregnant and lactating women | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products intended | ||||
| Total diet replacement for weight control defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 200 mg/meal | ||||
| Extract from Panax notoginseng and Astragalus membranaceus | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Extract from Panax notoginseng and Astragalus membranaceus’The labelling of food supplements containing extract from Panax notoginseng and Astragalus membranaceus shall bear a statement that those food supplements should not be consumed by the population under 18 years of age and by pregnant women. | Authorised on 23 December 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: NuLiv Science, 1050 W. Central Ave., Building C, Brea, CA 92821, USA.During the period of data protection, the novel food is authorised for placing on the market within the Union only by NuLiv Science, unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of NuLiv Science.End date of the data protection: 23 December 2025. | |
| Food supplements as defined in Directive 2002/46/EC for the general adult population, excluding food supplements for pregnant women | 35 mg/day | ||||
| Partially defatted chia seed (Salvia hispanica L.) powders | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Partially defatted chia seed (Salvia hispanica) powder’ | ||
| Powder with high protein content | |||||
| Unflavoured fermented milk products, including natural unflavoured buttermilk (excluding sterilised buttermilk) non-heat-treated after fermentation | 0,7 % | ||||
| Unflavoured fermented milk products, heat-treated after fermentation | 0,7 % | ||||
| Flavoured fermented milk products including heat-treated products | 0,7 % | ||||
| Confectionery | 10 % | ||||
| Fruit juices as defined by Council Directive 2001/112/ECnote and vegetable juices | 2,5 % | ||||
| Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products | 2,5 % | ||||
| Flavoured drinks | 3 % | ||||
| Food supplements as defined in Directive 2002/46/EC excluding food supplements for infants and young children | 7,5 g/day | ||||
| Powder with high fibre content | Authorised for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products on 13 November 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Functional Products Trading Arica S.A./BENEXIA, Luis Pasteur 5850, Oficina 403, Quinto Piso. Vitacura, Santiago – Chile. During the period of data protection, partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products is authorised for placing on the market within the Union only by Functional Products Trading Arica S.A./BENEXIA, unless a subsequent applicant obtains authorisation for the same novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Functional Products Trading Arica S.A./BENEXIA.End date of the data protection: 13 November 2028. | ||||
| Confectionery | 4 % | ||||
| Fruit juices as defined by Directive 2001/112/EC and vegetable juices | 2,5 % | ||||
| Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products | 4 % | ||||
| Flavoured drinks | 4 % | ||||
| Food supplements as defined in Directive 2002/46/EC excluding food supplements for infants and young children | 12 g/day | ||||
| Cakes and pastries | 5 g/100 g | ||||
| Processed fruit and vegetables (including vegetable-based dishes) | 10 g/100 g | ||||
| Bread and rolls | 10 g/100 g | ||||
| Pasta based products | 8 g/100 g | ||||
| Protein products | 10 g/100 g | ||||
| Defatted rapeseed powder | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘defatted rapeseed powder’.The labelling of food supplements containing defatted rapeseed powder shall bear a statement(a) that they should not be used if other foods containing added defatted rapeseed powder are consumed the same day; and(b) they should not be consumed by infants and children under 10 years of age.Any foodstuff containing ‘defatted rapeseed powder’ from Brassica rapa L. and Brassica napus L.” shall bear a statement that this ingredient may cause allergic reaction to consumers who are allergic to mustard and products thereof. That statement shall appear in close proximity to the list of ingredients. | Authorised on 15 March 2026. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘NapiFeryn BioTech Sp. z o.o.’, Stanisława Dubois 114/116, 93-465 Łódź, Poland. During the period of data protection, the novel food defatted rapeseed powder is authorised for placing on the market within the Union only by ‘NapiFeryn BioTech Sp. z o.o.’ unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘NapiFeryn BioTech Sp. z o.o.’.End date of the data protection: 15 March 2031. | |
| Bakery products (bread and rolls, fine bakery wares) | 20 g/100g | ||||
| Bread bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No 828/2014 | 20 g/100g | ||||
| Breakfast cereals | 20 g/100g | ||||
| Cereal bars | 20 g/100g | ||||
| Pasta | 10 g/100g | ||||
| Pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No 828/2014 | 10 g/100g | ||||
| Non-alcoholic powdered drinks | 5 g/100 ml (reconstituted according to the instructions) | ||||
| Fruit-based liquid foodstuffs (of the ‘smoothie’ variety) | 3 g/100 g | ||||
| Dairy analogues | 5 g/100 g | ||||
| Meat analogues | 15 g/100 g | ||||
| Soups (dry mixture) and (ready-to-eat) | 5 g/100 ml (marketed as such or reconstituted according to the instructions) | ||||
| Savoury sauces | 5 g/100 g | ||||
| Salad dressing | 5 g/100 g | ||||
| Vegetable puree | 7 g/100 g | ||||
| Nut spreads | 7 g/100 g | ||||
| Chocolate confectionary | 7 g/100 g | ||||
| Chips, crisps, fries and dough-based analogues | 15 g/100 g | ||||
| Snacks other than chips | 20 g/100 g | ||||
| Meat products | 15 g/100 g | ||||
| Foods for special medical purposes as defined under Regulation (EU) No 609/2013, excluding foods for infants and young children, and children under 10 years of age. | In accordance with the particular nutritional requirements of the persons for whom the products are intended but, in any case, not higher than 30 g/day in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children, and children under 10 years of age. | 10 g/day for the general population above 10 years of age | ||||
| Partially defatted rapeseed powder from Brassica rapa L. andBrassica napus L. | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Partially defatted Rapeseed powder’.Any foodstuff containing ‘Partially defatted Rapeseed powder’ from Brassica rapa L. and Brassica napus L.’ shall bear a statement that this ingredient may cause allergic reaction to consumers who are allergic to mustard and products thereof. That statement shall appear in close proximity to the list of ingredients. | ||
| Cereal bars mixed | 20 g/100 g | ||||
| Muesli and similar breakfast cereals | 20 g/100 g | ||||
| Extruded breakfast cereal products | 20 g/100 g | ||||
| Snacks (excluding potato crisps) | 15 g/100 g | ||||
| Breads and rolls with added special ingredients (such as seeds, raisins, herbs) | 7 g/100 g | ||||
| Brown breads bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 | 7 g/100 g | ||||
| Multigrain bread and rolls | 7 g/100 g | ||||
| Meat substitutes | 10 g/100 g | ||||
| Meat balls | 10 g/100 g | ||||
| Pasteurised fruit-based preparations produced using high-pressure treatment | Specified food category | Maximum levels | The wording ‘pasteurised by high-pressure treatment’ shall be displayed next to the name of the fruit preparations as such and in any product in which it is used | ||
| Types of fruit:apple, apricot, banana, blackberry, blueberry, cherry, coconut, fig, grape, grapefruit, mandarin, mango, melon, peach, pear, pineapple, prune, raspberry, rhubarb, strawberry | |||||
| Pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Pea and rice protein fermented by Shiitake mushroom mycelia’. | Authorised on 24.1.2023. This inclusion is based on proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: MycoTechnology, Inc., 18250 E. 40th Avenue, Suite 50, Aurora, 80011 Colorado, United States. During the period of data protection, the novel food pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia is authorised for placing on the market within the Union only by MycoTechnology, Inc. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of MycoTechnology, Inc.End date of the data protection: 24.1.2028. | |
| Bakery wares, breads, rolls, croutons, pizza | 5 g/100 g | ||||
| Breakfast cereals and cereal bars | 33 g/100 g | ||||
| Fruit- and vegetable-based drinks | 20 g/100 ml | ||||
| Ready-to-mix beverage powders | 93 g/100 g | ||||
| Cocoa and chocolate confectionary | 7 g/100 g | ||||
| Dairy analogues and non-dairy meal replacements for weight control | 11 g/100 g | ||||
| Fermented milk-based products | 5 g/100 g | ||||
| Pasta-based products | 15 g/100 g | ||||
| Meat preparations and meat products | 14 g/100 g | ||||
| Soups (ready-to-eat) and soup concentrates or powders | 3 g/100 g | ||||
| Salads | 26 g/100 g | ||||
| Meat analogues | 40 g/100 g | ||||
| Milk-based drinks | 1 g/100 g | ||||
| Single meal replacements for weight control | 1 g/100 g | ||||
| Phenylcapsaicin | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘phenylcapsaicin’. | Authorised on 19 December 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: aXichem AB, Södergatan 26, SE 211 34, Malmö Sweden. During the period of data protection, the novel food phenylcapsaicin is authorised for placing on the market within the Union only by aXichem AB, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of aXichem AB. | |
| Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants, young children and children under the age of 11 years | 2,5 mg/day | ||||
| Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 11 years | 2,5 mg/day | ||||
| Phosphated maize starch | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phosphated maize starch’ | ||
| Baked bakery products | 15 % | ||||
| Pasta | |||||
| Breakfast cereals | |||||
| Cereal bars | |||||
| Phosphated wheat starch | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phosphated wheat starch’. | ||
| Baked bakery products | 15 % | ||||
| Pasta | |||||
| Breakfast cereals | |||||
| Cereal bars | |||||
| Phosphatidylserine from fish phospholipids | Specified food category | Maximum levels of phosphatidylserine | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish phosphatidylserine’ | ||
| Beverages based on yoghurt | 50 mg/100 ml | ||||
| Powders based on milk powders | 3500 mg/100 g (equivalent to 40 mg/100 ml ready to drink) | ||||
| Foods based on yoghurt | 80 mg/100 g | ||||
| Cereal bars | 350 mg/100 g | ||||
| Chocolate based confectionary | 200 mg/100 g | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In compliance with Regulation (EU) No 609/2013 | ||||
| Food supplements as defined in Directive 2002/46/EC | 300 mg/day | ||||
| Phosphatidylserine from soya phospholipids | Specified food category | Maximum levels of phosphatidylserine | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Soya phosphatidylserine’ | ||
| Beverages based on yoghurt | 50 mg/100 ml | ||||
| Powders based on milk powder | 3,5 g/100 g (equivalent to 40 mg/100 ml ready to drink) | ||||
| Foods based on yoghurt | 80 mg/100 g | ||||
| Cereal bars | 350 mg/100 g | ||||
| Chocolate based confectionary | 200 mg/100 g | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In compliance with Regulation (EU) No 609/2013 | ||||
| Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid | Specified food category | Maximum levels of phosphatidylserine | The designation of the novel food on the labelling of the foodstuffs containing shall be ‘Soy phosphatidylserine and phosphatidic acid’ | The product is not intended to be marketed to pregnant or breast-feeding women | |
| Breakfast cereals | 80 mg/100 g | ||||
| Cereal bars | 350 mg/100 g | ||||
| Foods based on yogurt | 80 mg/100 g | ||||
| Soy-based yogurt-like products | 80 mg/100 g | ||||
| Yogurt based-drinks | 50 mg/100 g | ||||
| Soy-based yogurt-like drinks | 50 mg/100 g | ||||
| Powders based on milk powder | 3,5 g/100 g (equivalent to 40 mg/100 ml ready-to drink) | ||||
| Food Supplements as defined in Directive 2002/46/EC | 800 mg/day | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In compliance with Regulation (EU) No 609/2013 | ||||
| Phospholipides from egg yolk | Specified food category | Maximum levels | |||
| Not specified | |||||
| Phytoglycogen | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phytoglycogen’ | ||
| Processed foods | 25 % | ||||
| Phytosterols/phytostanols | Specified food category | Maximum levels | In accordance with Annex III.5 of Regulation (EU) No 1169/2011 | ||
| Rice drinks | 1.They shall be presented in such a manner that they can be easily divided into portions that contain either a maximum of 3 g (in case of 1 portion/day) or a maximum of 1 g (in case of 3 portions/day) of added phytosterols/phytostanols.The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.Salad dressings, mayonnaise and spicy sauces shall be packed as single portions | ||||
| Rye bread with flour containing ≥ 50 % rye (wholemeal rye flour, whole or cracked rye kernels and rye flakes) and ≤ 30 % wheat; and with ≤ 4 % added sugar but no fat added. | |||||
| Salad dressings, mayonnaise and spicy sauces. | |||||
| Soya drink | |||||
| Milk type products, such as semi-skimmed and skimmed milk type products, possibly with the addition of fruits and/or cereals, where possibly the milk fat has been reduced, or where milk fat and/or protein has been partly or fully replaced by vegetable fat and/or protein. | |||||
| Products based on fermented milk such as yoghurt and cheese type products (fat content < 12 % per 100 g), where possibly the milk fat has been reduced, or where milk fat and/or protein has been partly or fully replaced by vegetable fat and/or protein | |||||
| Spreadable fats as defined in Annex VII, Part VII and Appendix II, points B and C of Regulation (EU) No 1308/2013, and excluding cooking and frying fats and spreads based on butter or other animal fat. | |||||
| Food Supplements as defined in Directive 2002/46/EC | 3 g/day | ||||
| Plum kernel oil | Specified food category | Maximum levels | |||
| For frying and as seasoning | In line with normal food use of vegetable oils | ||||
| Potassium magnesium trichloride hexahydrate | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be potassium magnesium mineral salt.2. Where the addition of the novel food to a final product result in an amount of potassium and/or magnesium that is considered significant in accordance with Point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011, the nutrition declaration shall contain the amount of potassium and/or magnesium. | Authorised on 20 August 2025.This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: BK Giulini, GmbH, member of ICL Group, Am Hafen 2, 68526 Ladenburg, Germany.During the period of data protection, the novel food potassium magnesium trichloride hexahydrate is authorised for placing on the market within the Union only by BK Giulini GmbH, member of ICL Group, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of BK Giulini GmbH, member of ICL Group.End date of the data protection: 20 August 2030 | |
| Raw cured (or seasoned) meat | 1050 mg/100 g | ||||
| Cooked cured (or seasoned) meat | 700 mg/100 g | ||||
| Cereal-based dishes | 600 mg/100 g | ||||
| Preserved or partly preserved sausages | 1050 mg/100 g | ||||
| Potato proteins (coagulated) and hydrolysates thereof | Not specified | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Potato protein’ | |||
| Prolyl oligopeptidase (enzyme preparation) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Prolyl oligopeptidase’ | ||
| Food Supplements as defined in Directive 2002/46/EC for general adult population | 120 PPU/day (2,7 g of enzyme preparation/day) (2 × 106 PPI/day)PPU – Prolyl Peptidase Units or Proline Protease UnitsPPI – Protease Picomole International | ||||
| Heat-treated Lemna minor and Lemna gibba | Specified food category | Maximum levels | 1.The designation of the novel food on the labelling of the foodstuffs containing it shall be‘Lemna minor and Lemna gibba plants’. | ||
| Not specified | |||||
| Protein concentrate from Lemna gibba and Lemna minor | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be protein concentrate from the Lemna gibba and Lemna minor plants or protein concentrate from the Lemna gibba plant depending on the presence of Lemna minor.2. Where foods containing the novel food include an amount of vitamin K that is considered significant in accordance with point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011, the nutrition declaration shall indicate the amount of vitamin K. | Authorised on 30 April 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ABC Kroos BV, Drosteweg 8, 8101 NB Raalte, NETHERLANDS. During the period of data protection, the novel food protein concentrate from Lemna gibba and Lemna minor is authorised for placing on the market within the Union only by ABC Kroos BV, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ABC Kroos BV.End date of the date protection: 30 April 2029. | |
| Cereal bars | 10 g/100 g | ||||
| Prepacked bread and rolls | 1,7 g/100 g | ||||
| Powdered drink mixes | 20 g/100 g | ||||
| Noodles | 6 g/100 g | ||||
| Food supplements as defined in Directive 2002/46/EC for the adult population | 1 g/day | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be protein concentrate from the Lemna gibba and Lemna minor plants or protein concentrate from Lemna gibba plant depending on the presence of Lemna minor.2. The labelling of food supplements containing the novel food shall bear a statement that they should only be consumed by adults.3. Where food supplements containing the novel food include an amount of vitamin K that is considered significant in accordance with point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011 and Article 8 of Directive 2002/46/EC, the labelling of food supplements containing novel food shall indicate the amount of vitamin K. | |||
| Protein extract from pig kidneys | Specified food category | Maximum levels | |||
| Food supplements as defined in Directive 2002/46/EC | 12,6 mg protein extract from pig kidney/day containing 0,9 mg/day diamine oxidase (DAO) taken in 3 doses per day, each dose containing a maximum of 0,3 mg DAO | ||||
| Food for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended, but not higher than 12,6 mg protein extract from pig kidney/day containing 0,9 mg/day DAO | ||||
| Pyrroloquinoline quinone disodium salt | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Pyrroloquinoline quinone disodium salt’.Food supplements containing Pyrroloquinoline quinone disodium salt shall bear the following statement:This food supplement should be consumed by adults only excluding pregnant and lactating women | Authorised on 2 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Mitsubishi Gas Chemical Company, Inc., Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan. During the period of data protection the novel food Pyrroloquinoline quinone disodium salt is authorised for placing on the market within the Union only by Mitsubishi Gas Chemical Company, Inc., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Mitsubishi Gas Chemical Company, Inc.End date of the data protection: 2 september 2023 | |
| Food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women | 20 mg/day | ||||
| Rapeseed oil high in unsaponifiable matter | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rapeseed oil extract’ | ||
| Food Supplements as defined in Directive 2002/46/EC | 1,5 g per portion recommended for daily consumption | ||||
| Rapeseed Protein | As a vegetable protein source in foods except in infant formula and follow-on formula | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Rapeseed protein.2. Any foodstuff containing rapeseed protein shall bear a statement that this ingredient may cause allergic reaction to consumers who are allergic to mustard and products thereof. Where relevant, this statement shall appear in close proximity to the list of ingredients. | |||
| Refined shrimp peptide concentrate | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘refined shrimp peptide concentrate’. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Marealis AS., Stortorget 1, Kystens Hus, 2nd floor, N-9008 Tromsø Postal address: P.O. Box 1065, 9261 Tromsø, Norway. During the period of data protection the novel food refined shrimp peptide concentrate is authorised for placing on the market within the Union only by Marealis AS unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Marealis AS.End date of the data protection: 20 November 2023. | |
| Food Supplements as defined in Directive 2002/46/EC for the adult population | 1200 mg/day | ||||
| Rhamnogalacturonan-I enriched carrot extract | Specified food category | Maximum levels | 1.The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rhamnogalacturonan-I carrot extract’.2.The labelling of food supplements containing the novel food shall bear a statement that the food supplements should not be consumed by children under 3 years of age. | Authorised on 2 July 2026. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: NutriLeads B.V., Bronland 12-N. 6708 WH Wageningen, NETHERLANDS.During the period of data protection, the novel food Rhamnogalacturonan-I enriched carrot extract (cRG-I) is authorised for placing on the market within the Union only by NutriLeads B.V., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of NutriLeads B.V.End date of the data protection: 2 July 2031. | |
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 1500 mg/day for the general population above 3 years of age | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013, excluding foods for infants and young children | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 | 1500 mg/day | ||||
| Meal replacement for weight control, excluding meal replacement for infants and young children | 500 mg/meal | ||||
| Processed cereal based food and baby food for infants and young children as defined by Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of infants and young children and with a maximum of 625 mg/100 ml (for beverages) and 450 mg/100 g (meals) | ||||
| Muesli and similar mixed breakfast cereals | 5000 mg/100 g | ||||
| Cereal bars | 3750 mg/100 g | ||||
| Fruit based drinks, except product defined in part I of Annex I to Directive 2001/112/EC | 500 mg/100 ml | ||||
| Biscuits, rusks and cookies | 3750 mg/100 g | ||||
| Soups and soup concentrates | 750 mg/100 ml (marketed as such or reconstituted according to the instructions) | ||||
| Flavoured milk-based drinks | 750 mg/100 g | ||||
| Yogurt based drinks | 750 mg/100 g | ||||
| Milk analogues | 750 mg/100 g | ||||
| Cream analogues | 10000 mg/100 g | ||||
| Cheese analogues | 3750 mg/100 g | ||||
| Yogurt analogues | 1200 mg/100 g | ||||
| Rhizomucor pusillus mycelium | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rhizomucor pusillus mycelium’.The labelling of food supplements containing ‘Rhizomucor pusillus mycelium’ shall bear a statement that they should not be consumed by persons under 18 years of age, and pregnant and lactating women. | Authorised on 26 July 2026. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘The Protein Brewery B.V.’, Goeseelsstraat 10, 4817 MV, Breda, Netherlands.During the period of data protection, the novel food Rhizomucor pusillus mycelium is authorised for placing on the market within the Union only by ‘The Protein Brewery B.V.’ unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘The Protein Brewery B.V.’.End date of the data protection: 26 July 2031. | |
| Rhizomucor pusillus mycelium powder | |||||
| Breakfast cereals, and cereal-, fruit- or vegetable-based snacks | 30 g/100 g | ||||
| Biscuits | 10 g/100 g | ||||
| Cereal bars | 35 g/100 g | ||||
| Dairy analogues except drinks | 20 g/100 g | ||||
| Non-alcoholic beverages | 10 g/100 g | ||||
| Flatbread and steamed breads | 20 g/100 g | ||||
| Chocolate confectionery | 15 g/100 g | ||||
| Cocoa-based spreads | 20 g/100 g | ||||
| Meal replacements for weight control for the adult population (as drinks) | Maximum 2 meals/day up to a maximum of 40 g/day | ||||
| Food supplements as defined in Directive 2002/46/EC, for the general adult population, excluding pregnant and lactating women | 6 g/day | ||||
| Trans-resveratrol | Specified food category | Maximum levels | 1.The designation of the novel food on the labelling of the food supplements containing it shall be ‘Trans-resveratrol’.2.The labelling of food supplements containing trans-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision. | ||
| Food supplements as defined in Directive 2002/46/EC for the adult population | 150 mg/day | ||||
| Trans-resveratrol (microbial source) | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the food supplements containing it shall be Trans-resveratrol.2. The labelling of food supplements containing trans-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision. | ||
| Food supplements as defined in Directive 2002/46/EC | In line with normal use in food supplements of resveratrol extracted from Japanese knotweed (Fallopia japonica) | ||||
| Rooster comb extract | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rooster comb extract’ or ‘Cockerel comb extract’ | ||
| Milk-based drinks | 40 mg/100 g or mg/100 ml | ||||
| Milk based fermented drinks | 80 mg/100 g or mg/100 ml | ||||
| Yoghurt-type products | 65 mg/100 g or mg/100 ml | ||||
| Fromage frais | 110 mg/100 g or mg/100 ml | ||||
| Sacha inchi oil from Plukenetia volubilis | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sacha inchi oil (Plukenetia volubilis)’ | ||
| As for linseed oil | In line with normal food use of linseed oil | ||||
| Salatrims | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be reduced energy fat (salatrims).2. There shall be a statement that excessive consumption may lead to gastro-intestinal disturbance.3. There shall be a statement that the products are not intended for use by children. | ||
| Bakery products and confectionary | |||||
| Schizochytrium sp. oil rich in DHA and EPA | Specified food category | Maximum levels of DHA and EPA combined | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Food supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women | 3000 mg/day | ||||
| Food supplements as defined in Directive 2002/46/EC for pregnant and lactating women | 450 mg/day | ||||
| Food supplements as defined in Directive 2002/46/EC for children from 18 months to 18 years of age | 250 mg/day | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 250 mg/meal | ||||
| Milk based drinks and similar products intended for young children | 200 mg/100 g | ||||
| Processed cereal based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 | |||||
| Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen | |||||
| Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014note | |||||
| Bakery products (breads, rolls and sweet biscuits) | |||||
| Breakfast cereals | 500 mg/100 g | ||||
| Cooking fats | 360 mg/100 g | ||||
| Dairy analogues, except drinks | 600 mg/100 g for cheese; 200 mg/100 g for soy and imitation milk products (excluding drinks) | ||||
| Dairy products except milk-based drinks | 600 mg/100 g for cheese; 200 mg/100 g for milk products (including milk, fromage frais and yoghurt products; excluding drinks) | ||||
| Non-alcoholic beverages (including dairy analogue and milk-based drinks) | 80 mg/100 g | ||||
| Cereal/nutrition bars | 500 mg/100 g | ||||
| Spreadable fats and dressings | 600 mg/100 g | ||||
| Fish analogues | 300 mg/100 g | ||||
| Meat analogues | 300 mg/100 g | ||||
| Schizochytrium sp. (ATCC PTA-9695) oil | Specified food category | Maximum levels of DHA | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Oil from the microalgae Schizochytrium sp..2. The labelling of food supplements containing more than 250 mg DHA/day shall bear a statement that they should not be consumed by children under 3 years of age. | ||
| Dairy products except milk-based drinks | 200 mg/100 g or for cheese products 600 mg/100 g | ||||
| Dairy analogues except drinks | 200 mg/100 g or for analogues to cheese products 600 mg/100 g | ||||
| Spreadable fats and dressings | 600 mg/100 g | ||||
| Breakfast cereals | 500 mg/100 g | ||||
| Food Supplements as defined in Directive 2002/46/EC | 250 mg DHA/day for the general population | ||||
| 1 g DHA/day for the general population excluding infants and young children | |||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 250 mg/meal | ||||
| Milk-based drinks and similar products intended for young children | 200 mg/100 g | ||||
| Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen | |||||
| Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 | |||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Bakery products (breads, rolls, and sweet biscuits) | 200 mg/100 g | ||||
| Cereal bars | 500 mg/100 g | ||||
| Cooking fats | 360 mg/100 g | ||||
| Non-alcoholic beverages (including dairy analogue and milk-based drinks) | 80 mg/100 g | ||||
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 | 200 mg/100 g | ||||
| Fruit/vegetable puree | 100 mg/100 g | ||||
| Schizochytrium sp. (CABIO-A-2) oil | Specified food category | Maximum levels of DHA | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’. | ||
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Schizochytrium sp. (FCC-3204) oil | Specified food category | Maximum levels of DHA | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’The labelling of food supplements containing Schizochytrium sp. (FCC-3204) oil shall bear a statement that they should not be consumed by infants and children under 3 years of age. | ||
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Food supplements as defined in Directive 2002/46/EC for the general population above 3 years of age | 1 g/day | ||||
| Protein products, excluding dairy analogues | 1 g/100 g | Authorised for use in protein products, excluding dairy analogues, on 30 April 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Fermentalg, 4 rue Rivière 33500 Libourne, France. During the period of data protection, the novel food for use in protein products, excluding dairy analogues, is authorised for placing on the market within the Union only by Fermentalg, unless a subsequent applicant obtains authorisation for the same novel food without reference to the proprietary scientific evidence or scientific data protected under Article 26 of Regulation (EU) 2015/2283 or with the agreement of Fermentalg.End date of the date protection: 30 April 2030. | |||
| Schizochytrium sp. oil | Specified food category | Maximum levels of DHA | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’ | ||
| Dairy products except milk-based drinks | 200 mg/100 g or for cheese products 600 mg/100 g | ||||
| Dairy analogues except drinks | 200 mg/100 g or for analogues to cheese products 600 mg/100 g | ||||
| Spreadable fat and dressings | 600 mg/100 g | ||||
| Breakfast cereals | 500 mg/100 g | ||||
| Food Supplements as defined in Directive 2002/46/EC | 250 mg DHA/day for general population | ||||
| 450 mg DHA/day for pregnant and lactating women | |||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 250 mg/meal | ||||
| Milk-based drinks and similar products intended for young children | 200 mg/100 g | ||||
| Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 | |||||
| Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen | |||||
| Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No 828/2014 | |||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Bakery products (breads, rolls, and, sweet biscuits) | 200 mg/100 g | ||||
| Cereal bars | 500 mg/100 g | ||||
| Cooking fats | 360 mg/100 g | ||||
| Non-alcoholic beverages (including dairy analogue and milk-based drinks) | 80 mg/100 ml | ||||
| Fruit/vegetable puree | 100 mg/100 g | ||||
| Schizochytrium sp. (T18) oil | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’. | ||
| Dairy products except milk-based drinks | 200 mg/100 g or for cheese products 600 mg/100 g | ||||
| Dairy analogues except drinks | 200 mg/100 g or for analogues to cheese products 600 mg/100 g | ||||
| Spreadable fats and dressings | 600 mg/100 g | ||||
| Breakfast cereals | 500 mg/100 g | ||||
| Food supplements as defined in Directive 2002/46/EC | 250 mg DHA/day for general population | ||||
| 450 mg DHA/day for pregnant and lactating women | |||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 250 mg/meal | ||||
| Milk-based drinks and similar products intended for young children | 200 mg/100 g | ||||
| Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen | |||||
| Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 | |||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Bakery products (breads, rolls and, sweet biscuits) | 200 mg/100 g | ||||
| Cereal bars | 500 mg/100g | ||||
| Cooking fats | 360 mg/100 g | ||||
| Non-alcoholic beverages (including dairy analogue and milk-based drinks) | 80 mg/100 ml | ||||
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 | 200 mg/100 g | ||||
| Fruit/vegetable puree | 100 mg/100 g | ||||
| Schizochytrium sp. (WZU477) oil | Specified food category | Maximum levels of DHA | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’ | Authorised on 16 May 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Progress Biotech bv, Canaalstaete, Kanaalweg 33, 2903LR Capelle aan den Ijssel, the Netherlands.During the period of data protection, the novel food is authorised for placing on the market within the Union only by Progress Biotech bv unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Progress Biotech bv.End date of the data protection: 16 May 2026 (5 years). | |
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Schizochytrium limacinum (TKD-1) oil | Specified food category | Maximum levels of DHA | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium limacinum’. | ||
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Schizochytrium limacinum (ATCC-20889) oil | Specified food category | Maximum levels of DHA | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium limacinum’. | Authorised on 18 August 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: BioPlus Life Sciences, Pharmed Gardens, Whitefield Road, Bangalore 560048 INDIA.During the period of data protection, the novel food Schizochytrium limacinum (ATCC-20889) oil is authorised for placing on the market within the Union only by BioPlus Life Sciences, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of BioPlus Life Sciences.End date of the data protection: 18 August 2030 | |
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Seeds and seed flour of Vigna subterranea (L.) Verdc. (traditional food from a third country) | Specified food category | Maximum levels | 1.The designation of the novel food on the labelling of the foodstuffs containing it shall be‘Bambara (Vigna subterranea) seeds/nut/bean/groundnut’or‘Bambara (Vigna subterranean) seed/nut/bean/groundnut flour’ depending on the form used.2.The labelling of the foodstuffs containing the traditional food shall bear a statement that the seeds and the seed flour of Vigna subterranea may cause allergic reactions to consumers with known allergies to peanuts and soybeans. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredients, in close proximity to the name of the food.3.When the seeds are sold uncooked, the labelling shall bear a statement that they should be soaked and boiled before consumption. | ||
| Not specified | |||||
| Selenium-containing yeast (Yarrowia lipolytica) biomass | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘selenium-containing yeast (Yarrowia lipolytica) biomass’.The labelling of food supplements containing selenium-containing yeast (Yarrowia lipolytica) biomass shall bear a statement that the food supplements should not be consumed by infants and children under 4 years of age/children under 7 years of age/children under 11 years of age/children and adolescents under 18 years of agenote. | ||
| Food supplements as defined in Directive 2002/46/ECnote, excluding food supplements for infants and children under 4 years of age | 50 mg/day for children from 4 to 6 years of age, resulting in 10 μg of selenium per day100 mg/day for children from 7 to 10 years of age, resulting in 20 μg of selenium per day500 mg/day for adolescents from 11 to 17 years of age, resulting in 100 μg of selenium per day800 mg/day for adults, resulting in 160 μg of selenium per day | ||||
| 3'-Sialyllactose (3'-SL) sodium salt(microbial source) | Specified food category | Maximum levels (expressed as 3'-Sialyllactose) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘3'-Sialyllactose sodium salt’.The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed:a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day.b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.End date of the data protection: 18 February 2026. | |
| Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products | 0,25 g/L | ||||
| Unflavoured fermented milk-based products | 0,25 g/L (beverages) | ||||
| 0,5 g/kg (products other than beverages) | |||||
| Flavoured fermented milk-based products including heat-treated products | 0,25 g/L (beverages) | ||||
| 2,5 g/kg (products other than beverages) | |||||
| Beverages (flavoured drinks, excluding drinks with a pH less than 5) | 0,25 g/L | ||||
| Cereal bars | 2,5 g/kg | ||||
| Infant formula as defined in Regulation (EU) No 609/2013 | 0,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined in Regulation (EU) No 609/2013 | 0,15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 | 0,15 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| 1,25 g/kg for products other than beverages | |||||
| Milk-based drinks and similar products intended for young children | 0,15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013 | 0,5 g/L (beverages) | ||||
| 5 g/kg (products other than beverages) | |||||
| Food for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food Supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 0,5 g/day | ||||
| 3′-Sialyllactose (‘3′-SL’) sodium salt(produced by derivative strains of E. coli BL21(DE3)) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘3′-Sialyllactose sodium salt’.The labelling of food supplements containing 3′-Sialyllactose (3′-SL) sodium salt shall bear a statement that(a) they should not be consumed by children under 3 years of age;(b) they should not be used if other foods containing added 3′-sialyllactose sodium salt are consumed the same day. | Authorised on 6 February 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Chr. Hansen A/S’, Boege Allé 10-12, 2970 Hoersholm, Denmark. During the period of data protection, the novel food 3′-Sialyllactose sodium salt is authorised for placing on the market within the Union only by Chr. Hansen A/S unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘Chr. Hansen A/S’.End date of the data protection: 6 February 2028. | |
| Infant formula as defined under Regulation (EU) No 609/2013 | 0,28 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 0,28 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No 609/2013 | 0,28 g/L or 0,28 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Milk based drinks and similar products intended for young children | 0,28 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than 0,28 g/L or 0,28 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. | ||||
| Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food Supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children | 0,7 g/day | ||||
| 3′-Sialyllactose (3′-SL) sodium salt(produced using a derivative strain of E. coli W (ATCC 9637)) | Specified food category | Maximum levels (expressed as 3′-Sialyllactose) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘3′-Sialyllactose sodium salt’.The labelling of food supplements containing 3′-Sialyllactose (3′-SL) sodium salt shall bear a statement that they should not be consumed:(a) if foods containing added 3′-Sialyllactose sodium salt are consumed on the same day;(b) by children under 3 years of age. | Authorised on 30 April 2024.This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Kyowa Hakko Bio Co., Ltd, Nakano Central Park South, Nakano 4-10-2, Nakano-ku Tokyo, 164-0001 Japan. During the period of data protection, the novel food 3′-sialyllactose sodium salt produced using a derivative strain of E. coli W (ATCC 9637) is authorised for placing on the market within the Union only by Kyowa Hakko Bio Co., Ltd, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Kyowa Hakko Bio Co., Ltd.End date of the data protection: 30 April 2029. | |
| Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products | 0,25 g/L | ||||
| Unflavoured fermented milk-based products | 0,25 g/L (beverages) | ||||
| 0,5 g/kg (products other than beverages) | |||||
| Flavoured fermented milk-based products including heat-treated products | 0,25 g/L (beverages) | ||||
| 2,5 g/kg (products other than beverages) | |||||
| Beverages (flavoured drinks, excluding drinks with a pH less than 5) | 0,25 g/L | ||||
| Cereal bars | 2,5 g/kg | ||||
| Infant formula as defined under Regulation (EU) No 609/2013 | 0,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 0,15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013 | 0,15 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| 1,25 g/kg for products other than beverages | |||||
| Milk based drinks and similar products | 0,15 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013 | 0,5 g/L (beverages) | ||||
| 5,0 g/kg (products other than beverages) | |||||
| Food for special medical purposes as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 1,0 g/day | ||||
| 6’-Sialyllactose (6’-SL) sodium salt(microbial source) | Specified food category | Maximum levels (expressed as 6’-Sialyllactose) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘6’-Sialyllactose sodium salt’.The labelling of food supplements containing 6’-Sialyllactose (6’-SL) sodium salt shall bear a statement that they should not be consumed:a) if foods containing added 6’-Sialyllactose sodium salt are consumed on the same day.b) by infants and young children | Authorised on 17 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 6’-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.End date of the data protection: 17 February 2026. | |
| Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products | 0,5 g/L | ||||
| Unflavoured fermented milk-based products | 0,5 g/L (beverages) | ||||
| 2,5 g/kg (products other than beverages) | |||||
| Flavoured fermented milk-based products including heat-treated products | 0,5 g/L (beverages) | ||||
| 5,0 g/kg (products other than beverages) | |||||
| Beverages (flavoured drinks, excluding drinks with a pH less than 5) | 0,5 g/L | ||||
| Cereal bars | 5,0 g/kg | ||||
| Infant formula as defined under Regulation (EU) No 609/2013 | 0,4 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 0,3 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013 | 0,3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| 2,5 g/kg for products other than beverages | |||||
| Milk based drinks and similar products intended for young children | 0,3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013 | 1,0 g/L (beverages) | ||||
| 10,0 g/kg (products other than beverages) | |||||
| Food for special medical purposes as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food Supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 1,0 g/day | ||||
| 6’-Sialyllactose (‘6′-SL’) sodium salt(produced by derivative strains of E. coli BL21(DE3)) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘6′-Sialyllactose sodium salt’.The labelling of food supplements containing 6′-Sialyllactose (6′-SL) sodium salt shall bear a statement that(a) they should not be consumed by children under 3 years of age;(b) they should not be consumed if other foods containing added 6′-sialyllactose sodium salt are consumed the same day. | Authorised on 4 June 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Chr. Hansen A/S’, Bøge Allé 10-12, 2970 Hoersholm, Denmark. During the period of data protection, the novel food 6′-Sialyllactose sodium salt is authorised for placing on the market within the Union only by Chr. Hansen A/S unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘Chr. Hansen A/S’.End date of the data protection: 4 June 2028. | |
| Infant formula as defined under Regulation (EU) No 609/2013 | 0,70 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 0,70 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No 609/2013 | 0,70 g/L or 0,70 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Milk based drinks and similar products intended for young children | 0,70 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than 0,70 g/L or 0,70 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. | ||||
| Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food Supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children | 1,8 g/day | ||||
| 6′-Sialyllactose (6′-SL) sodium salt(produced by derivative strain of E. coli W (ATCC 9637)) | Specified food category | Maximum levels (expressed as 6′-Sialyllactose) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘6′-Sialyllactose sodium salt’.The labelling of food supplements containing 6′-Sialyllactose (6′-SL) sodium salt shall bear a statement that they should not be consumed:(a) if foods containing added 6′-Sialyllactose sodium salt are consumed on the same day;(b) by children under 3 years of age. | Authorised on 13.11.2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Kyowa Hakko Bio Co., Ltd, 1-9-2, Otemachi, Choyoda-ku Tokyo, 100-0004, Japan. During the period of data protection, the novel food 6′-sialyllactose sodium salt produced by derivative strain of E. coli W (ATCC 9637) is authorised for placing on the market within the Union only by Kyowa Hakko Bio Co., Ltd, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Kyowa Hakko Bio Co., Ltd.End date of the data protection: 13.11.2028. | |
| Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products | 0,5 g/L | ||||
| Unflavoured fermented milk-based products | 0,5 g/L (beverages) | ||||
| 2,5 g/kg (products other than beverages) | |||||
| Flavoured fermented milk-based products including heat-treated products | 0,5 g/L (beverages) | ||||
| 5,0 g/kg (products other than beverages) | |||||
| Beverages (flavoured drinks, excluding drinks with a pH less than 5) | 0,5 g/L | ||||
| Cereal bars | 5,0 g/kg | ||||
| Infant formula as defined under Regulation (EU) No 609/2013 | 0,4 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Follow-on formula as defined under Regulation (EU) No 609/2013 | 0,3 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013 | 0,3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| 2,5 g/kg for products other than beverages | |||||
| Milk based drinks and similar products | 0,3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | ||||
| Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013 | 1,0 g/L (beverages) | ||||
| 10,0 g/kg (products other than beverages) | |||||
| Food for special medical purposes as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food Supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 1,0 g/day | ||||
| Syrup from Sorghum bicolor (L.) Moench(Traditional food from a third country) | Not specified | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sorghum (Sorghum bicolor) syrup’ | |||
| Fermented soybean extract | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Fermented soybean extract.2. The labelling of food supplements containing fermented soybean extract shall bear a statement that persons taking medication should only consume the product under medical supervision. | ||
| Food Supplements as defined in Directive 2002/46/EC (capsules, tablets or powder form) intended for the adult population, excluding pregnant and lactating women | 100 mg/day | ||||
| Spermidine-rich wheat germ extract (Triticum aestivum) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the food supplements containing it shall be ‘spermidine-rich wheat germ extract’ | ||
| Food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women | Equivalent of max. 6 mg/day spermidine | ||||
| Sucromalt | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Sucromalt.2. The designation of the novel food on the labelling shall be accompanied by indication that the product is a source of glucose and fructose. | ||
| Not specified | |||||
| Sugar cane fibre | Specified food category | Maximum levels | |||
| Bread | 8 % | ||||
| Bakery goods | 5 % | ||||
| Meat and muscle products | 3 % | ||||
| Seasonings and spices | 3 % | ||||
| Grated cheeses | 2 % | ||||
| Special diet foods | 5 % | ||||
| Sauces | 2 % | ||||
| Beverages | 5 % | ||||
| Sugars obtained from cocoa (Theobroma cacao L.) pulp | Not specified | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘sugars obtained from cocoa (Theobroma cacao L.) pulp’, ‘Glucose obtained from cocoa (Theobroma cacao L.) pulp’ or ‘Fructose obtained from cocoa (Theobroma cacao L.) pulp’, depending on the form used. | |||
| Sunflower oil extract | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sunflower oil extract’ | ||
| Food Supplements as defined in Directive 2002/46/EC | 1,1 g/day | ||||
| Synsepalum dulcificum dried fruits | Specified food category | Maximum levels | 1.The designation of the novel food on the labelling of food supplements containing it shall be ‘dried Synsepalum dulcificum fruits’2.The labelling of food supplements containing Synsepalum dulcificum dried fruits shall bear a statement that this food supplement should be consumed by adults only excluding pregnant and lactating women. | Authorised on 5 December 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Medicinal Gardens S.L. Marqués de Urquijo 47, 1° D, Office 1, Madrid, 28008, Spain.During the period of data protection, the novel food is authorised for placing on the market within the Union only by Medicinal Gardens S.L. unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Medicinal Gardens S.L.End date of the data protection: 5 December 2026. | |
| Food Supplements as defined in Directive 2002/46/EC for adult population excluding pregnant and lactating women | 0,7 g/day | ||||
| Tetrahydrocurcuminoids | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘tetrahydrocurcuminoids’.The labelling of food supplements containing tetrahydrocurcuminoids shall bear a statement thata) they should be consumed by adults only, excluding pregnant and lactating women;b) they should not be consumed if other food supplements containing curcumin and/or curcuminoids are consumed on the same day. | Authorised on 11 July 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Sabinsa Europe GmbH’, Monzastrasse 4, 63225 Langen, Germany. During the period of data protection, the novel food tetrahydrocurcuminoids is authorised for placing on the market within the Union only by ‘Sabinsa Europe GmbH’ unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘Sabinsa Europe GmbH’.End date of the data protection: 11 July 2027. | |
| Food Supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and lactating women | 140 mg/day | ||||
| Dried Tenebrio molitor larva (yellow mealworm) | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Dried Tenebrio molitor larva (yellow mealworm).2. The labelling of the foodstuffs containing dried Tenebrio molitor larva (yellow mealworm) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans and products thereof, and to dust mites. This statement shall appear in close proximity to the list of ingredients. | Authorised on 22 June 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: SAS EAP Group, 35 Boulevard du Libre Échange, 31650 Saint-Orens-de-Gameville, France.During the period of data protection, the novel food is authorised for placing on the market within the Union only by SAS EAP Group, unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283, or with the agreement of SAS EAP Group.End date of the data protection: 22 June 2026. | |
| Dried Tenebrio molitor larva, whole or in powder | |||||
| Protein products | 10 g/100 g | ||||
| Biscuits | 10 g/100 g | ||||
| Legumes-based dishes | 10 g/100 g | ||||
| Pasta-based products | 10 g/100 g | ||||
| Dried Tetraselmis chuii microalgae | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Dried microalgae Tetraselmis chuii’ or ‘Dried microalgae T. chuii’Food supplements containing dried microalgae Tetraselmis chuii shall bear the following statement: ‘Contains negligible amounts of iodine’ | ||
| Sauces | 20 % or 250mg/day | ||||
| Special salts | 1 % | ||||
| Condiment | 250 mg/day | ||||
| Food Supplements as defined in Directive 2002/46/EC | 250 mg/day | ||||
| Therapon barcoo/Scortum | Intended use identical to that of the salmon, namely the preparation of culinary fish products and dishes, including cooked, raw, smoked and baked fish products | ||||
| D-Tagatose | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be D-Tagatose.2. The labelling of any product where the level of D-Tagatose exceeds 15 g per serving and all beverages containing greater than 1 % D-Tagatose (as consumed) shall bear a statement excessive consumption may produce laxative effects. | ||
| Not specified | |||||
| Taxifolin-rich extract | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘taxifolin-rich extract’ | ||
| Yogurt plain/Yogurt with fruits(*) | 0,020 g/kg | ||||
| Kephir(*) | 0,008 g/kg | ||||
| Buttermilk(*) | 0,005 g/kg | ||||
| Milk powder(*) | 0,052 g/kg | ||||
| Cream(*) | 0,070 g/kg | ||||
| Sour cream(*) | 0,050 g/kg | ||||
| Cheese(*) | 0,090 g/kg | ||||
| Butter(*) | 0,164 g/kg | ||||
| Chocolate confectionery | 0,070 g/kg | ||||
| Non-alcoholic beverages | 0,020 g/L | ||||
| Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding infants, young children, children and adolescents younger than 14 years | 100 mg/day | ||||
| (*)When used in milk products Taxifolin-rich extract may not replace in whole or in part, any milk constituent | |||||
| Trehalose | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Trehalose and shall be displayed on the labelling of the product as such or in the list of ingredients of foodstuffs containing it.2. The designation of the novel food on the labelling shall be accompanied by indication that the Trehalose is a source of glucose. | ||
| Not specified | |||||
| UV-treated mushrooms (Agaricus bisporus) | Specified food category | Maximum levels of vitamin D2 | 1. The designation on the label of the novel food as such or of the foodstuffs containing it shall be UV-treated mushrooms (Agaricus bisporus).2. The designation on the label of the novel food as such or of the foodstuffs containing it shall be accompanied by indication that a controlled light treatment was used to increase vitamin D levels or UV treatment was used to increase vitamin D2 levels. | ||
| Mushrooms (Agaricus bisporus) | 20 μg of vitamin D2/100 g fresh weight | ||||
| UV-treated baker’s yeast (Saccharomyces cerevisiae) | Specified food category | Maximum levels of vitamin D2 | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘vitamin D yeast’ or ‘vitamin D2 yeast’ | ||
| Yeast-leavened breads and rolls | 5 μg/100 g | ||||
| Yeast-leavened fine bakery wares | 5 μg/100 g | ||||
| Food supplements as defined in Directive 2002/46/EC | In accordance with Directive 2002/46/EC | ||||
| Pre-packed fresh or dry yeast for home baking | 45 μg/100 g for fresh yeast200 μg/100 g for dried yeast | 1. The designation of the novel food on the labelling of the foodstuffs shall be vitamin D yeast or vitamin D2 yeast.2. The labelling of the novel food shall bear a statement that the foodstuff is only intended for baking and that it should not be eaten raw.3. The labelling of the novel food shall bear instructions for use for the final consumers so that a maximum concentration of 5 μg/100 g of vitamin D2 in final home-baked products is not exceeded. | |||
| Dishes, incl. ready-to-eat meals (excluding soups and salads) | 3 μg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘vitamin D yeast’ or ‘vitamin D2 yeast’ | |||
| Soups and salads | 5 μg/100 g | ||||
| Fried or extruded cereal, seed or root-based products | 5 μg/100 g | ||||
| Infant formula and follow-on formula as defined by Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Processed cereal-based food as defined by Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 | ||||
| Processed fruit products | 1,5 μg/100 g | ||||
| Processed vegetables | 2 μg/100 g | ||||
| Bread and similar products | 5 μg/100 g | ||||
| Breakfast cereals | 4 μg/100 g | ||||
| Pasta, doughs and similar products | 5 μg/100 g | ||||
| Other cereal based products | 3 μg/100 g | ||||
| Spices, seasonings, condiments, sauce ingredients, dessert sauces/toppings | 10 μg/100 g | ||||
| Protein products | 10 μg/100 g | ||||
| Cheese | 2 μg/100 g | ||||
| Dairy dessert and similar products | 2 μg/100 g | ||||
| Fermented milk or fermented cream | 1,5 μg/100 g | ||||
| Dairy powders and concentrates | 25 μg/100 g | ||||
| Milk based products, whey and cream | 0,5 μg/100 g | ||||
| Meat and dairy analogues | 2,5 μg/100 g | ||||
| Total diet replacement for weight control as defined by Regulation (EU) No 609/2013 | 5 μg/100 g | ||||
| Meal replacements for weight control | 5 μg/100 g | ||||
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| UV-treated bread | Specified food category | Maximum levels of vitamin D2 | The designation on the label of the novel food shall be accompanied by ‘contains vitamin D produced by UV-treatment’ | ||
| Yeast leavened bread and rolls (without toppings) | 3 μg vitamin D2/100 g | ||||
| UV-treated milk | Specified food category | Maximum levels of vitamin D3 | 1. The designation on the label of the novel food shall be UV-treated.2. Where UV-treated milk contains an amount of vitamin D that is considered significant in accordance with Point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011 of the European Parliament and of the Council, the designation for the labelling shall be accompanied by contains vitamin D produced by UV-treatment or milk containing vitamin D resulting from UV-treatment. | ||
| Pasteurised whole milk as defined in Regulation (EU) No 1308/2013 to be consumed as such | 5-32 μg/kg for general population excluding infants | ||||
| Pasteurised semi-skimmed milk as defined in Regulation (EU) No 1308/2013 to be consumed as such | 1-15 μg/kg for general population excluding infants | ||||
| Vitamin D2 mushroom powder | Specified food category | Maximum levels of vitamin D2note | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘UV-treated mushroom powder containing vitamin D’ or ‘UV-treated mushroom powder containing vitamin D2’The labelling of food supplements containing vitamin D2 mushroom powder shall bear a statement that they should not be consumed by infants | Authorised on 27 August 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Oakshire Naturals, LP., PO Box 388 Kennett Square, Pennsylvania 19348, United States. During the period of data protection, the novel food vitamin D2 mushroom powder is authorised for placing on the market within the Union only by Oakshire Naturals, LP., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Oakshire Naturals, LP.End date of the data protection: 27 August 2025. | |
| Breakfast cereals | 2,25 μg of vitamin D2/100 g | ||||
| Yeast-leavened bread and pastries | 2,25 μg of vitamin D2/100 g | ||||
| Grain products and pastas | 2,25 μg of vitamin D2/100 g | ||||
| Fruit juice and fruit/vegetable blend beverages | 1,125 μg of vitamin D2/100 mL | ||||
| Milk and dairy products (excluding fluid milks) | 2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages) | ||||
| Cheese (excluding cottage cheese, ricotta cheese, and hard-grating cheeses) | 2,25 μg of vitamin D2/100 g | ||||
| Meal replacement bars and beverages | 2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages) | ||||
| Dairy analogues | 2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages) | ||||
| Meat analogues | 2,25 μg of vitamin D2/100 g | ||||
| Soups and broths | 2,25 μg of vitamin D2/100 g | ||||
| Extruded vegetable snacks | 2,25 μg of vitamin D2/100 g | ||||
| Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infants | 15 μg/day | ||||
| Food supplements as defined in Directive 2002/46/EC intended for the general population excluding infants | 15 μg/day | ||||
| Vitamin D2 mushroom powder | Specified food category | Maximum levels of vitamin D2 | 1.The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘UV-treated mushroom powder containing vitamin D2’2.The labelling of food supplements containing vitamin D2 mushroom powder shall bear a statement that they should not be consumed by infants and children under 3 years of age. | Authorised on 19 December 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: MBio, Monaghan Mushrooms, Tullygony, Tyholland, Co. Monaghan, Ireland. During the period of data protection, the novel food vitamin D2 mushroom powder is authorised for placing on the market within the Union only by MBio, Monaghan Mushrooms, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of MBio, Monaghan Mushrooms.End date of the date protection: 19 December 2026. | |
| Breakfast cereals | 2,1 μg/100 g | ||||
| Yeast leavened bread and similar pastries | 2,1 μg/100 g | ||||
| Grain products and pasta and similar products | 2,1 μg/100 g | ||||
| Fruit/vegetable juices and nectars | 1,1 μg/100 ml (marketed as such or reconstituted as instructed by the manufacturer) | ||||
| Dairy products and analogues other than beverages | 2,1 μg/100 g (marketed as such or reconstituted as instructed by the manufacturer) | ||||
| Dairy products and analogues as beverages | 1,1 μg/100 ml (marketed as such or reconstituted as instructed by the manufacturer) | ||||
| Milk and dairy powders | 21,3 μg/100 g (marketed as such or reconstituted as instructed by the manufacturer) | ||||
| Meat analogues | 2,1 μg/100 g | ||||
| Soups | 2,1 μg/100 ml (marketed as such or reconstituted as instructed by the manufacturer) | ||||
| Extruded vegetable snack | 2,1 μg/100 g | ||||
| Meal replacement for weight control | 2,1 μg/100 g | ||||
| Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infants | In accordance with the particular nutritional requirements of the persons for whom the products are intended | ||||
| Food supplements as defined in Directive 2002/46/EC excluding food supplements intended for infants and young children | 15 μg of vitamin D2/day | ||||
| Vitamin D2 mushroom powder | Specified food category | Maximum levels of vitamin D2 (μg/100 g or 100 ml) | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be UV-treated mushroom powder containing vitamin D22. The labelling of food supplements containing vitamin D2 mushroom powder shall bear a statement that they should not be consumed by infants and children under 3 years of age. | Authorised on 24 January 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Monterey Mushrooms Inc, 260 Westgate Drive Watsonville, CA 95076, the United States.During the period of data protection, the novel food vitamin D2 mushroom powder is authorised for placing on the market within the Union only by Monterey Mushrooms Inc, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Monterey Mushrooms Inc.End date of the date protection: 24 January 2028. | |
| Milk analogues | 1,1 | ||||
| Dairy analogues other than milks | 2,2 | ||||
| Breakfast cereals and cereal bars | 2,2 | ||||
| Soups | 2,2 | ||||
| Dried soups | 22,5 | ||||
| Whey powder | 14,1 | ||||
| Fruit/vegetable juices and nectars | 1,1 | ||||
| Fruit/vegetable juice powder | 12,4 | ||||
| Fruit/vegetable juice concentrate (liquid) | 3,4 | ||||
| Soft drinks marketed in relation to physical exercise and fermented non-alcoholic drinks (with exclusion of dairy fermented drinks) | 1,1 | ||||
| Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infants | In accordance with the particular nutritional requirements of the persons for whom the products are intended but not higher than 15 μg/day | ||||
| Total diet replacement for weight control as defined inRegulation (EU) No 609/2013 | 15 μg/day | ||||
| Meal replacements for weight control | 5 μg/meal | ||||
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 15 μg/day | ||||
| Vitamin D2 mushroom powder | Specified food category | Maximum levels of vitamin D2 (μg/100 g or 100 ml) | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be UV-treated mushroom powder containing vitamin D2.2. The labelling of food supplements containing vitamin D2 mushroom powder shall bear a statement that they should not be consumed by infants and young children. | Authorised on 30 April 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Luxidum GmbH, Tempelhof 3, 74594 Kressberg, Germany.During the period of data protection, the novel food vitamin D2 mushroom powder is authorised for placing on the market within the Union only by Luxidum GmbH, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Luxidum GmbH.End date of the date protection: 30 April 2030. | |
| Breakfast cereals | 2,4 | ||||
| Yeast-leavened breads and pastries | 2,4 | ||||
| Pasta based products and similar products | 2,4 | ||||
| Fruit beverages (except products defined in Part I of Annex I to Directive 2001/112/EC) and vegetable beverages | 1,2 | ||||
| Concentrated or dehydrated fruit beverages (except products defined in Part I of Annex I to Directive 2001/112/EC) and concentrated or dehydrated vegetable beverages | 8,4 | ||||
| Yoghurt drinks and other fermented milk-based drinks, flavoured milks | 1,2 | ||||
| Milk concentrate | 2,4 | ||||
| Milk powder, whey powder | 24 | ||||
| Cream powder | 98,4 | ||||
| Whey | 2,4 | ||||
| Dairy dessert and similar products | 2,4 | ||||
| Cheese | 2,4 | ||||
| Meal replacements for weight control | 2,4 | ||||
| Meat and dairy analogues | 2,4 | ||||
| Soups | 2,4 | ||||
| Dried soups | 21,6 | ||||
| Extruded snacks, potato crisps, sticks | 2,4 | ||||
| Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infants | In accordance with the particular nutritional requirements of the persons for whom the products are intended but not higher than 15 μg/day | ||||
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 15 μg/day | ||||
| Vitamin K2 (menaquinone) | To be used in compliance with Directive 2002/46/EC, Regulation (EU) No 609/2013 and/or Regulation (EC) No 1925/2006 | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Menaquinone’ or ‘Vitamin K2’ | |||
| Wheat bran extract | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Wheat bran extract’ | The ‘Wheat Bran Extract’ may not be introduced onto the market as a food supplement or food supplement ingredient. Nor may it be added to infant formula. | |
| Beer and substitutes | 0,4 g/100 g | ||||
| Ready to eat cereals | 9 g/100 g | ||||
| Dairy products | 2,4 g/100 g | ||||
| Fruit and vegetable juices | 0,6 g/100 g | ||||
| Soft drinks | 0,6 g/100 g | ||||
| Meat preparations | 2 g/100 g | ||||
| Wolffia arrhiza and/or Wolffia globosa fresh plants (Traditional food from a third country) | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Wolffia arrhiza and Wolffia globosa’ or ‘Wolffia arrhiza’ or ‘Wolffia globosa’ depending on the plant used. | ||
| Wolffia arrhiza and/or Wolffia globosa fresh plants as such | |||||
| Xylo-oligosaccharides | Specified food category | Maximum levelsnote | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Xylo-oligosaccharides’ | ||
| White bread | 14 g/kg | ||||
| Wholemeal bread | 14 g/kg | ||||
| Breakfast cereals | 14 g/kg | ||||
| Biscuits | 14 g/kg | ||||
| Soy drink | 3,5 g/kg | ||||
| Yoghurtnote | 3,5 g/kg | ||||
| Fruit spreads | 30 g/kg | ||||
| Chocolate confectionery | 30 g/kg | ||||
| Food supplements as defined in Directive 2002/46/EC for the general adult population | 2 g/day | ||||
| Yarrowia lipolytica yeast biomass | Specified food category | Maximum levels | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be Yarrowia lipolytica yeast biomass.2. Food supplements containing the novel food should bear a statement that they should not be consumed if other foods with added Yarrowia lipolytica yeast biomass are consumed on the same day. | ||
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 6 g/day for children from 10 years of age, adolescents and general adult population3 g/day for children from 3 to 9 years of age | ||||
| Meal replacements for weight control for the adult population | 3 g/meal (maximum 2 meals/day up to a maximum of 6 g/day) | ||||
| Foods for special medicalpurposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended but not in any case higher than 6 g/day | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 | 6 g/day | ||||
| Unflavoured milk products | 5 g/kg | ||||
| Flavoured fermented milk products | 10 g/kg | ||||
| Cheese and cheese products; (excluding desserts) | 10 g/kg | ||||
| Nut spreads | 30 g/kg | ||||
| Processed potato products | 10 g/kg | ||||
| Cocoa and chocolate confectionary | 10 g/kg | ||||
| Grains and breakfast cereals | 20 g/kg | ||||
| Pasta based products and noodles | 10 g/kg | ||||
| Pre-cooked or processed cereals | 10 g/kg | ||||
| Bread and rolls | 6 g/kg | ||||
| Fine bakery wares | 15 g/kg | ||||
| Heat-treated meat products | 15 g/kg | ||||
| Herbs and spices; seasonings and condiments | 50 g/kg | ||||
| Soups and broths | 5 g/kg | ||||
| Sauces | 10 g/kg | ||||
| Salads and savoury based sandwich spreads | 30 g/kg | ||||
| Yeast and yeast products | 30 g/kg | ||||
| Protein products, excluding dairy analogues and beverage whiteners | 30 g/kg | ||||
| Flavoured drinks | 10 g/l | ||||
| Coffee, coffee extracts | 20 g/kg | ||||
| Other non-alcoholic beverages | 10 g/l | ||||
| Potato-, cereal-, flour- or starch-based snacks | 300 g/kg | ||||
| Processed nuts | 20 g/kg | ||||
| Yeast beta-glucans | Specified food category | Maximum levels of pure beta-glucans from yeast (Saccharomyces cervisiae) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’ | ||
| Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 1,275 g/day for children older than 12 years and general adult population0,675 g/day for children younger than 12 years | ||||
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 | 1,275 g/day | ||||
| Food for special medical purposes as defined in Regulation (EU) No 609/2013, excluding food for special medical purposes intended for infants and young children | 1,275 g/day | ||||
| Beverages based on fruit and/or vegetable juices including concentrate and dehydrated juices | 1,3 g/kg | ||||
| Fruit-flavoured drinks | 0,8 g/kg | ||||
| Cocoa beverages preparation powder | 38,3 g/kg (powder) | ||||
| Other beverages | 0,8 g/kg (ready to drink) | ||||
| 7 g/kg (powder) | |||||
| Cereal bars | 6 g/kg | ||||
| Breakfast cereals | 15,3 g/kg | ||||
| Wholegrain and high fibre instant hot breakfast cereals | 1,5 g/kg | ||||
| Cookie-type biscuits | 6,7 g/kg | ||||
| Cracker-type biscuits | 6,7 g/kg | ||||
| Milk based beverages | 3,8 g/kg | ||||
| Fermented milk products | 3,8 g/kg | ||||
| Milk product analogues | 3,8 g/kg | ||||
| Dried milk/milk powder | 25,5 g/kg | ||||
| Soups and soup mixes | 0,9 g/kg (ready to eat) | ||||
| 1,8 g/kg (condensed) | |||||
| 6,3 g/kg (powder) | |||||
| Chocolate and confectionery | 4 g/kg | ||||
| Protein bars and powders | 19,1 g/kg | ||||
| Jam, marmalade and other fruit spreads | 11,3 g/kg | ||||
| Zeaxanthin | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Zeaxanthin’. | ||
| Food Supplements as defined in Directive 2002/46/EC | 2 mg/day | ||||
| Zinc L-pidolate | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Zinc L-pidolate’ | ||
| Foods covered by Regulation (EU) No 609/2013 | 3 g/day | ||||
| Milk based drinks and similar products intended for young children | |||||
| Meal replacement for weight control | |||||
| Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen | |||||
| Food bearing statement on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 | |||||
| Food Supplements as defined in Directive 2002/46/EC |
| Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements | Data protection | |
|---|---|---|---|---|---|
| Frozen, dried and powder forms of Acheta domesticus (house cricket) | Specified food category | Maximum levels (g/100g)(marketed as such or reconstituted according to the instructions) | 1.The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Frozen Acheta domesticus (house cricket)’, ‘ Dried/powdered Acheta domesticus (house cricket)’depending on the form used.2.The labelling of the foodstuffs containing frozen, dried or powder forms of Acheta domesticus (house cricket) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, molluscs and products thereof, and to dust mites.This statement shall appear in close proximity to the list of ingredients. | Authorised on 3 March 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Fair Insects BV, Industriestraat 3, 5107 NC Dongen, the Netherlands.During the period of data protection, the novel food is authorised for placing on the market within the Union only by Fair Insects BV, unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283, or with the agreement of Fair Insects BV.End date of the data protection: 3 March 2027. | |
| Frozen | Dried or powder | ||||
| Frozen, dried, and powder forms of Acheta domesticus | |||||
| Protein products other than meat analogues | 40 | 20 | |||
| Bread and rolls | 30 | 10 | |||
| Bakery wares, cereal bars, and stuffed pasta products | 30 | 15 | |||
| Biscuits | 30 | 8 | |||
| Pasta-based products (dry) | 3 | 1 | |||
| Soups and soup concentrates or powders | 20 | 5 | |||
| Processed potato products, legumes- and vegetable- based dishes, and pasta- or pizza-based products | 15 | 5 | |||
| Corn flour based snacks | 40 | 20 | |||
| Beer-like beverages, alcoholic drink mixes | 1 | 1 | |||
| Nuts, oilseeds and chickpeas | 40 | 25 | |||
| Sauces | 30 | 10 | |||
| Meat preparations | 40 | 16 | |||
| Meat analogues | 80 | 50 | |||
| Chocolate confectionary | 30 | 10 | |||
| Frozen fermented milk based products | 15 | 5 | |||
| Frozen, dried and powder forms of Locusta migratoria (migratory locust) | Specified food category | Maximum levels (g/100 g)(marketed as such or reconstituted according to the instructions) | 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be frozen Locusta migratoria (migratory locust), dried/powder Locusta migratoria (migratory locust), Whole Locusta migratoria (migratory locust) powder depending on the form used.2. The labelling of the foodstuffs containing frozen dried or powder forms of Locusta migratoria (migratory locust) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, molluscs and products thereof, and to mites.This statement shall appear in close proximity to the list of ingredients. | Authorised on 5.12.2021.This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Fair Insects BV, Industriestraat 3, 5107 NC Dongen, the Netherlands.During the period of data protection, the novel food is authorised for placing on the market within the Union only by Fair Insects BV, unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283, or with the agreement of Fair Insects BV.End date of the data protection: 5.12.2026. | |
| Frozen | Dried orPowder | ||||
| Frozen, dried and powder forms of Locusta migratoria | |||||
| Processed potato products; legumes-based dishes and pasta-based products | 15 | 5 | |||
| Meat analogues | 80 | 50 | |||
| Soups and concentrated soups | 15 | 5 | |||
| Canned/jarred legumes and vegetables | 20 | 15 | |||
| Salads | 15 | 5 | |||
| Beer-like beverages, Alcoholic drink mixes | 2 | 2 | |||
| Chocolate confectionery | 30 | 10 | |||
| Nuts, oilseeds and chickpeas | 20 | ||||
| Frozen fermented milk-based products | 15 | 5 | |||
| Sausages | 30 | 10 | |||
| Frozen, dried and powder forms of yellow mealworm (Tenebrio molitor larva) | Specified food category | Maximum levels (g/100g)(marketed as such or reconstituted according to the instructions) | 1. Depending on the form used, the designation of the novel food on the labelling of the foodstuffs containing it shall be frozen yellow mealworm (Tenebrio molitor larva), dried yellow mealworm (Tenebrio molitor larva), or yellow mealworm (Tenebrio molitor larva) powder.2. The labelling of the foodstuffs containing frozen, dried and powder forms of yellow mealworm (Tenebrio molitor larva) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans and products thereof and to dust mites. This statement shall appear in close proximity to the list of ingredients. | Authorised on 1 March 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: Fair Insects BV, Industriestraat 3, 5107 NC Dongen, the Netherlands.During the period of data protection, the novel food is authorised for placing on the market within the Union only by Fair Insects BV, unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283, or with the agreement of Fair Insects BV.End date of the date protection: 1 March 2027. | |
| Frozen | Dried or powder | ||||
| Frozen, dried and powder forms of yellow mealworm (Tenebrio molitor larva) | |||||
| Multigrain bread and rolls; crackers and breadsticks | 30 | 10 | |||
| Cereal bars | 30 | 15 | |||
| Dried pasta based products; pasta based dishes (excluding dried puffed pasta); pizza and pizza-like dishes | 15 | 10 | |||
| Dried stuffed pasta based products | 30 | 15 | |||
| Pre-mixes (dry) for baked products | 30 | 15 | |||
| Sauces | 30 | 10 | |||
| Potato, legumes based dishes | 15 | 10 | |||
| Whey powder | 40 | 20 | |||
| Meat analogues | 80 | 50 | |||
| Soups and salads | 20 | 5 | |||
| Chips/crisps | 40 | 20 | |||
| Beer-like beverages; mixed alcoholic drinks; alcoholic drink mixes | 1 | 1 | |||
| Chocolate confectionary | 30 | 10 | |||
| Nuts, oilseeds and chickpeas | 40 | 30 | |||
| Frozen fermented milk-based products | 15 | 5 | |||
| Meat preparations | 40 | 16 | |||
| UV-treated powder of whole Tenebrio molitor larvae (yellow mealworm) | Specified food category | Maximum levels (g/100 g)(Maximum levels of vitamin D3 (μg/100 g food)) | 1.The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘UV-treated Tenebrio molitor larvae (yellow mealworm) powder’.2.The labelling of the foodstuffs containing UV-treated powder of whole Tenebrio molitor larvae (yellow mealworm) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, and products thereof, and to dust mites.This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredients, in close proximity to the name of the food.3.Where the novel food is added to final product that contain an amount of vitamin D that is considered significant in accordance with Point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011, the designation of the novel food shall be accompanied by ‘containing vitamin D produced by UV treatment’, and the nutrition declaration shall contain the amount of vitamin D. | Authorised on 10 February 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Nutri’Earth’, 68 rue Louis Joseph Gay Lussac, 62220 Carvin, France.During the period of data protection, the novel food UV-treated powder of whole Tenebrio molitor larvae (yellow mealworm) is authorised for placing on the market within the Union only by ‘Nutri’Earth’, unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283, or with the agreement of ‘Nutri’Earth’.End date of the data protection: 10 February 2030. | |
| Bread and rolls | 4,0 (≤ 3,2 μg vitamin D3 /100 g food) | ||||
| Cakes | 4,0 (≤ 3,2 μg vitamin D3 /100 g food) | ||||
| Pasta-based products | 3,5 (≤ 2,8 μg vitamin D3 /100 g food) | ||||
| Processed potato products | 3,0 (≤ 2,4 μg vitamin D3 /100 g food) | ||||
| Cheese and cheese products | 1,0 (≤ 0,8 μg vitamin D3 /100 g food) | ||||
| Fruit and vegetable compotes | 3,5 (≤ 2,8 μg vitamin D3 /100 g food) | ||||
| Authorised Novel Food | Specifications | |||
|---|---|---|---|---|
| N-Acetyl-D-neuraminic acid | Description:N-Acetyl-D-neuraminic acid is a white to off-white crystalline powderDefinition:Chemical name:IUPAC names:N-Acetyl-D-neuraminic acid (dihydrate)5-Acetamido-3,5-dideoxy-D-glycero-D-galacto-non-2-ulopyranosonic acid (dihydrate)Synonyms:Sialic acid (dihydrate)Chemical formula:C11H19NO9 (acid)C11H23NO11 (C11H19NO9 * 2H2O) (dihydrate)Molecular mass:309,3 Da (acid)345,3 (309,3 + 36,0) (dihydrate)CAS No.:131-48-6 (free acid)50795-27-2 (dihydrate)Specifications:Description: white to off-white crystalline powderpH (20 °C, 5 % solution): 1,7 – 2,5N-Acetyl-D-neuraminic acid (dihydrate): > 97,0 %Water (dihydrate calculates to 10,4 %): ≤ 12,5 % (w/w)Ash, sulphated: < 0,2 % (w/w)Acetic acid (as free acid and/or sodium acetate): < 0,5 % (w/w)Heavy Metals:Iron: < 20,0 mg/kgLead: < 0,1 mg/kgResidual proteins: < 0,01 % (w/w) Residual solvents:2-Propanol: < 0,1 % (w/w)Acetone: < 0,1 % (w/w)Ethyl acetate: < 0,1 % (w/w)Microbiological criteria:Salmonella: Absence in 25 gAerobic mesophilic total count:< 500 CFU/gEnterobacteriaceae: Absence in 10 gCronobacter (Enterobacter) sakazakii: Absence in 10 gListeria monocytogenes: Absence in 25 gBacillus cereus: < 50 CFU/gYeasts: < 10 CFU/gMoulds: < 10 CFU/gResidual endotoxins: < 10 EU/mgCFU: Colony Forming Units; EU: Endotoxin Units. | |||
| Roasted seeds of Dipteryx alata Vogel (baru) (traditional food from a third country) | Description/Definition:The traditional food consists of whole roasted nuts (seeds) of Dipteryx alata Vogel [Family: Fabaceae (alt. Leguminosae)].Synonyms: Coumarouna alata (Vogel) Taub.Common names: Baru, bajuró, cumaru, cumarurana, and feijão-coco.Typical composition range:Water activity: ≤ 0,5Moisture (g/100 g): ≤ 5Protein (g/100 g): 20-35Ash (g/100 g): ≤ 3,5Total carbohydrates (g/100 g): 40-50Fat (g/100 g): 20-35Heavy metals:Lead: ≤ 0,1 mg/kgArsenic: ≤ 0,1 mg/kgCadmium: ≤ 0,2 mg/kgProcess contaminants:Acrylamide: ≤ 300 μg/kgMycotoxins:Sum of Aflatoxins (B1+B2+G1+G2): < 4 μg/kgAflatoxin B1: < 2 μg/kgMicrobiological criteria:Total aerobic mesophilic count: ≤ 5000 cfu/gYeast & Moulds: ≤ 100 cfu/gE. coli: ≤ 10 cfu/gSalmonella: Not detected in 25 gColiforms: ≤ 100 cfu/gEnterobacteriaceae: ≤ 1000 cfu/gBacillus cereus: ≤ 100 cfu/gStaphylococcus aureus: ≤ 100 cfu/gSpores of sulphite-reducing clostridia: ≤ 100 cfu/gcfu: colony forming units | |||
| Frozen, dried and powder forms of Acheta domesticus (house cricket) | Description/Definition:The novel food consists of the whole, frozen, dried and powder forms of the house cricket. The term ‘house cricket’ refers to the adult Acheta domesticus, an insect species that belongs to the Gryllidae family.The novel food is intended to be marketed in three different forms, namely: (i) thermally processed and frozen whole A. domesticus (AD frozen); (ii) thermally processed and freeze-dried whole A. domesticus (AD dried), and (iii) thermally processed freeze-dried and ground whole A. domesticus (whole AD powder).A minimum 24 hours fasting period is required before killing the insects by freezing, to allow the adults to discard their bowel content. | |||
| Characteristics/Composition (AD frozen):Ash (% w/w): 0,6–1,2Moisture (% w/w): 76–82Crude protein (N x 6,25) (% w/w): 12–21Digestible Carbohydrates (% w/w): 0,1–2Fat (% w/w): 3–12of which saturated (% w/w): 36–45Peroxide value (Meq O2/kg fat): ≤ 5Dietary fibre (% w/w): 0,8–3noteChitin (% w/w): 0,7–3,0Heavy metals:Lead: ≤ 0,05 mg/kgCadmium: ≤ 0,06 mg/kgMycotoxins:Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 μg/kgAflatoxin B1 (μg/kg): ≤ 2Deoxynivalenol: ≤ 200 μg/kgOchratoxin A: ≤ 1 μg/kgDioxins and dioxin like PCBsSum of dioxins and dioxin-like PCBs UB, (noteWHO2005 PCDD/F-PCB-TEQ): ≤ 1,25 pg/g fatMicrobiological criteria:Total aerobic colony count: ≤ 105noteCFU/gYeasts and moulds: ≤ 100 CFU/gEscherichia coli: ≤ 50 CFU/gSalmonella spp.: Absence in 25 gListeria monocytogenes: Absence in 25 gSulfite-reducing Anaerobes: ≤ 30 CFU/gBacillus cereus (presumptive): ≤ 100 CFU/gEnterobacteriaceae (presumptive): < 100 CFU/gCoagulase-positive staphylococci: ≤ 100 CFU/g | Characteristics/Composition (AD dried or powder):Ash (% w/w): 2,9–5,1Moisture (% w/w): ≤ 5Crude protein (N x 6,25) (% w/w): 55–65Digestible Carbohydrates (% w/w): 1–4Fat (% w/w): 29–35of which saturated (% w/w): 36–45Peroxide value (Meq O2/kg fat): ≤ 5Dietary fibre (% w/w): 3–6noteChitin (% w/w): 5,3-10,0Heavy metals:Lead: ≤ 0,05 mg/kgCadmium: ≤ 0,06 mg/kgMycotoxins:Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 μg/kgAflatoxin B1 (μg/kg): ≤ 2Deoxynivalenol: ≤ 200 μg/kgOchratoxin A: ≤ 1 μg/kgDioxins and dioxin like PCBsSum of dioxins and dioxin-like PCBs UB, (noteWHO2005 PCDD/F-PCB-TEQ): ≤ 1,25 pg/g fatMicrobiological criteria:Total aerobic colony count: ≤ 105 CFU/gYeasts and moulds: ≤ 100 CFU/gEscherichia coli: ≤ 50 CFU/gSalmonella spp.: Absence in 25 gListeria monocytogenes: Absence in 25 gSulfite-reducing Anaerobes: ≤ 30 CFU/gBacillus cereus (presumptive): ≤ 100 CFU/gEnterobacteriaceae (presumptive): < 100 CFU/gCoagulase-positive staphylococci: ≤ 100 CFU/g | |||
| Acheta domesticus (house cricket) partially defatted powder | Description/Definition:The novel food is partially defatted powder obtained from whole Acheta domesticus (house cricket) following a series of steps involving a 24 hours fasting period of the insects to allow them to discard their bowel content, the sacrifice of the insects by freezing, washing, thermal processing, drying, oil extraction (mechanical extrusion), and grinding. | |||
| Characteristics/Composition:Crude protein (N x 6,25) (% w/w): 74,0 - 78,0Fat (% w/w): 9,0 – 12,0Moisture (% w/w): 3,0 – 6,0Crude fibre (% w/w): 8,0 – 10,0Chitinnote (% w/w): 4,0-8,5Ash (% w/w): ≤ 5,6Peroxide value (Meq O2/kg fat): ≤ 5,0Manganese: ≤ 100,0 mg/kgCyanide: ≤ 5,0 mg/kgHeavy metals:Lead: ≤ 0,1 mg/kgCadmium: ≤ 0,025 mg/kgMycotoxins:Aflatoxins (Sum of B1, B2, G1, G2): ≤ 0,4 μg/kgDeoxynivalenol: ≤ 200,0 μg/kgOchratoxin A: ≤ 1,0 μg/kgDioxins and dioxin like PCBs:Sum of dioxins and dioxin-like PCBs UB, (noteWHO2005 PCDD/F-PCB-TEF): ≤ 1,25 pg/g fatMicrobiological criteria:Total aerobic microbial count: ≤ 105 CFU/gYeasts and moulds: ≤ 100 CFU/gEscherichia coli: ≤ 50 CFU/gSalmonella spp.: Not detected in 25 gListeria monocytogenes: Not detected in 25 gBacillus cereus (presumptive): ≤ 100 CFU/gEnterobacteriaceae (presumptive): < 100 CFU/gCoagulase-positive staphylococci: ≤ 100 CFU/g | ||||
| Adansonia digitata (Baobab) dried fruit pulp | Description/Definition:The Baobab (Adansonia digitata) fruits are harvested from trees. The hard shells are cracked open and the pulp is separated from the seeds and the shell. This is milled, separated into coarse and fine lots (particle size 3 to 600 μ) and then packaged.Typical nutritional components:Moisture (loss on drying) (g/100 g): 4,5-13,7Protein (g/100 g): 1,8-9,3Fat (g/100 g): 0-1,6Total carbohydrate (g/100 g): 76,3-89,5Total sugars (as glucose): 15,2-36,5Sodium (mg/100 g): 0,1-25,2Analytical specifications:Foreign matter: Not more than 0,2 %Moisture (loss on drying) (g/100 g): 4,5-13,7Ash (g/100 g): 3,8-6,6 | |||
| Ajuga reptans extract from cell cultures | Description/Definition:Hydroalcoholic extract from Ajuga reptans L. tissue cultures which is substantially equivalent to extracts from flowering aerial parts of Ajuga reptans obtained by traditional cultures. | |||
| Akkermansia muciniphila (pasteurised) | Description:Pasteurised Akkermansia muciniphila (strain ATCC BAA-835, CIP 107961) is produced by anaerobic growth of the bacteria followed by pasteurisation, concentration of the cells, cryopreservation, and freeze drying.Characteristics/Composition:Total A. muciniphila cell count (cells/g): 2,5 × 1010 to 2,5 × 1012Viable A. muciniphila cell count (CFU/g): < 10 (LoD)(*)Water activity: ≤ 0,43Moisture (%): ≤ 12,0Protein (%): ≤ 35,0Fat (%): ≤ 4,0Crude ash (%): ≤ 21,0Carbohydrates (%): 36,0 – 86,0Microbiological criteria:Aerobic mesophilic total count: ≤ 500 CFU(**)/gSulphite reducing anaerobes: ≤ 50 CFU/gCoagulase+ Staphylococci: ≤ 10 CFU/gEnterobacteriaceae: ≤ 10 CFU/gYeast: ≤ 10 CFU/gMould: ≤ 10 CFU/gBacillus cereus: ≤ 100 CFU/gListeria spp.: Absence in 25 gSalmonella spp.: Absence in 25 gEscherichia coli: Absence in 1 g(*)LoD: Limit of Detection;(**)Colony Forming Units. | |||
| L-Alanyl-L-Glutamine | Description/Definition:L-Alanyl-L-Glutamine is produced by fermentation with a genetically modified strain of Escherichia coli. During the fermentation process, the ingredient is secreted into the growth medium from which it is subsequently separated and purified to a concentration of > 98 %.Appearance: White crystalline powderPurity: > 98 %Infrared spectroscopy: Conformity with ref. standardAppearance of solution: Colourless and clearAssay (dry basis): 98-102 %Related substances (each): ≤ 0,2 %Residue on ignition: ≤ 0,1 %Loss on drying: ≤ 0,5 %Optical rotation: +9,0 - +11,0opH (1 %; H2O): 5,0-6,0Ammonium (NH4): ≤ 0,020 %Chloride (Cl): ≤ 0,020 %Sulphate (SO4): ≤ 0,020 %Microbiological criteria:Escherichia coli: Absence/g | |||
| Algal oil from the microalgae Ulkenia sp. | Description/Definition:Oil from the micro-algae Ulkenia sp.Acid value: ≤ 0,5 mg KOH/gPeroxide value (PV): ≤ 5,0 meq/kg oilMoisture and volatiles: ≤ 0,05 %Unsaponifiables: ≤ 4,5 %Trans-fatty acids: ≤ 1,0 %DHA content: ≥ 32 % | |||
| Allanblackia seed oil | Description/Definition:Allanblackia seed oil is obtained from the seeds of the allanblackia species: A. floribunda (synonymous with A. parviflora) and A. stuhlmannii.Composition of fatty acids (as a % of the total fatty acids):Lauric acid — Myristic acid — Palmitic acid (C12:0 – C14:0 – C16:0): sum of these acids < 4,0 %Stearic acid (C18:0): 45-58 %Oleic acid (C18:1): 40-51 %Poly unsaturated fatty acids (PUFA): < 2 %Characteristics:Free fatty acids: max 0,1 % of total fatty acidsTrans fatty acids: max 1,0 % of total fatty acidsPeroxide value: max 1,0 meq/kgUnsaponifiable matter: max 1,0 % (w/w) of the oilSaponification value: 185-198 mg KOH/g | |||
| Aloe macroclada Baker leaf extract | Description/Definition:Powdered gel extract derived from the leaves of Aloe macroclada Baker which is substantially equivalent to the same gel derived from Aloe vera (L.) Burm.f. leaves.Ash: 25 %Dietary fibres: 28,6 %Fat: 2,7 %Moisture: 4,7 %Polysaccharides: 9,5 %Protein: 1,63 %Glucose: 8,9 % | |||
| Frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm) | Description/Definition:The novel food consists of the frozen, paste, dried, and powder forms of the whole lesser mealworm. The term ‘lesser mealworm’ refers to the larval form of Alphitobius diaperinus, an insect species that belongs to the family of Tenebrionidae (darkling beetles).The entire lesser mealworms are meant for human consumption, no parts are removed.The novel food is intended to be marketed in 4 different forms, namely: (i) whole blanched and frozen A. diaperinus larvae (ADL frozen), (ii) paste from whole blanched, ground, and frozen A. diaperinus larvae (ADL paste), (iii) whole blanched, and freeze-dried A. diaperinus larvae (ADL dried), and (iv) powder from whole blanched, freeze-dried and ground A. diaperinus larvae (ADL powder).A minimum 24 hours fasting period is required to allow the larvae to discard their bowel content before killing the insects by a thermal treatment. | |||
| Characteristics/Composition (ADL frozen or paste):Ash (% w/w): ≤ 1,5Moisture (% w/w): 65-80Crude protein (N × 6,25) (% w/w): 12-25Digestible Carbohydrates (% w/w): 0,4-2Fat (% w/w): 5-12Peroxide value (Meq O2/kg fat): ≤ 0,2Dietary fibre (% w/w): 1-4Chitin (% w/w): 1,0-2,6Heavy metals:Lead: ≤ 0,1 mg/kgCadmium: ≤ 0,05 mg/kgMycotoxins:Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 μg/kgAflatoxin B1 (μg/kg): ≤ 2Deoxynivalenol: ≤ 200 μg/kgOchratoxin A: ≤ 1 μg/kgMicrobiological criteria:Total aerobic colony count: ≤ 105CFU/gYeasts and moulds: ≤ 100 CFU/gEscherichia coli: ≤ 50 CFU/gSalmonella spp.: Absence in 25 gListeria monocytogenes: Absence in 25 gSulphite-reducing Anaerobes: ≤ 30 CFU/gBacillus cereus: ≤ 100 CFU/gEnterobacteriaceae: ≤ 100 CFU/gCoagulase-positive staphylococci: ≤ 100 CFU/g | Characteristics/Composition (ADL dried or powder):Ash (% w/w): ≤ 5Moisture (% w/w): 1-5Crude protein (N × 6,25) (% w/w): 50-70Digestible Carbohydrates (% w/w): 1,5-3,5Fat (% w/w): 20-35Peroxide value (Meq O2/kg fat): ≤ 5Dietary fibre (% w/w): 3-6Chitin (% w/w): 3,0-9,1Heavy metals:Lead: ≤ 0,1 mg/kgCadmium: ≤ 0,05 mg/kgMycotoxins:Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 μg/kgAflatoxin B1 (μg/kg): ≤ 2Deoxynivalenol: ≤ 200 μg/kgOchratoxin A: ≤ 1 μg/kgMicrobiological criteria:Total aerobic colony count: ≤ 105 CFU/gYeasts and moulds: ≤ 100 CFU/gEscherichia coli: ≤ 50 CFU/gSalmonella spp.: Absence in 25 gListeria monocytogenes: Absence in 25 gSulfite-reducing Anaerobes: ≤ 30 CFU/gBacillus cereus: ≤ 100 CFU/gEnterobacteriaceae: ≤ 100 CFU/gCoagulase-positive staphylococci: ≤ 100 CFU/g | |||
| Juice of the stems of the Angelica keiskei plant (‘Ashitaba stem juice’) | Description:The novel food is a viscous yellow liquid obtained via physical means of the stems of mature Angelica keiskei (‘Ashitaba’) plants. Angelica keiskei is native to Japan and is called Ashitaba in Japanese, hence the reference to Ashitaba stem juice.The juice is then pasteurised, mixed with cyclodextrins at an approximate ratio of 30 % of Ashitaba stem juice to 70 % cyclodextrins, and the mixture is then sterilised, freeze-dried, and sieved.Source: Angelica keiskei (family Apiaceae)Characteristics/Composition of the juice:Chalcones (xanthoangelol +4-hydroxyderricin) (% w/v): 1,0–2,25Carbohydrates (%): 5,0–7,5Water (%): 90,0–95,0Fat (% w/v): 0,1–0,3Protein (% w/v): 0,15-0,45Sum of angular-type dihydropyranocoumarins: ≤ 10 mg/kgSum of furanocoumarins: ≤ 100 mg/kgHeavy metals:Lead: ≤ 0,1 mg/kgArsenic: ≤ 0,3 mg/kgMercury: ≤ 0,1 mg/kgCadmium: ≤ 1,0 mg/kgMicrobiological criteria:Total viable aerobic count: ≤ 1000 CFU/gTotal yeast/moulds count: ≤ 100 CFU/gEscherichia coli: Absence in 10 gColiforms: ≤ 30 CFU/gSalmonella spp.: Absence in 25 gCFU: Colony Forming Units | |||
| Antarctic Krill oil from Euphausia superba | Description/Definition:To produce lipid extract from Antarctic Krill (Euphausia superba) deep-frozen crushed krill or dried krill meal is subjected to lipid extraction with an approved extraction solvent (under Directive 2009/32/EC). Proteins and krill material are removed from the lipid extract by filtration. The extraction solvents and residual water are removed by evaporation.Saponification value: ≤ 230 mg KOH/gPeroxide value (PV): ≤ 3 meq O2/kg oilOxidative stability: All food products containing Antarctic Krill oil from Euphausia superba should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC).Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °CPhospholipids: ≥ 35 % to < 60 %Trans-fatty acids: ≤ 1 %EPA (eicosapentaenoic acid): ≥ 9 %DHA (docosahexaenoic acid): ≥ 5 % | |||
| Antarctic Krill oil rich in phospholipids from Euphausia superba | Description/Definition:Oil rich in phospholipids is produced from Antarctic krill (Euphausia superba) by repeated solvent washings with an approved solvent (under Directive 2009/32/EC) to increase phospholipid content of the oil. Solvents are removed from the final product by evaporation.Saponification value: ≤ 230 mg KOH/gPeroxide value (PV): ≤ 3 meq O2/kg oilMoisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °CPhospholipids: ≥ 60 %Trans-fatty acids: ≤ 1 %EPA (eicosapentaenoic acid): ≥ 9 %DHA (docosahexaenoic acid): ≥ 5 % | |||
| Antrodia camphorata mycelia powder | Description/Definition:The novel food is the freeze-dried mycelia of the fungus Antrodia camphorata (strain BCRC 39106), which has been grown by solid-state cultivation. The freeze-dried mycelia are then milled into a powder. Antrodia camphorata is a synonym of Taiwanofungus camphoratus (family: Fomitopsidaceae).Characteristics/Composition:Loss on drying (Moisture): < 10 %Carbohydrates: ≤ 80 g/100 gProtein: ≤ 20 g/100 gAsh: ≤ 6 g/100gFat: ≤ 6 g/100 gTotal triterpenoids: 1,0 – 10,0 g/100 gAntroquinonol: 1,0 – 20,0 mg/gHeavy metals:Arsenic: < 0,5 mg/kgMicrobiological criteria:Total aerobic microbial count: ≤ 103 *CFU/gTotal yeast and mould count: ≤ 100 CFU/gEscherichia coli: Not detected in 10 gSalmonella spp.: Not detected in 25 gStaphylococcus aureus: Not detected in 10 g*CFU: Colony Forming Units | |||
| Aqueous ethanolic extract of Labisia pumila | Description/Definition:The novel food is a hydroalcoholic extract obtained from a dried whole plant of Labisia pumila (Blume) Fern.-Vill.The production process of the novel food starts with washing, drying and grinding of the plant Labisia pumila. The ground plant material is then extracted twice with a mixture of water and ethanol (50/50 v/v). The liquid extract is then concentrated, mixed with maltodextrin (which is used as a drying aid) in a ratio of 2:1 and spray-dried.Characteristics/composition (including maltodextrin):Particle size: > 90 % through 120 mesh (125 μm)Ash: < 10 %Acid-insoluble ash: < 1 %Moisture: < 8 %Ethanol: < 1 % (w/w)Gallic acid: 2-10 % (w/w)Carbohydrate: 70-90 g/100 gProtein: < 9 % (w/w)Total fat: < 3 % (w/w)Saponin (as ardisiacripsin A): < 1,5 % (w/w)Microbiological criteria:Aerobic plate count: < 1×104 CFU/gYeast and mould: < 5×102 CFU/gE. coli: not detected in 10 gS.aureus: not detected in 10 gSalmonella: not detected in 25 gP. aeruginosa: not detected in 10 gcfu: colony forming unitsw/w: weight per weight | |||
| Apple fruit cell culture biomass | Description/Definition:The novel food is a biomass of cultivated and homogenised cells of the Swiss apple variety Uttwiler Spätlauber (Malus domestica Borkh.).The production process consists of collecting under sterile conditions specific sections of the apple, which are then placed on solid medium with the aim to induce the formation of a primary callus tissue comprised of dedifferentiated cells under sterile conditions. The callus cells are then cultivated in liquid medium and subsequently homogenised, heat treated and dried.Characteristics/composition:Moisture: 10,9–15,5 g/100 gAsh: 11,8–20,8 g/100 gProteins: 14,3–20,0 g/100 gFats: 0,6–2,5 g/100 gNon-digestible carbohydrates: 17,1–25,2 g/100 gOther carbohydrates (calculatednote): 21,9–38,9 g/100 gTotal sugars: 17,1–32,6 g/100gFructose: 10,8–20,2 g/100 gGlucose: 3,8–7,0 g/100 gTotal phenols: 0,15–0,29 g/100 gMalic acid: 0,41–1,19 g/100 gSuccinic acid: 0,14–0,26 g/100 g | |||
| Arachidonic acid-rich oil from the fungus Mortierella alpina | Description/Definition:The clear yellow arachidonic acid-rich oil is obtained by fermentation of the non-genetically modified strains IS-4, I49-N18, FJRK-MA01 and CBS 210.32 of the fungus Mortierella alpina using a suitable liquid. The oil is then extracted from the biomass and purified.Arachidonic acid: ≥ 40 % by weight of the total fatty acid contentFree fatty acids: ≤ 0,45 % of the total fatty acid contentTrans fatty acids: ≤ 0,5 % of the total fatty acid contentUnsaponifiable matter: ≤ 1,5 % Peroxide value (PV): ≤ 5 meq/kgAnisidin value: ≤ 20Acid value: ≤ 1,0 KOH/gMoisture: ≤ 0,5 % | |||
| Argan oil from Argania spinosa | Description/Definition:Argan oil is the oil obtained by cold pressing of the almond like kernels of the fruits of Argania spinosa (L.) Skeels. Kernels may be roasted prior to pressing, but with no direct contact with a flame.Composition:Palmitic acid (C16:0): 12-15 %Stearic acid (C18:0): 5-7 %Oleic acid (C18:1): 43-50 %Linoleic acid (C18:2): 29-36 %Unsaponifiable matter: 0,3-2 %Total sterols: 100-500 mg/100 gTotal tocopherols: 16-90 mg/100 gOleic acidity: 0,2-1,5 %Peroxide value (PV): < 10 meq O2/kg | |||
| Astaxanthin-rich oleoresin from Haematococcus pluvialis algae | Description:Astaxanthin is a carotenoid produced by Haematococcus pluvialis algae. Production methods for the growth of the algae are variable; using ‘closed’ systems exposed to sunlight or strictly controlled illuminated light alternatively open ponds may be used. The algal cells are harvested and dried; the oleoresin is extracted using either super critical CO2 or a solvent (ethyl acetate). The Astaxanthin is diluted and standardized to 2,5 %, 5,0 %, 7,0 %, 10 %, 15 % or 20 % using olive oil, safflower oil, Sunflower oil or MCT (Medium Chain Triglycerides).Characteristics/Composition:Fat: 42,2-99 %Protein: ≤ 4,4 %Carbohydrate: ≤ 52,8 %Fibre: < 1,0 %Ash: ≤ 4,2 %Specification of Carotenoids % w/wTotal Astaxanthins: 2,9-11,1 %9-cis-astaxanthin: 0,3-30,0 %13-cis-astaxanthin: 0,2-7,0 %Astaxanthin monoesters: 66,7-91,5 %Astaxanthin diesters: 0,16-32,5 %Beta-Carotene: 0,01-0,3 %Lutein: ≤ 1,8 %Canthaxanthin: ≤ 1,30 %Microbiological criteria:Total aerobic bacteria: < 3000 CFU/gYeast and Moulds: < 100 CFU/gColiforms: < 10 CFU/gE. coli: NegativeSalmonella: NegativeStaphylococcus: Negative | |||
| Partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) | Description/Definition:The novel food is partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa), residues obtained from the solid by-product of beer production that contains 45-70 % spent barley and 30-55 % spent rice.The novel food is produced by enzymatically treating the pasteurised spent barley and rice residues of the mash step of beer production. Several mechanical treatment steps of the partial hydrolysate are employed to obtain the final product.Characteristics/composition:Appearance: powderDegree of hydrolysis: 1-7 %Proteins (N x 6,25): 78-90 %Moisture: 2-8 %Carbohydrates: 2-10 %Fat: 0-2 %Ash: 1-8 %Heavy metals:Arsenic (mg/kg): ≤ 0,2Cadmium (mg/kg): ≤ 0,1Lead (mg/kg): ≤ 0,2Mercury (mg/kg): ≤ 0,01Mycotoxins:Aflatoxin B1: ≤ 2 μg/kgSum of aflatoxins (B1, B2, G1, G2): ≤ 4 μg/kgDeoxynivalenol: < 200 μg/kgFumonisins (sum of B1, B2): ≤ 200 μg/kgOchratoxin A: ≤ 3 μg/kgZearalenone: ≤ 20 μg/kgPatulin: ≤ 50 μg/kgAntinutritional factors:Phytic acid: < 0,25 %Microbiological criteria:Total aerobic microbial count (CFU/g): < 104Coliforms (CFU/g): < 100Total yeast and mould count (CFU/g): < 100Salmonella spp.: Not detected in 25 gEscherichia coli (CFU/g): < 10Staphylococcus aureus (CFU/g): < 10Listeria monocytogenes: Not detected in 25 gBacillus cereus (CFU/g): < 100CFU: colony forming units | |||
| Basil seeds (Ocimum basilicum) | Description/Definition:Basil (Ocimum basilicum L.) belongs to the family ‘Lamiaceae’ within the order ‘Lamiales’. Post-harvest the seeds are cleaned mechanically. Flowers, leaves and other parts of the plant are removed. Highest level of purity of Basil seeds has to be ensured by filtering (optical, mechanical). Production process of fruit juice and fruit/vegetable blend beverages containing Basil seeds (Ocimum basilicum L.) includes seed pre-hydration and pasteurisation steps. Microbiological controls and monitoring systems are in place.Dry Matter: 94,1 %Protein: 20,7 %Fat: 24,4 %Carbohydrate: 1,7 %Dietary Fibre: 40,5 % (Method: AOAC 958,29)Ash: 6,78 % | |||
| Beta-glucan from Euglena gracilis microalgae | Description/Definition:The novel food, beta-glucan from Euglena gracilis microalgae (paramylon), is a linear, unbranched beta-1,3-D-glucan polymer derived from the non-GM microalga Euglena gracilis.The novel food is produced by fermentation, followed by pH adjustment and homogenization to release the beta-glucan granules. The granules are isolated by decanting and washing, and subsequently, acidified and filtered. After drying, the product is milled. The process includes conditions such as an alkaline pH and heat-killing step of the microalga to ensure the absence of viable Euglena gracilis cells in the novel food.Characteristics/composition:Appearance: cream white powderBeta-glucannote: (%) ≥ 95Moisture (%): ≤ 6Ash (%): ≤ 1Heavy metals:Lead (mg/kg): ≤ 0,5Cadmium (mg/kg): ≤ 0,5Mercury (mg/kg): ≤ 0,05Arsenic (mg/kg): ≤ 0,02Microbiological criteria:Total aerobic microbial count (CFU/g): ≤ 3000Total yeast and mould count (CFU/g): ≤ 100Coliforms (MPN/g): ≤ 30Escherichia coli: Not detected in 10 gStaphylococcus aureus: Not detected in 10 gSalmonella spp.: Not detected in 25 gListeria monocytogenes: Not detected in 25 gCFU: colony forming units, MPN: most probable number. | |||
| Betaine | Description/Definition:Betaine (N,N,N-trimethylglycine or carboxy-N,N,N-trimethylmethanaminium), in anhydrous (CH3)3N+CH2COO– (CAS No: 107-43-7) and monohydrate (CH3)3N+CH2COO–.H2O (CAS No: 590-47-6) forms is obtained from processing of sugar beets (i.e. molasses, vinasses or betaine-glycerol).Characteristics/CompositionAppearance: Free-flowing white crystalsBetaine: ≥ 99,0 % (w/w on dry weight basis)Moisture: ≤ 2,0 % (anhydrous); ≤ 15,0 % (monohydrate)Ash: ≤ 0,1 %pH: 5,0-7,0Residual protein: ≤ 1,0 mg/gHeavy metals:Arsenic: < 0,1 mg/kgMercury: < 0,005 mg/kgCadmium: < 0,01 mg/kgLead: < 0,05 mg/kgMicrobiological criteria:Total viable count: ≤ 100 CFU/gColiforms: Negative/10 gSalmonella sp.: Negative/25 gYeast: ≤ 10 CFU/gMould: ≤ 10 CFU/gCFU: Colony Forming Units. | |||
| Fermented black bean extract | Description/Definition:Fermented black bean extract (Touchi extract) is a fine light-brown protein-rich powder obtained by water extraction of small soybeans (Glycine max (L.) Merr.) fermented with Aspergillus oryzae. The extract contains an α-glucosidase inhibitor.Characteristics:Fat: ≤ 1,0 %Protein: ≥ 55 % Water: ≤ 7,0 %Ash: ≤ 10 %Carbohydrate: ≥ 20 %α-glucosidase inhibitory activity: IC50 min 0,025 mg/mlSoy isoflavone: ≤ 0,3 g/100 g | |||
| Bovine lactoferrin | Description/Definition:Bovine lactoferrin is a protein that occurs naturally in cows’ milk. It is an iron-binding glycoprotein of approximately 77 kDa and consists of a single polypeptide chain of 689 amino acids.Production process: Bovine lactoferrin is isolated from skimmed milk or cheese whey via ion exchange and subsequent ultra-filtration steps. Finally, it is dried by freeze drying or spraying and the large particles are sieved out. It is a virtually odourless, light pinkish powder.Physical-Chemical properties of Bovine lactoferrin:Moisture: < 4,5 %Ash: < 1,5 %Arsenic: < 2,0 mg/kgIron: < 350 mg/kgProtein: > 93 %of which bovine lactoferrin: > 95 %of which other proteins: < 5,0 %pH (2 % solution, 20 °C): 5,2-7,2Solubility (2 % solution, 20 °C): complete | |||
| Bovine milk basic whey protein isolate | DescriptionBovine milk basic whey protein isolate is a yellowish grey powder obtained from bovine skimmed milk via a series of isolation and purification steps.Characteristics/CompositionTotal protein (w/weight of product): ≥ 90 %Lactoferrin (w/weight of product): 25-75 %Lactoperoxidase (w/weight of product): 10-40 %Other proteins (w/weight of product): ≤ 30 %TGF-β2: 12-18 mg/100 gMoisture: ≤ 6,0 %pH (5 % solution w/v): 5,5 – 7,6Lactose: ≤ 3,0 %Fat: ≤ 4,5 %Ash: ≤ 3,5 %Iron: ≤ 25 mg/100 gHeavy MetalsLead: < 0,1 mg/kgCadmium: < 0,2 mg/kgMercury: < 0,6 mg/kgArsenic: < 0,1 mg/kgMicrobiological criteria:Aerobic mesophilic count: ≤ 10000 CFU/gEnterobacteriaceae: ≤ 10 CFU/gEscherichia coli: Negative/gCoagulase positive Staphylococci: Negative/gSalmonella: Negative/25 gListeria: Negative/25 gCronobacter spp.: Negative/25 gMoulds: ≤ 50 CFU/gYeasts: ≤ 50 CFU/gCFU: Colony Forming Units | |||
| Bovine milk beta-lactoglobulin (β-lactoglobulin) | Description:Beta-lactoglobulin (β-lactoglobulin) protein is a white to cream powder produced from bovine whey by a series of steps involving filtration, concentration, crystallisation, re-dissolution (in water), pH adjustment to acidic or neutral pH, re-concentration and drying.CAS number: 9045-23-2Molecular weight: 36,7 kDa (dimer); 18,3 kDa (monomer)Characteristics/Composition:pH (10 % solution): 3,5-8,0Protein (N x 6,38) (%): ≥ 86,0Beta-lactoglobulin (% of protein): ≥ 90,0Lactose (%): ≤ 1,0Fat (%): ≤ 1,0Ash (%): ≤ 5,0Moisture (%): ≤ 5,5Heavy Metals:Cadmium (mg/kg): < 0,2Lead (mg/kg): < 0,1Mercury (mg/kg): < 0,01Contaminants:Aflatoxin M1 (μg/kg): < 0,01Microbiological criteria:Total plate count: ≤ 5000 CFU/gTotal yeast/moulds count: ≤ 10 CFU/gEnterobacteriaceae: ≤ 10 CFU/gSalmonella spp.: Absent in 25 gBacillus cereus: < 100 CFU/gListeria monocytogenes: Absent in 25 gStaphylococcus aureus: < 10 CFU/gSulfite-reducing clostridia: < 10 CFU/gCFU: Colony Forming Units; kDa: kiloDaltons | |||
| Bovine milk osteopontin | DescriptionBovine milk osteopontin is isolated from pasteurised or microfiltered bovine whey or milk by ion exchange chromatography, ultrafiltration to remove low molecular weight components and spray drying. During this filtration steps lactose and whey proteins predominantly alpha-lactalbumin and beta lactoglobulin are removed.Characteristics/CompositionProtein % as is (N × 6,38): 76,5–80,5Bovine milk osteopontin (bmOPN) (% of protein): ≥ 84,5Full-length bmOPN (MW 33,9 kDa) (% of bmOPN): ≥ 15N-terminal fragment bmOPN (MW 19,8 kDa) (% of bmOPN): ≥ 70Other milk protein (% of protein): ≤ 14,5Moisture: < 9,5 %Lactose: ≤ 1,0 %Fat: ≤ 1,0 %Ash: ≤ 11 %Insolubility index (mL) ≤ 1,0Heavy metalsLead: < 0,05 mg/kgCadmium: < 0,05 mg/kgMercury: < 0,05 mg/kgArsenic: < 0,5 mg/kgAflatoxin M1 < 0,1 μg/kgMicrobiological criteriaTotal plate count (30 °C) (CFU/g): ≤ 5000Mould/yeast (CFU/g): ≤ 100Bacillus cereus (CFU/g): < 50Sulfur-reducing Clostridia (CFU/g): < 10Staphylococcus aureus: Not detected in 1 gEnterobacteriaceae (CFU/g): < 10Salmonella spp.: Not detected in 25 gCFU: Colony Forming Units | |||
| Buglossoides arvensis seed oil | Description/Definition:Refined Buglossoides oil is extracted from the seeds of Buglossoides arvensis (L.) I.M.JohnstAlpha-linolenic acid: ≥ 35 % w/w of total fatty acidsStearidonic acid: ≥ 15 % w/w of total fatty acidsLinoleic acid: ≥ 8,0 % w/w of total fatty acidsTrans fatty acids: ≤ 2,0 % w/w of total fatty acidsAcid value: ≤ 0,6 mg KOH/gPeroxide value (PV): ≤ 5,0 meq O2/kgUnsaponifiable content: ≤ 2,0 %Protein content (total nitrogen): ≤ 10 μg/mlPyrrolizidine alkaloids: Not detectable with a detection limit of 4,0 μg/kg | |||
| Calanus finmarchicus oil | Description/Definition:The novel food is ruby coloured, slightly viscous oil with a slight shellfish odour extracted from the crustacean (marine zooplankton) Calanus finmarchicus. The ingredient consists primarily of wax esters (> 85 %) with minor amounts of triglycerides and other neutral lipids.Specifications:Water: < 1,0 %Wax esters: > 85 %Total fatty acids: > 46 %Eicosapentaenoic acid (EPA): > 3,0 %Docosahexaenoic acid (DHA): > 4,0 %Total fatty alcohols: > 28 %C20:1 n-9 fatty alcohol: > 9,0 %C22:1 n-11 fatty alcohol: > 12 %Trans fatty acids: < 1,0 %Astaxanthin esters: ≤ 0,25 %Peroxide value (PV): < 3,0 meq. O2/kg | |||
| Calcium fructoborate | Description/DefinitionThe novel food is calcium fructoborate, a calcium salt tetrahydrate of a bis(fructose) ester of boric acid in the form of a powder, represented by Ca[(C6H10O6)2B]2•4H2O, with a molecular mass of 846 Da.The novel food is produced by chemical synthesis whereby fructose is combined with boric acid in water to produce a bis(fructose) ester of boric acid through various heating and mixing processes. Calcium carbonate is then added to produce a solution containing the calcium salt of fructoborate (tetrahydrate). The solution is freeze-dried, ground to produce the final powdered product, and then packaged and stored under representative storage conditions (22 ± 1°C RH 55-60 %).Characteristics/compositionFree moisture: < 5,0 %Calcium: 4,5-5 %Boron: 2,5-2,9 %Fructose: 80-85 %Ash: 15-16 %Heavy metalsArsenic: ≤ 1 mg/kgMicrobiological criteriaTotal plate count: ≤ 1000 CFU/g (a)Yeast and mould: < 100 CFU/gColiforms: ≤ 10 CFU/gEscherichia coli: < 10 CFU/gSalmonella spp.: Absence in 25 gCoagulase-positive staphylococci: Absence in 1 g(a)CFU: colony forming units | |||
| Calcium L-Methylfolate | Description:The novel food is produced by chemical synthesis starting from folic acid.It is a white to light yellowish, almost odourless, crystalline powder, sparingly soluble in water and very slightly soluble or insoluble in most organic solvents.Definition:Chemical formula: C20H23CaN7O6Systematic name: N-{4-[[((6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl)methyl]amino]benzoyl}-L-glutamic acid, calcium salt.CAS Numbers: 129025-21-4 (Calcium salt with an unspecified ratio of L-5-MTHF/Ca2+) and 151533-22-1 (Calcium salt with specified 1:1 ratio of L-5-MTHF/Ca2+).Molecular weight: 497,5 DaltonsSynonyms: L-methylfolate, calcium; L-5-methyltetrahydrofolic acid, calcium salt [(L-5-MTHF-Ca)]; (6S)-5-methyltetrahydrofolic acid, calcium salt [(6S)-5-MTHF-Ca]; (6S)-5-methyl-5,6,7,8-tetrahydropteroyl-L-glutamic acid, calcium salt, and L-5-methyl-tetrahydrofolic acid (L-5-MTHF) without the cation specified.Structural formula:CharacteristicsPurity: > 95 % (Dry basis)Water: ≤ 17,0 %Calcium (on anhydrous and solvent free basis): 7,0 – 8,5 %Calcium D-methylfolate (6R, αS isomer): ≤ 1,0 %Other folates and related substances: ≤ 2,5 %Ethanol: ≤ 0,5 %ContaminantsCFU: colony forming units | |||
| Infants and young children | General population excluding infants and young children | |||
| Lead: ≤ 1 mg/kg | Lead: ≤ 1 mg/kg | |||
| Boron: ≤ 10 mg/kg | Boron: ≤ 10 mg/kg | |||
| Cadmium ≤ 0,5 mg/kg | Cadmium ≤ 0,5 mg/kg | |||
| Mercury ≤ 1,0 mg/kg | Mercury ≤ 1,5 mg/kg | |||
| Arsenic ≤ 1,5 mg/kg | Arsenic ≤ 1,5 mg/kg | |||
| Platinum ≤ 2 mg/kg | Platinum ≤ 10 mg/kg | |||
| Microbiological criteria:Total viable aerobic counts: ≤ 1000 CFU/gTotal yeast and mould count: ≤ 100 CFU/g | ||||
| Calcidiol monohydrate | Description/Definition:The novel food is calcidiol monohydrate (25-hydroxycholecalciferol monohydrate). The novel food contains the monohydrate form of the major circulating metabolite of vitamin D3 in the body and is a source of 1,25-dihydroxyvitamin D, the biologically active form of vitamin D.Conversion factor: 1 μg calcidiol = 2,5 μg vitamin D3 for doses up to 10 μg/day.The production process of the novel food starts with a yeast fermentation which results in a mixture of sterols, with trienol being the major sterol obtained. After the fermentation, purification and several chemical steps follow. The chemical steps include saponification and extraction, where the trienol is isolated from the biomass. This is followed by a hydroxylation step to separate the trienol from the other sterols. Trienol is then epoxidised and subsequently reduced to give 25-hydroxydehydrocholesterol. A photoreaction follows, to obtain a mixture of 25-hydroxy-previtamin D3, 25-hydroxy-tachysterol and 25-hydroxy-lumisterol. Thereafter, the 25-hydroxy-previtamin D3 is thermally isomerised to ‘“Calcidiol”’ and recrystallized to obtain the novel food of the required purity.The novel food is intended to be placed on the market as a diluted form ‘“0,25 % w/w”’, containing 0,250-0,275 % w/w of calcidiol (anhydrous). The novel food needs to be placed on the market in a preparation guaranteeing its stability.Chemical name according to IUPAC:(1S,3Z)-3-[(2E)-2-[(1R,3αS,7αR)-1-[(2R)-6-hydroxy-6-methylheptan-2-yl]-7α-methyl-2,3,3α,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol; hydrateCAS Number: 63283-36-3 (Calcifediol monohydrate)Empirical formula: C27H44O2.H2OMolecular weight: 418,7 g/molCharacteristics/composition:25(OH)D3.H2O: 97,0-100 %Total related substances: ≤ 1,5 %, of which: Δ22-25(OH)D3: ≤ 0,5 %; Lumisterolnote: ≤ 0,5 %; pre-25(OH)D3note: ≤ 0,5 %; Tachysterolnote: ≤ 0,5 %; trans-Vitamin D3note: ≤ 0,5 %Other impurities: ≤ 0,10 %Water content: 3,8-5,0 %Acetone: ≤ 1000 mg/kgIsopropanol: ≤ 10 mg/kgHeavy metals:Arsenic: ≤ 1 mg/kg | |||
| Dried nuts of Canarium ovatum Engl. | Description/Definition:The traditional food consists of the unroasted dried nuts of Canarium ovatum Engl. (family: Burseraceae) commonly known as Pili nuts. Pili nuts are produced only by plants of Canarium ovatum Engl. varieties Laysa, Magnaye, M. Orolfo, Lanuza and Magayon and can be placed on the market with or without the shell. The edible part of the nut is the kernel.Typical composition range:Fat: 57-73 %Protein: 11-15 %Water: 1-5 %Carbohydrates: 8-16,5 %Ash: 2,8-3,4 %Microbiological criteria:Moulds and yeasts: ≤ 100 CFU/gTotal colony count at 30 °C: ≤ 10000 CFU/gColiforms: ≤ 100 CFU/gEscherichia coli: ≤ 10 CFU/gStaphylococcus aureus: Absence in 25 gSalmonella spp.: Absence in 25 gListeria monocytogenes: Absence in 25 gSulphite reducing anaerobes: ≤ 10 CFU/gCFU: Colony Forming Units | |||
| Canarium indicum L. dried nuts (Kenari) (Traditional food from a third country) | Description/Definition:The traditional food is processed dried kenari nuts. The term ‘Kenari Nuts’ refers to the kernels of ripe Kenari Fruit, scientifically known as Canarium indicum L. (or Canarium amboinense Hochr.; family: Burseraceae).Composition:Ash: ≤ 5 (g/100 g)Moisture: ≤ 6 (g/100 g)Protein: 12,8 – 14,4 g/100 gCarbohydrates: 11,0 – 16,4 g/100 gFat: 59,3 – 66,3 g/100 gDietary fibre: 4,4 – 9,8 g/100 gMicrobiological criteria:Aerobic Plate Count: ≤ 5,0 × 103 CFU/gColiforms: < 3 MPN/gE. coli: < 3 MPN/gYeasts and moulds: < 10 CFU/gSalmonella: Absent in 25 gStaphylococcus aureus (absent/25 g)Listeria monocytogenes (absent/25 g)AflatoxinsAflatoxins B1: ≤ 2 mcg/kgAflatoxins (Sum of B1, B2, G1, G2): ≤ 4 mcg/kgDioxins and dioxin like PCBsSum of dioxins: ≤ 0,75 pg/g fatSum of dioxins and dioxin-like PCBs: ≤ 1,5 pg/g fatHeavy metalsCadmium (Cd): ≤ 0,02 mg/kgLead (Pb): ≤ 0,07 mg/kgCFU: Colony Forming Units | |||
| Cellobiose | Description/Definition:Cellobiose is a disaccharide with two glucose monomers linked by a β-(1–4) glucosidic bond, that is produced from sucrose and glucose in a two-step enzymatic reaction, followed by a series of purification steps.Characteristics/composition:Cellobiose DM (%): ≥ 99Moisture (%): < 1Other identified sugars (%): ≤ 1Optical rotation [α]D (c 10, water): +33–36Ash (g/100 g): < 0,1Protein content (g/100 g): < 0,01Heavy metals:Arsenic: < 0,1 mg/kgMicrobiological criteria:Total aerobic count (cfu/g): ≤ 1000Yeast and moulds (cfu/g): ≤ 100Salmonella (in 25 g): n.d.Coliforms (cfu/g): ≤ 10E. coli (in 10 g): n.d.cfu: colony forming unitsn.d.: not detected | |||
| Cetylated fatty acids | Description/Definition:The novel food concerns primarily a mixture of cetylated myristic acid and cetylated oleic acid synthesised from cetyl alcohol, myristic acid and oleic acid, and to a lesser degree, other cetylated fatty acids and other compounds from olive oil.Characteristics/composition:Ester content: 70-80 %, of which: Cetyl oleate: 22-30 %, Cetyl myristate: 41-56 %Triglycerides: 22-25 %Acid value (mg KOH/g): ≤ 5Saponification value (mg KOH/g): 130-150Microbiological criteria:Total aerobic microbial count: ≤ 1000 CFU/gYeasts and moulds: ≤ 100 CFU/gKOH: potassium hydroxideCFU: colony forming units | |||
| Chewing gum base (monomethoxypolyethylene glycol) | Description/Definition:The novel food ingredient is a synthetic polymer (Patent number WO2006016179). It consists of branched polymers of monomethoxypolyethylene glycol (MPEG) grafted onto polyisoprene-graft-maleic anhydride (PIP-g-MA), and unreacted MPEG (less than 35 % by weight).White to off-white colour.CAS No.: 1246080-53-4Characteristics:Moisture: < 5,0 %Aluminium: < 3,0 mg/kgLithium: < 0,5 mg/kgNickel: < 0,5 mg/kgResidual anhydride: < 15 μmol/gPolydispersity index: < 1,4Isoprene: < 0,05 mg/kgEthylene oxide: < 0,2 mg/kgFree maleic anhydride: < 0,1 %Total oligomeres (less than 1000 Dalton): ≤ 50 mg/kgEthylene glycol: < 200 mg/kgDiethylene glycol: < 30 mg/kgMonoethylene glycol methyl ether: < 3,0 mg/kgDiethylene glycol methyl ether: < 4,0 mg/kgTriethylene glycol methyl ether: < 7,0 mg/kg1,4-Dioxane: < 2,0 mg/kgFormaldehyde: < 10 mg/kg | |||
| Chewing gum base (Methyl vinyl ether-maleic anhydride copolymer) | Description/Definition:Methyl vinyl ether-maleic anhydride copolymer is an anhydrous copolymer of methyl vinyl ether and maleic anhydride.Free-flowing, white to white-off powderCAS No: 9011-16-9Purity:Assay value: At least 99,5 % in dry matterSpecific viscosity (1 % MEK): 2-10Residual methyl vinyl ether: ≤ 150 ppmResidual maleic anhydride: ≤ 250 ppmAcetaldehyde: ≤ 500 ppmMethanol: ≤ 500 ppmDilauroyl peroxide: ≤ 15 ppmTotal heavy metals: ≤ 10 ppmMicrobiological criteria:Total aerobic plate count: ≤ 500 CFU/gMould/yeast: ≤ 500 CFU/gEscherichia coli: Negative to testSalmonella: Negative to testStaphylococcus aureus: Negative to testPseudomonas aeruginosa: Negative to test | |||
| Chia oil from Salvia hispanica | Description/Definition:Chia oil is produced from Chia (Salvia hispanica L.) seeds (99,9 % pure) by cold pressing. No solvents are used and, once pressed, the oil is held in decantation tanks and a filtration process employed to remove impurities. It can also be produced by extraction with supercritical CO2.Production process:Produced by cold pressing. No solvents are used and, once pressed, the oil is held in decantation tanks and a filtration process employed to remove impurities.Acidity expressed as oleic acid: ≤ 2,0 %Peroxide value (PV): ≤ 10 meq/kgInsoluble impurities: ≤ 0,05 %Alpha linolenic acid: ≥ 60 %Linoleic acid: 15-20 % | |||
| Chia seeds (Salvia hispanica) | Description/Definition:Chia (Salvia hispanica L.) is a summer annual herbaceous plant belonging to the Labiatae family. Post-harvest the seeds are cleaned mechanically. Flowers, leaves and other parts of the plant are removed.Dry matter: 90-97 %Protein: 15-26 %Fat: 18-39 %Carbohydrate (*): 18-43 %Crude Fibre(**): 18-43 %Ash: 3-7 %(*)Carbohydrates include the fibre value(**)Crude fibre is the part of fibre made mainly of indigestible cellulose, pentosans and ligninProduction process:Production process of fruit juices and fruit juice blends beverages, containing Chia seeds, includes seed pre-hydration and pasteurisation steps. Microbiological controls and monitoring systems are in place. | |||
| Chitin-glucan from Aspergillus niger | Description/Definition:Chitin-glucan is obtained from the mycelium of Aspergillus niger; it is a slightly yellow, odourless, free-flowing powder. It has a dry matter content of 90 % or more.Chitin-glucan is composed largely of two polysaccharides:chitin, composed of repeating units of N-acetyl-D-glucosamine (CAS No: 1398-61-4),beta (1, 3)-glucan, composed of repeating units of D-glucose (CAS No: 9041-22-9).Loss on drying: ≤ 10 %Chitin-glucan: ≥ 90 %Ratio of chitin to glucan: 30:70 to 60:40Ash: ≤ 3,0 %Lipids: ≤ 1,0 %Proteins: ≤ 6,0 % | |||
| Chitin-glucan complex from Fomes fomentarius | Description/Definition:Chitin-glucan complex is obtained from the cell walls of the fruit bodies of the fungus Fomes fomentarius. It consists primarily of two polysaccharides:Chitin, composed of repeating units of N-acetyl-D-glucosamine (CAS No: 1398-61-4);Beta-(1,3)(1,6)-D-glucan, composed of repeating units of D-glucose (CAS No: 9041-22-9).The production process consists of several steps, including: cleaning, reduction in size and grinding, softening in water and heating in an alkaline solution, washing, drying. No hydrolysis is applied during the production process.Appearance: Powder, odourless, flavourless, brownPurity:Moisture: ≤ 15 %Ash: ≤ 3,0 %Chitin-glucan: ≥ 90 %Ratio of chitin to glucan: 70:20Total carbohydrates, excluding glucans: ≤ 0,1 %Proteins: ≤ 2,0 %Lipids: ≤ 1,0 %Melanins: ≤ 8,3 %Additives: NonepH: 6,7-7,5Heavy metals:Lead (ppm): ≤ 1,00Cadmium (ppm): ≤ 1,00Mercury (ppm): ≤ 0,03Arsenic (ppm): ≤ 0,20Microbiological criteria:Total mesophilic bacteria: ≤ 103/gYeast and moulds: ≤ 103/gColiforms at 30 °C: ≤ 103/gE. coli: ≤ 10/gSalmonella and other pathogenic bacteria: Absence/25 g | |||
| Chitosan extract from fungi (Agaricus bisporus; Aspergillus niger) | Description/Definition:The chitosan extract (containing mainly poly(D-glucosamine)) is obtained from stems of Agaricus bisporus or from the mycelium of Aspergillus niger.The patented production process consists of several steps, including: extraction and deacetylation (hydrolysis) in alkaline medium, solubilisation in acidic medium, precipitation in alkaline medium, washing and drying.Synonym: Poly(D-glucosamine)Chitosan CAS number: 9012-76-4Chitosan formula: (C6H11NO4)nAppearance: fine free-flowing powderAspect: Off –white to slightly brownishOdour: OdourlessPurity:Chitosan content (% w/w dry weight):≥ 85Glucan content (% w/w dry weight): ≤ 15Loss on drying (% w/w dry weight): ≤ 10Viscosity (1 % in 1 % acetic acid): 1-15Degree of acetylation (in % mol/wet weight): 0-30Viscosity (1 % in 1 % acetic acid) (mPa.s): 1-14 for chitosan from Aspergillus niger; 12-25 for chitin from Agaricus bisporusAsh (% w/w dry weight): ≤ 3,0Proteins (% w/w dry weight): ≤ 2,0Particle size: > 100 nmTapped density (g/cm3): 0,7-1,0Fat binding capacity 800 × (w/w wet weight): passHeavy metals:Mercury (ppm): ≤ 0,1Lead (ppm): ≤ 1,0Arsenic (ppm): ≤ 1,0Cadmium (ppm): ≤ 0,5Microbiological criteria:Aerobic count (CFU/g): ≤ 103Yeast and mould count (CFU/g): ≤ 103Escherichia coli (CFU/g): ≤ 10Enterobacteriaceae (CFU/g): ≤ 10Salmonella: Absence/25gListeria monocytogenes: Absence/25g | |||
| Chondroitin sulphate | Description/Definition:Chondroitin sulphate (sodium salt) is a biosynthetic product. It is obtained by chemical sulphation of chondroitin derived from fermentation by the bacterium Escherichia coli O5:K4:H4 strain U1-41 (ATCC 23502).Chondroitin sulphate (sodium salt) (% dry basis): 95-105MWw (weight avg.) (kDa): 5-12MWn (number avg.) (kDa): 4-11Dispersity (wh/w0,05): ≤ 0,7Sulphation pattern (ΔDi-6S) (%): ≤ 85Loss on drying (%) (105 °C to constant weight): ≤ 10,0Residue on ignition (% dry basis): 20-30Protein (% dry basis): ≤ 0,5Endotoxins (EU/mg): ≤ 100Total organic impurities (mg/kg): ≤ 50 | |||
| Chromium Picolinate | Description/Definition:Chromium picolinate is a reddish free-flowing powder, slightly soluble in water at pH 7. The salt is also soluble in polar organic solvents.Chemical name: tris(2pyridinecarboxylato-N,O)chromium(III) or 2-pyridinecarboxylic acid chromium(III) saltCAS No.: 14639-25-9Chemical formula: Cr(C6H4NO2)3Chemical characteristics:Chromium Picolinate: ≥ 95 %Chromium (III): 12-13 %Chromium (VI): not detectedWater: ≤ 4,0 % | |||
| Chromium-containing yeast (Yarrowia lipolytica) biomass | Description/Definition:The novel food is the dried and heat-killed chromium-containing biomass of the yeast Yarrowia lipolytica.The novel food is produced by fermentation in the presence of chromium chloride followed by a number of purification steps and a heat-killing step of the yeast to ensure the absence of viable Yarrowia lipolytica cells in the novel food.Characteristics/Composition:Total chromium: 18–23 μg/gChromium (VI): < 10 μg/kg (i.e. limit of detection)Protein: 40–50 g/100 gDietary fibre: 24–32 g/100 gSugars: < 2 g/100 gFat: 6–12 g/100 gTotal ash: ≤ 15 %Water: ≤ 5 %Dry matter: ≥ 95 %Heavy metals:Lead: ≤ 3,0 mg/kgCadmium: ≤ 1,0 mg/kgMercury: ≤ 0,1 mg/kgMicrobiological criteria:Total aerobic microbial count: ≤ 5 × 103 CFU/gTotal yeast and mould count: ≤ 102 CFU/gViable Yarrowia lipolytica cells: < 10 CFU/g (i.e. limit of detection)Coliforms: ≤ 10 CFU/gSalmonella spp.: Absence in 25 gCFU: colony forming units | |||
| Cistus incanus L. Pandalis herb’ | Description:Cistus incanus L. Pandalis herb; species belonging to the Cistaceae family and native to the Mediterranean region, Chalkidiki Peninsula.The novel food consists of the dried and cut aerial parts (young shoots with woody parts) of Cistus incanus L. Pandalis | |||
| Citicoline | Description/Definition:Citicoline is produced by a microbial process.Citicoline is composed of cytosine, ribose, pyrophosphate and choline.White crystalline powderChemical name: Choline cytidine 5′-pyrophosphate, Cytidine 5′-(trihydrogen diphosphate) P’-[2-(trimethylammonio)ethyl]ester inner saltChemical formula: C14H26N4O11P2Molecular weight: 488,32 g/molCAS No.: 987-78-0pH (sample solution of 1 %): 2,5-3,5Purity:Assay value: ≥ 98 % of dry matterLoss on drying (100 °C for 4 hours): ≤ 5,0 %Ammonium: ≤ 0,05 %Arsenic: Not more than 2 ppmFree phosphoric acids: ≤ 0,1 %5′-Cytidylic acid: ≤ 1,0 %Microbiological criteria:Total plate count: ≤ 103 CFU/gYeast and moulds: ≤ 102 CFU/gEscherichia coli: Absence in 1 g | |||
| Clostridium butyricum | Description/Definition:Clostridium butyricum (CBM-588) is a Gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium. Depository number FERM BP-2789Microbiological criteria:Total viable aerobic count: ≤ 103 CFU/gEscherichia coli: Not detected in 1 gStaphylococcus aureus: Not detected in 1 gPseudomonas aeruginosa: Not detected in 1 gYeast and moulds: ≤ 102 CFU/g | |||
| Clostridium butyricum TO-A | Description/DefinitionClostridium butyricum TO-A, is a gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium. The TO-A strain is deposited under number FERM BP-10866.The novel food is produced by anaerobic fermentation of Clostridium butyricum TO-A followed by centrifugation and spray-drying and mixed with potato starch (to stabilise the spores by keeping a dry environment).The novel food is a mixture of viable spores and vegetative cells with about 85 % (range: 74 %–89 %) of spores.Characteristics/criteriaC. butyricum TO-A: 1-7 × 109 CFU/gMoisture: < 5 %Coliforms: < 10 CFU/gTAMC: ≤ 1 × 103 CFU/gTYMC: ≤ 1 × 102 CFU/gSalmonella spp.: not detected in 25 gAbbreviations: CFU, colony forming units; TAMC, total aerobic microbial count; TYMC, total yeast and mould count. | |||
| Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner dried cherry pulp and its infusion (Traditional food from a third country) | Description/Definition:The traditional food consists of the dried unroasted coffee cherry pulp of Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner (genus: Coffea family: Rubiaceae) and its infusion. The infusion can be used as such or concentrated or dried.Ripe coffee cherries are collected, and then the coffee beans are mechanically removed, prior or after a drying process, leaving the dried coffee cherry pulp, which can be milled to a powder.The separated coffee cherry pulp is also known as ‘cascara’, from the Spanish ‘cáscara’, meaning ‘husk’.Typically, the infusion is prepared by mixing up to 6 g of cascara pulp or husk in 100 ml of hot water (> 75 °C) for a few minutes and then pouring through a strainer, or using corresponding amounts in dried or instant infusions.Composition of the dried coffee cherry pulp:Water: < 18 %Water activity (aw): ≤ 0,65Ash: < 10,4 % DMProtein: < 15 % DMFat: < 5 % DMCarbohydrates: < 85 % DMMicrobiological criteria:Aerobic Plate Count: < 104 CFU/gTotal yeasts and moulds: < 100 CFU/gEnterobacteriaceae: < 50 CFU/gSalmonella: Absence in 25 gBacillus cereus: < 100 CFU/gMycotoxins:Ochratoxin A: < 5,0 μg/kgAflatoxin B1: < 2,0 μg/kgAflatoxin B1, B2, G1, G2 (as sum): < 4,0 μg/kgHeavy metals:Cadmium (Cd): < 0,05 mg/kgLead (Pb): < 1,0 mg/kgCopper: ≤ 50 mg/kgMercury: ≤ 0,02 mg/kgArsenic: ≤ 0,2 mg/kgImpurities:Benzo(a)pyrene: < 10,0 μg/kgSum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene: < 50,0 μg/kgPesticides:Pesticide levels in the traditional food shall comply with levels set by Regulation (EC) No 396/2005 for ‘0639000’ for ‘Herbal infusions from any other parts of the plant’.CFU: Colony Forming UnitsDM: Dry Matter | |||
| D-ribose | DescriptionD-ribose is an aldopentose monosaccharide which is produced by fermentation using a transketolase-deficient strain of Bacillus subtilis.Chemical formula: C5H10O5CAS No: 50-69-1Molecular mass: 150,13 DaCharacteristics/CompositionAppearance: Dry with powdery texture, white to slightly yellow in colourSpecific rotation [α]D25: – 19,0° to – 21,0°D-ribose purity (% dry basis):-HPLC/RInote Method 98,0–102,0 %Ash: < 0,2 %Loss on drying (moisture): < 0,5 %Clarity on solution: ≥ 95 % transmittanceHeavy metalsLead: ≤ 0,1 mg/kgArsenic: ≤ 0,1 mg/kgCadmium: ≤ 0,1 mg/kgMercury: ≤ 0,1 mg/kgMicrobiological criteriaTotal plate count: ≤ 100 CFUnote/gYeast: ≤ 100 CFU/gMoulds: ≤ 100 CFU/gColiforms: ≤ 10 CFU/gSalmonella sp: Negative/25 g | |||
| Dried Euglena gracilis | Description/Definition:The novel food is dried whole cell Euglena, which is the dried biomass of the microalga Euglena gracilis.The novel food is produced by fermentation followed by filtration and a heat-killing step of the microalga to ensure the absence of viable Euglena gracilis cells in the novel food.Characteristics/Composition:Total carbohydrates: ≤ 75 %β-glucan: > 50 %Protein: ≥ 15 %Fat: ≤ 15 %Ash: ≤ 10 %Moisture: ≤ 6 %Heavy metals:Lead: ≤ 0,5 mg/kgCadmium: ≤ 0,5 mg/kgMercury: ≤ 0,05 mg/kgArsenic: ≤ 0,02 mg/kgMicrobiological criteria:Aerobic plate count: ≤ 10000 CFU/gColiforms: ≤ 100 MPN/gYeast and mould: ≤ 500 CFU/gEscherichia coli: Absence in 10 gStaphylococcus aureus: Absence in 10 gSalmonella: Absence in 25 gListeria monocytogenes: Absence in 25 gCFU: colony forming units.MPN: most probable number | |||
| Extract of defatted cocoa powder | Cocoa (Theobroma cacao L.) ExtractAppearance: Dark brown powder free of visible impuritiesPhysical and chemical properties:Polyphenol content: Min 55,0 % GAETheobromine content: Max 10,0 %Ash content: Max 5,0 %Moisture content: Max 8,0 %Bulk density: 0,40-0,55 g/cm3pH: 5,0-6,5Residual solvent: Max 500 ppm | |||
| Low fat cocoa extract | Low fat Cocoa (Theobroma cacao L.) extractAppearance: Dark red to purple powderCocoa extract, concentrate: Min 99 %Silicon dioxide (technological aid): Max 1,0 %Cocoa flavanols: Min. 300 mg/gEpicatechin: Min. 45 mg/gLoss on drying: Max. 5,0 % | |||
| Coriander seed oil from Coriandrum sativum | Description/Definition:Coriander seed oil is an oil containing glycerides of fatty acids that is produced from the seeds of the coriander plant Coriandrum sativum L.Yellowish to brown colour, bland tasteCAS No.: 8008-52-4Composition of fatty acids:Palmitic acid (C16:0): 2-5 %Stearic acid (C18:0): < 1,5 %Petroselinic acid (cis-C18:1(n-12)): 60-75 %Oleic acid (cis-C18:1 (n-9)): 7-15 %Linoleic acid (C18:2): 12-19 %α-Linolenic acid (C18:3): < 1,0 %Trans fatty acids: ≤ 1,0 %Purity:Refractive index (20 °C): 1.466-1.474Acid value: ≤ 4 mg KOH/gPeroxide value (PV): ≤ 5,0 meq/kgIodine value: 88-110 unitsSaponification value: 179-200 mg KOH/gUnsaponifiable matter: ≤ 15 g/kg | |||
| Cranberry extract powder | Description/Definition:Cranberry extract powder is a water-soluble phenolic-rich powder extract prepared through an ethanolic extraction from the juice concentrate of sound, mature berries of the cranberry cultivar Vaccinium macrocarpon.Characteristics/CompositionMoisture (% w/w): ≤ 4Proanthocyanidins — PACs (% w/w dry weight)OSC-DMAC method: 55.0-60.0 orBL-DMAC method: 15.0-18.0Total phenolics (GAEnote, % w/w dry weight)noteFolin-Ciocalteau method: > 46.2Solubility (water): 100 %, with no visible insoluble particlesEthanol Content (mg/kg): ≤ 100Screen Analysis: 100 % through 30 mesh screenAppearance and aroma, as powder: Free-flowing, deep red colour. Earthy aroma with no burnt character.Heavy metals:Arsenic (ppm): < 3Microbiological criteria:Yeast: < 100 CFUnote/gMould: < 100 CFU/gAerobic plate count: < 1000 CFU/gColiforms: < 10 CFU/gEscherichia coli: < 10 CFU/gSalmonella: Absent in 375 g | |||
| Crataegus pinnatifida dried fruit | Description/Definition:Dried fruits of Crataegus pinnatifida species belonging to the Rosaceae family and native to north China and Korea.Composition:Dry matter: 80 %Carbohydrates: 55 g/kg fresh weightFructose: 26,5–29,3 g/100 gGlucose: 25,5–28,1 g/100 gVitamin C: 29,1 mg/100 g fresh weightSodium: 2,9 g/100 g fresh weightCompotes are products obtained by thermal processing of the edible part of one or several species of fruits, whole or in pieces, sieved or not, without significant concentration. Sugars, water, cider, spices and lemon juice may be used. | |||
| α-cyclodextrin | Description/Definition:A non-reducing cyclic saccharide consisting of six α-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolyzed starch. Recovery and purification of α-cyclodextrin may be carried out using one of the following procedures: precipitation of a complex of α-cyclodextrin with 1-decanol, dissolution in water at elevated temperature and re-precipitation, steam-stripping of the complexant, and crystallisation of α-cyclodextrin from the solution; or chromatography with ion-exchange or gel filtration followed by crystallisation of α-cyclodextrin from the purified mother liquor; or membrane separation methods such as ultra-filtration and reverse osmosis: Description: Virtually odourless, white or almost white crystalline solid.Synonyms: α-cyclodextrin, α-dextrin, cyclohexaamylose, cyclomaltohexaose, α-cycloamylaseChemical name: CyclohexaamyloseCAS No.: 10016-20-3Chemical formula: (C6H10O5)6Formula weight: 972,85Assay: ≥ 98 % (dry basis)Identification:Melting range: Decomposes above 278 °CSolubility: Freely soluble in water; very slightly soluble in ethanolSpecific rotation: [α]D25: Between +145o and +151o (1 % solution)Chromatography: The retention time for the major peak in a liquid chromatogram of the sample corresponds to that for α-cyclodextrin in a chromatogram of reference α-cyclodextrin (available from Consortium für Elektrochemische Industrie GmbH, München, Germany or Wacker Biochem Group, Adrian, MI, USA) using the conditions described in the METHOD OF ASSAYPurity:Water: ≤ 11 % (Karl Fischer Method)Residual complexant: ≤ 20 mg/kg(1-decanol)Reducing substances: ≤ 0,5 % (as glucose)Sulphated ash: ≤ 0,1 %Lead: ≤ 0,5 mg/kgMethod of assay:Determine by liquid chromatography using the following conditions:Sample solution: Weigh accurately about 100 mg of test sample into a 10 ml volumetric flask and add 8 ml of deionised water. Dissolve the sample completely using an ultra-sonification bath (10-15 min) and dilute to the mark with purified deionised water. Filter through a 0,45-micrometer filterReference solution: Weigh accurately about 100 mg of α-cyclodextrin into a 10 ml volumetric flask and add 8 ml of deionised water. Dissolve the sample completely using an ultra-sonification bath and dilute to the mark with purified deionised water.Chromatography: Liquid chromatograph equipped with a refractive index detector and an integrating recorder.Column and packing: Nucleosil-100-NH2 (10 μm) (Macherey & Nagel Co. Düren, Germany) or similarLength: 250 mmDiameter: 4 mmTemperature: 40 °CMobile phase: acetonitrile/water (67/33, v/v)Flow rate: 2,0 ml/minInjection volume: 10 μlProcedure: Inject the sample solution into the chromatograph, record the chromatogram, and measure the area of the α-CD peak. Calculate the percentage of α-cyclodextrin in the test sample as follows:% α-cyclodextrin (dry basis) = 100 × (AS/AR) (WR/WS)whereAS and AR are the areas of the peaks due to α-cyclodextrin for the sample solution and reference solution, respectively.WS and WR are the weights (mg) of the test sample and reference α-cyclodextrin, respectively, after correcting for water content. | |||
| γ-cyclodextrin | Description/Definition:A non-reducing cyclic saccharide consisting of eight α-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolysed starch. Recovery and purification of γ-cyclodextrin may be carried out by precipitation of a complex of γ-cyclodextrin with 8-cyclohexadecen-1-one, dissolution of the complex with water and n-decane, steam-stripping of the aqueous phase and recovery of gamma-CD from the solution by crystallisation.Virtually odourless, white or almost white crystalline solidSynonyms: γ-cyclodextrin, γ-dextrin, cyclooctaamylose, cyclomaltooctaose, γ-cycloamylaseChemical name: CyclooctaamyloseCAS number: 17465-86-0Chemical formula: (C6H10O5)8Assay: ≥ 98 % (dry basis)Identification:Melting range: Decomposes above 285 °CSolubility: Freely soluble in water; very slightly soluble in ethanolSpecific rotation: [α]D25: between + 174o and + 180o (1 % solution)Purity:Water: ≤ 11 %Residual complexant (8-cyclohexadecen-1-one (CHDC)): ≤ 4 mg/kgResidual solvent (n-decane): ≤ 6mg/kgReducing substances: ≤ 0,5 % (as glucose)Sulphated ash: ≤ 0,1 % | |||
| Cyperus esculentus (tiger nut) oil | Description:The novel food is obtained from a pasteurisation of Cyperus esculentus (tiger nut) L. tuber followed by a cold-pressing process.Fatty acid composition:Palmitic acid: 12-15 %Stearic acid: 5-8 %Oleic acid: 65-69 %Linoleic acid: 9-12 %Characteristics:Acidity: ≤ 2 %Peroxide value: ≤ 20 meq/kgSaponification value: ≤ 189 mg KOH/gp-anisidine: < 1Heavy metals:Lead: ≤ 0,1 mg/kgCadmium: ≤ 0,1 mg/kgMycotoxins:Aflatoxins (sum of B1, B2, G1, G2): < 4 μg/kgAflatoxin B1: < 1 μg/kgOchratoxin A: < 3 μg/kgMicrobiological criteria:Total Aerobic Microbial Count: ≤ 103 CFU /gTotal Yeast and Mould Count: ≤ 102 CFU /gColiforms: ≤ 10 CFU /gSalmonella: Not detected in 25gListeria monocytogenes: Not detected in 25gEnterobacteriaceae: < 102 CFU /gCFU: colony forming units | |||
| Decorticated grains of Digitaria exilis (Kippist) Stapf (fonio)(Traditional food from a third country) | Description/DefinitionThe traditional food is the decorticated grain (bran removed) of Digitaria exilis (Kippist) Stapf.Digitaria exilis (Kippist) Stapf) is an annual herbaceous plant belonging to the Poaceae family.Typical nutritional components of decorticated grain of fonioCarbohydrates: 76,1 g/100 g of fonioWater: 12,4 g/100 g of fonioProtein: 6,9 g/100 g of fonioFat: 1,2 g/100 g of fonioFibre: 2,2 g/100 g of fonioAsh: 1,2 g/100 g of fonioPhytate content: ≤ 2,1 mg/g | |||
| Dextran preparation produced by Leuconostoc mesenteroides | 1. Powdered form: Carbohydrates: 60 % with: (Dextran: 50 %, Mannitol: 0,5 %, Fructose: 0,3 %, Leucrose: 9,2 %) Protein: 6,5 % Lipid: 0,5 % Lactic acid: 10 % Ethanol: traces Ash: 13 % Moisture: 10 %2. Liquid form: Carbohydrates: 12 % with: (Dextran: 6,9 %, Mannitol: 1,1 %, Fructose: 1,9 %, Leucrose: 2,2 %) Protein: 2,0 % Lipid: 0,1 % Lactic acid: 2,0 % Ethanol: 0,5 % Ash: 3,4 % Moisture: 80 % | |||
| Diacylglycerol oil of plant origin | Description/Definition:Manufactured from glycerol and fatty acids derived from edible vegetable oils, in particular from soybean oil (Glycine max) or rapeseed oil (Brassica campestris, Brassica napus) using a specific enzyme.Acylglycerol Distribution:Diacylglycerols (DAG): ≥ 80 %1,3-Diacylglycerols (1,3-DAG): ≥ 50 %Triacylglycerols (TAG): ≤ 20 %Monoacylglycerols (MAG): ≤ 5,0 %Fatty Acid Composition (MAG, DAG, TAG):Oleic acid (C18:1): 20-65 %Linoleic acid (C18:2): 15-65 %Linolenic acid (C18:3): ≤ 15 %Saturated fatty acids: ≤ 10 %Others:Acid value: ≤ 0,5 mg KOH/gMoisture and volatile: ≤ 0,1 %Peroxide value (PV): ≤ 1,0 meq/kgUnsaponifiables: ≤ 2,0 %Trans fatty acids≤ 1,0 %MAG = monoacylglycerols, DAG = diacylglycerols, TAG = triacylglycerols | |||
| Dihydrocapsiate (DHC) | Description/Definition:Dihydrocapsiate is synthesised by enzyme-catalysed esterification of vanillyl alcohol and 8-methylnonanoic acid. Following the esterification dihydrocapsiate is extracted with n-hexane.Viscous to colourless to yellow liquidChemical formula: C18 H28 O4CAS No: 205687-03-2Physical-chemical properties:Dihydrocapsiate: > 94 %8-Methylnonanoic acid: < 6,0 %Vanillyl acohol: < 1,0 %Other synthesis related substances: < 2,0 % | |||
| Dried aerial parts of Hoodia parviflora | Description/Definition:It is the whole dried aerial parts of Hoodia parviflora N.E.Br., (family Apocynaceae)Characteristics/CompositionPlant material: Aerial parts of at least 3-year-old plantsAppearance: Light green to tan fine powderSolubility (water): > 25 mg/mLMoisture: < 5,5 %Aw: < 0,3pH: < 5,0Protein: < 4,5 g/100 gFat: < 3 g/100 gCarbohydrate (including dietary fibre): < 80 g/100 gDietary fibre: < 55 g/100 gTotal sugars: < 10,5 g/100 gAsh: < 20 %HoodigosidesP57: 5–50 mg/kgL: 1000–6000 mg/kgO: 500–5000 mg/kgTotal: 1500–11000 mg/kgHeavy metals:Arsenic: < 1,00 mg/kgMercury: < 0,1 mg/kgCadmium: < 0,1 mg/kgLead: < 0,5 mg/kgMicrobiological criteria:Aerobic plate count: < 105 CFU/gEscherichia coli: < 10 CFU/gStaphylococcus aureus: < 50 CFU/gTotal coliforms: < 10 CFU/gYeast: ≤ 100 CFU/gMould: ≤ 100 CFU/gSalmonella species: Negative/25 gListeria monocytogenes: Negative/25 gCFU: Colony Forming Units | |||
| Dried extract of Lippia citriodora from cell cultures | Description/Definition:Dried extract of Lippia citriodora (Palau) Kunth from cell cultures HTN®Vb. | |||
| Echinacea angustifolia extract from cell cultures | Description/Definition:Extract of the roots of Echinacea angustifolia obtained from plant tissue culture which is substantially equivalent to a root extract from Echinacea angustifolia obtained in ethanol-water titrated to 4 % echinacoside. | |||
| Echinacea purpurea extract from cell cultures | Description/Definition:Dried extract of Echinacea purpurea from cell cultures EchiPure-PC™ | |||
| Echium plantagineum oil | Description/Definition:Echium oil is the pale yellow product obtained by refining oil extracted from the seeds of Echium plantagineum L. Stearidonic acid: ≥ 10 % w/w of total fatty acidsTrans fatty acids: ≤ 2,0 % (w/w of total fatty acids)Acid value: ≤ 0,6 mg KOH/gPeroxide value (PV): ≤ 5,0 meq O2/kgUnsaponifiable content: ≤ 2,0 %Protein content (total nitrogen): ≤ 20 μg/mlPyrrolizidine alkaloids: Not detectable with a detection limit 4,0 μg/kg | |||
| Ecklonia cava phlorotannins | Description/DefinitionEcklonia cava phlorotannins are obtained via alcohol extraction from the edible marine alga Ecklonia cava. The extract is a dark brown powder, rich in phlorotannins, polyphenolic compounds found as secondary metabolites in certain brown algae species.Characteristics/CompositionPhlorotannin content: 90 ± 5 %Antioxidant activity: > 85 %Moisture: < 5 %Ash: < 5 %Microbiological criteriaTotal viable cell count: < 3000 CFU/gMould/yeast: < 300 CFU/gColiforms: Negative to testSalmonella spp.: Negative to testStaphylococcus aureus: Negative to testHeavy metals and HalogensLead: < 3,0 mg/kgMercury: < 0,1 mg/kgCadmium: < 3,0 mg/kgArsenic: < 25,0 mg/kgInorganic Arsenic: < 0,5 mg/kgIodine: 150,0 – 650,0 mg/kgCFU: Colony Forming Units | |||
| Egg membrane hydrolysate | DescriptionThe egg membrane hydrolysate is derived from the eggshell membranes of chicken eggs. The eggshells undergo hydro-mechanical separation in order to obtain the egg membranes, which are then further processed using a patented solubilisation method. Following the solubilisation process, the solution is filtered, concentrated, spray-dried and packaged.Characteristics/Composition | |||
| Chemical parameters | Methods | |||
| Total nitrogen-containing compounds (% w/w): ≥ 88 | Combustion according to AOAC 990.03 and AOAC 992.15 | |||
| Collagen (% w/w): ≥ 15 | SircolTM Soluble Collagen Assay | |||
| Elastin (% w/w): ≥ 20 | FastinTM Elastin Assay | |||
| Total glycosaminoglycans (% w/w): ≥ 5 | USP26 (chondroitin sulphate K0032 method) | |||
| Calcium: ≤ 1 % | ||||
| Physical parameterspH: 6,5 – 7,6Ash (% w/w): ≤ 8Moisture (% w/w): ≤ 9Water activity: ≤ 0,3Solubility (in water): solubleBulk density: ≥ 0,6 g/ccHeavy metalsArsenic ≤ 0,5 mg/kgMicrobiological criteriaAerobic plate count: ≤ 2500 CFU/gEscherichia coli: ≤ 5 MPN/gSalmonella: Negative (in 25 g)Coliforms: ≤ 10 MPN/gStaphylococcus aureus: ≤ 10 CFU/gMesophilic spore count: ≤ 25 CFU/gThermophilic spore count: ≤ 10 CFU/10 gYeast: ≤ 10 CFU/gMould: ≤ 200 CFU/gCFU: Colony Forming Units; MPN = Most Probable Number; USP: United States Pharmacopeia. | ||||
| Egg membrane hydrolysate (enzymatically produced) | Description:The novel food is a protein hydrolysate produced by enzymatic (food enzyme papain) hydrolysis of chicken (Gallus gallus domesticus) egg membranes. The product is a water-soluble cream-yellowish powder.Characteristics/Composition:Crude protein (% w/w): ≥ 70Collagen (% w/w): 15-30Moisture (% w/w): ≤ 8Microbiological criteria:TAMC (a): ≤ 5 × 104 CFU (b)/gTYMC (c): ≤ 100 CFU/gEscherichia coli: Absence in 10 gSalmonella spp.: Absence in 25 gListeria monocytogenes: Absence in 25 g(a) TAMC = Total Aerobic Microbial Count; (b) CFU = Colony Forming Units; (c) TYMC = Total Yeast and Mould Count. | |||
| Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis) | Description/Definition:A highly purified extract from the leaves of green tea (Camellia sinensis (L.) Kuntze) in the form of a fine, off-white to pale pink powder. It is composed of a minimum of 90 % epigallo-catechin gallate (EGCG), and has a melting point between approx. 210 and 215 °CAppearance: off-white to pale pink powderChemical name: polyphenol (-) epigallocatechin-3-gallateSynonyms: epigallocatechin gallate (EGCG)CAS No.: 989-51-5INCI name: epigallocatechin gallateMolecular mass: 458,4 g/molLoss on drying: max 5,0 %Heavy metals:Arsenic: max 3,0 ppmLead: max 5,0 ppmAssay:Min. 94 % EGCG (on dry material)max. 0,1 % caffeineSolubility: EGCG is fairly soluble in water, ethanol, methanol and acetone | |||
| L-ergothioneine | DefinitionChemical name (IUPAC): (2S)-3-(2-thioxo-2,3-dihydro-1H-imidazol-4-yl)-2-(trimethylammonio)-PropanoateChemical formula: C9H15N3O2SMolecular mass: 229,3 DaCAS No.: 497-30-3 | |||
| Parameter | Specification | Method | ||
| Appearance | White powder | Visual | ||
| Optical rotation | [α]D ≥ (+) 122° (c = 1, H2O)a) | Polarimetry | ||
| Chemical purity | ≥ 99,5 %≥ 99,0 % | HPLC [Eur. Ph. 2,2.29]1H-NMR | ||
| Identification | Compliant with the structureC: 47,14 ± 0,4 %H: 6,59 ± 0,4 %N: 18,32 ± 0,4 % | 1H-NMRElemental analysis | ||
| Total residual solvents(methanol, ethyl acetate, isopropanol, ethanol) | [Eur. Ph. 01/2008:50400]< 1000 ppm | Gas chromatography[Eur. Ph. 01/2008:20424] | ||
| Loss on drying | Internal standard < 0,5 % | [Eur. Ph. 01/2008:20232] | ||
| Impurities | < 0,8 % | HPLC/GPC or 1H-NMR | ||
| Heavy metalsb) c) | ||||
| Lead | < 3,0 ppm | ICP/AES | ||
| Cadmium | < 1,0 ppm | (Pb, Cd) | ||
| Mercury | < 0,1 ppm | Atomic fluorescence (Hg) | ||
| Microbiological specificationsb) | ||||
| Total viable aerobic count (TVAC) | ≤ 1 x 103 CFU/g | [Eur. Ph. 01/2011:50104] | ||
| Total yeast and mould count (TYMC) | ≤ 1 x 102 CFU/g | |||
| Escherichia coli | Absence in 1 g | |||
| Eur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-performance liquid chromatography; GPC: gel permeation chromatography; ICP/AES: Inductively coupled plasma atomic emission spectroscopy;CFU: colony-forming units.a) Lit. [α]D = (+) 126,6o (c = 1, H2O)b) Analyses conducted on each batchc) Maximum levels in accordance with Regulation (EC) No 1881/2006 | ||||
| Inulin-propionate ester | Description/Definition:The novel food, inulin-propionate ester, is obtained by synthesis from inulin and propionic anhydride.Physical and chemical properties:Appearance: white to off-white powderComposition:Inulin (% w/w): 65-95Free propionic acid (% w/w): < 1Esterified propionate (% w/w): 5-35Inulin-propionate ester (% w/w) after hydrolysis: 100-112Total nitrogen (g/100 g): < 0,1Total fat (g/100g): < 0,5Sodium (% w/w): < 0,1Chemical parameters:Arsenic: < 0,1 mg/kgCadmium: < 0,01 mg/kgLead: < 0,05 mg/kgMercury: < 0,05 mg/kgMicrobiological parameters:Total Aerobic Count: < 1000 CFU/gListeria spp.: ND/25 gE. coli: < 10 CFU/gEnterobacteriaceae: < 10 CFU/gCFU: Colony Forming Units | |||
| Roasted and popped kernels from the seeds of Euryale ferox Salisb. (makhana) (Traditional food from a third country) | Description/DefinitionThe traditional food consists of the roasted and popped kernels of the seeds of the fresh plants of Euryale ferox Salisb. (family: Nymphaeaceae, commonly referred to also as prickly water lily) to be consumed as a snack. The traditional food is produced via a series of steps involving the collection, washing, and drying of the seeds, a first roasting in oil, tempering at ambient temperatures, a subsequent second roasting in oil to pop the kernels, followed by hitting of the hot seeds to release the popped kernels. The traditional food is also known as makhana or fox nuts.Typical nutritional components:Fat: 13,0 g/100 gCarbohydrates: 75,0 g/100 gFibre: 2,5 g/100 gProtein: 7 g/100 gMoisture (% w/w): < 5,0Ash: < 0,5 g/100 gMicrobiological criteria:Total plate count: < 103 CFU/gTotal yeast and mould count: < 100 CFU/gTotal Enterobacteriaceae: < 10 CFU/gSalmonella spp.: Absence in 25 gListeria monocytogenes: Absence in 25 gHeavy metals:Selenium: ≤ 0,8 mg/kgCopper: ≤ 30,0 mg/kgLead: ≤ 0,1 mg/kgArsenic: ≤ 0,1 mg/kgCadmium: ≤ 0,1 mg/kgTin: ≤ 3,5 mg/kgMercury: ≤ 0,025 mg/kgMycotoxins:Aflatoxin B1: ≤ 2,0 μg/kgSum of aflatoxins B1, B2, G1, and G2: ≤ 4,0 μg/kgOchratoxin A: ≤ 1,0 μg/kgCitrinin: ≤ 20,0 μg/kgCyanotoxins:Microcystins: ≤ 0,0015 mg/kgPesticides:Pesticides: ≤ 0,01 mg/kgProcess contaminants:Acrylamide: ≤ 40,0 μg/kgSum of PAHs: ≤ 10,0 μg/kgSum of dioxin-like PCBs: ≤ 0,35 pg/g3-MCPD: ≤ 20,0 μg/kgGlycidyl fatty acid esters (expressed as glycidol): ≤ 500,0 μg/kgSum of 3-MCPD and 3-MCPD fatty acid esters: ≤ 750,0 μg/kgCFU: Colony Forming Units; PAHs: Polycyclic Aromatic Hydrocarbons; PCBs: Polychlorinated Biphenyls; 3-MCPD: 3-MonoChloroPropane Diol. | |||
| Extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) | Description/DefinitionThe mixture of the three herbal roots is yellowish brown fine powder produced by hot-water extraction, concentration by evaporation, and spray dryingComposition of the extract of mixture of the 3 herbal rootsCynanchum wilfordii root: 32,5 % (w/w)Phlomis umbrosa root: 32,5 % (w/w)Angelica gigas root: 35,0 % (w/w)SpecificationsLoss on drying: NMT 100 mg/gAssayCinnamic acid: 0,012 – 0,039 mg/gShanzhiside methyl ester: 0,20 – 1,55 mg/gNodakenin: 3,35 – 10,61 mg/gMethoxsalen: < 3 mg/gPhenols: 13,0 – 40,0 mg/gCoumarins: 13,0 – 40,0 mg/gIridoids: 13,0 – 39,0 mg/gSaponins: 5,0 – 15,5 mg/gNutritive componentsCarbohydrates: 600 – 880 mg/gProteins: 70 – 170 mg/gFats: < 4 mg/gMicrobiological parametersTotal viable plate count: < 5000 CFU/gTotal mold and yeast: < 100 CFU/gColiform bacteria: < 10 CFU/gSalmonella: Negative/25 gEscherichia coli: Negative/25 gStaphylococcus aureus: Negative/25 gHeavy metalsLead: < 0,65 mg/kgArsenic: < 3,0 mg/kgMercury: < 0,1 mg/kgCadmium: < 1,0 mg/kgCFU: Colony Forming Units | |||
| Ferric Sodium EDTA | Description/Definition:Ferric Sodium EDTA (ethylenediaminetetraacetic acid) is an odourless free-flowing, yellow to brown powder with a chemical purity of more than 99 % (w/w). It is freely soluble in water.Chemical formula: C10H12FeN2NaO8 * 3H2OChemical characteristics:pH of 1 % solution: 3,5-5,5Iron: 12,5-13,5 %Sodium: 5,5 %Water: 12,8 %Organic matter (CHNO): 68,4 %EDTA: 65,5-70,5 %Water insoluble matter: ≤ 0,1 %Nitrilo-triacetic acid: ≤ 0,1 % | |||
| Ferrous ammonium phosphate | Description/Definition:Ferrous ammonium phosphate is a grey/green fine powder, practically insoluble in water and soluble in dilute mineral acids.CAS No.: 10101-60-7Chemical formula: FeNH4PO4Chemical characteristics:pH of 5 % suspension in water: 6,8-7,8Iron (total): ≥ 28 %Iron (II): 22-30 % (w/w)Iron (III): ≤ 7,0 % (w/w)Ammonia: 5-9 % (w/w)Water: ≤ 3,0 % | |||
| Fish peptides from Sardinops sagax | Description/Definition:The novel food ingredient is a peptide mixture, which is obtained by an alkaline protease-catalysed hydrolysis of fish (Sardinops sagax) muscle, subsequent isolation of the peptide fraction by column chromatography, concentration under vacuum and spray drying.Yellowish white powderPeptides (1) (short chain peptides, dipeptides and tripeptides with a molecular weight of less than 2 kDa): ≥ 85 g/100 gVal-Tyr (dipeptide): 0,1-0,16 g/100 gAsh: ≤ 10 g/100 gMoisture: ≤ 8 g/100 g(1)Kjeldahl method | |||
| Flavonoids from Glycyrrhiza glabra | Description/Definition:Flavonoids derived from the roots or rootstock of Glycyrrhiza glabra L. are extracted with ethanol followed by further extraction of this ethanolic extract with medium-chain triglycerides. It is a dark-brown coloured liquid, containing 2,5 % to 3,5 % of glabridin.Moisture: < 0,5 %Ash: < 0,1 %Peroxide value (PV): < 0,5 meq/kgGlabridin: 2,5-3,5 % of fatGlycyrrhizinic acid: < 0,005 %Fat including polyphenol-type substances: ≥ 99 %Protein: < 0,1 %Carbohydrates: not detectable | |||
| Fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L.(Traditional food from a third country) | Description/DefinitionThe traditional food is the fruit pulp from the cocoa (Theobroma cacao L) plant, which is the ‘aqueous, mucilaginous and acidic substance in which the seeds are embedded’.Cocoa fruit pulp is obtained by splitting cocoa pods followed by separation from husks and beans; the pulp is then subject to pasteurisation and freezing. Cocoa pulp juice and/or cocoa concentrated pulp juice are produced following processing (enzymatic treatment, pasteurization, filtration, and concentration).Typical compositional data of cocoa fruit pulp, pulp juice, concentrated pulp juiceProtein (g/100 g): 0,0 to 2,0Total fat (g/100 g): 0,0 to 0,2Total sugars (g/100 g): > 11,0Brix level (° Brix): ≥ 14pH: 3,3 to 4,0Microbiological criteriaTotal Plate Count (aerobic): < 10000 cfunote/gEnterobacteriaceae: ≤ 10 cfu/gSalmonella: Absence in 25 g | |||
| Frozen, dried and powder forms of Locusta migratoria (migratory locust) | Description/Definition:The novel food consists of the frozen, dried and powder forms of migratory locust. The term ‘migratory locust’ refers to the adult of Locusta migratoria, an insect species that belongs to the Acrididae family (subfamily Locustinae).The novel food is intended to be marketed in three different forms, namely: (i) thermally processed and frozen L. migratoria (LM frozen); (ii) thermally processed and freeze-dried L. migratoria (LM dried), and (iii) thermally processed freeze-dried and ground whole L. migratoria (whole LM powder). The LM dried may be marketed as such or in powder.For LM frozen and LM dried, legs and wings must be removed to reduce the risk of intestinal constipation that could be possibly caused by ingestion of the large spines on the insect tibia. The whole LM powder is obtained via mechanical grinding of the insect with legs and wings, and sieving to reduce particle size below 1 mm.A minimum 24 hours fasting period is required before killing the insects by freezing, to allow the adults to discard their bowel content. | |||
| Parameters | LM frozen | LM dried | Whole LM powder | |
| Characteristics/Composition | ||||
| Ash (% w/w) | 0,6-1,0 | 2,0-3,1 | 1,8-1,9 | |
| Moisture (% w/w) | 67-73 | ≤ 5 | ≤ 5 | |
| Crude protein (N × 6,25) (% w/w) | 11-21 | 43-53 | 50 – 60 | |
| Fat (% w/w) | 7-13 | 31-41 | 31-41 | |
| Saturated fatty acids (% fat) | 35-43 | 35-43 | 35-43 | |
| Digestible carbohydrates (% w/w) | 0,1-2,0 | 0,1-2,0 | 1,0-3,5 | |
| noteDietary fibre (% w/w) | 1,5-3,5 | 5,5-9,0 | 5,5-9,0 | |
| Chitin (% w/w) | 1,7-2,4 | 6,4-10,4 | 10,5-13,9 | |
| Peroxide value (Meq O2/kg fat) | ≤ 5 | ≤ 5 | ≤ 5 | |
| Contaminants | ||||
| Lead (mg/kg) | ≤ 0,07 | ≤ 0,07 | ≤ 0,07 | |
| Cadmium (mg/kg) | ≤ 0,05 | ≤ 0,05 | ≤ 0,05 | |
| Aflatoxins (Sum of B1, B2, G1, G2) (μg/kg) | ≤ 4 | ≤ 4 | ≤ 4 | |
| Aflatoxin B1 (μg/kg) | ≤ 2 | ≤ 2 | ≤ 2 | |
| Deoxynivalenol (μg/kg) | ≤ 200 | ≤ 200 | ≤ 200 | |
| Ochratoxin A (μg/kg) | ≤ 1 | ≤ 1 | ≤ 1 | |
| Sum of dioxins and dioxins-like PCBs UB (noteWHO2005 PCDD/F-PCB-TEQ) (pg/g fat) | ≤ 1,2 | ≤ 1,2 | ≤ 1,2 | |
| Microbiological criteria | ||||
| Total aerobic colony count (noteCFU/g) | ≤ 105 | ≤ 105 | ≤ 105 | |
| Enterobacteriaceae (presumptive) (CFU/g) | ≤ 100 | ≤ 100 | ≤ 100 | |
| Escherichia coli (CFU/g) | ≤ 50 | ≤ 50 | ≤ 50 | |
| Listeria monocytogenes | Not detected in 25g | Not detected in 25g | Not detected in 25g | |
| Salmonella spp. | Not detected in 25g | Not detected in 25g | Not detected in 25g | |
| Bacillus cereus (presumptive) (CFU/g) | ≤ 100 | ≤ 100 | ≤ 100 | |
| Coagulase positive Staphylococci (CFU/g | ≤ 100 | ≤ 100 | ≤ 100 | |
| Sulfite-reducing Anaerobes (CFU/g) | ≤ 30 | ≤ 30 | ≤ 30 | |
| Yeasts and moulds (CFU/g) | ≤ 100 | ≤ 100 | ≤ 100 | |
| Fucoidan extract from the seaweed Fucus vesiculosus | Description/Definition:Fucoidan from the seaweed Fucus vesiculosus is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic solvents. The resulting extract is concentrated and dried to yield the fucoidan extract with the following specifications:Off-white to brown powderOdour and Taste: Bland odour and tasteMoisture: < 10 % (105 °C for 2 hours)pH value: 4,0-7,0 (1 % suspension at 25 °C)Heavy metals:Arsenic (inorganic): < 1,0 ppmCadmium: < 3,0 ppmLead: < 2,0 ppmMercury: < 1,0 ppmMicrobiological criteria:Total aerobic microbial count: < 10000 CFU/gYeast and mould count: < 100 CFU/gTotal enterobacteria count: Absence/gEscherichia coli: Absence/gSalmonella: Absence/10 gStaphylococcus aureus: Absence/gComposition of the two permitted types of extracts, based on the level of fucoidan:Extract 1:Fucoidan: 75-95 %Alginate: 2,0-5,5 %Polyphloroglucinol: 0,5-15 %Mannitol: 1-5 %Natural salts/Free Minerals: 0,5-2,5 %Other carbohydrates: 0,5-1,0 %Protein: 2,0-2,5 %Extract 2:Fucoidan: 60-65 %Alginate: 3,0-6,0 %Polyphloroglucinol: 20-30 %Mannitol: < 1,0 %Natural salts/Free Minerals: 0,5-2,0 %Other carbohydrates: 0,5-2,0 %Protein: 2,0-2,5 % | |||
| Fucoidan extract from the seaweed Undaria pinnatifida | Description/Definition:Fucoidan from seaweed Undaria pinnatifida is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic solvents. The resulting extract is concentrated and dried to yield the fucoidan extract with the following specifications:Off-white to brown powderOdour and Taste: Bland odour and tasteMoisture: < 10 % (105 °C for 2 hours)pH value: 4,0-7,0 (1 % suspension at 25 °C)Heavy metals:Arsenic (inorganic): < 1,0 ppmCadmium: < 3,0 ppmLead: < 2,0 ppmMercury: < 1,0 ppmMicrobiology:Total aerobic microbial count: < 10000 CFU/gYeast and mould count: < 100 CFU/gTotal enterobacteria count: Absence/gEscherichia coli: Absence/gSalmonella: Absence/10 gStaphylococcus aureus: Absence/gComposition of the two permitted types of extracts, based on the level of fucoidan:Extract 1:Fucoidan: 75-95 %Alginate: 2,0-6,5 %Polyphloroglucinol: 0,5-3,0 %Mannitol: 1-10 %Natural salts/Free Minerals: 0,5-1,0 %Other carbohydrates: 0,5-2,0 %Protein: 2,0-2,5 %Extract 2:Fucoidan: 50-55 %Alginate: 2,0-4,0 %Polyphloroglucinol: 1,0-3,0 %Mannitol: 25-35 %Natural salts/Free Minerals: 8-10 %Other carbohydrates: 0,5-2,0 %Protein: 1,0-1,5 % | |||
| 2′-Fucosyllactose(synthetic) | Definition:Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)- D-glucopyranoseChemical formula: C18H32O15CAS No: 41263-94-9Molecular weight: 488,44 g/molDescription:2′-fucosyllactose is a white to off-white powder that is produced by a chemical synthesis process.Purity:2'-Fucosyllactose: ≥ 95 %D-Lactose: ≤ 1,0 w/w %L-Fucose: ≤ 1,0 w/w %Difucosyl- D-lactose isomers: ≤ 1,0 w/w %2′-Fucosyl- D-lactulose: ≤ 0,6 w/w %pH (20 °C, 5 % solution): 3,2-7,0Water (%): ≤ 9,0 %Ash, sulphated: ≤ 0,2 %Acetic acid: ≤ 0,3 %Residual solvents (methanol, 2-propanol, methyl acetate, acetone): ≤ 50,0 mg/kg singly, ≤ 200,0 mg/kg in combinationResidual proteins: ≤ 0,01 %Heavy Metals:Palladium: ≤ 0,1 mg/kgNickel: ≤ 3,0 mg/kgMicrobiological criteria:Aerobic mesophilic bacteria total count: ≤ 500 CFU/gYeasts and Moulds: ≤ 10 CFU/gResidual endotoxins: ≤ 10 EU/mg | |||
| Specifications | Data protection | |||
| Definition:Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranoseChemical formula: C18H32O15CAS No: 41263-94-9Molecular weight: 488,44 g/mol | 2′-Fucosyllactose produced with a genetically modified strain of Corynebacterium glutamicum ATCC 13032 authorised on 16 May 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: ‘Advanced Protein Technologies Corporation’, 7th Floor GyeongGi-BioCenter, 147, Gwanggyo-ro, Yeongtong-gu, Suwon-si Gyeonggi-do, 16229 South Korea. During the period of data protection, 2′-Fucosyllactose produced with a genetically modified strain of Corynebacterium glutamicum ATCC 13032 is authorised for placing on the market within the Union only by ‘Advanced Protein Technologies Corporation’ unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ‘Advanced Protein Technologies Corporation’.End date of the data protection: 16 May 2028. | |||
| 2′-Fucosyllactose(microbial source) | Source: Genetically modified strain of Escherichia coli K-12 | Source: Genetically modified strain of Escherichia coli BL-21 | Source: Genetically modified strain of Corynebacterium glutamicum ATCC 13032 | |
| Description:2′-Fucosyllactose is a white to off-white powder that is produced by a microbiological process.Purity:2′-Fucosyllactose: ≥ 83 %D-Lactose: ≤ 10,0 %L-Fucose: ≤ 2,0 %Difucosyl-D-lactose: ≤ 5,0 %2′-Fucosyl-D-lactulose: ≤ 1,5 %Sum of saccharides (2′-Fucosyllactose, D-Lactose, L-Fucose, Difucosyl-D-lactose, 2′-Fucosyl-D-lactulose): ≥ 90 %pH (20 C, 5 % solution): 3,0-7,5Water: ≤ 9,0 %Sulphated ash: ≤ 2,0 %Acetic acid: ≤ 1,0 %Residual proteins: ≤ 0,01 %Microbiological criteria:Aerobic mesophilic bacteria total count: ≤ 3000 CFU/gYeasts: ≤ 100 CFU/gMoulds: ≤ 100 CFU/gEndotoxins: ≤ 10 EU/mgCFU: Colony Forming Units; EU: Endotoxin Units | Description:2′-Fucosyllactose is a white to off white powder and the liquid concentrate (45 % ± 5 % w/v) aqueous solution is a colourless to slight yellow clear aqueous solution. 2′-Fucosyllactose is produced by a microbiological process.Purity:2′-Fucosyllactose: ≥ 90 %Lactose: ≤ 5,0 %Fucose: ≤ 3,0 %3-Fucosyllactose: ≤ 5,0 %Fucosylgalactose: ≤ 3,0 %Difucosyllactose: ≤ 5,0 %Glucose: ≤ 3,0 %Galactose: ≤ 3,0 %Water: ≤ 9,0 % (powder)Ash, sulphated: ≤ 0,5 % (powder and liquid)Residual proteins: ≤ 0,01 % (powder and liquid)Heavy Metals:Lead: ≤ 0,02 mg/kg (powder and liquid)Arsenic: ≤ 0,2 mg/kg (powder and liquid)Cadmium: ≤ 0,1 mg/kg (powder and liquid)Mercury: ≤ 0,5 mg/kg (powder and liquid)Microbiological criteria:Total plate count: ≤ 104 CFU/g (powder), ≤ 5 000 CFU/g (liquid)Yeasts and Moulds: ≤ 100 CFU/g (powder); ≤ 50 CFU/g (liquid)Enterobacteriaceae/Coliforms: absence in 11 g (powder and liquid)Salmonella: negative/100 g (powder), negative/200 ml (liquid)Cronobacter: negative/100 g (powder), negative/200 ml (liquid)Endotoxins: ≤ 10 EU/mg (powder), ≤ 10 EU/μl (liquid)Aflatoxin M1: ≤ 0,025 μg/kg (powder and liquid)CFU: Colony Forming Units; EU: Endotoxin Units | Description:2′-Fucosyllactose is a white to off white/ivory powder that is produced by a microbiological process.Purity:2′-Fucosyllactose (w/w dry matter): ≥ 94,0 %D-Lactose (w/w dry matter): ≤ 3,0 %L-Fucose (w/w dry matter): ≤ 3,0 %3-Fucosyllactose (w/w dry matter): ≤ 3,0 %Difucosyllactose (w/w dry matter): ≤ 2,0 %D-Glucose (w/w dry matter): ≤ 3,0 %D-Galactose (w/w dry matter): ≤ 3,0 %Water: ≤ 9,0 %Ash: ≤ 0,5 %Residual proteins: ≤ 0,005 %Contaminants:Arsenic: ≤ 0,03 mg/kgAflatoxin M1: ≤ 0,025 μg/kgEthanol: ≤ 1000 mg/kgMicrobiological criteria:Total plate count: ≤ 500 CFU/gYeasts and Moulds: ≤ 100 CFU/gEnterobacteriaceae: absence in 10 gSalmonella: absence in 25 gCronobacter spp.: absence in 10 gEndotoxins: ≤ 100 EU/gCFU: Colony Forming Units; EU: Endotoxin Units | ||
| 2′-Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’)(microbial source) | Description/Definition:2′-Fucosyllactose/Difucosyllactose mixture is a purified, white to off-white powder or agglomerates thereof that is produced by a microbial process.Source: Genetically modified Escherichia coli strain K-12 DH1Characteristics/Composition:Appearance: White to off white powder or agglomeratesSum of 2′-Fucosyllactose, Difucosyllactose, D-Lactose, L-Fucose, and 3-Fucosyllactose (% of dry matter): ≥ 92,0 % (w/w)Sum of 2′-Fucosyllactose and Difucosyllactose (% of dry matter): ≥ 85,0 % (w/w)2′-Fucosyllactose (% of dry matter): ≥ 75,0 % (w/w)Difucosyllactose (% of dry matter): ≥ 5,0 % (w/w)D-Lactose: ≤ 10,0 % (w/w)L-Fucose: ≤ 1,0 % (w/w)2′-Fucosyl-D-lactulose: ≤ 2,0 (w/w)Sum of other carbohydratesnote: ≤ 6,0 % (w/w)Moisture: ≤ 6,0 % (w/w)Ash, sulfated: ≤ 0,8 % (w/w)pH (20 °C, 5 % solution): 4,0 -6,0Residual protein: ≤ 0,01 % (w/w)Microbiological criteria:Aerobic mesophilic total plate count: ≤ 1000 CFU/gEnterobacteriaceae: ≤ 10 CFU/gSalmonella sp.: Negative/25 gYeast: ≤ 100 CFU/gMould: ≤ 100 CFU/gResidual endotoxins: ≤ 10 EU/mgCFU: Colony Forming Units; EU: Endotoxin Units | |||
| 3-Fucosyllactose (‘3-FL’)(microbial source) | Description:3-Fucosyllactose (3-FL) is a purified, white to off-white powder that is produced by microbial fermentation and contains limited levels of D-Lactose, L-Fucose, D-Galactose, and D-Glucose.Source: Genetically modified strain of Escherichia coli K-12.Definition:Chemical formula: C18H32O15Chemical name: β-D-galactopyranosyl-(1→4)[-α-L-fucopyranosyl-(1→3)]-D-glucopyranoseMolecular mass: 488,44 DaCAS No 41312-47-4Characteristics/Composition:3-Fucosyllactose (% of dry matter): ≥ 90,0 % (w/w)D-Lactose (% of dry matter): ≤ 5,0 % (w/w)L-Fucose (% of dry matter): ≤ 3,0 % (w/w)Sum of D-Galactose/D-Glucose (% of dry matter): ≤ 3,0 % (w/w)Sum of other carbohydratesa (% of dry matter): ≤ 3,0 % (w/w)Moisture: ≤ 5,0 % (w/w)pH (20 °C, 5 % solution): 3,0-7,5Residual protein: ≤ 0,01 % (w/w)Ash (%): ≤ 0,5Heavy metals/Contaminants:Arsenic: ≤ 0,2 mg/kgCadmium: ≤ 0,05 mg/kgLead: ≤ 0,05 mg/kgMercury: ≤ 0,1 mg/kgAflatoxin M1: ≤ 0,025 μg/kgAflatoxin B1: ≤ 0,1 μg/kgResidual endotoxins: ≤ 0,3 EU/mgMicrobiological criteria:Total plate count: ≤ 1000 CFU/gEnterobacteriaceae: Absence in 10 gSalmonella sp.: Absence in 25 gCronobacter (Enterobacter) sakazakii: Absence in 10 gListeria monocytogenes: Absence in 25 gBacillus cereus: ≤ 10 CFU/gYeast: ≤ 100 CFU/gMould: ≤ 100 CFU/gCFU: Colony Forming Units; EU: Endotoxin Units; aSum of other carbohydrates: 3-Fucosyllactose isomer, difucosyllactose isomer, and oligomers. | |||
| 3-Fucosyllactose (‘3-FL’)(produced by a derivative strain of E. coli BL21(DE3)) | Description:3-Fucosyllactose (3-FL) is a purified, white to off-white powder that is produced by microbial fermentation and contains limited levels of D-Lactose, L-Fucose, D-Galactose, and D-Glucose.Definition:Chemical name: β-D-Galactopyranosyl-(1→4)- [α-L-fucopyranosyl-(1→3)]- D-glucopyranoseChemical formula: C18H32O15Molecular mass: 488,44 DaCAS No: 41312-47-4Source: A genetically modified strain of Escherichia coli BL21(DE3)Characteristics/Composition:3-Fucosyllactose (% of dry matter): ≥ 90,0 % (w/w)D-Lactose (% of dry matter): ≤ 5,0 % (w/w)D-glucose (% of dry matter): ≤ 3,0 % (w/w)D-galactose (% of dry matter): ≤ 3,0 % (w/w)L-Fucose (% of dry matter): ≤ 3,0 % (w/w)Sum of other carbohydrates (% of dry matter): ≤ 5,0 % (w/w)Moisture: ≤ 9,0 % (w/w)Ash: ≤ 1,0 % (w/w)Residual protein: ≤ 0,01 % (w/w)Heavy metals and contaminants:Arsenic: ≤ 0,2 mg/kgAflatoxin M1: ≤ 0,025 μg/kgMicrobiological criteria:Standard plate count: ≤ 1000 CFU/gEnterobacteriaceae: ≤ 10 CFU/gSalmonella spp.: Absence in 25 gYeast and mould: ≤ 100 CFU/gCronobacter (Enterobacter) sakazakii.: Absence in 10 gResidual endotoxins: ≤ 10 EU/mg | |||
| 3-Fucosyllactose (‘3-FL’)(produced by derivative strain of E. coli K-12 DH1) | Description:3-Fucosyllactose (3-FL) is a purified and concentrated white to off-white powder produced by microbial fermentation and contains limited levels of D-Lactose, 3-Fucosyllactulose, and L-Fucose.Definition:Chemical name: β-D-Galactopyranosyl-(1→4)- [α-L-fucopyranosyl-(1→3)]- D-glucopyranoseChemical formula: C18H32O15Molecular mass: 488,44 DaCAS No: 41312-47-4Source: Genetically modified strain of Escherichia coli K-12 DH1Characteristics/Composition:3-Fucosyllactose (% w/w of dry matter): ≥ 90,0D-Lactose (% w/w): ≤ 5,03-Fucosyllactulose (% w/w): ≤ 1,5L-Fucose (% w/w): ≤ 1,0Sum of 3-Fucosyllactose, 3-Fucosyllactulose, D-Lactose and L-Fucose, (% w/w dry matter): ≥ 92,0Sum of other carbohydrates (% w/w): ≤ 5,0Moisture (% w/w): ≤ 6,0pH (20 °C, 5 % solution): 3,2 -7,0Ash (% w/w): ≤ 0,5Acetic acid (% w/w): ≤ 1,0Residual protein (% w/w): ≤ 0,01Heavy metals and contaminants:Arsenic: ≤ 0,2 mg/kgAflatoxin M1: ≤ 0,025 μg/kgMicrobiological criteria:Total plate count: ≤ 1000 CFU/gEnterobacteriaceae: Absence in 10 gSalmonella spp.: Absence in 25 gYeast and mould: ≤ 100 CFU/gCronobacter spp.: Absence in 10 gListeria monocytogenes: Absence in 25 gPresumptive Bacillus cereus: ≤ 50 CFU/gEndotoxins: ≤ 10 EU/mgCFU: Colony Forming Units; EU: Endotoxin Units | |||
| Galacto-oligosaccharide | Description/Definition:Galacto-oligosaccharide is produced from milk lactose by an enzymatic process using β-galactosidases from Aspergillus oryzae, Bifidobacterium bifidum, Pichia pastoris, Sporobolomyces singularis, Kluyveromyces lactis and Papiliotrema terrestris.GOS: min. 46 % Dry Matter (DM)Lactose: max. 40 % DMGlucose: max. 22 % DMAsh: max. 4,0 % DMProtein: max. 4,5 % DMNitrite: max. 2 mg/kg | |||
| Glucosamine HCl from Aspergillus niger and genetically modified strain of E. coli K-12 | White crystalline odourless powderMolecular formula: C6H13NO5 · HClRelative molecular mass: 215,63 g/molD-Glucosamine HCl 98,0-102,0 % of reference standard (HPLC)Specific rotation + 70,0o - + 73,0o | |||
| Glucosamine sulphate KCl from Aspergillus niger and genetically modified strain of E. coli K-12 | White crystalline odourless powderMolecular formula: (C6H14NO5)2SO4 · 2KClRelative molecular mass: 605,52 g/molD-Glucosamine Sulphate 2KCl 98,0-102,0 % of reference standard (HPLC)Specific Rotation +50,0o to +52,0o | |||
| Glucosamine sulphate NaCl from Aspergillus niger and genetically modified strain of E. coli K-12 | White crystalline odourless powderMolecular formula: (C6H14NO5)2SO4 · 2NaClRelative molecular mass: 573,31 g/molD-Glucosamine HCl: 98-102 % of reference standard (HPLC)Specific Optical Rotation: +52o - +54o | |||
| Glucosyl hesperidin | Description/Definition:The novel food is a pale yellow to yellow-brown powder consisting of monoglucosyl hesperidin and produced enzymatically from hesperidin, which is isolated from the peels, juice, or seeds of citrus fruits, and dextrin.Following the inactivation of the enzymes used in the process, the solution undergoes a multistep purification process that includes filtration, chromatographic separation, intermediate concentration and decolourisation. The purified solution is then concentrated by evaporation, micro-filtrated and spray-dried.Characteristics/composition:Chemical (IUPAC) name: (2S)-7 -[(O-6-Deoxy-α-l-mannopyranosyl-(1→6)-O-[α-d-glucopyranosyl-(1→4)]-β-d-glucopyranosyl)oxy]-2,3-dihydro-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-oneSynonym: 4G-α-d-glucopyranosyl-hesperidinCAS No: 161713–86- 6Chemical formula: C34H44O20Monoglucosyl hesperidin (MGH) (dry basis) 75,0-85,0 %Hesperidin (dry basis):10-20 %Loss on drying ≤ 6 %Residue on ignition ≤ 2 %Heavy metalsLead ≤ 0,1 mg/kgArsenic ≤ 0,1 mg/kgMicrobiological criteriaTotal aerobic microbial count: ≤ 100 CFU/gTotal coliforms: Not detected in 10 gSalmonella spp. Not detected in 25 gYeast and moulds: ≤ 100 CFU/gCFU: colony forming units. | |||
| Guar Gum | Description/Definition:Native guar gum is the ground endosperm of seeds from natural strains of guar Cyamopsis tetragonolobus L. Taub. (Leguminosae family). It consists of a high molecular weight polysaccharide, primarily composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as a galactomannan (galactomannan content not less than 75 %).Appearance: White to yellowish powderMolecular weight: Between 50000 – 8000000 DaltonsCAS number: 9000-30-0Einecs Number: 232-536-8Purity: As specified by Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Councilnote & by Commission Implementing Regulation (EU) 2015/175 of 5 February 2015 laying down special conditions applicable to the import of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxinsnote.Physico-chemical properties:PowderShelf-life: 2 yearsColour: WhiteOdour: LightAverage diameter of particles: 60-70μmMoisture: Max 15 %Viscosity * at 1 hour —Viscosity * at 2 hours: Min 3600 mPa.sViscosity * at 24 hours: Min 4000 mPa.sSolubility: Soluble in hot and cold waterpH for 10g/L, at 25 °C - 6-7,5FlakesUseful life: 1 yearColour: White/off white with absence or minimal presence of black spotsOdour: LightAverage diameter of particles: 1-10 mmMoisture: Max 15 %Viscosity * at 1 hour: Min 3000 mPa.sViscosity * at 2 hours —Viscosity * at 24 hours —Solubility — Soluble in hot and cold waterpH for 10g/L, at 25 °C - 5-7,5(*)The measurements of viscosity are carried out under the following conditions: 1 %, 25 °C, 20 rpm | |||
| Heat-treated milk products fermented with Bacteroides xylanisolvens | Description/Definition:Heat-treated fermented milk products are produced with Bacteroides xylanisolvens (DSM 23964) as starter culture.Semi-skimmed milk (between 1,5 % and 1,8 % fat) or skimmed milk (0,5 % fat or less) is pasteurised or ultra-heat-treated before starting the fermentation with Bacteroides xylanisolvens (DSM 23964). The resulting fermented milk product is homogenised and then heat-treated to inactivate Bacteroides xylanisolvens (DSM 23964). The final product does not contain viable cells of Bacteroides xylanisolvens (DSM 23964)(1).(1)Modified DIN EN ISO 21528-2. | |||
| Hydroxytyrosol | Description/Definition:Hydroxytyrosol is a pale yellow viscous liquid obtained by chemical synthesisMolecular formula: C8H10O3Molecular weight: 154,6 g/molCAS No: 10597-60-1Moisture ≤ 0,4 %Odour: CharacteristicTaste: Slightly bitterSolubility (water): Miscible with waterpH: 3,5-4,5Refractive Index: 1,571-1,575Purity:Hydroxytyrosol: ≥ 99 %Acetic acid: ≤ 0,4 %Hydroxytyrosol acetate: ≤ 0,3 %Sum of homovanillic acid, iso-homovanilic acid, and 3-methoxy-4hydroxyphenylglycol: ≤ 0,3 %Heavy MetalsLead: ≤ 0,03 mg/kgCadmium: ≤ 0,01 mg/kgMercury: ≤ 0,01 mg/kgResidual SolventsEthyl acetate: ≤ 25,0 mg/kgIsopropanol: ≤ 2,50 mg/kgMethanol: ≤ 2,00 mg/kgTetrahydrofuran: ≤ 0,01 mg/kg | |||
| Ice Structuring Protein type III HPLC 12 | Description/Definition:The Ice Structuring Protein (ISP) preparation is a light-brown liquid produced by submerged fermentation of a genetically-modified strain of food-grade baker’s yeast (Saccharomyces cerevisiae) in which a synthetic gene for the ISP has been inserted into the yeast’s genome. The protein is expressed and secreted into the growth medium where it is separated from the yeast cells by micro-filtration and concentrated by ultra-filtration. As a result, the yeast cells are not transferred into the ISP preparation as such or under an altered form. The ISP preparation consists of native ISP, glycosylated ISP and proteins and peptides from the yeast and sugars as well as acids and salts commonly found in food. The concentrate is stabilised with 10 mM citric acid buffer.Assay: ≥ 5 g/l active ISPpH: 2,5-3,5Ash: ≤ 2,0 %DNA: Not detectable | |||
| Aqueous extract of dried leaves of Ilex guayusa | Description/Definition:Dark brown liquid. Aqueous extracts of dried leaves of Ilex guayusa.Composition:Protein: < 0,1 g/100 mlFat: < 0,1 g/100 mlCarbohydrate: 0,2–0,3 g/100 mlTotal sugars: < 0,2 g/100 mlCaffeine: 19,8–57,7 mg/100 mlTheobromine: 0,14–2,0 mg/100 mlChlorogenic acids: 9,9–72,4 mg/100ml | |||
| Infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner(Traditional food from a third country) | Description/Definition:The traditional food consists of an infusion of leaves from Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner (family: Rubiaceae).The traditional food is prepared by mixing a maximum of 20 g of dried leaves from Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner with 1 L of hot water. Leaves are removed and the infusion is then subjected to pasteurization (at least 71 °C for 15 seconds).Composition:Visual: Brown green liquidOdour and taste: CharacteristicChlorogenic acid (5-CQA): < 100 mg/LCaffeine: < 80 mg/LEpigallocatechin gallate (EGCG): < 700 mg/LMicrobiological criteria:Total plate count: < 500 CFU/gTotal yeast and mould count: < 100 CFU/gTotal coliforms: < 100 CFU/gEscherichia coli: Absence in 1 gSalmonella: Absence in 25 gHeavy metals:Lead (Pb): < 3,0 mg/LArsenic (As): < 2,0 mg/LCadmium (Cd): < 1,0 mg/LCFU: Colony Forming Units | |||
| Iron hydroxide adipate tartrate | Description/Definition:Iron hydroxide adipate tartrate (IHAT) is an odourless, engineered nanomaterial in powder form that is insoluble in water and is manufactured by a chemical synthesis involving a series of steps involving acid-base reaction, precipitation, filtration, and drying.The food supplements containing the novel food are manufactured in capsular form. Excess adipate, tartrate and sodium chloride are used at levels resulting from the production process to help stabilise IHAT and ensure the authorised particle size distribution. If other forms of food supplements (e.g. tablets, pastilles, sachets of powders, gummies, syrups, etc.) are used in combination with adipate, tartrate and sodium chloride or in combination with other substances, or if other substances are used in the capsular form food supplements containing the novel food, it must be ensured that the authorised IHAT particle size distribution is maintained. | |||
| Common name | Iron oxo-hydroxide adipate tartrate | |||
| Other names | Iron hydroxide adipate tartrate, Iron oxyhydroxide adipate tartrate | |||
| Trade name | IHAT | |||
| CAS number | 2460638-28-0 | |||
| Molecular formula(calculated) | FeOm(OH)n(H2O)x(C4H6O6)y(C6H10O4)zwhere: m and n are undefined as per accepted practice for ferric iron oxohydroxidesnotex = 0,28-0,88y = 0,78-1,50z = 0,04-0,19Tartaric (C4H6O6) and adipic (C6H10O4) acid are represented in their protonated form. | |||
| Molecular weight | Average molecular weight: 35803,4 Da (lower-upper bound: 27670,5-45319,4 Da) | |||
| Characteristics/Composition:Physical/chemicalIron (% dry matter): 24,0-36,0Adipate: (% dry matter): 1,5-4,5Tartrate: (% dry matter): 28,0-40,0Water content (%): 10,0-21,0Sodium (% dry matter): 9,0-11,0Chloride (% dry matter): 2,6-4,2Phase distributionSoluble (%): 2,0-4,0Nano (%): 92,0-98,0Micro (%): 0,0-3,0Primary particle sizeMedian diameternote: 1,5-2,3 nmMean diameternote: 1,8-2,8 nmDv(10)note: 1,5-2,5 nmDv(50)note: 2,5-3,5 nmDv(90)note: 5,0-6,0 nmHeavy metalsArsenic: < 0,80 mg/kgNickel: < 50,0 mg/kgResidual solventsEthanol: < 500 mg/kgMicrobiological criteriaTotal aerobic microbial count: < 10 CFU/gTotal yeast and mould count: < 10 CFU/g | ||||
| Iron milk caseinate | Description:Iron milk caseinate is an iron-casein-phosphate complex in the form of a creamy or beige powder produced by the dissolution of ferric iron salts (ferric sulfate or ferric chloride) in a casein solution obtained from bovine milk in the presence of potassium orthophosphate following a series of steps involving pasteurisation, concentration, and drying.Characteristics/Composition:Protein (%): 50,0 – 65,0Ash (%): 20,0 – 40,0Moisture (%): < 8,0Fat (%): < 1,0Iron (%): 2,0 – 4,0Potassium (%): 5,0 – 15,0Phosphorus (%): 2,0 – 6,0Sodium (%): < 4,0Heavy metals:Lead: < 0,5 mg/kgArsenic: ≤ 1,0 mg/kgCadmium: < 0,5 mg/kgMercury: < 0,1 mg/kgMycotoxins:Aflatoxin M1: ≤ 0,02 mg/kgMicrobiological criteria:Aerobic plate count: ≤ 1000 CFU/gColiforms: ≤ 10 CFU/gSalmonella spp.: Absence in 25 gYeast and mould: ≤ 10 CFU/gEscherichia coli: ≤ 10 CFU/gStaphylococcus aureus: Absence in 1 gCFU: Colony Forming Units | |||
| Isomalto-oligosaccharide | Powder:Solubility (water) (%): > 99Glucose (% dry basis): ≤ 5,0Isomaltose + DP3 to DP9 (% dry basis): ≥ 90Moisture (%): ≤ 4,0Sulphated ash(g/100 g): ≤ 0,3Heavy metals:Lead (mg/kg): ≤ 0,5Arsenic (mg/kg): ≤ 0,5Syrup:Dried solids (g/100 g): > 75Glucose (% dry basis): ≤ 5,0Isomaltose + DP3 to DP9 (% dry basis): ≥ 90pH: 4 - 6Sulphated ash(g/100 g): ≤ 0,3Heavy metals:Lead (mg/kg): ≤ 0,5Arsenic (mg/kg): ≤ 0,5 | |||
| Isomalto-oligosaccharide | PowderSolubility (water) (%): > 99,0Glucose (% dry basis): ≤ 5,0Isomaltose + DP3 to DP9 (% dry basis): ≥ 90,0Moisture (%): ≤ 4,0Sulphated ash (g/100 g): ≤ 0,3Heavy metals:Lead (mg/kg): ≤ 0,5Arsenic (mg/kg): ≤ 0,5Microbiological criteria:Total Aerobic Microbial Count: ≤ 1000 CFU/gYeasts and moulds: ≤ 100 CFU/gEscherichia coli: Absence in 10 gSalmonella spp.: Absence in 25 gSyrupDried solids (g/100 g): > 75Glucose (% dry basis): ≤ 5,0Isomaltose + DP3 to DP9 (% dry basis): ≥ 90pH: 4–6Sulphated ash (g/100 g): ≤ 0,3Heavy metals:Lead (mg/kg): ≤ 0,5Arsenic (mg/kg): ≤ 0,5Microbiological criteria:Total Aerobic Microbial Count: ≤ 1000 CFU/gYeasts and moulds: ≤ 100 CFU/gEscherichia coli: Absence in 10 gSalmonella spp.: Absence in 25 gCFU: colony forming units | |||
| Isomaltulose | Description/Definition:A reducing disaccharide that consists of one glucose and one fructose moiety linked by an alpha-1,6-glycosidic bond. It is obtained from sucrose by an enzymatic process. The commercial product is the monohydrate. Appearance: Virtually odourless, white or almost white crystals with a sweet tasteChemical name: 6-O-α-D-glucopyranosyl-D-fructofuranose, monohydrateCAS No.: 13718-94-0Chemical formula: C12H22O11 · H2OStructural formulaFormula weight: 360,3 (monohydrate)Purity:Assay: ≥ 98 % on the dry basisLoss on drying: ≤ 6,5 % (60 °C, 5 hours)Heavy metals:Lead: ≤ 0,1 mg/kgDetermine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5(1), ‘Instrumental methods’(1)Food and Nutrition Paper 5 Rev. 2 — Guide to specifications for general notices, general analytical techniques, identification tests, test solutions and other reference materials (JECFA), 1991, 322 pp., English, ISBN 92-5-102991-1. | |||
| Isomaltulose powder | Description/Definition:The novel food is isomaltulose powder produced from sucrose by a microbiological process using Serratia plymuthica. The dry matter content is a mixture of mono-and disaccharides, mainly composed of isomaltulose (≥ 75 %) and trehalulose (≤ 13 %) and, to a minor extent, glucose, fructose, sucrose and oligosaccharides (traces).Characteristics/composition:Isomaltulose (% DM): ≥ 75Trehalulose (% DM): ≤ 13Glucose (% DM): ≤ 3Fructose (% DM): ≤ 4Sucrose (% DM): ≤ 5Moisture (%): ≤ 7Ash (%): ≤ 0,05Protein (%): < 0,1Chemical identity of isomaltulose:Chemical (IUPAC) name: α-D-glucopyranosyl-(1 → 6)-D-fructofuranoseCommon name: IsomaltuloseCAS number: 13718–94-0Molecular formula: C12H22O11Molecular weight: 342,30 g/molChemical identity of trehalulose:Chemical (IUPAC) name: α-D-glucopyranosyl-(1 → 1)-D-fructofuranoseCommon name: TrehaluloseCAS number: 51411–23-5Molecular formula: C12H22O11Molecular weight: 342,30 g/molHeavy metals:Lead (mg/kg): ≤ 0,1Microbiological criteria:Total aerobic microbial count: < 100 CFU/gTotal yeast and mould count: < 100 CFU/gE. coli: < 10 CFU/gEnterobacteriaceae: < 100 CFU/gSalmonella: not detected in 25 gCFU: colony forming unitsDM: dry matter | |||
| Jatropha curcas L. (edible variety) kernels | Description:The kernels are obtained from the seeds of the ripe fruits of the edible variety of the Jatropha curcas L. plants that produce kernels with non-detectable levels of phorbol esters, following a series of steps involving the cleaning and de-husking of the fruits to obtain the seeds, the drying of the seeds, the cleaning of the seeds to remove debris and other residues, mechanical deshelling of the seeds to obtain the kernels, and the hydrothermal treatment (> 120 °C for 40 minutes) of the kernels to reduce anti-nutrients and the microbiological load.As the edible variety of the Jatropha curcas L. plants, producing kernels that contain non-detectable levels of phorbol esters, are phenotypically undistinguishable from the non-edible variety, only the appropriate edible variety of Jatropha curcas L. plants should be used in the production of the novel food. The entire production process must ensure that the mixing of edible and non-edible kernels does not occur.The absence of mixing of edible with non-edible kernels shall be confirmed by analytical controls for phorbol esters carried on each batch of the seeds after the seed-drying step and before the deshelling step according to the sampling procedure of Table A. Five laboratory samples extracted from each aggregate sample are de-shelled, ground, and analysed for phorbol esters using a validated UHPLC-UV-MS (b) method. Only the batches in which phorbol esters are undetectable in all five samples are further processed to the seed deshelling and kernel hydrothermal treatment steps.Table A | |||
| Batch weight (tons) | Weight or number of sublots | Number of incremental samples | ||
| ≥ 500 | 100 tons | 100 | ||
| > 100 and < 500 | 5 sub-lots | 100 | ||
| > 10 and ≤ 100 | 5 sub-lots | 100 | ||
| > 5,0 and ≤ 10 | — | 80 | ||
| > 1 and ≤ 5,0 | — | 60 | ||
| > 0,1 and ≤ 1,0 | — | 30 | ||
| ≤ 0,1 | — | 10 | ||
| Each sub-lot shall be sampled separately. Aggregate samples are composed by a minimum of 10 incremental samples. The minimum amount of an aggregate sample shall be 3,5 kg. This amount may increase proportionally according to the number of incremental samples taken.Characteristics/Composition:Moisture: ≤ 3 %Total fat: 54-64 %Total protein: 21-32 %Total fibre: 6-10 %Ash: 3-5 %Contaminants:Phorbol esters (μg TPA eq (a)/g kernel) (b): ≤ 0,75 (LOD) (c)Lead: ≤ 0,20 mg/kgCadmium: ≤ 0,20 mg/kgSum of aflatoxins B1, B2, G1, G2: ≤ 4,0 μg/kgMicrobiological criteria:Total aerobic microbial count: ≤ 1000 CFU/gTotal yeast/moulds count: ≤ 100 CFU/gEnterobacteriaceae: ≤ 10 CFU/gSalmonella sp.: Absent in 25 gListeria monocytogenes: ≤ 100 CFU/g(a) TPAeq:12-O-tetradecanoylphorbol-13-acetate equivalent; (b) Validated Ultra-High-Performance Liquid Chromatography coupled to Ultraviolet Spectrophotometry and Mass Spectrometry (UHPLC-UV-MS) method for detection of phorbol ester peaks; (c) Limit of Detection (Only batches with concentrations of PEs below the LOD can be fully processed.); CFU: Colony Forming Units. | ||||
| Lactitol | Description/Definition:Crystalline powder or colourless solution manufactured via catalytic hydrogenation of lactose. Crystalline products occur in anhydrous, monohydrate and dihydrate forms. Nickel is used as a catalyst.Chemical name: 4-O-β-D-Galactopyranosyl-D-glucitolChemical formula: C12H24O11Molecular weight: 344,31 g/molCAS No: 585-86-4Purity:Solubility (in water): Very soluble in waterSpecific rotation [α]D20 = + 13o to + 16oAssay: ≥ 95 % d.b (d.b — expressed on the dry weight basis)Water: ≤ 10,5 %Other polyols: ≤ 2,5 % d.bReducing sugars: ≤ 0,2 % d.bChlorides: ≤ 100 mg/kg d.bSulphates: ≤ 200 mg/kg d.bSulphated ash: ≤ 0,1 % d.bNickel: ≤ 2,0 mg/kg d.bArsenic: ≤ 3,0 mg/kg d.bLead: ≤ 1,0 mg/kg d.b | |||
| Lacto-N-fucopentaose I and 2'-Fucosyllactose (‘LNFP-I and 2'-FL’) mixture (produced using a derivative strain of E. coli K-12 DH1) | Description:Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture is a purified and concentrated white to off-white powder produced using genetically modified strain of Escherichia coli K-12 DH1.Definition:Lacto-N-fucopentaose IChemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→3)-2-(acetylamino)-2- deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranoseChemical formula: C32H55NO25Molecular mass: 853,77 DaCAS No: 7578-25-82'-FucosyllactoseChemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranoseChemical formula: C18H32O15Molecular mass: 488,44 DaCAS No: 41263-94-9Characteristics/Composition:Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture (% w/w of dry matter): ≥ 75,0Lacto-N-fucopentaose I (% w/w of dry matter): 50,0 – 75,02'-Fucosyllactose (% w/w of dry matter): 15,0 – 35,0Lacto-N-Tetraose (% w/w): ≤ 5,03-Fucosyllactose (% w/w): ≤ 1,0D-Lactose (% w/w): ≤ 10,0Difucosyllactose (% w/w): ≤ 2,0Lacto-N-fucopentaose I fructose isomer (% w/w): ≤ 1,52'-Fucosyl-D-lactulose (% w/w): ≤ 1,0Sum of L-Fucose and 2′-Fucosyl-D-lactitola (% w/w): ≤ 1,0Sum of Lacto-N-fucopentaose I, 2'-Fucosyllactose, Lacto-N-Tetraose, Difucosyllactose, 3-Fucosyllactose, D-Lactose, L-Fucose, 2′-Fucosyl-D-lactitol, Lacto-N-fucopentaose I fructose isomer, and 2'-Fucosyl-D-lactulose (% w/w dry matter): ≥ 90,0Sum of other carbohydrates (% w/w): ≤ 6,0Moisture (% w/w): ≤ 8,0pH (20 °C, 5 % solution): 4,0 -7,0Ash (% w/w): ≤ 0,5Residual protein (% w/w): ≤ 0,01Heavy metals and contaminants:Arsenic: ≤ 0,2 mg/kgCadmium: ≤ 0,1 mg/kgLead: ≤ 0,02 mg/kgMercury: ≤ 0,1 mg/kgAflatoxin M1: ≤ 0,025 μg/kgMicrobiological criteria:Total plate count: ≤ 1000 CFU/gEnterobacteriaceae: Absence in 10 gSalmonella spp.: Absence in 25 gYeasts and moulds: ≤ 100 CFU/gCronobacter spp.: Absence in 10 gListeria monocytogenes: Absence in 25 gPresumptive Bacillus cereus: ≤ 50 CFU/gEndotoxins: ≤ 10 EU/mg | |||
| aL-Fucose and 2′-Fucosyl-D-lactitol peaks on the High Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAEC–PAD) chromatogram overlap.CFU: Colony Forming Units; EU: Endotoxin Units | ||||
| Lacto-N-neotetraose(synthetic) | Definition:Chemical name: β-D-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)- D-glucopyranoseChemical formula: C26H45NO21CAS No: 13007-32-4Molecular weight: 707,63 g/molDescription:Lacto-N-neotetraose is a white to off-white powder. Produced by a chemical synthesis process and is isolated by crystallisation.Purity:Assay (water free): ≥ 96 %D-Lactose: ≤ 1,0 %Lacto-N-triose II: ≤ 0,3 %Lacto-N-neotetraose fructose isomer: ≤ 0,6 %pH (20 °C, 5 % solution): 5,0-7,0Water: ≤ 9,0 %Ash, sulphated: ≤ 0,4 %Acetic acid: ≤ 0,3 %Residual solvents (methanol, 2-propanol, methyl acetate, acetone): ≤ 50 mg/kg singly, ≤ 200 mg/kg in combinationResidual proteins: ≤ 0,01 %Palladium: ≤ 0,1 mg/kgNickel: ≤ 3,0 mg/kgMicrobiological criteria:Aerobic mesophilic bacteria total count: ≤ 500 CFU/gYeasts: ≤ 10 CFU/gMoulds: ≤ 10 CFU/gResidual endotoxins: ≤ 10 EU/mg | |||
| Lacto-N-neotetraose(microbial source) | DefinitionChemical name: β-D-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranoseChemical formula: C26H45NO21CAS No: 13007-32-4Molecular weight: 707,63 g/molDescription/SourceLacto-N-neotetraose is a white to off-white powder that is produced by a microbiological process using genetically modified strain of Escherichia coli K-12, and/or of Escherichia coli BL21(DE3). An additional optional genetically modified degradation strain of Escherichia coli BL21(DE3) may be used in the production process to degrade intermediate carbohydrate by-products and remaining starting carbohydrate substrates.PurityAssay (water free): ≥ 80 %D-Lactose: ≤ 10,0 %Lacto-N-triose II: ≤ 3,0 %para-Lacto-N-neohexaose: ≤ 5,0 %Lacto-N-neotetraose fructose isomer: ≤ 1,0 %Sum of saccharides (Lacto-N-neotetraose, D-Lactose, Lacto-N-triose II, para-Lacto-N-neohexaose, Lacto-N-neotetraose fructose isomer): ≥ 92 % (% w/w dry matter)pH (20 °C, 5 % solution): 4,0-7,0Water: ≤ 9,0 %Ash, sulphated: ≤ 1,0 %Residual solvents (methanol): ≤ 100 mg/kgResidual proteins: ≤ 0,01 %Microbiological criteriaAerobic mesophilic bacteria total count: ≤ 500 CFU/gYeasts and moulds: ≤ 50 CFU/gResidual endotoxins: ≤ 10 EU/mgCFU: Colony Forming Units; EU: Endotoxin Units | |||
| Lacto-N-tetraose (‘LNT’) (microbial source) | Definition:Chemical formula: C26H45NO21Chemical name: β-D-Galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranoseMolecular mass: 707.63 DaCAS No 14116-68-8Description:Lacto-N-tetraose is a purified, white to off-white amorphous powder or agglomerates that is produced by a microbial process.Source:Genetically modified strain of Escherichia coli strain K-12 DH1Characteristics/Composition:Appearance: White to off white powder or agglomeratesSum of lacto-N-tetraose, D-Lactose and lacto-N-triose II (% of dry matter): ≥ 90.0 % (w/w)Lacto-N-tetraose (% of dry matter): ≥ 70.0 % (w/w)D-Lactose: ≤ 12.0 % (w/w)Lacto-N-triose II: ≤ 10.0 % (w/w)Para-lacto-N-hexaose-2: ≤ 3.5 % (w/w)Lacto-N-tetraose fructose isomer: ≤ 1.0 % (w/w)Sum of other carbohydrates: ≤ 5.0 % (w/w)Moisture: ≤ 6.0 % (w/w)Ash, sulfated: ≤ 0.5 % (w/w)pH (20 °C, 5 % solution): 4.0 -6.0Residual protein: ≤ 0.01 % (w/w)Microbiological criteria:Aerobic mesophilic bacteria total plate count: ≤ 1000 CFU/gEnterobacteriaceae: ≤ 10 CFU/gSalmonella spp.: Negative/25 gYeast: ≤ 100 CFU/gMould: ≤ 100 CFU/gResidual endotoxins: ≤ 10 EU/mgCFU: Colony Forming Units | |||
| Lacto-N-tetraose (‘LNT’)(produced by derivative strains of E. coli BL21(DE3)) | Description:Lacto-N-tetraose is a purified and concentrated white to off-white powder that is produced by a microbial fermentation process.Definition:Chemical name: β-D-Galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranoseChemical formula: C26H45NO21CAS No: 14116-68-8Molecular mass: 707.63 DaSource: Two genetically modified strains (a production strain and an optional degradation strain) of Escherichia coli BL21(DE3)Characteristics/Composition:Lacto-N-tetraose (% of dry matter): ≥ 75,0 % (w/w)D-Lactose (% of dry matter): ≤ 5,0 % (w/w)Lacto-N-triose II (% of dry matter): ≤ 5,0 % (w/w)Para-lacto-N-hexaose (% of dry matter): ≤ 5,0 % (w/w)D-galactose and D-glucose (% of dry matter): ≤ 5,0 % (w/w)Sum of other carbohydratesa: ≤ 15,0 % (w/w)Moisture: ≤ 9,0 % (w/w)Ash: ≤ 1,0 % (w/w)Residual protein: ≤ 0,01 % (w/w)Heavy metals and contaminants:Arsenic: ≤ 0,2 mg/kgAflatoxin M1: ≤ 0,025 μg/kgMicrobiological criteria:Standard plate count: ≤ 1000 CFU/gEnterobacteriaceae: ≤ 10 CFU/gSalmonella spp.: Absence in 25 gYeast and mould: ≤ 100 CFU/gCronobacter (Enterobacter) sakazaki: Absence in 10 gResidual endotoxins: ≤ 10 EU/mga Sum of other carbohydrates = 100 (% (w/w) of dry matter) – quantified carbohydrates (% (w/w) of dry matter) – Ash (% (w/w) of dry matter). CFU: Colony Forming Units; EU: Endotoxin Units | |||
| Lacto-N-tetraose (‘LNT’)(produced by a derivative strain of Escherichia coli K-12 MG1655) | Definition:Chemical formula: C26H45NO21Chemical name: β-D-Galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranoseMolecular mass: 707,63 DaCAS No 14116-68-8Description:Lacto-N-tetraose is a white to off-white powder produced by microbial fermentation and further isolated, purified and concentrated.Source: Genetically modified strain of Escherichia coli strain K-12 MG1655 (ATCC 700926)Characteristics/Composition:Sum of lacto-N-tetraose, D-Lactose and lacto-N-triose II (% of dry matter): ≥ 90 % (w/w)Lacto-N-tetraose (% of dry matter): ≥ 85 % (w/w)D-Lactose: ≤ 7 % (w/w)Lacto-N-tetraose fructose isomer: ≤ 1 % (w/w)Lacto-N-triose II: ≤ 7 % (w/w)Sum of other carbohydrates: ≤ 5 % (w/w)Water: ≤ 7 % (w/w)Protein: ≤ 0,01 % (w/w)Ash: ≤ 0,5 % (w/w)pH (20 °C, 10 % solution): 4,0-6,5Contaminants:Arsenic: ≤ 0,2 mg/kgCadmium: ≤ 0,1 mg/kgLead: ≤ 0,02 mg/kgMercury: ≤ 0,1 mg/kgAflatoxin M1: ≤ 0,025 μg/kgMicrobiological criteria:Aerobic plate count: ≤ 1000 CFU/gYeasts and moulds: ≤ 100 CFU/gEnterobacteriaceae: Absence in 10 gSalmonella sp.: Absence in 25 gCronobacter spp.: Absence in 10 gListeria monocytogenes: Absence in 25 gBacillus cereus: ≤ 50 CFU/gEndotoxins: ≤ 10 EU/mg | |||
| Lonicera caerulea L. berries (haskap)(Traditional food from a third country) | Description/Definition:The traditional food are fresh and frozen berries from Lonicera caerulea var. edulis.Lonicera caerulea L. is a deciduous shrub belonging to the Caprifoliaceae family.Typical nutritional components of haskap berries (given in fresh berries):Carbohydrates: 12,8 %Fibre: 2,1 %Lipids: 0,6 %Proteins: 0,7 %Ash: 0,4 %Water: 85,5 % | |||
| Lucerne leaf extract from Medicago sativa | Description/Definition:The Lucerne (Medicago sativa L.) is processed within 2 hours after harvest. It is chopped and crushed. By passing through an oleaginous-type press, the Lucerne provides a fibrous residue and press juice (10 % of dry matter). The dry matter of this juice contains about 35 % of crude protein. The press juice (pH 5,8-6,2) is neutralised. Preheating and vapour injection allows coagulation of proteins associated with carotenoid and chlorophyll pigments. The protein precipitate is separated by centrifugation and thereafter dried. After adding ascorbic acid the Lucerne protein concentrate is granulated and stored in inert gas or in cold storage.Composition:Protein: 45-60 %Fat: 9-11 %Free carbohydrates (soluble fibre): 1-2 %Polysaccharides (insoluble fibre): 11-15 %including cellulose: 2-3 %Minerals: 8-13 %Saponins: ≤ 1,4 %Isoflavones: ≤ 350 mg/kgCoumestrol: ≤ 100 mg/kgPhytates: ≤ 200 mg/kgL-canavanine: ≤ 4,5 mg/kg | |||
| Lycopene | Description/Definition:Synthetic lycopene is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Synthetic lycopene consists of ≥ 96 % lycopene and minor quantities of other related carotenoid components. Lycopene is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Antioxidative protection has to be assured.Chemical name: LycopeneCAS No.: 502-65-8 (all-trans lycopene)Chemical formula: C40H56Formula weight: 536,85 Da | |||
| Lycopene from Blakeslea trispora | Description/Definition:The purified lycopene from Blakeslea trispora consists of ≥ 95 % lycopene and ≤ 5 % other carotenoids. It is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Anti-oxidative protection has to be assured.Chemical name: LycopeneCAS No.: 502-65-8 (all trans lycopene)Chemical formula: C40H56Formula weight: 536,85 Da | |||
| Lycopene from tomatoes | Description/Definition:The purified lycopene from tomatoes (Lycopersicon esculantum L.) consists of ≥ 95 % lycopene and ≤ 5 % other carotenoids. It is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Anti-oxidative protection has to be assured.Chemical name: LycopeneCAS No.: 502-65-8 (all trans lycopene)Chemical formula: C40H56Formula weight: 536,85 Da | |||
| Lycopene oleoresin from tomatoes | Description/Definition:Lycopene oleoresin from tomatoes is obtained by solvent extraction of ripe tomatoes (Lycopersicon esculentum Mill.) with subsequent removal of the solvent. It is a red to dark brown viscous, clear liquid.Total lycopene: 5-15 %Thereof trans-lycopene: 90-95 %Total carotenoids (calculated as lycopene): 6,5-16,5 %Other carotenoids: 1,75 %(Phytoene/phytofluene/β-carotene): (0,5-0,75/0,4-0,65/0,2-0,35 %)Total tocopherols: 1,5-3,0 %Unsaponifiable matter: 13-20 %Total fatty acids: 60-75 %Water (Karl Fischer): ≤ 0,5 % | |||
| Yellow tomato extract | Description/Definition:The novel food is a carotenoid-rich extract derived from the pulp of ripe yellow tomatoes (Lycopersicon esculentum Mill.) using supercritical CO2 extractionCharacteristics/composition:Appearance: Viscous, dark brown liquidMoisture: < 0,5 %Proteins: 0,2 %–0,6 %Total lipids: > 95 %Saturated fat: 12 %–25 %Monounsaturated fat: 17 %–30 %Polyunsaturated fat: 50 %–65 %Trans fatty acids: ≤ 2 %Unsaponifiable matter: < 20 %Acid value: < 5 mg KOH/g(*)Peroxide value: ≤ 15 meqO2/kg(**)Carotenoids:Total carotenoids: 10-13 g/100 gPhytoene + phytofluene (including cis- and all-trans isomers): 7-10 g/100 gbeta-Carotene: 0,1-0,5 g/100 gzeta-Carotene: 2-4 g/100 gLycopene: 0,1-0,4 g/100 gHeavy metalsLead: ≤ 1 mg/kgCadmium: ≤ 1 mg/kgMercury: ≤ 0,1 mg/kgArsenic: ≤ 1 mg/kgMicrobiological criteria:Total aerobic microbial count: ≤ 1000 CFU/gE. coli: Not detected in 10 gSalmonella: Not detected in 25 gStaphylococcus aureus: Not detected in 10 gYeasts/moulds: ≤ 100 CFU/g(*)Acid value based all fatty acids.(**)Based on Codex Alimentarius guidelines for peroxid value in concentrated oil https://www.fao.org/3/y2774e/y2774e04.htmAbbreviation: CFU, colony forming units | |||
| Hen egg white lysozyme hydrolysate | Description/DefinitionHen egg white lysozyme hydrolysate is obtained from hen egg white lysozyme by an enzymatic process, using subtilisin from Bacillus licheniformis.The product is a white to light yellow powder.SpecificationProtein (TN(*) x 5,30): 80-90 %Tryptophan: 5-7 %Ratio Tryptophan/LNAA(**): 0,18-0.25Degree of hydrolysis: 19-25 %Moisture: < 5 %Ash: < 10 %Sodium: < 6 %Heavy metalsArsenic: < 1 ppmLead: < 1 ppmCadmium: < 0,5 ppmMercury: < 0,1 ppmMicrobiological criteriaTotal aerobic count: < 103 CFU/gTotal combined yeasts/moulds count: < 102 CFU/gEnterobacteria: < 10 CFU/gSalmonella spp: Absence in 25 gEscherichia coli: Absence in 10 gStaphylococcus aureus: Absence in 10 gPseudomonas aeruginosa: Absence in 10 g*TN: total nitrogen**LNAA: large neutral amino acids | |||
| Magnesium citrate malate | Description/Definition:Magnesium citrate malate is a white to yellowish-white, amorphous powder.Chemical formula: Mg5(C6H5O7)2(C4H4O5)2Chemical name: Pentamagnesium di-(2-hydroxybutanedioate)-di-(2- hydroxypropane-1,2,3-tricarboxylate)CAS No.: 1259381-40-2Molecular weight: 763,99 Daltons (anhydrous)Solubility: Freely soluble in water (about 20 g in 100 ml)Description of the physical state: Amorphous powderAssay magnesium: 12,0-15,0 %Loss on drying (120 °C/4 hours): ≤ 15 %Colour (solid): White to yellowish-whiteColour (20 % aqueous solution): Colourless to yellowishAppearance (20 % aqueous solution): Clear solutionpH (20 % aqueous solution): Approx. 6,0Impurities:Chloride: ≤ 0,05 %Sulphate: ≤ 0,05 %Arsenic: ≤ 3,0 ppmLead: ≤ 2,0 ppmCadmium: ≤ 1 ppmMercury: ≤ 0,1 ppm | |||
| Magnesium L-threonate | Description/Definition:The novel food is produced by chemical synthesis and consists of magnesium L-threonate.Chemical identity:Chemical (IUPAC) name: Magnesium (2R,3S)-2,3,4-trihydroxybutanoate monohydrateCommon name: magnesium L-threonateMolecular formula: C8H16MgO11CAS number: 500304-76-7Molecular weight: 312,5 DaCharacteristics/composition:Appearance: White powderMg L-threonate monohydrate: 98 %–102 %Magnesium: 7,2 %–8,3 %L-Threonate: 82 %-91 %Oxalic acid: ≤ 1 %Ethanol: ≤ 5000 ppmLoss on drying: ≤ 5,0 %Microbiological criteria:Total aerobic microbial count: ≤ 100 CFU/gTotal yeast and moulds count: ≤ 10 CFU/gE. coli: Not detected in 10 gSalmonella: Not detected in 25 gAbbreviations: CAS: chemical abstracts service, IUPAC: International Union of Pure and Applied Chemistry, CFU: colony forming unit | |||
| Magnolia Bark Extract | Description/Definition:Magnolia bark extract is obtained from the bark of the plant Magnolia officinalis L. and produced with supercritical carbon dioxide. The bark is washed and oven dried to reduce moisture content before being crushed and extracted with supercritical carbon dioxide. The extract is dissolved in medical-grade ethanol and re-crystallised to yield magnolia bark extract.Magnolia bark extract is mainly composed of two phenolic compounds, magnolol and honokiol.Appearance: Light brownish powderPurity:Magnolol: ≥ 85,2 %Honokiol: ≥ 0,5 %Magnolol & Honokiol: ≥ 94 %Total Eudesmol: ≤ 2 %Moisture: 0,50 %Heavy metals:Arsenic (ppm): ≤ 0,5Lead (ppm): ≤ 0,5Methyl eugenol (ppm): ≤ 10Tubocurarine (ppm): ≤ 2,0Total Alkaloid (ppm): ≤ 100 | |||
| Maize-germ oil high in unsaponifiable matter | Description/Definition:Maize-germ oil high in unsaponifiable matter is produced by vacuum distillation and it is different from refined maize-germ oil in the concentration of the unsaponifiable fraction (1,2 g in refined maize-germ oil and 10 g in ‘maize-germ oil high in unsaponifiable matter’).Purity:Unsaponifiable matter: > 9,0 g/100 gTocopherols: ≥ 1,3 g/100 gα-tocopherol (%): 10-25 %β-tocopherol (%): < 3,0 %γ-tocopherol (%): 68-89 %δ-tocopherol (%): < 7,0 %Sterols, triterpenic alcohols, methylsterols: > 6,5 g/100 gFatty acids in triglycerides:palmitic acid: 10,0-20,0 %stearic acid: < 3,3 %oleic acid: 20,0-42,2 %linoleic acid: 34,0-65,6 %linolenic acid: < 2,0 %Acid value: ≤ 6,0 mg KOH/gPeroxide value (PV): ≤ 10 mEq O2/kgHeavy metals:Iron (Fe): < 1500 μg/kgCopper (Cu): < 100 μg/kgImpurities:Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 μg/kgTreatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons (PAH) are not enriched in the production of ‘maize-germ oil high in unsaponifiable matter’ | |||
| Methylcellulose | Description/Definition:Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups.Chemical name: Methyl ether of celluloseChemical formula: The polymers contain substituted anhydroglucose units with the following general formula:C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following:HCH3 orCH2CH3Molecular weight: Macromolecules: from about 20000 (n about 100) up to about 380000 g/mol (n about 2000)Assay: Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder.Solubility: Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol, ether and chloroform. Soluble in glacial acetic acid.Purity:Loss on drying: ≤ 10 % (105 °C, 3 hours)Sulphated Ash: ≤ 1,5 % determined at 800 ± 25 °CpH: ≥ 5,0 and ≤ 8,0 (1 % colloidal solution)Heavy metals:Arsenic: ≤ 3,0 mg/kgLead: ≤ 2,0 mg/kgMercury: ≤ 1,0 mg/kgCadmium: ≤ 1,0 mg/kg | |||
| 1-Methylnicotinamide chloride | Definition:Chemical name: 3-carbamoyl-1-methyl-pyridinium chlorideChemical formula: C7H9N2OClCAS No: 1005-24-9Molecular weight: 172,61 DaDescription1-Methylnicotinamide chloride is white or off-white, crystalline solid produced by a chemical synthesis process.Characteristics/CompositionAppearance: White – off-white, crystalline solidPurity: ≥ 98,5 %Trigonelline: ≤ 0,05 %Nicotinic Acid: ≤ 0,10 %Nicotinamide: ≤ 0,10 %Largest unknown impurity: ≤ 0,05 %Sum of unknown impurities: ≤ 0,20 %Sum of all impurities: ≤ 0,50 %Solubility: soluble in water and methanol. Practically insoluble in 2-propanol and dichloromethaneMoisture: ≤ 0,3 %Loss on drying: ≤ 1,0 %Residue on ignition: ≤ 0,1 %Residual Solvents and Heavy MetalsMethanol: ≤ 0,3 %Heavy metals: ≤ 0,002 %Microbiological criteria:Total aerobic microbial count: ≤ 100 CFU/gMould/yeast: ≤ 10 CFU/gEnterobacteriaceae: absence in 1 gPseudomonas aeruginosa: absence in 1 gStaphylococcus aureus: absent in 1 gCFU: Colony Forming Units | |||
| (6S)-5-methyltetrahydrofolic acid, glucosamine salt | Description/Definition:Chemical name: N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, glucosamine saltChemical formula: C32H51N9O16Molecular weight: 817,80 g/mol (anhydrous)CAS No.: 1181972-37-1Appearance: Creamy to light-brown powderPurity:Diastereoisomeric purity: At least 99 % of (6S)-5-methyltetrahydrofolic acidGlucosamine assay: 34-46 % in dry basis5-Methyltetrahydrofolic acid assay: 54-59 % in dry basisWater: ≤ 8,0 %Heavy metals:Lead: ≤ 2,0 ppmCadmium: ≤ 1,0 ppmMercury: ≤ 0,1 ppmArsenic: ≤ 2,0 ppmBoron: ≤ 10 ppmMicrobiological criteria:Total aerobic microbial count: ≤ 100 CFU/gYeasts and moulds: ≤ 100 CFU/gEscherichia coli: Absence in 10g | |||
| Monomethylsilanetriol (Organic Silicon) | Description/Definition:Chemical name: Silanetriol, 1-methyl-Chemical formula: CH6O3SiMolecular weight: 94,14 g/molCAS No: 2445-53-6Purity:Organic Silicon (monomethylsilanetriol) preparation (aqueous solution):Acidity (pH): 6,4-6,8Silicon: 100-150 mg Si/lHeavy metals:Lead: ≤ 1,0 μg/lMercury: ≤ 1,0 μg/lCadmium: ≤ 1,0 μg/lArsenic: ≤ 3,0 μg/lSolvents:Methanol: ≤ 5,0 mg/kg (residual presence) | |||
| Monosodium salt of L-5-methyltetrahydrofolic acid | Description/Definition:The novel food is produced by chemical synthesis and consists of L-5-methyltetrahydrofolic acid.Molecular formula: C20H24N7NaO6Chemical name: N-[4-[[(2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-(6S)-pteridinyl)methyl]amino]benzoyl]-l-glutamic acidCAS number: 2246974-96-7Molecular weight: 481,44 g/molCharacteristics/composition:Appearance: White to yellow or beige powderAssay & related compounds: Assay 5-MeTHFA-Na on dry basis: > 95 %; Sum of folate-related substances: ≤ 2,5Sodium: 4 %–5 % w/wWater: ≤ 1,0 %Residual solvents: Ethanol: ≤ 0,5 %; Isopropanol: ≤ 0,5 %Diastereomeric purity: (6R)-Mefolinate: ≤ 1,0 % areaElemental impurities:Boron: ≤ 10 mg/kgPlatinum: ≤ 10 mg/kg (for foods intended for infants and young children and food supplements intended for pregnant women then ≤ 2 mg/kg)Arsenic: ≤ 1,5 mg/kgCadmium: ≤ 0,5 mg/kgLead: ≤ 1,0 mg/kgMercury: ≤ 1,5 mg/kg (for foods intended for infants and young children and food supplements intended for pregnant women then ≤ 1 mg/kg)Microbiological criteria:Total aerobic microbial count: ≤ 100 CFU/gTotal yeast and moulds count: ≤ 100 CFU/gE. coli: Not detected in 10 gAbbreviations: CFU: colony forming unit; IR: infra-red; MeTHFA: methyltetrahydrofolic acid. | |||
| Mung bean (Vigna radiata) protein | Description/Definition:The novel food is mung bean protein powder extracted from seeds of the plant Vigna radiata by several processing steps followed by pasteurization and spray drying.Characteristics/composition:Moisture: ≤ 6 %Protein (w/w)(a): ≥ 84 %Ash (w/w): ≤ 6,0 %Fat (w/w): ≤ 5,5 %Carbohydrate (w/w): ≤ 5,0 by calculationMicrobiological criteria:Aerobic plate count: < 5000 CFU/g (b)Yeasts and moulds: < 100 CFU/gColiforms: < 100 CFU/gEscherichia coli: < 10 CFU/gListeria monocytogenes: Not detected in 25 gSalmonella spp.: Not detected in 25 g(a)w/w: weight per weight.(b)CFU: colony forming units. | |||
| Mycelial extract from Shiitake mushroom (Lentinula edodes) | Description/Definition:The novel food ingredient is a sterile aqueous extract obtained from the mycelium of Lentinula edodes cultivated in a submerged fermentation. It is a light brown, slightly turbid liquid.Lentinan is a β-(1-3) β-(1-6)-D-glucan which has a molecular weight of approximately 5 × 105 Daltons, a degree of branching of 2/5 and a triple helical tertiary structure.Purity/Composition of the mycelial extract from Lentinula edodes:Moisture: 98 %Dry matter: 2 %Free glucose: < 20 mg/mlTotal protein(1): < 0,1 mg/mlN-containing constituents(2): < 10 mg/mlLentinan: 0,8 – 1,2 mg/ml\(1)Bradford method(2)Kjeldahl method | |||
| Nicotinamide riboside chloride | Description/Definition:The novel food is a synthetic form of nicotinamide riboside. The novel food contains ≥ 90 % nicotinamide riboside chloride, predominantly in its β form, the remaining components being residual solvents, reaction by-products and degradation products.Nicotinamide riboside chloride:CAS number: 23111-00-4EC number: 807-820-5IUPAC name: 1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]pyridin-1-ium-3-carboxamide;chlorideChemical formula: C11H15N2O5ClMolecular weight: 290,7 g/molCharacteristics/Composition:Colour: White to light brownForm: PowderIdentification: Conforms by NMR (nuclear magnetic resonance)Nicotinamide riboside chloride: ≥ 90 %Water content: ≤ 2 %Residual solvents:Acetone: ≤ 5000 mg/kgMethanol: ≤ 1000 mg/kgAcetonitrile: ≤ 50 mg/kgMethyl tert-butyl ether: ≤ 500 mg/kgReaction by-products:Methyl acetate: ≤ 1000 mg/kgAcetamide: ≤ 27 mg/kgAcetic acid: ≤ 5000 mg/kgHeavy metals:Arsenic: ≤ 1 mg/kgMercury*: ≤ 0,1 mg/kgCadmium*: ≤ 1 mg/kgLead*: ≤ 0,5 mg/kgMicrobiological criteria:Total Plate Count: ≤ 1000 CFU/gYeast and Mould: ≤ 100 CFU/gEscherichia coli: Absence in 10 gCFU: colony forming units(*)only for foods for special medical purposes, total diet replacement for weight control and meal replacements | |||
| Noni fruit juice (Morinda citrifolia) | Description/Definition:Noni fruits (fruits of Morinda citrifolia L.) are pressed. The obtained juice is pasteurised. An optional fermentation step before or after the pressing may occur.Rubiadin: ≤ 10 μg/kgLucidin: ≤ 10 μg/kg | |||
| Noni fruit juice powder (Morinda citrifolia) | Description/Definition:Seeds and skin of the sun-dried fruits of Morinda citrifolia are separated. The obtained pulp is filtered to separate juice from the flesh. Desiccation of the produced juice occurs in one or two ways:Either by atomisation using maize maltodextrins, this mixture is obtained by keeping the rates of inflow of the juice and maltodextrins constantOr by zeodratation or drying and then mixing with an excipient, this process allows the juice to be dried initially and then mixed with maltodextrins (same amount as used in atomisation). | |||
| Noni fruit puree and concentrate (Morinda citrifolia) | Description/Definition:The fruits of Morinda citrifolia are harvested by hand. Seeds and skin may be separated mechanically from the pureed fruits. After pasteurisation, the puree is packaged in aseptic containers and stored under cold conditions.Morinda citrifolia concentrate is prepared from M. citrifolia puree by treatment with pectinolytic enzymes (50– 60 °C for 1-2 h). Then the puree is heated to inactivate the pectinases and then immediately cooled. The juice is separated in a decanter centrifuge. Afterwards the juice is collected and pasteurised, prior to being concentrated in a vacuum evaporator from a brix of 6 to 8 to a brix of 49 to 51 in the final concentrate.Composition:Puree:Moisture: 89-93 %Protein: < 0,6 g/100 gFat: ≤ 0,4 g/100 gAsh: < 1,0 g/100 gTotal carbohydrates: 5-10 g/100 gFructose: 0,5-3,82 g/100 gGlucose: 0,5-3,14 g/100 gDietary fibre: < 0,5-3 g/100 g5,15-dimethylmorindol (1): ≤ 0,254 μg/mlLucidin (1): Not detectableAlizarin (1): Not detectableRubiadin (1): Not detectableConcentrate:Moisture: 48-53 %Protein: 3-3,5 g/100 gFat: < 0,04 g/100 gAsh: 4,5-5,0 g/100 gTotal carbohydrates: 37-45 g/100 gFructose: 9-11 g/100 gGlucose: 9-11 g/100 gDietary fibre: 1,5-5,0 g/100 g5,15-dimethylmorindol (1): ≤ 0,254 μg/ml(1)By an HPLC-UV method developed and validated for the analysis of anthraquinones in Morinda citrifolia puree and concentrate. Limits of detection: 2,5 ng/ml (5,15 dimethylmorindol); 50,0 ng/ml (lucidin); 6,3 ng/ml (alizarin) and 62,5 ng/ml (rubiadin). | |||
| Noni leaves (Morinda citrifolia) | Description/Definition:After cutting, the leaves of Morinda citrifolia are subject to drying and roasting steps. The product has a particle size ranging from broken leaves to coarse powder with fines. It is of greenish brown to brown colour.Purity/Composition:Moisture: < 5,2 %Protein: 17- 20 %Carbohydrate: 55-65 %Ash: 10-13 %Fat: 4-9 %Oxalic acid: < 0,14 %Tannic acid: < 2,7 %5,15-dimethylmorindol: < 47 mg/kgRubiadin: non detectable, ≤ 10 μg/kgLucidin: non detectable, ≤ 10 μg/kg | |||
| Noni fruit powder (Morinda citrifolia) | Description/Definition:Noni fruit powder is made from pulped noni (Morinda citrifolia L.) fruits by freeze-drying. Fruits are pulped and seeds are removed. After freeze-drying during which water is removed from noni fruits, the remaining noni pulp is milled to a powder and encapsulated.Purity/CompositionMoisture: 5,3-9 %Protein: 3,8-4,8 g/100 gFat: 1-2 g/100 gAsh: 4,6-5,7 g/100 gTotal carbohydrates: 80-85 g/100 gFructose: 20,4-22,5 g/100 gGlucose: 22-25 g/100 gDietary fibre: 15,4-24,5 g/100 g5,15-dimethylmorindol (1): ≤ 2,0 μg/ml(1)By an HPLC-UV method developed and validated for the analysis of anthraquinones in Morinda citrifolia fruit powder. Limits of detection: 2,5 ng/ml (5,15 dimethylmorindol) | |||
| Odontella aurita microalgae | Silicon: 3,3 %Crystalline silica: max 0,1-0,3 % as impurity | |||
| Oil enriched with phytosterols/phytostanols | Description/Definition:Oil enriched with phytosterols/phytostanols is composed of an oil fraction and a phytosterol fraction.Acylglycerol Distribution:Free fatty acids (expressed as oleic acid): ≤ 2,0 %Monoacylglycerols (MAG): ≤ 10 %Diacylglycerols (DAG): ≤ 25 %Triacylglycerols (TAG): Making up the balancePhytosterol fraction:β-sitosterol: ≤ 80 %β-sitostanol: ≤ 15 %campesterol: ≤ 40 %campestanol: ≤ 5,0 %stigmasterol: ≤ 30 %brassicasterol ≤ 3,0 %other sterols/stanols: ≤ 3,0 %Others:Moisture and volatile: ≤ 0,5 %Peroxide value (PV): < 5,0 meq/kgTrans fatty acids: ≤ 1 %Contamination/Purity (GC-FID or equivalent method) of phytosterols/phytostanols:Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of contaminants, best ensured by a purity of more than 99 %. | |||
| Oil extracted from squids | Acid value: ≤ 0,5 KOH/g oilPeroxide value (PV): ≤ 5 meq O2/kg oilp-Anisidine value: ≤ 20Cold test at 0 °C: ≤ 3 hoursMoisture: ≤ 0,1 % (w/w)Unsaponifiable matter: ≤ 5,0 %Trans fatty acids: ≤ 1,0 %Docosahexaeonic acid: ≥ 20 %Eicosapentaenoic acid: ≥ 10 % | |||
| Partially defatted chia seed (Salvia hispanica) powders | Description/Definition:The novel foods are partially defatted chia seed (Salvia hispanica) powders obtained by pressing and grinding of the whole seeds of Salvia hispanica L.Physical–sensorial:Foreign matter: 0,1 % | |||
| Powder with high protein content | Powder with high fibre content | |||
| Particle size | ≤ 130 μm | ≤ 400 μm | ||
| Chemical composition: | ||||
| Salvia hispanica powder with high protein content | Salvia hispanica powder with high fibre content | |||
| Moisture | ≤ 9,0 % | ≤ 9,0 % | ||
| Protein | ≥ 40,0 % | ≥ 24,0 % | ||
| Fat | ≤ 17 % | ≤ 12 % | ||
| Fibre | ≤ 30 % | ≥ 50 % | ||
| Microbiological criteria:Total plate count: ≤ 10000 CFU/gYeasts: ≤ 500 CFU/gMoulds: ≤ 500 CFU/gStaphylococcus aureus: ≤ 10 CFU/gColiforms: < 100 MPN/gEnterobacteriaceae: ≤ 100 CFU/gBacillus cereus: ≤ 50 CFU/gEscherichia coli: Not detected in 10 gListeria monocytogenes: Not detected in 25 gSalmonella spp.: Absence in 25 gContaminants:Arsenic: ≤ 0,1 ppmCadmium: ≤ 0,1 ppmLead: ≤ 0,1 ppmMercury: ≤ 0,1 ppmTotal aflatoxins: ≤ 4 ppbOchratoxin A: ≤ 1 ppb | ||||
| Defatted rapeseed powder | Description:The novel food is a white to off-white dried powder remaining after aqueous and organic solvent extraction (ethanol and ethyl acetate) of hulled and dehulled cold-pressed rapeseed cake originating from non-genetically modified double low (00) cultivars of Brassica napus L. and Brassica rapa L.Characteristics/Composition:Crude protein (% w/w): 28-45Fat (% w/w): ≤ 2Ash (% w/w): ≤ 5Moisture (% w/w): ≤ 7Total dietary fibrenote (% w/w): 37–70Total glucosinolates (mmol/kg (mg/kg)): ≤ 0,1 (≤ 40)Phytates (% w/w): ≤ 2Heavy and other metals:Lead (mg/kg): ≤ 0,2Arsenic (total) (mg/kg): ≤ 0,1Cadmium (mg/kg): ≤ 0,1Mercury (mg/kg): ≤ 0,02Aluminium (mg/kg): ≤ 35Residual solvents:Residual ethanol (mg/kg): < 200Residual ethyl acetate (mg/kg): < 200Microbiological criteria:Total plate count: ≤ 10000 CFUnote/gEnterobacteriaceae: ≤ 10 CFU/gE.coli: Absent in 10 gSalmonella spp.: Absence in 25 gYeast and moulds: ≤ 100 CFU/gTotal coliform count: ≤ 10 CFU/gB. cereus: ≤ 100 CFU/g | |||
| Partially defatted rapeseed powder from Brassica rapa L. and Brassica napus L. | Definition:The powder is produced from the partially defatted seeds of non-genetically modified Brassica rapa L. and Brassica napus L. double low (00) cultivars through a series of processing steps to reduce glucosinolates and phytates.Source: Brassica rapa L. and Brassica napus L. seedsCharacteristics/Composition:Protein (N × 6,25): 28,0 – 43,0 %Lipids: 10,0 – 22,0 %Total Carbohydrates (*): 33,0 – 45,0 %Total Fibre (**): 33,0 – 46,0 %Moisture: < 11,0 %Ash: < 8,0 %Total Glucosinolates: < 0,3 mmol/kg (≤ 120 mg/kg)Phytate: < 1,5 %Peroxide value (in novel food weight): ≤ 3,0 mEq O2/kgHeavy Metals:Lead: < 0,2 mg/kgArsenic (inorganic): < 0,2 mg/kgCadmium: < 0,2 mg/kgMercury: < 0,1 mg/kgAluminium: < 35,0 mg/kgMicrobiological criteria:Total plate count (30 °C): < 5000 CFU/gEnterobacteriaceae: < 10 CFU/gSalmonella sp.: Negative/25 gYeast and mould: < 100 CFU/gBacillus cereus: < 100 CFU/g(*)By difference: 100 % – [protein % + moisture % + fat % + ash %](**)AOAC 2011.25 (Enzymatic gravimetry)CFU: Colony Forming Units, AOAC: Association of Official Agricultural Chemists | |||
| Extract from Panax notoginseng and Astragalus membranaceus | Description/Definition:The novel food contains two extracts. One is an ethanol extract of the roots of Astragalus membranaceus (Fisch.) Bunge. The other is a hot water extract of the roots of Panax notoginseng (Burkill) F.H. Chen that is further concentrated using absorption on a resin and subsequent elution with 60 % ethanol. At the end of the manufacturing process both extracts are mixed (45–47,5 % of each extract) with maltodextrin (5–10 %).Characteristics/Composition:Total saponins: 1,5-5 %Ginsenoside Rb1: 0,1-0,5 %Astragaloside I: 0,01-0,1 %Carbohydrates: ≥ 90 %Protein: ≤ 4,5 %Ash: ≤ 1 %Moisture: ≤ 5 %Fat: ≤ 1,5 %Heavy metals:Arsenic: ≤ 0,3 mg/kgMicrobiological criteria:Total plate count: ≤ 5000 CFU/gTotal yeast and mould count: ≤ 500 CFU/gEnterobacteriaceae: < 10 CFU/gEscherichia coli: Absence in 25 gSalmonella: Absence in 375 gStaphylococcus aureus: Absence in 25 gCFU: colony forming units | |||
| Pasteurised fruit-based preparations produced using high-pressure treatment | Parameter | Target | Comments | |
| Fruit storage before high-pressure treatment | Minimum 15 days at – 20 °C | Fruit harvested and stored in conjunction with good/hygienic agricultural and manufacturing practices | ||
| Fruit added | 40 % to 60 % of thawed fruit | Fruit homogenised and added to other ingredients | ||
| pH | 3,2 to 4,2 | |||
| o Brix | 7 to 42 | Assured by added sugars | ||
| aw | < 0,95 | Assured by added sugars | ||
| Final storage | 60 days maximum at + 5 °C maximum | Equivalent to storage regimen for conventionally processed product | ||
| Pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia | Description:The novel food is produced from the fermentation of a mixture of 65 % pea and 35 % rice protein concentrates by the mycelia of the Shiitake mushroom (Lentinula edodes) followed by heat treatment to terminate the fermentation and a series of drying steps to form a powder.Characteristics/Composition:Protein (% dry weight, N x 6,25): ≥ 75,0Moisture: ≤ 7,0Total fat (% dry weight): ≤ 10,0Ash (% dry weight): ≤ 10,0Carbohydrates (% by calculation): ≤ 15,0Mycotoxins:Aflatoxin B1 (μg/kg): < 1,0Aflatoxin B2 (μg/kg): < 1,0Aflatoxin G1 (μg/kg): < 1,0Aflatoxin G2 (μg/kg): < 1,0Aflatoxin total (B1+B2+G1+G2) (μg/kg): < 3,0Heavy metals:Arsenic (μg/g): < 0,1Cadmium (μg/g): < 0,1Lead (μg/g): < 0,3Mercury (μg/g): < 0,1Microbiological criteria:Total aerobic microbial count: < 1000 CFU/gTotal yeast/moulds count: < 100 CFU/gColiforms: ≤ 10 CFU/gSalmonella spp.: Absent in 25 gEscherichia coli: < 10 CFU/gListeria monocytogenes: Absent in 25 g*CFU: Colony Forming Units | |||
| Phenylcapsaicin | Description/Definition:Phenylcapsaicin (N-[(4-hydroxy-3-methoxyphenyl)methyl]-7-phenylhept-6-ynamide, C21H23NO3, CAS no: 848127-67-3), is synthesized chemically via a two step synthesis process involving in a first step the production of the acetylenic acid intermediate through a reaction of phenyl acetylene with a carboxylic acid derivative, and in a second step a series of reactions of the acetylenic acid intermediate with vanillylamine derivative to produce phenylcapsaicin.Characteristics/Composition:Purity (% of dry matter): ≥ 98 %Moisture: ≤ 0,5 %Total synthesis related production by-products: ≤ 1,0 %N,N-dimethyl formamide: ≤ 880 mg/kgDichloromethane: ≤ 600 mg/kgDimethoxyethane: ≤ 100 mg/kgEthyl acetate: ≤ 0,5 %Other solvents: ≤ 0,5 %Heavy metals:Lead: ≤ 1,0 mg/kgCadmium: ≤ 1,0 mg/kgMercury: ≤ 0,1 mg/kgArsenic: ≤ 1,0 mg/kgMicrobiological criteria:Total plate count: ≤ 10 CFU/gColiforms: ≤ 10 CFU/gEscherichia coli: Negative/10 gSalmonella sp.: Negative/10 gYeast and mould: ≤ 10 CFU/gCFU: Colony Forming Units | |||
| Phosphated maize starch | Description/Definition:Phosphated maize starch (phosphated distarch phosphate) is a chemically modified resistant starch derived from high amylose starch by combining chemical treatments to create phosphate cross-links between carbohydrate residues and esterified hydroxyl groups.The novel food ingredient is a white or nearly white powder.CAS No: 11120-02-8Chemical formula: (C6H10O5)n [(C6H9O5)2PO2H]x [(C6H9O5)PO3H2]yn = number of glucose units; x, y = degrees of substitutionThe chemical characteristics of phosphated distarch phosphate:Loss on drying: 10-14 %pH: 4,5-7,5Dietary fibre: ≥ 70 %Starch: 7-14 %Protein: ≤ 0,8 %Lipids: ≤ 0,8 %Residual bound phosphorus: ≤ 0,4 % (as phosphorus) ‘high amylose maize’ as source | |||
| Phosphated wheat starch | Description:Phosphated distarch phosphate produced from wheat starch (phosphated wheat starch) is a chemically modified resistant starch derived from wheat starch by combining chemical treatments to create phosphate cross-links within and between individual starch molecules.The novel food ingredient is a white or near white free flowing powder.Characteristic/Composition:CAS No: 11120-02-8Chemical formula: (C6H10O5)n [(C6H9O5)2PO2H]x [(C6H9O5)PO3H2]yn = number of glucose units; x, y = degrees of substitution | |||
| Parameter | Powder form 1 | Powder form 2 | ||
| Phosphated Distarch Phosphate (Dry basis) | ≥ 85 % | ≥ 75 % | ||
| Unmodified Wheat Starch (Dry basis) | ≤ 15 % | ≤ 25 % | ||
| Moisture | 9-12 % | |||
| Total dietary fibre (dry matter basis) | ≥ 76,0 % | ≥ 66,0 % | ||
| Ash | ≤ 3 % | |||
| Protein | ≤ 0,5 % | |||
| Total fat | ≤ 0,50 % | ≤ 0,34 % | ||
| Residual bound phosphorus | ≤ 0,4 % (as phosphorus) | |||
| pH (25 % slurry) | 4,5 – 6,5 | |||
| Heavy metals:Arsenic: ≤ 1 mg/kgLead: ≤ 2 mg/kgMercury: ≤ 0,1 mg/kgMicrobiological criteria:Total viable aerobic counts: ≤ 104 CFU/gTotal yeast and mould count: ≤ 200 CFU/gEscherichia coli: Negative to testSalmonella spp.: Negative to testCFU: Colony Forming Units | ||||
| Phosphatidylserine from fish phospholipids | Description/Definition:The novel food ingredient is yellow to brown powder. Phosphatidylserine is obtained from fish phospholipids by an enzymatic transphosphorylation with the amino acid L-serine.Specification of the phosphatidylserine product manufactured from fish phospholipids:Moisture: < 5,0 %Phospholipids: ≥ 75 %Phosphatidylserine: ≥ 35 %Glycerides: < 4,0 %Free L-serine: < 1,0 %Tocopherols: < 0,5 % (1)Peroxide value (PV): < 5,0 meq O2/kg(1)Tocopherols may be added as antioxidants according to Commission Regulation (EU) No 1129/2011 | |||
| Phosphatidylserine from soya phospholipids | Description/Definition:The novel food ingredient is off-white to light yellow powder. It is also available in liquid form with a clear brown to orange colour. The liquid form contains medium chain triacylglycerides (MCT) as a carrier. It contains lower levels of Phosphatidylserine due to the fact that it includes significant amounts of oil (MCT).Phosphatidylserine from soya phospholipids is obtained through enzymatic transphosphatidylation of high-phosphatidylcholine soybean lecithin with the amino acid L-serine. Phosphatidylserine consists of a glycerophosphate skeleton conjugated with two fatty acids and L-serine via a phosphodiester linkage.Characteristics of Phosphatidylserine from soya phospholipids:Powder form:Moisture: < 2,0 %Phospholipids: ≥ 85 %Phosphatidylserine: ≥ 61 %Glycerides: < 2,0 %free L-serine: < 1,0 %Tocopherols: < 0,3 %Phytosterols: < 0,2 %Liquid form:Moisture: < 2,0 %Phospholipids: ≥ 25 %Phosphatidylserine: ≥ 20 %Glycerides: not applicablefree L-serine: < 1,0 %Tocopherols: < 0,3 %Phytosterols: < 0,2 % | |||
| Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid | Description/Definition:The product is manufactured through enzymatic conversion of soy lecithin. The phospholipid product is a highly concentrated, yellow-brown powder form of phosphatidylserine and phosphatidic acid at an equal level.Specification of the product:Moisture: ≤ 2,0 %Total phospholipids: ≥ 70 %Phosphatidylserine: ≥ 20 %Phosphatidic acid: ≥ 20 %Glycerides: ≤ 1,0 %Free L-serine: ≤ 1,0 %Tocopherols: ≤ 0,3 %Phytosterols: ≤ 2,0 %Silicon dioxide is used with a maximum content of 1,0 % | |||
| Phospholipides from egg yolk | 85 % and 100 % pure Phospholipides from egg yolk | |||
| Phytoglycogen | Description: White to off-white powder which is an odourless, colourless, flavourless polysaccharide derived from non-GM sweet corn using conventional food processing techniquesDefinition: Glucose polymer (C6H12O6)n with linear linkages of α(1 – 4) glycosidic bonds branched every 8 to 12 glucose units by α(1 – 6) glycosidic bondsSpecifications:Carbohydrates: 97 %Sugars: 0,5 %Fibre: 0,8 %Fat: 0,2 %Protein: 0,6 % | |||
| Phytosterols/phytostanols | Description/Definition:Phytosterols and phytostanols are sterols and stanols that are extracted from plants and may be presented as free sterols and stanols or esterified with food grade fatty acids.Composition (with GC-FID or equivalent method):β-sitosterol: < 81 %β-sitostanol: < 35 %campesterol: < 40 %campestanol: < 15 %stigmasterol: < 30 %brassicasterol: < 3,0 %other sterols/stanols: < 3,0 %Contamination/Purity (GC-FID or equivalent method):Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of contaminants, best ensured by a purity of more than 99 % of the phytosterol/phytostanol ingredient. | |||
| Phytosterols/phytostanols | Description/Definition:Phytosterols and phytostanols are sterols and stanols that are extracted from the sunflower plant and may be presented as free sterols and stanols or esterified with food grade fatty acids.Composition (with GC-FID or equivalent method):β-sitosterol: < 81 %β-sitostanol: < 35 %campesterol: < 40 %campestanol: < 15 %stigmasterol: < 30 %brassicasterol: < 3,0 %other sterols/stanols: 3,0 % to < 7,0 %note | |||
| Plum kernel oil | Description/Definition:Plum kernel oil is a vegetable oil obtained by cold pressing of plum (Prunus domestica) kernels.Composition:Oleic acid (C18:1): 68 %Linoleic acid (C18:2): 23 %γ-Tocopherol:80 % of total tocopherolsβ-Sitosterol: 80-90 % of total sterolsTriolein: 40-55 % of triglyceridesCyanhydric acid: maximum 5 mg/kg oil | |||
| Potassium magnesium trichloride hexahydrate | Description / Definition:The novel food is a mineral salt, which mainly consists of potassium magnesium trichloride hexahydrate. It is a white, off-white crystalline, fine granular, slightly hygroscopic product with a characteristic saline taste. It is produced by a multi-step crystallisation process of seawater from the Dead Sea by solar evaporation.Synonym:Potassium magnesium chloride hydrate, carnallite.Identity:Positive by X-ray diffractionCharacteristics:Melting point (range): 149,6 – 160,2 °CSolubility:pH 1,94: 4,13 and 6,80: freely solublepH 8,06: slightly solubleInsoluble parts: ≤ 0,3 % (w/w)Water at 180 °C (water of crystallisation plus moisture): 32 %–40 %Main constituents:Chloride: 40 % – 42 % (w/w)Potassium: 11,0 % – 13,6 % (w/w)Magnesium: 7,9 % – 8,9 % (w/w)Calcium: ≤ 0,2 % (w/w)Sodium: ≤ 2,75 % (w/w)Heavy metals:Arsenic < 0,1 mg/kgCadmium < 0,1 mg/kgMercury < 0,05 mg/kgLead < 0,1 mg/kgTrace elements:Bromide: ≤ 0,40 % (w/w)Strontium: ≤ 25 mg/kgManganese: ≤ 3,0 mg/kgIron: ≤ 4,0 mg/kgCopper: ≤ 0,5 mg/kgBoron: ≤ 10 mg/kgAluminium: ≤ 1,0 mg/kgTotal phosphorous: ≤ 5 mg/kgSulfate: < 500 mg/kgNitrite: < 10 mg/kgNitrate: < 400 mg/kgChlorate: < 0,2 mg/kgBromate: < 1 mg/kgFluoride: ≤ 5 mg/kgIodine: < 0,1 mg/kgMicrobiological parameters:Total plate count: < 100 CFU/gE. coli: not detected in 1 gSalmonella: not detected in 25 gSalt-tolerant microorganisms: < 100 CFU/gSum parameters:Total organic carbon: < 0,10 % (w/w)CFU: colony forming units | |||
| Potato proteins (coagulated) and hydrolysates thereof | Dry substance: ≥ 800 mg/gProtein (N * 6,25): ≥ 600 mg/g (dry substance)Ash: ≤ 400 mg/g (dry substance)Glycoalkaloid (total): ≤ 150 mg/kgLysinoalanine (total): ≤ 500 mg/kgLysinoalanine (free): ≤ 10 mg/kg | |||
| Prolyl oligopeptidase (enzyme preparation) | Specification of the enzyme:Systematic name: Prolyl oligopeptidaseSynonyms: Prolyl endopeptidase, proline-specific endopeptidase, endoprolylpeptidaseMolecular weight: 66 kDaEnzyme Commission number: EC 3.4.21.26CAS number: 72162-84-6Source: A genetically modified strain of Aspergillus niger (GEP-44)Description: Prolyl oligopeptidase is available as an enzyme preparation containing approximately 30 % maltodextrin.Specifications of the enzyme preparation of prolyl oligopeptidase:Activity: > 580000 PPI(1)/g (> 34,8 PPU(2)/g)Appearance: MicrogranulateColour: Off-white to orange yellowish. The colour may change from batch to batchDry Matter: > 94 %Gluten: < 20 ppmHeavy metals:Lead: ≤ 1,0 mg/kgArsenic: ≤ 1,0 mg/kgCadmium: ≤ 0,5 mg/kgMercury: ≤ 0,1 mg/kgMicrobiological criteria:Total aerobic plate count: ≤ 103 CFU/gTotal yeasts and moulds: ≤ 102 CFU/gSulphite reducing anaerobes: ≤ 30 CFU/gEnterobacteriaceae: < 10 CFU/gSalmonella: Absence in 25 gEscherichia coli: Absence in 25 gStaphylococcus aureus: Absence in 10 gPseudomonas aeruginosa: Absence in 10 gListeria monocytogenes: Absence in 25 gAntimicrobial activity: AbsentMycotoxins: Below limits of detection: Aflatoxin B1, B2, G1, G2 (< 0,25 μg/kg), total Aflatoxins (< 2,0 μg/kg), Ochratoxin A (< 0,20 μg/kg), T-2 Toxin (< 5 μg/kg), Zearalenone (< 2,5 μg/kg), Fumonisin B1 and B2 (< 2,5 μg/kg)(1)PPI – Protease Picomole International(2)PPU – Prolyl Peptidase Units or Proline Protease Units | |||
| Heat-treated Lemna minor and Lemna gibba | Description/Definition:Lemna minor and Lemna gibba plant material cultivated under controlled conditions consisting of heat treated small green leaves with some minor white roots.Characteristics/compositionMoisture 91–95 g/100 gProtein (N × 6,25) 1–4 g/100 gCarbohydrates 1–3 g/100 gDietary fibre 0,5–3 g/100 gAsh 1–2 g/100 gFat 0,2–0,6 g/100 gOxalates (as calcium oxalate) < 1,6 g/kgBeta-carotene < 3,160 μg/100 gFolate < 38 μg/100 gPhylloquinone < 46 μg/100 gCopper < 2,5 mg/kgIron < 53 mg/kgManganese ≤ 6 mg/kgMolybdenum < 0,5 mg/kgZinc < 20 mg/kgChromium < 1 mg/kgBoron < 15 mg/kgContaminantsNitrate < 520 mg/kgNitrite < 1,75 mg/kgLead < 0,3 mg/kgCadmium < 0,2 mg/kgMercury < 0,05 mg/kgArsenic < 0,05 mg/kgMicrocystins < 23 μg/kgNodularins < 7 μg/kgIAA < 0,1 mg/kgMicrobiological criteriaTotal aerobic microbial count: < 5000 CFU/gEscherichia coli: < 100 CFU/gBacillus cereus: < 100 CFU/gCoagulase-positive staphylococci: Not detected in 10 gListeria monocytogenes: Absence in 25 gSalmonella spp. Absence in 25 gTotal yeast and mould count: < 100 CFU/gIAA: indole-3-acetic acid; CFU: colony forming unit. | |||
| Protein concentrate from Lemna gibba and Lemna minor | Description/Definition:The novel food is a protein concentrate produced from the Lemna gibba (70–100 %) and Lemna minor (0–30 %) plant species. The manufacturing process of the protein concentrate involves mechanical separation of the protein fraction from insoluble fibres, followed by precipitation under acidic conditions, pasteurisation and spray drying.The cultivation is carried out in basins in greenhouses under controlled conditions. The water used for the cultivation is filtered and UV-treated. The cultivation conditions are monitored to control the growth of algae, yeast and fungi. The pH is maintained between 5,5 and 6,5.Characteristics/composition:Appearance: green powderMoisture: 1,5-8 %Protein (Nx6,25): 60-75 %Ash: 4-12 %Fat: 2-11 %Fibre: 6-17 %Ash: 4-12 %Vitamins:β-Carotene: < 755 mg/kgVitamin K1 (Phylloquinone): < 16 mg/100 gMinerals:Boron: < 10 mg/kgCopper: < 12 mg/kgMolybdenum: < 40 mg/kgIron: < 670 mg/kgZinc: < 50 mg/kgManganese: < 100 mg/kgAntinutritional factors:Oxalic acid: < 1900 mg/kgHeavy metals:Lead (mg/kg): ≤ 0,3Cadmium (mg/kg): ≤ 0,2Mercury (mg/kg): ≤ 0,1Arsenic (mg/kg): ≤ 0,2Cyanotoxins:Microcystins-/Nodularin: < 0,19 mg/kgOther contaminants:Lysino-alanine (bound): < 500 mg/kgLysino-alanine (free): < 10 mg/kgNitrate: < 3000 mg/kgPesticides:Pesticide levels in accordance with Code number 0254000 (‘Subgroup (d) watercresses’ in the group of Leaf vegetables, herbs and edible flowers) set out in Regulation (EC) No 396/2005.Microbiological criteria:Total colony count: < 104 CFU/gBacillus cereus: < 100 CFU/gClostridium perfringens: < 100 CFU/gCoagulase-positive Staphylococci: < 100 CFU/gEscherichia coli: < 10 CFU/gEnterobacteriaceae: < 10 CFU/gListeria monocytogenes: Not detected in 25 gSalmonella spp.: Not detected in 25 gYeasts and moulds: < 10 CFU/gCFU: colony forming units. | |||
| Protein extract from pig kidneys | Description/Definition:The protein extract is obtained from homogenised pig kidneys through a combination of salt precipitation and high-speed centrifugation. The obtained precipitate contains essentially proteins with 7 % of the enzyme diamine oxidase (enzyme nomenclature E.C. 1.4.3.22) and is resuspended in a physiologic buffer system. The obtained protein extract from pig kidney is formulated in appropriate forms and dosage to reach the active sites of digestion.Basic product:Specification: Protein extract from pig kidney with natural content of diamine oxidase (DAO):Physical condition: liquidColour: brownishAppearance: slightly turbid solutionpH value: 6,4-6,8Enzymatic activity: > 2677 kHDU DAO/ml (DAO REA (DAO Radio Extraction Assay))Microbiological criteria:Brachyspira spp.: negative (Real Time PCR)Listeria monocytogenes: negative (Real Time PCR)Staphylococcus aureus: < 100 CFU/gInfluenza A: negative (Reverse Transcription Real Time PCR)Escherichia coli: < 10 CFU/gTotal aerobic microbiological count: < 105 CFU/gYeasts/moulds count: < 105 CFU/gSalmonella: Absence/10 gBile salt resistant enterobacteriaceae: < 104 CFU/gFinal product:Specification protein extract from pig kidney with natural content of DAO (E.C. 1.4.3.22) in appropriate forms and dosage to reach the active sites of digestion:Physical condition: solidColour: yellow greyEnzymatic activity: 110-220 kHDU DAO/g (DAO REA (DAO Radio Extraction Assay))Acid stability 15 min 0,1M HCl followed by 60 min Borat pH = 9,0: > 68 kHDU DAO/g (DAO REA (DAO Radio Extraction Assay))Humidity: < 10 %Microbiological criteria:Staphylococcus aureus: < 100 CFU/gEscherichia coli: < 10 CFU/gTotal aerobic microbiological count: < 104 CFU/gTotal combined yeasts/moulds count: < 103 CFU/gSalmonella: Absence/10 gBile salt resistant enterobacteriaceae: < 102 CFU/gPCR: Polymerase Chain Reaction; HDU (Histamine Degrading Units) | Description/Definition:The protein extract is obtained from homogenised pig kidneys through a series of steps involving a number of acetone washes to defat and dehydrate the homogenized pig kidneys, followed by draining, drying, milling, and sieving to produce a powder containing essentially proteins with a 7-9 % (on average) content of the enzyme diamine oxidase (enzyme nomenclature E.C. 1.4.3.22). The protein extract from pig kidney is formulated in appropriate forms and dosage to reach the active sites of digestion.Basic product:Specification: Protein extract from pig kidney with natural content of diamine oxidase (DAO):Physical condition: powderColour: pale brownEnzymatic activity: ≥ 0,10 mU/mg (ultra-high performance liquid chromatography linked with fluorescent detection)Humidity: < 10 %Residual solvents:Acetone: < 5000 mg/kgMicrobiological criteria:Staphylococcus aureus: < 100 CFU/gEscherichia coli: < 10 CFU/gTotal aerobic microbiological count: < 104 CFU/gTotal combined yeasts/moulds count: < 103 CFU/gSalmonella: Absence/10 gBile salt resistant enterobacteriaceae: < 102 CFU/gListeria monocytogenes: absence in 25 gFinal product:Specification protein extract from pig kidney with natural content of DAO (E.C. 1.4.3.22) in appropriate forms and dosage to reach the active sites of digestion:Physical condition: solidColour: pale brownEnzymatic activity: 2,29-4,6 mU/g (ultra-high performance liquid chromatography linked with fluorescent detection).Acid stability 15 min 0,1M HCl followed by 60 min Borat pH = 9,0: > 1,4 mU DAO/g (ultra-high performance liquid chromatography linked with fluorescent detection)Humidity: < 10 %Microbiological criteria:Staphylococcus aureus: < 100 CFU/gEscherichia coli: < 10 CFU/gTotal aerobic microbiological count: < 104 CFU/gTotal combined yeasts/moulds count: < 103 CFU/gSalmonella: Absence/10 gBile salt resistant enterobacteriaceae: < 102 CFU/gListeria monocytogenes: absence in 25 gmU: milliUnit (expressed in mU/mg) measures nanomols (nmol) of histamine degraded by the DAO per minute using ultra-high performance liquid chromatography linked with fluorescent fetection (O. Comas-Basté et al. Analytical and Bioanalytical Chemistry 411:7595-7602 (2019)). 1 mU corresponds to 48000 HDU of the DAO Radio Extraction Assay (REA) method. | ||
| Pyrroloquinoline quinone disodium salt | Definition:Chemical name: disodium 9-carboxy-4,5-dioxo-1H-pyrrolo[5,4-f]quinoline-2,7-dicarboxylateChemical formula: C14H4N2Na2O8CAS No: 122628-50-6Molecular weight: 374,17 DaDescriptionPyrroloquinoline quinone disodium salt is a reddish–brown powder produced by the non-genetically modified bacterium Hyphomicrobium denitrificans strain CK-275.Characteristics/CompositionAppearance: Reddish-brown powderPurity: ≥ 99,0 % (dry weight)UV absorbance (A322/A259): 0,56 ± 0,03UV absorbance (A233/A259): 0,90 ± 0,09Moisture: ≤ 12,0 %Residual SolventEthanol: ≤ 0,05 %Heavy metalsLead: < 3 mg/kgArsenic: < 2 mg/kgMicrobiological criteria:Total viable cell count: ≤ 300 CFU/gMould/yeast: ≤ 12 CFU/gColiforms: absent in 1 gHyphomicrobium denitrificans: ≤ 25 CFU/gCFU: Colony Forming Units | |||
| Rapeseed oil high in unsaponifiable matter | Description/Definition:Rapeseed oil high in unsaponifiable matter’ is produced by vacuum distillation and it is different from refined rapeseed oil in the concentration of the unsaponifiable fraction (1 g in refined rapeseed oil and 9 g in ‘rapeseed oil high in unsaponifiable matter’). There is a minor reduction of triglycerides containing monounsaturated and polyunsaturated fatty acids.Purity:Unsaponifiable matter: > 7,0 g/100 gTocopherols: > 0,8 g/100 gα-tocopherol (%): 30-50 %γ-tocopherol (%): 50-70 %δ-tocopherol (%): < 6,0 %Sterols, triterpenic alcohols, methylsterols: > 5,0 g/100 gFatty acids in triglycerides:palmitic acid: 3-8 %stearic acid: 0,8-2,5 %oleic acid: 50-70 %linoleic acid: 15-28 %linolenic acid: 6-14 %erucic acid: < 2,0 %Acid value: ≤ 6,0 mg KOH/gPeroxide value (PV): ≤ 10 mEq O2/kgHeavy metals:Iron (Fe): < 1000 μg/kgCopper (Cu): < 100 μg/kgImpurities:Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 μg/kgTreatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons (PAH) are not enriched in the production of ‘rapeseed oil high in unsaponifiable matter. | |||
| Rapeseed Protein | Definition:Rapeseed protein is an aqueous protein-rich extract from rapeseed press cake originating from non-genetically modified Brassica napus L. and Brassica rapa L.Description:White to off-white, spray dried powderTotal protein: ≥ 90 %Soluble protein: ≥ 85 %Moisture: ≤ 7,0 %Carbohydrates: ≤ 7,0 %Fat: ≤ 2,0 %Ash: ≤ 4,0 %Fibre: ≤ 0,5 %Total glucosinolates: ≤ 1 mmol/kgPurity:Total phytate: ≤ 1,5 %Lead: ≤ 0,5 mg/kgMicrobiological criteria:Yeast and mould count: ≤ 100 CFU/gAerobic bacteria count: ≤ 10000 CFU/gTotal coliform count: ≤ 10 CFU/gEscherichia coli: Absence in 10 gSalmonella: Absence in 25 g | |||
| Refined shrimp peptide concentrate | DescriptionRefined shrimp peptide concentrate is a peptide mixture obtained from northern shrimp (Pandalus borealis) shells and heads via a series of purification steps following enzymatic proteolysis using a protease from Bacillus licheniformis and/or Bacillus amyloliquefaciens.Characteristics/CompositionTotal Dry matter (%): ≥ 95,0 %Peptides (w/weight dry matter): ≥ 87,0 % of which peptides with molecular weight < 2 kDa: ≥ 99,9 %Fat (w/w): ≤ 1,0 %Carbohydrates (w/w): ≤ 1,0 %Ash (w/w): ≤ 15,0 %Calcium: ≤ 2,0 %Potassium: ≤ 0,15 %Sodium: ≤ 3,5 %Heavy MetalsArsenic (inorganic): ≤ 0,22 mg/kgArsenic (organic): ≤ 51,0 mg/kgCadmium: ≤ 0,09 mg/kgLead: ≤ 0,18 mg/kgTotal mercury: ≤ 0,03 mg/kgMicrobiological criteria:Total viable cell count: ≤ 20000 CFU/gSalmonella: ND/25gListeria monocytogenes: ND/25gEscherichia coli: ≤ 20 CFU/gCoagulase positive Staphylococcus aureus: ≤ 200 CFU/gPseudomonas aeruginosa: ND/25gMould/yeast: ≤ 20 CFU/gCFUColony Forming UnitsNDNot Detectable | |||
| Rhamnogalacturonan-I enriched carrot extract | Description/Definition:The novel food is an extract of carrot pomace selectively enriched for rhamnogalacturonan-I domains by an enzymatic process (degrading selectively the pectin portion), followed by inactivation of the enzymes and further purification, heat treatment, drying and pasteurisation.Source: Daucus carota L., subspecies Sativus.Physical and chemical properties:Colour: Off-white to beigeOdour/taste: NeutralSolubility: soluble in waterWater activity: < 0,6Composition:Rhamnogalacturonan-I: ≥ 70 %Rhamnose: ≥ 9 %Moisture: ≤ 7 %Free sugars: ≤ 3 %Soluble dietary fibre: ≥ 60 %Total dietary fibre: ≥ 70 %Crude protein: ≤ 4 %Ash: ≤ 5 %Fat: ≤ 2 %Contaminants:Lead: ≤ 1,0 mg/kgCadmium: ≤ 1,0 mg/kgArsenic: ≤ 0,1 mg/kgMercury: ≤ 0,1 mg/kgPerchlorate: ≤ 0,05 mg/kgMicrobiological criteria:TAMC: ≤ 1 × 103 CFU/gTYMC: ≤ 1 × 102 CFU/gBacillus cereus: < 1 × 102 CFU/gEnterobacteriaceae: < 1 × 102 CFU/gEscherichia coli: < 10 CFU/gSalmonella spp.: not detected in 25 gListeria monocytogenes: not detected in 25 gSulphite reducing anaerobes: < 30 CFU/gAbbreviations: CFU, colony forming units; TAMC, total aerobic microbial count; TYMC, total yeast and mould count. | |||
| Rhizomucor pusillus mycelium | Description:The novel food is the biomass of the fungus Rhizomucor pusillus (strain CBS 143028), which has been produced via fermentation. The biomass is then harvested, pasteurised to inactivate the viable fungus cells, dried and milled into a whitish odourless powder. Rhizomucor pusillus is a filamentous fungus belonging to the Mucoraceae family.Characteristics/Composition:Moisture: 4-7 g/100 gCrude protein content (N × 6,25): 44-68 g/100 gTotal fat content: 4-8 g/100 gTotal dietary fibre: 25-39 g/100 gTotal digestible carbohydrates: ≤ 3 g/100 gAsh: ≤ 6 g/100 gMicrobiological criteria:Total aerobic microbial count: ≤ 103 CFU (*)/gBacillus cereus: ≤ 100 CFU/gClostridium perfringens: < 10 CFU/gCoagulase-positive staphylococci: ≤ 50 CFU/gEnterobacteriaceae: ≤ 10 CFU/gEscherichia coli: ≤ 10 CFU/gListeria monocytogenes: Not detected in 25 gSalmonella spp.: Not detected in 25 gYeasts and moulds: < 100 CFU/g(*)CFU = Colony Forming UnitsHeavy metals:Arsenic (As): ≤ 0,1 mg/kgCadmium (Cd): ≤ 0,1 mg/kgLead (Pb): ≤ 0,1 mg/kgMercury (Hg): ≤ 0,1 mg/kgMycotoxins:Aflatoxins (B1, B2, G1, G2): < 0,1 μg/kgDiacetoxyscirpenol: < 20 μg/kgFumonisins (B1, B2): < 100 μg/kgHT2 Toxin: < 7,5 μg/kgT2 Toxin: < 7,5 μg/kgNivalenol: < 150 μg/kgOchratoxin A: < 1,0 μg/kgDeoxynivalenol (DON): < 150 μg/kgZearalenone: < 20 μg/kg | |||
| Trans-resveratrol | Description/Definition:Synthetic: Trans-resveratrol is off-white to beige crystals.Chemical name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diolChemical formula: C14H12O3Molecular weight: 228,25 DaCAS No: 501-36-0Purity:Trans-resveratrol: ≥ 98 %-99 %Total by-products (related substances): ≤ 0,5 %Any single related substance: ≤ 0,1 %Sulphated ash: ≤ 0,1 %Loss on drying: ≤ 0,5 %Heavy metals:Lead: ≤ 1,0 ppmMercury: ≤ 0,1 ppmArsenic: ≤ 1,0 ppmImpurities:Diisopropylamine: ≤ 50 mg/kgMicrobial source: A genetically modified strain of Saccharomyces cerevisiaeAppearance: Off-white to slight yellow powderTrans-resveratrol content: Min. 98 % w/w (dry weight basis)Ash: Max. 0,5 % w/wMoisture: Max. 3 % w/w | |||
| Rooster comb extract | Description/Definition:Rooster comb extract is obtained from Gallus gallus by enzymatic hydrolysis of rooster comb and by subsequent filtration, concentration and precipitation steps. The principal constituents of rooster comb extract are the glycosaminoglycans hyaluronic acid, chondroitin sulphate A and dermatan sulphate (chondroitin sulphate B). White or almost white hygroscopic powder.Hyaluronic acid: 60-80 %Chondroitin sulphate A: ≤ 5,0 %Dermatan sulphate (chondroitin sulphate B): ≤ 25 %pH: 5,0-8,5Purity:Chlorides: ≤ 1,0 %Nitrogen: ≤ 8,0 %Loss on drying: (105 °C for 6 hours): ≤ 10 %Heavy metals:Mercury: ≤ 0,1 mg/kgArsenic: ≤ 1,0 mg/kgCadmium: ≤ 1,0 mg/kgChromium: ≤ 10 mg/kgLead: ≤ 0,5 mg/kgMicrobiological criteria:Total viable aerobic count: ≤ 102 CFU/gEscherichia coli: Absence in 1 gSalmonella: Absence in 1 gStaphylococcus aureus: Absence in 1 gPseudomonas aeruginosa: Absence in 1g | |||
| Sacha Inchi oil from Plukenetia volubilis | Description/Definition:Sacha inchi oil is a 100 % cold pressed vegetable oil obtained from the seeds of Plukenetia volubiis L. It is a transparent, fluid (liquid) and shiny oil at room temperature. It has a fruity, light, green vegetable taste without undesirable flavours.Aspect, limpidity, shine, colour: Fluid at room temperature, clean, shiny yellow goldOdour and taste: Fruity, vegetable without non acceptable taste or odourPurity:Water and Volatiles: < 0,2 g/100 gImpurities insoluble in hexane: < 0,05 g/100 gOleic acidity: < 2,0 g/100 gPeroxide value (PV): < 15 meq O2/kgTrans fatty acids: < 1,0 g/100 gTotal unsaturated fatty acids: > 90 %Omega 3 alpha linolenic acid (ALA): > 45 %Saturated fatty acids: < 10 %No trans fatty acids (< 0,5 %)No erucic acid (< 0,2 %)More than 50 % of tri-linolenin and di-linolenin-triglyceridesPhytosterols composition and levelNo cholesterol (< 5,0 mg/100 g) | |||
| Salatrims | Description/Definition:Salatrim is the internationally recognised acronym for (short and long chain acyl triglyceride molecules). Salatrim is prepared by non-enzymatic inter-esterification of triacetin, tripropionin, tributyrin, or their mixtures with hydrogenated canola, soybean, cottonseed, or sunflower oil. Description: Clear, slightly amber liquid to a light coloured waxy solid at room temperature. Free of particulate matter and of foreign or rancid odour.Glycerol ester disribution:Triacylglycerols: > 87 %Diacylglycerols: ≤ 10 %Monoacylglycerols: ≤ 2,0 %Fatty acid composition:MOLE % LCFA (long chain fatty acids): 33-70 %MOLE % SCFA (short chain fatty acids): 30-67 %Saturated long chain fatty acids: < 70 % by weightTrans fatty acids: ≤ 1,0 %Free fatty acids as oleic acid: ≤ 0,5 %Triacylglycerol profile:Triesters (short/long of 0,5 to 2,0): ≥ 90 %Triesters (short/long = 0): ≤ 10 %Unsaponifiable material: ≤ 1,0 %Moisture: ≤ 0,3 %Ash: ≤ 0,1 %Colour: ≤ 3,5 Red (Lovibond)Peroxide value (PV): ≤ 2,0 Meq/Kg | |||
| Schizochytrium sp. oil rich in DHA and EPA | Acid value: ≤ 0,5 mg KOH/gPeroxide value (PV): ≤ 5,0 meq/kg oilOxidative stability: All food products containing Schizochytrium sp. oil rich in DHA and EPA should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC)Moisture and volatiles: ≤ 0,05 %Unsaponifiables: ≤ 4,5 %Trans-fatty acids: ≤ 1 %DHA content: ≥ 15 %EPA content: ≥ 10 % | |||
| Schizochytrium sp. (ATCC PTA-9695) oil | The novel food is obtained from the strain ATCC PTA-9695 of the microalgae Schizochytrium sp.Peroxide value (PV): ≤ 5,0 meq/kg oilUnsaponifiables: ≤ 3,5 %Trans-fatty acids: ≤ 2,0 %Free fatty acids: ≤ 0,4 %Docosapentaenoic acid (DPA) n-6: ≤ 7,5 %DHA content: ≥ 35 % | |||
| Schizochytrium sp. (CABIO-A-2) oil | Description/Definition:The novel food is an oil produced from the strain CABIO-A-2 of the microalgae Schizochytrium sp.Composition:DHA content: ≥ 35,0 %Acid value: ≤ 0,5 mg KOH/gPeroxide value: ≤ 5,0 meq/kgMoisture and volatiles: ≤ 0,05 %Unsaponifiables: ≤ 3,5 %Trans-fatty acids: ≤ 2,0 %Free fatty acids: ≤ 0,4 %p-Anisidine value: ≤ 10 | |||
| Schizochytrium sp. (FCC-3204) oil | Description/Definition:The novel food is an oil produced from the strain FCC-3204 of the microalgae Schizochytrium sp.Composition:Acid value: ≤ 0,5 mg KOH/gPeroxide value (PV): ≤ 5,0 meq/kg oilMoisture and volatiles: ≤ 0,05 %Unsaponifiables: ≤ 4,5 %Trans-fatty acids: ≤ 1,0 %Docosahexaenoic acid (DHA): ≥ 32,0 %p-anisidine value: ≤ 10 | |||
| Schizochytrium sp. oil | Acid value: ≤ 0,5 mg KOH/gPeroxide value (PV): ≤ 5,0 meq/kg oilMoisture and volatiles: ≤ 0,05 %Unsaponifiables: ≤ 4,5 %Trans-fatty acids: ≤ 1,0 %DHA content: ≥ 32,0 % | |||
| Schizochytrium sp. (T18) oil | Acid value: ≤ 0,8 mg KOH/gPeroxide value (PV): ≤ 5,0 meq/kg oilMoisture and volatiles: ≤ 0,05 %Unsaponifiables: ≤ 3,5 %Trans-fatty acids: ≤ 2,0 %Free fatty acids: ≤ 0,4 %DHA content: ≥ 35 % | |||
| Schizochytrium sp. (WZU477) oil | Description/Definition:The novel food is an oil produced from the strain WZU477 of the microalgae Schizochytrium sp.Composition:Acid value: ≤ 0,5 mg KOH/gPeroxide value (PV): ≤ 5,0 meq/kg oilMoisture and volatiles: ≤ 0,05 %Unsaponifiables: ≤ 4,5 %Trans-fatty acids: ≤ 1,0 %Docosahexaenoic acid (DHA): ≥ 32,0 %p-anisidine value: ≤ 10 | |||
| Schizochytrium limacinum (TKD-1) oil | Description/Definition:The novel food is an oil produced from the strain TKD-1 of the microalgae species Schizochytrium limacinum.Composition:DHA content: ≥ 35,0 %Acid value: ≤ 0,5 mg KOH/gPeroxide value: ≤ 5,0 meq/kgMoisture and volatiles: ≤ 0,05 %Unsaponifiables: ≤ 3,5 %Trans-fatty acids: ≤ 2,0 %Free fatty acids: ≤ 0,4 %p-Anisidine value: ≤ 10 | |||
| Schizochytrium limacinum (ATCC-20889) oil | Description/Definition:The novel food is an oil produced from the strain ATCC-20889 of the microalgae species Schizochytrium limacinum.Composition:Acid value: ≤ 0,5 mg KOH/gPeroxide value (PV): ≤ 5,0 meq/kg oilMoisture and volatiles: ≤ 0,05 %Unsaponifiables: ≤ 4,5 %Trans-fatty acids: ≤ 1,0 %Docosahexaenoic acid (DHA): ≥ 32 %p-anisidine value: ≤ 10 | |||
| Syrup from Sorghum bicolor (L.) Moench.(Traditional food from a third country) | Description/DefinitionThe traditional food is syrup from Sorghum bicolor (L.) Moench (genus, Sorghum; family, Poaceae (alt. Gramineae)).The syrup is obtained from stalks of S. bicolor, after applying production processes such as crushing, extraction, and evaporation including a heat treatment in order to obtain a minimum of 74 °Brix syrupCompositional data of syrup from Sorghum bicolor (L.) MoenchWater: 22,7 g/100 gAsh: 2,4Sugars, total: > 74,0 g/100 g | |||
| Fermented soybean extract | Description/Definition:Fermented soybean extract is an odourless milk-white coloured powder. It is comprised of 30 % fermented soybean extract powder and 70 % resistant dextrin (as carrier) from corn-starch, which is added during the processing. Vitamin K2 is removed during the manufacturing process.Fermented soybean extract contains nattokinase isolated from natto, a foodstuff produced by the fermentation of non-genetically modified soybeans (Glycine max (L.)) with a selected strain of Bacillus subtilis var. natto.Nattokinase activity: 20000 -28000 Fibrin degradation unit/g(1)Identity: ConfirmableCondition: No offensive taste or smellLoss on drying: ≤ 10 %Vitamin K2: ≤ 0,1 mg/kgHeavy metals:Lead: ≤ 5,0 mg/kgArsenic: ≤ 3,0 mg/kgMicrobiological criteria:Total viable aerobic count: ≤ 103 CFU(3)/gYeast and mould: ≤ 102 CFU/gColiforms: ≤ 30 CFU/gSpore-forming bacteria: ≤ 10 CFU/gEscherichia coli: Absence/25 gSalmonella: Absence/25 gListeria: Absence/25 g(1)Assay method as described by Takaoka et al. (2010). | |||
| Seeds and seed flour of Vigna subterranea (L.) Verdc. (traditional food from a third country) | Description/Definition:The traditional food consists of de-shelled whole dried seeds of Vigna subterranea (L.) Verdc. [Family: Fabaceae (alt. Leguminosae)] or the flour obtained by several steps, including heat treatment and milling of the seeds.Synonyms: Cryptolobus subterraneus (L.) Spreng., Glycine subterranea L., Tetrodea subterranea (L.) Raf., Voandzeia subterranea (L.) Thouars.Common names: Bambara groundnut, Bambara nut, Bambara bean, Bambara pea, Nyimo bean.Dried seedsTypical composition range:Moisture: 7-11 %Protein: > 15 %Carbohydrates: 32-65 %Sugar: < 6,0 %Fat: 4-7 %Fiber: 7-31 %Heavy metals:Arsenic: < 0,05 mg/kgCadmium: < 0,02 mg/kgLead: < 0,05 mg/kgMercury: < 0,01 mg/kgMycotoxins:Sum of Aflatoxins (B1+B2+G1+G2): < 4 μg/kgAflatoxin B1: < 2 μg/kgSum of Fumonisin (B1+B2+B3): < 60 μg/kgDeoxynivalenol: < 0,1 mg/kgOchratoxin A: < 0,5 μg/kgZearalenone: < 0,1 mg/kgOther contaminants or anti-nutrient factors:Hydrocyanic acid (including hydrocyanic acid bound in cyanogenic glycosides): < 15 mg/kgMicrobiological criteria:Aerobic mesophilic spores: < 1 Spore/gAlicyclobacillus: Not detected in 10 gPresumptive Bacillus cereus: < 10 cfu/gColiforms: < 10 cfu/gE. coli: < 10 cfu/gSalmonella: Not detected in 25 gStaphylococcus aureus: < 10 cfu/gTotal Plate Count: < 5000 cfu/gYeast & Moulds: < 100 cfu/gDried seed flourTypical composition range:Moisture: 4-7 %Protein: > 15 %Carbohydrates: 55-75 %Sugar: < 20 %Fat: 4-9 %Fiber: 10-30 %Heavy metals:Arsenic: < 0,05 mg/kgCadmium: < 0,02 mg/kgLead: < 0,05 mg/kgMercury: < 0,01 mg/kgMycotoxins:Sum of Aflatoxins (B1+B2+G1+G2): < 4 μg/kgAflatoxin B1: < 2 μg/kgSum of Fumonisin (B1+B2+B3): < 60 μg/kgDeoxynivalenol: < 0,1 mg/kgOchratoxin A: < 0,5 μg/kgZearalenone: < 0,1 mg/kgOther contaminants or anti-nutrient factors:Hydrocyanic acid (including hydrocyanic acid bound in cyanogenic glycosides): < 10 mg/kgPhytic acid: < 0,01 g/100 gMicrobiological criteria:Aerobic mesophilic spores: < 1 Spore/gAlicyclobacillus: Not detected in 10 gPresumptive Bacillus cereus: < 10 cfu/gColiforms: < 10 cfu/gE. coli: < 10 cfu/gSalmonella: Not detected in 25 gStaphylococcus aureus: < 10 cfu/gTotal Plate Count: < 1000 cfu/gYeast & Moulds: < 100 cfu/gcfu: colony forming units | |||
| Selenium-containing yeast (Yarrowia lipolytica) biomass | Description/Definition:The novel food is the dried and heat-killed selenium-containing biomass of the yeast Yarrowia lipolytica.The novel food is produced by fermentation in the presence of sodium selenite followed by a number of purification steps including a heat-killing step of the yeast to ensure the absence of viable Yarrowia lipolytica cells in the novel food.Characteristics/Composition:Total selenium: 165–200 μg/gSe-methioninenote: 100–140 μg/gProtein: 40–50 g/100 gDietary fibre: 24–32 g/100 gSugars: < 1 g/100 gFat: 6–12 g/100 gTotal ash: ≤ 15 %Water: ≤ 5 %Dry matter: ≥ 95 %Heavy metals:Lead: ≤ 3,0 mg/kgCadmium: ≤ 1,0 mg/kgMercury: ≤ 0,1 mg/kgMicrobiological criteria:Total aerobic microbial count: ≤ 5 × 103 CFU/gTotal yeast and mould count: ≤ 102 CFU/gViable Yarrowia lipolytica cellsnote: < 10 CFU/g (i.e. limit of detection)Coliforms: ≤ 10 CFU/gSalmonella spp.: Absence in 25 gCFU: colony forming units | |||
| 3'-Sialyllactose (3'-SL) sodium salt(microbial source) | Description:3'-Sialyllactose (3'-SL) sodium salt is a purified, white to off-white powder or agglomerate that is produced by a microbial process and contains limited levels of lactose, 3'-sialyl-lactulose, and sialic acidSource: Genetically modified strain of Escherichia coli K-12 DH1Definition:Chemical formula: C23H38NO19NaChemical name: N-Acetyl-α-D-neuraminyl-(2→3)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium saltMolecular mass: 655,53 DaCAS No 128596-80-5Characteristics/Composition:Appearance: White to off-white powder or agglomerateSum of 3'-Sialyllactose sodium salt, D-Lactose, and Sialic acid (% of dry matter): ≥ 90,0 % (w/w)3'-Sialyllactose sodium salt (% of dry matter): ≥ 88,0 % (w/w)D-Lactose: ≤ 5,0 % (w/w)Sialic acid: ≤ 1,5 % (w/w)3'-Sialyl-lactulose: ≤ 5,0 % (w/w)Sum of other carbohydrates: ≤ 3,0 % (w/w)Moisture: ≤ 8,0 % (w/w)Sodium: 2,5 – 4,5 % (w/w)Chloride: ≤ 1,0 % (w/w)pH (20 °C, 5 % solution): 4,5 -6,0Residual protein: ≤ 0,01 % (w/w)Microbiological criteria:Aerobic mesophilic bacteria total plate count: ≤ 1000 CFU/gEnterobacteriaceae: ≤ 10 CFU/gSalmonella sp.: Absence in 25 gYeast: ≤ 100 CFU/gMould: ≤ 100 CFU/gResidual endotoxins: ≤ 10 EU/mgCFU: Colony Forming Units; EU: Endotoxin Units. | |||
| 3′-Sialyllactose (‘3′-SL’) sodium salt(produced by derivative strains of E. coli BL21(DE3)) | Description:3'-Sialyllactose (3′-SL) sodium salt is a purified, white to off-white powder or agglomerate produced by a microbial process and contains limited levels of lactose, 3'-sialyl-lactulose, and sialic acid.Definition:Chemical name: N-Acetyl-α-D-neuraminyl-(2→3)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium saltChemical formula: C23H38NO19NaMolecular mass: 655,53 DaCAS No: 128596-80-5Source: Two genetically modified strains (a production strain and an optional degradation strain) of Escherichia coli BL21(DE3)Characteristics/Composition:3′-Sialyllactose sodium salt (% of dry matter): ≥ 88,0 % (w/w)3′-Sialyl-lactulose (% of dry matter): ≤ 5,0 % (w/w)D-Lactose (% of dry matter): ≤ 5,0 % (w/w)Sialic acid (% of dry matter): ≤ 1,5 % (w/w)N-acetyl-D-glucosamine (% of dry matter): ≤ 1,0 % (w/w)Sum of other carbohydrates (% of dry matter)a: ≤ 5,0 % (w/w)Moisture: ≤ 9,0 % (w/w)Ash: ≤ 8,5 % (w/w)Residual protein: ≤ 0,01 % (w/w)Sodium: ≤ 4,2 % (w/w)Microbiological criteria:Standard plate count: ≤ 1000 *CFU/gEnterobacteriaceae: ≤ 10 CFU/gSalmonella spp.: Absence in 25 gYeast and mould: ≤ 100 CFU/gCronobacter (Enterobacter) sakazakii: Absence in 10 gResidual endotoxins: ≤ 10 **EU/mgaSum of other carbohydrates = 100 (% (w/w) of dry matter) – 3'-Sialyllactose sodium salt (% (w/w) of dry matter) – quantified carbohydrates (% (w/w) of dry matter) – Ash (% (w/w) of dry matter);*CFU: Colony Forming Units;**EU: Endotoxin Units | |||
| 3′-Sialyllactose (3′-SL) sodium salt(produced using a derivative strain of E. coli W (ATCC 9637)) | Description:3′-Sialyllactose (3′-SL) sodium salt is a purified, concentrated, white to off-white powder that is produced by a microbial process. It contains limited levels of Sialic acid, D-Lactose, D-Glucose, and 3′-Sialyllactulose and 6′-Sialyllactose sodium salts.Source:Genetically modified strain of Escherichia coli W (ATCC 9637)Definition:Chemical formula: C23H38NO19NaChemical name: N-Acetyl-α-D-neuraminyl-(2→3)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium saltMolecular mass: 655,53 DaCAS No: 128596-80-5Characteristics/Composition:3′-Sialyllactose sodium salt (% w/w of dry matter): ≥ 82,0Sialic acid (% w/w of dry matter): ≤ 6,0D-Lactose (% w/w of dry matter): ≤ 3,0D-Glucose (% w/w of dry matter): ≤ 3,0Sum of 3′- Sialyllactulose and 6′-Sialyllactose sodium salts (% w/w of dry matter): ≤ 5,0Sum of other carbohydratesa (% w/w of dry matter): ≤ 12,0Moisture (% w/w): ≤ 10,5Sodium (% w/w): ≤ 5,0pH (25 °C, 5 % solution): 4,5 -7,5Residual protein (% w/w): ≤ 0,01Heavy metals and contaminants:Arsenic (mg/kg): ≤ 0,2Lead (mg/kg): ≤ 0,2Cadmium (mg/kg): ≤ 0,2Mercury (mg/kg): ≤ 0,1Aflatoxin M1: < 0,025 (μg/kg)Microbiological criteria:Τοtal plate count: ≤ 1000 CFU/gEnterobacteriaceae: Absence in 10 gCronobacter spp.: Absence in 10 gSalmonella spp.: Absence in 25 gYeasts and moulds: ≤ 100 CFU/gListeria monocytogenes: Absence in 25 gPresumptive Bacillus cereus: ≤ 50 CFU/gResidual endotoxins: ≤ 10 EU/mgaSum of other carbohydrates = 100 % w/w of dry matter – 3′-Sialyllactose (acid, % w/w of dry matter) –quantified carbohydrates ((% w/w of dry matter), Sialic acid + D-Lactose + D-Glucose + (3′- Sialyllactulose and 6′-Sialyllactose (acids)) – sodium (w/w of dry matter); CFU: Colony Forming Units; EU: Endotoxin Units | |||
| 6’-Sialyllactose (‘6’-SL’) sodium salt(microbial source) | Description:6’-Sialyllactose (6’-SL) sodium salt is a purified, white to off-white powder or agglomerate that is produced by a microbial process and contains limited levels of lactose, 6’-sialyl-lactulose, and sialic acid.Source: Genetically modified strain of Escherichia coli K-12 DH1Definition:Chemical formula: C23H38NO19NaChemical name: N-Acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium saltMolecular mass: 655,53 DaCAS No 157574-76-0Characteristics/Composition:Appearance: White to off-white powder or agglomerateSum of 6’-Sialyllactose sodium salt, D-Lactose and Sialic acid (% of dry matter): ≥ 94,0 % (w/w)6’-Sialyllactose sodium salt (% of dry matter): ≥ 90,0 % (w/w)D-Lactose: ≤ 5,0 % (w/w)Sialic acid: ≤ 2,0 % (w/w)6’-Sialyl-lactulose: ≤ 3,0 % (w/w)Sum of other carbohydrates: ≤ 3,0 % (w/w)Moisture: ≤ 6,0 % (w/w)Sodium: 2,5-4,5 % (w/w)Chloride: ≤ 1,0 % (w/w)pH (20 °C, 5 % solution): 4,5-6,0Residual protein: ≤ 0,01 % (w/w)Microbiological criteria:Aerobic mesophilic bacteria total plate count: ≤ 1000 CFU/gEnterobacteriaceae: ≤ 10 CFU/gSalmonella sp.: Absence in 25 gYeast: ≤ 100 CFU/gMould: ≤ 100 CFU/gResidual endotoxins: ≤ 10 EU/mgCFU: Colony Forming Units; EU: Endotoxin Units. | |||
| 6’-Sialyllactose (‘6’-SL’) sodium salt(produced by derivative strains of E. coli BL21(DE3)) | Description:6'-Sialyllactose (6′-SL) sodium salt is a purified, white to off-white powder or agglomerate produced by a microbial process and contains limited levels of lactose, 6'-sialyl-lactulose, and sialic acid.Definition:Chemical name: N-Acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium saltChemical formula: C23H38NO19NaMolecular mass: 655,53 DaCAS No: 157574-76-0Source: Two genetically modified strains (a production strain and an optional degradation strain) of Escherichia coli BL21(DE3)Characteristics/Composition:6′-Sialyllactose sodium salt (% of dry matter): ≥ 90,0 % (w/w)6′-Sialyl-lactulose (% of dry matter): ≤ 3,0 % (w/w)D-Lactose (% of dry matter): ≤ 5,0 % (w/w)Sialic acid (% of dry matter): ≤ 2,0 % (w/w)N-acetyl-D-glucosamine (% of dry matter): ≤ 3,0 % (w/w)Sum of other carbohydrates (% of dry matter): ≤ 5,0 % (w/w)Moisture: ≤ 9,0 % (w/w)Ash: ≤ 8,5 % (w/w)Residual protein: ≤ 0,01 % (w/w)Sodium: ≤ 4,2 % (w/w)Contaminants:Arsenic: ≤ 0,2 (mg/kg)Aflatoxin M1: ≤ 0,025 (μg/kg)Microbiological criteria:Standard plate count: ≤ 1000 CFU/gEnterobacteriaceae: ≤ 10 CFU/gSalmonella spp.: Absence in 25 gYeast and mould: ≤ 100 CFU/gCronobacter spp.: Absence in 10 gResidual endotoxins: ≤ 10 EU/mg | |||
| 6′ -Sialyllactose (6′-SL) sodium salt(produced by derivative strain of E. coli W (ATCC 9637)) | Description:6′-Sialyllactose (6′-SL) sodium salt is a purified, white to off-white powder that is produced by a microbial process, is further isolated, purified and concentrated. It contains limited levels of Sialic acid, D-Lactose, D-Glucose, 6′-Sialyllactulose, and 3′-Sialyllactose sodium salt.Source: Genetically modified strain of Escherichia coli W (ATCC 9637)Definition:Chemical formula: C23H38NO19NaChemical name: N-Acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium saltMolecular mass: 655,53 DaCAS No 157574-76-0Characteristics/Composition:6′-Sialyllactose sodium salt (% w/w of dry matter): ≥ 82,0Sialic acid (% w/w of dry matter): ≤ 6,0D-Lactose (% w/w of dry matter): ≤ 3,0D-Glucose (% w/w of dry matter): ≤ 3,0Sum of 6′- Sialyllactulose and 3′-Sialyllactose sodium salt (% w/w of dry matter): ≤ 5,0Sum of other carbohydratesa (% w/w of dry matter): ≤ 13,0Moisture (% w/w): ≤ 10,5Sodium (% w/w): ≤ 5,0pH (25 °C, 5 % solution): 4,5–7,5Residual protein (% w/w): ≤ 0,01Heavy metals and contaminants:Arsenic (mg/kg): ≤ 0,2Aflatoxin M1: < 0,025 (μg/kg)Microbiological criteria:Τοtal plate count: ≤ 1000 CFU/gEnterobacteriaceae: Absence in 10 gCronobacter spp.: Absence in 10 gSalmonella spp.: Absence in 25 gYeasts and moulds: ≤ 100 CFU/gListeria monocytogenes: Absence in 25 gPresumptive Bacillus cereus: ≤ 50 CFU/gResidual endotoxins: ≤ 10 EU/mga Sum of other carbohydrates = 100 % w/w of dry matter – 6′-Sialyllactose (acid, % w/w of dry matter) –quantified carbohydrates ((% w/w of dry matter), Sialic acid + D-Lactose + D-Glucose + (6′- Sialyllactulose and 3′-Sialyllactose (acids)) – sodium (w/w of dry matter); CFU: Colony Forming Units; EU: Endotoxin Units | |||
| Spermidine-rich wheat germ extract (Triticum aestivum) | Description/Definition:Spermidine-rich wheat germ extract is obtained from non-fermented, non-sprouting wheat germs (Triticum aestivum) by the process of solid-liquid extraction targeting specifically, but not exclusively polyamines.Spermidine:(N-(3-aminopropyl)butane-1,4-diamine):0,8-2,4 mg/gSpermine: 0,4-1,2 mg/gSpermidine trichloride < 0,1 μg/gPutrescine: < 0,3 mg/gCadaverine: ≤ 16,0 μg/gMycotoxins:Aflatoxins (total): < 0,4 μg/kgMicrobiological criteria:Total aerobic bacteria: < 10000 CFU/gYeast and moulds: < 100 CFU/gEscherichia coli: < 10 CFU/gSalmonella: Absence/25gListeria monocytogenes: Absence/25g | |||
| Sucromalt | Description/Definition:Sucromalt is a complex mixture of saccharides which is produced from sucrose and a starch hydrolysate by means of an enzymatic reaction. In this process, glucose units are attached to saccharides from the starch hydrolysate by means of an enzyme produced by the bacterium Leuconostoc citreum or by means of a recombinant strain of the production organism Bacillus licheniformis. The resulting oligosaccharides are characterised by the presence of α-(1→6) and α-(l→3) glycosidic compounds. The overall product is syrup, in addition to these oligosaccharides, contains mainly fructose but also the disaccharide leucrose and other disaccharides.Total solids: 75-80 %Moisture: 20-25 %Sulphatase: Max 0,05 %pH: 3,5-6,0Conductivity < 200 (30 %)Nitrogen < 10 ppmFructose: 35-45 % d.w.Leucrose: 7-15 % d.w.Other disaccharides: Mах 3 %Higher saccharides: 40-60 % d.w | |||
| Sugar cane fibre | Description/Definition:Sugar Cane Fibre is derived from the dry cell wall or fibrous residue remaining after expression or extraction of sugar juice from sugar cane, of the Saccharum genotype. It consists primarily of cellulose and hemicellulose.The production process consists of several steps, including: chipping, alkaline digestion, removal of lignins and other non-cellulosic components, bleaching of purified fibres, acid washing and neutralization.Moisture: ≤ 7,0 %Ash: ≤ 0,3 %Total Dietary Fibre (AOAC) dry basis (all insoluble): ≥ 95 %of which: Hemicellulose (20-25 %) and cellulose (70-75 %)Silica (ppm): ≤ 200Protein: 0,0 %Fat: TracepH: 4-7Heavy metals:Mercury (ppm): ≤ 0,1Lead (ppm): ≤ 1,0Arsenic (ppm): ≤ 1,0Cadmium (ppm): ≤ 0,1Microbiological criteria:Yeast and moulds (CFU/g): ≤ 1000Salmonella: AbsenceListeria monocytogenes: Absence | |||
| Sugars obtained from cocoa (Theobroma cacao L.) pulp | Description/Definition:Sugars are obtained from the concentrated cocoa pulp (Theobroma cacao L.) juice either via a drying process or via a purification process to produce high purity glucose or fructose.Sugars produced by a drying processNutritional composition:Total sugars (g/100g): > 80Moisture (%): < 5Microbiological criteria:Total Plate Count (aerobic) (cfu/g): < 104Moulds and Yeasts (cfu/g): < 50Enterobacteriaceae (cfu/g): < 10Salmonella spp.: Absence in 25 gAlicyclobacillus: Absence in 50 gThermo-acidophilic bacteria: Absence in 50 gSugars produced by a purification processNutritional composition of Glucose obtained from cocoa (Theobroma cacao L.) pulp:Glucose content (%): > 93Ash (%): < 0,2Moisture (%): < 1,0Nutritional composition of Fructose obtained from cocoa (Theobroma cacao L.) pulp:Fructose content (%): > 98Glucose content (%): < 0,5 %Ash (%): < 0,2Moisture (%):< 0,5Microbiological criteria for glucose and fructose obtained from cocoa (Theobroma cacao L.) pulp:Total Plate Count (aerobic) (cfu/g): < 104Salmonella spp.: Absence in 25 g | |||
| Sunflower oil extract | Description/Definition:The sunflower extract is obtained by a concentration factor of 10 of the unsaponifiable fraction of refined sunflower oil extracted from the seeds of the sunflower, Helianthus Annuus L.Composition:Oleic acid (C18:1): 20 %Linoleic acid (C18:2): 70 %Unsaponifiable matter: 8,0 %Phytosterols: 5,5 %Tocopherols: 1,1 % | |||
| Synsepalum dulcificum dried fruits | Description/Definition:The novel food is lyophilised pulp and skin of pitted fruits of Synsepalum dulcificum (Schumach. & Thonn.) Daniell that belongs to the Sapotaceae family. The resulting dried cake is milled into a powder.Characteristics/Composition:Moisture (g/100 g): < 6Ash (g/100 g): 3,5-8,5Total carbohydrates (g/100 g): 70-87Sugars (g/100 g): 50-75Fibre (g/100 g): 1-6,5Total protein (g/100 g): 3,5-6,0Miraculinnote(g/100 g): 1,5-2,5Total fat (g/100 g): 0,50-3,50Microbiological criteria:Total aerobic colony count: < 104 CFUnote/gBacillus cereus (presumptive): < 100 CFU/gSulfite-reducing Clostridia: ≤ 30 CFU/gTotal Enterobacteriaceae: < 100 CFU/gYeasts and moulds: < 500 CFU/gPesticides:Pesticide levels in accordance with Code number 0820990 (‘others’ in the group of fruit spices) set out in Regulation (EC) No 396/2005note | |||
| Dried Tenebrio molitor larva (yellow mealworm) | Description/Definition:The novel food is the whole, thermally dried yellow mealworm, either whole (blanched, oven-dried larva) or in the form of a powder (blanched, oven-dried, ground larva). The term ‘mealworm’ refers to the larval form of Tenebrio molitor, an insect species that belongs to the family of Tenebrionidae (darkling beetles).The entire mealworms are meant for human consumption and no parts are removed.A minimum 24 hours fasting period is required before the thermal drying step, to allow the larvae to discard their bowel content.Characteristics/Composition:Ash (% w/w): 3,5 – 4,5Moisture (% w/w): 1-8Crude protein (N x 6,25) (% w/w): 56–61Digestible Carbohydrates (% w/w): 1–6Fat (% w/w): 25–30of which saturated (% w/w): 4–9Peroxide value (Meq O2/kg fat): ≤ 5Dietary fibre (% w/w): 4–7Chitin (% w/w): 4–7Heavy metals:Lead: ≤ 0,075 mg/kgCadmium: ≤ 0,1 mg/kgMycotoxins:Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 μg/kgAflatoxin B1: ≤ 2 μg/kgDeoxynivalenol: ≤ 200 μg/kgOchratoxin A: ≤ 1 μg/kgMicrobiological criteria:Total aerobic colony count: ≤ 105 CFU/gYeasts and moulds: ≤ 100 CFU/gEscherichia coli: ≤ 50 CFU/gSalmonella spp.: Not detected in 25 gListeria monocytogenes: Not detected in 25 gSulfite-reducing Anaerobes: ≤ 30 CFU/gBacillus cereus (presumptive): ≤ 100 CFU/gEnterobacteriaceae (presumptive): < 10 CFU/gCoagulase-positive staphylococci: ≤ 100 CFU/g | |||
| Frozen, dried and powder forms of yellow mealworm (Tenebrio molitor larva) | Description/Definition:The novel food are frozen, dried and powder forms of yellow mealworm (Tenebrio molitor larva). The term ‘mealworm’ refers to the larval form of Tenebrio molitor, an insect species that belongs to the family of Tenebrionidae (darkling beetles). Another identified scientific synonym is Tenebrio molitor Linnaeus.The entire mealworms are meant for human consumption, no parts are removed.A minimum 24 hours fasting period is required before killing the insects by freezing, to allow the larvae to discard their bowel content.The novel food is intended to be placed on the market in three different forms, namely: whole, blanched and frozen T. molitor larva (frozen); whole, blanched and freeze-dried T. molitor larva (dried) which may be in powder form (powder). | |||
| Parameters | Frozen | Dried or powder | ||
| Characteristics/Composition | ||||
| Ash | 0,9-1,10 | 3,6-4,1 | ||
| Moisture (% w/w) | 69-75 | ≤ 5 | ||
| Crude protein (N x 6,25) (% w/w) | 14-19 | 54-60 | ||
| Fat (% w/w)of which saturated fatty acids (% fat) | 7-12,520-29 | 27-3020-29 | ||
| Digestible carbohydrates (% w/w) | 1-2 | 4-8 | ||
| Dietary fibre (% w/w) | 1,2-3,5 | 4-6 | ||
| Chitin(*) (% w/w) | ≤ 3 | 4-9 | ||
| Peroxide value (Meq O2/kg fat) | ≤ 5 | ≤ 5 | ||
| Contaminants | ||||
| Heavy metals | ||||
| Lead (mg/kg) | ≤ 0,01 | ≤ 0,075 | ||
| Cadmium (mg/kg) | ≤ 0,05 | ≤ 0,1 | ||
| Mycotoxins | ||||
| Aflatoxins (Sum of B1, B2, G1, G2) (μg/kg) | ≤ 4 | ≤ 4 | ||
| Aflatoxin B1 (μg/kg) | ≤ 2 | ≤ 2 | ||
| Deoxynivalenol (μg/kg) | ≤ 200 | ≤ 200 | ||
| Ochratoxin A (μg/kg) | ≤ 1 | ≤ 1 | ||
| Dioxins and PCBs | ||||
| Sum of dioxins and dl-PCBs (UB, WHO-TEQ2005)(**) (pg/g fat) | ≤ 0,75 | ≤ 0,75 | ||
| Microbiological criteria | ||||
| Total aerobic colony count (CFU/g) | ≤ 105 | ≤ 105 | ||
| Enterobacteriaceae (presumptive) (CFU/g) | ≤ 100 | ≤ 100 | ||
| Escherichia coli (CFU/g) | ≤ 50 | ≤ 50 | ||
| Listeria monocytogenes | Absence in 25g | Absence in 25g | ||
| Salmonella spp. | Absence in 25g | Absence in 25g | ||
| Bacillus cereus (presumptive) (CFU/g) | ≤ 100 | ≤ 100 | ||
| Coagulase positive Staphylococci (CFU/g | ≤ 100 | ≤ 100 | ||
| Sulfite-reducing Anaerobes (CFU/g) | ≤ 30 | ≤ 30 | ||
| Yeasts and moulds (CFU/g) | ≤ 100 | ≤ 100 | ||
| (*)Chitin calculated as the difference between the Acid Detergent Fibre fraction and the Acid Detergent Lignin fraction (ADF-ADL), as described by Hahn et al. (2018).(**)Upper bound sum of polychlorinated dibenzo-para-dioxins (PCDDs)-polychlorinated dibenzofurans (PCDFs) and dioxin-like polychlorinated biphenyls (PCBs) expressed as World Health Organization toxic equivalent (using WHO-TEFs of 2005)).CFU: colony forming units. | ||||
| UV-treated powder of whole Tenebrio molitor larvae (yellow mealworm) | Description/Definition:The novel food is the ultra-violet (UVB) light treated powder obtained from whole, thermally treated and ground Tenebrio molitor larvae (yellow mealworm).The term ‘mealworm’ refers to the larval form of Tenebrio molitor, an insect species that belongs to the family of Tenebrionidae (darkling beetles). Another identified scientific synonym is Tenebrio molitor Linnaeus.A minimum 24 hours fasting period is required before the thermal drying step, to allow the larvae to discard their bowel content. | |||
| Characteristics/Composition:Crude protein (N x 6,25) (% w/w): 50,0 – 55,0Fat (% w/w): 30,0 – 37,0Total carbohydrates (% w/w): 6,0 – 7,5Crude fibre (% w/w): 3,0 – 4,5Chitin* (% w/w): 5,5-8,5Ash (% w/w): 3,0 – 4,0Moisture (% w/w): 1,4 – 3,5Peroxide value (meq O2/kg fat): ≤ 5,0Water activity (aw): < 0,6Vitamin D3 (μg/100 g): 35,0 – 79,0Manganese (mg/kg): ≤ 11,5Copper (mg/kg): ≤ 16,0Heavy metals:Lead (mg/kg): ≤ 0,02Cadmium (mg/kg): ≤ 0,1Mercury (mg/kg): ≤ 0,005Arsenic (mg/kg): ≤ 0,05Mycotoxins:Aflatoxin B1 (μg/kg): ≤ 2Aflatoxins (Sum of B1 + B2 + G1 + G2, μg/kg): ≤ 4Deoxynivalenol (μg/kg): ≤ 200Ochratoxin A (μg/kg): ≤ 1Dioxins and PCBs:PCDDs/F + PCB TEQ (pg/g fat): ≤ 0,75Microbiological criteria:Bacillus cereus: ≤ 100 CFU**/gClostridium perfringens: ≤ 10 CFU/gβ-Glucuronidase-positive Escherichia coli: ≤ 10 CFU/gAerobic mesophilic bacteria: ≤ 105 CFU/gListeria monocytogenes: Not detected in 25 gYeasts and moulds: ≤ 100 CFU/gEnterobacteriaceae: < 10 CFU/gCoagulase-positive staphylococci: ≤ 100 CFU/gSulfite-reducing anaerobes: < 10 CFU/gSalmonella spp.: Not detected in 25 g*Chitin calculated as the difference between the Acid Detergent Fibre fraction and the Acid Detergent Lignin fraction (ADF-ADL), as described by Hahn et al. (2018); PCDDs/F + PCB TEQ: Upper bound sum of polychlorinated dibenzo-para-dioxins (PCDDs)-polychlorinated dibenzofurans (PCDFs) and dioxin-like polychlorinated biphenyls (PCBs) expressed as World Health Organization Toxic Equivalent Factors (TEQ) (using WHO-TEFs of 2005).**CFU: Colony Forming Units. | ||||
| Tetrahydrocurcuminoids | Description:The tetrahydrocurcuminoids are produced via a series of steps involving the extraction of curcuminoids from the dried, pulverised rhizomes of turmeric (Curcuma longa L.), hydrogenation (using palladium on carbon (Pd/C) as a catalyst), concentration, crystallisation, drying, and milling into a powder.Characteristics/Composition:Total tetrahydrocurcuminoids (dry basis) (% w/w): > 95,0Moisture (% w/w): ≤ 1,0Ash (% w/w): ≤ 1,0Palladium (mg/kg): < 5,0Microbiological criteria:Total aerobic microbial count: ≤ 5000 CFU/gTotal yeast/moulds count: ≤ 100 CFU/gEscherichia coli: < 10 CFU/gStaphylococcus aureus: ≤ 10 CFU/gEnterobacteriaceae: ≤ 10 CFU/gSalmonella spp.: Absence in 25 gColiforms: ≤ 10 CFU/gCFU: Colony Forming Units | |||
| Dried Tetraselmis chuii microalgae | Description/Definition:The dried product is obtained from the marine microalgae Tetraselmis chuii, belonging to the Chlorodendraceae family, cultivated in sterile sea water in closed photobioreactors insulated from the outside air.Purity/Composition:Identified by means of nuclear marker rDNA 18 S (sequence analysed no less than 1600 base pairs) in the National Centre for Biotechnology information (NCBI) database: Not less than 99,9 %Humidity: ≤ 7,0 %Proteins: 35-40 %Ashes: 14-16 %Carbohydrates: 30-32 %Fibre: 2-3 %Fat: 5-8 %Saturated fatty acids: 29-31 % of total fatty acidsMonounsaturated fatty acids: 21-24 % of total fatty acidsPolyunsaturated fatty acids: 44-49 % of total fatty acidsIodine: ≤ 15 mg/kg | |||
| Therapon barcoo/Scortum | Description/Definition:Scortum/Therapon barcoo is a species of fish in the family Terapontidae. It is an endemic fresh water species from Australia. It is now reared in fish farms.Taxonomic Identification: Class: Actinopterygii > order: Perciformes > family: Terapontidae > genus: Therapon or Scortum barcooComposition of fish flesh:Protein (%): 18-25Moisture (%): 65-75Ash (%): 0,5-2,0Energy (KJ/Kg): 6000-11500Carbohydrates (%): 0,0Fat (%): 5-15Fatty acids (mg FA/g fillet):Σ PUFA n-3: 1,2-20,0Σ PUFA n-6: 0,3-2,0PUFA n-3/n-6: 1,5-15,0Total omega 3 acids: 1,6-40,0Total omega 6 acids: 2,6-10,0 | |||
| D-Tagatose | Description/Definition:Tagatose is produced by isomerization of galactose by means of chemical or enzymatic conversion, or by epimerization of fructose by means of enzymatic conversion. These are single-step conversions.Appearance: White or almost white crystalsChemical name: D-tagatoseSynonym: D-lyxo-HexuloseCAS number: 87-81-0Chemical formula: C6H12O6Formula weight: 180,16 (g/mol)Purity:Assay: ≥ 98 % on a dry weight basisLoss on drying: ≤ 0,5 % (102 °C, 2 hours)Specific Rotation: [α]D20: – 4 to – 5,6o (1 % aqueous solution)(1)Melting range: 133– 137 °CHeavy metals:Lead: ≤ 1,0 mg/kg(*)(*)Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5. ‘Instrumental methods’(1).(1)Food and nutrition paper 5 Rev 2 – Guide to specifications for general notices, general analytical techniques, identification tests, test solutions and other reference materials (JECFA) 1991, 307 p.; English – ISBN 92-5-102991-1 | |||
| Taxifolin-rich extract | Description:Taxifolin-rich extract from the wood of Dahurian Larch (Larix gmelinii (Rupr.) Rupr) is a white to pale-yellow powder that crystallizes from hot aqueous solutions.Definition:Chemical name: [(2R,3R)-2-(3,4 dihydroxyphenyl)-3,5,7-trihydroxy-2,3-dihydrochromen-4-one, also called (+) trans (2R,3R)- dihydroquercetin] and with no more than 2 % of the cis-formSpecifications:Physical parameterMoisture: ≤ 10 %Compound analysisTaxifolin (m/m): ≥ 90,0 % of the dry weightHeavy Metals, PesticideLead: ≤ 0,5 mg/kgArsenic: ≤ 0,02 mg/kgCadmium: ≤ 0,5 mg/kgMercury: ≤ 0,1 mg/kgDichlorodiphenyltrichloroethane (DDT): ≤ 0,05 mg/kgResidual solventsEthanol: < 5000 mg/kgMicrobiological criteriaTotal Plate Count (TPC): ≤ 104 CFU/gEnterobacteria: ≤ 100/gYeast and Mould: ≤ 100 CFU/gEscherichia coli: Absence/1 gSalmonella: Absence/10 gStaphylococcus aureus: Absence/1 gPseudomonas: Absence/1gUsual range of components of the Taxifolin-rich extract (as per dry substance) | |||
| Extract component | Content, usual observed range (%) | |||
| Taxifolin | 90 – 93 | |||
| Aromadendrin | 2,5 – 3,5 | |||
| Eriodictyol | 0,1 – 0,3 | |||
| Quercetin | 0,3 – 0,5 | |||
| Naringenin | 0,2 – 0,3 | |||
| Kaempferol | 0,01 – 0,1 | |||
| Pinocembrin | 0,05 – 0,12 | |||
| Unidentified flavonoids | 1 – 3 | |||
| Water(*) | 1,5 | |||
| (*)Taxifolin in its hydrated form and during the drying process is a crystal. This results on the inclusion of water of crystallisation in a quantity of 1,5 %. | ||||
| Trehalose | Description/Definition:A non-reducing disaccharide that consists of two glucose moieties linkes by an α-1,1-glucosidic bond. It is obtained from liquefied starch or from sucrose by a multistep enzymatic process. The commercial product is the dihydrate. Virtually odourless, white or almost white crystals with a sweet tasteSynonyms: α,α-trehaloseChemical name: α-D-glucopyranosyl-α-D-glucopyranoside, dihydrateCAS No.: 6138-23-4 (dihydrate)Chemical formula: C12H22O11 · 2H2O (dihydrate)Formula weight: 378,33 (dihydrate)Assay: ≥ 98 % on the dry basisDetermine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5 (1), ‘Instrumental methods’Method of assay:Principle: trehalose is identified by liquid chromatography and quantified by comparison to a reference standard containing standard trehalosePreparation of sample solution: weigh accurately about 3 g of dry sample into a 100 ml volumetric flask and add about 80 ml of purified, deionised water. Bring sample to complete dissolution and dilute to mark with purified deionised water. Filter through a 0,45 micron filterPreparation of standard solution: dissolve accurately weighed quantities of dry standard reference trehalose in water to obtain a solution having known concentration of about 30 mg of trehalose per ml.Apparatus: liquid chromatography equipped with a refractive index detector and integrating recorderConditions:Column: Shodex Ionpack KS-801 (Showa Denko Co.) or equivalentlength: 300 mmdiameter: 10 mmtemperature: 50 °CMobile phase: waterflow rate: 0,4 ml/minInjection volume: 8 μlProcedure: inject separately equal volumes of the sample solution and the standard solution into the chromatograph.Record the chromatograms and measure the size of response of the trehalose peakCalculate the quantity, in mg, of trehalose in 1 ml of the sample solution by the following formula: % trehalose = 100 × (RU/RS) (WS/WU)whereRSpeak area of trehalose in the standard preparationRUpeak area of trehalose in the sample preparationWSweight in mg of trehalose in the standard preparationWUweight of dry sample in mgCharacteristics:Identification:Solubility: Freely soluble in water, very slightly soluble in ethanolSpecific rotation: [α]D20 = +179o (5 % aqueous solution, dihydrate), +199o (5 % aqueous solution, anhydrous substance)Melting point: 97 °C (dihydrate)Purity:Loss on drying: ≤ 1,5 % (60 °C, 5h)Total ash: ≤ 0,05 %Heavy metals:Lead: ≤ 1,0 mg/kg | |||
| UV-treated mushrooms (Agaricus bisporus) | Description/DefinitionCommercially grown Agaricus bisporus to which UV light treatment is applied to harvested mushrooms.UV radiation: a process of radiation in ultraviolet light within the wavelength of 200-800 nm.Vitamin D2Chemical name: (3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraen-3-olSynonym: ErgocalciferolCAS No: 50-14-6Molecular weight: 396,65 g/molContentsVitamin D2 in the final product: 5-20 μg/100 g fresh weight at the expiration of shelf life. | |||
| UV-treated baker’s yeast (Saccharomyces cerevisiae) | Description/DefinitionBaker’s yeast (Saccharomyces cerevisiae) is treated with ultraviolet light to induce the conversion of ergosterol to vitamin D2 (ergocalciferol). Vitamin D2 content in the yeast concentrate varies between 800 000 – 3 500 000 IU vitamin D/100 g (200-875 μg/g).The yeast shall be inactivated for use in infant formula and follow-on formula, processed cereal-based food and foods for special medical purposes as defined by Regulation (EU) No 609/2013, while for use in other foods the yeast may or may not be inactivated.The yeast concentrate is blended with regular baker’s yeast in order not to exceed the maximum level in the pre-packed fresh or dry yeast for home baking.Tan-coloured, free-flowing granules.Vitamin D2Chemical name: (5Z,7E,22E)-(3S)-9,10-secoergosta-5,7,10(19),22-tetraen-3-olSynonym: ErgocalciferolCAS No.: 50-14-6Molecular weight: 396,65 g/molMicrobiological criteria for the yeast concentrateColiforms: ≤ 103/gEscherichia coli: ≤ 10/gSalmonella: Absence in 25 g | |||
| UV-treated bread | Description/Definition:UV-treated bread is yeast leavened bread and rolls (without toppings) to which a treatment with ultraviolet radiation is applied after baking in order to convert ergosterol to vitamin D2 (ergocalciferol).UV radiation: A process of radiation in ultraviolet light within the wavelength of 240-315 nm for maximum of 5 seconds with energy input of 10-50 mJ/cm2.Vitamin D2:Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-olSynonym: ErgocalciferolCAS No: 50-14-6Molecular weight: 396,65 g/molContents:Vitamin D2 (ergocalciferol) in the final product: 0,75-3 μg/100 g(1)Yeast in dough: 1-5 g/100 g (2)(1)EN 12821, 2009, European Standard.(2)Recipe calculation. | |||
| UV-treated milk | Description/Definition:UV-treated milk is cow’s milk (whole and semi-skimmed) to which a treatment with ultraviolet (UV) radiation via turbulent flow is applied after pasteurisation. The treatment of the pasteurised milk with UV radiation results in an increase in the vitamin D3 (cholecalciferol) concentrations by conversion of 7-dehydrocholesterol to vitamin D3.UV radiation: A process of radiation in ultraviolet light within the wavelength of 200-310 nm with energy input of 1045 J/l.Vitamin D3:Chemical name: (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-olSynonym: CholecalciferolCAS No: 67-97-0Molecular weight: 384,6377 g/molContents:Vitamin D3 in the final product:Whole milk(1)0,5-3,2 μg/100 g(2)Semi-skimmed milk(1): 0,1–1,5 μg/100 g(2)(1)As defined by Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671).(2)HPLC | |||
| Vitamin D2 mushroom powder | Description/DefinitionVitamin D2 mushroom powder is a granular powder made from homogenised Agaricus bisporus mushrooms that have been exposed to UV light.The mushrooms are washed, homogenised and suspended in water to produce a mushroom slurry. The mushroom slurry is passed under a UV lamp. The slurry is then filtered, dried and ground, producing vitamin D2 mushroom powder.UV radiation: A process of radiation in ultraviolet light within a range of wavelength similar to those UV-treated novel foods authorised under the novel food regulation.Characteristics/CompositionVitamin D2 content: 1 000–1 300 μg/g of mushroom powdernoteMoisture: ≤ 10,0 %Ash: ≤ 13,5 %Heavy MetalsLead (as Pb): ≤ 0,5 mg/kgCadmium: ≤ 0,5 mg/kgMercury: ≤ 0,1 mg/kgArsenic: ≤ 0,3 mg/kgMycotoxinsAflatoxins (sum of B1+B2+G1+G2): < 4 μg/kgMicrobiological criteria:Total plate count: ≤ 5000 CFUnote/gYeast and mould: ≤ 100 CFU/gSalmonella sp.: Absent in 25 gStaphylococcus aureus: ≤ 10 CFU/gEscherichia coli: ≤ 10 CFU/gColiforms: ≤ 10 CFU/gEnterobacteriaceae: ≤ 10 CFU/gListeria monocytogenes: Absent in 25 g | |||
| Vitamin D2 mushroom powder | Description/Definition:The novel food is mushroom powder produced from the dried whole Agaricus bisporus mushrooms. The process includes drying, milling and the controlled exposure of the mushroom powder to UV irradiation.UV radiation: A process of radiation in ultraviolet light within a range of wavelength similar to those UV-treated novel foods authorised under Regulation (EU) 2015/2283.Characteristics/composition:Vitamin D2 content: 137-595 μg/g of mushroom powderAsh: ≤ 13,5 %Water activity: < 0,5Moisture content: ≤ 7,5 %Total carbohydrates: ≤ 60 %Crude protein (N × 6,25): ≥ 22 %Fat: ≤ 4,5 %Heavy metals:Lead: ≤ 0,5 mg/kgCadmium: ≤ 0,5 mg/kgMercury: ≤ 0,1 mg/kgArsenic: ≤ 0,3 mg/kgMycotoxins:Aflatoxin B1: ≤ 0,10 μg/kgAflatoxins (sum of B1 + B2 + G1 + G2): < 4 μg/kgMicrobiological criteria:Total plate count: ≤ 5000 CFUTotal yeast and mould count: < 100 CFU/gE. coli: < 10 CFU/gSalmonella spp.: Absence in 25 gStaphylococcus aureus: ≤ 10 CFU/gColiforms: ≤ 10 CFU/gListeria spp.: Absence in 25 gEnterobacteriaceae: < 10 CFU/gCFU: colony forming units. | |||
| Vitamin D2 mushroom powder | Description/Definition:The novel food is produced by controlled exposure of sliced/diced Agaricus bisporus mushrooms to UV irradiation followed by dehydration and grinding into a powder.UV radiation: A process of radiation in ultraviolet light within a range of wavelength similar to those UV-treated novel foods authorised under Regulation (EU) 2015/2283.Characteristics/composition:Vitamin D2 content: 125–375 μg/gMoisture: ≤ 7 %Ash: ≤ 13,5 %Water activity: < 0,5Fat: ≤ 4,5 %Total carbohydrates: ≤ 60 %Protein: ≤ 40 %Heavy metals:Lead: ≤ 0,5 mg/kgCadmium: ≤ 0,5 mg/kgMercury: ≤ 0,1 mg/kgArsenic: ≤ 0,3 mg/kgMycotoxins:Aflatoxin B1: ≤ 2 μg/kgAflatoxins (sum of B1 + B2 + G1 + G2): < 4 μg/kgMicrobiological criteria:Total aerobic microbial count: ≤ 5000 CFU/gTotal yeast and mould count: < 100 CFU/gColiforms: < 100 MPN/gSalmonella spp.: Absence in 25 gStaphylococcus aureus: Absence in 10 gEscherichia coli: Absence in 10 gListeria monocytogenes: Absence in 25 gCFU: colony forming units. MPN: most probable number. | |||
| Vitamin D2 mushroom powder | Description/Definition:The novel food is produced by controlled exposure of Agaricus bisporus mushrooms powder to UV irradiation.UV radiation: A process of radiation in ultraviolet light within a range of wavelength similar to those UV-treated novel foods authorised under Regulation (EU) 2015/2283.Characteristics/composition:Vitamin D2 content: 245-460 μg/gMoisture: ≤ 10 %Ash: ≤ 12 %Water activity: < 0,5Fat: ≤ 4,5 %Total carbohydrates: ≤ 45 %Protein: ≤ 36 %Heavy metals:Lead: ≤ 0,5 mg/kgCadmium: ≤ 0,5 mg/kgMercury: ≤ 0,1 mg/kgArsenic: ≤ 0,3 mg/kgMycotoxins:Aflatoxin B1: ≤ 2 μg/kgAflatoxins (sum of B1 + B2 + G1 + G2): < 4 μg/kgMicrobiological criteria:Total aerobic microbial count: ≤ 5000 CFU/gTotal yeast and mould count: < 100 CFU/gSalmonella spp.: Not detected in 25 gStaphylococcus aureus: Not detected in 10 gColiforms: ≤ 10 CFU/gEscherichia coli: Not detected in 10 gListeria monocytogenes: Not detected in 25 gCFU: colony forming units | |||
| Vitamin K2 (menaquinone) | This novel food is produced by a synthetic or microbiological process.Vitamin K2 (2-methyl-3-all-trans-polyprenyl-1,4-naphthoquinones), or the menaquinone series, is a group of prenylated naphthoquinone derivatives. The number of isoprene residues, where 1 isoprene unit consists of 5 carbons comprising the side chain, is used to characterise the menaquinone homologues containing primarily MK-7 and to a smaller extent MK-6.Vitamin K2 (menaquinones) series with menaquinone-7 (MK-7)(n = 6) being C46H64O2, menaquinone-6 (MK-6)(n = 5) being C41H56O2 and menaquinone-4 (MK-4)(n = 3) being C31H40O2.Chemical Name: (all-E)-2-(3,7,11,15,19,23,27-Heptamethyl-2,6,10,14,18,22,26-octacosaheptaenyl)-3-methyl-1,4-naphtalenedioneCAS Number: 2124-57-4Molecular formula: C46H64O2Molecular weight: 649 g/mol2-methyl-1,4-naphthoquinone (menadione moiety)Specification of synthetic Vitamin K2 (menaquinone-7)Appearance: Yellow powderPurity: Max 6,0 % cis-isomer, max 2,0 % other impuritiesContent: 97-102 % Menaquinone-7 (including at least 92 % all-trans Menaquinone-7)Specifications of microbiologically produced Vitamin K2 (menaquinone-7)Source: Bacillus subtilis spp. natto and Bacillus licheniformisAppearance: Yellow powder or oil suspension | |||
| Wheat bran extract | Description/Definition:White crystalline powder obtained by enzymatic extraction from Triticum aestivum L. bran, rich in arabinoxylan oligosaccharidesDry matter: Min. 94 %Arabinoxylan oligosaccharides: Min 70 % of dry matterAverage degree of polymerisation of arabinoxylan oligosaccharides: 3-8Ferulic acid (bound to arabinoxylan oligosaccharides): 1-3 % of dry matterTotal poly/oligosaccharides: Min 90 %Protein: Max 2 % of dry matterAsh: Max 2 % of dry matterMicrobiological parameters:Mesophilic bacteria – total count: Max 10 000/gYeasts: Max 100/gFungi: Max 100/gSalmonella: Absence in 25gBacillus cereus: Max 1000/gClostridium perfringens: Max 1000/g | |||
| Wolffia arrhiza and/or Wolffia globosa fresh plants (Traditional food from a third country) | Description/Definition:The traditional food consists of fresh plants of Wolffia arrhiza (L.) Horkel ex Wimm. and/or of Wolffia globosa (Roxb.) Hartog & Plas (family: Araceae).Microbiological criteria:Total plate count: < 103 CFU/gTotal yeast and mould count: < 100 CFU/gTotal Enterobacteriaceae: < 100 CFU/gEscherichia coli: < 100 CFU/gSalmonella: Absence in 25 gListeria monocytogenes: Absence in 25 gStaphylococcus aureus: Absence/10 gHeavy metals:Lead: < 0,3 mg/kgArsenic (inorganic): < 0,10 mg/kgCadmium: < 0,2 mg/kgChromium: < 1 mg/kgMercury: < 0,10 mg/kgTrace elements:Copper: < 0,8 mg/kgMolybdenum: < 0,3 mg/kgZinc: < 5 mg/kgBoron: < 5 mg/kgManganese: < 6 mg/kgCyanotoxins:Microcystins: 0,006 μg/gPesticides:Pesticide levels in accordance with Code number 0254000 (‘Subgroup (d) watercresses’ in the group of Leaf vegetables, herbs and edible flowers) set out in Regulation (EC) No 396/2005note. | |||
| Xylo-oligosaccharides | Description:The novel food is a mixture of xylo-oligosaccharides (XOS) which are obtained from corncobs (Zea mays subsp. mays) via hydrolysis by a xylanase from Trichoderma reesei followed by a purification process.Characteristics/Composition: | |||
| Parameter | Powder form 1 | Powder form 2 | Syrup form | |
| Moisture (%) | ≤ 5,0 | ≤ 5,0 | - | |
| Dry material (%) | - | - | 70-75 | |
| Protein (g/100 g) | < 0,2 | |||
| Ash (%) | ≤ 0,3 | |||
| pH | 3,5-5,0 | |||
| Total carbohydrate content (g/100 g) | ≥ 97 | ≥ 95 | ≥ 70 | |
| XOS content (dry basis) (g/100 g) | ≥ 95 | ≥ 70 | ≥ 70 | |
| Other carbohydrates (g/100 g)a | 2,5-7,5 | 2-16 | 1,5-31,5 | |
| Monosaccharides total (g/100 g) | 0-4,5 | 0-13 | 0-29 | |
| Glucose (g/100 g) | 0-2 | 0-5 | 0-4 | |
| Arabinose (g/100 g) | 0-1,5 | 0-3 | 0-10 | |
| Xylose (g/100 g) | 0-1,0 | 0-5 | 0-15 | |
| Disaccharides total (g/100 g) | 27,5-48 | 25-43 | 26,5-42,5 | |
| Xylobiose (XOS DP2) (g/100 g) | 25-45 | 23-40 | 25-40 | |
| Cellobiose (g/100 g) | 2,5-3 | 2-3 | 1,5-2,5 | |
| Oligosaccharides total (g/100 g) | 41-77 | 36-72 | 32-71 | |
| xylotriose (XOS DP3) (g/100 g) | 27-35 | 18-30 | 18-30 | |
| xylotetraose (XOS DP4) (g/100 g) | 10-20 | 10-20 | 8-20 | |
| xylopentaose (XOS DP5) (g/100 g) | 3-10 | 5-10 | 3-10 | |
| xylohexaose (XOS DP6) (g/100 g) | 1-5 | 1-5 | 1-5 | |
| Xyloheptaose (XOS DP7) (g/100 g) | 0-7 | 2-7 | 2-6 | |
| Maltodextrin (g/100 g)b | 0 | 20-25 | 0 | |
| Copper (mg/kg) | < 5,0 | |||
| Lead (mg/kg) | < 0,5 | |||
| Arsenic (mg/kg) | < 0,3 | |||
| Salmonella (CFUc/25 g) | Negative | |||
| E. coli (MPNd/100 g) | Negative | |||
| Yeast (CFU/g) | < 10 | |||
| Mould (CFU/g) | < 10 | |||
| aOther carbohydrates include monosaccharides (glucose, xylose and arabinose) and cellobiose.bMaltodextrin content is calculated according to the amount added in the process.DP:Degree of polymerizationcCFU: Colony Forming UnitsdMPN: Most Probable Number | ||||
| Yarrowia lipolytica yeast biomass | Description/Definition:The novel food is the dried and heat-killed biomass of the yeast Yarrowia lipolytica.Characteristics/Composition:Protein: 45-55 g/100 gDietary fibre: 24-30 g/100 gSugars: < 1 g/100 gFat: 7-10 g/100 gTotal ash: ≤ 12 %Water content: ≤ 5 %Dry matter content: ≥ 95 %Microbiological criteria:Total Aerobic Microbial Count: ≤ 5 × 103 CFU/gTotal Yeast and Mould Count: ≤ 102 CFU/gViable Yarrowia lipolytica cells(a): < 10 CFU/g (i.e. limit of detection)Coliforms: ≤ 10 CFU/gSalmonella spp.: Not detected in 25 gContaminants:Lead: ≤ 0,1 mg/kgMercury: ≤ 0,1 mg/kgCadmium: ≤ 0,1 mg/kgArsenic: ≤ 0,15 mg/kgAbbreviations: CFU, colony forming units(a)To be tested immediately after the heat-treatment step. Measures have to be in place to prevent cross-contamination with viable Y. lipolytica cells during packaging and/or storage of the novel food | |||
| Yeast beta-glucans | Description/Definition:Beta-glucans are complex, high molecular mass (100–200 kDa) polysaccharides, found in the cell wall of many yeasts and cereals.The chemical name for ‘yeast beta-glucans’ is (1-3),(1-6)-ß-D-glucans.Beta-glucans consist of a backbone of ß-1-3-linked glucose residues that are branched by ß-1-6-linkages, to which chitin and mannoproteins are linked by ß-1-4-bonds.Beta-glucans are isolated from yeast Saccharomyces cerevisiae.The tertiary structure of the glucan cell wall of Saccharomyces cerevisiae consists of chains of ß-1,3-linked glucose residues, branched by ß-1,6-linkages, forming a backbone to which are linked chitin via ß-1,4- bonds, ß-1,6-glucans and some mannoproteins.This novel food is available in three different forms: soluble, insoluble and insoluble in water, but dispersible in many liquid matrices.Chemical characteristics yeast (Saccharomyces cerevisiae) beta-glucans:Soluble form:Total carbohydrates: > 75 %Beta-glucans (1,3/1,6): > 75 %Ash: < 4,0 %Moisture: < 8,0 %Protein: < 3,5 %Fat: < 10 %Insoluble form:Total carbohydrates: > 70 %Beta-glucans (1,3/1,6): > 70 %Ash: ≤ 12 %Moisture: < 8,0 %Protein: < 10 %Fat: < 20 %Insoluble in water, but dispersible in many liquid matrices:(1,3)-(1,6)-ß-D-Glucans: > 80 %Ash: < 2,0 %Moisture: < 6,0 %Protein: < 4,0 %Total fat: < 3,0 %Microbiological data for insoluble in water, but dispersible in many liquid matrices:Total plate count: < 1000 CFU/gEnterobacteriaceae: < 100 CFU/gTotal coliforms: < 10 CFU/gYeast: < 25 CFU/gMould: < 25 CFU/gSalmonella: Absence in 25 gEscherichia coli: Absence in 1 gBacillus cereus: < 100 CFU/gStaphylococcus aureus: Absence in 1 gHeavy metals for insoluble in water, but dispersible in many liquid matrices:Lead: < 0,2 mg/kgArsenic: < 0,2 mg/kgMercury: < 0,1 mg/kgCadmium: < 0,1 mg/kg | |||
| Zeaxanthin | Description/Definition:Zeaxanthin is a naturally occurring xanthophyll pigment, it is an oxygenated carotenoid.The synthetic zeaxanthin is presented either as a spray-dried powder of gelatin or starch base (‘beadlets’) with added α-tocopherol and ascorbyl palmitate or as a corn oil suspension with added α-tocopherol. Synthetic zeaxanthin is produced by a multi-step chemical synthesis from smaller molecules.Orange-red crystalline powder with little or no odour.Chemical formula: C40H56O2CAS No: 144-68-3Molecular weight: 568,9 daltonsPhysical-chemical properties:Loss on drying: < 0,2 %All-trans zeaxanthin: > 96 %Cis-zeaxanthin: < 2,0 %Other carotenoids: < 1,5 %Triphenylphosphine oxid (CAS No 791-28-6): < 50 mg/kg | |||
| Zinc L-pidolate | Description/Definition:Zinc L-pidolate is a white to off-white powder, with characteristic odour.International non-proprietary name (INN): L-pyroglutamic acid, Zinc saltSynonyms: Zinc 5-oxoproline, Zinc pyroglutamate, Zinc pyrrolidone carboxylate, Zinc PCA, L-Zinc pidolateCAS No.: 15454-75-8Molecular formula: (C5 H6 NO3)2 ZnRelative anhydrous molecular mass: 321,4Appearance: White to slightly white powderPurity:Zinc L-pidolate (purity): ≥ 98 %pH (10 % aqueous sol.): 5,0-6,0Specific rotation: 19,6o- 22,8oWater: ≤ 10,0 %Glutamic acid: < 2,0 %Heavy metals:Lead: ≤ 3,0 ppmArsenic: ≤ 2,0 ppmCadmium: ≤ 1,0 ppmMercury: ≤ 0,1 ppmMicrobiological criteria:Total viable mesophilic count: ≤ 1000 CFU/gYeasts and moulds: ≤ 100 CFU/gPathogen: Absence |
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