Commission Implementing Regulation (EU) 2025/1549

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001^note, and in particular Articles 8 and 12 thereof,Whereas:

(1)Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission was to establish, by 1 January 2018, the Union list of novel foods authorised or notified under Regulation (EC) No 258/97 of the European Parliament and of the Council^note.

(2)The Union list of novel foods authorised or notified under Regulation (EC) No 258/97 was established by Commission Implementing Regulation (EU) 2017/2470^note.

(3)The Commission has identified errors in the Annex to Implementing Regulation (EU) 2017/2470. Corrections are needed in order to provide clarity and legal certainty to food business operators and to the Member States’ competent authorities, thus ensuring the proper implementation and use of the Union list of novel foods.

(4)Pursuant to Article 4(2) of Regulation (EC) No 258/97, the competent authority of the United Kingdom authorised in 2012 Schizochytrium sp. oil rich in DHA and EPA to be placed on the market as a novel food for use in a number of foods, including food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council^note intended for ‘normal population’ at levels of 250 mg/day, and in food supplements intended for pregnant and lactating women at 450 mg/day. The normal population is to be understood as the general population. However, the application included an intake assessment concerning the general population, excluding children below 18 months of age.

(5)In 2015, Commission Implementing Decision (EU) 2015/546^note authorised a change to the conditions of use of Schizochytrium sp. oil rich in DHA and EPA, increasing the maximum levels of DHA and EPA in food supplements for the adult population, with the exception of pregnant and lactating women, to 3000 mg/day.

(6)When the initial Union list of novel foods was established by Implementing Regulation (EU) 2017/2470, the use of this novel food in food supplements for children from 18 months to 18 years of age at levels of 250 mg/day was erroneously omitted. In addition, when the conditions of use of Schizochytrium sp. oil rich in DHA and EPA were amended by Commission Implementing Regulation (EU) 2022/1365^note, this amendment did not include the use of this novel food in food supplements for children from 18 months to 18 years of age at levels of 250 mg/day. It is therefore necessary to correct Implementing Regulation (EU) 2022/1365 to include the use of the novel food Schizochytrium sp. oil rich in DHA and EPA in food supplements for children from 18 months to 18 years of age at levels of 250 mg/day.

(7)The conditions of use of 3-Fucosyllactose (3-FL) produced by a derivative strain of Escherichia coli K-12 DH1 authorised as a novel food by Commission Implementing Regulation (EU) 2023/2210^note erroneously did not include foods for special medical purposes intended for infants and young children, as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council^note, that had been requested by the applicant and assessed by the European Food Safety Authority (‘the Authority’) in its opinion^note on this novel food. In that opinion the Authority concluded that the maximum use levels of 3-FL in food for special medical purposes intended for infants and young children should not be higher than the maximum levels specified for the proposed uses in the corresponding food categories for this group of the population which would be the 1,75 g/L maximum levels authorised in infant formula and follow on formula. It is therefore appropriate that this use is added in the conditions of use of this novel food, and Implementing Regulation (EU) 2023/2210 is corrected accordingly.

(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1 #

Implementing Regulation (EU) 2022/1365 is corrected in accordance with Annex I to this Regulation.

Article 2 #

Implementing Regulation (EU) 2023/2210 is corrected in accordance with Annex II to this Regulation.

Article 3 #

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Annex I · Correction to implementing regulation (eu) 2022/1365

In Annex to Implementing Regulation (EU) 2022/1365, the table is replaced by the following:

Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements | Data ProtectionSchizochytrium 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/dayFood supplements as defined in Directive 2002/46/EC for pregnant and lactating women | 450 mg/dayFood supplements as defined in Directive 2002/46/EC for children from 18 months to 18 years of age | 250 mg/dayFoods 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 intendedTotal diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 250 mg/mealMilk based drinks and similar products intended for young children | 200 mg/100 gProcessed cereal based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013Foods intended to meet the expenditure of intense muscular effort, especially for sportsmenFoods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014Bakery products (breads, rolls and sweet biscuits)Breakfast cereals | 500 mg/100 gCooking fats | 360 mg/100 gDairy 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 gCereal/nutrition bars | 500 mg/100 gSpreadable fats and dressings | 600 mg/100 gFish analogues | 300 mg/100 gMeat analogues | 300 mg/100 g

Annex II · Correction to implementing regulation (eu) 2023/2210

In point 1 of the Annex to Implementing Regulation (EU) 2023/2210, the table is replaced by the following:

Authorised novel foodConditions under which the novel food may be usedAdditional specific labelling requirementsOther requirementsData Protection‘3-Fucosyllactose (‘3-FL’) (produced by derivative strain of E. coli K-12 DH1)Specified food categoryMaximum 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 609/20131,75 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturerFollow-on formula as defined under Regulation (EU) No 609/20131,75 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturerUnflavoured pasteurised and unflavoured sterilised (including UHT) milk products2,0 g/LUnflavoured fermented milk-based products2,0 g/L (beverages)4,0 g/kg (products other than beverages)Flavoured fermented milk-based products including heat-treated products2,0 g/L (beverages)12,0 g/kg (products other than beverages)Cereal bars25,0 g/kgMilk based drinks and similar products2,0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer12,0 g/kg (products other than beverages)Beverages (flavoured drinks, excluding drinks with a pH less than 5)1,25 g/LTotal diet replacement foods for weight control as defined under Regulation (EU) No 609/20132,0 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 609/2013In 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 childrenIn 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 children4,0 g/day

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Annex I · Correction to implementing regulation (eu) 2022/1365

Annex II · Correction to implementing regulation (eu) 2023/2210

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