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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 1852/2001note, and in particular Article 12(1) thereof,Whereas:
(1)Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.
(2)Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470note has established a Union list of novel foods.
(3)On 14 December 2020, the company Luxidum GmbH (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place vitamin D2 mushroom powder on the Union market as a novel food. The applicant requested for the novel food to be used in a number of foods intended for the general population. The applicant also requested the novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Councilnote excluding food supplements for infants, and in foods for special medical purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Councilnote, excluding foods for special medical purposes intended for infants. Subsequently, on 5 July 2024, the applicant modified the initial request in the application on the use of vitamin D2 mushroom powder in food supplements to exclude young children.
(4)On 14 December 2020, the applicant also made a request to the Commission for the protection of the following proprietary data: the production processnote and the stability tests, including the respective certificate of analysisnote.
(5)On 28 May 2021, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of vitamin D2 mushroom powder as a novel food.
(6)On 30 April 2024, the Authority adopted its scientific opinion on the ‘Safety of vitamin D2 mushroom powder as a Novel food pursuant to Regulation (EU) 2015/2283 (NF 2020/2226)’note in accordance with Article 11 of Regulation (EU) 2015/2283.
(7)In its scientific opinion, the Authority concluded that the novel food, vitamin D2 mushroom powder, is safe under the proposed conditions of use.
(8)In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the data concerning the production process and the stability tests, including the respective certificate analysis, without which it could not have assessed the novel food and reached its conclusion.
(9)The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those data and studies and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2)(b) of Regulation (EU) 2015/2283.
(10)The applicant declared that it held proprietary and exclusive rights of reference to the data on the production process and the stability tests, including the respective certificate analysis, at the time it submitted the application, and that third parties cannot lawfully access, use or refer to those data.
(11)The Commission assessed all the information provided by the applicant and considered that it has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, data on the production process and the stability tests, including the respective certificate analysis, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place vitamin D2 mushroom powder on the market within the Union during a period of five years from the entry into force of this Regulation.
(12)However, restricting the authorisation of vitamin D2 mushroom powder and the reference to the data contained in the applicant’s file for their sole use does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.
(13)A labelling requirement should be provided in order to properly inform the consumers that infants and young children should not consume food supplements containing vitamin D2 mushroom powder.
(14)It is appropriate that the inclusion of vitamin D2 mushroom powder as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283.
(15)Vitamin D2 mushroom powder should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(16)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#
1.Vitamin D2 mushroom powder is authorised to be placed on the market within the Union.Vitamin D2 mushroom powder shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.
2.The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 2#
Only the company Luxidum GmbHnote is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 30 April 2025, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Luxidum GmbH.
Article 3#
The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of Luxidum GmbH.
Article 4#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
(1)in Table 1 (Authorised novel foods), the following entry is inserted:Authorised novel foodConditions under which the novel food may be usedAdditional specific labelling requirementsOther requirementsData protection‘Vitamin D2 mushroom powderSpecified food categoryMaximum 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 cereals2,4Yeast-leavened breads and pastries2,4Pasta based products and similar products2,4Fruit beverages (except products defined in Part I of Annex I to Directive 2001/112/EC) and vegetable beverages1,2Concentrated or dehydrated fruit beverages (except products defined in Part I of Annex I to Directive 2001/112/EC) and concentrated or dehydrated vegetable beverages8,4Yoghurt drinks and other fermented milk-based drinks, flavoured milks1,2Milk concentrate2,4Milk powder, whey powder24Cream powder98,4Whey2,4Dairy dessert and similar products2,4Cheese2,4Meal replacements for weight control2,4Meat and dairy analogues2,4Soups2,4Dried soups21,6Extruded snacks, potato crisps, sticks2,4Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infantsIn accordance with the particular nutritional requirements of the persons for whom the products are intended but not higher than 15 μg/dayFood supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children15 μg/day
(2)in Table 2 (Specifications), the following entry is inserted:Authorised Novel Food | SpecificationsVitamin 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
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
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