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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 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)Commission Implementing Regulation (EU) 2023/52note authorised the placing on the market of ‘3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)’ for use in infant formula, follow-on formula, 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 of the European Parliament and of the Councilnote, milk based drinks and similar products intended for young children, foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013, foods for special medical purposes as defined under Regulation (EU) No 609/2013, excluding foods for infants and young children, and food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Councilnote, for the general population, excluding infants and young children.
(4)On 25 April 2024, the company Chr. Hansen A/S (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the conditions of use of the novel food ‘3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)’. The applicant requested to increase the maximum authorised use levels of ‘3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)’ in infant formula, follow-on formula and foods for special medical purposes for infants and young children as defined in Regulation (EU) No 609/2013, from the current levels of 0,9 g/L, 0,9 g/L and 1,2 g/L respectively to 1,75 g/L for all three food categories. The applicant also requested to increase the maximum authorised use level of ‘3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)’ in food supplements as defined in Directive 2002/46/EC intended for the general population, excluding infants and young children, from the currently authorised level of 3,0 g/day to 4,0 g/day.
(5)In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 24 June 2024, requesting it to provide a scientific opinion on the changes of the conditions of use of ‘3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)’ as a novel food.
(6)On 24 March 2025, the Authority adopted its scientific opinion on the ‘safety of the extension of use of 3-fucosyllactose (3-FL) as a novel food pursuant to Regulation (EU) 2015/2283’note in accordance with Article 11 of Regulation (EU) 2015/2283.
(7)In its scientific opinion, the Authority concluded that the proposed change is safe under the proposed conditions of use, and therefore it is appropriate to amend the conditions of use of ‘3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)’.
(8)The information provided by the applicant and the Authority’s opinion give sufficient grounds to establish that the changes to the conditions of use of ‘3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)’ are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.
(9)The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(10)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#
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 2#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘3-Fucosyllactose (‘3-FL’) (produced by a derivative strain of E. coli BL21(DE3)’ 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 a derivative strain of E. coli BL21 (DE3))Specified food categoryMaximum levelsThe 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 609/20131,75 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 manufacturerProcessed cereal-based foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No 609/20131,20 g/l or 1,20 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturerMilk based drinks and similar products intended for young children1,20 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturerFoods 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 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 childrenIn accordance with the particular nutritional requirements of the persons for whom the products are intendedFood Supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children4 g/day
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