Commission Implementing Regulation (EU) 2025/1549 of 30 July 2025 correcting Implementing Regulations (EU) 2023/2210 and (EU) 2022/1365 as regards the conditions of use of the novel foods 3-Fucosyllactose produced by a derivative strain of Escherichia coli K-12 DH1 and Schizochytrium sp. oil rich in DHA and EPA

Official Journal EN of the European Union L series 2025/1549 31.7.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1549 of 30 July 2025 correcting Implementing Regulations (EU) 2023/2210 and (EU) 2022/1365 as regards the conditions of use of the novel foods 3-Fucosyllactose produced by a derivative strain of Escherichia coliK-12 DH1 and Schizochytriumsp. oil rich in DHA and EPA (Text with EEA relevance) 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(1), 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(2).

(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(3).

(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 Schizochytriumsp. 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(4)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.

(1) OJ L 327, 11.12.2015, p. 1, ELI: http://data.europa.eu/eli/reg/2015/2283/oj.

(2) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, (OJ L 43, 14.2.1997, p. 1, ELI: http://data.europa.eu/eli/reg/1997/258/oj).

(3) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, (OJ L 351, 30.12.2017, p. 72, ELI:

http://data.europa.eu/eli/reg_impl/2017/2470/oj).

(4) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51, ELI: http://data.europa.eu/eli/dir/2002/46/oj).

ELI: http://data.europa.eu/eli/reg_impl/2025/1549/oj 1/8EN OJ L, 31.7.2025

(5) In 2015, Commission Implementing Decision (EU) 2015/546(5) authorised a change to the conditions of use of Schizochytriumsp. 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 3 000 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(6), 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 Schizochytriumsp. 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(7) 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(8), that had been requested by the applicant and assessed by the European Food Safety Authority (‘the Authority’) in its opinion(9)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.

(5) Commission Implementing Decision (EU) 2015/546 of 31 March 2015 authorising an extension of use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 90, 2.4.2015, p. 11, ELI: http://data.europa.eu/eli/dec_impl/2015/546/oj).

(6) Commission Implementing Regulation (EU) 2022/1365 of 4 August 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA (OJ L 205, 5.8.2022, p. 230, ELI: http:// data.europa.eu/eli/reg_impl/2022/1365/oj).

(7) Commission Implementing Regulation (EU) 2023/2210 of 20 October 2023 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli K-12 DH1 as a novel food and amending Implementing Regulation

(EU) 2017/2470 (OJ L, 2023/2210, 23.10.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2210/oj).

(8) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35, ELI: http:// data.europa.eu/eli/reg/2013/609/oj).

(9) Safety of 3-fucosyllactose (3-FL) produced by a derivative strain of Escherichia coli K-12 DH1 as a novel food pursuant to Regulation

(EU) 2015/2283. EFSA Journal, 2023;21(6):8026.

2/8 ELI: http://data.europa.eu/eli/reg_impl/2025/1549/ojEN OJ L, 31.7.2025 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 30 July 2025.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2025/1549/oj 3/8ANNEX I CORRECTION TO IMPLEMENTING REGULATION (EU) 2022/1365 In Annex to Implementing Regulation (EU) 2022/1365, the table is replaced by the following:

Additional specific labelling Other Authorised novel food Conditions under which the novel food may be used Data Protection requirements requirements ‘Schizochytriumsp. oil Specified food category Maximum levels of DHA The designation of the novel food rich in DHA and EPA and EPA combined on the labelling of the foodstuffs containing it shall be “DHA and EPA-rich oil from the microalgae Schizochytriumsp.” Food supplements as defined 3 000 mg/day in Directive 2002/46/EC for the adult population excluding pregnant and lactating women Food supplements as defined 450 mg/day in Directive 2002/46/EC for pregnant and lactating women Food supplements as defined 250 mg/day in Directive 2002/46/EC for children from 18 months to 18 years of age Foods for special medical In accordance with the purposes as defined in particular nutritional Regulation (EU) No 609/2013 requirements of the persons for whom the products are intended Total diet replacement for 250 mg/meal weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control 4/8

ELI:

http://data.europa.eu/eli/reg_impl/2025/1549/oj EN OJ L,

31.7.2025Additional specific labelling Other Authorised novel food Conditions under which the novel food may be used Data Protection requirements requirements Milk based drinks and similar 200 mg/100 g products intended for young children 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 828/2014(1) 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- 600 mg/100 g for based drinks cheese; 200 mg/100 g for milk products (including milk, fromage frais and yoghurt products; excluding drinks)

ELI:

http://data.europa.eu/eli/reg_impl/2025/1549/oj 5/8 OJ L,

31.7.2025 ENAdditional specific labelling Other Authorised novel food Conditions under which the novel food may be used Data Protection requirements requirements Non-alcoholic beverages 80 mg/100 g (including dairy analogue and milk-based drinks) 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

(1) Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228,

31.7.2014, p. 5, ELI: http://data.europa.eu/eli/reg_impl/2014/828/oj).’ 6/8

ELI:

http://data.europa.eu/eli/reg_impl/2025/1549/oj EN OJ L,

31.7.2025ANNEX 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:

Additional specific labelling Other Authorised novel food Conditions under which the novel food may be used Data Protection requirements requirements ‘3-Fucosyllactose Specified food category Maximum levels (expressed as The designation of the novel food Authorised on 12 November 2023. This (‘3-FL’) (produced by 3-Fucosyllactose) on the labelling of the foodstuffs inclusion is based on proprietary derivative strain of E. containing it shall be scientific evidence and scientific data coliK-12 DH1) Infant formula as 1,75 g/L in the final product “3-Fucosyllactose”. protected in accordance with Article 26 defined under ready for use, marketed as such of Regulation (EU) 2015/2283.

The labelling of food supplements Regulation (EU) or reconstituted as instructed by containing 3-Fucosyllactose (3-FL) Applicant: “Glycom A/S”, Kogle Allé 4, No 609/2013 the manufacturer shall bear a statement that 2970 Hørsholm, Denmark. During the Follow-on formula as 1,75 g/L in the final product period of data protection, the novel food

(a) they should not be consumed by defined under ready for use, marketed as such 3-Fucosyllactose produced by derivative children under 3 years of age;

Regulation (EU) or reconstituted as instructed by strain of E. coliK-12 DH1 is authorised No 609/2013 the manufacturer (b) they should not be used if other for placing on the market within the foods containing added Union only by Glycom A/S unless a Unflavoured 2,0 g/L 3-Fucosyllactose are consumed subsequent applicant obtains pasteurised and on the same day. authorisation for the novel food without unflavoured sterilised reference to the proprietary scientific (including UHT) milk evidence or scientific data protected in products accordance with Article 26 of Regulation

(EU) 2015/2283 or with the agreement Unflavoured 2,0 g/L (beverages) of “Glycom A/S”. fermented milk-based products 4,0 g/kg (products other than End date of the data protection: beverages) 12 November 2028.’ Flavoured fermented 2,0 g/L (beverages) milk-based products including heat-treated 12,0 g/kg (products other than products beverages) Cereal bars 25,0 g/kg Milk based drinks and 2,0 g/L in the final product similar products ready for use, marketed as such or reconstituted as instructed by the manufacturer 12,0 g/kg (products other than beverages)

ELI:

http://data.europa.eu/eli/reg_impl/2025/1549/oj 7/8 OJ L,

31.7.2025 ENAdditional specific labelling Other Authorised novel food Conditions under which the novel food may be used Data Protection requirements requirements Beverages (flavoured 1,25 g/L drinks, excluding drinks with a pH less than 5) Total diet replacement 2,0 g/L (beverages) foods for weight 25,0 g/kg (products other than control as defined beverages) under Regulation (EU) No 609/2013 Foods for special In accordance with the medical purposes for particular nutritional infants and young requirements of the persons for children as defined whom the products are intended under Regulation (EU) but, in any case, not higher No 609/2013 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 In accordance with the medical purposes as particular nutritional defined under requirements of the persons for Regulation (EU) whom the products are intended No 609/2013 but, in any case, not higher excluding foods for 4,0 g/L or 4,0 g/kg in the final infants and young product ready for use, marketed children as such or reconstituted as instructed by the manufacturer.

Food Supplements as 4,0 g/day defined in Directive 2002/46/EC, for the general population, excluding infants and young children 8/8

ELI:

http://data.europa.eu/eli/reg_impl/2025/1549/oj EN OJ L,

31.7.2025