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

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 .

CORRECTION TO IMPLEMENTING REGULATION (EU) 2022/1365

ANNEX ISupplementary provisions

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 Protection ‘ 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 3 000  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 828/2014  ( 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-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 ( 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 ).’

CORRECTION TO IMPLEMENTING REGULATION (EU) 2023/2210

ANNEX IISupplementary provisions

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 food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data Protection ‘ 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