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