Article 1
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Commission Implementing Regulation (EU) 2025/1537 of 29 July 2025 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)
Commission Implementing Regulation (EU) 2025/1537 of 29 July 2025 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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 .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX 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 food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data Protection ‘ 3-Fucosyllactose (“3-FL”) (produced by a derivative strain of E. coli BL21 (DE3)) Specified food category Maximum levels 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 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 609/2013 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 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 1,20 g/l or 1,20 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer Milk based drinks and similar products intended for young children 1,20 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 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 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 children In accordance with the particular nutritional requirements of the persons for whom the products are intended Food Supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children 4 g/day
Other acts of the same type
Commission Implementing Regulation (EU) 2015/2305 of 10 December 2015 concerning the authorisation of a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets, and amending Regulations (EC) No 2148/2004 and (EC) No 1520/2007 (holder of authorisation Huvepharma NV) (Text with EEA relevance)Commission Implementing Regulation (EU) 2015/2306 of 10 December 2015 concerning the authorisation of L-cysteine hydrochloride monohydrate as a feed additive for cats and dogs (Text with EEA relevance)Commission Implementing Regulation (EU) 2015/2307 of 10 December 2015 concerning the authorisation of menadione sodium bisulphite and menadione nicotinamide bisulphite as feed additives for all animal species (Text with EEA relevance)Commission Implementing Regulation (EU) 2015/2322 of 10 December 2015 amending Regulation (EC) No 474/2006 establishing the Community list of air carriers which are subject to an operating ban within the Community (Text with EEA relevance)Commission Regulation (EU) 2015/2294 of 9 December 2015 amending Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the establishment of a new functional group of feed additives (Text with EEA relevance)Commission Implementing Regulation (EU) 2015/2295 of 9 December 2015 amending Regulation (EC) No 2074/2005 as regards lists of approved food establishments (Text with EEA relevance)Commission Regulation (EU) 2015/2285 of 8 December 2015 amending Annex II to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption as regards certain requirements for live bivalve molluscs, echinoderms, tunicates and marine gastropods and Annex I to Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (Text with EEA relevance)Commission Implementing Regulation (EU) 2015/2286 of 8 December 2015 Approving non-minor amendments to the specification for a name entered in the register of traditional specialities guaranteed [Belokranjska pogača (TSG)]Commission Implementing Regulation (EU) 2015/2315 of 8 December 2015 concerning the classification of certain goods in the Combined NomenclatureCommission Implementing Regulation (EU) 2015/2316 of 8 December 2015 concerning the classification of certain goods in the Combined NomenclatureCommission Implementing Regulation (EU) 2015/2317 of 8 December 2015 concerning the classification of certain goods in the Combined NomenclatureCommission Implementing Regulation (EU) 2015/2318 of 8 December 2015 concerning the classification of certain goods in the Combined Nomenclature
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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