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)

• CELEX: Implementing Regulation (EU) 2025/1537
• Articles: 3

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 .

Schedules & Appendices

ANNEX

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