Commission Implementing Regulation (EU) 2021/50 of 22 January 2021 authorising an extension of use and a change in the specifications of the novel food ‘2′-fucosyllactose/difucosyllactose mixture’ and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)
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 ↗
1. The entry in the Union list of authorised novel foods, as provided for in Article 6 of Regulation (EU) 2015/2283 referring to microbial source ‘2′-Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’)’ shall be amended as specified in the Annex to this Regulation. 2. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (1) in Table 1 (Authorised novel foods), the conditions under which the novel food ‘2′-Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’) (microbial source)’ may be used are added: Conditions under which the novel food may be used ‘ Specified food category Maximum levels Milk-based drinks and similar products intended for young children 1,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer’ (2) in Table 2 (Specifications), the entry for 2′- Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’) (microbial source) is replaced by the following: Authorised Novel Food Specification ‘ 2′-Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’) (microbial source) Description/Definition: 2′-Fucosyllactose/Difucosyllactose mixture is a purified, white to off-white powder or agglomerates thereof that is produced by a microbial process. Source : Genetically modified Escherichia coli strain K-12 DH1 Characteristics/Composition: Appearance: White to off white powder or agglomerates Sum of 2′-Fucosyllactose, Difucosyllactose, D-Lactose, L-Fucose, and 3-Fucosyllactose (% of dry matter): ≥ 92,0 % (w/w) Sum of 2′-Fucosyllactose and Difucosyllactose (% of dry matter): ≥ 85,0 % (w/w) 2′-Fucosyllactose (% of dry matter): ≥ 75,0 % (w/w) Difucosyllactose (% of dry matter): ≥ 5,0 % (w/w) D-Lactose: ≤ 10,0 % (w/w) L-Fucose: ≤ 1,0 % (w/w) 2′-Fucosyl-D-lactulose: ≤ 2,0 (w/w) Sum of other carbohydrates ( *1 ) : ≤ 6,0 % (w/w) Moisture: ≤ 6,0 % (w/w) Ash, sulfated: ≤ 0,8 % (w/w) pH (20 °C, 5 % solution): 4,0 -6,0 Residual protein: ≤ 0,01 % (w/w) Microbiological criteria: Aerobic mesophilic total plate count: ≤ 1000 CFU/g Enterobacteriaceae: ≤ 10 CFU/g Salmonella sp.: Negative/25 g Yeast: ≤ 100 CFU/g Mould: ≤ 100 CFU/g Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units ( *1 ) 2′-Fucosyl-galactose, Glucose, Galactose, Mannitol, Sorbitol, Galactitol, Trihexose, Allo-lactose and other structurally related carbohydrates.’
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