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)
Article 1
Article 2
ANNEX
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’ |
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 |