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)

• CELEX: Implementing Regulation (EU) 2021/50
• Articles: 3

Article 1

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.

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

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.’