ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data Protection
‘ 2'-Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’)
(microbial source)
Specified food category
Maximum levels
The designation of the novel food on the labelling of the foodstuffs containing it shall be “2'-Fucosyllactose/Difucosyllactose mixture”.
The labelling of food supplements containing the 2'-Fucosyllactose/Difucosyllactose mixture shall bear a statement that they should not be used if breast milk or other foods containing added 2'-Fucosyllactose and/or Difucosyllactose are consumed the same day.
Authorised on 19.12.2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 2'-Fucosyllactose/Difucosyllactose mixture is authorised for placing on the market within the Union only by Glycom 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 Glycom A/S.
End date of the data protection: 19.12.2024.’
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products
2,0 g/L
Unflavoured fermented milk-based products
2,0 g/L (beverages)
20 g/kg (products other than beverages)
Flavoured fermented milk-based products including heat-treated products
2,0 g/L (beverages)
20 g/kg (products other than beverages)
Beverages (flavoured drinks)
2,0 g/L
Cereal bars
20 g/kg
Infant formula as defined under Regulation (EU) No 609/2013
1,6 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
1,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013
1,2 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
10 g/kg for products other than beverages
Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013
4,0 g/L (beverages)
40 g/kg (products other than beverages)
Food for special medical purposes as defined under Regulation (EU) No 609/2013
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 intended for the general population excluding infants
4,0 g/day
(2)
in Table 2 (Specifications), the following entry is inserted in alphabetical order:
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 amorphous powder that is produced by a microbial process. After purification, the 2'-Fucosyllactose/Difucosyllactose mixture is isolated by spray drying.
Source: Genetically modified strain of Escherichia coli strain K-12 DH1
Characteristics/Composition
Appearance: White to off white powder or agglomerates
Sum of 2'-Fucosyllactose, Difucosyllactose, Lactose and Fucose (% 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 bacteria 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 ) 3'-Fucosyllactose, 2'-Fucosyl-galactose, Glucose, Galactose, Mannitol, Sorbitol, Galactitol, Trihexose, Allo-lactose and other structurally related carbohydrates.’
