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:
‘Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data Protection
3-Fucosyllactose (3-FL)
(microbial source)
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 they should not be consumed:
a)
if foods containing added 3-Fucosyllactose are consumed on the same day;
b)
by infants and children under 3 years of age.
Authorised on 12 December 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: DuPont Nutrition & Biosciences ApS Langebrogade 1, 1001 Copenhagen K, Denmark. During the period of data protection, the novel food 3-Fucosyllactose is authorised for placing on the market within the Union only by DuPont Nutrition & Biosciences ApS, 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 DuPont Nutrition & Biosciences ApS.
End date of the data protection: 12 December 2026.’
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products
0,85 g/L
Unflavoured and flavoured fermented milk-based products including heat-treated products
0,5 g/L (beverages)
5,0 g/kg (products other than beverages)
Dairy analogues
0,85 g/L (beverages)
8,5 g/kg (products other than beverages)
Flavoured drinks, energy and sports drinks
1,0 g/L
Cereal bars
30,0 g/kg
Infant formula as defined under Regulation (EU) No 609/2013
0,85 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
0,85 g/L 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
0,85 g/L (beverages) 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
0,3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
3,0 g/kg for products other than beverages
Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013
2,0 g/L (beverages)
30,0 g/kg (products other than beverages)
Foods 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, excluding food supplements for infants and young children
5,0 g/day
2.
in Table 2 (Specifications), the following entry is inserted:
‘Authorised Novel Food
Specification
3-Fucosyllactose (‘3-FL’)
(microbial source)
Description:
3-Fucosyllactose (3-FL) is a purified, white to off-white powder that is produced by microbial fermentation and contains limited levels of D-Lactose, L-Fucose, D-Galactose, and D-Glucose.
Source: Genetically modified strain of Escherichia coli K-12.
Definition:
Chemical formula: C 18 H 32 O 15
Chemical name: β-D-galactopyranosyl-(1→4)[-α-L-fucopyranosyl-(1→3)]-D-glucopyranose
Molecular mass: 488,44 Da
CAS No 41312-47-4
Characteristics/Composition:
3-Fucosyllactose (% of dry matter): ≥ 90,0 % (w/w)
D-Lactose (% of dry matter): ≤ 5,0 % (w/w)
L-Fucose (% of dry matter): ≤ 3,0 % (w/w)
Sum of D-Galactose/D-Glucose (% of dry matter): ≤ 3,0 % (w/w)
Sum of other carbohydrates a (% of dry matter): ≤ 3,0 % (w/w)
Moisture: ≤ 5,0 % (w/w)
pH (20 °C, 5 % solution): 3,0-7,5
Residual protein: ≤ 0,01 % (w/w)
Ash (%): ≤ 0,5
Heavy metals/Contaminants:
Arsenic: ≤ 0,2 mg/kg
Cadmium: ≤ 0,05 mg/kg
Lead: ≤ 0,05 mg/kg
Mercury: ≤ 0,1 mg/kg
Aflatoxin M1: ≤ 0,025 μg/kg
Aflatoxin B1: ≤ 0,1 μg/kg
Residual endotoxins: ≤ 0,3 EU/mg
Microbiological criteria:
Total plate count: ≤ 1 000 CFU/g
Enterobacteriaceae: Absence in 10 g
Salmonella sp.: Absence in 25 g
Cronobacter (Enterobacter) sakazakii : Absence in 10 g
Listeria monocytogenes : Absence in 25 g
Bacillus cereus : ≤ 10 CFU/g
Yeast: ≤ 100 CFU/g
Mould: ≤ 100 CFU/g
CFU: Colony Forming Units; EU: Endotoxin Units; a Sum of other carbohydrates: 3-Fucosyllactose isomer, difucosyllactose isomer, and oligomers.’
