1. 3-Fucosyllactose (3-FL) as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of 5 years from the date of entry into force of this Regulation only the initial applicant:
Company: DuPont Nutrition & Biosciences ApS;
Address: Langebrogade 1, 1001 Copenhagen K, Denmark,
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for that novel food without reference to the data protected pursuant to Article 2 or with the agreement of the applicant.
3. 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.
The studies contained in the application file on the basis of which the novel food referred to in Article 1 have been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of DuPont Nutrition & Biosciences ApS.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEXSupplementary provisions
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.’
