COMMISSION IMPLEMENTING REGULATION (EU) 2021/2029
of 19 November 2021
authorising the placing on the market of 3-Fucosyllactose (3-FL) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
Article 1
Article 2
Article 3
Article 4
ANNEX
‘Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
Data Protection |
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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:
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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.’ |
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Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products |
0,85 g/L |
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Unflavoured and flavoured fermented milk-based products including heat-treated products |
0,5 g/L (beverages) |
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5,0 g/kg (products other than beverages) |
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Dairy analogues |
0,85 g/L (beverages) |
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8,5 g/kg (products other than beverages) |
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Flavoured drinks, energy and sports drinks |
1,0 g/L |
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Cereal bars |
30,0 g/kg |
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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 |
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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 |
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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 |
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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 |
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3,0 g/kg for products other than beverages |
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Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013 |
2,0 g/L (beverages) |
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30,0 g/kg (products other than beverages) |
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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 |
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Food Supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children |
5,0 g/day |
‘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: C18H32O15 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 carbohydratesa (% 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; aSum of other carbohydrates: 3-Fucosyllactose isomer, difucosyllactose isomer, and oligomers.’ |