Regulation 6
SCHEDULE 6Amendments to the list of novel foods in the Annex to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of 3-fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) as a novel food
1. In Commission Implementing Regulation (EU) 2017/2470, the Annex (list of novel foods) is amended as follows.
2. In Table 1 (authorised novel foods), after the entry for “2’-Fucosyllactose/Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source)” insert the following entry—
“3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) | Specified food category Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products Unflavoured fermented milk-based products Flavoured fermented milk-based products including heat-treated products Cereal bars Infant formula and follow-on formula as defined in Regulation (EU) No609/2013(1) Milk-based drinks and similar products intended for young children (persons aged 1 year (12 months) up to the age of 3 years (36 months)) Food for special medical purposes as defined in Regulation (EU) No609/2013 Total diet replacement for weight control as defined in Regulation (EU) No609/2013 Flavoured drinks (excluding cola flavour and cola flavoured drinks) Food supplements as defined in the Food Supplements (Wales) Regulations 2003 intended for infants (persons under the age of 1 year (12 months)) and young children (persons aged 1 year (12 months) up to the age of 3 years (36 months)) Food supplements as defined in the Food Supplements (Wales) Regulations 2003 excluding food supplements for infants and young children | Maximum levels 2.0 g/l 2.0 g/l (beverages) 4.0 g/kg (products other than beverages) 2.0 g/l (beverages) 12.0 g/kg (products other than beverages) 25.0 g/kg 2.0 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 2.0 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 12.0 g/kg (products other than beverages) In accordance with the particular nutritional requirements of the persons for whom the products are intended 2.0 g/l (beverages) 25.0 g/kg (products other than beverages) 1.25 g/l 2.0 g/day 4.0 g/day | The designation of the novel food on the labelling of food containing it is “3-fucosyllactose”. The labelling of food supplements intended for infants and young children must bear a statement that they should not be consumed if breast milk or food with added 3-fucosyllactose is consumed on the same day. | Included in the list on 28 June 2024. 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, 2970 Hørsholm, Denmark. During the period of data protection, 3-fucosyllactose is authorised for placing on the market, within Wales, 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. The data protection will expire at the end of 27 June 2029.” |
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3. In Table 2 (specifications), after the entry for “2’-Fucosyllactose/Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source)” insert the following entry—
“3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) | Description/Definition 3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) is a purified carbohydrate powder or agglomerate containing at least 90% of 3-fucosyllactose on a dry matter basis obtained from microbial fermentation with a genetically modified strain of Escherichia coli K-12 DH1. Chemical name: β-D-Galactopyranosyl-(1→4)- [α-L-fucopyranosyl-(1→3)]- D-glucopyranose Chemical formula: C18H32O15 Molecular mass: 488.44 Da CAS No: 41312-47-4 Characteristics/Composition Appearance: Powder, agglomerates, powder with agglomerates Colour: White to off-white Assay (water-free) – Specified saccharides (includes 3-FL, D-lactose, L-fucose, and 3-fucosyllactulose): ≥ 92.0 % (w/w) Assay (water-free) – 3-FL: ≥ 90.0 % (w/w) L-Fucose: ≤ 1.0 % (w/w) D-Lactose: ≤ 5.0 % (w/w) 3-Fucosyllactulose: ≤ 1.5 % (w/w) Sum of other carbohydrates: ≤ 5.0 % (w/w) pH in 5% solution (20°C): 3.2 – 7.0 Water: ≤ 6.0 % (w/w) Ash, sulphated: ≤ 0.5 % (w/w) Acetic acid (relevant for crystallised 3-FL): ≤ 1.0 % (w/w) Residual protein by Bradford assay: ≤ 0.01 % (w/w) Residual endotoxins: ≤ 10 EU/mg Heavy metals Lead: ≤ 0.1 mg/kg Arsenic: ≤ 0.2 mg/kg Mycotoxins Aflatoxin M1: ≤ 0.025 µg/kg Microbiological criteria Aerobic mesophilic total plate count: ≤ 1000 CFU/g Enterobacteriaceae: absent in 10g Salmonella spp.: absent in 25g Bacillus cereus: ≤ 50 CFU/g Listeria monocytogenes: absent in 25g Cronobacter spp.: absent in 10g Yeasts: ≤ 100 CFU/g Moulds: ≤ 100 CFU/g EU: Endotoxin Units CFU: Colony Forming Units”. |
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EUR 2013/609, amended by S.I. 2019/651, 2023/28. S.I. 2019/651 was amended by S.I. 2020/1476, 2023/28.