Commission Implementing Regulation (EU) 2024/2102 of 30 July 2024 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food 2'-Fucosyllactose and as regards the specifications of the novel food 2'-Fucosyllactose produced with a derivative strain of Escherichia coli BL-21 — Full Text

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEXSupplementary provisions

ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (1) in Table 1 (Authorised novel foods), the entry for 2'-Fucosyllactose is replaced by the following: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements ‘ 2 ′ -Fucosyllactose Specified food category Maximum levels 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be “2′-Fucosyllactose”. 2. The labelling of food supplements containing 2′-Fucosyllactose shall bear a statement that the supplements should not be used if other foods with added 2′-fucosyllactose are consumed the same day. 3. The labelling of food supplements containing 2′-Fucosyllactose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added 2′-fucosyllactose are consumed the same day.’ Unflavoured pasteurised and sterilised (including UHT) milk-based products 1,2 g/l Unflavoured fermented milk-based products 1,2 g/l for beverages 19,2 g/kg for products other than beverages Flavoured fermented milk-based products including heat-treated products 1,2 g/l for beverages 19,2 g/kg for products other than beverages Dairy analogues, including beverage whiteners 1,2 g/l for beverages 12 g/kg for products other than beverages 400 g/kg for whitener Cereal bars 12 g/kg Table-top sweeteners 200 g/kg Infant formula as defined in Regulation (EU) No 609/2013 3,0 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer Follow-on formula as defined in Regulation (EU) No 609/2013 3,64 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 12 g/kg for products other than beverages 1,2 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer Milk based drinks and similar products intended for young children 1,2 g/l for milk-based drinks and similar products in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer Foods for special medical purposes as defined in Regulation (EU) No 609/2013 In accordance with the particular nutritional requirements of the persons for whom the products are intended Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 4,8 g/l for drinks 40 g/kg for bars Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No 828/2014 60 g/kg Flavoured drinks 1,2 g/l Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products 9,6 g/l – the maximum level refers to the products ready to use Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants 3,0 g/day for general population 1,2 g/day for young children (2) in Table 2 (Specifications) the entry for 2′-Fucosyllactose (microbial source) is replaced by the following: Specifications Data protection Definition: Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose Chemical formula: C 18 H 32 O 15 CAS No: 41263-94-9 Molecular weight: 488,44 g/mol 2′-Fucosyllactose produced with a genetically modified strain of Corynebacterium glutamicum ATCC 13032 authorised on 16 May 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: “Advanced Protein Technologies Corporation”, 7th Floor GyeongGi-BioCenter, 147, Gwanggyo-ro, Yeongtong-gu, Suwon-si Gyeonggi-do, 16229 South Korea. During the period of data protection, 2′-Fucosyllactose produced with a genetically modified strain of Corynebacterium glutamicum ATCC 13032 is authorised for placing on the market within the Union only by “Advanced Protein Technologies Corporation” 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 “Advanced Protein Technologies Corporation”. End date of the data protection: 16 May 2028.’ ‘ 2 ′ -Fucosyllactose (microbial source) Source: Genetically modified strain of Escherichia coli K-12 Source: Genetically modified strain of Escherichia coli BL-21 Source : Genetically modified strain of Corynebacterium glutamicum ATCC 13032 Description: 2′-Fucosyllactose is a white to off-white powder that is produced by a microbiological process. Purity: 2′-Fucosyllactose: ≥ 83 % D-Lactose: ≤ 10,0 % L-Fucose: ≤ 2,0 % Difucosyl-D-lactose: ≤ 5,0 % 2′-Fucosyl-D-lactulose: ≤ 1,5 % Sum of saccharides (2′-Fucosyllactose, D-Lactose, L-Fucose, Difucosyl-D-lactose, 2′-Fucosyl-D-lactulose): ≥ 90 % pH (20 C, 5 % solution): 3,0-7,5 Water: ≤ 9,0 % Sulphated ash: ≤ 2,0 % Acetic acid: ≤ 1,0 % Residual proteins: ≤ 0,01 % Microbiological criteria: Aerobic mesophilic bacteria total count: ≤ 3 000 CFU/g Yeasts: ≤ 100 CFU/g Moulds: ≤ 100 CFU/g Endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units Description: 2′-Fucosyllactose is a white to off white powder and the liquid concentrate (45 % ± 5 % w/v) aqueous solution is a colourless to slight yellow clear aqueous solution. 2′-Fucosyllactose is produced by a microbiological process. Purity: 2′-Fucosyllactose: ≥ 90 % Lactose: ≤ 5,0 % Fucose: ≤ 3,0 % 3-Fucosyllactose: ≤ 5,0 % Fucosylgalactose: ≤ 3,0 % Difucosyllactose: ≤ 5,0 % Glucose: ≤ 3,0 % Galactose: ≤ 3,0 % Water: ≤ 9,0 % (powder) Ash, sulphated: ≤ 0,5 % (powder and liquid) Residual proteins: ≤ 0,01 % (powder and liquid) Heavy Metals: Lead: ≤ 0,02 mg/kg (powder and liquid) Arsenic: ≤ 0,2 mg/kg (powder and liquid) Cadmium: ≤ 0,1 mg/kg (powder and liquid) Mercury: ≤ 0,5 mg/kg (powder and liquid) Microbiological criteria: Total plate count: ≤ 10 4 CFU/g (powder), ≤ 5 000 CFU/g (liquid) Yeasts and Moulds: ≤ 100 CFU/g (powder); ≤ 50 CFU/g (liquid) Enterobacteriaceae/Coliforms: absence in 11 g (powder and liquid) Salmonella: negative/100 g (powder), negative/200 ml (liquid) Cronobacter: negative/100 g (powder), negative/200 ml (liquid) Endotoxins: ≤ 10 EU/mg (powder), ≤ 10 EU/μl (liquid) Aflatoxin M1: ≤ 0,025 μg/kg (powder and liquid) CFU: Colony Forming Units; EU: Endotoxin Units Description: 2′-Fucosyllactose is a white to off white/ivory powder that is produced by a microbiological process. Purity: 2′-Fucosyllactose (w/w dry matter): ≥ 94,0 % D-Lactose (w/w dry matter): ≤ 3,0 % L-Fucose (w/w dry matter): ≤ 3,0 % 3-Fucosyllactose (w/w dry matter): ≤ 3,0 % Difucosyllactose (w/w dry matter): ≤ 2,0 % D-Glucose (w/w dry matter): ≤ 3,0 % D-Galactose (w/w dry matter): ≤ 3,0 % Water: ≤ 9,0 % Ash: ≤ 0,5 % Residual proteins: ≤ 0,005 % Contaminants : Arsenic: ≤ 0,03 mg/kg Aflatoxin M1: ≤ 0,025 μg/kg Ethanol: ≤ 1 000 mg/kg Microbiological criteria : Total plate count: ≤ 500 CFU/g Yeasts and Moulds: ≤ 100 CFU/g Enterobacteriaceae: absence in 10 g Salmonella : absence in 25 g Cronobacter spp.: absence in 10 g Endotoxins: ≤ 100 EU/g CFU: Colony Forming Units; EU: Endotoxin Units

Article 1

Article 2

Supplementary provisions

ANNEXSupplementary provisions

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