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 in alphabetical order: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data Protection ‘Lacto- N -tetraose (“LNT”) (microbial source) Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be “lacto- N- tetraose”. The labelling of food supplements containing lacto- N- tetraose shall bear a statement that they should not be used if breast milk or other foods containing added lacto- N- tetraose are consumed the same day. Authorised on 23.4.2020. 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, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food lacto- N- tetraose is authorised for placing on the market within the Union 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. End date of the data protection: 23.4.2025.’ Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products 1,0 g/l Unflavoured fermented milk-based products 1,0 g/l (beverages) 10 g/kg (products other than beverages) Flavoured fermented milk-based products including heat-treated products 1,0 g/l (beverages) 10 g/kg (products other than beverages) Beverages (flavoured drinks) 1,0 g/l Cereal bars 10 g/kg Infant formula as defined under Regulation (EU) No 609/2013 0,8 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 0,6 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer Processed cereal-based food, baby food for infants and young children as defined under Regulation (EU) No 609/2013 0,6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 5 g/kg for products other than beverages Milk based drinks and similar products intended for young children 0,6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 5 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) 20 g/kg (products other than beverages) Food 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 infants 2,0 g/day for young children, children, adolescents, and adults (2) in Table 2 (Specifications), the following entry is inserted in alphabetical order: Authorised Novel Food Specification ‘Lacto- N -tetraose (“LNT”) (microbial source) Definition: Chemical formula: C 26 H 45 O 21 Chemical name: β-D-Galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose Molecular mass: 707,63 Da CAS No 14116-68-8 Description: Lacto- N -tetraose is a purified, white to off-white amorphous powder that is produced by a microbial process. Source: Genetically modified strain of Escherichia coli strain K-12 DH1 Characteristics/Composition: Appearance: White to off-white powder Sum of lacto- N -tetraose, D-Lactose and lacto- N -tetraose II (% of dry matter): ≥ 90,0 % (w/w) Lacto- N -tetraose (% of dry matter): ≥ 70,0 % (w/w) D-Lactose: ≤ 12,0 % (w/w) Lacto- N -tetraose II: ≤ 10,0 % (w/w) Para -lacto- N -hexaose-2: ≤ 3,5 % (w/w) Lacto- N -tetraose fructose isomer: ≤ 1,0 % (w/w) Sum of other carbohydrates: ≤ 5,0 % (w/w) Moisture: ≤ 6,0 % (w/w) Ash, sulfated: ≤ 0,5 % (w/w) pH (20 °C, 5 % solution): 4,0–6,0 Residual protein: ≤ 0,01 % (w/w) Microbiological criteria: Aerobic mesophilic bacteria total plate count: ≤ 1 000 CFU/g Enterobacteriaceae : ≤ 10 CFU/g Salmonella sp.: Negative/25 g Yeast: ≤ 100 CFU/g Mould: ≤ 100 CFU/g Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units.’