COMMISSION IMPLEMENTING REGULATION (EU) 2020/484
of 2 April 2020
authorising the placing on the market of lacto-
N-
tetraose 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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‘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. |
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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 |
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Unflavoured fermented milk-based products |
1,0 g/l (beverages) 10 g/kg (products other than beverages) |
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Flavoured fermented milk-based products including heat-treated products |
1,0 g/l (beverages) 10 g/kg (products other than beverages) |
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Beverages (flavoured drinks) |
1,0 g/l |
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Cereal bars |
10 g/kg |
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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 |
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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 |
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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 |
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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 |
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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) |
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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 |
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Food Supplements as defined in Directive 2002/46/EC, excluding infants |
2,0 g/day for young children, children, adolescents, and adults |
Authorised Novel Food |
Specification |
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‘Lacto-N-tetraose (“LNT”) (microbial source) |
Definition: Chemical formula: C26H45O21 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 |
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