COMMISSION IMPLEMENTING REGULATION (EU) 2021/82
of 27 January 2021
authorising the placing on the market of 6’-sialyllactose sodium salt 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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6’-Sialyllactose (6’-SL) sodium salt (microbial source) |
Specified food category |
Maximum levels (expressed as 6’-Sialyllactose) |
The designation of the novel food on the labelling of the foodstuffs containing it shall be “6’-Sialyllactose sodium salt”. The labelling of food supplements containing 6’-Sialyllactose (6’-SL) sodium salt shall bear a statement that they should not be consumed:
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Authorised on 17 February 2021. 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 6’-sialyllactose sodium salt 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: 17 February 2026.’ |
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Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products |
0,5 g/L |
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Unflavoured fermented milk-based products |
0,5 g/L (beverages) |
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2,5 g/kg (products other than beverages) |
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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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Beverages (flavoured drinks, excluding drinks with a pH less than 5) |
0,5 g/L |
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Cereal bars |
5,0 g/kg |
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Infant formula as defined under Regulation (EU) No 609/2013 |
0,4 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 |
0,3 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 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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2,5 g/kg for products other than beverages |
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Milk based drinks and similar products intended for young children |
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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Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013 |
1,0 g/L (beverages) |
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10,0 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 food supplements for infants and young children |
1,0 g/day |
‘Authorised Novel Food |
Specification |
6’-Sialyllactose (“6’-SL”) sodium salt (microbial source) |
Description: 6’-Sialyllactose (6’-SL) sodium salt is a purified, white to off-white powder or agglomerate that is produced by a microbial process and contains limited levels of lactose, 6’-sialyl-lactulose, and sialic acid. Source: Genetically modified strain of Escherichia coli K-12 DH1 Definition: Chemical formula: C23H38NO19Na Chemical name: N-Acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt Molecular mass: 655,53 Da CAS No 157574-76-0 Characteristics/Composition: Appearance: White to off-white powder or agglomerate Sum of 6’-Sialyllactose sodium salt, D-Lactose and Sialic acid (% of dry matter): ≥ 94,0 % (w/w) 6’-Sialyllactose sodium salt (% of dry matter): ≥ 90,0 % (w/w) D-Lactose: ≤ 5,0 % (w/w) Sialic acid: ≤ 2,0 % (w/w) 6’-Sialyl-lactulose: ≤ 3,0 % (w/w) Sum of other carbohydrates: ≤ 3,0 % (w/w) Moisture: ≤ 6,0 % (w/w) Sodium: 2,5-4,5 % (w/w) Chloride: ≤ 1,0 % (w/w) pH (20 °C, 5 % solution): 4,5-6,0 Residual protein: ≤ 0,01 % (w/w) Microbiological criteria: Aerobic mesophilic bacteria total plate count: ≤ 1 000 CFU/g Enterobacteriaceae: ≤ 10 CFU/g Salmonella sp.: Absence in 25 g Yeast: ≤ 100 CFU/g Mould: ≤ 100 CFU/g Residual endotoxins: ≤ 10 EU/mg |