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Document 02020R0484-20210830
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)Text with EEA relevance
Consolidated text: 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)Text with EEA relevance
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)Text with EEA relevance
02020R0484 — EN — 30.08.2021 — 001.001
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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 (OJ L 103 3.4.2020, p. 3) |
Amended by:
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Official Journal |
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date |
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COMMISSION IMPLEMENTING REGULATION (EU) 2021/1318 of 9 August 2021 |
L 286 |
5 |
10.8.2021 |
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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
Company: Glycom A/S;
Address: Kogle Allé 4, DK-2970 Hørsholm, Denmark,
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of the applicant.
Article 2
The data contained in the application file on the basis of which lacto-N-tetraose has been assessed by the Authority, claimed by the applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283, shall not be used for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of the applicant.
Article 3
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 4
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:
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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.’ |
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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 |
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in Table 2 (Specifications), the following entry is inserted in alphabetical order:
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Authorised Novel Food |
Specification |
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‘Lacto-N-tetraose (“LNT”) (microbial source) |
Definition: Chemical formula: C26H45NO21 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 or agglomerates 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 or agglomerates Sum of lacto-N-tetraose, D-Lactose and lacto-N-triose 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-triose 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 spp.: Negative/25 g Yeast: ≤ 100 CFU/g Mould: ≤ 100 CFU/g Residual endotoxins: ≤ 10 EU/mg |
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CFU: Colony Forming Units.’ |
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