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Commission Implementing Regulation (EU) 2021/912 of 4 June 2021 authorising changes in the specifications of the novel food Lacto-N-neotetraose (microbial source) and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

Type Implementing Regulation

Publication 2021-06-07

State In force

Text As published

Department European Commission, SANTE

Source EUR-Lex

articles 2

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

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7.6.2021	EN	Official Journal of the European Union	L 199/10

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 ¹, and in particular Article 12 thereof,

Whereas:

(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 ² establishing the Union list of authorised novel foods, was adopted.

(3) Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising the placing on the Union market of a novel food and updating the Union list.

(4) Commission Implementing Decision (EU) 2016/375 ³ authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council ⁴, the placing on the market of chemically synthesized Lacto-N-neotetraose as a novel food ingredient.

(5) Pursuant to Article 5 of Regulation (EC) No 258/97, on 1 September 2016, the company Glycom A/S informed the Commission of its intention to place on the market Lacto-N-neotetraose of microbial source produced with Escherichia coli strain K-12 as a novel food ingredient.

(6) In the notification to the Commission, Glycom A/S also submitted a report issued by the competent authority of Ireland pursuant to Article 3(4) of Regulation (EC) No 258/97, which, on the basis of the scientific evidence submitted by that company, had concluded that Lacto-N-neotetraose produced with Escherichia coli strain K-12 is substantially equivalent to the synthetic Lacto-N-neotetraose authorised by Implementing Decision (EU) 2016/375. Therefore, Lacto-N-neotetraose of microbial source was included in the Union list of novel foods.

(7) On 23 June 2019, the company Chr. Hansen A/S (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for the authorisation of Lacto-N-neotetraose (microbial source) produced by the combined activity of the derivative strains PS-LNnT-JBT and DS-LNnT-JBT of Escherichia coli strain BL21(DE3) as a novel food under the same conditions of use as the ones currently authorised for synthetic and microbial sourced Lacto-N-neotetraose. The applicant requested an update of the union list with regard to the new source of that novel food.

(8) In addition, the applicant proposed updating some of the specifications of Lacto-N-neotetraose (microbial source) produced by that new source, as they differ from the specifications of the authorised microbiologically sourced Lacto-N-neotetraose produced with Escherichia coli strain K-12, as far as they concern an increase in the levels of ash from ≤ 0,4 % to ≤ 1,0 %; a higher level for the presence of yeasts and moulds from the current ≤ 10 Colony Forming Units (‘CFU’)/g of novel food for each type of microorganism to ≤ 50 CFU/g for the combination of the two; and the absence of methanol (from the current ≤ 100 mg/kg), and of Lacto-N-neotetraose fructose isomer (from the current ≤ 1,0 %).

(9) On 17 January 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of Lacto-N-neotetraose produced by the combined activity of the derivative strains PS-LNnT-JBT and DS-LNnT-JBT of Escherichia coli strain BL21(DE3) in accordance with the requirements of Article 11 of Regulation (EU) 2015/2283.

(10) On 22 October 2020, the Authority adopted its scientific opinion ‘Safety of lacto-N-neotetraose (LNnT) produced by derivative strains of E. coli BL21 as a novel food pursuant to Regulation (EU) 2015/2283’ ⁵.

(11) In its scientific opinion, the Authority concluded that Lacto-N-neotetraose (LNnT) produced by the combined activity of the derivative strains PS-LNnT-JBT and DS-LNnT-JBT of Escherichia coli strain BL21(DE3) as a novel food pursuant to Regulation (EU) 2015/2283 is safe for the currently authorised conditions of use. Therefore, that scientific opinion gives sufficient grounds to establish that Lacto-N-neotetraose (LNnT) produced by the combined activity of the derivative strains PS-LNnT-JBT and DS-LNnT-JBT of Escherichia coli strain BL21(DE3), complies with Article 12(1) of Regulation (EU) 2015/2283.

(12) It is therefore appropriate to amend the specifications of the microbiologically produced Lacto-N-neotetraose, to include the derivative strains PS-LNnT-JBT and DS-LNnT-JBT of Escherichia coli strain BL21(DE3) as the source of the novel food in addition to the authorised Escherichia coli strain K12 and to amend the proposed levels for the presence of ash and moulds, and yeast.

(13) The Annex to Regulation (EU) 2017/2470 should therefore be amended accordingly.

(14) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The entry in the Union list of authorised novel foods as provided for in Article 6 of Regulation (EU) 2015/2283 referring to the substance Lacto-N-neotetraose (microbial source) shall be amended as specified in 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 4 June 2021.

For the Commission

The President

Ursula VON DER LEYEN

OJ L 327, 11.12.2015, p. 1.

Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

Commission Implementing Decision (EU) 2016/375 of 11 March 2016 authorising the placing on the market of Lacto-N-neotetraose as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 70, 16.3.2016, p. 22).

Regulation (EC) No 258/97 of the European Parliament and of the Council concerning novel food and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

EFSA Journal 2020;18(11):6305.

ANNEX

In Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Lacto-N-neotetraose (microbial source)’ is replaced by the following:


‘Lacto-N-neotetraose (microbial source)	Definition: Chemical name: β-D-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose Chemical formula: C26H45NO21 CAS No: 13007-32-4 Molecular weight: 707,63 g/mol Source: — Genetically modified strain of Escherichia coli K-12, or — a combination of the genetically modified strains PS-LNnT-JBT and DS-LNnT-JBT of Escherichia coli BL21(DE3) Description: Lacto-N-neotetraose is a white to off-white powder that is produced by a microbiological process. Purity: Assay (water free): ≥ 80 % D-Lactose: ≤ 10,0 % Lacto-N-triose II: ≤ 3,0 % para-Lacto-N-neohexaose: ≤ 5,0 % Lacto-N-neotetraose fructose isomer: ≤ 1,0 % Sum of saccharides (Lacto-N-neotetraose, D-Lactose, Lacto-N-triose II, para-Lacto-N-neohexaose, Lacto-N-neotetraose fructose isomer): ≥ 92 % (% w/w dry matter) pH (20 °C, 5 % solution): 4,0-7,0 Water: ≤ 9,0 % Ash, sulphated: ≤ 1,0 % Residual solvents (methanol): ≤ 100 mg/kg Residual proteins: ≤ 0,01 % Microbiological criteria: Aerobic mesophilic bacteria total count: ≤ 500 CFU/g Yeasts and moulds: ≤ 50 CFU/g Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units’

‘Lacto-N-neotetraose (microbial source)

Definition: Chemical name: β-D-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose Chemical formula: C26H45NO21 CAS No: 13007-32-4 Molecular weight: 707,63 g/mol Source: — Genetically modified strain of Escherichia coli K-12, or — a combination of the genetically modified strains PS-LNnT-JBT and DS-LNnT-JBT of Escherichia coli BL21(DE3) Description: Lacto-N-neotetraose is a white to off-white powder that is produced by a microbiological process. Purity: Assay (water free): ≥ 80 % D-Lactose: ≤ 10,0 % Lacto-N-triose II: ≤ 3,0 % para-Lacto-N-neohexaose: ≤ 5,0 % Lacto-N-neotetraose fructose isomer: ≤ 1,0 % Sum of saccharides (Lacto-N-neotetraose, D-Lactose, Lacto-N-triose II, para-Lacto-N-neohexaose, Lacto-N-neotetraose fructose isomer): ≥ 92 % (% w/w dry matter) pH (20 °C, 5 % solution): 4,0-7,0 Water: ≤ 9,0 % Ash, sulphated: ≤ 1,0 % Residual solvents (methanol): ≤ 100 mg/kg Residual proteins: ≤ 0,01 % Microbiological criteria: Aerobic mesophilic bacteria total count: ≤ 500 CFU/g Yeasts and moulds: ≤ 50 CFU/g Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units’

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