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Document 32022R1525
Commission Implementing Regulation (EU) 2022/1525 of 13 September 2022 concerning the authorisation of L-lysine monohydrochloride and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 14498 as feed additives for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/1525 of 13 September 2022 concerning the authorisation of L-lysine monohydrochloride and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 14498 as feed additives for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/1525 of 13 September 2022 concerning the authorisation of L-lysine monohydrochloride and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 14498 as feed additives for all animal species (Text with EEA relevance)
C/2022/6489
OJ L 237, 14.9.2022, p. 12–16
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
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14.9.2022 |
EN |
Official Journal of the European Union |
L 237/12 |
COMMISSION IMPLEMENTING REGULATION (EU) 2022/1525
of 13 September 2022
concerning the authorisation of L-lysine monohydrochloride and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 14498 as feed additives for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
Whereas:
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(1) |
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. |
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(2) |
In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-lysine monohydrochloride and L-lysine sulphate. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. |
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(3) |
That application concerns the authorisation of L-lysine monohydrochloride and L-lysine sulphate produced by Corynebacterium glutamicum CGMCC 14498 as feed additives for all animal species, to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’. |
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(4) |
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 10 November 2021 (2) that, under the proposed conditions of use, L-lysine monohydrochloride and L-lysine sulphate produced by Corynebacterium glutamicum CGMCC 14498, when supplemented to diets in appropriate amounts, do not have an adverse effect on animal health, consumer safety or the environment. With respect to the safety of the user of those additives, the Authority could not conclude on the potential of L-lysine monohydrochloride to be toxic by inhalation and on the potential of L-lysine monohydrochloride and L-lysine sulphate to be irritant to skin or eyes, or on their potential to be a dermal sensitiser. Further, the Authority concluded that they are considered an efficacious source of the essential amino acid L-lysine for animal nutrition and that in order to be efficacious in ruminants, the additives should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(5) |
In view of the Authority’s opinion, the Commission therefore considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additives. |
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(6) |
The assessment of L-lysine monohydrochloride and L-lysine sulphate produced by Corynebacterium glutamicum CGMCC 14498 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation. |
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(7) |
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 substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.
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, 13 September 2022.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2021;19(12):6980.
ANNEX
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Identification number of the additive |
Name of the holder of authorisation |
Additive |
Composition, chemical formula, description, analytical method. |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
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mg additive/kg of complete feed with a moisture content of 12 % |
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Category of nutritional additives. Functional group: amino acids, their salts and analogues. |
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3c322iii |
- |
L-lysine monohydrochloride |
Additive composition Preparation of L-lysine monohydrochloride with a minimum of 78,8 % L-lysine and with a moisture ≤ 1 % Powder form |
All species |
- |
- |
- |
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4.10.2032 |
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Characterisation of the active substance L-lysine monohydrochloride produced by fermentation with Corynebacterium glutamicum CGMCC 14498 Chemical formula: C6H15ClN2O2 CAS Number: 657-27-2 Analytical methods (1) For the identification of L-lysine monohydrochloride in the feed additive:
For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine:
For the quantification of lysine in premixtures, compound feed and feed materials:
For the quantification of lysine in water:
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3c328 |
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L-lysine sulphate |
Additive composition Preparation of L-lysine sulphate with a minimum content of 73,0 % (L-lysine ≥ 55,0 % and other amino acids ≥ 10 %) Powder form |
All species |
- |
- |
10 000 |
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4.10.2032 |
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Characterisation of the active substance L-lysine sulphate produced by fermentation with Corynebacterium glutamicum CGMCC 14498 Chemical formula: [C6H14N2O2]2 SO4 CAS number: 60343-69-3 |
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Analytical methods (1) For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine:
For the identification of sulphate in the feed additive:
For the quantification of lysine in premixtures, compound feed and feed materials:
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(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en