COMMISSION IMPLEMENTING REGULATION (EU) 2022/1493

of 8 September 2022

concerning the authorisation of L-methionine produced by Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246 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:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-methionine produced by Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

(3) The application concerns the authorisation of L-methionine produced by Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246 as feed additives for all animal species to be classified in the additive category ‘nutritional additives’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 March 2022 (2) that, under the proposed conditions of use, neither of the two products of L-methionine produced by Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246 has an adverse effect on animal health, consumer health or the environment. As regards the safety of the user of that substance, the Authority concluded that the substance, in either products, is not an irritant to skin/eyes nor a dermal sensitiser and shows no toxicity by inhalation. However, the product L-methionine ≥ 90 % presents a risk to the user considering the exposure to endotoxins by inhalation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of that form of the substance.

(5) The Authority further concluded that L-methionine produced by Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246 is an effective source of methionine for all animal species and that in order to be as efficacious in ruminants as in non-ruminant species, the substance 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 report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6) The assessment of this substance shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation.

(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, 8 September 2022. For the Commission The President Ursula VON DER LEYEN

(1) OJ L 268, 18.10.2003, p. 29.

(2) EFSA Journal 2022;20(4):7247.