Commission Implementing Regulation (EU) 2023/1163 of 14 June 2023 concerning the authorisation of L-Lysine monohydrochloride and L-Lysine sulphate produced by Corynebacterium glutamicum CGMCC 17927 as feed additives for all animal species (Text with EEA relevance)

15.6.2023 EN Official Journal of the European Union L 154/41 COMMISSION IMPLEMENTING REGULATION (EU) 2023/1163 of 14 June 2023 concerning the authorisation of L-Lysine monohydrochloride and L-Lysine sulphate produced by Corynebacterium glutamicum CGMCC 17927 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 2003on 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 and for the grounds and procedures for granting such authorisation. (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 produced by Corynebacterium glutamicum CGMCC 17927. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (3) That application concerns the authorisation of L-Lysine monohydrochloride and L-Lysine sulphate produced by Corynebacterium glutamicum CGMCC 17927 as feed additives for all animal species, to be classified in the additive category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 September 2022(2)that, under the proposed conditions of use L-Lysine monohydrochloride and L-Lysine sulphate produced by Corynebacterium glutamicum CGMCC 17927, do not have an adverse effect on animal health, consumer safety or the environment. (5) The Authority concluded that exposure through inhalation to L-lysine monohydrochloride and L-Lysine sulphate produced with Corynebacterium glutamicum CGMCC 17927 is considered very likely and that in the absence of data, it cannot conclude on the potential of both additives to be irritant for skin and eyes or to be dermal sensitisers. (6) The Authority concluded that the additives have the potential to be efficacious for all animal species. 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. (7) The assessment of L-lysine monohydrochloride and L-Lysine sulphate produced with Corynebacterium glutamicum CGMCC 17927 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. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of users of the additives. (1) OJ L 268, 18.10.2003, p. 29. (2) EFSA Journal 2022;20(10):7613.L 154/42 EN Official Journal of the European Union 15.6.2023 (8) In view of the Authority’s opinion, the label of the additives and premixtures should raise awareness that the supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances. In addition, the Commission considers that a maximum level should be set up for L-lysine sulphate due to the potential adverse effects from the intrinsic high sulphate content in the additive. The level of 10 000mg/kg of complete feed was regarded as safe according to the Authority’s opinion of 16 June 2015(3)issued for another L-lysine sulphate. (9) 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 Authorisation 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 additives in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Entry into force 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, 14 June 2023. For the Commission The President Ursula VON DER LEYEN (3) EFSA Journal 2015;13(7):4155ANNEX Minimum Maximum Identifica- content content Species or tion Composition, chemical formula, description, Maximum End of period of Additive category of Other provisions number of analytical method. age mg of additive/kg of authorisation animal the additive complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: amino acids, their salts and analogues 3c322IV L-lysine Additive composition All species - 1. The lysine content shall be indicated 6 July 2033 monohy- L-lysine monohydrochloride with a on the labelling of the additive drochloride minimum content of 78,8 % of L-Lysine on a 2. The additive may be used via water for dry matter basis and maximum moisture drinking. content of 1 % 3. The directions for use of the additive Solid form and premixture shall indicate the sto­ rage conditions, the stability to heat Characterisation of the active substance treatment and the stability in water L-lysine monohydrochloride produced by for drinking. Corynebacterium glutamicum CGMCC 17927] 4. The label of the additive and premix­ Chemical formula: C H N O 6 14 2 2 ture shall indicate the following: ‘The CAS number: 657-27-2 supplementation with L-lysine monohydrochloride, in particular Analytical method(1) via water for drinking, should take For the identification of L-lysine into account all essential and condi­ monohydrochloride in the feed additive: Food tionally essential amino acids in order Chemical Codex ‘L-lysine to avoid imbalances.’ monohydrochloride monograph’ 5. For users of the additive and premix­ For the quantification of lysine in the feed tures, feed business operators shall additives and premixtures (containing more establish operational procedures and than 10 % lysine): – ion-exchange organisational measures to address chromatography coupled with post-column the potential risks resulting from derivatisation and optical detection (IEC- their use. Where those risks cannot VIS/FLD) – EN ISO 17180 be eliminated by such procedures For the quantification of lysine in premixtures and measures, the additive and pre­ and compound feed: – ion-exchange mixtures shall be used with personal chromatography coupled with post-column breathing eye and skin protective derivatisation and optical detection (IEC-VIS), equipment. Commission Regulation (EC) No 152/2009 (Annex III, F) 15.6.2023 EN Official Journal of the European Union L 154/43For the quantification of lysine in water: – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD); or – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) (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 L 154/44 EN Official Journal of the European Union 15.6.2023Minimum Maximum Identifica- content content Species or tion Composition, chemical formula, description, Maximum End of period of Additive category of Other provisions number of analytical method. age mg additive/kg of complete authorisation animal the additive feed with a moisture content of 12 % Category of nutritional additives. Functional group: amino acids, their salts and analogues 3c329 L-lysine sulphate Additive composition All species - - 10 000 1. The lysine content shall be indicated 6 July 2033 L-lysine sulphate with a minimum L-lysine on the labelling of the additive. content of 55 % on dry matter basis and a 2. The additive may be used via water for maximum content of: drinking. — 4 % moisture; 3. The directions for use of the additive — 26,5 % sulphate; and premixture shall indicate the sto­ — 0,8 % free amino acids other than lysine rage conditions, the stability to heat Solid form treatment and the stability in water for drinking. Characterisation of the active substance 4. The label of the additive and premix­ L-lysine sulphate produced by ture shall indicate the following: ‘The Corynebacterium glutamicum CGMCC supplementation with L-lysine sul­ 17927 phate, in particular via water for Chemical formula: C H N O -O S 12 28 4 4 4 drinking, should take into account CAS number: 60343-69-3 all essential and conditionally essen­ tial amino acids in order to avoid im­ Analytical method(1) balances.’ For the identification of sulphate in the feed 5. For users of the additive and premix­ additive (L-lysine sulphate): European tures, feed business operators shall Pharmacopoeia monograph 20301 establish operational procedures and For the quantification of lysine in the feed organisational measures to address additives and premixtures (containing more the potential risks resulting from than 10 % lysine): – ion-exchange their use. Where those risks cannot chromatography coupled with post-column be eliminated by such procedures derivatisation and optical detection (IEC- and measures, the additive and pre­ VIS/FLD) – EN ISO 17180 mixtures shall be used with personal breathing eye and skin protective equipment. 15.6.2023 EN Official Journal of the European Union L 154/45For the quantification of lysine in premixtures and compound feed: – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F) For the quantification of lysine in water: – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD); or – ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) (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 L 154/46 EN Official Journal of the European Union 15.6.2023