BAKGRUNN (fra kommisjonsforordningen)

(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.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of concentrated liquid L-lysine, concentrated liquid L-lysine monohydrochloride and L-lysine monohydrochloride produced by Escherichia coli NITE BP-02917. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of concentrated liquid L-lysine, concentrated liquid L-lysine monohydrochloride and L-lysine monohydrochloride, produced by Escherichia coli NITE BP-02917 as feed additives for all animal species, requesting those additives to be classified in the category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’ and in the category ‘sensory additives’, functional group ‘flavouring compounds’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 27 September 2022 (2) and of 11 May 2023 (3) that, under the proposed conditions of use, concentrated liquid L-lysine, concentrated liquid L-lysine monohydrochloride and L-lysine monohydrochloride, produced by Escherichia coli NITE BP-02917 are safe for the target species, consumers and the environment when used both as amino acids and as flavouring compounds. The Authority expressed concerns on the simultaneous oral administration of these additives as amino acids in feed and in water for drinking. It also concluded that concentrated liquid L-lysine, concentrated liquid L-lysine monohydrochloride and L-lysine monohydrochloride are not considered to have the potential to cause respiratory toxicity, or skin sensitisation. Concentrated liquid L-lysine monohydrochloride and L-lysine monohydrochloride are not considered skin and eye irritants while concentrated liquid L-lysine, due to its high pH may be corrosive for skin and eyes. The Authority further concluded that concentrated liquid L-lysine, concentrated liquid L-lysine monohydrochloride and L-lysine monohydrochloride produced by Escherichia coli NITE BP-02917 are an efficacious source of the essential amino acid L-lysine for non-ruminant animal species. For the supplemental L-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen. The three forms of the additive were also considered efficacious as feed flavouring compounds under the proposed conditions of use. The Authority did 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.

(5) The names ‘concentrated liquid L-lysine’ and ‘concentrated liquid L-lysine monohydrochloride’ should be changed to ‘L-lysine base, liquid’ and ‘L-lysine monohydrochloride, liquid’ as the minimum content of L-lysine of those additives is only 50 % and 22,4 % respectively.

(6) In view of the above, the Commission considers that L-lysine base, liquid, L-lysine monohydrochloride, liquid, and L-lysine monohydrochloride, produced by Escherichia coli NITE BP-02917 satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those additives should be authorised. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of L-lysine base, liquid.

(7) The Commission considers that, when the additives are used as amino acids, and in particular in the case of supplementation via water for drinking, it is appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids.

(8) The Commission considers that the physical characteristics of the powder of L-lysine monohydrochloride in relation to the particle size distribution and the dusting potential entails a risk of endotoxin exposure for users, therefore, a limitation on the maximum endotoxin exposure should be set up.

(9) The Commission considers that for the use of L-lysine base, liquid, L-lysine monohydrochloride, liquid, and L-lysine monohydrochloride, produced by Escherichia coli NITE BP-02917 as flavouring compounds, safety reasons do not require the setting of maximum contents. In order to allow better control, the recommended maximum content should be indicated on the label of the feed additives. Where such contents are exceeded, certain information should be indicated on the label of the premixtures concerned.

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