Commission Implementing Regulation (EU) 2020/997 of 9 July 2020 concerning the authorisation of L-lysine base, liquid, L-lysine sulphate and L-lysine monohydrochloride, technically pure, as feed additives for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2020/997of 9 July 2020concerning the authorisation of L-lysine base, liquid, L-lysine sulphate and L-lysine monohydrochloride, technically pure, 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 nutritionOJ L 268, 18.10.2003, p. 29., 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(1) of Regulation (EC) No 1831/2003, applications were submitted for the authorisation of L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 and L-lysine sulphate and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum CGMCC 7.266 as nutritional feed additives for use in feed and in water for drinking for all animal species. These applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(3)These applications concern the authorisation of L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 and L-lysine sulphate and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum CGMCC 7.266 as feed additives for all animal species to be classified in the additive category "nutritional additives", functional group "amino acids, their salts and analogues".(4)The European Food Safety Authority ("the Authority") concluded in its opinions of 7 October 2019EFSA Journal 2019;17(10):5886. and 28 January 2020EFSA Journal 2020;18(2): 6019. that, under the proposed conditions of use, L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 and L-lysine sulphate and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum CGMCC 7.266 do not have an adverse effect on animal health, consumer health or the environment. It could not conclude on the potential toxicity by inhalation of L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 and anticipated that L-lysine base, liquid, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 is corrosive to skin and eyes and poses an inhalation risk. For L-lysine sulphate and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum CGMCC 7.266, the Authority could not exclude that the additives are toxic by inhalation, irritant to skin or eyes, or on their potential to be a dermal sensitiser. Therefore, appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority concluded that L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 and L-lysine sulphate and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum CGMCC 7.266 are effective sources of the essential amino acid L-lysine for all animal species. For the supplemental L-lysine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. In its opinions mentioned above, the Authority referred to a previous statement concerning potential nutritional imbalances for amino acids, when they are administered via water for drinking. However, the Authority did not propose a maximum content for the supplementation with L-lysine. Thus, it is appropriate to indicate on the label of the additive, and premixtures containing it, an alert to take into account the dietary supply with all the essential and conditionally essential amino acids, particularly in the case of supplementation with L-lysine as amino acid via water for drinking.(5)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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.(6)The assessment of L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum NRRL-B-67439 or Corynebacterium glutamicum NRRL B-67535 and of L-lysine sulphate and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum CGMCC 7.266 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 additive 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: