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Safety of the feed additives consisting of l‐lysine monohydrochloride and l‐lysine sulfate produced by Corynebacterium glutamicum CCTCC M 2015595 for all animal species (Kempex Holland B. V.)

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Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 for all animal species. In 2019, the FEEDAP Panel issued an opinion on the safety and efficacy of the products. In that assessment, the Panel could not conclude on the safety of the additives for the target species, the consumers and the environment due to the uncertainties regarding the possible genetic modification of the strain used to obtain the production strain C. glutamicum CCTCC M 2015595 and on the possible presence of viable cells and DNA of the production strain in the final products. Moreover, in the absence of data, the FEEDAP Panel could not conclude on the safety of the additives for the users. The applicant provided supplementary data to characterise the strain from which the production strain under assessment was obtained. However, uncertainties remain on its origin and history of modification, including whether it has been genetically modified. The production strain C. glutamicum CCTCC M 2015595 did not show the presence of acquired antimicrobial resistance genes nor of toxin and virulence factors genes. Moreover, as viable cells and DNA of the production strain were not detected in both final formulations, l‐lysine HCl and l‐lysine sulfate do not raise safety concerns as regards the production strain. The FEEDAP Panel concluded that l‐lysine HCl and l‐lysine sulfate produced by C. glutamicum CCTCC M 2015595 are safe for the target species, consumers and for the environment. No additional data have been provided on the safety of the additives for users. Therefore, the conclusions from the Panel remained that in the absence of data, no conclusions on the safety of the additives for the user can be drawn.

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