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      Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain KCCM 10227 for all animal species

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          Abstract

          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 l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced using Corynebacterium glutamicum KCCM 10227 when used as nutritional additives in feed and water for drinking for all animal species. The active substance is l‐lysine. l‐lysine HCl and concentrated liquid l‐lysine (base) produced by the strain C. glutamicum KCCM 10227 do not represent a risk for the target species, the consumer and the environment. l‐lysine HCl produced by C. glutamicum KCCM 10227 is hazardous by inhalation, it is not irritant to skin but mildly irritant to eyes and it is not a skin sensitiser. Concentrated liquid l‐lysine (base) produced by C. glutamicum KCCM 10227 is hazardous by inhalation, not irritant to skin and eyes and it is not a skin sensitiser. l‐lysine HCl and concentrated liquid l‐lysine (base) are considered as efficacious sources 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.

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          Guidance on studies concerning the safety of use of the additive for users/workers

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            Guidance on the characterisation of microorganisms used as feed additives or as production organisms

            Draft Endorsed by the FEEDAP Panel * 18 May 2017 Submitted for public consultation 15 June 2017 End of public consultation 15 September 2017 Adopted by the FEEDAP Panel 21 February 2018 Implementation date 1 September 2018 * Sections 3.1 and 3.2 were also endorsed by the EFSA Panel on Genetically Modified Organisms (GMO), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) and EFSA Panel on Food Additives and Nutrient Sources Added to Food (ANS) on 18 May (GMO) and 7 June (CEF and ANS) 2017. Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the characterisation of microorganisms used as feed additives or as production organisms.
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              Guidance on the assessment of the safety of feed additives for the target species

              Draft Endorsed by the FEEDAP Panel 22 March 2017 Submitted for public consultation 6 April 2017 End of public consultation 31 May 2017 Adoption by the FEEDAP Panel 26 September 2017 Entry into force 1 May 2018 Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the safety for the target species.
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                Author and article information

                Journal
                EFSA J
                EFSA J
                10.1002/(ISSN)1831-4732
                EFS2
                EFSA Journal
                John Wiley and Sons Inc. (Hoboken )
                1831-4732
                02 May 2019
                May 2019
                : 17
                : 5 ( doiID: 10.1002/efs2.2019.17.issue-5 )
                : e05697
                Author notes
                [*] Correspondence: feedap@ 123456efsa.europa.eu
                Article
                EFS25697
                10.2903/j.efsa.2019.5697
                7009066
                f957b4c0-9139-44f1-bb38-dcfaafa05532
                © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.

                History
                Page count
                Figures: 2, Tables: 0, Pages: 15, Words: 7886
                Categories
                Scientific Opinion
                Scientific Opinion
                Custom metadata
                2.0
                May 2019
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:21.01.2020

                nutritional additive,amino acid,lysine monohydrochloride,lysine base,safety,efficacy

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