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      Safety and efficacy of a feed additive consisting of ferrous lysinate sulfate for all animal species (Phytobiotics Futterzusatzstoffe GmbH)

      research-article
      EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) , , , , , , , , , , , , , , , , , , , , , , , ,
      EFSA Journal
      John Wiley and Sons Inc.
      nutritional additive, compounds of trace elements, iron, ferrous lysinate sulfate, safety, efficacy, Plexomin® L‐Fe

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          Abstract

          Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ferrous lysinate sulfate as nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed ( FEEDAP) Panel was assigned to this mandate. Based on the results of a tolerance study, the FEEDAP Panel concluded that ferrous lysinate sulfate is safe in chickens for fattening when used up to the current maximum authorised levels of total iron in feed; this conclusion was extrapolated to all animal species and categories, at the respective maximum authorised iron levels in complete feed. The use of ferrous lysinate sulfate in animal nutrition up to the maximum iron content in complete feed authorised in the EU poses no concern to the safety of consumers. The FEEDAP Panel concluded that ferrous lysinate sulfate poses a risk to users by inhalation; the additive is not a dermal irritant, but is irritant to eyes and a skin sensitiser. The FEEDAP Panel considered that the use of ferrous lysinate sulfate in animal nutrition would not pose a risk for the environment. Owing to the limitations in the study provided, the FEEDAP Panel could not conclude on the efficacy of the additive for chickens for fattening, and thus, on the efficacy of ferrous lysinate sulfate for all animal species and categories.

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          Most cited references17

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

          (2012)
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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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              • Record: found
              • Abstract: found
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              Is Open Access

              Guidance on the assessment of the efficacy of feed additives

              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 efficacy of feed additives. Draft Endorsed by the FEEDAP Panel 28 November 2018 Submitted for public consultation 4 December 2017 End of public consultation 28 January 2018 Adoption by the FEEDAP Panel 17 April 2018 Implementation date 1 September 2018
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                Author and article information

                Contributors
                feedap@efsa.europa.eu
                Journal
                EFSA J
                EFSA J
                10.1002/(ISSN)1831-4732
                EFS2
                EFSA Journal
                John Wiley and Sons Inc. (Hoboken )
                1831-4732
                23 April 2021
                April 2021
                : 19
                : 4 ( doiID: 10.1002/efs2.v19.4 )
                : e06545
                Author notes
                [*] [* ] Correspondence: feedap@ 123456efsa.europa.eu
                Article
                EFS26545
                10.2903/j.efsa.2021.6545
                8063210
                2d86e9d8-30ab-4912-a953-2ff5a558d1a0
                © 2021 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: 0, Tables: 4, Pages: 15, Words: 5978
                Categories
                Anim2953
                Scientific Opinion
                Scientific Opinion
                Custom metadata
                2.0
                April 2021
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.0.2 mode:remove_FC converted:23.04.2021

                nutritional additive,compounds of trace elements,iron,ferrous lysinate sulfate,safety,efficacy,plexomin® l‐fe

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