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      Safety and efficacy of a feed additive consisting of 6‐phytase produced with Trichoderma reesei (CBS 126897) (Quantum® Blue) for fin fish (ROAL Oy)

      research-article
      EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) , , , , , , , , , , , , , , , , , , , , , , , , , , , ,
      EFSA Journal
      John Wiley and Sons Inc.
      digestibility enhancers, efficacy, fin fish, safety, zootechnical additive

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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 6‐phytase (Quantum® Blue) as a zootechnical feed additive for fin fish. The additive is authorised for use in poultry and pigs. The additive is available in solid and liquid forms, and the 6‐phytase contained in the product is produced by fermentation with a genetically modified strain of Trichoderma reesei. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the genetic modification of the production strain does not give rise to safety concerns; viable cells of the production strain and its DNA were not detected in the final products. The FEEDAP Panel concluded that, based on the data available, the additive tested is safe for fin fish at the highest recommended level of 2500 phytase activity unit (FTU)/kg complete feed. The Panel concluded that Quantum® Blue is not an irritant to skin and eyes nor a skin sensitiser. Owing to the proteinaceous nature of the active substance, 6‐phytase (Quantum® Blue) is considered a respiratory sensitiser. The use of Quantum® Blue as a feed additive is considered safe for the environment. The additive is considered to be efficacious as a zootechnical additive for salmonids and ornamental fish at 500 FTU/kg complete feed and other fin fish at 2500 FTU/kg complete feed.

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          Most cited references9

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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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              • 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
                15 May 2024
                May 2024
                : 22
                : 5 ( doiID: 10.1002/efs2.v22.5 )
                : e8709
                Author notes
                [*] [* ] Correspondence: feedap@ 123456efsa.europa.eu
                Article
                EFS28709
                10.2903/j.efsa.2024.8709
                11094571
                38751506
                5ecd578f-2beb-4cae-9634-e11fea7b84a5
                © 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH 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: 2, Pages: 12, Words: 6882
                Categories
                Scientific Opinion
                Scientific Opinion
                Custom metadata
                2.0
                May 2024
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.4.3 mode:remove_FC converted:15.05.2024

                digestibility enhancers,efficacy,fin fish,safety,zootechnical additive

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