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      Assessment of the application for renewal of authorisation of Ecobiol ® ( Bacillus amyloliquefaciens CECT 5940) as a feed additive for chickens for fattening and its extension of use for chickens reared for laying

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      EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) , , , , , , , , , , , , , , , , , , , , , , , ,
      EFSA Journal
      John Wiley and Sons Inc.
      zootechnical additive, Ecobiol®, Bacillus amyloliquefaciens, safety, efficacy, QPS, chickens

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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 the safety and efficacy of Ecobiol ® when used as a zootechnical additive in feed for chickens for fattening and chickens reared for laying at 1.0 × 10 9 colony forming units ( CFU)/kg feed. Ecobiol ® is the trade name for a feed additive based on Bacillus amyloliquefaciens CECT 5940, currently authorised for use in chickens for fattening. This opinion concerns the renewal of the authorisation of Ecobiol ® for chickens for fattening and the evaluation of the new use with chickens reared for laying. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel concludes that Ecobiol ® is safe under the current conditions of authorisation for the target species (chickens for fattening and chickens reared for laying), consumers of products from animals fed the additive and the environment. Ecobiol ® is not irritant to skin/eye or a skin sensitiser but should be considered a potential respiratory sensitiser. Due to a high dusting potential, exposure of users by inhalation is likely. There is no need for assessing the efficacy of Ecobiol ® in the context of the renewal of the authorisation. The additive, at the level of 1 × 10 9 CFU/kg feed, has the potential to be efficacious in chickens reared for laying.

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          Most cited references6

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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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            Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA - Opinion of the Scientific Committee

            (2007)
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              Scientific Opinion on the update of the list of QPS ‐recommended biological agents intentionally added to food or feed as notified to EFSA †

              Abstract EFSA is requested to assess the safety of a broad range of biological agents in the context of notification for market authorisation as sources of food and feed additives, food enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide a harmonised generic pre‐assessment to support safety risk assessments performed by EFSA's scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended), and the completeness of the body of knowledge are assessed. Identified safety concerns for a taxonomic unit are, where possible and reasonable in number, reflected as ‘qualifications’ in connection with a recommendation for a QPS status. The list of QPS recommended biological agents was reviewed and updated in the current opinion and therefore becomes the valid list. The 2016 update reviews previously assessed microorganisms including bacteria, yeasts and viruses used for plant protection purposes following an Extensive Literature Search strategy. The taxonomic units related to the new notifications received since the 2013 QPS opinion, were periodically evaluated for a QPS status and the results published as Statements of the BIOHAZ Panel. Carnobacterium divergens, Lactobacillus diolivorans, Microbacterium imperiale, Pasteuria nishizawae, Pediococcus parvulus, Bacillus flexus, Bacillus smithii, Xanthomonas campestris and Candida cylindracea were recommended for the QPS list. All taxonomic units previously recommended for the 2013 QPS list had their status reconfirmed as well their qualifications with the exception of Pasteuria nishizawae for which the qualification was removed. The exclusion of filamentous fungi and enterococci from the QPS evaluations was reconsidered but monitoring will be maintained and the status will be re‐evaluated in the next QPS Opinion update. Evaluation of bacteriophages should remain as a case‐by‐case procedure and should not be considered for QPS status.
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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
                20 February 2020
                February 2020
                : 18
                : 2 ( doiID: 10.1002/efs2.v18.2 )
                : e06014
                Author notes
                [*] [* ] Correspondence: feedap@ 123456efsa.europa.eu
                Article
                EFS26014
                10.2903/j.efsa.2020.6014
                7447869
                b1d15ad4-3cb0-496a-9189-6ed3cb853c1f
                © 2020 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: 0, Pages: 9, Words: 3646
                Categories
                Scientific Opinion
                Scientific Opinion
                Custom metadata
                2.0
                February 2020
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.8.7 mode:remove_FC converted:26.08.2020

                zootechnical additive,ecobiol®,bacillus amyloliquefaciens,safety,efficacy,qps,chickens

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