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      Assessment of the application for renewal of authorisation of Levucell SC ( Saccharomyces cerevisiae CNCM I‐1077) as a feed additive for lambs and horses

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          Abstract

          Levucell ® SC is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae. The product is currently authorised for use in feed for horses, lambs, dairy sheep and dairy goats, dairy cows and cattle for fattening. This opinion concerns the renewal of the authorisation of Levucell ® SC as a zootechnical additive for lambs and horses. S. cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety ( QPS) approach to establishing safety for the target species, consumers and the environment. The identity of the strain present in the additive was established. Accordingly, this strain is presumed safe for the target species, consumers of products from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, Levucell ®  SC is also considered safe for the target species, consumers of products from animals fed the additive and the environment. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. Furthermore, according to the information provided in the technical dossier, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions on the safety of the product for target species, consumers, users and the environment under the authorised conditions of use. Levucell ® SC is an eye irritant.

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          Most cited references9

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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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              Guidance on the renewal of the authorisation of feed additives

              (2013)
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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
                21 March 2019
                March 2019
                : 17
                : 3 ( doiID: 10.1002/efs2.2019.17.issue-3 )
                : e05639
                Author notes
                [*] Correspondence: feedap@ 123456efsa.europa.eu
                Article
                EFS25639
                10.2903/j.efsa.2019.5639
                7009252
                861617fd-c5e8-49ea-8ef7-cba348ce6eca
                © 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: 0, Tables: 0, Pages: 12, Words: 6196
                Categories
                Scientific Opinion
                Scientific Opinion
                Custom metadata
                2.0
                March 2019
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:21.01.2020

                levucell sc,saccharomyces cerevisiae cncm i‐1077,safety,efficacy,qps,lambs,horses

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