Safety and efficacy of ZM16 10 (Bacillus amyloliquefaciens DSM 25840) as a feed additive for weaned piglets and minor porcine species
Abstract Following a request from the European Commission, the EFSA 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 ZM16 10 for weaned piglets and minor porcine species. The additive is a preparation c...
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| Format: | Article |
| Language: | English |
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Wiley
2018-04-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2018.5200 |
| _version_ | 1818559335169523712 |
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| author | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Guido Rychen Gabriele Aquilina Giovanna Azimonti Vasileios Bampidis Maria de Lourdes Bastos Georges Bories Andrew Chesson Pier Sandro Cocconcelli Gerhard Flachowsky Jürgen Gropp Boris Kolar Maryline Kouba Marta López‐Alonso Secundino López Puente Alberto Mantovani Baltasar Mayo Fernando Ramos Roberto Edoardo Villa Robert John Wallace Pieter Wester Rosella Brozzi Maria Saarela |
| author_facet | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Guido Rychen Gabriele Aquilina Giovanna Azimonti Vasileios Bampidis Maria de Lourdes Bastos Georges Bories Andrew Chesson Pier Sandro Cocconcelli Gerhard Flachowsky Jürgen Gropp Boris Kolar Maryline Kouba Marta López‐Alonso Secundino López Puente Alberto Mantovani Baltasar Mayo Fernando Ramos Roberto Edoardo Villa Robert John Wallace Pieter Wester Rosella Brozzi Maria Saarela |
| author_sort | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
| collection | DOAJ |
| description | Abstract Following a request from the European Commission, the EFSA 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 ZM16 10 for weaned piglets and minor porcine species. The additive is a preparation containing viable spores of a strain of Bacillus amyloliquefaciens intended for use in feed at the proposed dose of 5 × 108 CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 108 CFU/L. The additive exists in two forms, ZM16 and ZM16 10, which contain the bacterium in concentrations of 1.25 × 109 CFU/g additive and 1.25 × 1010 CFU/g additive, respectively. The two formulations are considered equivalent when used to deliver the same dose. B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements of the QPS approach to the assessment of safety. Consequently, the additive can be presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy of the additive to skin and eyes or its dermal sensitisation. Insufficient evidence was provided to conclude on the efficacy of the additive in weaned piglets or minor weaned porcine species. |
| first_indexed | 2024-12-14T00:24:04Z |
| format | Article |
| id | doaj.art-cc67665eab6c4fbead97d61be08e30b5 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-14T00:24:04Z |
| publishDate | 2018-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-cc67665eab6c4fbead97d61be08e30b52022-12-21T23:25:07ZengWileyEFSA Journal1831-47322018-04-01164n/an/a10.2903/j.efsa.2018.5200Safety and efficacy of ZM16 10 (Bacillus amyloliquefaciens DSM 25840) as a feed additive for weaned piglets and minor porcine speciesEFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Guido RychenGabriele AquilinaGiovanna AzimontiVasileios BampidisMaria de Lourdes BastosGeorges BoriesAndrew ChessonPier Sandro CocconcelliGerhard FlachowskyJürgen GroppBoris KolarMaryline KoubaMarta López‐AlonsoSecundino López PuenteAlberto MantovaniBaltasar MayoFernando RamosRoberto Edoardo VillaRobert John WallacePieter WesterRosella BrozziMaria SaarelaAbstract Following a request from the European Commission, the EFSA 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 ZM16 10 for weaned piglets and minor porcine species. The additive is a preparation containing viable spores of a strain of Bacillus amyloliquefaciens intended for use in feed at the proposed dose of 5 × 108 CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 108 CFU/L. The additive exists in two forms, ZM16 and ZM16 10, which contain the bacterium in concentrations of 1.25 × 109 CFU/g additive and 1.25 × 1010 CFU/g additive, respectively. The two formulations are considered equivalent when used to deliver the same dose. B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements of the QPS approach to the assessment of safety. Consequently, the additive can be presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy of the additive to skin and eyes or its dermal sensitisation. Insufficient evidence was provided to conclude on the efficacy of the additive in weaned piglets or minor weaned porcine species.https://doi.org/10.2903/j.efsa.2018.5200zootechnical additiveZM16 10Bacillus amyloliquefacienssafetyQPSefficacy |
| spellingShingle | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Guido Rychen Gabriele Aquilina Giovanna Azimonti Vasileios Bampidis Maria de Lourdes Bastos Georges Bories Andrew Chesson Pier Sandro Cocconcelli Gerhard Flachowsky Jürgen Gropp Boris Kolar Maryline Kouba Marta López‐Alonso Secundino López Puente Alberto Mantovani Baltasar Mayo Fernando Ramos Roberto Edoardo Villa Robert John Wallace Pieter Wester Rosella Brozzi Maria Saarela Safety and efficacy of ZM16 10 (Bacillus amyloliquefaciens DSM 25840) as a feed additive for weaned piglets and minor porcine species EFSA Journal zootechnical additive ZM16 10 Bacillus amyloliquefaciens safety QPS efficacy |
| title | Safety and efficacy of ZM16 10 (Bacillus amyloliquefaciens DSM 25840) as a feed additive for weaned piglets and minor porcine species |
| title_full | Safety and efficacy of ZM16 10 (Bacillus amyloliquefaciens DSM 25840) as a feed additive for weaned piglets and minor porcine species |
| title_fullStr | Safety and efficacy of ZM16 10 (Bacillus amyloliquefaciens DSM 25840) as a feed additive for weaned piglets and minor porcine species |
| title_full_unstemmed | Safety and efficacy of ZM16 10 (Bacillus amyloliquefaciens DSM 25840) as a feed additive for weaned piglets and minor porcine species |
| title_short | Safety and efficacy of ZM16 10 (Bacillus amyloliquefaciens DSM 25840) as a feed additive for weaned piglets and minor porcine species |
| title_sort | safety and efficacy of zm16 10 bacillus amyloliquefaciens dsm 25840 as a feed additive for weaned piglets and minor porcine species |
| topic | zootechnical additive ZM16 10 Bacillus amyloliquefaciens safety QPS efficacy |
| url | https://doi.org/10.2903/j.efsa.2018.5200 |
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