Safety and efficacy of a feed additive consisting of sepiolite for all animal species (Sepiol S.A and Tolsa, S.A)
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 re‐evaluation of the authorisation of sepiolite as a feed additive for all animal species. The FEEDAP Panel consi...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-04-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2022.7250 |
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| author | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Gabriele Aquilina Georges Bories Luca Tosti Montserrat Anguita Jaume Galobart Orsolya Holczknecht Matteo Lorenzo Innocenti Paola Manini Fabiola Pizzo |
| author_facet | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Gabriele Aquilina Georges Bories Luca Tosti Montserrat Anguita Jaume Galobart Orsolya Holczknecht Matteo Lorenzo Innocenti Paola Manini Fabiola Pizzo |
| 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 Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the re‐evaluation of the authorisation of sepiolite as a feed additive for all animal species. The FEEDAP Panel considered that sepiolite is unlikely to be absorbed. Harmful amounts of residues of any chemical component in edible tissues/products, as a consequence of the use of sepiolite as a feed additive, are not expected. Sepiolite is not genotoxic and does not induce any toxicity effects following oral administration and, therefore, it was considered safe for the consumers. The additive was considered safe for dairy cows at the recommended use level with a safety factor of 2.5. The conclusion was extrapolated to other dairy ruminants but owing to the lack of sufficient data, no conclusions can be drawn on the safety of the additive for the other target species/categories. Based on the results of a chronic inhalation toxicity study, the additive is considered a respiratory irritant. Owing to the dusting potential of the additive and its silica content, handling the additive was considered a risk by inhalation for the users. It is not irritant or corrosive to skin or eyes. Due to the nickel content, it is considered a skin and respiratory sensitiser. The additive was considered safe for the environment. The FEEDAP Panel concluded that sepiolite was efficacious as a thickener‐suspending agent, binder and anticaking agent in feed for all animal species under the proposed conditions of use. |
| first_indexed | 2024-03-08T03:19:52Z |
| format | Article |
| id | doaj.art-abae781bc5e04a738ef1e348b97882f7 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-03-08T03:19:52Z |
| publishDate | 2022-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-abae781bc5e04a738ef1e348b97882f72024-02-12T10:36:13ZengWileyEFSA Journal1831-47322022-04-01204n/an/a10.2903/j.efsa.2022.7250Safety and efficacy of a feed additive consisting of sepiolite for all animal species (Sepiol S.A and Tolsa, S.A)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMojca Fašmon DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenGabriele AquilinaGeorges BoriesLuca TostiMontserrat AnguitaJaume GalobartOrsolya HolczknechtMatteo Lorenzo InnocentiPaola ManiniFabiola PizzoAbstract 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 re‐evaluation of the authorisation of sepiolite as a feed additive for all animal species. The FEEDAP Panel considered that sepiolite is unlikely to be absorbed. Harmful amounts of residues of any chemical component in edible tissues/products, as a consequence of the use of sepiolite as a feed additive, are not expected. Sepiolite is not genotoxic and does not induce any toxicity effects following oral administration and, therefore, it was considered safe for the consumers. The additive was considered safe for dairy cows at the recommended use level with a safety factor of 2.5. The conclusion was extrapolated to other dairy ruminants but owing to the lack of sufficient data, no conclusions can be drawn on the safety of the additive for the other target species/categories. Based on the results of a chronic inhalation toxicity study, the additive is considered a respiratory irritant. Owing to the dusting potential of the additive and its silica content, handling the additive was considered a risk by inhalation for the users. It is not irritant or corrosive to skin or eyes. Due to the nickel content, it is considered a skin and respiratory sensitiser. The additive was considered safe for the environment. The FEEDAP Panel concluded that sepiolite was efficacious as a thickener‐suspending agent, binder and anticaking agent in feed for all animal species under the proposed conditions of use.https://doi.org/10.2903/j.efsa.2022.7250example: sepiolitethickener‐suspending agentbinderanticaking agentall animal speciessafety |
| spellingShingle | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Birgit Dusemund Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Gabriele Aquilina Georges Bories Luca Tosti Montserrat Anguita Jaume Galobart Orsolya Holczknecht Matteo Lorenzo Innocenti Paola Manini Fabiola Pizzo Safety and efficacy of a feed additive consisting of sepiolite for all animal species (Sepiol S.A and Tolsa, S.A) EFSA Journal example: sepiolite thickener‐suspending agent binder anticaking agent all animal species safety |
| title | Safety and efficacy of a feed additive consisting of sepiolite for all animal species (Sepiol S.A and Tolsa, S.A) |
| title_full | Safety and efficacy of a feed additive consisting of sepiolite for all animal species (Sepiol S.A and Tolsa, S.A) |
| title_fullStr | Safety and efficacy of a feed additive consisting of sepiolite for all animal species (Sepiol S.A and Tolsa, S.A) |
| title_full_unstemmed | Safety and efficacy of a feed additive consisting of sepiolite for all animal species (Sepiol S.A and Tolsa, S.A) |
| title_short | Safety and efficacy of a feed additive consisting of sepiolite for all animal species (Sepiol S.A and Tolsa, S.A) |
| title_sort | safety and efficacy of a feed additive consisting of sepiolite for all animal species sepiol s a and tolsa s a |
| topic | example: sepiolite thickener‐suspending agent binder anticaking agent all animal species safety |
| url | https://doi.org/10.2903/j.efsa.2022.7250 |
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