Assessment of the feed additive consisting of biotin for all animal species for the renewal of its authorisation (ADISSEO, DSM Nutritional Products Ltd., NHU Europe GmbH)
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of biotin as a nutritional feed additive for all animal species. The applicants provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions regarding the safety of the additive. The FEEDAP Panel concluded that biotin remains safe for all animal species, consumers and environment under the authorised conditions of use. Regarding the user safety, the Panel concluded that biotin is not irritant to skin or eyes and is not a dermal sensitiser. Exposure to the additive by inhalation is likely. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Authors
- Ilen Röhe
- Kettil Svensson
- Alena Pechová (ORCID: https://orcid.org/0000-0002-3798-1899)
- Eleftherios Bonos (ORCID: https://orcid.org/0000-0002-8166-564X)
- Henrik Christensen (ORCID: https://orcid.org/0000-0003-4238-4658)
- Roberto Edoardo Villa (ORCID: https://orcid.org/0000-0001-5536-1370)
- Katerina Theodoridou (ORCID: https://orcid.org/0000-0002-2848-5594)
- Marta López‐Alonso (ORCID: https://orcid.org/0000-0001-6426-4273)
- Francesca Marcon (ORCID: https://orcid.org/0000-0002-0431-8310)
- Ronette Gehring (ORCID: https://orcid.org/0000-0002-1329-201X)
- Carlo Nebbia (ORCID: https://orcid.org/0000-0003-0624-7787)
- Miguel Prieto Maradona (ORCID: https://orcid.org/0000-0001-9202-3856)
- Orsolya Holczknecht
- Mojca Fašmon Durjava (ORCID: https://orcid.org/0000-0001-7750-0001)
- Maryline Kouba
- Boet Glandorf (ORCID: https://orcid.org/0000-0003-3743-5107)
- Giovanna Azimonti
- Birgit Dusemund
- Luca Tosti (ORCID: https://orcid.org/0000-0002-7656-3681)
- Jaume Galobart
- Maria Vittoria Vettori
- Fabiola Pizzo
Publication Details
- Journal
- EFSA Journal
- Published
- 2025-02-01
- DOI
- https://doi.org/10.2903/j.efsa.2025.9250
- Citations
- 1
- Primary Topic
- Agricultural safety and regulations
- Type
- article
- Field-Weighted Citation Impact
- 1.16
Funders
- European Food Safety Authority