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)

Roberto Edoardo Villa; Giovanna Azimonti; Eleftherios Bonos; Henrik Christensen; Mojca Durjava; Birgit Dusemund; Ronette Gehring; Boet Glandorf; Maryline Kouba; Marta López-Alonso; Francesca Marcon; Carlo Nebbia; Alena Pechová; Miguel Prieto-Maradona; Ilen Röhe; Katerina Theodoridou; Kettil Svensson; Luca Tosti; Jaume Galobart; Orsolya Holczknecht; Maria Vittoria Vettori; Fabiola Pizzo; EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

doi:10.2903/j.efsa.2025.9250

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)

Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Kettil Svensson, Luca Tosti, Jaume Galobart, Orsolya HolczknechtMaria Vittoria Vettori, Fabiola Pizzo, EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

School of Biological Sciences

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Abstract

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.

Original language	English
Article number	e9250
Journal	EFSA Journal
Volume	23
Issue number	2
DOIs	https://doi.org/10.2903/j.efsa.2025.9250
Publication status	Published - 12 Feb 2025

Keywords

all animal species
efficacy
nutritional additives
safety
vitamins

ASJC Scopus subject areas

Parasitology
Food Science
Microbiology
Animal Science and Zoology
veterinary (miscalleneous)
Plant Science

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10.2903/j.efsa.2025.9250Licence: CC BY-ND

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)
© 2025 European Food Safety Authority. This is an open access article published under a Creative Commons Attribution-NoDerivs License (https://creativecommons.org/licenses/by-nd/4.0/), which permits reproduction and redistribute in any medium, provided the author and source are cited and any subsequent modifications are not distributed.
Final published version, 140 KBLicence: CC BY-ND

Cite this

Villa, R. E., Azimonti, G., Bonos, E., Christensen, H., Durjava, M., Dusemund, B., Gehring, R., Glandorf, B., Kouba, M., López-Alonso, M., Marcon, F., Nebbia, C., Pechová, A., Prieto-Maradona, M., Röhe, I., Theodoridou, K., Svensson, K., Tosti, L., Galobart, J., ... EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) (2025). 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). EFSA Journal, 23(2), Article e9250. https://doi.org/10.2903/j.efsa.2025.9250

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title = "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)",

abstract = "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.",

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Villa, RE, Azimonti, G, Bonos, E, Christensen, H, Durjava, M, Dusemund, B, Gehring, R, Glandorf, B, Kouba, M, López-Alonso, M, Marcon, F, Nebbia, C, Pechová, A, Prieto-Maradona, M, Röhe, I, Theodoridou, K, Svensson, K, Tosti, L, Galobart, J, Holczknecht, O, Vettori, MV, Pizzo, F & EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2025, '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)', EFSA Journal, vol. 23, no. 2, e9250. https://doi.org/10.2903/j.efsa.2025.9250

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AU - Villa, Roberto Edoardo

AU - Azimonti, Giovanna

AU - Bonos, Eleftherios

AU - Christensen, Henrik

AU - Durjava, Mojca

AU - Dusemund, Birgit

AU - Gehring, Ronette

AU - Glandorf, Boet

AU - Kouba, Maryline

AU - López-Alonso, Marta

AU - Marcon, Francesca

AU - Nebbia, Carlo

AU - Pechová, Alena

AU - Prieto-Maradona, Miguel

AU - Röhe, Ilen

AU - Theodoridou, Katerina

AU - Svensson, Kettil

AU - Tosti, Luca

AU - Galobart, Jaume

AU - Holczknecht, Orsolya

AU - Vettori, Maria Vittoria

AU - Pizzo, Fabiola

AU - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

PY - 2025/2/12

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N2 - 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.

AB - 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.

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KW - efficacy

KW - nutritional additives

KW - safety

KW - vitamins

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DO - 10.2903/j.efsa.2025.9250

M3 - Article

AN - SCOPUS:86000254358

SN - 1831-4732

VL - 23

JO - EFSA Journal

JF - EFSA Journal

IS - 2

M1 - e9250

ER -

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)

Abstract

Keywords

ASJC Scopus subject areas

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