Assessment of the feed additives thiamine hydrochloride (3a820) and thiamine mononitrate (3a821) (vitamin B1) for all animal species for the renewal of their authorisation (DSM Nutritional Products Ltd. and Orffa Additives BV)
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B<sub>1</sub> (thiamine hydrochloride and thiamine mononitrate) for the renewal of its authorisation as nutritional feed additive for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that vitamin B<sub>1</sub> remains safe for all animal species, consumers and the environment. Thiamine mononitrate is not irritant to the eyes, while hydrochloride is not irritant to skin, but it is irritant to the eyes. Both salts of thiamine are considered skin and respiratory sensitisers, and any exposure is considered a risk. These conclusions would apply, in principle, to any preparations produced with the thiamine mononitrate. The Panel concluded there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Authors
- Ilen Röhe
- 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)
- Angelica Amaduzzi
- 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)
- 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
- Fabiola Pizzo
- Ruud Woutersen
- Maria Vittoria Vettori
- Eleni Gkimprixi
- Maria Dulak‐Lis
- Laura Iancu
Publication Details
- Journal
- EFSA Journal
- Published
- 2025-04-01
- DOI
- https://doi.org/10.2903/j.efsa.2025.9347
- Primary Topic
- Agricultural safety and regulations
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- European Food Safety Authority