Assessment of the feed additives betaine anhydrous (3a920) and betaine hydrochloride (3a925) for all animal species for the renewal of their authorisations (Orffa Additives B.V.)
2025
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) | 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 | Stefania Fusani | Jaume Galobart | Paola Manini | Alberto Navarro‐Villa | Fabiola Pizzo | Maria Vittoria Vettori | Orsolya Holczknecht
Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of betaine anhydrous and betaine hydrochloride for the renewal of its authorisation. The applicant provided evidence that the additives betaine anhydrous (solid form) and betaine hydrochloride (solid form) both produced by chemical synthesis currently on the market comply with the existing conditions of authorisation. The use of betaine anhydrous and betaine hydrochloride as feed additives in animal nutrition remains safe for target species, consumers and the environment under the current authorised conditions. Regarding user safety, betaine anhydrous and betaine hydrochloride are irritant to skin and eyes. Betaine hydrochloride is also a dermal and respiratory sensitiser. Any exposure to these additives is considered a risk. These conclusions apply, in principle, to any preparations containing the active substances. There is no need for assessing the efficacy of the additives in the context of this renewal of the authorisation.
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