# 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.)

## TL;DR

This paper assesses the safety of betaine anhydrous and betaine hydrochloride as animal feed additives and confirms they are safe under current conditions.

## Contribution

The study confirms the safety of betaine anhydrous and betaine hydrochloride for animal feed under existing authorization conditions.

## Key findings

- Betaine anhydrous and betaine hydrochloride are safe for target species, consumers, and the environment under current authorization conditions.
- Both additives are irritants to skin and eyes, and betaine hydrochloride is a dermal and respiratory sensitiser.
- No efficacy assessment was needed for the renewal of authorization.

## 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.