Assessment of the feed additive consisting of choline chloride for all animal species for the renewal of its authorisation (Andrés Pintaluba S.A., Taminco B.V., Balchem Italia S.r.l.)
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 | Montserrat Anguita | Jaume Galobart | Matteo L. Innocenti | Jordi Tarrés‐Call | Joana P. Firmino
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 choline chloride as a nutritional additive for all animal species. The additive is already authorised for use in all animal species (3a890). The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of the feed additive in animal nutrition under the proposed conditions of use remains safe for the target species, the consumers and the environment. Regarding user safety, the FEEDAP Panel concluded that the active substance choline chloride should be considered as a potential skin and respiratory sensitiser; therefore, any exposure via skin or respiratory tract is considered a risk. Although aqueous solutions of up to 70% choline chloride are considered non‐irritant to eyes, no conclusion can be reached on the eye irritation potential for more concentrated forms. These conclusions would apply, in principle, to any preparations produced with the active substance. The present application for renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive and therefore there is no need for re‐assessing the efficacy.
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