TY - JOUR
T1 - 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.)
AU - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
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 - Anguita, Montserrat
AU - Galobart, Jaume
AU - Innocenti, Matteo L
AU - Tarrés-Call, Jordi
AU - Firmino, Joana P
N1 - © 2025 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
PY - 2025/2
Y1 - 2025/2
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 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.
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 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.
KW - efficacy
KW - nutritional additives
KW - pro-vitamins and chemically well-defined substances having similar effect
KW - safety
KW - vitamins
U2 - 10.2903/j.efsa.2025.9264
DO - 10.2903/j.efsa.2025.9264
M3 - Article
C2 - 39981195
SN - 1831-4732
VL - 23
JO - EFSA Journal
JF - EFSA Journal
IS - 2
M1 - e9264
ER -