(fra kommisjonsforordningen)

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such an authorisation.

(2) Taurine was authorised for 10 years as feed additive for Canidae, Felidae, Mustelidae and carnivorous fish by Commission Implementing Regulation (EU) 2015/722 (2).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of a preparation of taurine as a feed additive for Canidae, Felidae, Mustelidae and carnivorous fish, and for the authorisation of a new use in poultry and porcine species, requesting the additive to be classified in the additive category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. The applicant later withdrew the application for poultry and porcine species.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 24 June 2025 (3) that the applicant has provided evidence that the preparation of taurine remains safe for Canidae, Felidae, Mustelidae, carnivorous fish, as well as for the consumers and the environment under the conditions currently authorised. The authority indicated that taurine at levels 0,05 %–0,25 % in complete feed is safe for cats with a margin of safety between 4 and 20. Based on the limited data set available from the literature on carnivorous finfish, it was considered that levels between 2,0 % and 2,5 % are safe. For the other species, the Authority concluded that levels up to 0,2 % taurine in complete feed are tolerated, but a margin of safety could not be provided. The Authority further concluded that taurine is a skin and eye irritant, and a skin and respiratory sensitiser. Any exposure to that substance is considered a risk. The Authority stated that the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, it concluded that there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. The Authority considered that there is no need for specific requirements of post-market monitoring.

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of taurine as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (4), the evaluation report of the Reference Laboratory is therefore not required.

(6) In view of the above, the Commission considers that the preparation of taurine satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. The Commission considers that for Canidae, Mustelidae, carnivorous finfish and other aquatic carnivorous species, except mammals a margin of safety could not be provided, therefore a maximum content need to be set for those species. Due to the impossibility to make an effective control to ensure compliance with the maximum content when the additive is used simultaneously in water and feed, the use in water should be permitted only in Felidae. In relation to the species and categories of animals, the Commission considers that the previous authorisation covered, under the generic term “fish,” all aquatic species, except mammals. There are studies on different species of crustaceans and molluscs for which taurine is required and there is no risk to authorise taurine for those species (5). In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.

(7) As a consequence of the renewal of the authorisation of the preparation of taurine as a feed additive, Implementing Regulation (EU) 2015/722 should be repealed.

(8) Implementing Regulation (EU) 2015/722 provides that taurine is allowed to be placed on the market and used as an additive consisting of a preparation, but the composition of such preparation has erroneously not been specified in the terms of the authorisation. A more accurate description of taurine authorised as a preparation at concentrations of 97 % should be provided for, by specifying the composition of the additive authorised as preparation. In addition, since maximum contents of the additive are set out for Canidae, Mustelidae and carnivorous finfish and other aquatic carnivorous species, except mammals, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,