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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionnote, and in particular Article 9(2) thereof,Whereas:
(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) 2015/722note.
(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 2025note 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 378/2005note, 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 speciesnote. 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,
HAS ADOPTED THIS REGULATION:
Article 1Renewal of the authorisation#
The authorisation of the preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect,’ is renewed subject to the conditions laid down in that Annex.
Article 2Repeal#
Implementing Regulation (EU) 2015/722 is repealed.
Article 3Transitional measures#
1.The feed additive taurine as authorised by Implementing Regulation (EU) 2015/722 and premixtures containing that additive which are intended for Canidae, Felidae, Mustelidae and carnivorous fish, and which are produced and labelled before 19 February 2027 in accordance with the rules applicable before 19 August 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
2.Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 19 August 2027 in accordance with the rules applicable before 19 August 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.
3.Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 19 August 2028 in accordance with the rules applicable before 19 August 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.
Article 4Entry into force#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
| Identification number of the additive | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of active substance/kg of complete feed with a moisture content of 12 % | ||||||||
| Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | ||||||||
| 3a370 | Taurine | Additive compositionPreparation of taurine containing a minimum of 97 % of taurine.Solid formCharacterisation of the active substanceTaurineC2H7NO3SCAS number: 107-35-7Purity: min. 98 %Taurine solid form, produced by chemical synthesisAnalytical methodnoteFor the determination of taurine in the feed additive: ion-exchange chromatography with post column ninhydrin derivatisation (Ph. Eur. 2.2.56 Method 1).For the determination of taurine in premixtures and compound feed: ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS) or reversed phase high performance liquid chromatography with post-column derivatisation and fluorescence detection (HPLC-FLD) (AOAC 999.12).For the determination of taurine in water for drinking: high performance liquid chromatography coupled to UV or fluorescence detection (HPLC-UV/FLD). | Felidae | - | - | - | 1. The additive may be used via water for drinking for Felidae.2. In the directions for use of the additive and premixtures: (a)the storage conditions, stability to heat treatment shall be indicated;(b)the stability in water for drinking shall be indicated for Felidae3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing protective equipment. | 19 August 2036 |
| Canidae | - | - | 2000 | |||||
| Mustelidae | - | - | 2000 | |||||
| Carnivorous finfishOther aquatic carnivorous species, except mammals | - | - | 25000 |
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.