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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)Inositol was authorised for a period of 10 years as a feed additive for fish and crustaceans by Commission Implementing Regulation (EU) No 1249/2014note.
(3)In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of inositol as a feed additive for food-producing finfish, ornamental finfish, food-producing crustaceans and ornamental crustaceans, 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.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 16 September 2025note that the applicant has provided evidence that inositol remains safe for food-producing finfish, ornamental finfish, food-producing crustaceans and ornamental crustaceans as well as for consumers and the environment under the conditions of use currently authorised. The Authority further stated that inositol is not irritant to skin and eyes and is not a skin sensitiser. 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 inositol 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, an evaluation report of the Reference Laboratory is therefore not required.
(6)In view of the above, the Commission considers that inositol satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed.
(7)As a consequence of the renewal of the authorisation of inositol as a feed additive, Implementing Regulation (EU) No 1249/2014 should be repealed.
(8)Since certain labelling conditions related to the storage conditions and stability have been modified and, in addition, the reference to certain animal species, 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 substance 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) No 1249/2014 is repealed.
Article 3Transitional measures#
1.The feed additive inositol as authorised by Implementing Regulation (EU) No 1249/2014 and premixtures containing that additive which are intended for fish and crustaceans, and which are produced and labelled before 18 December 2026 in accordance with the rules applicable before 18 June 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 18 June 2027 in accordance with the rules applicable before 18 June 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 18 June 2028 in accordance with the rules applicable before 18 June 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: nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect | ||||||||
| 3a900 | Inositol | Additive compositionInositolSolid formCharacterisation of the active substanceInositolChemical formula: C6H12O6CAS No: 87-89-8Inositol produced by chemical synthesis.Purity criteria: min. 97 %.Solid formAnalytical methodnoteFor identification of inositol in the feed additive: Liquid Chromatography and infrared absorption spectrophotometry – European Pharmacopoeia monograph 1805.For the quantification of inositol in the feed additive, premixtures and compound feed: microbiological activity analysis | Food-producing finfishOrnament al finfishFood-producing crustaceansOrnamental crustaceans | — | — | — | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated. | 18 June 2036 |
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