Commission Implementing Regulation (EU) 2025/2491

Contents

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 nutrition^note, 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 such authorisation.

(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of 25-hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)That application concerns the authorisation of a preparation of 25-hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 as a feed additive for all animal species except poultry, pigs and ruminants, requesting that 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’.

(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 May 2025^note that, under the proposed conditions of use, the preparation of 25-hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 is safe for all animal species except poultry, pigs and ruminants, as well as for consumers and the environment. The Authority also concluded that the additive is not irritant to the skin or eyes. However, due to lack of information, no conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system could be reached The Authority further concluded that the additive is efficacious in covering the target animals’ nutritional requirements. It did not consider that there is a 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 a previous assessment concerning another application for the authorisation of the same additive and verified by the Authority in its opinion of 5 of July 2023^note are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005^note, an evaluation report of the Reference Laboratory is therefore not required.

(6)In view of the above, the Commission considers that a preparation of 25-hydroxycholecalciferol produced with Saccharomyces cerevisiae CBS 146008 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for all animal species except poultry, pigs and ruminants. 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.

(7)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 1Authorisation#

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 authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2Entry 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 feed additive	Name of the Additive	Composition, chemical formula, description, analytical method.	Species or category of animal	Maximum content	Other provisions	End of period of authorisation
mg active substance/kg of complete feed with a moisture content of 12 %
Category: Nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect
Sub classification: vitamin D
3a670a	25-Hydroxycholecalciferol	Additive compositionPreparation with a maximum content of 1,25 % of 25-hydroxycholecalciferolSolid formCharacterisation of the active substance25-Hydroxycholecalciferol. Its precursor compound,5,7,24-cholestatrienol, is produced with Saccharomyces cerevisiae CBS 146008. After extraction, the precursor is converted chemically to 25-hydroxy-pro-vitamin D₃, which is further transformed photochemically to 25-hydroxycholecalciferol.Chemical formula: C₂₇H₄₄O₂•H₂OCAS number: 63283-36-3Purity criteria:25-hydroxycholecalciferol > 94 %;other sterol derivatives ≤ 1 % each;erythrosine < 5 mg/kg.Analytical method^noteFor the determination of 25-hydroxycholecalciferol in the feed additive: Ultra Performance Liquid Chromatography coupled to spectrophotometric detection (UPLC-UV).For the determination of 25-hydroxycholecalciferol in premixtures: High Performance Liquid Chromatography coupled to spectrophotometric detection (HPLC-UV).For the determination of 25-hydroxycholecalciferol in compound feed and in low concentrated premixtures: High Performance Liquid Chromatography coupled to tandem mass spectrometry (HPLC-MS/MS).	Salmonids	0,800	1. The additive shall be incorporated in feedingstuffs via the use of a premixture.2. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.3. Maximum content of the combination of 25-hydroxycholecalciferol with cholecalciferol (vitamin D3) per kg of complete feedingstuff: ≤ 1,500 mg (equivalent to 60 000 IU of cholecalciferol) for salmonids,≤ 0,075 mg (equivalent to 3 000 IU of cholecalciferol) for fish species other than salmonids and for ornamental fish,≤ 0,050 mg (equivalent to 2 000 IU of cholecalciferol) for other categories of animals except poultry, pigs and ruminants.4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the 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 and skin protective equipment.	31 December 2035
Finfish species other than salmonids			0,075
Ornamental fish			0,075
Other species and categories of animals except pigs, poultry and ruminants			0,050