(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)    Menadione sodium bisulphite (vitamin K3) and menadione nicotinamide bisulphite (vitamin K3) were authorised for 10 years as feed additives for cats and dogs by Commission Implementing Regulation  (EU) 2015/2307  .

(3)    In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of menadione sodium bisulphite (vitamin K3) and menadione nicotinamide bisulphite (vitamin K3) for all animal species, requesting the additives to be classified in the additive category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having a 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 19 November 2025  that, the applicant has provided evidence that menadione sodium bisulphite (vitamin K3) and menadione nicotinamide bisulphite (vitamin K3) remain safe for all animal species as well as for the consumers, the users and the environment under the conditions currently authorised. The Authority further concluded that the exposure of users to menadione sodium bisulphite (vitamin K3) and menadione nicotinamide bisulphite (vitamin K3) by any route is considered as risk and should be minimised. 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 additives. Therefore, it concluded that there is no need for assessing the efficacy of the additives 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 methods of analysis of menadione sodium bisulphite and menadione nicotinamide bisulphite as a feed additives 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 , the evaluation report of the Reference Laboratory is therefore not required.

(6)    In view of the above, the Commission considers that menadione sodium bisulphite (vitamin K3) and menadione nicotinamide bisulphite (vitamin K3) satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of those additives should be renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives. 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 menadione sodium bisulphite (vitamin K3) and menadione nicotinamide bisulphite,(vitamin K3) Implementing Regulation (EU) 2015/2307 should be repealed.

(8)    Since the specifications of the additives have been modified, 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,