BAKGRUNN (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 such an authorisation.

(2) Niacin and niacinamide were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 642/2013 (2).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, two applications were submitted for the renewal of the authorisation of niacin and niacinamide 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 similar effect’. Those applications were accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. The Commission considers that the name of the additive ‘niacin’ used in the initial authorisation should be replaced by the name ‘nicotinic acid’ as the term ‘niacin’ is one of the generic names used for nicotinic acid but also for other substances such as nicotinamide and related derivatives.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 26 September 2023 (3) that the applicant provided evidence that nicotinic acid and niacinamide remain safe for all animal species, consumers and the environment under the conditions of use currently authorised. The Authority concluded that nicotinic acid and niacinamide remain efficacious as an effective source of niacin in animal nutrition and that nicotinic acid and niacinamide are not irritant to skin but irritant to eyes. The Authority further concluded that they are not dermal sensitisers and the exposure through inhalation is likely. 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 the assessment carried out regarding the method of analysis of nicotinic acid and niacinamide as 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 (4), an evaluation report of the Reference Laboratory is therefore not required.

(6) In view of the above, the Commission considers that nicotinic acid and niacinamide satisfy the conditions for authorisation 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.

(7) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of nicotinic acid, 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 as a result of the change of the name of the additive ‘niacin’ by ‘nicotinic acid’.

(8) As a consequence of the renewal of the authorisation of nicotinic acid and niacinamide, Implementing Regulation (EU) No 642/2013 should be repealed.

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