(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) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of vermiculite. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of vermiculite as a feed additive for all poultry and ornamental birds, all porcine species, equines, leporids, camelids, pets and other non-food-producing animals, requesting that additive to be classified in the category ‘technological additives’ and in the functional group ‘anticaking agents’.

(4) The European Food Safety Authority (‘the Authority’) in its opinion of 20 March 2025 (2) concluded that vermiculite is considered safe at 10 000 mg/kg complete feed for chickens for fattening, chickens reared for laying or breeding and laying hens, and at 5 000 mg/kg complete feed for suckling and weaned piglets and pigs for fattening. However, considering the limitations of the studies assessed and the lack of a consistent margin of safety, no conclusion can be reached on the safety of vermiculite for other poultry species, ornamental birds, sows, other porcine species, equines, leporids, camelids, pets and other non-food-producing animals. It also concluded that the additive is safe for the consumer and the environment at the proposed conditions of use. Regarding user safety, the Authority concluded that the additive should be considered a skin and respiratory sensitiser, and that inhalation and dermal exposure should be considered a risk. Due to the lack of data, it could not conclude on the potential of the additive to be an eye irritant. It further concluded that vermiculite is efficacious as anticaking agent in feed, when used at 10 000 mg/kg complete feed, while noting that the concentration shown to be efficacious is higher than the maximum and safe use level for weaned piglets and pigs for fattening. The Authority also verified the amended report (3) on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) In view of the above, the Commission considers that vermiculite satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised for chickens for fattening, chickens reared for laying or reproduction and hens. 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.

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