Commission Implementing Regulation (EU) 2026/1234 of 11 June 2026 concerning the authorisation of vermiculite as a feed additive for chickens for fattening, chickens reared for laying or reproduction and hens

Official Journal EN of the European Union L series 2026/1234 12.6.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/1234 of 11 June 2026 concerning the authorisation of vermiculite as a feed additive for chickens for fattening, chickens reared for laying or reproduction and hens (Text with EEA relevance) 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(1), 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 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, (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal. 2025;23:e9362. https://doi.org/10.2903/j.efsa.2025.9362. (3) https://www.efsa.europa.eu/en/events/185th-plenary-meeting-feedap-panel-open-observers. ELI: http://data.europa.eu/eli/reg_impl/2026/1234/oj 1/3EN OJ L, 12.6.2026 HAS ADOPTED THIS REGULATION: Article 1 Authorisation The vermiculite specified in the Annex, belonging to the additive category ‘technological additives’ and the functional group ‘anticaking agents’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Entry 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. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 11 June 2026. For the Commission The President Ursula VON DER LEYEN 2/3 ELI: http://data.europa.eu/eli/reg_impl/2026/1234/ojANNEX Minimum Maximum content content Identification Species or End of period Name of the Composition, chemical formula, Maximum number of the category of Other provisions of additive description, analytical method age mg of additive/kg of complete additive animal authorisation feed with a moisture content of 12 % Category: technological additives. Functional group: anticaking agents. 1i561 Vermiculite Additive composition Chickens for — 10 000 10 000 1. In the directions for use of the 2 July 2036 Magnesium aluminium iron silicate, fattening additive and premixtures, the (vermiculite) containing ≥ 87,0 %, storage conditions shall be hydroxyapatite ≥ 1,0 % and diopside Chickens indicated. (Fe+2-bearing) ≥ 2,4 % reared for Powder form. laying or 2. When the additive is used as an reproduction anticaking agent directly in a feed Characterisation of the active substance material or complementary feed, it Vermiculite (magnesium aluminium Hens shall be used at a minimum level of iron silicate): 10 000 mg/kg feed. Obtained by mining and followed by thermal expansion (exfoliation) 3. For users of the additive and Chemical formula: (Mg,Fe2+,Al) (Al, premixtures, feed business 3 Si) O (OH) ·4(H O) . operators shall establish 4 10 2 2 2 Nickel ≤ 148 mg/kg operational procedures and Crystalline silica ≤ 0,06 % organisational measures to address Chromium ≤ 199 mg/kg potential risks resulting from their Free of asbestos(1) use. Where those risks cannot be eliminated by such procedures and Analytical method(2) measures, the additive and For the characterisation of the feed premixtures shall be used with additive: personal protective equipment, — X-ray diffraction (XRD) (EN including eye, skin and breathing 13925) and protection. Particular attention — X-ray fluorescence (XRF) shall be given to compliance with spectrometry (EN ISO 12677) Union legislation on the protection of workers from the inhalation risks related to exposure to crystalline silica and nickel. (1) Polarised light microscopy (PLM) and dispersion staining microscopy (2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en ELI: http://data.europa.eu/eli/reg_impl/2026/1234/oj 3/3 OJ L, 12.6.2026 EN