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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 nutritionnote, 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 2025note concluded that vermiculite is considered safe at 10000 mg/kg complete feed for chickens for fattening, chickens reared for laying or breeding and laying hens, and at 5000 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 10000 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 reportnote 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,
HAS ADOPTED THIS REGULATION:
Article 1Authorisation#
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 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 additive | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: anticaking agents. | ||||||||
| 1i561 | Vermiculite | Additive compositionMagnesium aluminium iron silicate, (vermiculite) containing ≥ 87,0 %, hydroxyapatite ≥ 1,0 % and diopside (Fe+2-bearing) ≥ 2,4 %Powder form.Characterisation of the active substanceVermiculite (magnesium aluminium iron silicate):Obtained by mining and followed by thermal expansion (exfoliation)Chemical formula: (Mg,Fe2+,Al)3(Al,Si)4O10(OH)2·4(H2O)2.Nickel ≤ 148 mg/kgCrystalline silica ≤ 0,06 %Chromium ≤ 199 mg/kgFree of asbestosnoteAnalytical methodnoteFor the characterisation of the feed additive:X-ray diffraction (XRD) (EN 13925) andX-ray fluorescence (XRF) spectrometry (EN ISO 12677) | Chickens for fatteningChickens reared for laying or reproductionHens | — | 10000 | 10000 | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. When the additive is used as an anticaking agent directly in a feed material or complementary feed, it shall be used at a minimum level of 10000 mg/kg feed.3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address 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 protective equipment, including eye, skin and breathing protection. Particular attention shall be given to compliance with Union legislation on the protection of workers from the inhalation risks related to exposure to crystalline silica and nickel. | 2 July 2036 |
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