Contents
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 clinoptilolite of volcanic origin. 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 clinoptilolite of volcanic origin as a feed additive for all terrestrial animal species, requesting that additive to be classified in the category ‘technological additives’ and in the functional groups ‘binders’ and ‘anticaking agents’.
(4)The European Food Safety Authority (‘the Authority’) in its opinion of 18 November 2025note concluded that clinoptilolite of volcanic origin at the maximum safe level of 20000 mg/kg complete feed is safe for all poultry for fattening, poultry reared for laying or reproduction, ornamental birds, suckling and weaned piglets and pigs for fattening. No conclusion can be drawn for other terrestrial species/categories. 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 is not irritant to the skin or eyes but should be considered a dermal and respiratory sensitiser. Exposure by dermal and inhalation routes is considered a risk and should be minimised. It further concluded that clinoptilolite of volcanic origin is efficacious as a pellet binder and anticaking agent in feed for terrestrial animal species, while noting that the efficacy as pellet binder has been shown at an inclusion level of 20000–30000 mg/kg complete feed, levels higher than the ones for which the safety has been supported. The Authority also verified the report 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)Following the opinion of the Authority, on 16 February 2026, the applicant formally requested the partial withdrawal of the above-mentioned application as regards the authorisation of the additive as anticaking agent for all terrestrial animals other than all poultry for fattening, poultry reared for laying or reproduction, ornamental birds, piglets (suckling and weaned), and pigs for fattening and the authorisation of the additive under functional group ‘binders’.
(6)In view of the above, the Commission considers that clinoptilolite of volcanic origin satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised for poultry for fattening, poultry reared for laying or reproduction, ornamental birds, piglets and pigs for fattening. 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.
(7)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 substance 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 | ||||||||
| 1i567 | Clinoptilolite of volcanic origin | Additive compositionClinoptilolite of volcanic origin containing:clinoptilolite ≥ 85,0 %Solid form.Characterisation of the active substanceClinoptilolite of volcanic origin (calcium hydrated aluminosilicate):Clinoptilolite ≥ 85,0 %,Feldspar, micas and clays ≤ 15,0 %CAS number 1318-02-1EC number 215-283-8Chemical formula:(Na,K,Ca)2–3Al3(Al,Si)2Si13O36•12H2OImpurities:Nickel ≤ 0,1 mg/kgRespirable crystalline silica ≤ 0,1 %Free of asbestosnoteAnalytical methodnoteFor the characterisation of the feed additive:X-ray diffraction (XRD) spectrometry (EN 13925) andX-ray fluorescence (XRF) spectrometry (EN ISO 12677) | Poultry for fatteningPoultry reared for laying or reproductionOrnamental birdsPigletsPigs for fattening | - | - | 20000 | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. The total quantity of clinoptilolite from all sources shall not exceed the maximum content of 20000 mg/kg complete 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 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. | 11.10.2036 |
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.