Date: 2026-01-27Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2026/167 of 26 January 2026 concerning the renewal of the authorisation of clinoptilolite of sedimentary origin as a feed additive for all animal species and repealing Implementing Regulation (EU) No 651/2013
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
This document is the Commission Implementing Regulation (EU) 2026/167, dated January 26, 2026. It concerns the renewal of the authorization of clinoptilolite of sedimentary origin as a feed additive for all animal species. This regulation repeals Implementing Regulation (EU) No 651/2013. The end of the period of authorisation is February 16, 2036.
**Key Points / Main Content**
* **Renewal of Authorization:**
* The authorization of clinoptilolite of sedimentary origin is renewed as a feed additive for all animal species.
* It belongs to the "technological additives" category.
* It belongs to the functional groups "binders" and "anticaking agents".
* **Conditions of Use and Composition:**
* The additive composition must consist of clinoptilolite of sedimentary origin ≥ 80% in solid form.
* The active substance is characterized as clinoptilolite (hydrated sodium calcium aluminosilicate) of sedimentary origin ≥ 80 % and clay minerals ≤ 20 % (free of fibres and quartz).
* CAS Number: 12173-10-3; EC number 687-562-6.
* The maximum content of the additive is 10,000 mg/kg of complete feed (with 12% moisture).
* **Requirements and Safety Measures:**
* Storage conditions must be indicated in the directions for use of the additive and premixtures.
* The total quantity of clinoptilolite from all sources shall not exceed 10,000 mg/kg complete feed.
* Feed business operators must establish operational procedures and organizational measures to address potential risks resulting from the additive's use.
* Personal protective equipment, including skin and breathing protection, shall be used when risks cannot be minimized.
* Particular attention should be given to compliance with Union legislation on worker protection from inhalation risks related to exposure to nickel.
* **Repeal of Previous Regulation:**
* Implementing Regulation (EU) No 651/2013 is repealed.
* **Entry into Force:**
* This Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union (20 days after January 27, 2026).
**Impact Analysis**
**Feed Business Operators**
* **Impact**
* Must comply with the renewed authorization requirements and conditions for using clinoptilolite of sedimentary origin as a feed additive.
* Face obligations related to storage conditions, maximum content limits, and the implementation of risk management measures.
* Operators have to establish operational procedures and organizational measures to address potential risks from using the additive.
* **Action Required**
* Update operational procedures and safety measures to align with the regulation.
* Ensure users of the additive and premixtures employ appropriate personal protective equipment.
* Provide clear directions for use, including storage conditions.
**Users of the Additive and Premixtures**
* **Impact**
* Subject to the safety measures and usage requirements outlined in the regulation.
* Experience potential changes in storage and handling procedures.
* Need to be aware of the risks associated with inhalation exposure to nickel and the need for personal protective equipment.
* **Action Required**
* Follow the updated directions for use and storage conditions for the additive and premixtures.
* Utilize appropriate personal protective equipment to minimize risks, particularly related to inhalation.
**Workers Handling the Additive**
* **Impact**
* Increased attention to safety measures and the use of personal protective equipment.
* Potential need for training on new operational procedures and risk management practices.
* **Action Required**
* Comply with Union legislation on the protection of workers from the inhalation risks related to exposure to nickel.
* Utilize appropriate personal protective equipment to minimize risks, particularly related to inhalation.
**European Food Safety Authority (EFSA)**
* **Impact**
* The conclusions of EFSA's opinion from 19 March 2025, regarding the safety of clinoptilolite of sedimentary origin, remain valid and underpin the renewal of the authorisation.
* **Action Required**
* No further assessment of the efficacy of the additive is required, as the application for renewal does not include a proposal for amending or supplementing the conditions of the original authorisation.
Key Entities Referenced
Regulation (EC) No 1831/2003: Regulation of the European Parliament and of the Council on additives for use in animal nutrition.
Implementing Regulation (EU) No 651/2013: Commission Implementing Regulation concerning the authorisation of clinoptilolite of sedimentary origin as a feed additive for all animal species, repealed by this document.
European Food Safety Authority: The European agency providing independent scientific advice and communication on risks associated with the food chain.
Clinoptilolite of sedimentary origin: A feed additive authorized for use in animal nutrition, whose authorization is being renewed.
Official Journal EN
of the European Union L series
2026/167 27.1.2026
COMMISSION IMPLEMENTING REGULATION(EU) 2026/167
of 26 January 2026
concerning the renewal of the authorisation of clinoptilolite of sedimentary origin as a feed additive
for all animal species and repealing Implementing Regulation (EU) No 651/2013
(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 and renewing such an authorisation.
(2) The substance clinoptilolite of sedimentary origin was authorised for a period of 10 years as a feed additive for all
animal species by Commission Implementing Regulation (EU) No 651/2013(2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of
the authorisation of clinoptilolite of sedimentary origin as a feed additive for all animal species, requesting the
additive to be classified in the additive category ‘technological additives’ and in the functional groups ‘binders’ and
‘anticaking agents’. That application was accompanied by the particulars and documents required under
Article 14(2) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 March 2025(3)that the additive
clinoptilolite of sedimentary origin remains safe for all animal species, consumers and the environment under the
conditions of use currently authorised. It also concluded that the additive is not a skin nor an eye irritant but should
be considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The Authority
also indicated that there is no need for assessing the efficacy of the additive, as the application for renewal of its
authorisation does not include a proposal for amending or supplementing the conditions of the original
authorisation which would have an impact on the efficacy of the additive.
(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 the clinoptilolite of
sedimentary origin as a feed additive 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.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) Commission Implementing Regulation (EU) No 651/2013 of 9 July 2013 concerning the authorisation of clinoptilolite of sedimentary
origin as a feed additive for all animal species and amending Regulation (EC) No 1810/2005 (OJ L 189, 10.7.2013, p. 1, ELI: http://
data.europa.eu/eli/reg_impl/2013/651/oj).
(3) EFSA Journal2025; 23:e9364 (https://doi.org/10.2903/j.efsa.2025.9364).
(4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC)
No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference
Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/
2005/378/oj).
ELI: http://data.europa.eu/eli/reg_impl/2026/167/oj 1/4EN
OJ L, 27.1.2026
(6) In view of the above, the Commission considers that the clinoptilolite of sedimentary origin satisfies the conditions
provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive 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 additive. Those protective measures should be without prejudice to
other workers’ safety requirements under Union law.
(7) As a consequence of the renewal of the authorisation of clinoptilolite of sedimentary origin as a feed additive,
Implementing Regulation (EU) No 651/2013 should be repealed.
(8) 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 1
Renewal of the authorisation
The authorisation of the substance specified in the Annex, belonging to the additive category ‘technological additives’ and
to the functional groups ‘binders’ and ‘anticaking agents’, is renewed, subject to the conditions laid down in that Annex.
Article 2
Repeal
Implementing Regulation (EU) No 651/2013 is repealed.
Article 3
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, 26 January 2026.
For the Commission
The President
Ursula VON DER LEYEN
2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/167/ojANNEX
Minimum Maximum
content content
Identification Species or
Name of the Composition, chemical formula, End of period of
number of the category of Maximum age Other provisions
additive description, analytical method mg of additive/kg of complete authorisation
feed additive animal
feed with a moisture content
of 12 %
Category: technological additives. Functional group: binders
1g568 Clinoptilolite of Additive composition All animal — — 10 000 1. In the directions for use of the 16 February
sedimentary Clinoptilolite of sedimentary species additive and premixtures, the 2036
origin origin ≥ 80 % Solid form. storage conditions shall be
indicated.
Characterisation of the active
substance 2. Total quantity of clinoptilolite
Clinoptilolite (hydrated sodium from all sources shall not exceed
calcium aluminosilicate) of the maximum content of
sedimentary origin ≥ 80 % and 10 000 mg/kg complete feed.
clay minerals ≤ 20 % (free of
fibres and quartz). 3. For users of the additive and
CAS Number 12173-10-3 premixtures, feed business
EC number 687-562-6 operators shall establish
operational procedures and
Analytical method(1) organisational measures to
For the determination of address potential risks resulting
clinoptilolite of sedimentary from their use. Where those risks
origin in feed additive: X-ray cannot be eliminated or reduced
diffraction (XRD). to a minimum 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 nickel.
(1) 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/2026/167/oj
3/4
OJ
L,
27.1.2026
ENMinimum Maximum
content content
Identification Species or
Name of the Composition, chemical formula, End of period of
number of the category of Maximum age Other provisions
additive description, analytical method mg of additive/kg of complete authorisation
feed additive animal
feed with a moisture content
of 12 %
Category: technological additives. Functional group: anticaking agents
1g568 Clinoptilolite of Additive composition All animal — — 10 000 1. In the directions for use of the 16 February
sedimentary Clinoptilolite of sedimentary species additive and premixtures, the 2036
origin origin ≥ 80 % Solid form. storage conditions shall be
indicated.
Characterisation of the active
substance 2. Total quantity of clinoptilolite
Clinoptilolite (hydrated sodium from all sources shall not exceed
calcium aluminosilicate) of the maximum content of
sedimentary origin ≥ 80 % and 10 000 mg/kg complete feed.
clay minerals ≤ 20 % (free of
fibres and quartz). 3. For users of the additive and
CAS Number 12173-10-3 premixtures, feed business
EC number 687-562-6 operators shall establish
operational procedures and
Analytical method(1) organisational measures to
For the determination of address potential risks resulting
clinoptilolite of sedimentary from their use. Where those risks
origin in feed additive: X-ray cannot be eliminated or reduced
diffraction (XRD). to a minimum 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 nickel.
(1) 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.
4/4
ELI:
http://data.europa.eu/eli/reg_impl/2026/167/oj
EN
OJ
L,
27.1.2026