Diclazuril in poultry feed: what changes with Regulation 2026/2086 for manufacturers and farms

Key data

Feed manufacturers and poultry farms using the 0.5% diclazuril preparation (marketed as Clinacox 0.5%) have an immediate obligation: to verify that their conditions of use comply with the new authorized framework. The Commission Implementing Regulation (EU) 2026/2086, in force since 18 September 2026, renews the authorization of this coccidiostat additive and expressly repeals the two regulations that governed it until now.

Non-compliance with the doses and conditions established can result in sanctions and product withdrawal from the market. This is not a minor change in form: regulatory consolidation means that any reference to previous regulations becomes void and must be updated in companies' records and technical documentation.

What does this regulation establish?

Regulation 2026/2086 renews the authorization of the 0.5% diclazuril preparation as a coccidiostat additive in feed intended for two categories of poultry:

• Broiler chickens
• Chickens reared for laying

The renewal confirms that the product continues to meet the safety and efficacy requirements evaluated by the EFSA (European Food Safety Authority). The authorization holder is Elanco GmbH.

One of the most relevant changes from an operational perspective is the express repeal of two previous regulations, which are replaced by this single act:

This consolidation simplifies the regulatory framework: there are no longer two parallel acts regulating the same product. From now on, all regulation applicable to 0.5% diclazuril in poultry feed is found in Regulation 2026/2086.

Economic and operational impact

The renewal of the authorization does not imply additional direct costs for operators who were already using Clinacox 0.5% in compliance. However, it does generate specific operational obligations that, if ignored, can result in significant economic consequences:

• Review of formulations and labeling: Feed manufacturers must ensure that their technical sheets, labels and product documentation refer to the new regulation (2026/2086) and not to the repealed ones (1118/2010 or 667/2013).
• Update of internal records: Any quality management or traceability system that cites the repealed regulations must be updated to avoid non-conformities in audits.
• Risk of product withdrawal: Non-compliance with the doses and conditions established in the new regulation can result in sanctions and product withdrawal from the market, with the consequent impact on the supply chain.
• Supply continuity assured: The renewal guarantees that Elanco GmbH can continue to market Clinacox 0.5%, so there is no risk of additive shortage.

Who does it affect?

• Compound feed manufacturers that include 0.5% diclazuril (Clinacox) in their formulations for broiler chickens or chickens reared for laying.
• Poultry farms that use feed with this coccidiostat additive, both in meat production and in rearing of laying hens.
• Elanco GmbH, as the authorization holder, which must ensure that the marketing of the product complies with the conditions of the new regulation.
• Quality and regulatory managers in companies in the sector that manage technical and regulatory compliance documentation.
• Veterinarians and technical advisors to poultry farms who prescribe or recommend the use of coccidiostats.

Practical example

A compound feed manufacturer for broiler chickens that has been using Clinacox 0.5% in its formulations for years has references to Regulation (EU) No 1118/2010 and Commission Implementing Regulation (EU) No 667/2013 in its technical sheets and labels.

With the entry into force of Regulation 2026/2086 on 18 September 2026, both references become obsolete. If this company undergoes an inspection by the competent authority and its documentation still cites the repealed regulations, it may face a non-conformity that results in sanctions or an obligation to withdraw batches from the market.

The concrete action is simple but urgent: update all technical sheets, labels and internal records to reference the Commission Implementing Regulation (EU) 2026/2086 as the current regulatory act, and verify that the doses and conditions of use of the additive comply with what is established in the new text.

What should companies do now?

1. Identify all documents that reference the repealed regulations: Technical sheets, labels, product specifications, quality records and contracts that cite Regulation (EU) No 1118/2010 or Commission Implementing Regulation (EU) No 667/2013 must be updated to reflect Regulation 2026/2086.
2. Verify the authorized conditions of use: Review that the doses and conditions of application of 0.5% diclazuril in the feed manufactured or used comply exactly with what is established in the new regulation.
3. Update quality management systems: Incorporate the new regulation number in internal procedures, audits and traceability systems to avoid non-conformities.
4. Communicate the change to the supply chain: Inform customers (poultry farms) and suppliers about the regulatory update, especially if you supply them with technical documentation that cites the repealed regulations.
5. Consult with the regulatory department or external advisor: Confirm that no other aspect of the authorization (indications, species, restrictions) has changed with respect to the previous regulations, and document this verification.

Official source

Consult complete regulation at official source

Notice: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:32026R2086