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#32026R0532Commission Implementing Regulation (EU) 2026/532 of 11 March 2026 renewing and expanding authorisation of monensin sodium (Coxidin) as a coccidiostat for poultry and repealing prior regulations

🇪🇺European Union··Other·Medium Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

This regulation renews the 10-year authorisation of two formulations of monensin sodium (Coxidin) – with wheat bran and with calcium carbonate – as a coccidiostat for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for reproduction. It raises the maximum authorised level from 100 mg/kg to 120 mg/kg for chickens and maintains 60–100 mg/kg for turkeys. Existing authorisations under Regulation (EC) No 109/2007 and Implementing Regulation (EU) No 140/2012 are repealed. EFSA confirmed safety for target animals, consumers (with specific MRLs), and the environment, while noting inhalation risks and skin/eye irritation depending on the formulation. A mandatory post-market resistance monitoring programme for Eimeria spp. must start in 2031.

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Key Changes

  • Maximum content increased to 120 mg monensin sodium/kg complete feed for chickens for fattening and chickens reared for laying
  • Authorisation extended to turkeys reared for reproduction (both formulations) and wheat-bran form for chickens reared for laying
  • Post-market monitoring programme for Eimeria resistance mandatory from 1 April 2031, with EU-wide field monitoring and sensitivity tests

+ 3 more changes with Pro

Obligations

What this law requires

high

Manufacturers and feed producers must not exceed maximum authorised levels of monensin sodium: 120 mg/kg complete feed for chickens for fattening and chickens reared for laying; 60-100 mg/kg complete feed for turkeys for fattening and turkeys reared for reproduction

Feed additive manufacturers, feed producers using monensin sodium (Coxidin)
operational
high

Implement post-market monitoring programme to trace and document any signs of resistance to monensin sodium in Eimeria spp., commencing five years after entry into force of this Regulation (by March 2031)

Authorisation holder (Huvepharma N.V.) and competent authorities
reporting
high

Ensure the preparation with wheat bran is not used as a skin sensitiser and provide eye irritation warnings; ensure the preparation with calcium carbonate is labelled as skin and respiratory sensitiser with appropriate protective measures

Feed additive manufacturers and distributors of monensin sodium (Coxidin)
disclosure
high

Implement protective measures to prevent adverse health effects from inhalation exposure to both formulations of the preparation for users of the additive

Manufacturers, distributors, and end-users handling monensin sodium (Coxidin)
operational
high

Cease production and marketing of monensin sodium (Coxidin) under the previous authorisations (Regulation (EC) No 109/2007 and Implementing Regulation (EU) No 140/2012) following the transitional period

Feed additive manufacturers and authorisation holders
prohibition

Affected Parties

Feed additive manufacturersPoultry farmers (chicken and turkey producers)+3 more…

Tags

feed additives,coccidiostats,monensin sodium