Safety of the preparation of monensin sodium (Coxidin®) produced with Streptomyces sp. LMG S-19095 as a coccidiostat for chickens for fattening and chickens reared for laying (Huvepharma N.V.)

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of monensin sodium (Coxidin®) produced with Streptomyces sp. LMG S-19095 as a coccidiostat for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. In 2024, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive for chickens for fattening and chickens reared for laying, nor on the potential of the formulation containing calcium carbonate to be irritant to skin and eyes and to be a skin sensitiser, and could not exclude a risk for the aquatic compartment when used in chickens for fattening. The applicant provided additional information to address the limitations regarding the safety of the additive and submitted a plan for the post marketing monitoring. During the assessment the applicant reduced the maximum recommended dose for the use of the additive in chickens for fattening and chickens reared for laying from 125 to 120 mg monensin sodium/kg complete feed. The Panel concludes that the use of monensin sodium from Coxidin® is safe up to the newly proposed maximum recommended level of 120 mg/kg complete feed for chickens for fattening and chickens reared for laying/breeding. Coxidin® formulated with calcium carbonate is not a skin irritant but should be considered as a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. No conclusions can be reached on its eye irritation potential. The use of monensin sodium from Coxidin® in complete feed for chickens for fattening and chickens reared for laying poses no risk for the environment. The proposal of the post-market monitoring plan of the applicant is appropriate.