During the European Medicines Agency Committee for Medicinal Products for Veterinary Use (CVMP) meeting 6-8 December 2016, the Committee concluded the referral procedure for veterinary medicinal products containing zinc oxide to be administered orally to food producing species.
The matter was referred to the Committee by the Netherlands and France under Article 35 of Directive 2001/82/EC due to concerns related to potential risk to the environment and increase of prevalence of antibiotic resistant bacteria from the use of products containing zinc oxide.
The Committee adopted by consensus an opinion concluding that overall the benefit-risk balance for the products concerned by this referral is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment. The CVMP acknowledged that there is a risk of co-selection for resistance associated with the use of zinc oxide, but at the present time, that risk is not quantifiable.
The Committee therefore recommended the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide.
Friday December 9, 2016/ EMA/ European Union.