The European Commission has finally decided to forbid the use of veterinary drugs that contain zinc oxide.
According to the draft of the Decision, the Commission has decided to withdraw the marketing authorisations and to deny new authorisation requests for the commercialisation of zinc oxide for its use in piglets. The Commission consulted the Member States and stakeholders, which presented their views on the potential adverse impact stemming from the immediate withdrawal of the marketing authorisations in certain Member States. While recognising that the environmental impact depended on the soil type, it is necessary to allow time to develop alternatives that are available and affordable and change pig farming practices without increasing the use of antimicrobials. Therefore, the Commission considers that the Member States must be granted a 5-year period to withdraw the marketing authorisations of veterinary drugs containing zinc oxide.
The matter had been referred to the Committee by the Netherlands and France under Article 35 of Directive 2001/82/EC due to concerns related to the potential risk to the environment and the increase of the prevalence of antibiotic-resistant bacteria from the use of products containing zinc oxide. The Committee concluded 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 that at present such risk is not quantifiable. The Committee adopted by consensus a final opinion recommending the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide.
Last March, the CVMP re-examined the case, concluding that the recommendations included in its initial judgement from December 2016 should be maintained, and left on the hands of the European Commission the final decision about these products.
Monday, 19 June 2017/ Comitology Register/ European Commission.