§ Mr. LuffTo ask the Secretary of State for Environment, Food and Rural Affairs if she will make a statement on the Government's policy in relation to the proposals from the European Commission to remove the authorisation for the anti-coccidial drugs Nicarbazin and Dimetridazole. [10206]
§ Mr. MorleyThe UK made representations to the Council of Ministers on 23 October opposing the Commission proposal to withdraw the authorisation of nicarbazin.
The proposal to withdraw nicarbazin was due solely to the company responsible for the product not having supplied a complete data dossier for re-evaluation by the agreed deadline.
The Veterinary Medicines Directorate and the Food Standards Agency are not aware of any evidence that nicarbazin is mutagenic. At the March 2001 Standing Committee for Animal Nutrition, the Commission agreed to postpone any decision on the future authorisation of nicarbazin and to allow the company time to submit additional information. The company commissioned the tests required to generate the missing data, and all reports are expected to be submitted by February 2002. Despite this, the Commission included nicarbazin in the proposal.
In view of this and potential serious bird health and welfare problems, the UK believed that the authorisation for nicarbazin should not have been withdrawn simply to meet an arbitrary Commission deadline.
Regarding dimetridazole, the UK did not oppose its inclusion in the proposal to withdraw authorisation.
The dossier submitted by the company responsible for the product was inadequate, consisting only of an index and no data. The company did not indicate a firm commitment at an early stage to submit the missing data. The Commission did not offer the company time to submit the data and unlike nicarbazin there has been evidence of safety concerns. The rapporteur for the product, France, indicated at a Standing Committee meeting that it would not support a proposal for the authorisation of DMZ to continue. Under those circumstances the UK felt it was impossible to argue for the continued authorisation of dimetridazole.
It should be noted that despite the UK's representations to the Council of Ministers, we failed to get the Commission to reconsider the proposal to withdraw nicarbazin, and along with dimetridazole the authorisations will be withdrawn. This will result in the products being removed from the market six months after the commission regulation is published.