Chemical name: Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: All the applications as a plant protection product. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: It is prohibited to place on the market or use plant protection products containing diniconazole-M. Diniconazole-M is not included in the list of authorised active substances in Annex I to Directive 91/414/EC. Authorisations for plant protection products containing diniconazole-M had to be withdrawn by 18 March 2009. From 19 September 2008 no authorisations for plant protection products containing diniconazole-M were allowed to be granted or renewed by the Member States and all uses of plant protection products containing diniconazole-M were prohibited as from 18 March 2010 at the latest. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: Based on the available data, concerns were raised about the operator, worker and bystander exposure to diniconazole-M. This is mainly due to the lack of substantial data to assess these risks. The draft assessment report proposes the following hazard classification of diniconazole-M for effects on human health: Xn: Harmful R22: Harmful if swallowed Category 3 carcinogen R40: Limited evidence of a carcinogenic effect Category 2 toxic to reproduction R61: May cause harm to the unborn child Neurotoxic effects after acute oral dosing were also found (above 250 mg/kg in rats and 100 mg/kg in mice: low spontaneous activity, ataxia, limb paralysis, loss of righting reflex, irregular respiration, muscular fibrillation and tremors). Expected effect of the final regulatory action in relation to human health: Reduction of risk from the use of plant protection products. Summary of known hazards and risks to the environment: Concerns were raised about the long-term risk to birds and mammals and the risk to aquatic organisms. However, the report indicated a lack of substantial data to completely assess the risk to birds, mammals and aquatic organisms exposed to diniconazole-M. The Draft Assessment Report concluded that diniconazole-M is toxic to birds. In the acute toxicity tests, mortalities and sub-lethal effects were observed in bobwhite quail (weakness, unsteadiness, lethargy) at the highest concentrations tested. The Draft Assessment Report also stressed that the long term risks to granivorous mammals was too high to meet Directive 91/414/EC requirements. Based on the available data the draft assessment report proposes the following hazard classification of diniconazole-M for effects on the environment: N: Harmful to the environment R50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Expected effect of the final regulatory action in relation to the environment: Reduction of risk from the use of plant protection products. Date of entry into force of the final regulatory action: 18/03/2010 Complete entry into force of all provisions of Commission Decision 2008/743/EC of 18 September 2008 was 18 March 2010 since all uses of plant protection products containing diniconazole-M were prohibited as from that date at the latest. |