Chemical name: Sulfurous acid, 2-[4-(1,1-dimethylethyl)phenoxy]cyclohexyl 2-propynyl ester 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 applications as a plant protection product Pesticide use or uses that remain allowed: Not relevant 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 propargite. Propargite is not included in the list of approved active substances under Regulation (EC) No 1107/2009, which replaces Directive 91/414/EEC. As a consequence, propargite is not approved for placing on the market pursuant to Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing propargite was prohibited as of 31 December 2012. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: It was concluded that it was not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing propargite satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC, Due to the fact that propargite exerts carcinogenic potential on different organs in two strains of rats and a genotoxic mode of action cannot be disregarded, no reliable reference values can be set until a new valid genotoxicity data package with the proposed specification is available. Therefore, the risk assessment for consumers, operators, workers and bystanders could not be conducted. Expected effect of the final regulatory action in relation to human health: Reduction of risk from the use of plant protection products containing propargite. Summary of known hazards and risks to the environment: It was concluded that it was not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing propargite satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC. The information on the environmental fate and behaviour of propargite in relation to the representative use assessed was insufficient to complete the necessary environmental exposure assessment at EU level. Many data gaps and four critical areas of concern were identified in the ecotoxicological risk assessment: A high risk of propargite to aquatic organisms was identified. A high long-term risk to mammals and a high risk to mammals from the consumption of contaminated water were identified. The risk from secondary poisoning to birds was identified as high, and the risk from secondary poisoning to mammals was assessed as high based on the available data. Expected effect of the final regulatory action in relation to the environment: Reduction of risk from the use of plant protection products containing propargite. Date of entry into force of the final regulatory action: 31/12/2012 Complete entry into force of all provisions of Regulation (EU) No 943/2011 of 22 September 2011 concerning the non-approval of the active substance propargite, in accordance with Regulation (EC) No 1107/2009 was by 31 December 2012. |