Chemical name: 1,4-Benzenedicarboxylic acid, 2,3,5,6-tetrachloro-, dimethyl 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 chlorthal-dimethyl. Chlorthal-dimethyl is not included in the list of approved active substances under Regulation (EC) No. 1107/2009 concerning the placing of plant protection products on the market, which replaces Directive 91/414/EEC. Authorisations for plant protection products containing chlorthal-dimethyl had to be withdrawn by 23 March 2010. As of 24 September 2009 no authorisations for plant protection products containing chlorthal-dimethyl were allowed to be granted or renewed by the Member States and all uses of plant protection products containing chlorthal-dimethyl are prohibited as from 23 March 2011. 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 plant protection products containing chlorthal-dimethyl satisfy in general the requirements laid down in Article 5(1) of Directive 91/414/EEC. It was proposed to classify chlorthal-dimethyl as carcinogen category 3; R40 "Limited evidence of carcinogenic effect" and R64 "May cause harm to breastfed babies". However, the studies presented are old (from 1963) and are not adequate for the purpose of clarifying the carcinogenic properties of the active substance. Chlorthal-dimethyl is considered of low acute oral, dermal and inhalation toxicity. During the evaluation of chlorthal-dimethyl it was found that its metabolite MPA leaches to groundwater and there were concerns as regards toxicological significance of that metabolite. The active substance is proposed to be classified as carcinogen category 3 and no convincing evidence has been provided that the metabolite MPA will not lead to any risk of carcinogenicity, therefore it must be considered relevant. Data from employees at the production plant regarding clinical signs and symptoms of poisoning revealed that acute overexposure may be slightly irritating to the eyes, ingestion may cause upset stomach and chronic overexposure may show evidence of liver and thyroid gland toxicity. Expected effect of the final regulatory action in relation to human health: Reduction of risk from the use of plant protection products containing chlorthal-dimethyl. Summary of known hazards and risks to the environment: It was concluded that it was not demonstrated that it may be expected that plant protection products containing chlorthal-dimethyl satisfy in general the requirements laid down in Article 5(1) of Directive 91/414/EEC. During the evaluation of chlorthal-dimethyl it was found that its metabolite MPA leaches to groundwater and there were concerns as regards toxicological significance of that metabolite. The active substance is proposed to be classified as carcinogen category 3 and no convincing evidence has been provided that the metabolite MPA will not lead to any risk of carcinogenicity, therefore it must be considered relevant. According to the evaluation presented in the DAR for the section on fate and behaviour the metabolite MPA exceeds the concentration in the groundwater of 0.1 g/L in all modelling scenarios. Chlorthal-dimethyl is proposed to be classified as N "Dangerous for the environment"; R51/53 "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 containing chlorthal-dimethyl. Date of entry into force of the final regulatory action: 23/03/2011 Complete entry into force of all provisions of Commission Decision 2009/715/EC of 23 September 2009 is 23 March 2011 since all uses of plant products containing chlorthal-dimethyl were prohibited as from that date at the latest. |