Chemical name: Phosphorodithioic acid, O,O-dimethyl S-[2-(methylamino)-2-oxoethyl]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. 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 the active substance dimethoate because dimethoate is not approved as active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 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 dimethoate is prohibited as of 17 July 2020. 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 no plant protection product containing the active substance dimethoate is expected to satisfy in general the requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EC) 546/2011. According to the evaluation related to human health the following concerns were identified: ? Dietary and non-dietary exposure risk assessment could not be conducted because: o Omethoate, the main metabolite of dimethoate, was concluded to be an in vivo mutagen and, since no threshold for this effect is assumed, the setting of toxicological reference values for this metabolite is not considered appropriate. o Positive gene mutation effects were observed in bacterial and mammalian cells in vitro with dimethoate without appropriate in vivo follow-up. Since a mutagenic potential could not be excluded for dimethoate, no threshold for this effect is assumed and therefore toxicological reference values could not be established. ? The technical specification (either the current or the revised one) is not supported by the (eco) toxicological assessment. The information available was insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009, in particular with regard to the risk to consumers. ? The consumer risk assessment is not finalised with regard to the unknown nature of residues that might be present in drinking water, consequent to water treatment following abstraction of surface water that might contain dimethoate and metabolites omethoate and O-Desmethyl dimethoate. ? From a scientific perspective, the endocrine disrupting of dimethoate could not be excluded. The experts may not have had the full information available to conclude on the endocrine disrupting potential of dimethoate. An interaction of dimethoate with the thyroid pathway cannot be excluded. Furthermore, during the peer review it was proposed that dimethoate should be classified as toxic for reproduction category 2. Expected effect of the final regulatory action in relation to human health: Reduction of risk for human health from the use of plant protection products containing dimethoate. Summary of known hazards and risks to the environment: It was concluded that no plant protection product containing the active substance dimethoate is expected to satisfy in general the requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EC) 546/2011. According to the evaluation related to environment the following concerns were identified: ? High risk to mammals and to non-target arthropods (for dimethoate) and to honeybees (for both dimethoate and omethoate) was concluded for all the assessed representative uses. The information available was insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009, in particular with regard to: ? The chronic risk assessment for birds could not be finalised since a reliable endpoint could not be derived. ? The risk assessment for birds and mammals when exposed to the relevant plant metabolites XXIII and XII could not be finalised. ? From a scientific perspective, the endocrine disrupting of dimethoate could not be excluded. The experts may not have had the full information available to conclude on the endocrine disrupting potential of dimethoate. An interaction of dimethoate with the thyroid pathway in mammals and wildlife cannot be excluded. Expected effect of the final regulatory action in relation to the environment: Reduction of risk for the environment from the use of plant protection products containing dimethoate Date of entry into force of the final regulatory action: 30/06/2019 |