Chemical name: Phosphorothioic acid, S-[2-(ethylsulfinyl)ethyl] O,O-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 the 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 oxydemeton-methyl. Oxydemeton-methyl is not included in the list of authorised active substances in Annex I to Directive 91/414/EEC. Authorisations for plant protection products containing oxydemeton-methyl had to be withdrawn by 21 November 2007. From 9 June 2007, no authorisations for plant protection products containing oxydemeton-methyl were allowed to be granted or renewed by the Member States and all uses of plant protection products containing oxydemeton-methyl were prohibited as from 21 November 2008. 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 metabolites, which are at the same level of toxicity as the active substance, and their presence at levels which might be of toxicological concerns. Concerns were identified with regard to consumer, operator, worker and bystander exposure. Oxydemeton-methyl has been classified as reproductive toxicant category 3; R62 (possibility of impaired fertility). It is toxic if swallowed, in contact with the skin and by inhalation and has also been classified as irritating to eyes and may cause skin sensitisation. Inhibition of blood and brain acetyl cholinesterase activities is the primary toxic effect for acute, short- or long-term exposure. The estimated and measured operator exposure assessment models gave values which are higher than the AOEL (0.001 mg/kg bw/day) for the use on pome fruits and cereals, even with the use of personal protective equipment. The worker and bystander exposures exceed the AOEL in the pome fruit scenario. A consumer risk assessment could not be performed, as no reliable information was available on the residue levels in plant commodities. 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: There is not sufficient information to assess the fate and behaviour of the substance in the environment and its ecotoxicological properties. In particular, the exposure of natural water systems could not be fully addressed. However, oxydemeton-methyl has been classified by the EU as dangerous for the environment. While the risk is low for earthworms and soil-micro organisms, oxydemeton-methyl is of high risk to birds, mammals, aquatic organisms and honey bees, as well as to non-target arthropods. 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: 21/11/2008 Complete entry into force of all provisions of Commission Decision 2007/392/EC of 21 May 2007 was 21 November 2008 since all uses of plant protection products containing oxydemeton-methyl were prohibited as from that date at the latest. |