Chemical name: Phosphorodithioic acid, O-ethyl S,S-bis(1-methylpropyl) ester, S,S-di-sec-butyl O-ethyl phosphorodithioate 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 cadusafos. Cadusafos is not included in the list of approved active substances under Regulation (EC) No 1107/2009, which replaces Directive 91/414/EEC. Authorisations for plant protection products containing cadusafos had to be withdrawn by 18 December 2007. As of 21 June 2007 no authorisations for plant protection products containing cadusafos were allowed to be granted or renewed by the Member States and all uses of plant protection products containing cadusafos are prohibited as from 18 December 2008. 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 cadusafos was not demonstrated to fulfil the safety requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC (replaced by Regulation 1107/2009) as regards human health. Given the substantial lack of available information at the time of the assessment, and in particular the lack of data on the residue level, it was not possible to demonstrate that the estimated exposure of consumers resulting from the acute and chronic intake assessment was acceptable. Moreover, concerns were identified with regard to the operators' exposure. The exposure scenario corresponds to one specific and restricted representative use, with many different restrictions (automatic drip irrigation, use of gloves, work rate of 1 ha/day, and no release of 'free' cadusafos above 1.12%). The models used to assess operator exposure, and which gives an estimated exposure level below the authorised thresholds, do not apply properly to this particular scenario. The acute toxicity of cadusafos is high, and the acute inhalation and dermal toxicity are very high. Cadusafos causes a decrease in cholinesterase in all species. The proposed classification of cadusafos pursuant to Directive 67/548/EEC is: T+ - Very toxic. R26/27 - Very toxic by inhalation and in contact with skin. R25 - Toxic if swallowed. Expected effect of the final regulatory action in relation to human health: Reduction of risk from the use of plant protection products containing cadusafos. Summary of known hazards and risks to the environment: It was concluded that cadusafos was not demonstrated to fulfil the safety requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC (replaced by Regulation (EC) No 1107/2009) as regards the environment. The evaluation raised concerns mainly regarding the risk to groundwater, which could not be sufficiently assessed due to a lack of substantial data. In addition, the information on the environmental fate and ecotoxicology of the substance was not considered sufficient to satisfy the requirements of the Directive. Concerns were identified for the risk to birds and mammals, and the possible impact of the substance on other non-target organisms. An acute and long-term risk was identified for insectivorous birds, and a risk was identified for earthworm-eating birds and mammals as well as for fish-eating birds and mammals for the use in potatoes. No conclusions for the risk to birds and mammals could be reached for the use in banana plantations due to the lack of data. Cadusafos was identified as very toxic to fish and aquatic invertebrates, and the toxicity to bees is considered high. A high acute and long-term risk was identified for earthworms. The proposed classification of cadusafos pursuant to Directive 67/548/EEC is: N - Dangerous for 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 containing cadusafos. Date of entry into force of the final regulatory action: 18/12/2008 Complete entry into force of all provisions of Commission Decision 2007/428/EC of 18 June 2007 is 18 December 2008 since all uses of plant protection products containing cadusafos were prohibited as from that date at the latest. |