Chemical name: Phosphorodithioic acid, O-ethyl S,S-dipropyl 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 the active substance ethoprophos because ethoprophos 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. EU Member States had to withdraw authorisations for plant protection products containing ethoprophos as active substance by 21 September 2019 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing ethoprophos is prohibited as of 21 March 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 ethoprophos 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 (EU) No 546/2011. According to the evaluation related to human health the following concerns were identified: - Ethoprophos is toxic to fatal when administered via the oral, dermal or inhalation routes. AChE inhibition in erythrocytes and brain was found to be the most sensitive endpoint of ethoprophos toxicity upon short-term exposure either via the oral, dermal or inhalation routes and in all species tested (rat, mouse, rabbit and dog). - Regarding the reproductive toxicity, ethoprophos produced reduced litter size and increased postnatal mortality in the presence of parental toxicity in rats. Abortions occurred in a rat developmental toxicity study in the presence of maternal toxicity. In rabbits, maternal toxicity was evident based on reduced body weight gain at all dose levels. - The genotoxic potential of ethoprophos - equivocal gene mutation and positive clastogenic effects seen in vitro were followed up with in vivo studies of limited reliability but showing also equivocal and positive results and a test to exclude an aneugenic potential was not provided. The information available was insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009. In more detail: - The analytical methods used in the older toxicological studies were not reported and therefore not validated, which questions the validity of the studies, in particular the repeated-dose dietary studies. - The need for further tests and risk assessment to unique human metabolites could not be finalised whilst an in vitro interspecies comparative metabolism study is not submitted. The developmental neurotoxicity could not be concluded in the absence of a comparative AChE assay after repeated dose to clarify whether the young animals may be more sensitive to ethoprophos exposure than the adults; in addition, the results of the rabbit developmental toxicity study cannot be relied upon with regard to the developing foetuses. - The potential endocrine mediated apical effects observed in levels 4 and 5 studies according to the OECD conceptual framework (OECD, 2012) such as thyroid C-cell tumours and pheochromocytoma that may be endocrine mediated through non-EATS modalities (regarding calcitonin or catecholamine) cannot be concluded; although it is acknowledged that there are no validated OECD test guidelines to address this concern. The consumer dietary risk assessment could not be finalized with respect to residues in primary and rotational crops, the nature of the residues in processed commodities and the livestock exposure assessment. Groundwater exposure assessment cannot be finalized Consumers risk assessment cannot be finalized with respect to residues that might be present in surface water and ground water, when surface water and ground water is abstracted for drinking water. 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 ethoprophos. Summary of known hazards and risks to the environment: It was concluded that no plant protection product containing the active substance ethoprophos 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 (EU) No 546/2011. According to the evaluation related to environment the following concerns were identified: - High acute risk to birds has been identified. - High acute risk to bees has been identified in the succeeding crop scenario. - High risk to soil dwelling non-target arthropods has been identified which could not be refined by existing higher tier data. - High risk to soil organisms other than microorganisms and earthworms for all representative uses has been identified. 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 long-term risk assessment for ethoprophos to birds could not be finalised in the absence of a valid Tier I reproductive endpoint. - Secondary poisoning from soil metabolites for birds and mammals. - Risk from soil metabolism to soil organisms cannot be finalised in the absence of the identification and characterisation of ethoprophos metabolites in soils. - The chronic risk to bees could not be finalised in absence of a Tier I endpoint. - The risk to earthworms could not be carried out in absence of a valid Tier I endpoint. Expected effect of the final regulatory action in relation to the environment: Reduction of risk for environment from the use of plant protection products containing ethoprophos. Date of entry into force of the final regulatory action: 28/02/2019 |