Chemical name: Phosphonic acid, (2,2,2-trichloro-1-hydroxyethyl)-, 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 plant protection products. Pesticide use or uses that remain allowed: Non 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 trichlorfon. Trichlorfon is not included in the list of authorised active substances in Annex I to Directive 91/414/EEC. Authorisations for plant protection products containing trichlorfon had to be withdrawn by 21 November 2007. From 25 May 2007 no authorisations for plant protection products containing trichlorfon were allowed to be granted or renewed by the Member States and all uses of plant protection products containing trichlorfon 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: It has not been demonstrated that it can be expected that, under the proposed conditions of use, plant protection products containing trichlorfon satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC regarding risks for human health because available information is insufficient to perform a risk assessment regarding the operator, worker, bystanders and consumer exposure. Moreover, according to the report of the European Food Safety Authority, trichlorfon is harmful during oral exposure and is a skin sensitizer. Notably, the most sensitive effect observed during short term exposure is reduction in acetyl cholinesterase (AChE) activity. Due to lack of data it was not possible to establish an AOEL (Acceptable Operator Exposure Level) and the risk assessment was performed on the basis of a provisional AOEL. In the absence of dermal absorption studies and taking into account physical and chemical properties, experts considered the default dermal absorption value of 100 % appropriate for the risk assessment. This resulted in exposure estimates that were much higher than the provisional AOEL for operators, workers and bystanders. 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. Summary of known hazards and risks to the environment: It has not been demonstrated that it can be expected that, under the proposed conditions of use, plant protection products containing trichlorfon satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC regarding risks for the environment. Due to a lack of supporting studies, available information is insufficient with regard to the fate and behaviour of the substance in the environment and its ecotoxicological properties. Concerns were identified with regard to the level of relevant impurities in the technical material and the risk to aquatic organisms. The use of trichlorfon that was examined during the risk assessment includes the use of a permanent structure that protects the plants (e.g. a glasshouse). Therefore, the risk to birds and mammals was regarded as low based on limited exposure to tomatoes under protection. The risk to non-target arthropods, earthworms, other soil non-target macro-organisms and non-target plants was also considered to be low. However, although the aquatic toxicity data are inadequate, the assessment on the existing study suggests that the risk to aquatic organisms can already be considered as high, and the risk to bees could not be assessed due to the lack of data. Moreover, due to the lack of information, a sound assessment of the route and rate of degradation of trichlorfon in soil could not be concluded. For similar reasons, potential for contamination of surface and groundwater by trichlorfon could not be adequately assessed. There is also an outstanding data gap for a study on the effects of trichlorfon on sewage treatment plants. 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 2007/356/EC of 21 May 2007 was 21 November 2008 since all uses of plant protection products containing trichlorfon were prohibited as from that date at the latest. |