Chemical name: Phosphorothioic acid, O,O-dimethyl O-(3,5,6-trichloro-2-pyridinyl) 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 chlorpyrifos-methyl because chlorpyrifos-methyl is not approved as an active substance under 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 chlorpyrifos-methyl as an active substance by 16 February 2020. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing chlorpyrifos-methyl is prohibited as of 16 April 2020. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: In conclusion, from the assessments made on the basis of the available information, no plant protection product containing the active substance chlorpyrifos-methyl is expected to satisfy 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. Consequently, it has not been established, with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Concerns were identified with regards to: The genotoxic potential of chlorpyrifos-methyl, which cannot be ruled out when taking into account the concerns raised for chlorpyrifos concerning chromosome aberration and DNA damage that may also apply to chlorpyrifos-methyl. In addition, the available scientific open literature on chlorpyrifos-methyl, although presenting some limitations, should be considered in a weight of evidence approach and raises some concerns about the potential for chlorpyrifos-methyl to damage DNA. Consequently, health based reference values cannot be established for chlorpyrifos-methyl and the dietary and non-dietary risk assessments cannot be conducted. This outcome was confirmed during the second expert meeting held in September 2019. Developmental neurotoxicity (DNT) -the available DNT study on chlorpyrifos-methyl did not allow for a full assessment of effects on brain development, in particular since effects on cerebellum height could not be evaluated due to the lack of controls in females and a no observed adverse effects level 'NOAEL' for DNT could not be established. Since DNT effects were observed in the available developmental neurotoxicity on chlorpyrifos (adverse effects were seen at the lowest dose tested in rats and a NOAEL could not be established) concerns exist also for chlorpyrifos-methyl. Moreover, epidemiological evidence exists showing an association between exposure to chlorpyrifos and/or chlorpyrifos-methyl during development and adverse neurodevelopmental outcomes in children. Based on the evidence for DNT, experts during the peer review suggested that classification of chlorpyrifos-methyl as toxic for the reproduction category 1B, H360D 'May damage the unborn child', in accordance with the criteria set out in Commission Regulation (EC) No 1272/200816 may be appropriate. 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 chlorpyrifos-methyl. Date of entry into force of the final regulatory action: 16/01/2020 Complete entry into force of all provisions of Commission Implementing Regulation (EU) 2020/17 of 10 January 2020 concerning the non-renewal of the approval of the active substance chlorpyrifos-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 was on 16 January 2020. |