Chemical name: methyl (2E)-3-methoxy-2-{2-[6-(trifluoromethyl)- 2-pyridyloxym ethyl] phenyl}acrylate 2-pyridyloxym ethyl] phenyl}acrylate 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 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 picoxystrobin. Picoxystrobin is not included in the list of approved active substances under Regulation (EC) No 1107/2009. As a consequence, picoxystrobin is not approved for placing on the market pursuant to Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. EU Member States had to withdraw authorisations for placing on the market of plant protection products containing picoxystrobin as active substance by 30 November 2017 at the latest. Any grace period granted by EU Member States for disposal, storage, placing on the market and use of existing stocks of plant protection products containing picoxystrobin had to expire by 30 November 2018 at the latest. 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 picoxystrobin 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 (EC) 546/2011. According to the evaluation related to human health the following concerns were identified: - The clastogenic and aneugenic potential of metabolite IN-H8612, found as a residue, cannot be excluded as equivocal results were observed in the in vivo micronucleus test. The information available is 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 assessment of the genotoxic potential of picoxystrobin could not be completed based on the information available in the dossier and therefore health-based reference values were not set during the peer review. - The consumer and the non-dietary risk assessments cannot be conducted as health-based reference values were not established during the peer review. - The compliance of the toxicity studies compared to the technical specification and the relevance of impurities has to be reconsidered once the genotoxic potential of picoxystrobin is properly addressed. - The endocrine disrupting potential of picoxystrobin. Picoxystrobin does not meet the conditions listed in Annex II, Point 3.6.5 of Regulation (EU) No 1107/2009 to be considered an endocrine disruptor, however, with regards to the scientific risk assessment, the absence of an endocrine-mediated effect could not be concluded as further data are needed to clarify the mode of action regarding effects in the 2 year rat study (interstitial cell hyperplasia and benign adenoma in the testes). The consumer risk assessment for metabolites could not be finalised as further data are needed to define the toxicological profile of the following metabolites: o-phthalic acid (INK2122), IN-QDK50, IN-QGU64. - Derivation of residue definitions for monitoring and risk assessment for plants and animal matrices: residue definitions would need to be considered pending the submission of data to address the toxicological profile of the active substance and metabolites. - For the groundwater metabolites IN-QDK50, IN-QDY63 and IN-QDY62 further data is required to exclude their genotoxic potential. Expected effect of the final regulatory action in relation to human health: Reduction of risk for the human health from the use of plant protection products containing picoxystrobin Summary of known hazards and risks to the environment: It was concluded that no plant protection product containing the active substance picoxystrobin 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 (EC) 546/2011. According to the evaluation related to environment the following concerns were identified: - The risk to earthworm-eating mammals for the metabolite IN-QDY63. - The risk to aquatic invertebrates. - The risk to earthworms from exposure to picoxystrobin. The information available is 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 BCF (bioconcentration factor) in fish for pertinent metabolites were not provided and therefore the risk from secondary poisoning via the aquatic food chain for birds and mammals could not be finalised. Expected effect of the final regulatory action in relation to the environment: Reduction of risk for the environment from the use of plant protection products containing picoxystrobin. Date of entry into force of the final regulatory action: 10/08/2017 |