Chemical name: 1,2-dihydro-2,2,4-trimethylquinolin-6-yl ethyl ether 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 ethoxyquin because ethoxyquin is not approved as an 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 all authorisations for plant protection products containing ethoxyquin as active substance by 3 September 2011 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing ethoxyquin is prohibited as of 3 September 2012. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: In conclusion from the assessments made on the basis of the submitted information, no plant protection products containing the active substance ethoxyquin are expected to satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of Council Directive 91/414/EEC. Ethoxyquin should therefore not be included in Annex I to Directive 91/414/EEC. According to the evaluation related to human health concerns were identified with regard to: consumers, operators and workers, since no residue definition and no reference values could be set for ethoxyquin and its metabolites. The information available is insufficient to satisfy the requirements set out in Annex II and Annex III to Directive 91/414/EEC in particular with regard to: the toxicological risk assessment for ethoxyquin and its metabolites and for the potentially genotoxic impurity 7 in the technical specification. the consumer, the operator and the worker risk assessment which could not be conducted (reference values and residue definition could not be set due to the limited toxicological data package). Expected effect of the final regulatory action in relation to human health: Reduction of potential risks for human health from the use of plant protection products containing ethoxyquin. Summary of known hazards and risks to the environment: In conclusion from the assessments made on the basis of the submitted information, no plant protection products containing the active substance ethoxyquin are expected to satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of Council Directive 91/414/EEC. Ethoxyquin should therefore not be included in Annex I to Directive 91/414/EEC. The information available is insufficient to satisfy the requirements set out in Annex II and Annex III to Directive 91/414/EEC in particular with regard to the exposure assessment of the environmental compartments via aerial deposition of potentially volatile photolytic transformation products and impurity 7, the risk assessment for non-target organisms. Expected effect of the final regulatory action in relation to the environment: Reduction of potential risks for the environment from the use of plant protection products containing ethoxyquin. Date of entry into force of the final regulatory action: 04/03/2011 Complete entry into force of all provisions of Commission Decision 2011/143/EU of 3 March 2011 concerning the non-inclusion of ethoxyquin in Annex I to Council Directive 91/414/EEC and amending Commission Decision 2008/941/EC was 4 March 2011. |