Chemical name: 1,3,5-Triazin-2-amine, 4-(cyclopropylimino)-N-(1,1-dimethylethyl)-1,4-dihydro-6-(methylthio)-, (4E)- 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 biocidal products of product-type 21 - antifouling products. 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 biocidal products containing cybutryne. Cybutryne is not included in the list of approved active substances under Regulation (EU) No 528/2012. As a consequence, cybutryne is not approved for making available on the market pursuant to Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products. It is prohibited to make available on the market biocidal products of producttype 21 (antifouling products) containing cybutryne as of 27 January 2017. Disposal, storage, making available on the market and use of existing stocks of biocidal products of product-type 21 (antifouling products) containing cybutryne is prohibited as of 27August 2017. The reasons for the final regulatory action were relevant to: Environment Summary of known hazards and risks to the environment: As result of the risk evaluation, a non-approval has been proposed based on the properties of the substance and the monitoring data supporting the potential environmental risk posed by the use of the substance as an antifouling booster biocide. The following detailed conclusions have been drawn from the evaluation: 1. Cybutryne is toxic and persistent. 2. Using a first tier assessment with the MAMPEC model, exposure to Cybutryne arising from in-service use of antifouling paint and activities (application/removal phase losses and in service losses) associated with commercial coastal and ocean-going vessels causes unacceptable risks to marine water and sediment organisms in the environment. A higher tier assessment using the concentrations of Cybutryne in the environment from monitoring data shows that the actual concentrations are higher than expected by the MAMPEC model and exceed the PNEC. Therefore, it is concluded that unacceptable risks are identified from the inservice life stage. 3. Cybutryne is a priority substance under the Water Framework Directive (WFD). Historical monitoring data exceed the AA-EQS (annual average environmental quality standard) derived under the WFD. 4. It is not possible to propose measures to mitigate the identified risks resulting from the in service life stage. 5. A low volume is currently placed on the European market for commercial ships. However, there is no guarantee or mechanism to control whether a higher volume could be brought on the market in the future. Expected effect of the final regulatory action in relation to the environment: Reduction of risk for the environment from the use of biocidal products containing cybutryne. Date of entry into force of the final regulatory action: 17/02/2016 |