Chemical name: polymeric zinc propylenebis(dithiocarbamate) 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 the active substance propineb because propineb is not approved as 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 propineb as active substance by 22 June 2018 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing propineb is prohibited as of 22 June 2019 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 propineb 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 Commission Regulation (EU) No 546/2011. According to the evaluation related to human health the following concerns were identified: - Potential endocrine disrupting properties of propineb, related to the hazards of the major metabolite 4-methylimidazolidine-2-thione (PTU, classified in the EU as Repr. cat 2 according to Regulation (EC) No 1272/2008) with endocrine-mediated adverse effects on the thyroid. The information available was insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009. In more detail: - The consumer risk assessment through dietary intake could not be conducted for the products of plant and animal origin considering the outstanding data to address the toxicity of PDA (Propane-1,2-diamine, a major metabolite), the magnitude of the different compounds included in the plant residue definition for risk assessment and to perform a comprehensive livestock exposure assessment. - The consumer risk assessment from the consumption of drinking water could not be finalised, while satisfactory information was not available to address the effect of water treatment processes on the nature of the PU (4 Methylimidazolidin-2-one, a metabolite) residues that might be present in surface water, when surface water is abstracted for drinking water. 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 propineb. 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 propineb 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 Commission Regulation (EU) No 546/2011. The information available was 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 risk assessment for honeybee brood could not be finalised. A high risk to honeybee brood development could not be excluded. - The risk assessment for the representative use on tomatoes could not be finalised with the exception of the risk assessment for soil micro and macro organisms. 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 propineb. Date of entry into force of the final regulatory action: 22/03/2018 Complete entry into force of all provisions of Commission Implementing Regulation (EU) No 2018/309 of 1 March 2018 concerning the non-renewal of approval of the active substance propineb, in accordance with Regulation (EC) No 1107/2009 was by 22 March 2018 |