Chemical name: Urea, N,N-dimethyl-N'-[4-(1-methylethyl)phenyl]- Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Severely Restricted Use or uses prohibited by the final regulatory action: All applications as plant protection product. Pesticide use or uses that remain allowed: Under Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, the Member States of the European Union are currently allowed to authorize the use of biocidal products In their territory for the following product types (PT): PT 7 - film preservatives, PT 10 - construction material preservatives. The approval of isoproturon for these product types (i.e. uses) is currently under review in the European Union and the regulatory decision is pending. 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 isoproturon. Isoproturon is not included in the list of approved active substances under Regulation (EC) No 1107/2009. As a consequence, isoproturon 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 isoproturon as active substance by 30 September 2016 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 isoproturon had to expire by 30 September 2017 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 isoproturon 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. Isoproturon is classified as carcinogenic category 2 and STOT-RE category 2. In addition, isoproturon is proposed in the pesticide peer review to be classified as toxic for reproduction category 2. Therefore, the conditions of the interim provisions of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 concerning human health for the consideration of endocrine disrupting properties would be met. With regard to the scientific risk assessment, results from reproductive toxicity studies indicated that isoproturon may be an endocrine disrupting compound in mammals. Furthermore, concerns were identified with regards to the potential for groundwater exposure above the parametric drinking water limit of 0.1 g/L for the toxicologically relevant metabolites of isoproturon in situations represented by all 9 pertinent groundwater scenarios, for all representative uses (metabolite didesmethyl-isoproturon was predicted to occur above 0.75 g/L in all scenarios and above 10 g/L in the majority of scenarios). 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 isoproturon. Summary of known hazards and risks to the environment: It was concluded that no plant protection product containing the active substance isoproturon 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 potential for groundwater exposure above the parametric drinking water limit of 0.1 g/L for the toxicologically relevant metabolites of isoproturon in situations represented by all 9 pertinent groundwater scenarios, for all representative uses (metabolite didesmethylisoproturon was predicted to occur above 0.75 g/L in all scenarios and above 10 g/L in the majority of scenarios); - a high long-term risk to birds and wild mammals for isoproturon; - a high risk to aquatic organisms for isoproturon in the majority of relevant FOCUS SW scenarios; - a high risk to aquatic organisms for the metabolite desmethyl-isoproturon. The information available for isoproturon 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 possible contribution to the animal intake of the 2-OH-isoproturon and OHmonodesmethyl- isoproturon metabolites detected in significant proportions in cereal straw (preemergence uses). In addition, the toxicological profile of these metabolites could not be defined. - the aquatic risk assessment from exposure to potential major aqueous phototransformation products. - the chronic risk to earthworms from exposure to the metabolite desmethyl-isoproturon. Additionally, isoproturon is classified as aquatic acute category 1, and aquatic chronic category 1 in accordance with Regulation (EC) No 1272/2008. 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 isoproturon. Date of entry into force of the final regulatory action: 01/07/2016 |