Chemical name: 3-(3,5-dichlorophenyl)-2,4-dioxo-N-(propan-2-yl)imidazolidine-1-carboxamide 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 iprodione. Iprodione is not included in the list of approved active substances under Regulation (EC) No 1107/2009. As a consequence, iprodione 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. Placing on the market of plant protection products containing iprodione as active substance is prohibited as of 6 March 2018. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing iprodione is prohibited as of 6 June 2018. 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 iprodione 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 genotoxic potential of metabolite RP 30228 (found as a residue and impurity in the technical material) that cannot be excluded and for which the setting of reference values cannot be confirmed based on the information available. It is noted that metabolite RP 30228 is predicted to occur in groundwater above 0.1 pg/L in one FOCUS GW scenario according to the representative uses. - Iprodione has currently harmonised classification as carcinogenic category 2. The pesticide peer review considers more appropriate classification as carcinogenic category 1 B and toxic for reproduction category 2. On this basis the interim provisions of Annex 11, Point 3.6.5 of Regulation (EC) No 1107/2009 concerning human health for the consideration of endocrine disrupting properties are met leading to a critical area of concern. This is supported by the available scientific evidence where iprodione is shown to be antiandrogenic compound and has adverse effects on different endocrine organs at the dose levels triggering the LOAEL in several toxicity studies. - For the representative uses considered, residue levels exceed the default value as referred to in point (b) of Article 18(1) of Regulation (EC) No 396/2005 (on maximum residue levels of pesticides in or on food and feed of plant and animal origin). Consequently, the requirement set out in Points 3.6.3 and 3.6.5 of Annex II to Regulation (EC) No 1107/2009 is not fulfilled. - an acute consumer risk that cannot be excluded based on a preliminary risk assessment. The assessment is likely to underestimate the exposure to the metabolite 3,5-dichloroaniline due to instability of the compound in residue sample storage and of residues not fully considered due to different data gaps. Moreover, possible common toxicological effects of 3,5-dichloroaniline and iprodione and similar metabolites have not been considered in the risk assessment.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: - operator exposure estimates that according to the supported indoor uses in lettuce could not be finalised; - the dietary consumer risk assessment in terms of food of plant and animal origin that could not be finalised given numerous data gaps identified that do not permit the establishment of final residue definitions for risk assessment. 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 iprodione. Summary of known hazards and risks to the environment: According to the evaluation related to environment the following concerns were identified: - the predicted concentrations in groundwater that exceed 0.1 pg/L for relevant metabolites RP 35606 and RP 30181. Metabolite RP 35606 also exceeds 0.75 pg/L, in acidic soils, and metabolite RP 30181 exceeds 0.75 pg/L in both acidic and slightly acidic to alkaline soils for both intended uses (carrots and lettuce). Iprodione is classified as carcinogen category 2 in accordance with Regulation (EC) No 1272/2008 and therefore these metabolites are considered relevant as it has not been demonstrated that they do not share the same intrinsic toxicological properties of iprodione. Furthermore, during the peer review it was proposed that iprodione should be classified as carcinogen category 1 B and as toxic for reproduction category 2. - the high long-term risk of iprodione to aquatic organisms. 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 proposed route of degradation in soil that was incomplete since it was based only on phenyl-labelled iprodione studies. Therefore, studies on the fate and behaviour of the hydantoin moiety iprodione in soil are required to demonstrate whether metabolite RP 30181 and/or other degradation/transformation products are formed at amounts requiring further assessment or not; - the long-term risk assessment for wild mammals for all the relevant routes of exposure that could not be finalised due to the lack of a reliable endpoint; - further information to address the potential for endocrine disruption of iprodione in fish 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 iprodione. Date of entry into force of the final regulatory action: 04/12/2017 |