Chemical name: Urea, N'-(3,4-dichlorophenyl)-N-methoxy-N-methyl- 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 linuron. Linuron is not included in the list of approved active substances under Regulation (EC) No 1107/2009. As a consequence, linuron 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. Authorisations for plant protection products containing linuron as active substance had to be withdrawn by the Member States by 3 June 2017 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing linuron is prohibited as of 4 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 linuron 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: - Child resident exposure is above the AOEL. - Operator exposure considering hand held sprayer application outdoors to low crops is above the Acceptable Operator Exposure Level (AOEL) even with the use of personal protective equipment. 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 basis for setting an Acute Reference Dose (ARfD) could not be established since developmental endpoints from an additional rabbit study not submitted during the peer review might be more critical compared to available developmental toxicity study in rabbits. - The consumer risk assessment could not be finalised due to a number of deficiencies in the data package, as follows: - the toxicological profile of the metabolite 3,4-dichloroaniline formed under all processing conditions could not be defined; - the metabolic profile of linuron in roots could not be elucidated; - an MRL for carrots could not be derived; - an ARfD could not be derived so no acute consumer risk assessment was possible. The consumer risk assessment from consumption of drinking water could not be finalized whilst the nature of residues in drinking water following water treatment had not been addressed. During the peer review of the assessment of linuron, experts from Member States and EFSA discussed whether linuron has endocrine disrupting properties and concluded that the available scientific evidence shows that linuron is antiandrogenic and has adverse effects on different endocrine organs at the lowest doses tested. It was concluded that there was human relevance for the effects seen. Furthermore, there were indications from open literature that linuron possesses anti-androgenic properties in fish and in birds. Therefore the concern that linuron has endocrine disrupting properties that may cause adverse effects on endocrine organs in humans and non-target organisms remains based on the information and assessment available. In addition, it was concluded that linuron shall be considered to have endocrine disrupting properties based on its harmonised classification as toxic for reproduction category 1B and carcinogenic category 2 in accordance with the legally applicable interim criteria that applied at the time of the evalution as laid down in the third paragraph of Point 3.6.5 of Annex II to Regulation (EC) No 1107/2009.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 linuron. Summary of known hazards and risks to the environment: It was concluded that no plant protection products containing the active substance linuron 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 the environment the following concerns were identified: - Due to the classification of linuron as toxic for reproduction category 1 and as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008 and in accordance with the legally applicable interim criteria that applied at the time of the evalution, it was concluded that linuron shall be considered to have endocrine disrupting properties in accordance with the third paragraph of Point 3.6.5 of Annex II to Regulation (EC) No 1107/2009. In addition, the available scientific evidence shows that linuron has endocrine disrupting properties that may cause adverse effects on endocrine organs in humans and non-target organisms. - A high risk was identified for birds, mammals, non-target arthropods and soil macro-organisms (except earthworms). 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 environmental exposure assessment could not be finalised for soil, aquatic and groundwater compartments due to the lack of reliable information on the route and rate of degradation of linuron in soil and other data gaps identified to complete the necessary information for fate and behaviour in the environment. - The aquatic risk assessment could not be finalised. - The risk assessment for non-target terrestrial plants could not be finalised.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 linuron. Date of entry into force of the final regulatory action: 02/03/2017 |