This draft Commission Implementing Regulation provides that the approval of the active substance S-metolachlor is not renewed in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorisations for plant protection products containing S-metolachlor as an active substance. The non-renewal of approval is based on the first evaluation of the substance for use as a pesticide active substance in the European Union under Regulation (EC) No 1107/2009. The substance was formerly assessed and approved under Directive 91/414/EEC.
In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II thereto) which must be met to enable approval.
During the evaluation and peer-review of S-metolachlor, a number of concerns and areas that could not be finalised were identified. These are detailed in the statement of the European Food Safety Authority (EFSA).
The decision is based on a risk assessment carried out by a rapporteur EU member State and peer reviewed by the European Food Safety Authority together with all EU member States, taking into account other factors legitimate to the matter.
In the case of S-metolachlor, the outcome of the risk assessment, as documented in the EFSA conclusion, is not favourable and identifies critical areas of concern.
These critical areas of concern have been identified: 1) the representative uses are shown to contaminate groundwater (by both the active substance and the groundwater relevant metabolites); and 2) all the representative uses are shown to pose risk for mammals, since high risk to earthworm-eating mammals via secondary poisoning was concluded.
Moreover, part of the risk assessment could not be finalised by EFSA, thus precluding the renewal, such as an issue not finalised for the risk assessment of two human metabolites, the consumer dietary risk assessment (and the consequent livestock exposure assessment), and the consumer risk assessment regarding the treatment of surface water. For the environmental compartment, the risk assessment for aquatic and the one for non-target terrestrial plants could not be finalised.
Therefore, the outcome of the risk assessment is not favourable to the renewal given that it can be concluded that several application scenarios are not acceptable. These concerns mean that S-metolachlor does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009.
Existing authorisations will need to be withdrawn; EU member States must withdraw existing plant protection products containing S-metolachlor at the latest by three months from the date of entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 is allowed for and shall expire at the latest six months from the entry into force (allowing for a final season of use).
This decision only concerns the placing on the market of this substance and plant protection products containing it. Following non-approval and the expiry of all grace periods for stocks of products containing this substance, separate action will likely be taken on MRLs and a separate notification will be made in accordance with SPS procedures.
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