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Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety; protection of animal or plant life or health; protection of the environment.
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. For orthosulfamuron, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant.
During the evaluation and peer-review of the substance, a number of concerns and areas that could not be finalised were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA); the Authority concluded that with the available information, the risk assessment to consumers, soil dwelling organisms except microorganisms and aquatic organisms could not be finalised. In addition, the Authority identified concerns that the exposure assessment to groundwater could not be finalised.
These concerns mean that orthosulfamuron does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and cannot be approved currently.
The substance was allowed to be authorised provisionally for a period not longer than three years in EU member States. As all such authorisations have expired, it is not necessary to provide an additional period to withdraw authorisations for plant protection products containing orthosulfamuron.
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