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European Union - Final Regulatory Action
Orthosulfamuron CAS number:
213464-77-8
Date circular:
12/06/2020

Chemical name: Benzamide, 2-[[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]amino]-N,N-dimethyl

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 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 orthosulfamuron. Orthosulfamuron is not included in the list of approved active substances under Regulation (EC) No 1107/2009. As a consequence, orthosulfamuron 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. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing orthosulfamuron is prohibited as of 7 June 2017.

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 it has not been demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing orthosulfamuron satisfy in general the requirements laid down in Article 5(1 )(a) and (b) of Directive 91/414/EEC.
The information available at the time of the evaluation was insufficient to satisfy the requirements set out in Directive 91/414/EEC in particular with regard to:
- the risk to consumers from residues after application and in rotational crops.
The available information was insufficient to finalise the consumer risk assessment.

Expected effect of the final regulatory action in relation to human health:

Reduction of any risk for the human health from the use of plant protection products containing orthosulfamuron.

Summary of known hazards and risks to the environment:

It was concluded that it has not been demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing orthosulfamuron satisfy in general the requirements laid down in Article 5(1 )(a) and (b) of Directive 91/414/EEC.
The information available at the time of the evaluation was insufficient to satisfy the
requirements set out in Directive 91/414/EEC in particular with regard to:
- the risk to aquatic and to soil dwelling organisms;
- the risk to groundwater from the active substance and its metabolites.
The available information was insufficient to finalise the aquatic exposure assessment, and thus the risk assessment to aquatic organisms could not be finalised.
The available information was insufficient to finalise the soil exposure assessment, and thus the risk assessment to soil dwelling organisms except micro-organisms could not be finalised.

Expected effect of the final regulatory action in relation to the environment:

Reduction of any risk for the environment from the use of plant protection products containing orthosulfamuron.

Date of entry into force of the final regulatory action: 07/06/2017