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European Union - Final Regulatory Action
Propisochlor CAS number:
86763-47-5
Date circular:
12/12/2012

Chemical name: 2-chloro-6'-ethyl-N-isopropoxymethylaceto-o-toluidide

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 propisochlor. Propisochlor is not included in the list of approved active substances under Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, which replaces Directive 91/414/EEC. Authorisations for plant protection products containing propisochlor had to be withdrawn by 27 October 2011. As of 30 March 2011 no authorisations for plant protection products containing propisochlor were allowed to be granted or renewed by the Member States. Member States can however grant a period of grace for the disposal, storage, placing on the market and use of existing stocks that must expire on 27 October 2012 at the latest.

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 was not demonstrated that it may be expected that plant protection products containing propisochlor satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC.

The evaluation revealed that it was not possible to perform a reliable consumer risk assessment and to conclude on a residue definition for propisochlor and its metabolites due to the lack of data on the toxicological relevance of several metabolites.

Concerns were raised related to the human health impact of the use of propisochlor since its use can lead to potential groundwater contamination of several metabolites with unknown toxicological relevance and with expected concentration much greater than the EU parametric values on drinking water.

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

Reduction of risk from the use of plant protection products containing propisochlor.

Summary of known hazards and risks to the environment:

It was concluded that it was not demonstrated that it may be expected that plant protection products containing propisochlor satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC.

The evaluation raised concerns about the groundwater contamination of several metabolites with unknown toxicological relevance. In addition, the evaluation identified high acute risk to herbivorous birds, high long term risk to herbivorous mammals, risk to earthworm-eating mammals and high chronic risk to earthworms for metabolite M2 (2-ethyl-6-methylphenyl)(isopropoxymethyl)amino](oxo)aceticacid) from the use of propisochlor as a plant protection product.

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

Reduction of risk from the use of plant protection products containing propisochlor.

Date of entry into force of the final regulatory action: 27/10/2012

Complete entry into force of all provisions of Commission Decision 2011/262/EU of 27 April 2011 is 27 October 2012 since all uses of plant products containing propisochlor will be prohibited as from that date at the latest.