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European Union - Final Regulatory Action
Phosalone CAS number:
2310-17-0
Date circular:
12/06/2008

Chemical name: Phosphorodithioic acid, S-[(6-chloro-2-oxo-3(2H)-benzoxazolyl)methyl] O,O-diethyl ester

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 the applications as plant protection products.

Pesticide use or uses that remain allowed:

-

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 phosalone. Phosalone is not included in the list of authorized active ingredients in Annex I to Directive 91/414/EEC. The authorizations for plant protection products containing phosalone had to be withdrawn by 22 June 2007. From 28 December 2006 no authorizations for plant protection products containing phosalone can be granted or renewed. Any period of grace granted by Member States under Article 4(6) of
Directive 91/414/EEC shall be as short as possible and shall expire not later than 22 June 2008.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

Considering phosalone only (and not metabolites), the acute and chronic exposure assessments give results below the ADI but may exceed in some cases the ARfD. However, the level of the proposed MRL in pome fruits, which is significantly lower than the level considered in the exposure assessments, causes concern in terms of consumer safety. The acute exposure of toddlers may result in the ARfD being extremely exceeded for samples in compliance with the proposed MRL but with high unit to unit variability of residues.

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

Reduction of risk from the use of plant protection products.

Summary of known hazards and risks to the environment:

A high long-term risk was identified for insectivorous birds, considering the blue tit as a focal species. A high acute risk was also identified for small herbivorous mammals, insectivorous mammals and earthworm-eating birds. Additionally, a high risk was identified for the aquatic environment. Even with a buffer zone of 50m the TER values are below the agreed trigger value for the available microcosm study.
The risk to honey bees and non-target arthropods (both in-field and off-field) is high.

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

Reduction of risk from the use of plant protection products.

Date of entry into force of the final regulatory action: 28/12/2006

Any period of grace granted by the Member States under Article 4(6) of Directive 91/414/EEC shall be as short as possible and shall ex ire not later than 22 June 2008.