Chemical name: 6,9-Methano-2,4,3-benzodioxathiepin, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-, 3-oxide

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, except the essential uses listed below

Pesticide use or uses that remain allowed:

Authorisations for essential uses may be maintained until 30 June 2007 by the EC Member States indicated below, provided that they:

(a) ensure that such plant protection products remaining on the market are relabelled in order to match the restricted use conditions;

(b) impose all appropriate risk mitigation measures to reduce any possible risks in order to ensure the protection of human and animal health and the environment; and

(c) ensure that alternative products or methods for such uses are being seriously sought, in particular, by means of action plans.

For all non-essential uses, for which existing authorisations had to be withdrawn by 2 June 2006, the EC Member States may grant a period of grace for disposal, storage, placing on the market and use of existing stocks that must expire no later than 2 June 2007. For essential uses that can continue to be authorised until 30 June 2007, the grace period for disposal, storage, placing on the market and use of existing stocks is 6 months (i.e. up to 31 December 2007).

Member State Use

Greece Cotton, tomato, peppers, pears, potato, alfa-alfa

Spain Hazel nut, cotton, tomato

Italy Hazel nut

Poland Hazel nut, strawberry, gerbera, ornamental bulbs

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

Endosulfan is not included in the list of authorised active ingredients in Annex I to Directive 91/414/EEC. The authorisations for plant protection products containing endosulfan had to be withdrawn by 2 June 2006. From 3 December 2005 no authorisations for plant protection products containing endosulfan could be granted or renewed. For certain essential uses for specific member States listed in the Annex to the Commission Decision 2005/864/EC a prolonged period of withdrawal may be allowed until 30 June 2007 under specific conditions (see point 2.5.2).

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

Summary of known hazards and risks to human health:

Exposure of operators under indoor conditions was not considered to have been sufficiently addressed with the available information.

Using acceptable exposure scenarios, the use of endosulfan on tomatoes in greenhouses, spraying with tractor mounted hydraulic nozzles for high crops, led to exposure potentially greater than the AOEL even when using standard PPE.

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

Reduction of risk from plant protection products.

Summary of known hazards and risks to the environment:

During the evaluation of this active substance, a number of areas of concern were identified. This was in particular the case concerning its environmental fate and behaviour, since the route of degradation of the active substance was not completely clear and unknown metabolites were found in soil degradation, water/sediment degradation and mesocosm studies.

In ecotoxicology many concerns remained since the long-term risk, in particular, due to the presence of the above mentioned metabolites, could not be sufficiently addressed with the available information. Moreover endosulfan is volatile, its main metabolite is persistent and it has been found in monitoring results of regions where the substance was not used.

Overall, the fate and behaviour of the substance in the environment, and in particular its degradation, persistence, potential of long range transport and potential of bioaccumulation were object of concerns.

Using NOEC values for the most sensitive aquatic organism, fish, after spray drift and run-off entry, for crop use (cotton, tomatoes and arable crops), the Toxicity Exposure Ratios (TER) indicated a potential long-term risk to fish even assuming a large buffer zone. There is also a potential high risk to terrestrial birds and mammals, honey bees and earthworms.

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

Reduction of risk from plant protection products.

Date of entry into force of the final regulatory action: 02/06/2006