Chemical name: 3-Azabicyclo[3.1.0]hexane-2,4-dione, 3-(3,5-dichlorophenyl)-1,5-dimethyl-

Final regulatory action has been taken for the category: Pesticide

Final regulatory action: The chemical is Severely Restricted

Use or uses prohibited by the final regulatory action:

Part A of the Annex to Commission Directive 2006/132/EC provided for two crops (cucumber in greenhouses (closed hydroponic systems) and plums (for processing)) on which the use of procymidone was in principle allowed and a maximum rate of 0,75g active substance per hectare per application. This means that Member States were allowed to grant national authorisations within those limits. All other uses not included in that list, i.e. other crops and higher rates of the active substance, were prohibited.

In addition, the following uses were not allowed to be authorised by Member States:

- air application,

- knapsack and hand-held applications neither by amateur nor by professional users,

- home gardening.

Pesticide use or uses that remain allowed:

Only uses as fungicide on the following crops could be authorised:

- cucumbers in greenhouses (closed hydroponic systems),

- plums (for processing),

at rates not exceeding 0.75 g a.s per hectare per application.

Member States had to ensure that all appropriate risk mitigation measures were applied. Particular attention had to be paid to the protection of:

- aquatic organisms. Where relevant, an appropriate distance had to be kept between treated areas and surface water bodies;

- birds and mammals. Conditions of authorisation had to include risk mitigation measures;

- consumers. The acute dietary exposure of which needed to be controlled,

- groundwater, if the active substance were to be applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation had to include risk mitigation measures;

- operators, who had to wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of equipment, unless the exposure to the substance was adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment;

- workers, who needed to wear suitable protective clothing, in particular gloves, if they had to enter a treated area before the specific re-entry period had expired.

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

Summary of the final regulatory action:

Commission Directive 2006/132/EC of 11 December 2006 amending Directive 91/414/EEC severely restricted the placing on the market and use of plant protection products containing procymidone.

The Commission Directive amended Annex I to Directive 91/414/EEC (which was replaced by Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market) to permit the use of procymidone from 1 January 2007 to 30 June 2008. It also set in place restrictions on the use of procymidone. The Directive imposed on the Member States a requirement to review all authorisations of procymidone to ensure that the restrictions set in Directive 2006/132/EC were respected as of 30 June 2007. It also required a re-evaluation of all authorised plant protection products containing procymidone by 30 June 2008.

The restrictions limited the application of procymidone to specific crops and defined maximum application rates. It also limited the period of procymidone's inclusion in Annex I to Directive 91/414/EEC to 18 months after entry into force of Directive 2006/132/EC on 1 January 2007.

It should be noted that this period has now expired. As of 30 June 2008, procymidone is no longer included in the list of authorised active substances in Annex I. Hence, procymidone is no longer allowed to be used as plant protection product in the European Union.

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 could be expected that plant protection products containing procymidone would fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. This conclusion was however subject to compliance with the particular requirements in sections 4, 5, 6 and 7 of the review report, as well as to the implementation of the provisions of Article 4(1) and the uniform principles laid down in Annex VI of Directive 91/414/EEC, for each procymidone containing plant protection product for which Member States would grant or review the authorisation.

Therefore, Member States had to ensure that all appropriate risk mitigation measures were applied. Member States were also requested to pay particular attention to the protection of

- consumers, the acute dietary exposure of which needed to be controlled;

- operators, who had to wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of equipment, unless the exposure to the substance was adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment;

- workers, who needed to wear suitable protective clothing, in particular gloves, if they had to enter a treated area before the specific re-entry period had expired.

Member States were requested to ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States could require that elements, such as sales data and a survey of use patterns, were provided so that a realistic picture of the use conditions and the possible toxicological impact of procymidone could be obtained.

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

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

Summary of known hazards and risks to the environment:

It was concluded that it could be expected that plant protection products containing procymidone would fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. This conclusion was however subject to compliance with the particular requirements in sections 4, 5, 6 and 7 of the review report, as well as to the implementation of the provisions of Article 4(1) and the uniform principles laid down in Annex VI of Directive 91/414/EEC, for each procymidone containing plant protection product for which Member States would grant or review the authorisation.

Therefore, Member States had to ensure that all appropriate risk mitigation measures are applied. Member States were requested to pay particular attention to the protection of:

- aquatic organisms. Where relevant, an appropriate distance had to be kept between treated areas and surface water bodies. This distance could depend on the application or not of drift reducing techniques or devices;

- birds and mammals. Conditions of authorisation needed to include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species;

- groundwater, if the active substance were to be applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation had to include risk mitigation measures.

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

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

Date of entry into force of the final regulatory action: 01/07/2007

The Directive entered into force on 1 January 2007. However, Member States had to apply the provisions of this Directive as of 1 July 2007.