# L_2007156EN.01003201.xml

| 16.6.2007 | EN | Official Journal of the European Union | L 156/32 |
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16.6.2007

EN

Official Journal of the European Union

L 156/32

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COMMISSION DECISION

of 13 June 2007

concerning the non-inclusion of diuron in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance

(notified under document number C(2007) 2468)

(Text with EEA relevance)

(2007/417/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the fourth subparagraph of Article 8(2) thereof,

Whereas:

| (1) | Article 8(2) of Directive 91/414/EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I of that Directive that are already on the market two years after the date of notification, while those substances are gradually being examined within the framework of a programme of work. |
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(1)

Article 8(2) of Directive 91/414/EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I of that Directive that are already on the market two years after the date of notification, while those substances are gradually being examined within the framework of a programme of work.

| (2) | Commission Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes diuron. |
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(2)

Commission Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes diuron.

| (3) | For diuron the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifiers. Moreover, those regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For diuron the rapporteur Member State was Denmark and all relevant information was submitted on 19 September 2003. |
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(3)

For diuron the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifiers. Moreover, those regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For diuron the rapporteur Member State was Denmark and all relevant information was submitted on 19 September 2003.

| (4) | The assessment report has been peer reviewed by the Member States and the EFSA and presented to the Commission on 14 January 2005 in the format of the EFSA Conclusion regarding the peer review of the pesticide risk assessment of the active substance diuron (4). This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 24 November 2006 in the format of the Commission review report for diuron. |
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(4)

The assessment report has been peer reviewed by the Member States and the EFSA and presented to the Commission on 14 January 2005 in the format of the EFSA Conclusion regarding the peer review of the pesticide risk assessment of the active substance diuron (4). This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 24 November 2006 in the format of the Commission review report for diuron.

| (5) | During the evaluation of this active substance, a number of concerns have been identified. The assessment of the data provided by the notifier indicated that even with protective equipment, operators would be exposed to quantities of the substance which exceed the Acceptable Operator Exposure Level (AOEL). It was not possible to reach a conclusion on the possible risk of groundwater contamination because of the lack of data on the degradation pattern of certain metabolites and the overly optimistic assumption made by the notifier that application rates may be considered significantly lower in practise. Similarly, based on the available data, it has not been demonstrated that the exposure for birds and mammals is acceptable. |
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(5)

During the evaluation of this active substance, a number of concerns have been identified. The assessment of the data provided by the notifier indicated that even with protective equipment, operators would be exposed to quantities of the substance which exceed the Acceptable Operator Exposure Level (AOEL). It was not possible to reach a conclusion on the possible risk of groundwater contamination because of the lack of data on the degradation pattern of certain metabolites and the overly optimistic assumption made by the notifier that application rates may be considered significantly lower in practise. Similarly, based on the available data, it has not been demonstrated that the exposure for birds and mammals is acceptable.

| (6) | The Commission invited the notifier to submit its comments on the results of the peer review and on its intention or not to further support the substance. The notifier submitted its comments which have been carefully examined. However, despite the arguments advanced, the above concerns remained unsolved, and assessments made on the basis of the information submitted and evaluated during the EFSA expert meetings have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing diuron satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. |
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(6)

The Commission invited the notifier to submit its comments on the results of the peer review and on its intention or not to further support the substance. The notifier submitted its comments which have been carefully examined. However, despite the arguments advanced, the above concerns remained unsolved, and assessments made on the basis of the information submitted and evaluated during the EFSA expert meetings have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing diuron satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.

| (7) | Diuron should therefore not be included in Annex I to Directive 91/414/EEC. |
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(7)

Diuron should therefore not be included in Annex I to Directive 91/414/EEC.

| (8) | Measures should be taken to ensure that existing authorisations for plant protection products containing diuron are withdrawn within a prescribed period and are not renewed and that no new authorisations for such products are granted. |
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(8)

Measures should be taken to ensure that existing authorisations for plant protection products containing diuron are withdrawn within a prescribed period and are not renewed and that no new authorisations for such products are granted.

| (9) | Any period of grace for disposal, storage, placing on the market and use of existing stocks of plant protection products containing diuron allowed by Member States, should be limited to a period no longer than 12 months to allow existing stocks to be used in no more than one further growing season. |
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(9)

Any period of grace for disposal, storage, placing on the market and use of existing stocks of plant protection products containing diuron allowed by Member States, should be limited to a period no longer than 12 months to allow existing stocks to be used in no more than one further growing season.

| (10) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(10)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Diuron shall not be included as active substance in Annex I to Directive 91/414/EEC.

Article 2

Member States shall ensure that:

| (a) | Authorisations for plant protection products containing diuron are withdrawn by 13 December 2007; |
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(a)

Authorisations for plant protection products containing diuron are withdrawn by 13 December 2007;

| (b) | from 16 June 2007 no authorisations for plant protection products containing diuron are granted or renewed under the derogation provided for in Article 8(2) of Directive 91/414/EEC. |
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(b)

from 16 June 2007 no authorisations for plant protection products containing diuron are granted or renewed under the derogation provided for in Article 8(2) of Directive 91/414/EEC.

Article 3

Any period of grace granted by Member States in accordance with the provisions of Article 4(6) of Directive 91/414/EEC, shall be as short as possible and shall expire not later than 13 December 2008.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 13 June 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/31/EC (OJ L 140, 1.6.2007, p. 44).

1

(2)  
  OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

2

(3)  
  OJ L 98, 7.4.2001, p. 6.

3

(4)  EFSA Scientific Report (2005) 25, 1-58. Conclusion on the peer review of diuron.

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