# L_2011061EN.01001801.xml

| 8.3.2011 | EN | Official Journal of the European Union | L 61/18 |
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8.3.2011

EN

Official Journal of the European Union

L 61/18

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COMMISSION DIRECTIVE 2011/31/EU

of 7 March 2011

amending Council Directive 91/414/EEC as regards a restriction of the use of the active substance pirimiphos-methyl

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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 Article 6(1) thereof,

Whereas:

| (1) | In accordance with Article 5(5) of Directive 91/414/EEC an inclusion may be reviewed at any time if there are indications that the criteria referred to in paragraphs 1 and 2 of that Article are no longer satisfied. |
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(1)

In accordance with Article 5(5) of Directive 91/414/EEC an inclusion may be reviewed at any time if there are indications that the criteria referred to in paragraphs 1 and 2 of that Article are no longer satisfied.

| (2) | By Commission Directive 2007/52/EC (2) pirimiphos-methyl was included as active substance in Annex I to Directive 91/414/EEC. The specific provision concerning that substance required the notifier however, to submit further studies confirming the operator exposure assessment. |
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(2)

By Commission Directive 2007/52/EC (2) pirimiphos-methyl was included as active substance in Annex I to Directive 91/414/EEC. The specific provision concerning that substance required the notifier however, to submit further studies confirming the operator exposure assessment.

| (3) | On 22 September 2009 the notifier submitted such studies to the United Kingdom, which had been designated rapporteur Member State by Commission Regulation (EC) No 451/2000 (3). |
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(3)

On 22 September 2009 the notifier submitted such studies to the United Kingdom, which had been designated rapporteur Member State by Commission Regulation (EC) No 451/2000 (3).

| (4) | The United Kingdom evaluated those studies and submitted to the Commission an addendum to the draft assessment report on 25 February 2010, which was circulated for comments to the other Member States, the European Food Safety Authority (EFSA) and the notifier. Account being taken of the draft assessment report, that addendum was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 January 2011 in the format of a revision of the Commission review report for pirimiphos-methyl of 16 March 2007. |
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(4)

The United Kingdom evaluated those studies and submitted to the Commission an addendum to the draft assessment report on 25 February 2010, which was circulated for comments to the other Member States, the European Food Safety Authority (EFSA) and the notifier. Account being taken of the draft assessment report, that addendum was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 January 2011 in the format of a revision of the Commission review report for pirimiphos-methyl of 16 March 2007.

| (5) | The studies included in the review report, as finalised on 28 January 2011, show that the risk to operators is not acceptable when hand-held equipment is used. |
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(5)

The studies included in the review report, as finalised on 28 January 2011, show that the risk to operators is not acceptable when hand-held equipment is used.

| (6) | Taking into account the draft assessment report, its addendum and the comments received from Member States, from EFSA and from the notifier, the conclusion continues to apply that plant protection products containing pirimiphos-methyl may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is, however, necessary to restrict the inclusion of pirimiphos-methyl by excluding hand-held applications. |
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(6)

Taking into account the draft assessment report, its addendum and the comments received from Member States, from EFSA and from the notifier, the conclusion continues to apply that plant protection products containing pirimiphos-methyl may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is, however, necessary to restrict the inclusion of pirimiphos-methyl by excluding hand-held applications.

| (7) | It is therefore appropriate to amend Directive 91/414/EEC accordingly. |
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(7)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

| (8) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(8)

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.

Article 2

Member States shall adopt and publish by 31 October 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 November 2011.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 3

Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing pirimiphos-methyl as active substance by 31 October 2011.

Article 4

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 7 March 2011.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 230, 19.8.1991, p. 1.

1

(2)  
  OJ L 214, 17.8.2007, p. 3.

2

(3)  
  OJ L 55, 29.2.2000, p. 25.

3

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ANNEX

In Annex I to Directive 91/414/EEC, row 162 is replaced by the following:

| ‘162 | pirimiphos-methyl
  CAS No 29232-93-7
  CIPAC No 239 | O-2-diethylamino-6-methylpyrimidin-4-yl

  O,O- dimethylphosphorothioate | ≥ 880 g/kg | 1 October 2007 | 30 September 2017 | PART A
  Only uses as insecticide for post harvest storage can be authorised.
  Hand-held applications shall not be authorised.
  PART B
  In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
  For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account.
  In this overall assessment Member States must pay particular attention to:






  — | the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure, |
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‘162

pirimiphos-methyl

CAS No 29232-93-7

CIPAC No 239

O-2-diethylamino-6-methylpyrimidin-4-yl

O,O- dimethylphosphorothioate

≥ 880 g/kg

1 October 2007

30 September 2017

PART A

Only uses as insecticide for post harvest storage can be authorised.

Hand-held applications shall not be authorised.

PART B

In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

—

the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure,

| — | the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.’ |
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—

the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.’

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