# L_2015039EN.01000701.xml

| 14.2.2015 | EN | Official Journal of the European Union | L 39/7 |
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14.2.2015

EN

Official Journal of the European Union

L 39/7

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/232

of 13 February 2015

amending and correcting Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance copper compounds

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the second alternative of Article 21(3) and Article 78(2) thereof,

Whereas:

| (1) | Commission Directive 2009/37/EC (2) included copper compounds as active substance in Annex I to Council Directive 91/414/EEC (3), under the condition that the Member States concerned ensure that the notifier at whose request copper compounds were included in that Annex provides further confirmatory information on the risk from inhalation and on the risk assessment for non-target organisms and for soil and water. |
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(1)

Commission Directive 2009/37/EC (2) included copper compounds as active substance in Annex I to Council Directive 91/414/EEC (3), under the condition that the Member States concerned ensure that the notifier at whose request copper compounds were included in that Annex provides further confirmatory information on the risk from inhalation and on the risk assessment for non-target organisms and for soil and water.

| (2) | Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4). |
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(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

| (3) | The notifier submitted additional information taking the form of studies on the risk from inhalation and on the risk assessment for non-target organisms and for soil and water to the rapporteur Member State France within the time period provided for its submission. |
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(3)

The notifier submitted additional information taking the form of studies on the risk from inhalation and on the risk assessment for non-target organisms and for soil and water to the rapporteur Member State France within the time period provided for its submission.

| (4) | France assessed the additional information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter 'the Authority', on 8 June 2012. |
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(4)

France assessed the additional information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter 'the Authority', on 8 June 2012.

| (5) | The Commission consulted the Authority which presented its opinion on the risk assessment of copper compounds on 22 May 2013 (5). |
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(5)

The Commission consulted the Authority which presented its opinion on the risk assessment of copper compounds on 22 May 2013 (5).

| (6) | The Commission invited the notifier to submit its comments on the review report for copper compounds. |
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(6)

The Commission invited the notifier to submit its comments on the review report for copper compounds.

| (7) | In the light of the additional information provided by the notifier, the Commission considered that the further confirmatory information required had not been fully provided and that, in particular, the specific provision of row 277 of Part A of the Annex to Implementing Regulation (EU) No 540/2011, concerning monitoring programmes for contamination by copper, is not sufficient to conclude on the environmental risk assessment. |
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(7)

In the light of the additional information provided by the notifier, the Commission considered that the further confirmatory information required had not been fully provided and that, in particular, the specific provision of row 277 of Part A of the Annex to Implementing Regulation (EU) No 540/2011, concerning monitoring programmes for contamination by copper, is not sufficient to conclude on the environmental risk assessment.

| (8) | It is confirmed that the active substance copper compounds is to be deemed to have been approved under Regulation (EC) No 1107/2009. It is, in particular, appropriate to require that the notifier presents to the Commission, the Authority and the Member States a monitoring programme for areas where the contamination of soil and water (including sediments) by copper is a concern or may become one, in order to verify whether further limitations of use are necessary to prevent any unacceptable environmental effect. The results of that monitoring programme should also be presented. |
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(8)

It is confirmed that the active substance copper compounds is to be deemed to have been approved under Regulation (EC) No 1107/2009. It is, in particular, appropriate to require that the notifier presents to the Commission, the Authority and the Member States a monitoring programme for areas where the contamination of soil and water (including sediments) by copper is a concern or may become one, in order to verify whether further limitations of use are necessary to prevent any unacceptable environmental effect. The results of that monitoring programme should also be presented.

| (9) | The maximum levels for certain heavy metals, as set in row 277 of Part A of the Annex to Implementing Regulation (EU) No 540/2011, were by mistake set with wrong measurement unit from those set in the respective FAO specifications. The maximum level set in the Annex to that Implementing Regulation should therefore be corrected. |
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(9)

The maximum levels for certain heavy metals, as set in row 277 of Part A of the Annex to Implementing Regulation (EU) No 540/2011, were by mistake set with wrong measurement unit from those set in the respective FAO specifications. The maximum level set in the Annex to that Implementing Regulation should therefore be corrected.

| (10) | The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(10)

The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (11) | Member States should be provided with time to amend or withdraw authorisations for plant protection products containing copper compounds. |
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(11)

Member States should be provided with time to amend or withdraw authorisations for plant protection products containing copper compounds.

| (12) | For plant protection products containing copper compounds, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest 18 months after the entry into force of this Regulation. |
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(12)

For plant protection products containing copper compounds, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest 18 months after the entry into force of this Regulation.

| (13) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(13)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Amendment to Implementing Regulation (EU) No 540/2011

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Article 2

Transitional measures

Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing copper compounds as active substance by 6 September 2015.

Article 3

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire on 6 September 2016 at the latest.

Article 4

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 13 February 2015.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 309, 24.11.2009, p. 1.

1

(2)  Commission Directive 2009/37/EC of 23 April 2009 amending Council Directive 91/414/EEC to include chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin as active substances (OJ L 104, 24.4.2009, p. 23).

2

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

3

(4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

4

(5)  Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance Copper (I), copper (II) variants namely copper hydroxide, copper oxychloride, tribasic copper sulfate, copper (I) oxide, Bordeaux mixture. EFSA Journal 2013;11(6):3235, 40 pp. doi:10.2903/j.efsa.2013.3235. Available online: www.efsa.europa.eu/efsajournal.htm

5

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ANNEX

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 277 on the active substance Copper Compounds is replaced by the following:

| Number | Common Name,
  Identification Numbers | IUPAC Name | Purity | Date of approval | Expiration of approval | Specific provisions |
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| ‘277 | Copper compounds: | | | 1 December 2009 | 31 January 2018 | PART A
  Only uses as bactericide and fungicide may be authorised.
  PART B
  In assessing applications to authorise plant protection products containing copper for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.
  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on copper compounds, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, |

Number

Common Name,

Identification Numbers

IUPAC Name

Purity

Date of approval

Expiration of approval

Specific provisions

‘277

Copper compounds:

1 December 2009

31 January 2018

PART A

Only uses as bactericide and fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing copper for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on copper compounds, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009, shall be taken into account.

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

—

the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate, |
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—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

| — | the protection of water and non-target organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate, |
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—

the protection of water and non-target organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate,

| — | the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effects and do not cause any unacceptable effect on the environment taking into account background levels of copper at the application site. |
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—

the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effects and do not cause any unacceptable effect on the environment taking into account background levels of copper at the application site.

The notifiers shall present to the Commission, the Authority and the Member States a monitoring programme for vulnerable areas where the contamination of the soil and water (including sediments) by copper is a concern or may become one.

That monitoring programme shall be submitted by 31 July 2015. The interim results of such monitoring programme shall be submitted as interim report to the Rapporteur Member State, the Commission and the Authority by 31 December 2016. Final results shall be submitted by 31 December 2017.’

Copper hydroxide

CAS No 20427-59-2

CIPAC No 44.305

Copper (II) hydroxide

≥ 573 g/kg

Copper oxychloride

CAS No 1332-65-6 or 1332-40-7

CIPAC No 44.602

Dicopper chloride trihydroxide

≥ 550 g/kg

Copper oxide

CAS No 1317-39-1

CIPAC No 44.603

Copper oxide

≥ 820 g/kg

Bordeaux mixture

CAS No 8011-63-0

CIPAC No 44.604

Not allocated

≥ 245 g/kg

Tribasic copper sulphate

CAS No 12527-76-3

CIPAC No 44.306

Not allocated

≥ 490 g/kg

The following impurities are of toxicological concern and must not exceed the levels below (expressed in g/g):

| | Lead max 0,0005 g/g of copper content; |
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Lead max 0,0005 g/g of copper content;

| | Cadmium max 0,0001 g/g of copper content; |
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Cadmium max 0,0001 g/g of copper content;

| | Arsenic max 0,0001 g/g of copper content. |
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Arsenic max 0,0001 g/g of copper content.

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