# L_2012218EN.01000301.xml

| 15.8.2012 | EN | Official Journal of the European Union | L 218/3 |
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15.8.2012

EN

Official Journal of the European Union

L 218/3

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COMMISSION IMPLEMENTING REGULATION (EU) No 735/2012

of 14 August 2012

amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance potassium hydrogen carbonate

(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 Article 13(2)(c) thereof,

Whereas:

| (1) | The active substance potassium hydrogen carbonate was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed in Part A of the Annex to 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 (5). |
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(1)

The active substance potassium hydrogen carbonate was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed in Part A of the Annex to 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 (5).

| (2) | In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its view on the draft review report for potassium hydrogen carbonate (6) on 16 December 2011. The draft review report and the view of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 13 July 2012 in the format of the Commission review report for potassium hydrogen carbonate. |
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(2)

In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its view on the draft review report for potassium hydrogen carbonate (6) on 16 December 2011. The draft review report and the view of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 13 July 2012 in the format of the Commission review report for potassium hydrogen carbonate.

| (3) | The Authority communicated its view on potassium hydrogen carbonate to the notifier, and the Commission invited it to submit comments on the review report. |
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(3)

The Authority communicated its view on potassium hydrogen carbonate to the notifier, and the Commission invited it to submit comments on the review report.

| (4) | It is confirmed that the active substance potassium hydrogen carbonate is to be deemed to have been approved under Regulation (EC) No 1107/2009. |
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(4)

It is confirmed that the active substance potassium hydrogen carbonate is to be deemed to have been approved under Regulation (EC) No 1107/2009.

| (5) | In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to amend the conditions of approval of potassium hydrogen carbonate. Taking into account the fact that the use of potassium hydrogen carbonate as insecticide was assessed by Belgium and has not shown additional risks, it is appropriate to allow this use in addition to the use as fungicide. |
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(5)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to amend the conditions of approval of potassium hydrogen carbonate. Taking into account the fact that the use of potassium hydrogen carbonate as insecticide was assessed by Belgium and has not shown additional risks, it is appropriate to allow this use in addition to the use as fungicide.

| (6) | The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(6)

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

| (7) | A reasonable period of time should be allowed before the application of this Regulation in order to allow Member States, the notifier and holders of authorisations for plant protection products containing potassium hydrogen carbonate to meet the requirements resulting from amendment to the conditions of the approval. |
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(7)

A reasonable period of time should be allowed before the application of this Regulation in order to allow Member States, the notifier and holders of authorisations for plant protection products containing potassium hydrogen carbonate to meet the requirements resulting from amendment to the conditions of the approval.

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

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

It shall apply from 1 February 2013.

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

Done at Brussels, 14 August 2012.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  
  OJ L 230, 19.8.1991, p. 1.

2

(3)  
  OJ L 344, 20.12.2008, p. 89.

3

(4)  
  OJ L 379, 24.12.2004, p. 13.

4

(5)  
  OJ L 153, 11.6.2011, p. 1.

5

(6)  Conclusion on the peer review of the pesticide risk assessment of the active substance potassium hydrogen carbonate, EFSA Journal 2012; 10(1):2524. Available online: www.efsa.europa.eu/efsajournal.htm

6

EFSA Journal

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ANNEX

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 244 on the active substance potassium hydrogen carbonate is replaced by the following:

| Number | Common name, identification numbers | IUPAC name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
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| ‘244 | Potassium hydrogen carbonate
  CAS No 298-14-6
  CIPAC No 853 | Potassium hydrogen carbonate | ≥ 99,5 %
  Impurities: | Pb max. 10 mg/kg |

Number

Common name, identification numbers

IUPAC name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘244

Potassium hydrogen carbonate

CAS No 298-14-6

CIPAC No 853

Potassium hydrogen carbonate

≥ 99,5 %

Impurities:

Pb max. 10 mg/kg

| | As max. 3 mg/kg |
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As max. 3 mg/kg

1 September 2009

31 August 2019

PART A

Only uses as fungicide and insecticide may be authorised.

PART B

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 potassium hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to honeybees. Conditions of use shall include, where appropriate, risk mitigation measures.’

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(1)  Further details on identity and specification of active substance are provided in their review report.

1

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