# C_2016357EN.01000901.xml

| 29.9.2016 | EN | Official Journal of the European Union | C 357/9 |
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29.9.2016

EN

Official Journal of the European Union

C 357/9

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COMMISSION IMPLEMENTING DECISION

of 28 September 2016

on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2019, 2020 and 2021 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council

(2016/C 357/05)

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 18 thereof,

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Whereas:

| (1) | A large number of active substances deemed to have been approved in accordance with Regulation (EC) No 1107/2009 and listed in Part A of Annex to Regulation (EC) No 540/2011 (2) have an expiry date set between 1 January 2019 and 31 December 2021. Part B of the Annex to Commission Implementing Regulation (EU) No 686/2012 (3) lists those active substances and allocates to the Member States the evaluation of those active substances, naming for each active substance a rapporteur and a co-rapporteur Member State for the purposes of the renewal procedure. |
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(1)

A large number of active substances deemed to have been approved in accordance with Regulation (EC) No 1107/2009 and listed in Part A of Annex to Regulation (EC) No 540/2011 (2) have an expiry date set between 1 January 2019 and 31 December 2021. Part B of the Annex to Commission Implementing Regulation (EU) No 686/2012 (3) lists those active substances and allocates to the Member States the evaluation of those active substances, naming for each active substance a rapporteur and a co-rapporteur Member State for the purposes of the renewal procedure.

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| (2) | In view of the time and resources necessary for completing the assessment of applications for the renewal of approvals for such a large number of active substances by the Member States and by the European Food Safety Authority, it is necessary to establish a work programme grouping together similar active substances setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009. |
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(2)

In view of the time and resources necessary for completing the assessment of applications for the renewal of approvals for such a large number of active substances by the Member States and by the European Food Safety Authority, it is necessary to establish a work programme grouping together similar active substances setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009.

| (3) | As reflected in recital 17 of Regulation (EC) No 1107/2009, low-risk substances should be identified and the placing on the market of plant protection products containing those substances should be facilitated. Moreover, in line with the objectives of Directive 2009/128/EC of the European Parliament and of the Council (4) the use of plant protection products having the least negative effects on human and animal health and on the environment should be promoted. The programme should therefore group together low-risk active substances in order to prioritise their assessment in view of a timely renewal of their approval. |
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(3)

As reflected in recital 17 of Regulation (EC) No 1107/2009, low-risk substances should be identified and the placing on the market of plant protection products containing those substances should be facilitated. Moreover, in line with the objectives of Directive 2009/128/EC of the European Parliament and of the Council (4) the use of plant protection products having the least negative effects on human and animal health and on the environment should be promoted. The programme should therefore group together low-risk active substances in order to prioritise their assessment in view of a timely renewal of their approval.

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| (4) | In addition, the substances, for which, given their properties, it is expected that they may fail to satisfy the approval criteria set out listed in points 3.6.2 to 3.6.5 and point 3.7 of Annex II to Regulation (EC) No 1107/2009, should also be identified. The programme should group together those substances in order to prioritise their assessment |
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(4)

In addition, the substances, for which, given their properties, it is expected that they may fail to satisfy the approval criteria set out listed in points 3.6.2 to 3.6.5 and point 3.7 of Annex II to Regulation (EC) No 1107/2009, should also be identified. The programme should group together those substances in order to prioritise their assessment

| (5) | Given the available resources of the authorities conducting the assessment of applications for the renewal of approvals, it cannot be excluded that as a result of the prioritisation of the assessment of substances provided for by this Decision the approval of some other active substances may expire before a decision has been taken on the renewal of the approval of such substances. In such cases, the approval period of such active substances should be extended in due time in accordance with Article 17 of Regulation (EC) No 1107/2009. |
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(5)

Given the available resources of the authorities conducting the assessment of applications for the renewal of approvals, it cannot be excluded that as a result of the prioritisation of the assessment of substances provided for by this Decision the approval of some other active substances may expire before a decision has been taken on the renewal of the approval of such substances. In such cases, the approval period of such active substances should be extended in due time in accordance with Article 17 of Regulation (EC) No 1107/2009.

| (6) | In addition to providing for the grouping together of similar active substances based on priorities for their assessment, Article 18 of Regulation (EC) No 1107/2009 also provides that the work programme is to include specific elements. Commission Implementing Regulations (EU) No 844/2012 (5) and (EU) No 686/2012 are, respectively, implementing points (a) to (e) and point (f) of the second paragraph of Article 18 of Regulation (EC) No 1107/2009, |
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(6)

In addition to providing for the grouping together of similar active substances based on priorities for their assessment, Article 18 of Regulation (EC) No 1107/2009 also provides that the work programme is to include specific elements. Commission Implementing Regulations (EU) No 844/2012 (5) and (EU) No 686/2012 are, respectively, implementing points (a) to (e) and point (f) of the second paragraph of Article 18 of Regulation (EC) No 1107/2009,

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HAS DECIDED AS FOLLOWS:

Sole Article

The work programme as set out in the Annex to this Decision is hereby adopted.

Done at Brussels, 28 September 2016.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

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

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

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(3)  Commission Implementing Regulation (EU) No 686/2012 of 26 July 2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of the active substances (OJ L 200, 27.7.2012, p. 5).

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(4)  Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71).

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(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

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ANNEX

| 1. | The work programme concerns active substances deemed to have been approved in accordance with Regulation (EC) No 1107/2009 which are listed in Part B of the Annex to Implementing Regulation (EU) No 686/2012. |
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1.

The work programme concerns active substances deemed to have been approved in accordance with Regulation (EC) No 1107/2009 which are listed in Part B of the Annex to Implementing Regulation (EU) No 686/2012.

| 2. | The priorities for the assessment of applications for the renewal of approvals of the active substances and grouping together similar active substances, as provided for in Article 18 of Regulation (EC) No 1107/2009, are as follows:






  (1) | The assessment of applications for the renewal of approvals of active substances which, given their properties, could be identified as potentially low-risk active substances shall be prioritised in order to allow the largest possible number of low-risk active substances to be approved without delay or with as little delay as possible. |
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2.

The priorities for the assessment of applications for the renewal of approvals of the active substances and grouping together similar active substances, as provided for in Article 18 of Regulation (EC) No 1107/2009, are as follows:

(1)

The assessment of applications for the renewal of approvals of active substances which, given their properties, could be identified as potentially low-risk active substances shall be prioritised in order to allow the largest possible number of low-risk active substances to be approved without delay or with as little delay as possible.

| (2) | The assessment of applications for the renewal of approvals of active substances for which, given their properties, it is expected that they may fail to satisfy the approval criteria set out in points 3.6.2 to 3.6.5 and point 3.7 of Annex II to Regulation (EC) No 1107/2009, shall be prioritised. Accordingly, such assessments shall be carried out without delay or with as little delay as possible. |
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(2)

The assessment of applications for the renewal of approvals of active substances for which, given their properties, it is expected that they may fail to satisfy the approval criteria set out in points 3.6.2 to 3.6.5 and point 3.7 of Annex II to Regulation (EC) No 1107/2009, shall be prioritised. Accordingly, such assessments shall be carried out without delay or with as little delay as possible.

| (3) | Where the approval of some active substances not covered by points (1) and (2) is likely to expire before a decision has been taken on the renewal of the approval of such substances, the approval period of those active substances shall be extended in due time in accordance with Article 17 of Regulation (EC) No 1107/2009. |
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(3)

Where the approval of some active substances not covered by points (1) and (2) is likely to expire before a decision has been taken on the renewal of the approval of such substances, the approval period of those active substances shall be extended in due time in accordance with Article 17 of Regulation (EC) No 1107/2009.

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