# L_2016231EN.01002001.xml

| 26.8.2016 | EN | Official Journal of the European Union | L 231/20 |
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26.8.2016

EN

Official Journal of the European Union

L 231/20

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1423

of 25 August 2016

renewing approval of the active substance picolinafen in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

(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 20(1) thereof,

Whereas:

| (1) | The approval of the active substance picolinafen, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2), expires on 30 June 2017. |
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(1)

The approval of the active substance picolinafen, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2), expires on 30 June 2017.

| (2) | An application for the renewal of the inclusion of picolinafen in Annex I to Council Directive 91/414/EEC (3) was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (4) within the time period provided for in that Article. |
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(2)

An application for the renewal of the inclusion of picolinafen in Annex I to Council Directive 91/414/EEC (3) was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (4) within the time period provided for in that Article.

| (3) | The applicant submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. The application was found to be complete by the rapporteur Member State. |
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(3)

The applicant submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. The application was found to be complete by the rapporteur Member State.

| (4) | The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 14 May 2014. |
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(4)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 14 May 2014.

| (5) | The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public. |
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(5)

The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

| (6) | On 22 October 2015 the Authority communicated to the Commission its conclusion (5) on whether picolinafen can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for picolinafen to the Standing Committee on Plants, Animals, Food and Feed on 29 January 2016. |
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(6)

On 22 October 2015 the Authority communicated to the Commission its conclusion (5) on whether picolinafen can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for picolinafen to the Standing Committee on Plants, Animals, Food and Feed on 29 January 2016.

| (7) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied. |
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(7)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied.

| (8) | It is therefore appropriate to renew the approval of picolinafen. |
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(8)

It is therefore appropriate to renew the approval of picolinafen.

| (9) | The risk assessment for the renewal of the approval of picolinafen is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing picolinafen may be authorised. It is therefore appropriate not to maintain the restriction to uses as a herbicide. |
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(9)

The risk assessment for the renewal of the approval of picolinafen is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing picolinafen may be authorised. It is therefore appropriate not to maintain the restriction to uses as a herbicide.

| (10) | In accordance with Article 14(1) 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 include certain conditions. |
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(10)

In accordance with Article 14(1) 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 include certain conditions.

| (11) | In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly. |
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(11)

In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

| (12) | Commission Implementing Regulation (EU) 2016/549 (6) extended the expiry date of picolinafen until 30 June 2017 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on renewal has already been taken ahead of this extended expiry date, this Regulation should apply from 1 November 2016. |
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(12)

Commission Implementing Regulation (EU) 2016/549 (6) extended the expiry date of picolinafen until 30 June 2017 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on renewal has already been taken ahead of this extended expiry date, this Regulation should apply from 1 November 2016.

| (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

Renewal of the approval of active substance

The approval of the active substance picolinafen, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3

Entry into force and date of application

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

It shall apply from 1 November 2016.

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

Done at Brussels, 25 August 2016.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  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).

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 Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (OJ L 322, 8.12.2010, p. 10).

4

(5)  EFSA Journal 2015; 13(11):4279. Available online: www.efsa.europa.eu

5

(6)  Commission Implementing Regulation (EU) 2016/549 of 8 April 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bentazone, cyhalofop butyl, diquat, famoxadone, flumioxazine, DPX KE 459 (flupyrsulfuron-methyl), metalaxyl-M, picolinafen, prosulfuron, pymetrozine, thiabendazole and thifensulfuron-methyl (OJ L 95 9.4.2016, p. 4).

6

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Picolinafen
  CAS No 137641-05-5
  CIPAC No 639 | 4′-fluoro-6-(α,α,α-trifluoro-m-tolyloxy)pyridine-2-carboxanilide | ≥ 980 g/kg | 1 November 2016 | 30 June 2031 | 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 picolinafen, and in particular Appendices I and II thereof, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the impurities in the technical active substance; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Picolinafen

CAS No 137641-05-5

CIPAC No 639

4′-fluoro-6-(α,α,α-trifluoro-m-tolyloxy)pyridine-2-carboxanilide

≥ 980 g/kg

1 November 2016

30 June 2031

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 picolinafen, and in particular Appendices I and II thereof, shall be taken into account.

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

—

the impurities in the technical active substance;

| — | the protection of mammals, especially of large herbivorous mammals; |
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—

the protection of mammals, especially of large herbivorous mammals;

| — | the protection of non-target terrestrial plants; |
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—

the protection of non-target terrestrial plants;

| — | the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; |
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—

the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

| — | the protection of aquatic organisms, especially of algae. |
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—

the protection of aquatic organisms, especially of algae.

Conditions of use shall include risk mitigation measures, where appropriate.

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

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ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

| (1) | in Part A, entry 38 on picolinafen is deleted; |
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(1)

in Part A, entry 38 on picolinafen is deleted;

| (2) | in Part B, the following entry is added:











  Number | Common Name, Identification Numbers | IUPAC Name | Purity (*1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘103 | Picolinafen
  CAS No 137641-05-5
  CIPAC No 639 | 4′-fluoro-6-(α,α,α-trifluoro-m-tolyloxy)pyridine-2-carboxanilide | ≥ 980 g/kg | 1 November 2016 | 30 June 2031 | 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 picolinafen, and in particular Appendices I and II thereof, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the impurities in the technical active substance; |

(2)

in Part B, the following entry is added:

Number

Common Name, Identification Numbers

IUPAC Name

Purity (*1)

Date of approval

Expiration of approval

Specific provisions

‘103

Picolinafen

CAS No 137641-05-5

CIPAC No 639

4′-fluoro-6-(α,α,α-trifluoro-m-tolyloxy)pyridine-2-carboxanilide

≥ 980 g/kg

1 November 2016

30 June 2031

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 picolinafen, and in particular Appendices I and II thereof, shall be taken into account.

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

—

the impurities in the technical active substance;

| — | the protection of mammals, especially of large herbivorous mammals; |
| --- | --- |

—

the protection of mammals, especially of large herbivorous mammals;

| — | the protection of non-target terrestrial plants; |
| --- | --- |

—

the protection of non-target terrestrial plants;

| — | the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

—

the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

| — | the protection of aquatic organisms, especially to algae. |
| --- | --- |

—

the protection of aquatic organisms, especially to algae.

Conditions of use shall include risk mitigation measures, where appropriate.’

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

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