# L_2016035EN.01000101.xml

| 11.2.2016 | EN | Official Journal of the European Union | L 35/1 |
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11.2.2016

EN

Official Journal of the European Union

L 35/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/177

of 10 February 2016

approving the active substance benzovindiflupyr, as a candidate for substitution, 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 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 24 in conjunction with Article 13(2) thereof,

Whereas:

| (1) | In accordance with Article 7(1) of Regulation (EC) No 1107/2009, France received on 20 December 2012 an application from Syngenta Crop Protection AG for the approval of the active substance benzovindiflupyr. |
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(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009, France received on 20 December 2012 an application from Syngenta Crop Protection AG for the approval of the active substance benzovindiflupyr.

| (2) | In accordance with Article 9(3) of that Regulation, France, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) of the admissibility of the application on 15 February 2013. |
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(2)

In accordance with Article 9(3) of that Regulation, France, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) of the admissibility of the application on 15 February 2013.

| (3) | On 25 March 2014 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. |
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(3)

On 25 March 2014 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

| (4) | The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in February 2015. |
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(4)

The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in February 2015.

| (5) | On 10 March 2015 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance benzovindiflupyr can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The Authority made its conclusion available to the public. |
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(5)

On 10 March 2015 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance benzovindiflupyr can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The Authority made its conclusion available to the public.

| (6) | On 13 July 2015 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for benzovindiflupyr and a draft Regulation providing that benzovindiflupyr is approved. |
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(6)

On 13 July 2015 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for benzovindiflupyr and a draft Regulation providing that benzovindiflupyr is approved.

| (7) | The applicant was given the possibility to submit comments on the review report. |
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(7)

The applicant was given the possibility to submit comments on the review report.

| (8) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the Commission review report, 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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(8)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the Commission review report, 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.

| (9) | The Commission however considers that benzovindiflupyr is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Benzovindiflupyr is a persistent and toxic substance in accordance with points 3.7.2.1 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the half-life in soil and fresh water sediment is higher than 120 days and the long-term no-observed effect concentration for freshwater organisms is less than 0,01 mg/L. Benzovindiflupyr therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009. |
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(9)

The Commission however considers that benzovindiflupyr is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Benzovindiflupyr is a persistent and toxic substance in accordance with points 3.7.2.1 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the half-life in soil and fresh water sediment is higher than 120 days and the long-term no-observed effect concentration for freshwater organisms is less than 0,01 mg/L. Benzovindiflupyr therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.

| (10) | It is therefore appropriate to approve benzovindiflupyr as a candidate for substitution. |
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(10)

It is therefore appropriate to approve benzovindiflupyr as a candidate for substitution.

| (11) | 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 include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information. |
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(11)

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 include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

| (12) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly. |
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(12)

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

| (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

Approval of the active substance as a candidate for substitution

The active substance benzovindiflupyr is approved as set out in Annex I as a candidate for substitution.

Article 2

Amendment 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

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, 10 February 2016.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  
  EFSA Journal 2015;13(3):4043. Available online: www.efsa.europa.eu

2

EFSA Journal

(3)  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).

3

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Benzovindiflupyr
  CAS No: 1072957-71-1
  CIPAC No: not available | N-[(1RS,4SR)-9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide | 960 g/kg (50/50) racemate | 2.3.2016 | 2.3.2023 | 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 benzovindiflupyr, 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 risk to aquatic organisms.
  Conditions of use shall include risk mitigation measures, where appropriate.
  The applicant shall submit confirmatory information as regards:






  (1) | the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Benzovindiflupyr

CAS No: 1072957-71-1

CIPAC No: not available

N-[(1RS,4SR)-9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide

960 g/kg (50/50) racemate

2.3.2016

2.3.2023

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 benzovindiflupyr, 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 risk to aquatic organisms.

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

The applicant shall submit confirmatory information as regards:

(1)

the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;

| (2) | the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification; |
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(2)

the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;

| (3) | the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water. |
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(3)

the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water.

The applicant shall submit to the Commission, the Member States and the Authority the information requested under points (1) and (2) by 2 September 2016 and the information requested under point (3) within two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

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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

In Part E of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

| | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
| ‘4 | Benzovindiflupyr
  CAS No: 1072957-71-1
  CIPAC No: not available | N-[(1RS,4SR)-9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide | 960 g/kg (50/50) racemate | 2.3.2016 | 2.3.2023 | 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 benzovindiflupyr, 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 risk to aquatic organisms.
  Conditions of use shall include risk mitigation measures, where appropriate.
  The applicant shall submit confirmatory information as regards:






  (1) | the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘4

Benzovindiflupyr

CAS No: 1072957-71-1

CIPAC No: not available

N-[(1RS,4SR)-9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide

960 g/kg (50/50) racemate

2.3.2016

2.3.2023

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 benzovindiflupyr, 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 risk to aquatic organisms.

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

The applicant shall submit confirmatory information as regards:

(1)

the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;

| (2) | the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification; |
| --- | --- |

(2)

the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;

| (3) | the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water. |
| --- | --- |

(3)

the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water.

The applicant shall submit to the Commission, the Member States and the Authority the information requested under points (1) and (2) by 2 September 2016 and the information requested under point (3) within two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.’

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

1

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