# L_2020213EN.01000701.xml

| 6.7.2020 | EN | Official Journal of the European Union | L 213/7 |
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6.7.2020

EN

Official Journal of the European Union

L 213/7

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/968

of 3 July 2020

renewing the approval of the active substance pyriproxyfen 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) | Commission Directive 2008/69/EC (2) included pyriproxyfen as an active substance in Annex I to Council Directive 91/414/EEC (3). |
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(1)

Commission Directive 2008/69/EC (2) included pyriproxyfen as an active substance in Annex I to Council Directive 91/414/EEC (3).

| (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 approval of the active substance pyriproxyfen, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 December 2020. |
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(3)

The approval of the active substance pyriproxyfen, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 December 2020.

| (4) | An application for the renewal of the approval of the active substance pyriproxyfen was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article. |
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(4)

An application for the renewal of the approval of the active substance pyriproxyfen was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

| (5) | The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State. |
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(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

| (6) | 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 (‘the Authority’) and the Commission on 14 December 2017. |
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(6)

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 (‘the Authority’) and the Commission on 14 December 2017.

| (7) | The Authority made the supplementary summary dossier available to the public. The Authority also circulated the renewal assessment report to the applicants and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission. |
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(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the renewal assessment report to the applicants and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

| (8) | On 17 May 2019, the Authority communicated to the Commission its conclusion (6) on whether pyriproxyfen can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report on pyriproxyfen to the Standing Committee on Plants, Animals, Food and Feed on 21 October 2019. |
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(8)

On 17 May 2019, the Authority communicated to the Commission its conclusion (6) on whether pyriproxyfen can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report on pyriproxyfen to the Standing Committee on Plants, Animals, Food and Feed on 21 October 2019.

| (9) | As regards the criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (7), the conclusion of the Authority indicates that pyriproxyfen is not an endocrine disrupter. |
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(9)

As regards the criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (7), the conclusion of the Authority indicates that pyriproxyfen is not an endocrine disrupter.

| (10) | The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined. |
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(10)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined.

| (11) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance pyriproxyfen that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
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(11)

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

| (12) | The risk assessment for the renewal of the approval of the active substance pyriproxyfen is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing pyriproxyfen may be authorised. |
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(12)

The risk assessment for the renewal of the approval of the active substance pyriproxyfen is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing pyriproxyfen may be authorised.

| (13) | It is therefore appropriate to renew the approval of pyriproxyfen. |
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(13)

It is therefore appropriate to renew the approval of pyriproxyfen.

| (14) | 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, however, necessary to provide for certain conditions. It is, in particular, appropriate to require further confirmatory information. |
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(14)

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, however, necessary to provide for certain conditions. It is, in particular, appropriate to require further confirmatory information.

| (15) | 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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(15)

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.

| (16) | Commission Implementing Regulation (EU) 2019/1589 (8) extended the approval period of pyriproxyfen to 31 December 2020 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal of the approval is taken ahead of the expiry of that extended approval period, this Regulation should apply from 1 August 2020, except for the provision concerning toluene content specified in column ‘Purity’ of the table in Annex I, which should apply from 1 August 2021. |
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(16)

Commission Implementing Regulation (EU) 2019/1589 (8) extended the approval period of pyriproxyfen to 31 December 2020 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal of the approval is taken ahead of the expiry of that extended approval period, this Regulation should apply from 1 August 2020, except for the provision concerning toluene content specified in column ‘Purity’ of the table in Annex I, which should apply from 1 August 2021.

| (17) | 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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(17)

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 the active substance

The approval of the active substance pyriproxyfen is renewed as set out in Annex I.

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 August 2020.

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

Done at Brussels, 3 July 2020.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  Commission Directive 2008/69/EC of 1 July 2008 amending Council Directive 91/414/EEC to include clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen as active substances (OJ L 172, 2.7.2008, p. 9).

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)  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).

5

(6)  
  EFSA Journal 2018;16(7):5307; Available online: www.efsa.europa.eu

6

EFSA Journal

(7)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

7

(8)  Commission Implementing Regulation (EU) 2019/1589 of 26 September 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, beta-cyfluthrin, bifenox, chlorotoluron, clofentezine, clomazone, cypermethrin, daminozide, deltamethrin, dicamba, difenoconazole, diflubenzuron, diflufenican, fenoxaprop-P, fenpropidin, fludioxonil, flufenacet, fosthiazate, indoxacarb, lenacil, MCPA, MCPB, nicosulfuron, picloram, prosulfocarb, pyriproxyfen, thiophanate-methyl, triflusulfuron and tritosulfuron (OJ L 248, 27.9.2019, p. 24).

8

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Pyriproxyfen.
  2-((1-(4-Phenoxyphenoxy)propan-2-yl)oxy)pyridine.
  CIPAC No: 715.
  CAS No: 95737-68-1.
  EC No (Einecs or ELINCS): 429-800-1 | 4-phenoxyphenyl (RS)-2(2-pyridyloxy) propyl ether | ≥ 970 g/kg
  From 1 August 2021 Max. impurity: Toluene
  5 g/Kg | 1 August 2020 | 31 July 2035 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pyriproxyfen and in particular Appendices I and II thereto, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the dietary exposure of consumers to residues of pyriproxyfen, |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Pyriproxyfen.

2-((1-(4-Phenoxyphenoxy)propan-2-yl)oxy)pyridine.

CIPAC No: 715.

CAS No: 95737-68-1.

EC No (Einecs or ELINCS): 429-800-1

4-phenoxyphenyl (RS)-2(2-pyridyloxy) propyl ether

≥ 970 g/kg

From 1 August 2021 Max. impurity: Toluene

5 g/Kg

1 August 2020

31 July 2035

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pyriproxyfen and in particular Appendices I and II thereto, shall be taken into account.

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

—

the dietary exposure of consumers to residues of pyriproxyfen,

| — | the protection of sediment-dwelling organisms and aquatic organisms, |
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—

the protection of sediment-dwelling organisms and aquatic organisms,

| — | the protection of bees. |
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—

the protection of bees.

As regards the protection of sediment-dwelling organisms and aquatic organisms, for outdoor use of the plant protection products containing pyriproxyfen Member States shall include in the specific conditions appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for sediment-dwelling organisms and aquatic organisms.

As regards the protection of bees, for outdoor use of plant protection products containing pyriproxyfen Member States shall include in the specific conditions a restriction of application to periods outside of the flowering of bee attractive crops, and appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for bees and bee larvae.

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water is abstracted for drinking water.

The applicant shall submit the requested confirmatory information within two years from the date of publication, by the Commission, 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 the identity and the specification of the active substance are provided in the renewal 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 179 on pyriproxyfen is deleted; |
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(1)

in Part A, entry 179 on pyriproxyfen is deleted;

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











  No | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘142 | Pyriproxyfen.
  2-((1-(4-Phenoxyphenoxy)propan-2-yl)oxy)pyridine.
  CIPAC No: 715.
  CAS No: 95737-68-1.
  EC No (Einecs or ELINCS): 429-800-1 | 4-phenoxyphenyl (RS)-2(2-pyridyloxy) propyl ether | ≥ 970 g/kg Max. impurity: Toluene
  5 g/Kg | 1 August 2020 | 31 July 2035 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pyriproxyfen and in particular Appendices I and II thereto, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the dietary exposure of consumers to residues of pyriproxyfen, |

(2)

in Part B, the following entry is added:

No

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘142

Pyriproxyfen.

2-((1-(4-Phenoxyphenoxy)propan-2-yl)oxy)pyridine.

CIPAC No: 715.

CAS No: 95737-68-1.

EC No (Einecs or ELINCS): 429-800-1

4-phenoxyphenyl (RS)-2(2-pyridyloxy) propyl ether

≥ 970 g/kg Max. impurity: Toluene

5 g/Kg

1 August 2020

31 July 2035

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pyriproxyfen and in particular Appendices I and II thereto, shall be taken into account.

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

—

the dietary exposure of consumers to residues of pyriproxyfen,

| — | the protection of sediment-dwelling organisms and aquatic organisms, |
| --- | --- |

—

the protection of sediment-dwelling organisms and aquatic organisms,

| — | the protection of bees. |
| --- | --- |

—

the protection of bees.

As regards the protection of sediment-dwelling organisms and aquatic organisms, for outdoor use of the plant protection products containing pyriproxyfen Member States shall include in the specific conditions appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for sediment-dwelling organisms and aquatic organisms.

As regards the protection of bees, for outdoor use of plant protection products containing pyriproxyfen Member States shall include in the specific conditions a restriction of application to periods outside of the flowering of bee attractive crops, and appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for bees and bee larvae.

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water is abstracted for drinking water.

The applicant shall submit the requested confirmatory information within two years from the date of publication, by the Commission, 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 the identity and the specification of the active substance are provided in the renewal report.

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