# L_2018190EN.01000801.xml

| 27.7.2018 | EN | Official Journal of the European Union | L 190/8 |
| --- | --- | --- | --- |

27.7.2018

EN

Official Journal of the European Union

L 190/8

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1061

of 26 July 2018

renewing the approval of the active substance carfentrazone-ethyl 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 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 (1) 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, and in particular Article 20(1) thereof,

Whereas:

| (1) | Commission Directive 2003/68/EC (2) included carfentrazone-ethyl as an active substance in Annex I to Council Directive 91/414/EEC (3). |
| --- | --- |

(1)

Commission Directive 2003/68/EC (2) included carfentrazone-ethyl 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). |
| --- | --- |

(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 carfentrazone-ethyl, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2018. |
| --- | --- |

(3)

The approval of the active substance carfentrazone-ethyl, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2018.

| (4) | An application for the renewal of the approval of carfentrazone-ethyl 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. |
| --- | --- |

(4)

An application for the renewal of the approval of carfentrazone-ethyl 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. |
| --- | --- |

(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 10 July 2015. |
| --- | --- |

(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 10 July 2015.

| (7) | 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. |
| --- | --- |

(7)

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.

| (8) | On 22 July 2016 (6), the Authority communicated to the Commission its conclusion on whether carfentrazone-ethyl 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 for carfentrazone-ethyl to the Standing Committee on Plants, Animals, Food and Feed on 24 January 2017. |
| --- | --- |

(8)

On 22 July 2016 (6), the Authority communicated to the Commission its conclusion on whether carfentrazone-ethyl 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 for carfentrazone-ethyl to the Standing Committee on Plants, Animals, Food and Feed on 24 January 2017.

| (9) | The applicant was given the opportunity to submit comments on the draft renewal report. |
| --- | --- |

(9)

The applicant was given the opportunity to submit comments on the draft renewal report.

| (10) | It has been established with respect to one or more representative uses of at least one plant protection product containing carfentrazone-ethyl that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
| --- | --- |

(10)

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

| (11) | It is therefore appropriate to renew the approval of carfentrazone-ethyl. |
| --- | --- |

(11)

It is therefore appropriate to renew the approval of carfentrazone-ethyl.

| (12) | The risk assessment for the renewal of the approval of carfentrazone-ethyl is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing carfentrazone-ethyl may be authorised. It is therefore appropriate to remove the restriction for use only as a herbicide. |
| --- | --- |

(12)

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

| (13) | 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 include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information. |
| --- | --- |

(13)

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

| (14) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(14)

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

| (15) | Taking into account that the current approval of carfentrazone-ethyl expires on 31 July 2018, this Regulation should enter into force as soon as possible. |
| --- | --- |

(15)

Taking into account that the current approval of carfentrazone-ethyl expires on 31 July 2018, this Regulation should enter into force as soon as possible.

| (16) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(16)

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 carfentrazone-ethyl 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 third 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 2018.

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

Done at Brussels, 26 July 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Commission Directive 2003/68/EC of 11 July 2003 amending Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole as active substances (OJ L 177, 16.7.2003, p. 12).

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 (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk assessment of the active substance carfentrazone-ethyl. EFSA Journal 2016;14(8):4569. Available online: www.efsa.europa.eu

6

EFSA Journal

---

ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Carfentrazone-ethyl
  CAS No 128639-02-1
  CIPAC No 587.202 | Ethyl (RS)-2-chloro-3-[2-chloro-4-fluoro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H- 1,2,4-triazol-1-yl]phenyl]propionate | ≥ 910 g/kg | 1 August 2018 | 31 July 2033 | 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 carfentrazone-ethyl, and in particular Appendices I and II thereof, shall be taken into account.
  In their overall assessment Member States shall pay particular attention to:






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

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Carfentrazone-ethyl

CAS No 128639-02-1

CIPAC No 587.202

Ethyl (RS)-2-chloro-3-[2-chloro-4-fluoro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H- 1,2,4-triazol-1-yl]phenyl]propionate

≥ 910 g/kg

1 August 2018

31 July 2033

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 carfentrazone-ethyl, and in particular Appendices I and II thereof, shall be taken into account.

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

—

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

| — | the protection of soil non-target organisms, |
| --- | --- |

—

the protection of soil non-target organisms,

| — | the protection of aquatic organisms, |
| --- | --- |

—

the protection of aquatic organisms,

| — | the protection of non-target terrestrial higher plants. |
| --- | --- |

—

the protection of non-target terrestrial higher plants.

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

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

| (1) | the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for carfentrazone-ethyl in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2), in particular as carcinogen category 2; |
| --- | --- |

(1)

the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for carfentrazone-ethyl in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2), in particular as carcinogen category 2;

| (2) | the effect of water treatment processes on the nature of residues present in drinking water. |
| --- | --- |

(2)

the effect of water treatment processes on the nature of residues present in drinking water.

The applicant shall submit the information mentioned in point (1) within one year after the publication on the website of the European Chemicals Agency of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to carfentrazone-ethyl.

The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.

---

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

(2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

---

ANNEX II

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

| (1) | in Part A, the entry 60 on carfentrazone-ethyl is deleted; |
| --- | --- |

(1)

in Part A, the entry 60 on carfentrazone-ethyl 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘125 | Carfentrazone-ethyl
  CAS No 128639-02-1
  CIPAC No 587.202 | Ethyl (RS)-2-chloro-3-[2-chloro-4-fluoro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H- 1,2,4-triazol-1-yl]phenyl]propionate | ≥ 910 g/kg | 1 August 2018 | 31 July 2033 | 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 carfentrazone-ethyl, and in particular Appendices I and II thereof, shall be taken into account.
  In their overall assessment Member States shall pay particular attention to:






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

(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

‘125

Carfentrazone-ethyl

CAS No 128639-02-1

CIPAC No 587.202

Ethyl (RS)-2-chloro-3-[2-chloro-4-fluoro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H- 1,2,4-triazol-1-yl]phenyl]propionate

≥ 910 g/kg

1 August 2018

31 July 2033

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 carfentrazone-ethyl, and in particular Appendices I and II thereof, shall be taken into account.

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

—

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

| — | the protection of soil non-target organisms; |
| --- | --- |

—

the protection of soil non-target organisms;

| — | the protection of aquatic organisms; |
| --- | --- |

—

the protection of aquatic organisms;

| — | the protection of non-target terrestrial higher plants. |
| --- | --- |

—

the protection of non-target terrestrial higher plants.

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

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

| (1) | the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for carfentrazone-ethyl in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2), in particular as carcinogen category 2; |
| --- | --- |

(1)

the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for carfentrazone-ethyl in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2), in particular as carcinogen category 2;

| (2) | the effect of water treatment processes on the nature of residues present in drinking water. |
| --- | --- |

(2)

the effect of water treatment processes on the nature of residues present in drinking water.

The applicant shall submit the information mentioned in point (1) within one year after the publication on the website of the European Chemicals Agency of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to carfentrazone-ethyl.

The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.’

---

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

(2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

---