# L_2017107EN.01002401.xml

| 25.4.2017 | EN | Official Journal of the European Union | L 107/24 |
| --- | --- | --- | --- |

25.4.2017

EN

Official Journal of the European Union

L 107/24

---

COMMISSION IMPLEMENTING REGULATION (EU) 2017/725

of 24 April 2017

renewing the approval of the active substance mesotrione 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 2003/68/EC (2) included mesotrione as an active substance in Annex I to Council Directive 91/414/EEC (3). |
| --- | --- |

(1)

Commission Directive 2003/68/EC (2) included mesotrione 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 mesotrione, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2017. |
| --- | --- |

(3)

The approval of the active substance mesotrione, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2017.

| (4) | An application for the renewal of the approval of mesotrione 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 mesotrione 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 23 February 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 23 February 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 7 March 2016 (6) the Authority communicated to the Commission its conclusion on whether mesotrione 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 mesotrione to the Standing Committee on Plants, Animals, Food and Feed on 6 December 2016. |
| --- | --- |

(8)

On 7 March 2016 (6) the Authority communicated to the Commission its conclusion on whether mesotrione 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 mesotrione to the Standing Committee on Plants, Animals, Food and Feed on 6 December 2016.

| (9) | It has been established with respect to one or more representative uses of at least one plant protection product containing mesotrione that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of mesotrione. |
| --- | --- |

(9)

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

| (10) | The risk assessment for the renewal of the approval of mesotrione is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing mesotrione may be authorised. It is therefore appropriate not to maintain the restriction for use only as herbicide. |
| --- | --- |

(10)

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

| (11) | 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. |
| --- | --- |

(11)

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.

| (12) | 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)

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.

| (13) | Commission Implementing Regulation (EU) 2016/950 (7) extended the approval period of mesotrione to 31 July 2017 in order to allow the renewal process to be completed before the expiry date of the approval of that substance. However, given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation shall apply from 1 June 2017. |
| --- | --- |

(13)

Commission Implementing Regulation (EU) 2016/950 (7) extended the approval period of mesotrione to 31 July 2017 in order to allow the renewal process to be completed before the expiry date of the approval of that substance. However, given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation shall apply from 1 June 2017.

| (14) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(14)

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 mesotrione, 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 June 2017.

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

Done at Brussels, 24 April 2017.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  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 mesotrione. EFSA Journal 2016;14(3):4419, 103 pp. doi:10.2903/j.efsa.2016.4419; Available online: www.efsa.europa.eu

6

EFSA Journal

(7)  Commission Implementing Regulation (EU) 2016/950 of 15 June 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,4 DB, beta-cyfluthrin, carfentrazone ethyl, Coniothyrium minitans Strain CON/M/91-08 (DSM 9660), cyazofamid, deltamethrin, dimethenamid-P, ethofumesate, fenamidone, flufenacet, flurtamone, foramsulfuron, fosthiazate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, mesotrione, oxasulfuron, pendimethalin, picoxystrobin, silthiofam and trifloxystrobin (OJ L 159, 16.6.2016, p. 3).

7

Coniothyrium minitans

---

ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Mesotrione
  CAS No 104206-82-8
  CIPAC No 625 | Mesotrione
  2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione | ≥ 920 g/kg
  R287431 max 2 mg/kg
  R287432 max 2 g/kg
  1,2-dichloroethane max 1 g/kg | 1 June 2017 | 31 May 2032 | 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 mesotrione, 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 protection of operators, |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Mesotrione

CAS No 104206-82-8

CIPAC No 625

Mesotrione

2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione

≥ 920 g/kg

R287431 max 2 mg/kg

R287432 max 2 g/kg

1,2-dichloroethane max 1 g/kg

1 June 2017

31 May 2032

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 mesotrione, 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 protection of operators,

| — | the protection of groundwater in vulnerable regions, |
| --- | --- |

—

the protection of groundwater in vulnerable regions,

| — | the protection of mammals, aquatic and non-target plants. |
| --- | --- |

—

the protection of mammals, aquatic and non-target plants.

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

The applicant shall submit confirmatory information as regards:

| 1. | the genotoxic profile of the metabolite AMBA; |
| --- | --- |

1.

the genotoxic profile of the metabolite AMBA;

| 2. | the potential endocrine disrupting mode of action of the active substance in particular level 2 and 3 tests, currently indicated in the OECD Conceptual framework (OECD 2012) and analysed in the EFSA Scientific opinion on the hazard assessment of endocrine disruptors; |
| --- | --- |

2.

the potential endocrine disrupting mode of action of the active substance in particular level 2 and 3 tests, currently indicated in the OECD Conceptual framework (OECD 2012) and analysed in the EFSA Scientific opinion on the hazard assessment of endocrine disruptors;

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

3.

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

The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under point 1 by 1 July 2017 and the relevant information requested under point 2 by 31 December 2017. The applicant shall submit to the Commission, the Member States and the Authority the confirmatory information requested under point 3 within a period of two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater be made public by the Commission.

---

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

---

ANNEX II

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

| (1) | in Part A, the entry 61 on Mesotrione is deleted; |
| --- | --- |

(1)

in Part A, the entry 61 on Mesotrione is deleted;

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











  ‘112 | Mesotrione
  CAS No 104206-82-8
  CIPAC No 625 | Mesotrione
  2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione | ≥ 920 g/kg
  R287431 max 2 mg/kg
  R287432 max 2 g/kg
  1,2-dichloroethane max 1 g/kg | 1 June 2017 | 31 May 2032 | 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 mesotrione, 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 protection of operators, |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |

(2)

in Part B, the following entry is added:

‘112

Mesotrione

CAS No 104206-82-8

CIPAC No 625

Mesotrione

2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione

≥ 920 g/kg

R287431 max 2 mg/kg

R287432 max 2 g/kg

1,2-dichloroethane max 1 g/kg

1 June 2017

31 May 2032

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 mesotrione, 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 protection of operators,

| — | the protection of groundwater in vulnerable regions, |
| --- | --- |

—

the protection of groundwater in vulnerable regions,

| — | the protection of mammals, aquatic and non-target plants. |
| --- | --- |

—

the protection of mammals, aquatic and non-target plants.

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

The applicant shall submit confirmatory information as regards:

| 1. | the genotoxic profile of the metabolite AMBA; |
| --- | --- |

1.

the genotoxic profile of the metabolite AMBA;

| 2. | the potential endocrine disrupting mode of action of the active substance in particular level 2 and 3 tests, currently indicated in the OECD Conceptual framework (OECD 2012) and analysed in the EFSA Scientific opinion on the hazard assessment of endocrine disruptors; |
| --- | --- |

2.

the potential endocrine disrupting mode of action of the active substance in particular level 2 and 3 tests, currently indicated in the OECD Conceptual framework (OECD 2012) and analysed in the EFSA Scientific opinion on the hazard assessment of endocrine disruptors;

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

3.

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

The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under point 1 by 1 July 2017 and the relevant information requested under point 2 by 31 December 2017. The applicant shall submit to the Commission, the Member States and the Authority the confirmatory information requested under point 3 within a period of two years after 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.’

---