# L_2018311EN.01001301.xml

| 7.12.2018 | EN | Official Journal of the European Union | L 311/13 |
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7.12.2018

EN

Official Journal of the European Union

L 311/13

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1913

of 6 December 2018

renewing the approval of the active substance tribenuron 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 2005/54/EC (2) included tribenuron as an active substance in Annex I to Council Directive 91/414/EEC (3). |
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(1)

Commission Directive 2005/54/EC (2) included tribenuron 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 tribenuron, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2019. |
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(3)

The approval of the active substance tribenuron, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2019.

| (4) | An application for the renewal of the approval of tribenuron 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 tribenuron 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 23 June 2016. |
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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 23 June 2016.

| (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 dossiers available to the public. |
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(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 dossiers available to the public.

| (8) | On 29 June 2017 the Authority communicated to the Commission its conclusion (6) on whether tribenuron 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 tribenuron to the Standing Committee on Plants, Animals, Food and Feed on 12 December 2017. |
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(8)

On 29 June 2017 the Authority communicated to the Commission its conclusion (6) on whether tribenuron 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 tribenuron to the Standing Committee on Plants, Animals, Food and Feed on 12 December 2017.

| (9) | 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 draft renewal report. The applicant submitted its comments, which have been carefully examined. |
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(9)

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 draft renewal report. The applicant submitted its comments, which have been carefully examined.

| (10) | It has been established with respect to one or more representative uses of at least one plant protection product containing tribenuron 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 tribenuron. |
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(10)

It has been established with respect to one or more representative uses of at least one plant protection product containing tribenuron 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 tribenuron.

| (11) | The risk assessment for the renewal of the approval of tribenuron is based on a limited number of representative uses, which, however, do not restrict the uses for which plant protection products containing tribenuron may be authorised. It is therefore appropriate to remove the restriction for use only as a herbicide. |
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(11)

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

| (12) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(12)

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

| (13) | Commission Implementing Regulation (EU) 2018/1262 (7) extended the expiry date of tribenuron to 31 October 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. Given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation shall apply from 1 February 2019. |
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(13)

Commission Implementing Regulation (EU) 2018/1262 (7) extended the expiry date of tribenuron to 31 October 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. Given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation shall apply from 1 February 2019.

| (14) | 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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(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 tribenuron 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 February 2019.

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

Done at Brussels, 6 December 2018.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  Commission Directive 2005/54/EC of 19 September 2005 amending Council Directive 91/414/EEC to include tribenuron as active substance (OJ L 244, 20.9.2005, p. 21).

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), 2017. Conclusion on the peer review of the pesticide risk assessment of the active substance tribenuron. EFSA Journal 2017;15(7):4912 [39 pp]. doi: 10.2903/j.efsa.2017.4912.

6

EFSA Journal

(7)  Commission Implementing Regulation (EU) 2018/1262 of 20 September 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, clomazone, cypermethrin, daminozide, deltamethrin, dimethenamid-p, diuron, fludioxonil, flufenacet, flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate-methyl and tribenuron (OJ L 238, 21.9.2018, p. 62).

7

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Tribenuron (parent)
  CAS No 106040-48-6
  CIPAC No 546 | 2-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid | ≥ 960 g/kg (expressed as tribenuron-methyl) | 1 February 2019 | 30 January 2034 | 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 tribenuron, 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 consumers, in particular to residues on animal products, |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Tribenuron (parent)

CAS No 106040-48-6

CIPAC No 546

2-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid

≥ 960 g/kg (expressed as tribenuron-methyl)

1 February 2019

30 January 2034

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 tribenuron, 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 consumers, in particular to residues on animal products,

| — | the protection of groundwater, |
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—

the protection of groundwater,

| — | the protection of aquatic organisms and of non-target terrestrial plants. |
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—

the protection of aquatic organisms and of non-target terrestrial plants.

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 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 106 on tribenuron is deleted; |
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(1)

in Part A, entry 106 on tribenuron 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘128 | Tribenuron (parent)
  CAS No 106040-48-6
  CIPAC No 546 | 2-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid | ≥ 960 g/kg (expressed as tribenuron-methyl) | 1 February 2019 | 30 January 2034 | 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 tribenuron, 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 consumers, in particular to residues on animal products, |

(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

‘128

Tribenuron (parent)

CAS No 106040-48-6

CIPAC No 546

2-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid

≥ 960 g/kg (expressed as tribenuron-methyl)

1 February 2019

30 January 2034

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 tribenuron, 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 consumers, in particular to residues on animal products,

| — | the protection of groundwater, |
| --- | --- |

—

the protection of groundwater,

| — | the protection of aquatic organisms and of non-target terrestrial plants. |
| --- | --- |

—

the protection of aquatic organisms and of non-target terrestrial plants.

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 renewal report.

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