# L_2016144EN.01003201.xml

| 1.6.2016 | EN | Official Journal of the European Union | L 144/32 |
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1.6.2016

EN

Official Journal of the European Union

L 144/32

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/864

of 31 May 2016

concerning the non-renewal of approval of the active substance triasulfuron, 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 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) and Article 78(2) thereof,

Whereas:

| (1) | Commission Directive 2000/66/EC (2) included triasulfuron as active substance in Annex I to Council Directive 91/414/EEC (3). |
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(1)

Commission Directive 2000/66/EC (2) included triasulfuron as 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 triasulfuron, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 June 2016. |
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(3)

The approval of the active substance triasulfuron, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 June 2016.

| (4) | An application for the renewal of the inclusion of triasulfuron in Annex I to Directive 91/414/EEC was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (5) within the time period provided for in that Article. |
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(4)

An application for the renewal of the inclusion of triasulfuron in Annex I to Directive 91/414/EEC was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (5) within the time period provided for in that Article.

| (5) | The applicant submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. 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 9 of Regulation (EU) No 1141/2010. 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 (hereinafter ‘the Authority’) and the Commission on 14 October 2013. |
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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 (hereinafter ‘the Authority’) and the Commission on 14 October 2013.

| (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. |
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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 dossier available to the public.

| (8) | On 8 January 2015 the Authority communicated to the Commission its conclusion (6) on whether triasulfuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority concluded that, due to an incomplete genotoxicity assessment of triasulfuron and its manufacturing impurity CGA 150829, it has not been possible to set the health based toxicological reference values. As a consequence, the assessment of the risk to consumers, operators, workers and bystanders could not be conducted. Furthermore, the Authority concluded that in specific geoclimatic situations there is a high potential for the representative uses assessed to result in groundwater exposure above the parametric drinking water limit of 0,1 μg/l, either by triasulfuron itself or by its soil metabolite CGA 150829. In addition, a high risk to aquatic plants was identified. |
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(8)

On 8 January 2015 the Authority communicated to the Commission its conclusion (6) on whether triasulfuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority concluded that, due to an incomplete genotoxicity assessment of triasulfuron and its manufacturing impurity CGA 150829, it has not been possible to set the health based toxicological reference values. As a consequence, the assessment of the risk to consumers, operators, workers and bystanders could not be conducted. Furthermore, the Authority concluded that in specific geoclimatic situations there is a high potential for the representative uses assessed to result in groundwater exposure above the parametric drinking water limit of 0,1 μg/l, either by triasulfuron itself or by its soil metabolite CGA 150829. In addition, a high risk to aquatic plants was identified.

| (9) | The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 17(1) of Regulation (EU) No 1141/2010, on the draft review 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 Article 17(1) of Regulation (EU) No 1141/2010, on the draft review report. The applicant submitted its comments, which have been carefully examined.

| (10) | However, despite the arguments put forward by the applicant, the concerns referred to in recital 8 could not be eliminated. |
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(10)

However, despite the arguments put forward by the applicant, the concerns referred to in recital 8 could not be eliminated.

| (11) | Consequently, it has not been established that it may be expected that, with respect to one or more representative uses of at least one plant protection product containing triasulfuron, the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. The approval of the active substance triasulfuron should therefore not be renewed. |
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(11)

Consequently, it has not been established that it may be expected that, with respect to one or more representative uses of at least one plant protection product containing triasulfuron, the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. The approval of the active substance triasulfuron should therefore not be renewed.

| (12) | Member States should be provided with time to withdraw authorisations for plant protection products containing triasulfuron. |
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(12)

Member States should be provided with time to withdraw authorisations for plant protection products containing triasulfuron.

| (13) | For plant protection products containing triasulfuron, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 30 September 2017. |
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(13)

For plant protection products containing triasulfuron, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 30 September 2017.

| (14) | This Regulation does not prejudice the submission of a further application for triasulfuron in accordance with Article 7 of Regulation (EC) No 1107/2009. |
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(14)

This Regulation does not prejudice the submission of a further application for triasulfuron in accordance with Article 7 of Regulation (EC) No 1107/2009.

| (15) | 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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(15)

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

Non-renewal of approval of active substance

The approval of the active substance triasulfuron is not renewed.

Article 2

Transitional measures

Member States shall withdraw authorisations for plant protection products containing triasulfuron as active substance by 30 September 2016.

Article 3

Grace periods

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire on 30 September 2017 at the latest.

Article 4

Amendments to Implementing Regulation (EU) No 540/2011

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 9 on triasulfuron is deleted.

Article 5

Entry into force

This Regulation shall enter into force on 1 July 2016.

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

Done at Brussels, 31 May 2016.

For the Commission

The President

Jean-Claude JUNCKER

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

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(2)  Commission Directive 2000/66/EC of 23 October 2000 including an active substance (triasulfuron) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 276, 28.10.2000, p. 35).

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(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).

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(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).

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(5)  Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (OJ L 322, 8.12.2010, p. 10).

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(6)  EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk assessment of the active substance triasulfuron. EFSA Journal 2015;13(1):3958, 78 pp. doi:10.2903/j.efsa.2015.3958.

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