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.)
Commission Implementing Regulation (EU) 2018/1913of 6 December 2018renewing 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/EECOJ L 309, 24.11.2009, p. 1., and in particular Article 20(1) thereof,Whereas:(1)Commission Directive 2005/54/ECCommission 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). included tribenuron as an active substance in Annex I to Council Directive 91/414/EECCouncil 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)..(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 540/2011Commission 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)..(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 844/2012Commission 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). 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.(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.(8)On 29 June 2017 the Authority communicated to the Commission its conclusionEFSA (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. 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.(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.(12)Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.(13)Commission Implementing Regulation (EU) 2018/1262Commission 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). 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,HAS ADOPTED THIS REGULATION:
Article 1Renewal of the approval of active substanceThe approval of the active substance tribenuron is renewed as set out in Annex I.
Article 2Amendments to Implementing Regulation (EU) No 540/2011The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3Entry into force and date of applicationThis Regulation shall enter into force on the twentieth day following that of its publication in the 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 CommissionThe PresidentJean-Claude JunckerANNEX I
Further details on identity and specification of active substance are provided in the renewal report.
Common Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
Tribenuron (parent)CAS No 106040-48-6CIPAC No 5462-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid≥ 960 g/kg (expressed as tribenuron-methyl)1 February 201930 January 2034For 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 aquatic organisms and of non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.
ANNEX IIThe Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:(1)in Part A, entry 106 on tribenuron is deleted;(2)in Part B, the following entry is added:
Further details on identity and specification of active substance are provided in the renewal report.
NumberCommon Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
"128Tribenuron (parent)CAS No 106040-48-6CIPAC No 5462-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid≥ 960 g/kg (expressed as tribenuron-methyl)1 February 201930 January 2034For 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 aquatic organisms and of non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate."
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Further details on identity and specification of active substance are provided in the renewal report.