Commission Implementing Regulation (EU) 2017/375 of 2 March 2017 renewing the approval of the active substance prosulfuron, as a candidate for substitution, 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. )
Modified by
  • Commission Implementing Regulation (EU) 2021/574of 30 March 2021amending Implementing Regulations (EU) 2017/375 and (EU) No 540/2011 as regards the conditions of approval of the active substance prosulfuron(Text with EEA relevance), 32021R0574, April 8, 2021
Commission Implementing Regulation (EU) 2017/375of 2 March 2017renewing the approval of the active substance prosulfuron, as a candidate for substitution, 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)
Article 1Renewal of the approval of the active substance as a candidate for substitutionThe approval of the active substance prosulfuron, as a candidate for substitution, 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 May 2017.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX I
Further details on identity and specification of active substance are provided in the review report.
Common Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
ProsulfuronCAS No 94125-34-5CIPAC No 5791-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3- trifluoropropyl)-phenylsulfonyl]-urea950 g/kgThe impurity 2-(3,3,3-trifluoro-propyl)-benzene sulphonamide shall not exceed 10 g/kg in the technical material1 May 201730 April 2024For 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 prosulfuron including its addendum, and in particular Appendices I and II thereto, shall be taken into account.In that 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 climatic conditions;the protection of consumers, taking into account exposure to metabolites of prosulfuron;the risk to non-target terrestrial and aquatic 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 31 on prosulfuron is deleted;(2)in Part E, the following entry is added:
Further details on identity and specification of active substance are provided in the review report.
Common Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
"6ProsulfuronCAS No 94125-34-5CIPAC No 5791-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3- trifluoropropyl)-phenylsulfonyl]-urea950 g/kgThe impurity 2-(3,3,3-trifluoro-propyl)-benzene sulphonamide shall not exceed 10 g/kg in the technical material.1 May 201730 April 2024PART AUse shall be limited to one application every three years on the same field at a maximum dose of 20 g active substance per hectare.PART BFor 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 prosulfuron, 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 groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to non-target terrestrial and aquatic plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the genotoxic potential of the metabolite triazine-amine (CGA150829) to confirm that this metabolite is not genotoxic and not relevant for risk assessment.The applicant shall submit that information to the Commission, the Member States and the Authority by 31 October 2017."
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Further details on identity and specification of active substance are provided in the review report.
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