Document ID: 02017R0375-20210428
Language: ENG

02017R0375 — EN — 28.04.2021 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>COMMISSION IMPLEMENTING REGULATION (EU) 2017/375</p><p>of 2 March 2017</p><p>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</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 058 4.3.2017, p. 3)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2021/574&#160;of 30&#160;March 2021</a></p></td><td><p>&#160;&#160;L&#160;120</p></td><td><p>9</p></td><td><p>8.4.2021</p></td></tr></table>
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)
Article 1
Renewal of the approval of the active substance as a candidate for substitution
The approval of the active substance prosulfuron, as a candidate for substitution, 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 .
It shall apply from 1 May 2017.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common Name, Identification Numbers</p></td><td><p>IUPAC Name</p></td><td><p>Purity&#160;<a>(<span>1</span>)</a></p></td><td><p>Date of approval</p></td><td><p>Expiration of approval</p></td><td><p>Specific provisions</p></td></tr><tr><td><p>Prosulfuron</p><p>CAS No 94125-34-5</p><p>CIPAC No 579</p></td><td><p>1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3- trifluoropropyl)-phenylsulfonyl]-urea</p></td><td><p>950 g/kg</p><p>The impurity 2-(3,3,3-trifluoro-propyl)-benzene sulphonamide shall not exceed 10 g/kg in the technical material</p></td><td><p>1 May 2017</p></td><td><p>30 April 2024</p></td><td><span><a><span>&#9658;M1</span></a></span><p>&#160;</p><p>For the implementation of the uniform principles, as referred to in Article&#160;29(6) of Regulation (EC) No&#160;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.</p><p>In that overall assessment Member States shall pay particular attention to:</p><div><p>&#8212;&#160;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;</p></div><div><p>&#8212;&#160;the protection of consumers, taking into account exposure to metabolites of prosulfuron;</p></div><div><p>&#8212;&#160;the risk to non-target terrestrial and aquatic plants.</p></div><p>Conditions of use shall include risk mitigation measures, where appropriate.</p><span>&#160;&#9668;</span></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>Further details on identity and specification of active substance are provided in the review report.</p></div></td></tr></tbody></table>
ANNEX II
The 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:
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>&#160;</p><div/></td><td><p>Common Name, Identification Numbers</p></td><td><p>IUPAC Name</p></td><td><p>Purity&#160;<a>(<span>*1</span>)</a></p></td><td><p>Date of approval</p></td><td><p>Expiration of approval</p></td><td><p>Specific provisions</p></td></tr><tr><td><p>&#8216;6</p></td><td><p>Prosulfuron</p><p>CAS No 94125-34-5</p><p>CIPAC No 579</p></td><td><p>1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3- trifluoropropyl)-phenylsulfonyl]-urea</p></td><td><p>950 g/kg</p><p>The impurity 2-(3,3,3-trifluoro-propyl)-benzene sulphonamide shall not exceed 10 g/kg in the technical material.</p></td><td><p>1 May 2017</p></td><td><p>30 April 2024</p></td><td><p>PART A</p><p>Use shall be limited to one application every three years on the same field at a maximum dose of 20&#160;g active substance per hectare.</p><p>PART B</p><p>For the implementation of the uniform principles, as referred to in Article&#160;29(6) of Regulation (EC) No&#160;1107/2009, the conclusions of the review report on prosulfuron, and in particular Appendices I and II thereof, shall be taken into account.</p><p>In this overall assessment Member States shall pay particular attention to:</p><div><p>&#8212;&#160;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;</p></div><div><p>&#8212;&#160;the risk to non-target terrestrial and aquatic plants.</p></div><p>Conditions of use shall include risk mitigation measures, where appropriate.</p><p>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.</p><p>The applicant shall submit that information to the Commission, the Member States and the Authority by 31&#160;October 2017.&#8217;</p></td></tr><tr><td><div><a>(<span>*1</span>)&#160;&#160;&#160;</a><p>Further details on identity and specification of active substance are provided in the review report.</p></div></td></tr></tbody></table>