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Date: 2019-02-05 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2019/168 of 31 January 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus thuringiensis subsp. Aizawai, Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauveria bassiana, benfluralin, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, epoxiconazole, fenpyroximate, fluazinam, flutolanil, fosetyl, Lecanicillium muscarium, mepanipyrim, mepiquat, Metarhizium anisopliae var. Anisopliae, metconazole, metrafenone, Phlebiopsis gigantea, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, Pythium oligandrum, rimsulfuron, spinosad, Streptomyces K61, thiacloprid, tolclofos-methyl, Trichoderma asperellum, Trichoderma atroviride, Trichoderma gamsii, Trichoderma harzianum, triclopyr, trinexapac, triticonazole, Verticillium albo-atrum and ziram (Text with EEA relevance.)

Issued by European Commission · Directorate-General for Health and Food Safety

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Executive Summary & Key Takeaways

Executive Summary: Commission Implementing Regulation (EU) 2019/168 amends Implementing Regulation (EU) No 540/2011, extending the approval periods for several active substances. This extension is due to delays in the assessment of these substances. The regulation took effect on the third day following its publication in the Official Journal of the European Union. Key Points / Main Content: Extension of Approval Periods: The regulation extends the expiration dates for the approval of several active substances listed in the Annex of Implementing Regulation (EU) No 540/2011. Specific Extensions: * The expiration date for Ziram and Pseudomonas chlororaphis strain: MA 342 is extended to April 30, 2020. * The expiration date for Mepanipyrim and Thiacloprid is extended to April 30, 2020. * The expiration date for Clodinafop and Pirimicarb is extended to April 30, 2020. * The expiration date for Rimsulfuron and Tolclofosmethyl is extended to April 30, 2020. * The expiration date for Triticonazole and Clopyralid is extended to April 30, 2020. * The expiration date for Cyprodinil and Fosetyl is extended to April 30, 2020. * The expiration date for Trinexapac and DichlorpropP is extended to April 30, 2020. * The expiration date for Metconazole and Pyrimethanil is extended to April 30, 2020. * The expiration date for Triclopyr and Metrafenone is extended to April 30, 2020. * The expiration date for Bacillus subtilis Cohn 1872 strain QST 713 and Spinosad is extended to April 30, 2020. * The expiration date for Flutolanil is extended to February 29, 2020. * The expiration date for Benfluralin is extended to February 29, 2020. * The expiration date for Fluazinam is extended to February 29, 2020. * The expiration date for Mepiquat is extended to February 29, 2020. * The expiration date for Bacillus thuringiensis subsp. Aizawai and Bacillus thuringiensis subsp. israeliensis is extended to April 30, 2020. * The expiration date for Bacillus thuringiensis subsp. kurstaki and Beauveria bassiana is extended to April 30, 2020. * The expiration date for Cydia pomonella Granulovirus CpGV and Lecanicillium muscarium is extended to April 30, 2020. * The expiration date for Metarhizium anisopliae var. Anisopliae and Phlebiopsis gigantea is extended to April 30, 2020. * The expiration date for Pythium oligandrum and Streptomyces K61 is extended to April 30, 2020. * The expiration date for Trichoderma atroviride is extended to April 30, 2020. * The expiration date for Trichoderma harzianum and Trichoderma asperellum is extended to April 30, 2020. * The expiration date for Trichoderma gamsii and Verticillium alboatrum is extended to April 30, 2020. * The expiration date for Abamectin and Epoxiconazole is extended to April 30, 2020. * The expiration date for Fenpyroximate is extended to April 30, 2020. Impact Analysis: Active Substance Producers/Applicants: Impact: Benefit from the extended approval periods, allowing continued market presence while awaiting renewal decisions. Action Required: Continue to cooperate with the assessment process for renewal of approvals. Member States: Impact: Need to ensure that plant protection products containing these active substances remain available on the market during the extended approval period, subject to national regulations. Action Required: Monitor and enforce compliance with the extended approval periods within their jurisdictions. European Commission: Impact: Responsible for setting new expiration dates based on renewal decisions, potentially adjusting dates depending on approval or non-renewal outcomes. Action Required: Continue the assessment process and make timely decisions on the renewal of the active substances.

Key Entities Referenced

European Union: A political and economic union of member states located primarily in Europe. European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU. Regulation (EC) No 1107/2009: A regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market. Commission Implementing Regulation (EU) No 540/2011: A commission implementing regulation setting out the list of approved active substances under Regulation (EC) No 1107/2009. Commission Implementing Regulation (EU) 2019/168: Commission Implementing Regulation amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of certain active substances. Commission Implementing Regulation (EU) 2018/524: Commission Implementing Regulation amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of certain active substances. Jean-Claude Juncker: The President of the European Commission at the time of the regulation. Brussels: The location where the regulation was adopted.
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5.2.2019 EN Official Journal of the European Union L 33/1 II (Non-legislative acts) REGULATIONS COMMISSION IMPLEMENTING REGULATION (EU) 2019/168 of 31 January 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus thuringiensis subsp. Aizawai, Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauveria bassiana, benfluralin, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, epoxiconazole, fenpyroximate, fluazinam, flutolanil, fosetyl, Lecanicillium muscarium, mepanipyrim, mepiquat, Metarhizium anisopliae var. Anisopliae, metconazole, metrafenone, Phlebiopsis gigantea, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, Pythium oligandrum, rimsulfuron, spinosad, Streptomyces K61, thiacloprid, tolclofos-methyl, Trichoderma asperellum, Trichoderma atroviride, Trichoderma gamsii, Trichoderma harzianum, triclopyr, trinexapac, triticonazole, Verticillium albo-atrum and ziram (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 the first paragraph of Article 17 thereof, Whereas: (1) Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009. (2) The approval periods of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, clodinafop, clopyralid, cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, rimsulfuron, spinosad, thiacloprid, tolclofos-methyl, triclopyr, trinexapac, tritico­ nazole and ziram were last extended by Commission Implementing Regulation (EU) 2018/524 (3). The approval periods of those substances will expire on 30 April 2019. (3) The approval periods of the active substances benfluralin, fluazinam, flutolanil and mepiquat will expire on 28 February 2019. (1) OJ L 309, 24.11.2009, p. 1. (2) 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). (3) Commission Implementing Regulation (EU) 2018/524 of 28 March 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, clopyralid, cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, thiacloprid, thiamethoxam, thiram, tolclofos-methyl, triclopyr, trinexapac, triticonazole and ziram (OJ L 88, 4.4.2018, p. 4).L 33/2 EN Official Journal of the European Union 5.2.2019 (4) The approval periods of the active substances abamectin, Bacillus thuringiensis subsp. Aizawai, Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauveria bassiana, Cydia pomonella Granulovirus (CpGV), epoxiconazole, fenpyroximate, Lecanicillium muscarium, Metarhizium anisopliae var. Anisopliae, Phlebiopsis gigantea, Pythium oligandrum, Streptomyces K61, Trichoderma asperellum, Trichoderma atroviride, Trichoderma gamsii, Trichoderma harzianum and Verticillium albo-atrum will expire on 30 April 2019. (5) Applications for the renewal of the approval of those substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (4). (6) Due to the fact that the assessment of those substances has been delayed for reasons beyond the control of the applicants, the approval of those active substances are likely to expire before a decision on the renewal of the approval has been taken. It is therefore necessary to postpone the expiry of the approval periods. (7) In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission will adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date. (8) Taking into account that the approval periods of the active substances benfluralin, fluazinam, flutolanil and mepiquat expire on 28 February 2019, this Regulation should enter into force as soon as possible. (9) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. (10) 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 The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation. Article 2 This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 31 January 2019. For the Commission The President Jean-Claude JUNCKER (4) Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implemen­ tation 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).5.2.2019 EN Official Journal of the European Union L 33/3 ANNEX Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in the sixth column, expiration of approval, of row 74, Ziram, the date is replaced by ‘30 April 2020’; (2) in the sixth column, expiration of approval, of row 89, Pseudomonas chlororaphis strain: MA 342, the date is replaced by ‘30 April 2020’; (3) in the sixth column, expiration of approval, of row 90, Mepanipyrim, the date is replaced by ‘30 April 2020’; (4) in the sixth column, expiration of approval, of row 92, Thiacloprid, the date is replaced by ‘30 April 2020’; (5) in the sixth column, expiration of approval, of row 123, Clodinafop, the date is replaced by ‘30 April 2020’; (6) in the sixth column, expiration of approval, of row 124, Pirimicarb, the date is replaced by ‘30 April 2020’; (7) in the sixth column, expiration of approval, of row 125, Rimsulfuron, the date is replaced by ‘30 April 2020’; (8) in the sixth column, expiration of approval, of row 126, Tolclofos-methyl, the date is replaced by ‘30 April 2020’; (9) in the sixth column, expiration of approval, of row 127, Triticonazole, the date is replaced by ‘30 April 2020’; (10) in the sixth column, expiration of approval, of row 129, Clopyralid, the date is replaced by ‘30 April 2020’; (11) in the sixth column, expiration of approval, of row 130, Cyprodinil, the date is replaced by ‘30 April 2020’; (12) in the sixth column, expiration of approval, of row 131, Fosetyl, the date is replaced by ‘30 April 2020’; (13) in the sixth column, expiration of approval, of row 132, Trinexapac, the date is replaced by ‘30 April 2020’; (14) in the sixth column, expiration of approval, of row 133, Dichlorprop-P, the date is replaced by ‘30 April 2020’; (15) in the sixth column, expiration of approval, of row 134, Metconazole, the date is replaced by ‘30 April 2020’; (16) in the sixth column, expiration of approval, of row 135, Pyrimethanil, the date is replaced by ‘30 April 2020’; (17) in the sixth column, expiration of approval, of row 136, Triclopyr, the date is replaced by ‘30 April 2020’; (18) in the sixth column, expiration of approval, of row 137, Metrafenone, the date is replaced by ‘30 April 2020’; (19) in the sixth column, expiration of approval, of row 138, Bacillus subtilis (Cohn 1872) strain QST 713, the date is replaced by ‘30 April 2020’; (20) in the sixth column, expiration of approval, of row 139, Spinosad, the date is replaced by ‘30 April 2020’; (21) in the sixth column, expiration of approval, of row 187, Flutolanil, the date is replaced by ‘29 February 2020’; (22) in the sixth column, expiration of approval, of row 188, Benfluralin, the date is replaced by ‘29 February 2020’; (23) in the sixth column, expiration of approval, of row 189, Fluazinam, the date is replaced by ‘29 February 2020’; (24) in the sixth column, expiration of approval, of row 191, Mepiquat, the date is replaced by ‘29 February 2020’; (25) in the sixth column, expiration of approval, of row 193, Bacillus thuringiensis subsp. Aizawai, the date is replaced by ‘30 April 2020’;L 33/4 EN Official Journal of the European Union 5.2.2019 (26) in the sixth column, expiration of approval, of row 194, Bacillus thuringiensis subsp. israeliensis, the date is replaced by ‘30 April 2020’; (27) in the sixth column, expiration of approval, of row 195, Bacillus thuringiensis subsp. kurstaki, the date is replaced by ‘30 April 2020’; (28) in the sixth column, expiration of approval, of row 197, Beauveria bassiana, the date is replaced by ‘30 April 2020’; (29) in the sixth column, expiration of approval, of row 198, Cydia pomonella Granulovirus (CpGV), the date is replaced by ‘30 April 2020’; (30) in the sixth column, expiration of approval, of row 199, Lecanicillium muscarium, the date is replaced by ‘30 April 2020’; (31) in the sixth column, expiration of approval, of row 200, Metarhizium anisopliae var. Anisopliae, the date is replaced by ‘30 April 2020’; (32) in the sixth column, expiration of approval, of row 201, Phlebiopsis gigantea, the date is replaced by ‘30 April 2020’; (33) in the sixth column, expiration of approval, of row 202, Pythium oligandrum, the date is replaced by ‘30 April 2020’; (34) in the sixth column, expiration of approval, of row 203, Streptomyces K61, the date is replaced by ‘30 April 2020’; (35) in the sixth column, expiration of approval, of row 204, Trichoderma atroviride, the date is replaced by ‘30 April 2020’; (36) in the sixth column, expiration of approval, of row 206, Trichoderma harzianum, the date is replaced by ‘30 April 2020’; (37) in the sixth column, expiration of approval, of row 207, Trichoderma asperellum, the date is replaced by ‘30 April 2020’; (38) in the sixth column, expiration of approval, of row 208, Trichoderma gamsii, the date is replaced by ‘30 April 2020’; (39) in the sixth column, expiration of approval, of row 209, Verticillium albo-atrum, the date is replaced by ‘30 April 2020’; (40) in the sixth column, expiration of approval, of row 210, Abamectin, the date is replaced by ‘30 April 2020’; (41) in the sixth column, expiration of approval, of row 211, Epoxiconazole, the date is replaced by ‘30 April 2020’; (42) in the sixth column, expiration of approval, of row 213, Fenpyroximate, the date is replaced by ‘30 April 2020’.

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