Commission Implementing Regulation (EU) 2020/2007 of 8 December 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 1,4-dimethylnaphthalene, 6-benzyladenine, acequinocyl, Adoxophyes orana granulovirus, aluminium sulfate, amisulbrom, Aureobasidium pullulans (strains DSM 14940 and DSM 14941), azadirachtin, Bacillus pumilus QST 2808, benalaxyl-M, bixafen, bupirimate, Candida oleophila strain O, chlorantraniliprole, disodium phosphonate, dithianon, dodine, emamectin, flubendiamide, fluometuron, fluxapyroxad, flutriafol, hexythiazox, imazamox, ipconazole, isoxaben, L-ascorbic acid, lime sulphur, orange oil, Paecilomyces fumosoroseus strain FE 9901, pendimethalin, penflufen, penthiopyrad, potassium phosphonates, prosulfuron, Pseudomonas sp. strain DSMZ 13134, pyridalyl, pyriofenone, pyroxsulam, quinmerac, S-abscisic acid, sedaxane, sintofen, sodium silver thiosulfate, spinetoram, spirotetramat, Streptomyces lydicus strain WYEC 108, tau-fluvalinate, tebufenozide, tembotrione, thiencarbazone, valifenalate, zinc phosphide
Date: 2020-12-08
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product








L_2020414EN.01001001.xml










9.12.2020   


EN


Official Journal of the European Union


L 414/10








            COMMISSION IMPLEMENTING REGULATION (EU) 2020/2007
of 8 December 2020
         
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 1,4-dimethylnaphthalene, 6-benzyladenine, acequinocyl, Adoxophyes orana granulovirus, aluminium sulfate, amisulbrom, Aureobasidium pullulans (strains DSM 14940 and DSM 14941), azadirachtin, Bacillus pumilus QST 2808, benalaxyl-M, bixafen, bupirimate, Candida oleophila strain O, chlorantraniliprole, disodium phosphonate, dithianon, dodine, emamectin, flubendiamide, fluometuron, fluxapyroxad, flutriafol, hexythiazox, imazamox, ipconazole, isoxaben, L-ascorbic acid, lime sulphur, orange oil, Paecilomyces fumosoroseus strain FE 9901, pendimethalin, penflufen, penthiopyrad, potassium phosphonates, prosulfuron, Pseudomonas sp. strain DSMZ 13134, pyridalyl, pyriofenone, pyroxsulam, quinmerac, S-abscisic acid, sedaxane, sintofen, sodium silver thiosulfate, spinetoram, spirotetramat, Streptomyces lydicus strain WYEC 108, tau-fluvalinate, tebufenozide, tembotrione, thiencarbazone, valifenalate, zinc phosphide


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 whereas part B sets out the active substances approved under Regulation (EC) No 1107/2009 and part E sets out the active substances approved under Regulation (EC) No 1107/2009 as candidates for substitution.












(2)


The approvals of the active substances 1-decanol, 6-benzyladenine, acequinocyl, aluminium sulfate, amisulbrom, azadirachtin, bupirimate, Candida oleophila strain O, chlorantraniliprole, dithianon, dodine, emamectin, flubendiamide, fluometuron, flutriafol, hexythiazox, imazamox, ipconazole, isoxaben, L-ascorbic acid, lime sulphur, orange oil, Paecilomyces fumosoroseus strain FE 9901, pendimethalin, prosulfuron, quinmerac, S-abscisic acid, sintofen, sodium silver thiosulfate, spinetoram, spirotetramat, tau-fluvalinate, tebufenozide, tembotrione, thiencarbazone, valifenalate and zinc phosphide will expire between 30 April 2024 and 31 October 2024. However, as Commission Implementing Regulation (EU) 2020/1740 (3) will apply to those active substances and will advance the date of submission of the dossier in support of the renewal of approval by 3 months, it is necessary to provide for a short extension of their respective approval periods to maintain the date of the dossier submission as required under Commission Implementing Regulation (EU) No 844/2012 (4) as applicants need time to prepare and submit the dossiers in the required format.












(3)


In addition, for emamectin, it appears from information provided by the applicant that delays in preparing the renewal dossier have been incurred due to the COVID-19 pandemic, despite the best efforts of the applicant to mitigate such delays. The designated rapporteur Member State for emamectin, the Netherlands, exceptionally agreed to accept the submission of the application for renewal of approval as required by Implementing Regulation (EU) 2020/1740 by 30 November 2021. Therefore, the approval period of emamectin should be extended also taking this additional period into account.












(4)


Furthermore, for chlorantraniliprole, it appears from information provided by the applicant that delays in preparing the application for renewal have been incurred due to the COVID-19 pandemic, despite the best efforts of the applicant to mitigate such delays. The designated rapporteur Member State for chlorantraniliprole, Ireland, exceptionally agreed to accept the submission of the application for renewal of approval as required by Implementing Regulation (EU) 2020/1740 by 31 December 2021. Therefore, the approval period of chlorantraniliprole should be extended also taking this additional period into account.












(5)


Commission Implementing Decision C/2018/3434 (5) established a work programme grouping together similar active substances and setting priorities on the basis of safety concerns for human and animal health or the environment.












(6)


In order to ensure a balanced distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and taking into account the resources necessary for assessment and decision-making, it is appropriate to extend the approval periods of certain active substances as set out in Implementing Decision C/2018/3434. The approval periods of 1,4-dimethylnaphthalene, Adoxophyes orana granulovirus, Aureobasidium pullulans (strains DSM 14940 and DSM 14941), Bacillus pumilus QST 2808, benalaxyl-M, Pseudomonas sp. strain DSMZ 13134, pyridalyl, pyriofenone, pyroxsulam and Streptomyces lydicus strain WYEC 108 should be extended by one year. For the same reasons, it is appropriate to extend the approval periods of the active substances bixafen, Candida oleophila strain O, disodium phosphonate, fluxapyroxad, Paecilomyces fumosoroseus strain FE 9901, penflufen, penthiopyrad, potassium phosphonates and sedaxane by one to three years, respectively.












(7)


Regulation (EU) No 540/2011 should therefore be amended accordingly.












(8)


In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no application for renewal of approval in accordance with Article 5(1) of Implementing Regulation (EU) 2020/1740 is submitted within 3 years before the respective expiry date laid down in the Annex to this Regulation, the Commission will reinstate the expiry date as it was before the adoption of this Regulation, or set it at the earliest possible date thereafter.












(9)


In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, 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 it was before the adoption of the present Regulation or at the date of the adoption of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission adopts a Regulation providing for the renewal of the approval of an active substance referred to in the Annex to this Regulation, the Commission will set, as appropriate under the circumstances, the earliest possible application date.












(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 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, 8 December 2020.


For the Commission


The President

Ursula VON DER LEYEN
            





(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) 2020/1740 of 20 November 2020 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, and repealing Commission Implementing Regulation (EU) No 844/2012 (OJ L 392, 23.11.2020, p. 20).

(4)  Commission 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).

(5)  Commission Implementing Decision of 6 June 2018 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2022, 2023 and 2024 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council. C/2018/3434 final (OJ C 195, 7.6.2018, p. 20).




ANNEX
The Annex to Regulation (EU) No 540/2011 is amended as follows:
Part A is amended as follows:






(1)


In the sixth column, expiration of approval, of entry 311, quinmerac, the date 30 April 2024 is replaced by31 July 2024.










(2)


In the sixth column, expiration of approval, of entry 314, zinc phosphide, the date 30 April 2024 is replaced by31 July 2024.










(3)


In the sixth column, expiration of approval, of entry 317, 6-benzyladenine, the date 31 May 2024 is replaced by 31 August 2024.










(4)


In the sixth column, expiration of approval, of entry 323, dodine, the date 31 May 2024 is replaced by 31 August 2024.










(5)


In the sixth column, expiration of approval, of entry 328, tau-fluvalinate, the date 31 May 2024 is replaced by 31 August 2024.










(6)


In the sixth column, expiration of approval, of entry 330, bupirimate, the date 31 May 2024 is replaced by 31 August 2024.










(7)


In the sixth column, expiration of approval, of entry 333, 1-decanol, the date 31 May 2024 is replaced by 31 August 2024.










(8)


In the sixth column, expiration of approval, of entry 334, isoxaben, the date 31 May 2024 is replaced by 31 August 2024.










(9)


In the sixth column, expiration of approval, of entry 335, fluometuron, the date 31 May 2024 is replaced by 31 August 2024.










(10)


In the sixth column, expiration of approval, of entry 341, sintofen, the date 31 May 2024 is replaced by 31 August 2024.










(11)


In the sixth column, expiration of approval, of entry 343, azadirachtin, the date 31 May 2024 is replaced by 31 August 2024.










(12)


In the sixth column, expiration of approval, of entry 345, lime sulphur, the date 31 May 2024 is replaced by 31 August 2024.










(13)


In the sixth column, expiration of approval, of entry 346, aluminium sulfate, the date 31 May 2024 is replaced by 31 August 2024.










(14)


In the sixth column, expiration of approval, of entry 350, tebufenozide, the date 31 May 2024 is replaced by 31 August 2024.










(15)


In the sixth column, expiration of approval, of entry 351, dithianon, the date 31 May 2024 is replaced by 31 August 2024.










(16)


In the sixth column, expiration of approval, of entry 352, hexythiazox, the date 31 May 2024 is replaced by 31 August 2024.










(17)


In the sixth column, expiration of approval, of entry 353, flutriafol, the date 31 May 2024 is replaced by 31 August 2024.




Part B is amended as follows:






(1)


In the sixth column, expiration of approval, of entry 24, fluxapyroxad, the date 31 December 2022 is replaced by 31 May 2025.










(2)


In the sixth column, expiration of approval, of entry 26, Adoxophyes orana granulovirus, the date 31 January 2023 is replaced by 31 January 2024.










(3)


In the sixth column, expiration of approval, of entry 37, C
andid
a oleophila strain O, the date 30 September 2023 is replaced by 31 December 2024.










(4)


In the sixth column, expiration of approval, of entry 39, Paecilomyces fumosoroseus strain FE 9901, the date 30 September 2023 is replaced by 31 December 2024.










(5)


In the sixth column, expiration of approval, of entry 40, potassium phosphonates, the date 30 September 2023 is replaced by 31 January 2026.










(6)


In the sixth column, expiration of approval, of entry 43, bixafen, the date 30 September 2023 is replaced by 31 May 2025.










(7)


In the sixth column, expiration of approval, of entry 48, sedaxane, the date 31 January 2024 is replaced by 31 May 2025.










(8)


In the sixth column, expiration of approval, of entry 49, emamectin, the date 30 April 2024 is replaced by 30 November 2024.










(9)


In the sixth column, expiration of approval, of entry 50, Pseudomonas sp. strain DSMZ 13134, the date 31 January 2024 is replaced by 31 January 2025.










(10)


In the sixth column, expiration of approval, of entry 52,
Aureobasidium pullulans (strains DSM 14940 and DSM 14941), the date 31 January 2024 is replaced by 31 January 2025.










(11)


In the sixth column, expiration of approval, of entry 53, pyriofenone, the date 31 January 2024 is replaced by 31 January 2025.










(12)


In the sixth column, expiration of approval, of entry 54, disodium phosphonate, the date 31 January 2024 is replaced by 31 January 2026.










(13)


In the sixth column, expiration of approval, of entry 55, penflufen, the date 31 January 2024 is replaced by 31 May 2025.










(14)


In the sixth column, expiration of approval, of entry 56, orange oil, the date 30 April 2024 is replaced by 31 July 2024.










(15)


In the sixth column, expiration of approval, of entry 57, penthiopyrad, the date 30 April 2024 is replaced by 31 May 2025.










(16)


In the sixth column, expiration of approval, of entry 58, benalaxyl-M, the date 30 April 2024 is replaced by 30 April 2025.










(17)


In the sixth column, expiration of approval, of entry 59, tembotrione, the date 30 April 2024 is replaced by 31 July 2024.










(18)


In the sixth column, expiration of approval, of entry 60, spirotetramat, the date 30 April 2024 is replaced by 31 July 2024.










(19)


In the sixth column, expiration of approval, of entry 61, pyroxsulam, the date 30 April 2024 is replaced by 30 April 2025.










(20)


In the sixth column, expiration of approval, of entry 62, chlorantraniliprole, the date 30 April 2024 is replaced by 31 December 2024.










(21)


In the sixth column, expiration of approval, of entry 63, sodium silver thiosulfate, the date 30 April 2024 is replaced by 31 July 2024.










(22)


In the sixth column, expiration of approval, of entry 64, pyridalyl, the date 30 June 2024 is replaced by 30 June 2025.










(23)


In the sixth column, expiration of approval, of entry 68, 1,4-dimethylnaphthalene, the date 30 June 2024 is replaced by 30 June 2025.










(24)


In the sixth column, expiration of approval, of entry 69, amisulbrom, the date 30 June 2024 is replaced by 30 September 2024.










(25)


In the sixth column, expiration of approval, of entry 65, S-abscisic acid, the date 30 June 2024 is replaced by 30 September 2024.










(26)


In the sixth column, expiration of approval, of entry 66, L-ascorbic acid, the date 30 June 2024 is replaced by 30 September 2024.










(27)


In the sixth column, expiration of approval, of entry 67, spinetoram, the date 30 June 2024 is replaced by 30 September 2024.










(28)


In the sixth column, expiration of approval, of entry 70, valifenalate, the date 30 June 2024 is replaced by 30 September 2024.










(29)


In the sixth column, expiration of approval, of entry 71, thiencarbazone, the date 30 June 2024 is replaced by 30 September 2024.










(30)


In the sixth column, expiration of approval, of entry 72, acequinocyl, the date 31 August 2024 is replaced by 30 November 2024.










(31)


In the sixth column, expiration of approval, of entry 73, ipconazole, the date 31 August 2024 is replaced by 30 November 2024.










(32)


In the sixth column, expiration of approval, of entry 74, flubendiamide, the date 31 August 2024 is replaced by 30 November 2024.










(33)


In the sixth column, expiration of approval, of entry 75, Bacillus pumilus QST 2808, the date 31 August 2024 is replaced by 31 August 2025.










(34)


In the sixth column, expiration of approval, of entry 79, Streptomyces lydicus strain WYEC 108, the date 31 December 2024 is replaced by 31 December 2025.




Part E is amended as follows:






(1)


In the sixth column, expiration of approval, of entry 6, prosulfuron, the date 30 April 2024 is replaced by 31 July 2024.










(2)


In the sixth column, expiration of approval, of entry 7, pendimethalin, the date 31 August 2024 is replaced by 30 November 2024.










(3)


In the sixth column, expiration of approval, of entry 8, imazamox, the date 31 October 2024 is replaced by 31 January 2025.