Commission Implementing Regulation (EU) 2018/1266 of 20 September 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, carboxin, clethodim, cycloxydim, dazomet, diclofop, dithianon, dodine, fenazaquin, fluometuron, flutriafol, hexythiazox, hymexazol, indolylbutyric acid, isoxaben, lime sulphur, metaldehyde, paclobutrazol, pencycuron, sintofen, tau-fluvalinate and tebufenozide (Text with EEA relevance.)
Date: 2018-09-20
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product








L_2018238EN.01008101.xml










21.9.2018   


EN


Official Journal of the European Union


L 238/81








            COMMISSION IMPLEMENTING REGULATION (EU) 2018/1266
of 20 September 2018
         
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, carboxin, clethodim, cycloxydim, dazomet, diclofop, dithianon, dodine, fenazaquin, fluometuron, flutriafol, hexythiazox, hymexazol, indolylbutyric acid, isoxaben, lime sulphur, metaldehyde, paclobutrazol, pencycuron, sintofen, tau-fluvalinate and tebufenozide
(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)


Applications for the renewal of the approval of 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, carboxin, clethodim, cycloxydim, dazomet, diclofop, dithianon, dodine, fenazaquin, fluometuron, flutriafol, hexythiazox, hymexazol, indolylbutyric acid, isoxaben, lime sulphur, metaldehyde, paclobutrazol, pencycuron, sintofen, tau-fluvalinate and tebufenozide were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (3). However, the approval of those substances is likely to expire for reasons beyond the control of the applicant before a decision has been taken on the renewal of their approval. It is therefore necessary to extend their approval periods in accordance with Article 17 of Regulation (EC) No 1107/2009.












(3)


In view of the time and resources necessary for completing the assessment of applications for renewal of approval of a large number of active substances the approvals of which are expiring between 2019 and 2021, Commission Implementing Decision C(2016) 6104 (4) 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 as provided for in Article 18 of Regulation (EC) No 1107/2009.












(4)


As the active substances 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, carboxin, clethodim, cycloxydim, dazomet, diclofop, dithianon, dodine, fenazaquin, fluometuron, flutriafol, hexythiazox, hymexazol, indolylbutyric acid, isoxaben, lime sulphur, metaldehyde, paclobutrazol, pencycuron, sintofen, tau-fluvalinate and tebufenozide do not fall in the prioritised categories of Implementing Decision C(2016) 6104, their approval period should be extended by either two or three years, taking into account the current date of expiry, the fact that in accordance with Article 6(3) of Implementing Regulation (EU) No 844/2012 the supplementary dossier for an active substance is to be submitted no later than 30 months before expiry of the approval, the need to ensure a balanced distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and decision-making.












(5)


It is therefore appropriate to extend the approval period for the active substances carboxin, clethodim, cycloxydim, dazomet, diclofop, fenazaquin, hymexazol, indolylbutyric acid, metaldehyde, and paclobutrazol by two years, and the approval period of the active substances 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, dithianon, dodine, fluometuron, flutriafol, hexythiazox, isoxaben, lime sulphur, pencycuron, sintofen, tau-fluvalinate and tebufenozide by three years.












(6)


Where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the expiry date should remain the same as before this Regulation or it should be set at the earliest date thereafter.












(7)


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)


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












(9)


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 twentieth 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, 20 September 2018.


For the Commission


The President

Jean-Claude JUNCKER
            





(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) 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).

(4)  Commission Implementing Decision of 28 September 2016 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2019, 2020 and 2021 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (OJ C 357, 29.9.2016, p. 9).




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 316, Cycloxydim, the date is replaced by ‘31 May 2023’;










(2)


in the sixth column, expiration of approval, of row 317, 6-Benzyladenine, the date is replaced by ‘31 May 2024’;










(3)


in the sixth column, expiration of approval, of row 322, Hymexazol, the date is replaced by ‘31 May 2023’;










(4)


in the sixth column, expiration of approval, of row 323, Dodine, the date is replaced by ‘31 May 2024’;










(5)


in the sixth column, expiration of approval, of row 326, Indolylbutyric acid, the date is replaced by ‘31 May 2023’;










(6)


in the sixth column, expiration of approval, of row 328, Tau-fluvalinate, the date is replaced by ‘31 May 2024’;










(7)


in the sixth column, expiration of approval, of row 329, Clethodim, the date is replaced by ‘31 May 2023’;










(8)


in the sixth column, expiration of approval, of row 330, Bupirimate, the date is replaced by ‘31 May 2024’;










(9)


in the sixth column, expiration of approval, of row 333, 1-decanol, the date is replaced by ‘31 May 2024’;










(10)


in the sixth column, expiration of approval, of row 334, Isoxaben, the date is replaced by ‘31 May 2024’;










(11)


in the sixth column, expiration of approval, of row 335, Fluometuron, the date is replaced by ‘31 May 2024’;










(12)


in the sixth column, expiration of approval, of row 337, Carboxin, the date is replaced by ‘31 May 2023’;










(13)


in the sixth column, expiration of approval, of row 339, Dazomet, the date is replaced by ‘31 May 2023’;










(14)


in the sixth column, expiration of approval, of row 340, Metaldehyde, the date is replaced by ‘31 May 2023’;










(15)


in the sixth column, expiration of approval, of row 341, Sintofen, the date is replaced by ‘31 May 2024’;










(16)


in the sixth column, expiration of approval, of row 342, Fenazaquin, the date is replaced by ‘31 May 2023’;










(17)


in the sixth column, expiration of approval, of row 343, Azadirachtin, the date is replaced by ‘31 May 2024’;










(18)


in the sixth column, expiration of approval, of row 344, Diclofop, the date is replaced by ‘31 May 2023’;










(19)


in the sixth column, expiration of approval, of row 345, Lime sulphur, the date is replaced by ‘31 May 2024’;










(20)


in the sixth column, expiration of approval, of row 346, Aluminium sulfate, the date is replaced by ‘31 May 2024’;










(21)


in the sixth column, expiration of approval, of row 348, Paclobutrazol, the date is replaced by ‘31 May 2023’;










(22)


in the sixth column, expiration of approval, of row 349, Pencycuron, the date is replaced by ‘31 May 2024’;










(23)


in the sixth column, expiration of approval, of row 350, Tebufenozide, the date is replaced by ‘31 May 2024’;










(24)


in the sixth column, expiration of approval, of row 351, Dithianon, the date is replaced by ‘31 May 2024’;










(25)


in the sixth column, expiration of approval, of row 352, Hexythiazox, the date is replaced by ‘31 May 2024’;










(26)


in the sixth column, expiration of approval, of row 353, Flutriafol, the date is replaced by ‘31 May 2024’.