25.3.2017   

EN

Official Journal of the European Union

L 80/1

(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 the active substances included in this Regulation were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (3). However, the approval of those substances may 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 the renewal of approvals of the 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)

The presumed low-risk substances should be prioritised in accordance with Implementing Decision C/2016/6104. The approval of those substances should therefore be extended by a period as short as possible. Taking into account the distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and decision-making, that period should be of 1 year for the active substances paraffin oil/(CAS 64742-46-7), paraffin oil/(CAS 72623-86-0), paraffin oil/(CAS 8042-47-5), paraffin oil/(CAS 97862-82-3) and sulphur.

(5)

For active substances which do not fall in the prioritised categories in Implementing Decision C/2016/6104, the approval period should be extended by either 2 or 3 years, taking into account the present date of expiry, the fact that according to Article 6(3) of Implementing Regulation (EU) No 844/2012 the supplementary dossier for an active substance shall 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. It is therefore appropriate to extend the approval periods for 2-phenylphenol (including its salts such as the sodium salt), chlormequat, dimethachlor, etofenprox, penconazole, propaquizafop, tetraconazole, tri-allate, and zeta-cypermethrin by 2 years, and to extend the approval periods of active substances bensulfuron, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad by 3 years.

(6)

The Commission received an application for the renewal of the approval of the active substance quizalofop-P (variant quizalofop-p-ethyl) and a separate application for the renewal of the approval of the active substance quizalofop-P (variant quizalofop-p-tefuryl). Given this fact and due to the different risk profiles of quizalofop-p-ethyl and quizalofop-p-tefuryl, it is appropriate to consider them as two different active substances for the purpose of the renewal procedure. The variant quizalofop-p-ethyl does not fall in the prioritised categories in Implementing Decision C/2016/6104. Therefore, and taking into account the reasons given in recital 5, it is appropriate to extend its approval period by 2 years.

(7)

In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases 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 Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.

(8)

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.

(9)

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

(10)

Taking into account that the approvals of some of the substances expire on 31 October 2019, and that applicants should submit supplementary dossiers 30 months before the expiry of the approval, this Regulation should enter into force as soon as possible.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,