Commission Implementing Regulation (EU) 2018/1659Show full title

Commission Implementing Regulation (EU) 2018/1659

of 7 November 2018

amending Implementing Regulation (EU) No 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Regulation (EU) 2018/605

(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 Article 19 thereof,

Whereas:

(1) Commission Implementing Regulation (EU) No 844/2012(2) provides for the implementation of the renewal procedure for active substances as provided for in Regulation (EC) No 1107/2009.

(2) Commission Regulation (EU) 2018/605(3) introduced new scientific criteria for the determination of endocrine disrupting properties, which reflect the current state of scientific and technical knowledge. Those criteria are to apply as of 10 November 2018 to applications for the renewal of the approval of active substances in accordance with Regulation (EC) No 1107/2009, including pending applications.

(3) Applications for the renewal of the approval of an active substance which are submitted before 10 November 2018 and for which, by that date, the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 has not voted on a draft Regulation concerning the renewal or non-renewal of the approval of that active substance, should be considered pending applications.

(4) For such pending applications, it is possible that the information submitted by the applicant does not allow to conclude the assessment as regards whether the scientific criteria for the determination of endocrine disrupting properties set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 are met or not and to conclude whether the approval criteria set out in those points are met or not. Therefore, the European Food Safety Authority (‘the Authority’) should be able to request additional information from the applicant in order to conclude whether the approval criteria set out in those points are met or not. Such additional information should be submitted within a time period set by the Authority, which should be as short as possible in order to avoid unjustified delays of the renewal procedure, and which should be based on the type of information to be submitted.

(5) Within the period given to provide the additional information, applicants should also be able to apply for the derogation under Article 4(7) of Regulation (EC) No 1107/2009.

(6) Where, based on the information already available, the Authority has been able to conclude that the substance meets the scientific criteria for the determination of endocrine disrupting properties, applicants should be able to submit additional information as regards the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 and/or be able to submit documentary evidence showing that the conditions for the application of the derogation under Article 4(7) of that Regulation are met.

(7) Where the Authority requires such additional information from the applicant, the period foreseen for the preparation of the conclusion by the Authority should be extended in order for that information to be taken into account.

(8) When requesting additional information from the applicant, the Authority should consider that animal testing is to be minimised and tests on vertebrates are to be undertaken only as a last resort, in accordance with Article 62 of Regulation (EC) No 1107/2009.

(9) Taking into account that the scientific criteria for the determination of endocrine disrupting properties introduced by Regulation (EU) 2018/605 apply as of 10 November 2018, this Regulation should enter into force as soon as possible and apply from 10 November 2018.

(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:

(1)

OJ L 309, 24.11.2009, p. 1.

(2)

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).

(3)

Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).