5.2.2016   

EN

Official Journal of the European Union

L 30/7

(1)

The approval of the active substance lambda-cyhalothrin, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2), expires on 30 June 2016.

(2)

An application for the renewal of the inclusion of lambda-cyhalothrin in Annex I to Council Directive 91/414/EEC (3) was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (4) within the time period provided for in that Article.

(3)

The applicants submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. The application was found to be complete by the rapporteur Member State.

(4)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 28 February 2013.

(5)

The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(6)

On 11 March 2015, the Authority communicated to the Commission the revised version of its conclusion of 23 April 2014 (5) on whether lambda-cyhalothrin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for lambda-cyhalothrin to the Standing Committee on Plants, Animals, Food and Feed on 28 May 2015.

(7)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 are satisfied. Those approval criteria are therefore deemed to be satisfied.

(8)

The risk assessment for the renewal of the approval of lambda-cyhalothrin is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing lambda-cyhalothrin may be authorised. It is therefore appropriate not to maintain the restriction to uses as an insecticide.

(9)

The Commission however considers that lambda-cyhalothrin is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. The Acceptable Operator Exposure Level (AOEL) is significantly lower than those of the majority of the approved active substances within the group of insecticides. Moreover, lambda-cyhalothrin is a bioaccumulative and toxic substance in accordance with points 3.7.2.2 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the bioconcentration factor is greater than 2000 and the long-term no-observed effect concentration for freshwater organisms is less than 0,01 mg/L. Lambda-cyhalothrin therefore fulfils the conditions set in the first and second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.

(10)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, necessary to include certain conditions. It is, in particular, appropriate to require further confirmatory information.

(11)

It is therefore appropriate to renew the approval of lambda-cyhalothrin as a candidate for substitution.

(12)

In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(13)

Commission Implementing Regulation (EU) 2015/1885 (6) extended the expiry date of lambda-cyhalothrin to 30 June 2016 in order to allow the renewal process to be completed before the expiry of its approval. However, given that a decision on renewal has been taken ahead of the extended expiry date, this Regulation should apply from 1 April 2016.

(14)

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