Renewal of the approval of the active substance garlic extract

(1)

Commission Directive 2008/127/EC (2) included garlic extract as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance garlic extract, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 August 2021.

(4)

An application for the renewal of the approval of the active substance garlic extract was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

(6)

The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 28 March 2019.

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

(8)

On 16 April 2020, the Authority communicated to the Commission its conclusion (6) on whether garlic extract can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented to the Standing Committee on Plants, Animals, Food and Feed a renewal report for garlic extract on 16. and 17 July 2020 and a draft Regulation providing for the renewal of approval of that active substance on 4 December 2020.

(9)

As regards the criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (7), the Authority concluded that garlic extract is considered not to meet the criteria for endocrine disruption for humans and for non-target organisms, as laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, respectively..

(10)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined.

(11)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance garlic extract that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(12)

The risk assessment for the renewal of the approval of the active substance garlic extract is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing garlic extract may be authorised.

(13)

It is therefore appropriate to renew the approval of garlic extract.

(14)

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

(15)

Commission Implementing Regulation (EU) 2020/1160 (8) extended the approval period of garlic extract to 31 August 2021 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal of the approval has been taken ahead of that extended expiry date, this Regulation shall apply from 1 March 2021.

(16)

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