(1)

Commission Directive 2005/58/EC (2) included bifenazate 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 bifenazate, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 31 July 2022.

(4)

An application for the renewal of the approval of the active substance bifenazate was submitted to the Rapporteur Member State 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 29 January 2016.

(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 4 January 2017, the Authority communicated to the Commission its conclusion (6) on whether bifenazate can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009, where EFSA identified high risk to birds, mammals and non-target arthropods for all representative uses and in addition, a high risk to operators and workers for a majority of the representative uses. Furthermore, the risk assessment could not be finalised for aquatic organisms and consumers.

(9)

The Commission mandated EFSA in 17 November 2020 to assess the risk when bifenazate is applied once a year using the lowest dose presented in the dossier. The rapporteur Member State updated its draft Renewal Assessment Report accordingly and the Authority updated its conclusion on 30 August 2021 (7) in which it identified a high risk to birds via long term exposure to bifenazate for all representative uses. Furhtermore, the consumer risk assessment could not be finalised. The Commission presented a renewal report regarding bifenazate to the Standing Committee on Plants, Animals, Food and Feed on 19 July 2017 and 22 October 2021 and a draft of this Regulation on 1 December 2021.

(10)

The Commission invited the applicant to submit its comments on both conclusions of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012 (8), 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 bifenazate that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(12)

It is therefore appropriate to renew the approval of bifenazate.

(13)

In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to provide for certain conditions and restrictions. It is, in particular, appropriate to restrict the use of plant protection products containing bifenazate to non-edible crops in permanent greenhouses and to require further confirmatory information.

(14)

The restriction to use on non-edible crops will exclude dietary exposure of consumers and is required since the consumer risk assessment could not be finalised. As a high risk was identified to birds via long term exposure to bifenazate, a restriction to use in greenhouses as defined in Article 3 of Regulation (EC) No 1107/2009 will ensure that birds are not exposed to bifenazate. In addition, as the Authority identified a high risk to mammals for some representative uses and a high chronic risk to bees based on the available data, the restriction to use only in greenhouses will also prevent exposure to those non-target organisms as well as in drinking water.

(15)

As regards the criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (9), on the basis of the available scientific information summarised in the conclusion of the Authority, the Commission considers that bifenazate is not to be considered as having endocrine disrupting properties.

(16)

In order to increase the confidence in the conclusion that bifenazate does not have endocrine disrupting properties, the applicant should provide an updated assessment, in accordance with point 2.2(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, and in accordance with the guidance for the identification of endocrine disruptors (10).

(17)

The risk assessment for the renewal of the approval of the active substance bifenazate is based on representative uses as an acaricide. In the light of this risk assessment, it is not necessary to maintain the restriction to use only as an acaricide.

(18)

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

(19)

Commission Implementing Regulation (EU) 2021/745 (11) extended the approval period of bifenazate to 31 July 2022 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 has been taken ahead of that extended expiry date, this Regulation shall apply as soon as possible.

(20)

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