(1)

Commission Directive 2004/99/EC (2) included thiacloprid 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 thiacloprid as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2020.

(4)

An application for the renewal of the approval of thiacloprid 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 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 31 October 2017.

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the 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 22 January 2019 the Authority communicated to the Commission its conclusion (6) on whether thiacloprid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9)

The Authority identified a critical concern in relation to the contamination of groundwater by metabolites of thiacloprid. In particular, metabolites M30, M34 and M46 are predicted to occur above the parametric drinking water limit of 0,1 μg/L in all pertinent scenarios for all proposed uses of thiacloprid. These metabolites are considered a priori of concern since it cannot be excluded that they share the same carcinogenic properties of the parent active substance thiacloprid, which is classified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (7) as carcinogenic category 2. Therefore, it cannot currently be established that the presence of metabolites of thiacloprid in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health. The Authority also concluded that the assessment of the risks to aquatic organisms, bees and non-target terrestrial plants could not be finalised based on the information provided in the dossier.

(10)

Additionally, thiacloprid is classified in accordance with Regulation (EC) No 1272/2008 also as toxic for reproduction category 1B. The applicant provided information attempting to demonstrate that exposure of humans to thiacloprid can be considered negligible. The Authority presented the outcome of the assessment of that information in its conclusion. Nevertheless, given the concerns identified in recital 9, a conclusion on whether exposure to humans is negligible for the purposes of point 3.6.4 of Annex II to Regulation (EC) No 1107/2009, is not necessary for the decision on whether the approval of thiacloprid can be renewed.

(11)

Furthermore, given the concerns identified, it is also not possible to provide for an approval in accordance with Article 4(7) to Regulation (EC) No 1107/2009.

(12)

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

(13)

However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.

(14)

Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance thiacloprid in accordance with Article 20(1)(b) of that Regulation.

(15)

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

(16)

Member States should be given sufficient time to withdraw authorisations for plant protection products containing thiacloprid.

(17)

For plant protection products containing thiacloprid, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 12 months.

(18)

Commission Implementing Regulation (EU) 2019/168 (8) extended the approval period of thiacloprid to 30 April 2020 in order to allow the renewal process to be completed before the expiry of the approval period of that substance. However, given that a decision on the non-renewal of the approval is taken ahead of the expiry of that extended approval period, this Regulation should apply as soon as possible.

(19)

This Regulation does not prevent the submission of a further application for the approval of thiacloprid pursuant to Article 7 of Regulation (EC) No 1107/2009.

(20)

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