Renewal of approval of the low-risk active substance calcium carbonate

(1)

Commission Directive 2008/127/EC (2) included calcium carbonate 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 calcium carbonate, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 August 2022.

(4)

An application for the renewal of the approval of the active substance calcium carbonate 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 23 October 2019. 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.

(7)

On 9 February 2021, the Authority communicated to the Commission its conclusion (6) on whether calcium carbonate can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(8)

The Commission presented a renewal report and a draft Regulation regarding calcium carbonate to the Standing Committee on Plants, Animals, Food and Feed on 19 May 2021.

(9)

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.

(10)

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

(11)

The risk assessment for the renewal of the approval of the active substance calcium carbonate is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing calcium carbonate may be authorised. It is therefore appropriate not to maintain the restriction to use as a repellent.

(12)

The Commission further considers that calcium carbonate is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Calcium carbonate is not a substance of concern and fulfils the conditions set in point 5.1 of Annex II to Regulation (EC) No 1107/2009. It is therefore appropriate to renew the approval of calcium carbonate as a low-risk substance.

(13)

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

(14)

Commission Implementing Regulation (EU) 2021/745 (7) extended the approval period of calcium carbonate until 31 August 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 the expiry of that extended approval period, this Regulation should start to apply earlier than that date.

(15)

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