Commission Implementing Regulation (EU) 2023/1488 of 6 July 2023 renewing the approval of the low-risk active substance quartz sand in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009, of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC⁽¹⁾, and in particular Article 20(1) in conjunction with Article 22(1) thereof,

Whereas:

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

2. According to Article 78(3) of Regulation (EC) No 1107/2009, 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 quartz sand, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 August 2023⁽⁵⁾.

4. An application for the renewal of the approval of the active substance quartz sand was submitted to Latvia, the rapporteur Member State, and Romania, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012⁽⁶⁾ and within the time period provided for in that Article.

5. The applicants also submitted the supplementary dossiers required by Article 6 of Implementing Regulation (EU) No 844/2012 to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’). The application was found to be admissible 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 Authority and the Commission on 2 March 2021. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of quartz sand.

7. The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicants 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 August 2022, the Authority communicated to the Commission its conclusion⁽⁷⁾ which indicated that quartz sand can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

9. The Commission presented a renewal report regarding quartz sand and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on on 8 December 2022 and on 25 May 2023 respectively.

10. The Commission invited the applicants to submit their comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicants submitted their comments, which have been carefully examined and taken into consideration.

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

12. The Commission further considers that quartz sand is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Quartz sand is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009.

13. It is therefore appropriate to renew the approval of quartz sand as a low-risk active substance.

14. 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 and the outcome of the risk assessment, it is, however, necessary to set a minimum purity of quartz sand and a maximum amount of the impurity respirable crystalline silica (SiO2) with a diameter ≤ 10 μm as manufactured in order to underpin the safety of the active substance to be used in plant protection products.

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

16. This Regulation should apply from the day after the date of expiry of the approval of quartz sand.

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

HAS ADOPTED THIS REGULATION: