Commission Implementing Regulation (EU) 2021/1452 of 3 September 2021 renewing the approval of the active substance potassium hydrogen carbonate as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2021/1452@2021-09-03/en
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, and in particular Article 20(1) in conjunction with Article 22(1) thereof,
Whereas:
(1) Commission Directive 2008/127/EC included potassium hydrogen carbonate on 1 September 2009 as an active substance in Annex I to Council Directive 91/414/EEC.
(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.
(3) The approval of the active substance potassium hydrogen carbonate, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 August 2022.
(4) Applications for the renewal of the approval of the active substance potassium hydrogen carbonate were submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 within the time period provided for in that Article.
(5) The applicants 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 19 December 2019. The Authority made the supplementary summary dossier available to the public and launched a public consultation on the draft renewal assessment report. The Authority also circulated the draft renewal assessment report to the applicants and to the Member States for comments and forwarded the comments received to the Commission.
(7) On 20 April 2021, the Authority communicated to the Commission its conclusion on whether potassium hydrogen 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 potassium hydrogen carbonate to the Standing Committee on Plants, Animals, Food and Feed on 5 and 6 July 2021.
(9) The Commission invited the applicants to submit their comments on the conclusion of the Authority and, in accordance with Article 14(1), third paragraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicants submitted their comments, which were 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 potassium hydrogen 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 potassium hydrogen carbonate is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing potassium hydrogen carbonate may be authorised. It is therefore appropriate not to maintain the restriction to use as a fungicide or insecticide.
(12) The Commission further considers that potassium hydrogen carbonate is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Potassium hydrogen 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 potassium hydrogen 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 extended the approval period of potassium hydrogen carbonate until 31 August 2022, in order to allow the completion of the renewal process before the expiry of that approval period. However, given that a decision to renew the approval has been taken ahead of that extended expiry date, 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,
HAS ADOPTED THIS REGULATION:
Article 1 Renewal of the approval of the active substance
The approval of the active substance potassium hydrogen carbonate as low risk substance is renewed as set out in Annex I.
Article 2 Amendments to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3 Entry into force and date of application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 November 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 3 September 2021. For the Commission The President Ursula von der Leyen
ANNEX
ANNEX I
Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions Potassium hydrogen carbonate CAS No 298-14-6 CIPAC No 853 Potassium hydrogen carbonate 990 g/kg 1 November 2021 31 October 2036 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report of potassium hydrogen carbonate, and in particular Appendices I and II thereto, shall be taken into account.
ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in Part A, entry 244 on potassium hydrogen carbonate is deleted;
(2) in Part D, the following entry is added: Number Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions 32 Potassium hydrogen carbonate CAS No 298-14-6 CIPAC No 853 IUPAC name: Potassium hydrogen carbonate 990 g/kg 1 November 2021 31 October 2036 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report of potassium hydrogen carbonate, and in particular Appendices I and II thereto, shall be taken into account.