2024/2930
2.12.2024
COMMISSION IMPLEMENTING DECISION (EU) 2024/2930
of 28 November 2024
postponing the expiry date of the approval of dazomet for use in biocidal products of product-type 8 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 14(5) thereof,
After consulting the Standing Committee on Biocidal Products,
Whereas:
(1) Dazomet was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) as an active substance for use in biocidal products of product-type 8, subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) In accordance with Article 86 of Regulation (EU) No 528/2012, dazomet was deemed to have been approved under that Regulation on the date of its inclusion in Annex I to Directive 98/8/EC of the European Parliament and of the Council. That approval was to expire on 31 July 2022.
(3) On 26 January 2021, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of dazomet for use in biocidal products of product-type 8 (‘the application’).
(4) On 24 March 2021, the evaluating competent authority of Belgium informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.
(5) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.
(6) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(7) Commission Implementing Decision (EU) 2021/1289 (3) postponed the expiry date of the approval of dazomet for use in biocidal products of product-type 8 to 31 January 2025, in order to allow sufficient time for the examination of the application.
(8) On 14 June 2024 the evaluating competent authority submitted the renewal assessment report to the Agency. The Agency is expected to adopt its opinion on the renewal of the approval of the active substance by the second quarter of 2025.
(9) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to finalise the examination of the application. Taking into account the time-limits for the preparation and submission by the Agency of its opinion, and the time needed for the Commission to decide whether the approval of dazomet for use in biocidal products of product-type 8 may be renewed, the expiry date should be postponed to 31 July 2026.
(10) After the further postponement of the expiry date of the approval, dazomet remains approved for use in biocidal products of product-type 8 subject to the conditions set out in Annex I to Directive 98/8/EC,
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of dazomet for use in biocidal products of product-type 8 set out in Annex I to Directive 98/8/EC is postponed to 31 July 2026.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the
Official Journal of the European Union
.
Done at Brussels, 28 November 2024.
For the Commission
The President
Ursula VON DER LEYEN
(1)
OJ L 167, 27.6.2012, p. 1
, ELI:
http://data.europa.eu/eli/reg/2012/528/oj
.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (
OJ L 123, 24.4.1998, p. 1
, ELI:
http://data.europa.eu/eli/dir/1998/8/oj
).
(3) Commission Implementing Decision (EU) 2021/1289 of 2 August 2021 postponing the expiry date of approval of dazomet for use in biocidal products of product-type 8 (
OJ L 279, 3.8.2021, p. 45
, ELI:
http://data.europa.eu/eli/dec_impl/2021/1289/oj
).
ELI: http://data.europa.eu/eli/dec_impl/2024/2930/oj
ISSN 1977-0677 (electronic edition)