Commission Implementing Regulation (EU) 2025/2345 of 19 November 2025 renewing the approval of dazomet as an active substance 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
Date: 2025-11-19
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, market approval, preservative, wood product








L_202502345EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/2345


20.11.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/2345
of 19 November 2025
         
renewing the approval of dazomet as an active substance 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(4), point (a), thereof,

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 (wood preservatives). Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved under that Regulation subject to the requirements set out in Annex I to Directive 98/8/EC. That inclusion was to expire on 31 July 2022.












(2)


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’). The application was evaluated by the competent authority of Belgium (‘the evaluating competent authority’).












(3)


On 14 June 2024, the evaluating competent authority submitted a recommendation on the renewal of the approval of dazomet to the European Chemicals Agency (‘the Agency’).












(4)


In accordance with Article 75(1), second subparagraph, point (a), of Regulation (EU) No 528/2012, the Biocidal Products Committee prepares the opinion of the Agency regarding the applications for renewal of approval of active substances. The Biocidal Products Committee adopted the opinion of the Agency on 25 February 2025 (3), having regard to the conclusions of the evaluating competent authority.












(5)


In its opinion, the Agency concluded that biocidal products of product-type 8 containing dazomet may be expected to still satisfy the criteria laid down in Article 19(1), point (b), of Regulation (EU) No 528/2012, provided that certain conditions concerning their use are complied with. Therefore, the conditions for renewal set out in Article 12(1), read in conjunction with Article 4(1), of Regulation (EU) No 528/2012 are considered satisfied.












(6)


It is therefore appropriate to renew the approval of dazomet for use in biocidal products of product-type 8, subject to compliance with certain conditions, including a condition for placing on the market of treated articles treated with or incorporating dazomet in line with Article 58(2) and (3) of Regulation (EU) No 528/2012.












(7)


A period of transition should be set for new requirements concerning the placing on the market of treated articles treated with or incorporating dazomet in order to allow sufficient time for economic operators to adapt.












(8)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS REGULATION:



Article 1
The approval of dazomet as an active substance for use in biocidal products of product-type 8 is renewed, subject to the conditions set out in the Annex.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 November 2025.


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)  Biocidal Products Committee (BPC), Opinion on the application for renewal of the approval of the active substance: Dazomet, Product type: 8, ECHA/BPC/458/2025, adopted on 25 February 2025.




ANNEX










Common Name


IUPAC Name
Identification Numbers


Minimum degree of purity of the active substance (1)



Expiry date of approval


Product type


Specific conditions




Dazomet


Tetrahydro-3,5-dimethyl-2H-1,3,5-thiadiazine-2-thione
EC No: 208-576-7
CAS No: 533-74-4


96 % weight/weight


31 August 2040


8








1.


The authorisation of biocidal products containing dazomet as an active substance is subject to the following conditions:






(a)


the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level assessment of the active substance;










(b)


Member States’ competent authorities or, in the case of a Union authorisation, the Commission, shall specify in the summary of the biocidal product characteristics the relevant instructions for use and precautions to be indicated on the label of the treated articles under Article 58(3), second subparagraph, point (e), of Regulation (EU) No 528/2012.














2.


The placing on the market of treated articles is subject to the following condition: as from 1 March 2026, the person responsible for the placing on the market of a treated article treated with or incorporating dazomet shall ensure that the label of that treated article provides the information listed in Article 58(3), second subparagraph, of Regulation (EU) No 528/2012.










(1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product made available on the market may be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.



ELI: http://data.europa.eu/eli/reg_impl/2025/2345/oj
ISSN 1977-0677 (electronic edition)