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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 productsnote, and in particular Article 14(4), point (a), thereof,Whereas:
(1)Cis-tricos-9-ene was included in Annex I to Directive 98/8/EC of the European Parliament and of the Councilnote as an active substance for use in biocidal products of product-type 19 (repellents and attractants). Pursuant to Article 86 of Regulation (EU) No 528/2012, it is therefore deemed approved under that Regulation subject to the requirements set out in Annex I to Directive 98/8/EC. That approval was to expire on 30 September 2024. Commission Implementing Decision (EU) 2024/1283 postponed that expiry date to 31 March 2027note.
(2)On 6 April 2023, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of cis-tricos-9-ene for use in biocidal products of product-type 19 (‘the application’). The application was evaluated by the competent authority of Austria (‘the evaluating competent authority’).
(3)On 20 March 2025, the evaluating competent authority submitted a recommendation on the renewal of the approval of cis-tricos-9-ene 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. That Committee adopted the opinion of the Agency on 27 November 2025note, having regard to the conclusions of the evaluating competent authority.
(5)In its opinion, the Agency concluded that biocidal products of product-type 19 containing cis-tricos-9-ene 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 cis-tricos-9-ene for use in biocidal products of product-type 19, subject to compliance with certain conditions.
(7)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 the active substance cis-tricos-9-ene for use in biocidal products of product-type 19 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.
| Common Name | IUPAC NameIdentification Numbers | Minimum degree of purity of the active substancenote | Expiry date of approval | Product type | Specific conditions |
|---|---|---|---|---|---|
| Muscalure | cis-tricos-9-eneEC No: 248-505-7CAS No: 27519-02-4 | 80,1 % weight/weight | 30 June 2041 | 19 | When assessing the product in the context of the authorisation procedure of biocidal products containing cis-tricos-9-ene as an active substance, the Member States’ competent authorities or, in the case of a Union authorisation the Commission, shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but which were not addressed in the Union level assessment of the active substance. |
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