EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/2574/2022  
(POOL/E4/2022/2574/2574 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving (13Z) -Hexadec -13-en-11-yn-1-yl acetate as an active substance for use in 
biocidal products of product -type 19 in accordance with Regulation (EU) No 528/2012 of 
the European Parliament and of the Council  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving (13Z) -Hexadec -13-en-11-yn-1-yl acetate as an active substance for use in 
biocidal products of product -type 19 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 
products1, and in particular Article 9(1), point (a), thereof,  
Whereas:  
(1) On 13 March 2018 , the European Chemicals Agency (‘the Agency’)  received  an 
application, in accordance with Article 7(1) of Regulation (EU) No 528/2012 , for the 
approval of (13Z) -Hexadec -13-en-11-yn-1-yl acetate as an active substance for use in 
bioci dal products of product -type 19, repellents and attractants , as described  in Annex 
V to that Regulation . The application was evaluated by the competent authority of 
France  (‘the evaluating competent authority’).  
(2) On 1 June 2021,  the evaluating competent authority submitted the assessm ent report 
together with the conclusions  of its evaluation  to the Agency . The Agency  discussed 
the assessment report and the conclusions of the evaluating competent authority  in 
technical meetings . 
(3) 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 approval of active substances. I n accordance with 
Article 8(4) of Regulation (EU) No 528/2012 , the Biocidal Product s Committee 
adopted the opinion of the Agency2 on 8 March 2022, having regard to the conclusions 
of the evaluating competent authority.  
(4) In that opinion  the Agency  concludes that  biocidal products of product -type 19 
containing (13Z) -Hexadec -13-en-11-yn-1-yl acetate  may be expected to 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.  
(5) In its  opinion the Agency recommends that (13Z) -Hexadec -13-en-11-yn-1-yl acetate  
be approved subject to the condition s that only biocidal products consisting of a 
passive non -retrievable dispenser (for example a wax emulsion inserted into a ball) to 
be applied using a compressed air gun may be authorised, and that biocidal products 
                                                 
1 OJ L 167, 27.6.2012, p. 1.  
2 Biocidal Products Committee Opinion on the application for approval of the active substance (13Z) -
Hexadec -13-en-11-yn-1-yl acetate; Product -type: 19; ECHA/BPC/323/2022, adopted on 8 March 2022.    
EN 2  EN may only be authorised for professional use , as the representative biocidal product and 
category of user submitted in the application for approval of the active substance   (‘the 
conditions proposed by the Agency ’). The Agency proposed to impose those 
conditions as a consequence of the acceptance of the adaptations in the data submitted 
for the approval of the active substance by the evaluating competent authority , in 
accordance with Annex IV to Regulation (EU) No 52 8/2012 . The evaluating 
competent authority accepted the adaptations because  (13Z) -Hexadec -13-en-11-yn-1-
yl acetate is a pheromone, which is a class of substances generally recognised as being 
of low concern to human and animal health and the environment, and because of  the 
very low exposure of humans and the environment to the active substance due to  use 
of the representative biocidal product.   
(6) However, restrictive conditions for the making available on the market or the use of 
biocidal products containing an active substance are usually established in the 
approval of an active substance when risks are identified during the examination of 
approval of the active substance and no other suitable risk mitigation measures can be 
identified on a specific use . No r isks to human health, animal health or the 
environment have been identified by the Agency in its opinion which would 
necessitate the conditions proposed by the Agency . The approval of an active 
substance is also usually not restricted only to the represent ative product and user 
category presented in the application for approval.  Moreover, the imposition of the 
conditions  proposed by the Agency  would limit innovation in the development of 
products containing a pheromone , which is a class of substances generally recognised 
as being of low concern  to human and animal health and the environment .  
(7) The Commission therefore considers  it not necessary to include the condition s 
proposed by the Agency  in this Regulation . However, in order to emphasise the 
possible need for additional data on the active substance to demonstrate the safety for 
human health, animal health or the environment of other uses or category of users in 
the case of an application for authorisation of products other than the re presentative 
product, it is  appropriate to lay down  that the product assessment needs to  pay 
particular attention to the exposures, the risks and the efficacy linked to any of the uses 
covered by an application for authorisation , but not a ddressed in the Union level  risk 
assessment of the active substance, and that, for uses leading to higher exposure of the 
users, bystanders or the environment compared to the Union level risk assessment of 
the active substance, applications for product authorisation need to  contain all data 
required for active substances in accordance with Annex II to Regulation (EU) No 
528/2012 , subject to the possibilities of adaptation  of the data requirements  in 
accordance with  Annex IV to that Regulation . 
(8) Taking into account the opinion  of the Agency, it is appropriate to approve (13Z) -
Hexadec -13-en-11-yn-1-yl acetate  as an active substance for use in bi ocidal products 
of product -type 19 subject to compliance with certain conditions.  
(9) The measures provided for in this R egulation are in accordance with the opinion of the 
Standing Committee  on Biocidal Products , 
HAS ADOPTED THIS REGULATION:  
Article 1  
(13Z) -Hexadec -13-en-11-yn-1-yl acetate  is approved as an active substance for use in biocidal 
products of product -type 19 subject to the conditions  set out in the Annex.   
EN 3  EN 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 direct ly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN