EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1911/2023 
(POOL/E4/2023/1911/1911 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving Willaertia magna c2c maky  as an active substance for use in biocidal 
products of product -type 11 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 DECISION (EU) …/…  
of XXX  
not approving Willaertia magna c2c maky  as an active substance for use in biocidal 
products of product -type 11 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 Funct ioning 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 (b) , thereof,  
Whereas:  
(1) On 16 December 2018, the Commission decided not to approve Willaertia magna c2c 
maky  as an active substance for use in biocidal products of product -type 112. 
(2) On 9 August 2019, the European Chemicals Agency (‘the Agency’) received  a new 
application, in accordance with Article 7(1) of Regulation (EU) No 528/2012 , for the 
approval of Willaertia magna c2c maky  as an active substance for use in biocidal 
products of product -type 11 , preservatives for liquid  cooling and processing systems , 
as described  in Annex V to that Regulation . That application was evaluated by the 
competent authority of Malta  (‘the evaluating competent authority’).  
(3) On 16 June 2022 , the evaluating competent authority submitted the assessment report 
together with the conclus ions of its evaluation to the Agency. The Agency  discussed 
the assessment report and the conclusions of the evaluating competent authority  in 
technical meetings . 
(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 approval of active substances. On 5 June 2023, i n 
accordance  with Article 8(4) of Regulation (EU) No 528/2012 , the Biocidal Products 
Committee adopted the opinion of the Agency3, having regard to the conclusions of 
the evaluating competent authority.  
(5) In its opinion  of 5 June 2023 , the Agency concludes that bioci dal products of product -
type 11 containing Willaertia magna c2c maky  may not be expected to satisfy the 
criteria laid down in Article 19(1), point (b) (i), (iii) and (iv) , of Regulation (EU) No 
                                                 
1 OJ L 167, 27.6.2012,  p. 1.  
2 Commission Implementing Decision (EU) 2018/1985 of 13 December 2018 not approving Willaertia 
magna c2c maky  as an active substance for use in biocidal products of product -type 11 (OJ L 317, 
14.12.2018, p. 27 ). 
3 Biocidal Products Committee Opinion on the application for approval of the active substance Willaertia 
magna c2c maky ; Product -type: 11 ; ECHA/BPC/376/2023 , adopted on 5 June 2023 .   
EN 2  EN 528/2012.  Despite the submission of a new application for approval  and certain 
additional data compared to the data included in the first evaluation on which the 
Agency submitted its opinion in 20184, unacceptable risks were identified for human 
health during  the secondary exposure of by -standers and of the general public, in 
particular related to the possible 'trojan -horse effect ’ of Willa ertia magna c2c maky  
having ingested Legionella pneumophila . Furthermore, unacceptable risks were 
identified for  the environment  for the same reasons , as well as due to  concerns on the 
full impact of a continuous release into the environment of Willa ertia magna c2c 
maky , especially on microbial populations  present in the environment.  Finally , the 
Agency found that sufficient efficacy of Willaertia magna c2c maky  to contr ol 
Legionella pneumophila was still not demonstrated . 
(6) Taking into account the opinion of the Agency  of 5 June 2023 , the conditions for 
approval of Willaertia magna c2c maky  laid down in Article 4(1) of Regulation (EU) 
No 528/2012  are not met.  Therefore, Willaertia magna c2c maky  should not be 
approved for use in biocidal products of product -type 11 .  
(7) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee  on Biocidal Products , 
HAS ADOPTED THIS DECISION:  
Article 1  
Willaertia magna c2c maky  is not approved as an active substance for use in biocidal products 
of product -type 11. 
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,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  
                                                 
4 Biocidal Products Committee Opinion on the application for approval of the active substance: 
Willaertia magna c2c maky , product -type 11, ECHA/BPC/206/2018, adopted on 26 April 2018.