EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2158/2022 
(POOL/E4/2022/2158/2158 -EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving d -Allethrin as an existing active substance for use in biocidal products of 
product -type 18 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 d -Allethrin as an existing active substance for use in biocidal products of 
product -type 18 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 Regulatio n (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 89(1), third subparagraph,  thereof,  
Whereas:  
(1) Commission Delegated Regulation (EU) No 1062/20142 establishes a list of e xisting 
active substances to be evaluated for their possible approval for use in biocidal 
products. That list includes (RS)-3-Allyl -2-methyl -4-oxocyclopent -2- enyl-
(1R,3R;1R,3S) -2,2-dimethyl -3-(2-methylprop -1-enyl) -cyclopropanecarboxylate 
(mixture of 4 isomers 1R trans, 1R: 1R trans, 1S: 1R cis, 1R: 1R cis, 1S 4:4:1:1) ( ‘d-
Allethrin ’) (CAS No : 231937 -89-6). 
(2) D-Allethrin  has been evaluated for use in  biocidal products of product -type 18, 
(insecticide s, acaricides and products to control other arthropods ), as described in  
Annex V to Regulation (EU) No  528/2012.  
(3) Germany  was designated as the rapporteur Member State  and its evaluating competent 
authority submitted the assessment report together with its conclusions to the 
European Chemical s Agency  (‘the Agency’) on 11 January  2017. After the submission 
of the assessment report, discussions took place in technical meetings organised by the 
Agency.   
(4) In accor dance with Article 75(1) , 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. In accordance with Article 7(2) of 
Delegated Regulation (E U) No  1062/2014, the Biocidal  Products Committee adopted 
the opinion of the Agency on 12 October  20213, having regard to the conclusions of 
the evaluating competent authority.  
                                                 
1 OJ L 167, 27.6.2012,  p. 1.  
2 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for 
the systematic examination of all existing active substances contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament a nd of the Co uncil (OJ L 294, 10.10.2014, 
p. 1). 
3 Biocidal Products Committee  Opinion on the application for approval of the active substance : d-
Allethrin , Product type: 18, ECHA/BPC/ 293/2021, adopted on 12 October  2021.  
EN 2  EN (5) According to  the opinion  of the Agency , biocidal products of product -type 18 
containing  d-Allethrin  cannot be expected to meet  the criteria  laid down   in Article 
19(1) , point s (b)(iii) , and (iv) , of Regulation (EU) No 528/2012 .  
(6) In its opinion, the Agency noted that t he proposed reference specification s, establis hed 
on the b asis of data provided by one of the applicants, are not in line with the 
composition of the material that was used for testing to generate the toxicological data 
provided  by the applicants.  As a result, on the basis of the data provided in the 
applications, it could not be established whether the representative biocidal product s 
could fulfil the criteria referred to in Article 19(1) , point (b) of Regulation (EU) No 
528/2012 .  
(7) According to the opinion of the Agency, based on t he available toxicological data, an 
unacceptable risk has been identified for the general public due to secondary exposure 
to genotoxic photometabolites formed after the application of the representative 
products .  
(8) In addition,  according to the opinion of the Agency , an unacceptable risk to the 
environment has  been identified  for the aquatic compartment (surface water and 
sediment) and for soil .  
(9) In conclusion, no safe use could be identified when considering the risks to human 
health and the environment for each of the representative biocidal products  submitted 
in the applications .  
(10) The conditions for approval of d-Allethrin laid down in Article 4(1) of Regulation 
(EU) No 528/2012  are therefore not met.   
(11) Taking into account the opinion of the Agency , it is not appropriate to approve d-
Allethrin  for use in biocidal products of product -type 18.  
(12) 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  
D-Allethrin  (CAS No: 231937 -89-6) is not approved as an active substance for use in biocidal 
products of product -type 18. 
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