EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/334/2023 
(POOL/E4/2023/334/334 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving Chrysanthemum cinerariaefolium  extract from open and mature flowers of 
Tanacetum cinerariifolium obtained with supercritical carbon dioxide as an 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 REGULATION (EU) …/...  
of XXX  
approving Chrysanthemum cinerariaefolium  extract from open and mature flowers of 
Tanacetum cinerariifolium obtained with supercritical carbon dioxide as an 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 relevanc e) 
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 us e 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 existing 
active substances to be evaluated for their possible approval for use in biocidal 
products.  That list includes Chrysanthemum cinerariaefolium  extract from open and 
mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon  
dioxide . 
(2) Chrysanthemum cinerariaefolium  extract from open and mature flowers of Tanacetum 
cinerariifolium obtained with supercritical carbon dioxide has been evaluated for use 
in biocidal products of product -type 18, insecticides, acar icides and products to control 
other arthropods , as described  in Annex V to Directive 98/8/EC  of the European 
Parliament  and of the Council3, which correspond s to product -type 18 as described  in 
Annex V to Regulation (EU) No 528/2012 . 
(3) Spain  was designated as the rapporteur Member State and its evaluating competent 
authority submitted the assessment report together with its conclusions to the 
Commission  on 1 September 201 0. After the submission of the assessment report, 
discussions took place  in technical meetings organised by the Commission and, after 1 
September 2013, by the European Chemicals Agency (‘the Agency’) . 
(4) It follows  from Article 90(2) of Regulation (EU) 528/2012 that substances for which 
the Member States’ evaluation has been comp leted by 1 September 2013 should be 
assessed in accordance with the provisions of Directive 98/8/EC.  
                                                 
1 OJ L 167, 27.6.2012,  p. 1.  
2 Commission Delegated Regula tion (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 and of the Council  (OJ L 294, 10.10.2014, 
p. 1). 
3 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) .  
EN 2  EN (5) 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.  In accordance with 
Article 7(2) of Delegated Regulation (EU) No 1062/2014, the Biocidal Produc ts 
Committee adopted the opinion of the Agency4 on 22 November  2022, having regard 
to the conclusions of the evaluating competent authority.  
(6) In the opinion , the Agency  concludes that  biocidal products o f product -type 18 
containing Chrysanthemum cinerariaef olium  extract from open and mature flowers of 
Tanacetum cinerariifolium obtained with supercritical carbon dioxide may be 
expected to satisfy the requirements laid down in Article 5 (1), points (b), (c) and (d) , 
of Directive 98/8/EC, provided that certain conditions  concerning their use are 
complied with.  
(7) Taking into account the opinion of the Agency, it is appropriate to approve 
Chrysanthemum cinerariaefolium  extract from open and mature flowers of Tanacetum 
cinerariifolium obtained with supercritical carb on dioxide  as an active substance  for 
use in bi ocidal products of product -type 18 subject to compliance with certain 
conditions.  
(8) A reasonable period should be allowed to elapse before an active substance is 
approved in order to permit interested parties to  take the preparatory measures 
necessary to meet the new requirements.  
(9) 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  
Chrysanthemum cine rariaefolium  extract from open and mature flowers of Tanacetum 
cinerariifolium obtained with supercritical carbon dioxide is approved as an active substance 
for use in biocidal products of product -type 18 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,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  
 
                                                 
4 Biocidal Products Committee Opinion on the application for approval of the active substance 
Chrysanthemum cinerariaefolium , extract from op en and mature flowers of Tanacetum cinerariifolium  
obtained with supercritical carbon dioxide ; Product -type 1 8; ECHA/BPC/ 366/2022, adopted on 22 
November  2022.