EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10268/2022 
(POOL/E4/2022/10268/10268 -EN.docx)  
[…](2022) 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 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 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 19 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 19 (repellents and att ractants ), as described  in 
Annex V to Directive 98/8/EC  of the European Parliament  and of the Council3, which 
correspond to product -type 19 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) 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 B iocidal Products Committee adopted the opinion of the 
Agency4 on 3 December  2021, having regard to the conclusions of the evaluating 
competent authority.  
(6) According to  that opinion , biocidal products o f product -type 19 containing 
Chrysanthemum cinerariaefol ium 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 requirements  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 carbon  dioxide  as an active substance  for 
use in bi ocidal products of product -type 19 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 t ake 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 cinera riaefolium  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 19 subject to the conditions set out in the Annex.  
Artic le 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 Brussel s, 
 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 open and mature flowers of Tanacetum cinerariifolium  
obtained with supercritical carbon dioxide ; Product -type 19 ; ECHA/BPC/ 313/2021, adopted on 3 
December  2021.