EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11464/2020 
(POOL/E4/2020/11464/11464 -EN.doc)  
[…](2020) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 528/2012 of the European Parliament and of the Council 
to include carbon dioxide generated from propane, butane or a mixture of both by 
combustion as an active substance in Annex I thereto  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Article 28(1) of Regulation (EU) No 528/2012 (the BPR) empowers the Commission 
to adopt delegated acts in order to include an active substance into Annex I to the 
BPR after receiving the opinion of the European Chemicals Agency (ECHA), 
provided that there is evidence that the active substance do not give rise to concern 
according to the condi tions set out in Article 28(2) of that Regulation.  A simplified 
authorisation procedure is provided in Chapter V of the BPR for biocidal products 
containing active substances  listed in Annex I to the BPR and fulfilling other 
conditions set out in Article 2 5 of that Regulation . 
Carbon dioxide  generated from propane, butane or a mixture of both by combustion 
has been assessed as an existing active substance within the review programme set 
out in Article 89(1) of the BPR established by Commission Delegated Regulation 
(EU) No 1062/2014 (the Review Regulation)  for use in biocidal products of product -
type n° 19 “repellents and attractants ”. 
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the 
Biocidal Product Committee of ECHA  adopted its opinion on  16 June 2020 
(ECHA/BPC/ 249/2020 ), conclud ing that biocidal products of product -type n°19 
using  carbon dioxide generated from propane, butane or a mixture of both by 
combustion may be expected to satisfy the requirements of Article 19(1)(b)  of 
Regulation (EU) No 528/2012 . The opinion  of ECHA also concluded that this active 
substance  does not give rise to concern and is eligible for inclusion in Annex I to 
Regulation (EU) No 528/2012.  Such inclusion would in particular reduce the 
admin istrative burden , facilitate the placing on the EU market of biocidal products 
presenting lower concerns for human health, an imal health and the environment , and 
promote innovation for such biocidal products.  
The opinion  of ECHA of 16 June 2020 is consider ed as an opinion of the Agency 
pursuant to Article 28(1) of  Regulation (EU) No 528/2012 . 
This draft Delegated Regulation therefore proposes to include  carbon dioxide 
generated from propane, butane or a mixture of both by combustion  in Annex I to 
Regulation  (EU) No 528/2012 . 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission has consulted an expert group (the 'Biocides CA meeting') 
consisting of representatives of Member States' competent authorities for biocidal 
products, of the European Chemi cals Agency, of the biocides industry and of the 
civil society  during the meeting of 25 September 20 20. 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The delega ted Regulation  amends Annex I to Regulation (EU) No 528/2012 . EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 528/2012 of the European Parliament and of the Council 
to include carbon dioxide generated from propane, butane or a mixture of both by 
combustion as an  active substance in Annex I thereto  
(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 M ay 2012 concerning the making available on the market and use of biocidal 
products1, and in particular Article 28(1) thereof,  
Whereas:  
(1) Commission Delegated Regulation (EU) No 1062/20142 establishes a list of existing 
active substances to be evaluated for t heir possible approval for use in biocidal 
products. That lists includes carbon dioxide generated from propane, butane or a 
mixture of both by combustion . 
(2) Carbon dioxide generated from propane, butane or a mixture of both by combustion  
has been evaluated for use in  biocidal products of product -type 19, repellents and 
attractants , as described  in Annex V to Regulation (EU) No  528/2012.  
(3) France  was designated as the rapporteur Member State  and its evaluating competent 
authority submitted the assessment report  together with its conclusions to the 
European Chemicals Agency  (‘the Agency’)  on 18 September 2019.  
(4) In accordance with Article 7 (2) of Delegated  Regulation (EU) No  1062/2014 , the 
Biocidal Products Committee adopted the opinion of the Agency on 16 June 202 03, 
having regard to the conclusions of the evaluating competent authority.  
(5) According to that opinion,  biocidal products of product -type 19 using carbon  dioxide 
generated from propane, butane or a mixture of both by combustion  may be expected  
to satisfy the requirements of Article 19(1)(b)  of Regulation (EU) No 528/2012 . The 
opinion of the Agency also concluded that this active substance  does not give rise to 
concern and is eligible for inclusion in Annex I to Regulation (EU) No 528/2012 . 
(6) Taking into account the opinion of the Agency , it is therefore appropriate to include 
carbon dioxide generated from propane, butane or a mixture of both by combustion in 
                                                 
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 Council (OJ L 294, 10.10.2014, 
p. 1). 
3 Biocidal Products Committee  Opinion on the application for approval of the active substance : Carbon 
dioxide generated from propane, butane or a mixture of both by combustion , Product type: 19, 
ECHA/BPC/ 249/2020 , adopted on  16 June 2020.  EN 3  EN Annex I to Regulation (E U) No 528/2012 . As carbon dioxide  generated from propane, 
butane o r a mixture of both by combustion  has been assessed based on a n active 
substance  dossier complying with the requirement s set out in Article 11(1) of 
Directive 98/8/EC  of the European Parliament and of the Council4, carbon dioxide  
generated from propane, butane or a mixture of both by combustion  should be 
included in category 6 of Annex I to Regulation (EU) No 528/2012,  "Substanc es for 
which a Member State has validated an active substance dossier in accordance with 
Article 7(3) of this Regulation or accep ted such a dossier  in accordance with Article 
11(1) of Directive 98/8/EC ".  
(7) Article 89(3) of Regulation (E U) No 528/2012 contains transitional measures where 
an existing active substance included in the work programme for the systematic 
examination of exis ting active substances is approved in accordance with that 
Regulation. With respect to carbon dioxide  generated from propane, butane or a 
mixture of both by combustion  for product -type 19 , the date of approval for the 
purposes of Article 89(3) of that Regu lation should be set at  1 July 2022 , in order to 
allow sufficient time for applications for authorisation to be submitted in accordance 
with the second subparagraph of Article 89(3) of that Regulation , 
HAS ADOPTED THIS REGULATION:  
Article 1 
Annex I to Regulation (E U) No 528/2012  is amended in accordance with the  Annex to this 
Regulation . 
Article 2 
For the purposes of Article 89(3) of Regulation (E U) No 528/2012, the date of approval of 
carbon dioxide  generated from propane, butane or a mixture of both b y combustion  for 
product -type 19 is 1 July 2022 . 
Article  3 
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 dir ectly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  
                                                 
4 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 ).