EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/1104 
(POOL/E4/2023/1104/1104 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving sulfur dioxide generated from sulfur by combustion as an active substance 
for use in biocidal products of product -type 4 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 sulfur dioxide generated from sulfur by combustion as an active substance 
for use in biocidal products of product -type 4 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 Un ion, 
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 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 sulfur dioxide generated from sulfur by combustion  for 
product -type 4. 
(2) Sulfur dioxide generated from sulfur by combustion has been evaluated for use in 
biocidal products of product -type 4, food and feed area  disinfectants , as described  in 
Annex V to Regulation (EU) No 528/2012 . 
(3) Germany was designated as t he rapporteur Member State  and its  evaluating competent 
authority submitted the assessment report together with its conclusions  of its 
evaluation  to the European Chemicals Agency (‘ ECHA’ ). Discussions took place in 
technical meetings organised by ECHA . 
(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 ECHA  
regarding the applications for approval of active substances.  In accordance with 
Article 7(2) of Del egated Regulation (EU) No 1062/2014 read in conjunction with 
Article 75(1) and (4) of Regulation (EU) No 528/2012 , the Biocidal Products 
Committee adopted the opinion of ECHA3 on 26 September  2022, having regard to the 
conclusions of the evaluating compete nt authority.  
(5) According to  that opinion , biocidal products o f product -type 4 containing sulfur 
dioxide generated from sulfur by combustion may be expected to satisfy the criteria  
                                                 
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 C ouncil  (OJ L 294, 10.10.2014, 
p. 1). 
3 Biocidal Products Committee Opinion on the application for approval of the active substance Sulfur 
dioxide generated from sulfur by combustion ; Product -type 4; ECHA/BPC/354/2022 .   
EN 2  EN laid down in Article 19(1), point (b), of Regulation (EU) No 528/2012, provided that 
certain conditions concerning their use are complied with.  
(6) Taking into account the opinion of ECHA , it is appropriate to approve sulfur dioxide 
generated from sulfur by combustion as an active substance  for use in bi ocidal 
products of product -type 4 subject to compliance with certain conditions.  
(7) A reasonable period should be allowed to elapse before an existing active substance is 
approved in order to permit interested parties to take the preparatory measures 
necessary to meet the new requirem ents. 
(8) 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  
Sulfur dioxide generated from sulfur by combustion is approved as an active substan ce for use 
in biocidal products of product -type 4 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