EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/325/2023 
(POOL/E4/2023/325/325 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving sulfur dioxide released from sodium metabisulfite as an active substance for 
use in biocidal products of product -type 9 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 released from sodium metabisulfite as an active substance for 
use in biocidal products of product -type 9 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 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 9(1), point (a), thereof,  
Whereas:  
(1) On 2  December 2013, the European Chemicals Agency (‘the Agency’) received  an 
application, in accordance with Article 7(1) of Regulation (EU) No 528/2012 , for the 
approval of sulfur dioxide released from sodium metabisulfite as an active substance 
for use in bioci dal products of product -type 9 , fibre, leather, rubber and polymerised 
materials preservatives , as described  in Annex V to Regulation (EU) No 528/2012 . 
That application was evaluated by the competent authority of Germany (‘the 
evaluating competent aut hority’).  
(2) On 22 January  2018 , the evaluating competent authority submitted the assessment 
report on the application together with the conclusions of its evaluation to the Agency. 
The Agency discussed the assessment report and the conclusions in technical 
meetings.  
(3) 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. I n accordance with 
Article 8(4) of Regulation (EU) No 528/2012 , the Biocidal Products Committee 
adopted the opinion of the Agency  on 26 September 20222, having regard to the 
conclusions of the evaluating competent authority . 
(4) In the opinion , the Agency concludes that  biocidal products of product -type 9  using 
sulfur dioxide released from sodium metabisulfite may be expected to satisfy the 
criteria laid down in  Article 19(1), point (b), of Regulation (EU) No 528/2012, 
provided that certain conditions concerning their use are complied with.  
(5) Taking into account the opinion  of the Agency, it is appropriate to approve sulfur 
dioxide released from sodium metabisulfit e as an active substance for use in bi ocidal 
products of product -type 9 subject to compliance with certain conditions.  
                                                 
1 OJ L 167, 27.6.2012,  p. 1.  
2 Biocidal Products Committee Opinion on the application for approval of the active substance sulfur 
dioxide released from sodium metabisulfite; Product -type 9; ECHA/BPC/355/2022, adopted on 26 
September 2022.   
EN 2  EN (6) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee  on Biocidal Products , 
HAS ADOPT ED THIS REGULATION:  
Article 1  
Sulfur dioxide released from sodium metabisulfite is approved as an active substance for use 
in biocidal products  of product -type 9 subject to the conditions set out in the Annex.  
Article 2 
This Regulation shall enter into for ce 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