EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10276/2022 
(POOL/E4/2022/10276/10276 -EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION  
of XXX  
not approving methylene dithiocyanate as an existing active substance for use in biocidal 
products of product -type 12 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 DECISION  
of XXX  
not approving methylene dithiocyanate as an existing active substance for use in biocidal 
products of product -type 12 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 Regulatio n (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 e xisting 
active substa nces to be evaluated for their possible approval for use in biocidal 
products. That list includes methylene dithiocyanate (EC No: 228-652-3; CAS No : 
6317 -18-6). 
(2) Methylene dithiocyanate has been evaluated for use in  biocidal products of product -
type 12, slimicides , as described in Annex V to Directive 98/8/EC of the European 
Parliament and of the Council3, which correspond to product -type 12 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 
Commission  on 7 August 2013 . After the submission of the assessment report, 
discussions took place in technical meetings organised 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’ e valuation has been completed by 1 September 2013 should be 
evaluated in accordance with the provisions of Directive 98/8/EC.   
(5) In accordance with Article 75(1) , 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  Products Committee adopted 
                                                 
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 Co uncil (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 the opinion of the Agency on 8 March  20224, having regard to the conclusions of the 
evaluating competent authority.  
(6) According to  the opinion  of the Agency , biocidal products of product -type 12 
containing  methylene dithiocyanate  cannot be expected to meet  the criteria  laid down 
in Article 5(1), points (b) (iii) and (iv) , and (c), read in conjunction with Article 10(1) 
of Directive 98/8/EC . The applicant did not submit data  of sufficient quality  to meet  
the data requirements  set out in point 2. 7 (specification of purity of the active 
substance in g/kg or g/l, as appropriate ), point 2. 8 (identi ty of impurities and additives 
together with the structural formula and the possible range expressed as g/kg or g/l, as 
appropriate ), and point 4.1  (analytical methods for the determination of pure active 
substance and, where appropriate, for relevant degradation products, isomers and 
impurities of the active substance and additives)  of Title II of Annex II A to Directive  
98/8/EC . As a result, it was  impossib le to confirm the minimum purity of the active 
substan ce and to set a reference specification for methylene dithio cyanate. Moreover, 
it was not possible to confirm that the material used to conduct (eco)toxicological 
studies cover the presented specifications and to conclude on the relevance of the 
impurities  due to the lack of (eco)toxicological data. Lastly, the environment al risk 
assessment identified unacceptable risks , and no suitable risk mitigation measure 
could be identified . 
(7) Taking into account the opinion of the Agency , it is not appropriate to approve 
methylene dithiocyanate for use in biocidal products of product -type 12.  
(8) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee  on Biocidal products , 
HAS ADOPTED THIS DECISION:  
Article 1  
Methylene dithiocyanate (EC No: 228-652-3; CAS No: 6317 -18-6) is not approved as an 
active substance for use in biocidal products of product -type 12. 
Article 2 
This Decision shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  
                                                 
4 Biocidal Products Committee  Opini on on the application for approval of the active substance : 
methylene dithiocyanate , Product type: 12, ECHA/BPC/ 322/2022, adopted on 8 March  2022.