EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1196/2022 
(POOL/E4/2022/1196/1196 -EN.docx)  
[…](2022) XXX  draft 
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving silver nitrate as an active substance for use in biocidal products of 
product -type 7 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 (EU) …/…  
of XXX  
not approving silver nitrate as an active substance for use in biocidal products of 
product -type 7 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 (b), thereof,  
Whereas:  
(1) Pursuant to Article 11(1)  of Directive 98/8/EC  of the European Parliament and of the 
Council2, an application for approval of silver nitrate for use in biocidal products of 
product -type 7, film preservatives , as described in Annex V  of that Directive , 
corresponding to product -type 7, f ilm preservatives , as described in Annex V to 
Regulation (EU) No 528/2012 , was submitted to  the competent authority of Sweden  
on 23 December 2010.  
(2) Pursuant to Article 90(2), first subparagraph, of Regulation (EU) No 528/2012, 
applications submitted for the purposes of Dire ctive 98/8/EC for which the Member 
States’ evaluation in accordance with Article 11(2) of Directive 98/8/EC has not been 
completed by 1 September 2013 are to be evaluated by the competent authorities in 
accordance with the provisions of that Regulation.  
(3) On 10 February 2022, during the evaluation of the active substance by the evaluating 
competent authority, the applicant withdrew its application and no longer requests the 
approval of silver nitrate as an active substance for use in biocidal products of prod uct-
type 7.  
(4) Silver nitrate is not included for product -type 7 in Annex II to Commission Delegated 
Regulation (EU) No 1062/20143, which lists the active s ubstance/product -type 
combinations included in the work programme for the examination of existing bioci dal 
active substances contained in biocidal products . Biocidal products of product -type 7 
containing s ilver nitrate are therefore not covered by the transitional provisions laid 
down in Article 89(2) of Regulation (EU) No 528/2012  and may therefore not be made 
available or used on the Union market.  
                                                 
1 OJ L 167, 27.6.2012, p. 1.  
2 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).  
3 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 and of the Council (OJ L 294, 10.10.2014, p. 
1).  
EN 2  EN (5) However, i n accordance with the transitional provision set out in Article 94(1) , point 
(a), of Regulation (EU) No 528/2012 , a treated article treated with or intentionally 
incorporating one or more biocidal prod ucts containing only active substances that are 
under examination for the relevant product -type in the work programme referred to in 
Article 89(1) of that Regulation on 1 September 2016 or for which an application for 
approval for the relevant product -type is submitted by that date, or containing only a 
combination of such substances and active substances included in the list drawn up in 
accordance with Article 9(2) of that Regulation for the relevant product -type and use 
or included in Annex  I, may be plac ed on the market until the date falling 180 days 
after a decision not to approve one of the active substances for the relevant use, when 
such decision is adopted after 1 September 2016 . 
(6) As the applicant has withdrawn the application for approval of silver nitrate  for use in 
biocidal products of product -type 7, there is no biocidal product to be evaluated. 
Consequently, the competent authority did not finalise the assessment report and the 
European Chemicals Agency did not prepare an opinion. Finally, as the re is no 
biocidal product of product -type 7 containing silver nitrate that may be expected to 
meet the criteria laid down in Article 19(1), point (b), of Regulation (EU) No 
528/2012, the conditions laid down in Article 4(1) of that Regulation are not met. 
Considering also the need to ensure that treated articles treated with or intentionally 
incorporating silver nitrate for product -type 7 are no longer placed on the Union 
market, it is appropriate not to approve silver nitrate for use in biocidal products o f 
product -type 7. 
(7) 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  
Silver nitrate (EC No: 231 -853-9; CAS No: 7761 -88-8) is not approved as an active substance 
for use in biocidal products of product -type 7. 
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