EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels,  
C(2010)XXX final D009665/01 
CA-May10-Doc.3.5  
Draft 
COMMISSION DECISION 
of […] 
concerning the non-inclusion of  certain substances in Annex I, IA or IB to Directive 
98/8/EC of the European Parliament and of the Council concerning the placing of 
biocidal products on the market  
EN 2   EN Draft 
COMMISSION DECISION 
of  
concerning the non-inclusion of certain substances in Annex I, IA or IB to 
Directive 98/8/EC of the European Parliament  and of the Council concerning the placing 
of biocidal products on the market 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to 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
1, and in 
particular the second subparagraph of Article 16(2) thereof, 
Whereas: (1) Commission Regulation (EC)  No 1451/2007 of 4 December 2007 on the second phase 
of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of 
the European Parliament and of the Counc il concerning the pl acing of biocidal 
products on the market
2 establishes a list of active substances to be assessed, with a 
view to their possible inclusion in Anne x I, IA or IB to Directive 98/8/EC. 
(2) For a number of substance/product  type combinations included  in that list, either all 
participants have discontinue d their participation from the review programme, or no 
complete dossier was received within the tim e period specified in Articles 9 and 12(3) 
of Regulation (EC) No 1451/2007 by the Memb er State designated as Rapporteur for 
the evaluation. 
(3) Consequently, and pursuant to Articles 11( 2), 12(1) and 13(5) of Regulation (EC) 
No 1451/2007, the Commission informed the Member States accordingly. That information was also made pub lic by electronic means.  
(4) Within the period of three months from those publicati ons, a number of companies 
indicated an interest in taking over the role of participant for the substances and product-types concerned. However, those co mpanies subsequently failed to submit a 
complete dossier. 
                                                
 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3.   
EN 3   EN (5) Pursuant to Article 12(5 ) of Regulation (EC) No 1451/2007, the substances and 
product types concerned should th erefore not be included in Annexes I, IA or IB to 
Directive 98/8/EC. 
(6) In the interest of legal certa inty, it should be specified as of which date biocidal 
products containing active substances for th e product-types indicate d in the Annex to 
this Decision shall no longer be placed on the market.  
(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 
The substances indicated in the Annex to this  Decision shall not be included for the product-
types concerned in Annexes I, IA  or IB to Directive 98/8/EC.  
Article 2 
For the purposes of Article 4(2) of Re gulation (EC) No 1451/2007, biocidal products 
containing active substances for the product-type s indicated in the Annex to this Decision 
shall no longer be placed on the market  with effect from 1 November 2011. 
Article 3 
This Decision is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 Janez POTO ČNIK 
 Member of the Commission  
EN 4   EN ANNEX  
 
Substances and product types not to be included in Annexes I, IA or IB to 
Directive 98/8/EC  
  
Name EC number CAS number Product-
type RMS 
Formaldehyde 200-001-8 50-00-0 4 DE 
Formaldehyde 200-001-8 50-00-0 6 DE 
Benzoic acid 200-618-2 65-85-0 20 DE 
Sodium benzoate 208-534-8 532-32-1 11 DE 
Sodium benzoate 208-534-8 532-32-1 20 DE 
2-Butanone, peroxide 215-661-2 1338-23-4 9 HU 
2-Butanone, peroxide 215-661-2 1338-23-4 22 HU 
Tolnaftate 219-266-6 2398-96-1 9 PL 
Triclosan 222-182-2 3380-34-5 3 DK 
Silicon dioxide – amorphous 231-545-4 7631-86-9 3 FR 
N'-tert-butyl-N-cyclopropyl-6-(m ethylthio)-1,3,5-triazine-2,4-
diamine 248-872-3 28159-98-0 7 NL 
N'-tert-butyl-N-cyclopropyl-6-(m ethylthio)-1,3,5-triazine-2,4-
diamine 248-872-3 28159-98-0 10 NL 
Mixture of cis- and trans-p-menthane-3,8 diol / Citriodiol 255-953-7 42822-86-6 1 UK 
Mixture of cis- and trans-p-menthane-3,8 diol / Citriodiol 255-953-7 42822-86-6 2 UK