. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/286 
21 July 2009  
 (09-3561) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  EUROPEAN COMMUNITIES
  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  European Commission 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
European Commission 
EC-TBT Enquiry Point Fax:  +(32) 2 299 80 43 E-mail:  ec-tbt@ec.europa.eu Website: http://ec.europa.eu/enterprise/tbt/
  
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Biocidal products – 
chemicals.  
5. Title, number of pages and language(s) of the notified document:  Proposal for a 
Regulation of the European Parliament and of the Council concer ning the placing on the 
market and use of biocidal products (COM (2009)  267) (194 pages, in English, French and 
Spanish).  
6. Description of content:  This draft Regulation will repeal and replace the ex isting Directive 
98/8/EC concerning the placing of biocidal products on the market. It will maintain the principle of a two-step authorisation: firstly, the active substance is evaluated and included in 
Annex I and secondly, a product authorisation is granted to the biocidal product containing 
the active substance. The draft Regulation will  introduce the possibility to grant Community 
authorisation to low-risk biocidal products and biocidal products containing new active 
substances (those that were not on the ma rket on 14 May 2000) which will allow these 
products access to the entire Community market. Al l other products will be subject to national 
authorisations, and potenti ally, mutual recognition. 
The draft Regulation will also c over materials and arti cles treated with bi ocidal products. It 
will be required that only authorised biocidal products may be used for the treatment of such 
materials and articles. 
Under the draft Regulation, new rules on obligator y data sharing of vert ebrate animal studies 
and data waiving will be set out  in order to reduce the number of animal tests and the costs of 
the industry.  G/TBT/N/EEC/286 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable:  The 
draft Regulation aims to improve  environmental and human health  protection with respect to 
biocidal products while increasing the comp etitiveness of enterprises and harmonising the 
internal market. The draft Regulation will also provide incentives for future product 
development and innovation.   
8. Relevant documents:   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 
http://eur-lex.europa.e u/JOHtml.do?uri=OJ:L :1998:123:SOM:EN:HTML   
9. Proposed date of adoption:   
Proposed date of entry into force:    Not before 2011 
The Regulation shall apply from 1 January 2013 but transitional periods ar e foreseen for in-situ 
generated active substanc es, treated materials 
and articles, etc.  
10. Final date for comments:  90 days from date of notification 
11. Text available from: National enquiry point [  ], or addre ss, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
European Commission 
EC-TBT Enquiry Point 
Fax:  + (32) 2 299 80 43 E-mail:  ec-tbt@ec.europa.eu
 
 The text is available on the EC-TBT Website : http://ec.europa.eu/enterprise/tbt/
 
and at 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2009:0267:FIN:EN:PDF  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2009:0267:FIN:ES:PDF  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2009:0267:FIN:FR:PDF  
http://eur-lex.europa.eu/Le xUriServ/LexUriServ.do?ur i=CELEX:DKEY=496597:EN:NOT  
and 
here.