WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/99 
7 February 2006 
 (06-0500) 
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 government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   European Commission 
Name and address (including telephone and fax numbers, e-mail and web-site 
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@cec.eu.int  
3. Notified under Article 2.9.2 [   X  ], 2.10.1 [   ], 5.6.2 [  X  ], 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):   All micro-organisms 
including viruses and fungi placed on the ma rket before 14 May 2000 and used as active 
substances in biocidal products as defined in Directive 98/8/EC. 
5. Title, number of pages and langua ge(s) of the notified document:         
Draft Commission Directive ../…/EC of […] amending Annexes IVA and IVB to 
Directive 98/8/EC of the European Parliament  and of the Council concerning the placing of 
biocidal products on the market (3 pages for the draft Directive and 12 pages Annexes, in 
English (other EU languages are in preparation)) 
6. Description of content:    
The proposed Directive amends the current Anne x IV to Directive 98/8/EC on the placing 
of biocidal products on the market.  The amen dments to Annex IV are based on Directive 
2001/36/EC amending Directive 91/414/EEC conc erning the placing of plant protection 
products on the market. 
The only changes proposed concern areas where Directive 91/414/EEC concerning the 
placing of plant protection products on the market and Directive 98/8/EC on the placing of biocidal products on the market differ due to th e nature of the use of the products such as 
the exposure assessment and also the introductio n of some new points regarding monitoring 
which are aligned to some of the principles contained in Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and 
Directive 2000/54/EC on the protection of workers from risks related to exposure to 
biological agents at work. G/TBT/N/EEC/99 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable:    
According to Directive 98/8/EC, an applicant for authorisation of a biocidal product shall 
submit to the competent authority of a Member  State a dossier for the biocidal product and 
the active substance(s) contained in the biocid al product satisfying, in the light of current 
scientific and technical knowledge, the requirements set out in the Annexes to the Directive.  
The Directive distinguishes between the data re quirements for biocidal products containing 
chemical active substances (Annexes II a nd III) and biocidal products containing micro-
organism(s), viruses and fungi as active substa nce (Annex IV).  This differentiation is 
appropriate in order to accommodate the nature of each type of active substance e.g. differences concerning assessment of fate and behaviour in the environment and residues 
which is specific for chemical substances a nd assessment of infectiveness and pathogenicity 
which is specific to micro-organisms. 
As the micro-organisms notified under Directive 98/8/EC for evaluation are also under 
assessment in the framework  of Directive 91/414/EEC, a harmonisation of the data 
requirements would allow that economic opera tors submit virtually the same dossier for 
micro-organisms, with only minor amendments, for the purposes of both Directives.  This 
will reduce the dossier preparation costs for participants in the review programmes under 
the two Directives. 
Finally, the proposed amendments to Anne x IV to Directive 98/8/EC are based on 
Directive 2001/36/EC and also align the legislation with Directive 2001/18/EC and 
Directive 2000/54/EC. 
Industry operating within the framework of Dir ective 98/8/EC, and in particular the review 
program as established by Article 16(2), is  obliged to submit dossiers satisfying the 
requirements which are set out in Annex II and III (for chemical biocides) or Annex IV (for microbial biocides).  This submission will allo w Member States to review the risks and 
hazards posed when biocides are used. According to Commission Regulation (EC) 
No. 2032/2003, which sets the details of  the review program for existing active 
substances/micro-organisms, dossiers are to be  submitted at various deadlines in order to 
allow for a gradual phasing in of active substances already placed on the market.  Active micro-organism dossiers are to be submitted at  the latest by 30 April 2006, due to being 
notified as active substances contained in biocid es used as insecticides.  Consequently, the 
proposed Directive amending the current Annex IV  to Directive 98/8/EC must be adopted at 
the end of March 2006, in order to facilitate the submission of the dossiers for active micro-organism contained in biocidal products used as insecticides. 
8. Relevant documents:    
Directive 98/8/EC of the European Parliame nt and the Council on the placing of biocidal 
products on the market (OJ L 123, 24.4.1998, page 1). Available in all EU languages. 
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection 
products on the market (OJ L 230, 19.8.1991, page 1). Available in all EU languages. 
Commission Directive 2001/36/EC of 16 May 2001 amending Council Directive 
91/414/EEC concerning the placing of plant pr otection products on the market (OJ L 164, 
20.6.2001, page 1). Available in all EU languages. 
Directive 2001/18/EC of the European Parlia ment and of the Council of 12 March 2001 on 
the deliberate release into the environment of genetically modified organisms and repealing 
Council Directive 90/220/EEC (OJ L 106, 17.4 .2001, page 1). Available in all EU 
languages.  G/TBT/N/EEC/99 
 Page 3 
 
 
  Directive 2000/54/EC of the European Parliame nt and of the Council of 18 September 2000 
on the protection of workers from risks related to exposure to biological agents at work (OJ 
L 262, 17.10.2000, page 21). Available in all EU languages. 
Further information can be found on the Commission's websites at: http://europa.eu.int/comm/environment/biocides/index.htm  and http://ecb.jrc.it/biocides  
9. Proposed date of adoption:   Adoption end of March 2006  
Proposed date of entry into force:  Entry into force April 2006  
10. Final date for comments:    10 March 2006 
11. Texts available from:  National enquiry point [    ] or address, 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@cec.eu.int