WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/79 
7 March 2005 
 (05-0956) 
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 COMMISSION 
 
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 active substances 
placed on the market before 14 May 2000 and us ed in biocidal products as defined in 
Directive 98/8/EC. 
5. Title, number of pages and language(s) of the notified document:   Draft Commission 
Regulation (EC) No …/.. of […] amending Commission Regulation (EC) No 2032/2003 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 Council concerning the placing of biocidal products on the market  (7 pages + 80 Annexes,  in English;  other EU languages are in 
preparation) 
6. Description of content:   The proposed draft Regulation, which is also notified under the 
terms of the Agreement on Sanitary and Phystosanitary measures, amends certain 
provisions of Regulation  (EC) No 2032/2003 a nd adapts its Annexes to technical progress. 
The main objective of the draft Regulation is the designation of Rapporteur Member States 
for the lists in parts C and D of Annex V of Regulation (EC) No 2032/2003 which flows 
directly from Article 5 of Regulation (EC) No 2032/2003. It also updates Annexes I, II and III to Regulation (EC) No 2032/2003, due to participant withdrawals in accordance with 
Article 8 of Regulation (EC) No 2032/2003, or fa ilure to submit dossi ers by the foreseen 
deadlines.  
The draft Regulation would also introduce a ne w procedure to allow marketing possibilities 
of biocidal products containing non-notif ied active substances beyond 1 September 2006, 
provided a complete dossier is submitted before 1 March 2006. Furthermore, it would G/TBT/N/EEC/79 
Page 2  
 
 provide for the possibility for Member States to  request continued use of non-notified active 
substances for uses considered essential (in pa rticular when no safer alternatives are 
available) subject to justification and approval by the Commission.  
Finally, two new Annexes would be introduced  to Regulation (EC) No 2032/2003. The first 
one contains new deadlines for submission of dossiers for substances for which, following 
withdrawals or non-submission of dossiers, othe r companies have taken over the role of a 
participant as established in Article 8 to Re gulation (EC) No  2032/2003. The second one 
lists existing active substances which were on th e market before 14 May 2000, and were not 
identified, but for which there are socio-econom ic reasons to grant a phase-out period until 
1 September 2006. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Directive 98/8/EC lays down in Article 16 that the Commission and the Member States have to review all existing active substances in biocidal products within a 10-year 
programme of work with regard to the saf ety of their use for human health and the 
environment with a view of their possible inclusion into Annex I or IA to the Directive. 
Once the review of an active substance is co mpleted, biocidal products containing it will 
have to be authorised in the Member States.  According to Article 5 of the Directive, 
Member States can only authorise biocidal produc ts, if the active substance (or substances) 
is listed in Annex I or IA and if the produc t, among others, complies with further conditions 
defined in Article 5 of the Directive. 
Initially the first phase of the review progra mme was established by Regulation (EC) No 
1896/2000, which required that producers, fo rmulators, associations, or other persons 
including Member States could identify and/or  notify their active substances for the purpose 
of being reviewed.  Regulation (EC) No 2032/ 2003 defined the rules for the second phase of 
the review programme and established the list of identified existing active substances, the 
list of notified existing active substances and defined the c onsequences for the substances 
concerned, in particular the detailed progra mme for the evaluation of the notified existing 
active substances.  Furthermore, the Regula tion (EC) No 2032/2003 laid down the rules for 
joining or replacing participants for the submission of complete dossiers.  Finally, the 
Regulation laid down the rules for the evalua tion of dossiers by the Rapporteur Member 
States and the processing of the competent au thority reports by the Commission and the 
other Member States in order to prepare the Commission’s decision to either include or not 
include an existing active substance in A nnex I, IA or IB to Directive 98/8/EC. 
8. Relevant documents:   Directive 98/8/EC of the European Parliament and the Council on 
the placing of biocidal products on the market (OJ L 123, 24.4.1998, page 1) 
Commission Regulation (EC) No. 1896/2000 on th e first phase of the programme referred 
to in Article 16(2) of Directive 98/8/EC on bi ocidal products (OJ L 228, 8.9.2000, page 6) 
Commission Regulation (EC) No. 2032/2003 on the second phase of the 10-year work 
programme referred to in Article 16(2) of Di rective 98/8/EC of the European Parliament 
and of the Council concerning the placing of bi ocidal products on the market, and amending 
Regulation (EC) No 1896/2000. 
All legislative texts and 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   G/TBT/N/EEC/79 
 Page 3 
 
 
 9. Proposed date of adoption:   
Proposed date of entry into force:   }Adoption in  May 2005 
Entry into force in June 2005 
10. Final date for comments:   15 April 2005 
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