WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/256 
16 February 2005 
 (05-0641) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
1. Member to Agreement notifying:   EUROPEAN COMMUNITIES
 
If applicable, name of local government involved: 
2. Agency responsible:   Commission of the European Communities. Directorate-General 
Environment, Directorate B – Biotechnology and Pesticides. 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):   All active substances placed on the market before 14 May 2000 and used in 
biocidal products as defined in Directive 98/8/EC. 
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Member States of the European Communities (EEC) and third countries exporting 
the products concerned to the EEC  
5. Title, language and number of pages of the notified document:    
Draft Commission Regulation (EC) N°---/--- of [---] amending Commission Regulation 
(EC) N°. 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. N° of pages:  7 pages for the draft Regulation and 80 pages Annexes Languages:  English (other EU languages are in preparation) 
6. Description of content:   
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 safety 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 completed, 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 products, if the active substance (or 
substances) is listed in Annex I or IA and if the product, among others, complies with further conditions defined in Article 5 of the Directive. 
Initially the first phase of the review programme was established by Regulation 
1896/2000, which required that producers, formulators, associations, or other persons including Member States could identify and/or notify their active substances for the 
purpose of being reviewed.  Regulation 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 consequences for the substances concerned, in particular the detailed programme for the evaluation of the notified existing active substances.  Furthermore, the Regulation 2032/2003 laid down 
the rules for joining or replacing participants for the submission of complete dossiers.  G/SPS/N/EEC/256 
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 Finally, the Regulation laid down the rules for the evaluation of dossiers by the 
Rapporteur Member States and the processing of the competent authority 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 Annex I, IA or IB to Directive 98/8/EC. 
The proposed draft Regulation amends certain provisions of Regulation 2032/2003 and 
adapts its Annexes to technical progress, in order to designate Rapporteur Member States for the review of existing active substances on the 3
rd and 4th priority lists and to 
reflect the withdrawal of participants and non-submission of dossiers for substances on the first priority list. 
In addition, it is proposed to introduce some new provisions to take account of, among 
others, the fact that certain existing active substances were not identified in the first phase of the review program despite being placed on the market before 14 May 2000, and where immediate withdrawal would lead to disproportionate socio-economic impacts or would lead to negative consequences for the protection of public health.  It is 
therefore appropriate to draw up a further list of active substances in an additional 
Annex that should be allowed to remain on the market until 1 September 2006. 
The draft Regulation also introduces a system for an extension of the marketing period 
of biocidal products containing certain existing active substances for which no notification was submitted, but the use of which is considered essential, for reasons of protecting public health and protection of cultural heritage or the uses are critical for 
the functioning of society in the absence of technically and economically feasible 
alternatives or substitutes that are acceptable from the standpoint of environment or health. Finally, the draft Regulation lays down new deadlines for submission of dossiers for 
substances for which, following withdrawals or non-submission of dossiers, other companies have taken over the role of a participant as established in Article 8 to 
Regulation 2032/2003. 
7. Objective and rationale:  [ X ] food safety, [ X ] animal health, [   ] plant protection, 
[ X ] protect humans from anima l/plant pest or disease,  [   ]  protect territory from 
other damage from pests 
8. International standard, guideline or recommendation:  
[   ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [ X ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:    
9. Relevant documents and language(s ) in which these are available:   
Directive 98/8/EC of the European Parliament and the Council on the placing of 
biocidal products on the market (OJL 123, 24.4.1998, page 1).  Available in all EU 
languages. Commission Regulation (EC) N°. 1896/2000 on the first phase of the programme 
referred to in Article 16(2) of Directive 98/8/EC on biocidal products (OJL 228, 8.9.2000, page 6).  Available in all EU languages. 
Commission Regulation (EC) N°. 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, and amending Regulation (EC) N° 1896/2000 (OJL 307, 24.11.2003, p.1).  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  G/SPS/N/EEC/256 
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 http://ecb.jrc.it/biocides  
The draft Regulation is currently available in English upon request.  Other language 
versions are in preparation. 
10. Proposed date of adoption:   May 2005 
11. Proposed date of entry into force:   June 2005 
12. Final date for comments:  28 March 2005 
Agency or authority designated to handle comments:  [ X ] National notification 
authority, [   ] National enquiry point, or address, fax number and E-mail address (if available) of other body:    
13. Texts available from:  [   ] National notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: