WORLD TRADE
ORGANIZATIONG/SPS/N/EEC/213
4 September 2003
(03-4630)
Committee on Sanitary and 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 C – Air quality, Climate change, Chemicals & Biotechnology
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable):  All active substances 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 (EC) and third countries exporting the
products concerned to the EC.
5. Title, language and number of pages of the notified document:   Draft Commission
Regulation (EC) No …/... of [...] 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 biocid al products on the market, and amending
Regulation (EC) No 1896/2000.  (113 pages, available in English (text and annexes),
Danish, German, Greek, Spanish, French, It alian, Dutch, Portuguese, Finnish, Swedish
(text only).
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 pos sible 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, is:
(i) sufficiently effective
(ii) has no unacceptable effects on the target organisms, such as unacceptable resistance
or cross-resistance or unnecessary suffering and pain for vertebrates
(iii) has no unacceptable effects itself or as a result of its residues, on human or animal
health, directly or indirectly (through dr inking water, food or feed, indoor air or
consequences in the place of work) or on surface water or groundwater,
(iv) has no unacceptable effect itself, or as a result of its residues, on the environment
having particular regard to the following considerations:G/SPS/N/EEC/213
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- its fate and distribution in the environment, particularly contamination of surface
waters (including estuarian and seawater), groundwater and drinking water;
- its impact on non-target organisms
(v) the nature and quantity of its active substances and, where appropriate, any
toxicologically or ecotoxicologically significant impurities and co-formulants, and itsresidues of toxicological or environmental significance, which result from authorised
uses, can be determined according to the relevant requirements in Annex IIA, IIB,
IIIA, IIIB, IVA or IVB to the Directive
(vi) its physical and chemical properties have been determined and deemed acceptable for
purposes of the appropriate use, storage, and transport of the products
Regulation 1896/2000 established the first phase of this review programme. The new draft
Regulation establishes all necessary provisions for the second phase. For substances notnotified, no dossiers will be provided to allow their evaluation. It is therefore not possible
to demonstrate that their continued use meets the requirements established by Directive
98/8/EC and their marketing and use will have to be phased out after a period of grace of 3
years, unless a complete dossier will be prepared during that period of grace. The draft
Commission Regulation provides for the detailed rules for the implementation of thesecond phase of the programme of work for the systematic examination of all active
substances already on the market in biocidal products when Directive 98/8/EC entered into
force (on 14 May 2000).
Annex I contains the exhaustive list of existing active substances (i.e. those used in biocidal
products on 14 May 2000 in the EC).
Annex II contains the list of notified existing active substances (i.e. those for which
operators will prepare comprehensive dossiers allowing for the evaluation of the safety of
their use regarding human health and the envi ronment with a view of their inclusion into
one of the Annexes of the Directive. The Regulation further lays down all necessary details
regarding the submission of dossiers, including the schedule for their submission andevaluation (Annex V).
Annex III contains the list of ‘only-identified’ substances (i.e those for which, at the current
time no operator expressed an interest to prepare a dossier or have them included in theAnnexes of the Directive). Marketing and use of these substances for biocidal purposes will
have to cease as of 1 September 2006. However if operators deem this necessary in the
future, they can prepare dossiers for these substances and request inclusion into one of the
Annexes of the Directive at a later stage.
7. Objective and rationale:  [  X ] food safety, [ X ] animal health, [   ] plant protection,
[ X ] protect humans from animal/plant pest or disease, [   ] protect territory from other
damage from pests.
8. International standard, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection Convention, [ X ] None
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:G/SPS/N/EEC/213
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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
(OJ L 123, 24.4.1998, page 1)
Commission Regulation 1896/2000 on the 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)
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
10. Proposed date of adoption:   End October 2003
11. Proposed date of entry into force:   Mid November 2003
12. Final date for comments:  24 October 2003
Agency or authority designated to handle co mments:  [ X ] EC notification authority,
[   ] National enquiry point, or address, fax number and E-mail address (if available) of
other body:
13. Texts available from:  [   ] National notification authority, [ X ] EC enquiry point, or
address, fax number and E-mail address (if available) of other body: