WORLD TRADE
ORGANIZATIONG/TBT/N/EEC/32
29 August 2003
(03-4541)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated 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:  0032 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 [    ], 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
used 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 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) No 1896/2000. (113
pages, in English (text and annexes), Dani sh, German, Greek, Spanish, French, Italian,
Dutch, Portuguese, Finnish, Swedish (text only)
6. Description of content:   The draft Commission Regulation provides for the detailed rules
for the implementation of the second 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 and
evaluation (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 the
Annexes of the Directive).  Marketing and use of these substances for biocidal purposes willG/TBT/N/EEC/32
Page 2
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, 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 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 theirpossible 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:
- 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
its residues of toxciological or environmental significance, which result from
authorised uses, can be determined acco rding 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 not
notified, no dossiers will be provided to allow their evaluation.  It is therefore not possibleto 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 three years, unless a complete dossier will be prepared during that period of grace.G/TBT/N/EEC/32
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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, p. 1).
Commission Regulation 1896/2000 on the first phase of the programme referred to in
Article 16(2) of Directive 98/8/EC on bicodial products (OJ L 228, 8.9.2000, p. 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
9. Proposed date of adoption:  End October 2003
Proposed date of entry into force:  Mid November 2003
10. Final date for comments:   60 days from the date of notification
11. Texts available from:  National enquiry point [  X ] 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:  0032 2 299 80 43,
E-mail:  ec-tbt@cec.eu.int