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Project description
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Study
on Impact of the
implementation of Directive 98/8/EC
concerning the placing on the market of biocidal products
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(Study
contract 07010401/2006/443173/MAR/B3)
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Commissioned by:
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European Commission
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Carried out by:
Hydrotox GmbH, Stefan Gartiser
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Co-operation partners:
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Ökopol GmbH, Antonia Reihlen
Risk & Policy Analysts Ltd., Jan Vernon
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Duration:
September 2006 - September 2007
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| 1. Background |
| Directive 98/8/EC (the Directive) governs the authorisation
and the placing on the market of biocidal products in the European
Union. This Directive establishes a 2-tier system where the Community
evaluates and approves active substances, whilst thereafter individual
Member States authorise products containing these substances. A basic
provision of the Directive is the establishment of a positive list
of active substances that may be used in biocidal products without
unacceptable effects on the environment, human or animal health (Annex
I or IA of the Directive). In addition, Member States are obliged
to mutually recognise authorisations and registrations granted by
other Member States. |
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| An evaluation of all so-called existing substances is
to be carried out during a transition period, ending in May 2010.
Details of the work programme are specified in three Review Regulations. |
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| Within the scope of this review programme, it was also
agreed that products containing existing undefended substances which
had not been notified for evaluation shall be removed from the market
by 1 September 2006. Other products containing defended substances
can remain on the market while the substances are being evaluated.
Once the evaluation of an active substance is finalised and a decision
made as to whether or not to include it in Annex I or IA of the Directive,
marketing authorisations must be, as appropriate, granted, modified
or cancelled for products containing that substance. |
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| 2. Objectives of the study |
| Hydrotox, RPA and Ökopol have been selected to
carry out a study on behalf of the European Commission (DG Environment)
to identify positive and negative impacts of the implementation of
Directive 98/8/EC on biocidal products (the Directive). |
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| The purpose of the study is to provide the Commission
with key findings and lessons learned from the implementation of the
Directive, six years after its coming into force and, more critically,
at the turn of 1 September 2006, which was the deadline for removing
from the market all products containing undefended active substances. |
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| The findings and lessons shall also be accompanied by
a set of detailed recommendations to mitigate any unwanted effects
of the implementation of the Directive. |
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| The key objective of the study is to learn from the
main stakeholders, including Member States competent authorities and
industry, the positive and negative impacts of the implementation
of the Directive (impacts on companies business, availability of products,
influence on retail prices of products, effects on competition, etc.).
This will include also a quantitative (number of products available)
and qualitative (adequacy of the products offer to respond to market
demands and specific needs) analysis of the consequences of the removal
from the market by 1 September 2006 of products containing undefended
substances. |
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| A further objective of the study is to analyse whether,
and if so, how the current regulatory framework should be amended
to solve the problems identified, taking into consideration the likely
environmental, economic and social impacts of any amendment. |
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| The findings, lessons and recommendations of the study
will provide a basis for the Commission to prepare its own report
on the implementation of the Directive as required under Article 18(5)
of the Directive and propose, where appropriate, amendments to the
current regulatory framework. |
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| 3. Study approach |
| An analysis of the biocide market will be performed,
with special emphasis on the withdrawal of biocidal products after
the implementation of the Directive in 1998. Several national biocidal
product registers will be evaluated. Additionally stakeholders from
competent authorities, industry, commercial associations, users of
biocides and other experts will be consulted to obtain their general
views on the positive and negative impacts of the Directive and the
reasons why certain active substances have not been defended. The
stakeholder consultation will be supported by tailored questionnaires,
available from the Commission
website. |
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| Following the analytical overview, four case studies
will be selected for further evaluation of the issues identified.
These will cover different product types, companies (SME and large
companies, producers and downstream users) and member states. Due
to the ongoing process of evaluation of active substances the product
types concerned will belong to the first and second priority lists.
The assessment will focus on issues such as the suitability of simplified
procedures, problems experienced by large or SME producers as well
as formulators and any impacts on their competitiveness and economic
viability, the influence of the Directive on competition between R&D-based
producers and generic producers and the impact of non-availability
of suitable Biocidal products on users. Consultation will be supported
by interviews, company visits, and potentially workshops. |
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| Amendments to the Directive, proposed by
Member States or stakeholders in order to address any negative impacts
of the Directive, will be analysed in order to identify their potential
impacts. Key advantages and disadvantages of the amendments, compared
to the current situation, will be described. The overall results of
all three work items will be summarized in a final report. |
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| 4. Time schedule |
| The study began on September 19th 2006 and
has a duration of 12 months. |
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| Contact |
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Expert Advisor in the European
Commission:
Pierre CHORAINE
Environment Directorate-General
Tel. : ++32-2-298-69-33
e-mail: ierre.choraine@ec.europa.eu
http://ec.europa.eu/environment/biocides/ |
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Project Direction:
Stefan GARTISER
Hydrotox GmbH
Tel.: ++49-761- 4 55 12-0
e-mail: gartiser@hydrotox.de
www.hydrotox.de |
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Subcontracted partner:
Dirk Jepsen
Ökopol GmbH
Tel. ++49-40-39 10 02-0
e-mail: 
www.oekopol.de |
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Subcontracted partner:
Jan VERNON
Risk & Policy Analysts Ltd.
Tel. ++44-1508-52 84 65
e-mail: jan@rpalon.demon.co.uk
www.rpaltd.co.uk |
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