Opinion of the Economic and Social Committee on the "White Paper — Strategy for a Future Chemicals Policy"
Date: 2001-10-17
Institutions: European Economic and Social Committee
Subjects: EU publication, chemical industry, chemical product, competitiveness, consumer protection, environmental protection

8.2.2002

EN

Official Journal of the European Communities

C 36/99

Opinion of the Economic and Social Committee on the ‘White Paper — Strategy for a Future
Chemicals Policy’

(2002/C 36/19)

On 26 March 2001, the Commission decided to consult the Economic and Social Committee, under
Article 175 of the Treaty establishing the European Community, on the ‘White Paper — Strategy for a
future Chemicals Policy’.

The Section for Agriculture, Rural Development and the Environment, which was responsible for
preparing the Committee’s work on the subject, adopted its opinion on 27 September 2001. The
rapporteur was Mr Colombo.

At its 385th plenary session on 17 October 2001 the Committee adopted the following opinion by
70 votes to none, with three abstentions.

1.

Introduction

1.1.
The European Commission has adopted a white paper
setting out the strategy for a future Community chemicals
policy in keeping with the ‘sustainable development’ approach.
The main objective of the strategy is to ensure a high level of
protection for human health and the environment, while
ensuring the efficient functioning of the internal market and
promoting innovation and competitiveness in the European
chemicals industry.

1.2.
The white paper ties in with the initiatives planned
under the ‘Environment 2010: Our future, Our choice’ (1)
programme, adopted by the Commission in January 2001,
which centres on four priority areas: climate change, environ-
ment and health, nature and biodiversity, and the management
of natural resources.

1.3.
A major strand of the environment and health agenda
for the coming years will be the total rethink of the Community
risk management system for chemicals, coupled with the
equally important strategy for reducing the dangers posed by
pesticides.

1.4.
The challenge is to succeed in setting up a risk
evaluation and management system for the chemicals pro-
duced, used and sold, in order to enable society to enjoy the
benefits of their use while reducing their harmful effects and
ensuring that there are no unacceptable risks to human health
or the environment.

1.5.
In the chapter on chemicals in the new Community
environment programme, the Commission clearly identifies
the fundamental problem to be addressed: ‘existing substances’
that were on the market in 1981 when Community chemicals
legislation came into force. In many cases, we are only now

(1) COM(2001) 31 final. Committee opinion OJ C 221 of 7.8.2001.

beginning to understand the risks associated with their use.
Although existing substances account for over 99 % of the
total volume of all substances on the market, they are currently
not automatically subject to the same testing requirements as
those placed on the market since 1981. At that time, there
were approximately 100 000 existing substances; currently
the number of existing substances marketed in volumes of
over 1 tonne is estimated at 30 000.

1.6.
The Commission has already compiled a list of
140 dangerous substances requiring priority attention and risk
assessment. However, the current assessment process is slow
and costly, and does not allow the system to work efficiently
and effectively. The allocation of responsibilities is inappropri-
ate, as the authorities are responsible for assessment, while the
companies producing, importing or using the substances bear
no responsibility. For that reason,
it is difficult to obtain
precise information as to the use of chemicals, and information
on exposure arising from downstream uses is also somewhat
scarce.

1.7.
Decisions on further testing of a given existing chemi-
cal can only be taken via the complex committee procedure
and can only be requested from industry after authorities have
proved that a substance may present a serious risk. Without
test results, however, it is practically impossible to provide such
proof. Final risk assessments have therefore been completed for
only a small number of substances.

The Commission white paper aims to balance the need
1.8.
to protect human health and the environment with the need
to boost the innovative nature and competitiveness of the
European chemical
the Commission
intends to increase transparency by making information on
chemicals more accessible and clarifying the various phases of
the decision-making process for the public.

industry. Meanwhile,

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1.9.
According to the Commission, the system adopted
will help to stimulate innovation and to create a working
framework within which the European industry can compete
with other world competitors on a level playing field. The
Community policy is also designed to dovetail with inter-
national efforts, as chemical production and trade and the
transnational impact of certain chemical substances have made
chemical safety an international issue.

1.10.
The guiding principle is the precautionary principle
and an important objective is to encourage the substitution
of dangerous by less dangerous substances, where suitable
alternatives are available.

2. Gist of the White Paper

2.1.

The key elements of the white paper are the following:

— a single efficient and coherent regulatory framework that
provides equivalent knowledge about the hazards of
substances marketed before and after the September
1981 watershed (‘existing’ and ‘new’ substances) and their
uses, in order to provide a consistent level of protection
for human health and the environment;

— reversal of responsibility for testing and risk assessment
of chemicals, from national authorities to industry;

2.4.
Under the new scheme, a company which places a
particular substance on the market will be responsible for
supplying all the requisite information concerning risks, and
the authorities will be called in to evaluate the data provided
by industry and to decide on substance-tailored testing pro-
grammes following industry proposals. Increased responsi-
bility will also pass to users in the manufacturing chain
(formulators and downstream users) who will be more
accountable and will have to supply data on the particular uses
they make of a substance.

2.5.
The new single system for assessing both existing and
new chemicals is known as REACH (registration, evaluation
and authorisation of chemicals), and it consists of the following
three elements:

— registration of basic information for around 30 000 sub-
stances (all existing and new substances exceeding an
annual production volume of 1 tonne) submitted by
companies in a central database;
it is estimated that
around 80 % of these substances would require only
registration;

— evaluation of the registered information for all substances
exceeding a production volume of 100 tonnes (approxi-
mately 5 000 substances, corresponding to 15 % of the
total) or, in cases of concern, also for substances at lower
tonnage;
the evaluation will be carried out by the
relevant authorities and will include the development of
substance-tailored testing programmes focusing on the
effects of long-term exposure;

— promotion of innovation and competitiveness, without
compromising the high level of protection for the
environment and public health;

— specific authorisation will be required for substances that
are carcinogenic, mutagenic or toxic to reproduction
(CMRs) and persistent organic pollutants (POPs);

— introduction of a tailor-made authorisation system, where
is ensured for the most dangerous

stringent control
substances;

— PBTs (1)

(excluding the above-mentioned POPs) and
VPVBs (2) will be identified through further research. The
Commission will decide at a later stage how substances
with these properties should be treated.

— more transparent and detailed information about chemi-

cals.

The white paper seeks to convert the current dual
2.2.
system, which has differing testing requirements for new and
existing substances, into a single efficient and coherent system
for dealing with the majority of chemical substances.

2.6.
Taking the volume placed on the market as the main
factor, and subject to a series of other conditions, the suggested
deadlines for the submission of registration dossiers are:

— by the end of 2005 at the latest, for substances exceeding

a marketed volume of 1 000 tonnes per year,

2.3.
The strategy addresses the problems inherent in the
current risk assessment and risk management system and seeks
in particular, with the large quantities of existing
to deal,
substances on the market whose effects on human health and
on the environment are unknown.

(1) PBT = substances that are persistent, bio-accumulative and toxic.
(2) VPVB = substances that are very persistent and very bio-

accumulative.

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— by the end of 2008 at the latest, for substances exceeding

a marketed volume of 100 tonnes per year,

— by the end of 2012 at the latest, for substances exceeding

a marketed volume of 1 tonne per year.

2.7.
The Commission proposes to establish a central body
to administer the REACH system, including a central database
containing all the information on registered substances and
chemicals, and to provide the Member States with technical
and scientific support for the evaluation of chemical sub-
stances. This body should also conduct sample checks and
computerised screening of registered substances that give
particular cause for concern.

3. Background

3.1.
In principle, the white paper provides a great oppor-
tunity to break the age-old, deeply ingrained common precon-
ception linking chemical production with danger and pol-
lution. It also provides the framework for an overall review of
the impact of chemical production and use on human health
and the environment.

3.2.
To achieve this objective, all the stakeholders must be
prepared to agree on a framework for evaluation and regu-
latory measures that can strike a balance between the sacro-
sanct concerns of protecting the environment and human
health, and the need to produce chemicals safely, efficiently
and competitively.

3.3.
The strategic importance of the chemicals industry can
be highlighted by a number of key figures. The EU chemicals
industry employs 1,7 million people directly, and over
3 million jobs are dependent on it. It generates net earnings of
EUR 46,4 billion, which amounts to 65 % of the net earnings
of all manufacturing industry. The sector includes both
multinationals and over 36 000 SMEs.

A sector of this strategic importance must be able to
3.4.
respond rapidly to signs of diminishing competitiveness or
social importance. The number of employees in the chemicals
sector fell by 13 % in the 1990s, whereas employment levels
in the USA remained more or less stable. This trend seems to
cast a shadow over Europe’s capacity to maintain its position
as a world leader.

3.5.
It is therefore clear that with the active participation of
the interested parties and an informed public behind it, this
far-reaching, ambitious process could give the European
chemicals industry a chance to dispel the widespread hostility
towards the sector, whose products are essential in a modern
society for the development of increasingly advanced new
processes and technologies. This hostility is worryingly appar-
ent when, for instance, the decentralised authorities come to
consider licences for new installations.

3.6.
It is clear that the challenge to the innovative capacity
of the chemicals industry will have repercussions on many
other chemical-using sectors. The Committee therefore wel-
comes the fact that the Commission has commissioned a study
on the effects which measures subsequent to the white paper
could have on other sectors of the economy. The Committee
reserves the right to comment on the findings of this study in
connection with the legislative proposals triggered by the
white paper.

The Committee also believes it is necessary to devise
3.7.
accompanying measures to reward innovative companies and
encourage the many producer, importer and user SMEs to cut
their use of substances that raise specific health and the
environmental concerns, and to develop substitutes.

4. General comments

4.1.
By definition, the white paper is limited to tracing the
general outline of a future Community strategy in the chemi-
cals field, without providing the detail typical of legislation.
The Committee’s opinion will therefore reflect the nature of
the proposal in question, while nonetheless drawing attention
to certain strategically important elements of the white paper
that deserve greater attention.

The ESC endorses the strategy’s general approach and

4.2.
in particular the fact that:

— it is founded on the principles of sustainability, precaution
and substitution, with a view to safeguarding environ-
mental, user and consumer safety, not least by providing
more information;

— it names innovation as a driving force in the recovery of
competitiveness and the re-launch of a safe chemicals
industry, starting with a major commitment to scientific

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research at Community level,
in order to enable the
chemicals industry to continue to play its vital role in
modern society;

— it is committed to promoting non-animal testing;

— it makes companies (manufacturers,

importers, users)
accountable, as they will carry the burden of the substance
registration process.

4.3.
The Committee notes the conclusions of the Environ-
ment Council of 7 June 2001. In particular, it agrees with the
principle that
the new European chemicals policy must
contribute to sustainable development, securing a high level of
protection for the environment and public health, including
that of workers, and also innovation and competitiveness in
the European chemicals industry. The Committee also supports
the objective of making 2020 the deadline by which only
chemicals that do not have a significantly negative impact on
health and the environment should be produced or used.

4.4.
The white paper’s inadequate mention of workers,
however, gives cause for concern, given that the experience
gained in bargaining between the social partners has secured
major improvements in working conditions and health and
safety in the workplace, as well as considerable progress in the
relationship between factories and local areas, through the
involvement of public authorities.

In the ESC’s view, this experience ought to serve as a
4.5.
major point of reference in the future process, not least
because workers are the first to face the risk arising from
finished products and also intermediate compound products
whose safety credentials are often unknown. In this respect,
the Committee notes that it would be useful to launch a
process of worker education and training, drawing on the
wealth of experience that has been built up on production
sites.

4.7.
The ESC agrees on the vital need — as mentioned in
the introduction — to uphold the precautionary principle and
promote the substitution of certain substances in cases where
reliable scientific data indicate that their use is likely to have
adverse effects on the environment or human health, even if
there is no scientific certainty as to the exact nature or scale of
the potential harm. This will
involve careful cost-benefit
analyses in terms of sustainability. In this respect, the Com-
mittee notes the concerns expressed by environmental and
consumer associations, who feel that the Commission’s pro-
posal is not sufficiently plain on the need to stop producing
chemicals that are known to be toxic, persistent and bioaccu-
mulative. The use of substitutes for dangerous substances
should be promoted wherever a suitable alternative exists.

4.8.
The proportionality principle too should be applied, in
relation both to the intrinsic danger of substances and the
impact on the costs of the individual company having to
supply the documentation required. This principle should
guide the search for flexible formulas that enable the European
chemical industry to maintain its competitive position as a
world leader, without undermining the principle of protecting
human health and the environment.

4.9.
On the basis of the responsibility principle, companies
that produce, import, market or use chemicals will have to
provide the requisite information regarding the properties and
uses of existing substances. This will speed up the pursuit of
the policy objectives listed above, especially if the collection of
that data and information is tied into appropriate schemes.
Such schemes should be the same for all operators in the use
chain (from production to consumption and disposal) and
should use the most advanced tests that technological inno-
vation and the scientific community can offer, to identify
properties that have been proven or are presumed dangerous
for homogeneous categories of substance.

adopting

recommends

The Committee

4.6.
specific
measures to help the 36 000 SMEs in the chemicals sector,
which account for 28 % of European production, to adapt to
the new legislation. The Committee is also of the view that
the Community research programmes planned under the
Vith framework programme should be geared towards provid-
ing adequate support for the white paper’s objectives, starting
with the need to devise proper support
instruments for
research and innovation, in order to speed up the identification
and use of substitute chemicals that do not present any risks
to human health or the environment. More specifically, in
vitro tests should be developed to do away with animal
experimentation once and for all.

4.10.
The Committee supports the Commission’s proposal
(point 8.2) to make the current European Chemicals Bureau
(ECB) into the central body responsible for managing the
REACH system and providing Member States with the necess-
ary technical and scientific support for the evaluation of
chemical substances in particular. This body must be provided
with resources that are commensurate with the new tasks it is
to perform.

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5. Specific comments

5.1.
The white paper (point 3.4) estimates that the collec-
tion and analysis of data on the 30 000 existing substances
produced in quantities of over one tonne will take 11 years,
with a total cost to companies of up to EUR 2,1 billion. The
Commission is still convinced that the adoption of a ‘sub-
stance-tailored’ test is the safest and most efficient way forward.
The Committee would mention however that the interested
parties have all expressed concern that the testing process
will prove too lengthy, complex and burdensome. More
specifically, the use of ‘quantity produced’ as the criterion for
defining the three categories of chemicals to be tested and
registered seems necessary but also inadequate. The danger is
that
it could encourage evasive behaviour, especially for
imports, and neglect the potential risk posed by using even
modest amounts. It would be preferable to divide the sub-
stances up into groups or families, by chemical structure
and/or properties. This could speed up the entire process of
reviewing substances while also cutting costs.

5.2.
The REACH system (point 4) is undoubtedly a step in
the right direction compared with the current convoluted
procedures, as it will secure greater transparency and more
widespread dissemination of
information on the intrinsic
properties of existing chemicals. It remains however a complex
system that will not be easy to manage, in particular given the
diverse competencies and responsibilities of the Commission
and Member States. The Committee also believes further
clarification is required of the concept of ‘increased flexibility’
in relation to the exemptions in point 4.3 for the authorisation
of highly problematic substances. The assessment process
must never undermine the precautionary principle.

5.3.
The Committee is also concerned that the Member
States generally have trouble adjusting their technical, scientific
and administrative structures to Community legislation. In
view of the need to guarantee producers a level playing field
and consumers maximum certainty and information, while
respecting confidential information covered by industrial secre-
cy, the Committee is concerned that the human and financial
resources allocated to the ECB must be commensurate with
the work required of it. These resources must also take into
account the increased adjustments that will be required by
enlargement.

companies must be encouraged to cooperate and to submit
joint dossiers on individual substances, with precise indications
of the uses for which the substance was designed and produced.
The Committee is aware that this proposal could be difficult
to implement from a legal point of view. Nevertheless, with a
view to speeding up the application of the white paper’s
principles, consideration could be given to appropriate forms
of cooperation between major producers, importers and users
of chemical substances that individually do not exceed the
tonnage thresholds, in cases where overall European consump-
tion does.

5.5.
On the subject of imports, the repeated assurance that
as importers are subject to the same obligations there would
be no negative effects on the competitive position of European
companies is not convincing as:

— the EU is a major exporter, so an increase in internal costs
could make exports more difficult and/or encourage
alternative production in countries where safety and
environmental protection are not really a consideration;

— it is not clear whether the obligation concerns each legally
autonomous company or rather the controlling group
(stating the responsibility of a group of companies with
common ownership would reduce the risk of evasive
behaviour);

— it is not necessarily the case that the need to seek less
dangerous substitutes leads to investment in innovation,
if the products to be substituted continue to be marketed
in other regions of the world and if, more generally,
consumers are not made aware of the better health or
environmental performance justifying an increase in the
cost of a product;

— the cost and burdens imposed by the REACH system may
hinder the activities of SME importers, and discourage
the import of small quantities into the EU; this could
have negative effects for competition and employment.

In the Committee’s view, to avoid unnecessary data
5.4.
overlaps (the impact of which on costs is inversely proportion-
ate to the scale of production and the size of the company)

The Committee therefore believes that one of the basic
5.6.
keys to defending the competitive position of the European
chemicals industry is by striving to transfer EU laws to

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international level, with a view to establishing harmonised
regulations. Far from being a marginal aspect of the strategy,
this objective is a cornerstone in the application of the
precautionary principle at world level. An initial positive step
in this direction was the signing of the convention on POPs
(persistent organic pollutants) on 22 May in Stockholm (1).

(1) For the content of the convention, see IP/01/730.

Brussels, 17 October 2001.

5.7.
The ESC is aware of the practical problems that remain
unsolved with regard to translating the broadly acceptable
general policies of the white paper into specific laws. Neverthe-
less, it would stress the need for all the stakeholders to take a
positive stance vis à vis the complexities of the implementation
phase.
intends to monitor the process and make its
own contribution towards a future chemicals industry that
maintains and strengthens competitiveness in a context of
safety and maximum protection for public health and the
environment.

It

The President

of the Economic and Social Committee

Göke FRERICHS

Opinion of the Economic and Social Committee on the ‘Proposal for a Directive of the European
Parliament and of the Council on the approximation of the laws, regulations and administrative
provisions of the Member States relating to the advertising and sponsorship of tobacco products
(presented by the Commission pursuant to Articles 47(2), 55 and 95 of the EC Treaty)’

(2002/C 36/20)

On 3 July 2001, the Council decided to consult the Economic and Social Committee, under Article 95 of
the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Employment, Social Affairs and Citizenship, which was responsible for preparing the
Committee’s work on the subject, adopted its opinion on 3 October 2001. The rapporteur was Mr Fuchs.

At its 385th plenary session held on 17 and 18 October 2001 (meeting of 17 October), the Economic
and Social Committee adopted the following opinion by 50 votes to 18, with seven abstentions.

1.

Introduction

1.1.
The ESC notes that, as part of the move towards the
completion of the single market, the draft Directive under
review is to replace Directive 98/43/EC of 6 July 1998, which
has been annulled by the Court of Justice of the European
Communities (1). The draft Directive is to regulate the advertis-
ing of tobacco products and related sponsorship. The goal is
to harmonise the legal and administrative provisions of the
Member States in order to remove obstacles to the operation
of the single market, thereby ensuring freedom of movement
for goods and services.

(1) Case C-376/98 of 5.10.2000, Germany v. Parliament and Council.

1.2. Most Member States have adopted legislation to regu-
late tobacco advertising and related sponsorship. The scope of
these national
laws varies. Directive 89/552/EC banning
television advertising of tobacco products has, however, been
incorporated into national law by all Member States. In its
proposal the Commission points out that Member States fall
into one of three groups, namely:

a)

b)

c)

states which have introduced limited restrictions on
tobacco advertising: Luxembourg, Sweden, Spain, Greece,
Germany and Austria;

states which have introduced a total ban on tobacco
advertising: France, Italy, Portugal and Finland;

states which are in the process of amending their laws:
United Kingdom, Ireland, The Netherlands, Denmark and
Belgium.