Opinion of the European Economic and Social Committee on the (COM(2003) 644 final - 2003/0256 COD - 2003/0257 COD)
Date: 2004-03-31
Institutions: European Economic and Social Committee
Subjects: Community certification, EU office or agency, chemical product, environmental risk prevention, scientific report

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Opinion of the European Economic and Social Committee on the

— ‘proposal for a Regulation of the European Parliament and of the Council concerning the Regis-
tration, Evaluation, Authorisation and Restriction of Chemicals (Reach), establishing a European
Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent
Organic Pollutants}’ and the

— ‘proposal for a Directive of the European Parliament and of the Council amending Council
Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of
the Council concerning the registration, evaluation, authorisation and restriction of chemicals’

(COM(2003) 644 final - 2003/0256 COD - 2003/0257 COD)

(2004/C 112/24)

On 8 December 2003 the Council decided to consult the European Economic and Social Committee,
under Article 95 of the Treaty establishing the European Community, on the above-mentioned proposals

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 4 March 2004. The rapporteur was Mr
Braghin.

At its 407th plenary session (meeting of 31 March 2004), the European Economic and Social Committee
adopted the following opinion with 129 votes in favour, no dissenting votes and two abstentions.

1.

Introduction

1.1 Over the last thirty years, control of chemicals has stea-
dily been transferred to Community level. The first Community
in this field was Directive 67/548/EEC on the
instrument
approximation of rules relating to the classification, packaging
and labelling of dangerous substances. Alongside these rules,
the directive also made provision for a future requirement to
information on chemicals placed on the
provide further
market (1). The sixth amendment to this directive (contained in
Directive 79/831/EEC) introduced a procedure for the notifica-
tion of ‘new substances’,
i.e. substances first placed on the
market after 18 September 1981. The seventh amendment
(contained in Directive 92/32/EC) laid down uniform principles
and rules for the notification procedures.

The legislation was subsequently extended to cover the
1.2
determination, evaluation and control of the risks of both new
and existing substances. The basic principles for this were laid
down in Council Regulation 793/93, as supplemented by Regu-
lation 1488/94 in the case of existing substances and by Direc-
tive 93/67/EEC in the case of new substances.

The Chester Environment Council in April 1998 decided
1.3
that the existing legislation should be reviewed in order to
develop a new coherent and integrated approach to chemicals
policy in line with the precautionary and sustainability prin-
responsibilities
ciple, with an appropriate distribution of
between the parties involved in the control of chemicals. The
matter was discussed again by several subsequent Councils. The
Commission, working in the broader context of the sustainable
development espoused by the Helsinki European Council
in
December 1999, then put forward its white paper on chemi-
policy
cals,

chemicals

Strategy

entitled

future

for

a

(1) OJ 196 of 16.8.1967, p.1.

(COM (2001) 88 final). The white paper was drawn up jointly
by the Environment and Industry DGs, so as to take balanced
account of both the competitiveness objectives of the chemicals
industry and environmental protection requirements (2).

1.4
The new system envisaged in the white paper (termed
REACH: Registration, Evaluation, Authorisation of Chemicals)
involved a uniform regulatory framework for both existing and
new substances, based on three elements: registration, evalua-
tion and authorisation of substances with hazardous properties.
The overriding aim was to guarantee a high level of protection
for human health and the environment. To this end, the onus
and responsibility of providing appropriate information and an
initial risk evaluation was transferred to the manufacturer/
importer and,
to downstream users. The
system was to be introduced within a precise timeframe, giving
precedence
and to
substances produced in particularly high quantities.

to particularly problematic products

in specific cases,

2. Key points of the proposal

2.1
The present proposal for a regulation and a directive
therefore aims to replace the existing legislation because the
Commission thinks that it is inefficient, not conducive to inno-
vation and unable to guarantee sufficient protection for human
health and the environment. The new system is designed to
meet five key objectives:

— to establish a coherent registration system that progressively
covers both new and existing substances, over a differen-
tiated timeframe of around ten years from the entry into
force of the new regulation;

(2) EESC opinion: CESE 1327/2001 of 17 October 2001 in OJ C 36 of

8.2.2002.

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— to move the burden of risk assessment from government
agencies to the producing/importing companies, who at the
same time remain responsible for providing complete infor-
the substance
mation dossiers on the characteristics of
which they intend to register;

— to include downstream users in requests to supply informa-
tion and in the testing of substances, when necessary and
appropriate;

— to introduce an authorisation procedure for hazardous

substances;

— to ensure greater transparency and openness for the public
by providing easier access to information on chemicals.

2.2
The proposal seeks to simplify the complex existing
legislation on the use of chemicals and enshrine it in a single
instrument. This will entail the repeal of a number of existing
directives and regulations. The proposal is based on the above-
mentioned REACH system obliging companies which produce
or import more than a tonne of a chemical per year to register
it on a single central database. Producer and importer firms will
have to supply not only technical information on the proper-
ties, uses and safe handling of substances (as already required
under existing legislation), but also on their safety and on
management of the risk to man and the environment. This
information will then have to be passed on in the successive
stages of the production chain, so that users can use or market
the substances responsibly and wisely and without risking the
health of workers, final consumers or the environment.

2.3
The proposal as it now stands was drafted with involve-
ment of all interested parties. The process included an internet
consultation, beginning in May 2003 and lasting two months,
on an initial draft regulation. This yielded some 6000 opinions,
from all the parties concerned. On the basis of the various
views expressed, the draft was amended to produce the present
version. The requirements have been simplified in accordance
with the quantities produced or imported. In the Commission's
view, the direct and indirect costs of implementation will there-
fore be considerably lower than previously forecast.

2.4
A new European Chemicals Agency will manage the
substances database, receive the registration dossiers, and be
responsible for providing the public with non-confidential
information. The agency will have a number of committees
with differing roles, and a board of appeal.

2.6
The dossiers will be evaluated by competent authorities
set up by the Member States, who will check their compliance
with the registration requirements (which vary according to the
quantities produced or imported), the animal testing conditions,
and the quality and completeness of the assessments of the risk
for human health and the environment. The substance evalua-
tion programme will be based on a rolling plan prepared by
the relevant national authority, using the priority criteria set by
the Agency.

2.7
Substances which cause particular concern, such as
CMRs, PBTs, vPvBs (1), and other substances with serious and
irreversible effects on health or the environment, will require
authorisation for specific uses by the Commission. Authorisa-
tion will only be granted if the use of the substance can be
properly controlled; otherwise an analysis will be made of the
level of the risk, the socio-economic importance and the exis-
tence of substitutes, in order to ascertain whether authorisation
is justified. In order to ensure that the risks are acceptable,
restrictions can be introduced following a proposal from the
Commission or a Member State, according to the procedure set
out in Article 130. These restrictions can include a ban on use.

the sector,

To safeguard the competitiveness of

the
2.8
current version of the proposal has reduced the number of test
requirements and made them less complex than in the initial
version (which reflected existing legislation), particularly as
regards substances with volumes between 1 and 10 tonnes. A
number of substances are being exempted, including polymers
and some intermediaries, and the rules for downstream users
have been simplified. The Commission proposes that safety
information may be exchanged in the form of safety data
sheets (SDS). These sheets are already used in the existing legis-
lation, but they are now being modified. The new measures
should help companies achieve
the desired results with
minimum cost.

2.9
Innovation should be encouraged by raising the current
threshold for new substances, exempting quantities between 10
kg and 1 tonne from the test requirements, making it easier for
downstream users to find new innovative substances, and
extending to 10 years (15 in the pharmaceutical sector) the
exemption period for substances at the research stage.

These measures have significantly reduced the esti-
2.10
mated costs – both the direct costs to industry and the indirect
costs, which are much lower than the anticipated benefits for
human health.

All substances of which more than a tonne is produced
2.5
or imported in a year must be registered. The Commission
thinks that for around 80 % of these, no further action will be
required.

(1) Substances that are carcinogenic, mutagenic or toxic to reproduc-
tion (CMRs), substances that are persistent, bio-accumulative and
toxic (PBTs) and substances that are very persistent and very bio-
accumulative (vPvBs).

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3. General comments

3.1
The Committee reiterates its view that sustainable devel-
opment and protection of health and the environment should
be among the EU's priority objectives. The Committee's earlier
opinion on the white paper thus supported the introduction of
the REACH system and endorsed its objectives, including the
move to make manufacturers, importers or users responsible
for preparing documentation on chemicals with a view to regis-
tration and an initial risk assessment. The Committee also
supported the establishment of an EU registration system and
of a Community body to manage it. The Committee recognises
that the regulation proposed by the Commission has identified
the right objectives and that it will reduce the requirements for
registering new substances; these requirements are viewed as
one reason why so few new substances have been registered in
Europe in the last twenty years. The new regulation should
thus encourage innovation. At the same time, however, it will
form a significant undertaking not just for the chemicals sector
but for the production system as a whole.

3.1.1
The EU economy is going through a period of modest
growth, and legislative initiatives that could threaten competi-
tiveness, industrial growth and jobs must therefore be scruti-
nised very carefully. As many stakeholders have pointed out,
the impact assessment available does not definitively establish
that the proposed REACH system strikes an effective costs/
benefits balance. The Committee agrees that as far as possible
and bearing in mind the need to fulfil safety requirements, the
competitive capacity of the EU chemical industry must not be
hampered, as the industry is a world leader and is a key sector
in almost all Member States. The repercussions for all the other
production sectors which use chemical substances and prepara-
including sectors that might
tions must also be addressed,
appear to be less affected (e.g.
iron and steel, textiles, engi-
neering, electronics) and those in which SMEs could face
special difficulties, bearing in mind the new dimension of the
25-member Union.

The Committee urges that consideration be given to
3.1.2
amendments to the regulation that help to simplify procedures.
In this context,
the dialogue with stakeholders which was
launched very fruitfully in the extended consultation process in
2003 should be continued, so as to safeguard legitimate health
protection requirements and the equally legitimate require-
ments of competitiveness and employment. To this end, the
Committee calls
to
promote development and innovation opportunities. Such
measures are particularly necessary for SMEs, as the costs of
the REACH system could eat into a significant percentage of
their turnover.

for more effective practical measures

3.1.2.1
The Committee notes and endorses the initiatives
launched by the Commission and the European Chemicals
Bureau as part of an ‘interim’ strategy pending finalisation of
the legislative instruments by the European Parliament and the
Council. The strategy includes involvement of stakeholders in
the preparation of more user-friendly technical guidance docu-
ments, more detailed impact assessments for specific sectors,

and the formation of strategic partnerships for pilot imple-
menting projects. Having acquired direct knowledge of experi-
ence in this field in North-Rhine Westphalia, the Committee
applauds this approach and hopes that it will be involved in it
too. It reserves any further comments until the results of the
pilot stage are known.

Regulatory simplification,

3.1.3
the possibility of a more
rapid evaluation based on more extensive knowledge, and the
provision of more detailed information on the characteristics
and risks inherent in the production and use of chemicals
throughout
the production chain could all have beneficial
effects: productivity could increase and there could be positive
spin-off for the whole development of environmental legisla-
tion (1). A competitive advantage could also be secured: such an
advantage is obvious in the case of the waste treatment sector,
or other sectors which manufacture products for the final
consumer, provided there are appropriate mechanisms (e.g. a
label recognisable to the consumer) to act as a form of market
recognition and ‘reward’ for manufacturers who adapt to envir-
onmental and consumer health protection legislation. These
objectives must be pursued expressly, and could become opera-
tional
if EU standards are adopted internationally following
targeted action by the Community authorities. To achieve this,
a constructive dialogue will also be needed with the relevant
authorities, economic operators and the world of work,
together with an information and education policy for the final
consumer.

3.2 The European Chemicals Agency

3.2.1
The Commission proposes the establishment of a Euro-
pean Chemicals Agency to manage the technical, scientific and
administrative aspects of the REACH system and ensure the
consistency of the evaluation and decision-making process at
Community level. Under the proposal, the Agency is to provide
criteria to guide Member States' selection of substances for
evaluation and will also issue opinions and recommendations
in the authorisation and restriction procedures, as well as
giving guidelines on data confidentiality.

3.2.2
The Committee fully endorses the decision to set up an
Agency rather than merely extending the duties of the Euro-
pean Chemicals Bureau within the Joint Research Centre (as
had been proposed in the white paper). However,
the
Committee feels that the powers and responsibilities assigned
to the Agency are too limited. According to the Commission
proposal, its role is solely to provide scientific and/or technical
advice, while the operational management of
the system
appears to be largely left to the Member States, who are to
operate on the basis of guidelines, opinions and recommenda-
tions from the Agency. The Committee wonders whether under
such a system it will be possible to select evaluation priorities
in a truly effective and consensual manner, and ensure that
every decision draws on the wider spectrum of competences
and specialisations presumably to be found in the Agency's
committees.

(1) For example the water framework directive, the IPPC directive, and

the directives on hazardous waste.

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(which the proposal

The example of the European Agency for the Evalua-
3.2.3
tion of Medicinal Products
rightly
considers as the most similar body) shows that analysing
to strike a fair balance
dossiers centrally makes it easier
between differing viewpoints, while national agencies – espe-
cially when faced with a new responsibility – have a tendency
to apply the precautionary principle. The Committee believes
that it is both possible and desirable to harness the national
authorities in a network in which they can continue to carry
out well coordinated and jointly defined operational duties. The
experience of the European Chemicals Bureau confirms that
involving local authorities in a network and giving them
responsibilities is important for establishing a consensus in the
decision-making process.

3.2.4
The Committee therefore thinks that the new Agency
should be given precise duties and responsibilities in a number
of areas: for setting the criteria for deciding evaluation priori-
ties; for drawing up opinions on authorisation requests; for
participation in the adoption procedure for restrictions on
some dangerous substances and preparations; and for drawing
up proposals for EU harmonisation of classifications and label-
ling. The tasks and membership of the Agency's bodies (the
management board, committees, forum and board of appeal)
will have to be revised in the light of this new definition of
duties and responsibilities.

In particular,

the Committee does not

3.2.5
think that
setting up a body made of national representatives is the best
way of settling disputes or dealing with appeals arising as a
result of divergences between national
authorities. The
Committee advocates
establishment of a forum for
collecting and disseminating useful information, updating data-
bases, and providing technical assistance for the relevant autho-
rities and businesses (especially small firms). This forum should
include scientists and experts chosen by the Agency, inter alia
from the industry.

the

authorities where necessary or

3.2.6
In general, the Committee hopes that the Agency will
be structured and financed in such a way that it can immedi-
ately assume full responsibility for evaluation, albeit involving
and drawing on the expertise and staff of
the competent
national
appropriate but
without a priori
limiting its powers and responsibilities.
Pending the establishment of the Agency, the Committee also
in conjunction
hopes that the European Chemicals Bureau,
with national and local authorities and stakeholders, will be in
a position to verify the smooth operation of the processes
devised during pilot schemes or in specific fields.

3.2.7
In particular, the Committee points out the inadequacy
of the provisions in Article 105 for involving stakeholders,
which merely mention ‘contacts’ with representatives of
industry, consumer protection, worker protection and environ-
mental protection organisations.

3.3 The registration system

3.3.1
The regulation requires companies which manufacture
or import one tonne or more of a chemical to submit a tech-
nical dossier to the competent authorities containing informa-
tion on the substance and a preliminary report on the
determination and reduction of the risk. For volumes of 10
tonnes or more, 100 tonnes or more and 1000 tonnes or
more, there is an increasingly tight scale of requirements for
the tests to be used for drafting the report.

3.3.1.1
Companies are likely to have to develop new tests
and knowledge about substances according to their importing
and manufacturing needs, and hence their registration require-
ments, and use this knowledge to ensure that any possible risks
are managed in a responsible and well informed manner. They
will also have to inform downstream users of the risks involved
in such uses, and these users will only have to produce a
chemical safety evaluation if the product is to be used for a
purpose other than the one foreseen.

3.3.1.2
The registration system will undoubtedly require
significant commitment of time and resources, especially for
importers and downstream users who have not had to fulfil
similar obligations in the past. However, the new system is
vital for protecting human health and the environment, and for
the proper operation of the single market. Moreover, it could
give the most innovative companies and those best able to
adapt to the new market conditions the opportunity to extend
their market.

There is a certain logic in requiring speedier action and
3.3.2
more extensive information when larger volumes of chemicals
are produced/imported; this approach is simple, and can be
applied directly. However, it is not necessarily the best way of
identifying real risk, either in terms of intrinsic hazard or of
exposure. Retaining a criterion (that of volumes) which the
Committee has already described as too rough could involve
unjustified costs for companies (1).

3.3.3
The practical application of the system could be made
more flexible, as regards the complexity of the dossier which
every manufacturer/importer must submit in their registration
application, and with a view to pinpointing substances which,
although produced or imported in quantities of less than 10
tonnes, require a more thorough risk analysis. This flexibility
could be achieved by making use of the analyses of intrinsic
hazards and of the information on use and exposure that is
already available or easily obtainable from data already in the
possession of manufacturers and authorities, and also by
drawing on existing knowledge and analysis of structural affi-
nities with known problematic or dangerous substances. The
Committee calls on the Commission to explore this avenue as a
way of fine-tuning the operation of the REACH system.

(1) See the Committee's earlier opinion on the white paper, point 5.1.

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3.3.4
The Commission proposes a series of rules on data
availability, with a view to reducing animal testing and the
costs for companies. In particular, the most important data can
be shared, subject to payment of a fee. Assistance will also be
provided to find other registrants to exchange data with.
However, this mechanism does not appear to have sufficient
support nor to be able to encourage alliances, other than
between partners who already cooperate or are already tied to
each other for supply reasons.

animal

Although the

concern to reduce

testing
3.3.5
deserves support, this is only one aspect of the problem. More
effective systems should be put in place for reducing if not
eliminating unnecessary duplication of dossiers and tests,
including analytical and in vitro tests. To this end, arrange-
ments should be devised for encouraging cooperation between
manufacturers, importers and downstream users, with mechan-
isms for sharing out costs in a way that is fair and that can also
be borne by SMEs. The Committee thinks that it would be
worth considering forms of assistance for the preparation of
dossiers and encouraging interested parties (especially down-
stream users and SMEs) to form groupings on a voluntary
basis, while guaranteeing the safeguarding of intellectual and
industrial property rights.

3.3.6
Provision is made for information all along the produc-
tion chain, both upstream and downstream, with the sheet
required under Annex I replacing the safety data sheet currently
provided under Directive 91/155/EEC. The two-track system
that will
for a number of years may pose
problems for the smooth operation of the single market.

inevitably exist

3.4 Evaluation (Title VI)

3.4.1
Evaluation – of both the dossier and the substances –
is to be conducted by the Member States. The task of the
just be to develop criteria for prioritising
Agency will
substances for evaluation and to intervene in the event of
evaluation differences between Member States. During the start-
up period in particular, the fact that a Member State's evalua-
tion mechanism has to be approved by other Member States by
means of a written procedure could slow matters down consid-
erably, and perhaps even lead to cross-vetos.

sions are extremely important. The Committee therefore thinks
that it should primarily be the job of the Agency, albeit in
close cooperation with the relevant national authorities, as this
would ensure speedier action, a more consistent approach and
the involvement of wider competences.

3.4.2.1 Giving this task to the Agency does not mean
wresting power from the relevant national authorities:
the
Agency's specialist and political bodies should draw up evalua-
tion priorities and give the national authorities the task of
the specific evaluation activities. The national
carrying out
authorities
a
substance be evaluated if they so wish, explaining why they
take this view and then including it in the centralised decision-
making process.

could always propose

independently

that

the current proposal

3.4.3 One shortcoming of
is that,
except in the case of particular substances that have already
been singled out, it makes no explicit provision for the evalua-
tion of possible interactions and accumulation processes which
might render the use of certain chemicals more dangerous. The
Committee thinks that rather than being left up to companies,
this aspect should be included in the Agency's operating
programmes, in cooperation with the relevant national authori-
ties.

An unforeseen threat could be posed by substances,
3.4.4
preparations, products and articles imported from regions of
the world that conceivably do not have adequate controls and
do not respect the GLP required for compiling the data that are
to be supplied for registration and risk evaluation. The compe-
tent authorities should be particularly attentive to this,
inter
alia so as not to give an undue competitive advantage to non-
EU producers.

The Committee calls for clearer identification of the
3.4.5
responsibilities of manufacturers,
importers and downstream
users – in the form of specific provisions if necessary – in
order to deal with cases in which they fail to meet the regula-
tion's requirements regarding documentation, risk evaluation
and measures to ensure more controlled and safer use.

3.5 Authorisation

A precondition for using substances safely and mini-
3.4.2
mising the risk to people and the environment is the avail-
ability of scientifically sound data that have been collected in a
uniform manner and validated (i.e. undergone a control process
– the evaluation provided for in Title VI), with a solid analysis
of the costs/benefits ratio in specific uses. The first stage in
determining the risk is the establishment of a chemical safety
report, which is now to be the responsibility of the manufac-
turer/importer (whereas in the present system it is up to the
competent authority), together with the provision of substance
data. The ensuing dossier and substance evaluation procedure
is a delicate and complex matter, based on the information
provided by manufacturers/importers, and the resulting deci-

that

3.5.1
The aim of the authorisation system is to guarantee
the smooth operation of the single market and ensure that the
use of substances of particular concern is properly controlled
these substances are replaced by safer alternative
or
substances or technologies. The Committee endorses this aim,
and therefore agrees that
the producer/importer should be
required to supply further data in order to show that the risks
can be controlled or that they are outweighed by the socio-
economic benefits. The Committee also agrees that authorisa-
tion should be granted for a single specific use, so that use can
be controlled more effectively and so that downstream users
can be properly informed.

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3.5.1.1
The Committee thinks that in any event the authori-
sation should apply for a limited time. It therefore suggests that
after five years a further evaluation and ensuing authorisation
be undertaken, if necessary, as is the case with other authorisa-
tion procedures. This would stimulate innovation for the devel-
opment of safe alternatives and would encourage application of
the substitution principle as a first alternative for dangerous
chemicals.

be affected (the paints and varnishes, pigments, tanning, timber
and furniture, synthetics, electrical and electronic appliance
industries would seem to be particularly hit by the cost of the
documentation to be supplied) and in SMEs, as these are often
dependent on a single supplier and thus lack bargaining power
for obtaining data under economically acceptable conditions.
Without further investigation and a clear regulatory framework,
unfairness could arise in the abovementioned cases and in
similar ones.

3.5.2
The restrictions laid down in the authorisation must be
introduced across the whole EU and must be independent of
production/import volume, so as to avoid any serious risk to
health or the environment. The Committee agrees that a recast
version of Directive 76/769/EEC should provide the starting
point for the new procedure regarding restrictions, but calls for
early action to update the lists of dangerous substances in cases
where there is a sound scientific basis for so doing.

the

that

The Committee points out

3.5.3
legislation
governing the protection of the health and safety of workers
from the risks related to the use of chemical substances should
continue to apply and to be developed, without prejudice to
REACH. Consideration should doubtless be given to deter-
mining the extent to which it would be possible to incorporate
provisions to this effect into the REACH legislation and to
enhance its compatibility with Council Directive 98/24/EC,
which sets out obligations to carry out assessments, in consul-
tation with the parties concerned.

3.5.4
The Committee thinks that other substances with risks
equivalent to those of CMRs, PBTs and vPvBs (already identifi-
able with clear, objective criteria and thus included in Annex
XIII) should be taken into consideration as soon as the risks are
identified, and should be subject to the authorisation process
independently of the quantities used.

3.6 Downstream users

3.6.1
The Committee approves the move to oblige down-
stream users to consider the safety of their uses of substances,
primarily on the basis of information from their supplier, and
to take appropriate risk management measures. They are
required to notify any new use which had not been envisaged
(and therefore documented) by the supplier. For this require-
ment to be feasible, especially for SMEs, the supplier must have
completed his registration and must provide the downstream
user with non-confidential data regarding the substance. A
weakness of the current proposal is that the producer/supplier
is not likely to have to provide a complete set of information.
This could place an excessive burden on the downstream user
when it comes to obtaining documentation. The Committee
thinks that this aspect, and the possibility of having recourse to
the Agency, need further clarification if the implementing costs
of the new system really are to be kept down.

3.6.2
In this context it would be helpful to hold a series of
seminars or conferences with interested parties to check on the
situation, both in the production sectors that are most likely to

3.7 Data sharing

3.7.1
The Commission proposes a number of measures for
sharing the data collected and avoiding unnecessary animal
testing. The Committee supports this objective and agrees that
new registrants should be able to use these data, either by
making a direct payment to the originator or via an arbitration
board. However,
the proposed
measures are not specific enough: the provisions for the use of
shared data need to be fleshed out in order to ensure fair condi-
tions for all operators, especially SMEs.

the Committee thinks that

the

The

supports

Committee

pre-registration
3.7.2
mechanism for firms that are preparing for a registration, so as
to enable them to share the data already available, provided
that there is a guarantee that confidential information will not
be disclosed. It also supports the setting-up of ‘substance infor-
mation exchange fora’ (SIEF), whose role could extend beyond
the currently proposed aim of avoiding duplicate animal
testing.

3.8 Worker information and training

The Committee thinks that the information provided
3.8.1
by the REACH system is essential for evaluating and reducing
risks relating not only to health and environmental protection
but also to the health and safety of workers in the workplace.
This information is thus extremely important for the conduct
of any professional activity.

3.8.2
Experience built up in recent years in the chemicals
sector, through regular dialogue between the social partners,
shows that the availability and proper use of this information
has enabled the sector to achieve a lower level of workplace
accidents and environmental damage than other sectors.

3.8.3
In the light of this fruitful experience, which has not
been widely reported, the Committee stresses the added value
of providing workers and their representatives with any useful
the chemical
information obtained from the evaluation of
safety of a substance or preparation and contained in the safety
data sheets. The Committee therefore hopes that the fruitful
experience in the chemicals sector will be extended to down-
stream sectors,
training
programmes for workers and their representatives, building on
the protection instruments laid down in existing legislation on
dangerous substances and promoting more harmonised appli-
cation thereof.

for example by means of special

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3.9 Impact assessment

The Commission's figures for the direct and indirect
3.9.1
costs of the system over the next ten years have been criticised
by various parties as being too low. The Committee notes the
new evaluation which takes account of the changes made to
the earlier draft document following consultations. The impact
assessment has thus been expressly updated and should be
more realistic. However, a number of imponderables remain,
particularly as regards indirect costs, downstream users, and the
impact on the new Member States.

3.9.2
The Committee therefore asks the Commission to
launch a specific debate on this with the various sectoral orga-
nisations at EU and national level, particularly in those sectors
which private studies suggest will be particularly affected by
the new regulation. The Commission should thus be able to
ascertain whether
its analysis is justified and review any
measures that prove to be excessively burdensome.

The Committee is concerned about

3.9.3
the possible
economic impact and asks the Commission to make a more
detailed assessment of this, bearing in mind the importance of
the use of chemicals across all sectors of
the economy,
including agriculture and services. The Committee also asks the
Commission to give more thought to the potential impact on
the acceding countries.

3.9.4
It is thought that the new system will encourage inno-
vation, and it is certainly true that some of the measures will
make it easier to identify and market more new substances.
The Committee therefore approves these changes. In general,
however, it considers that the mechanisms (which are mostly
automatic) designed to encourage innovation are still
too
generic, and that not enough has been done to gauge the
impact in quantitative terms.

At

first sight

3.9.5
the costs/benefits ratio appears very
favourable, especially in the health field. However, it must not
be forgotten that while the costs are borne directly by
economic operators, the benefits will generally be felt elsewhere
or by society as a whole, and over a longer period than the
costs. This may well explain many of the negative reactions
and concerns voiced. To counter these, action is needed on two
fronts. Firstly, efforts should be made to achieve a broader
consensus, backed up by sectoral analyses (quantitative and
otherwise). Secondly, a pro-active policy must be adopted to
safeguard competitiveness, making the EU legislation a bench-
mark for other areas of the world. This calls for targeted action
by the Commission in all international forums.

4. Conclusions

4.1 Whilst the Committee supports the objectives and appli-
cation of the REACH system, it thinks that particular attention
must be paid to the implementing arrangements, with a view

to ensuring that the new legislation (however opportune) does
not jeopardise the competitiveness and growth of the industry
and hence aggravate employment problems. This requirement,
which relates to the drive to pursue socially, economically and
environmentally sustainable development,
takes on a more
concrete aspect in the present instance, as the impact assess-
ment does not establish a proven balance between costs and
benefits.

impact

The political commitment to provide legislation safe-
4.2
for all
safety and environmental
guarding health,
chemical users and for the general public has to be met
without damaging the competitiveness of the industry. The
Committee therefore calls on the Commission, the European
Parliament and the Council to give serious consideration to any
amendment that could help to simplify procedures, cut red
tape and thus reduce the attendant costs, continuing the
consultations with stakeholders with this aim in mind.

4.3
The Committee also recommends devising measures to
inform interested parties, and particularly SMEs and down-
stream users, of the content of the regulation and the changes
introduced. This should help to counter the present negative
attitude which does not
fully appreciate the advantages of
simplifying existing chemicals legislation, having a swifter and
more efficient evaluation (with fewer risks and ensuing respon-
sibilities), and easier application of environmental
legislation
(on emissions, waste, worker safety, etc.).

Similarly, it must be explained that the annexes contain
4.4
implementing instructions, generic guidelines, and technical
and scientific provisions regarding research and experiment
methodology; they do not increase red tape but make the regu-
lation easier to apply, nor are they any more voluminous than
the annexes to the existing legislation. Where legally possible, it
might
to introduce a clear distinction
between those annexes that are to have legal force and those
which can be used as an ‘operator's guide’ or guideline for
experts. These latter annexes could then be more easily updated
in the light of technical and scientific progress.

therefore be useful

The Committee appreciates the method used by the
4.5
Commission to draw up the proposal, which has involved
extensive consultations.
the consultation and
It hopes that
involvement of stakeholders will continue so that the text can
be further improved, notably by:

— making any alterations that help simplify procedures and
therefore reduce costs, without changing the objectives
being pursued;

— extending and strengthening the tasks of the future Euro-
pean Chemicals Agency (in particular in the dossier and
substance evaluation procedure – Title VI) so that
it
becomes the hub of the new system, in close and construc-
tive cooperation with the competent national authorities;

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Official Journal of the European Union

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— modifying the duties and membership of

the Agency's
bodies so as to ensure balanced representation of
the
various responsible parties and bring in Europe's top scien-
tists;

— setting up instruments and methods to prevent unnecessary
duplication of dossiers and tests, and help reduce animal
testing, and devising mechanisms to ensure a fair distribu-
tion of costs;

— clarifying the distribution of duties between manufacturers/
importers and downstream users, as some of the chemicals
produced/imported are subsequently purchased by busi-
nesses that market mixtures for a variety of uses;

— drawing up a support plan for SMEs and downstream users
in particular, to facilitate the implementation of the REACH
system and the setting-up of groupings for this purpose;

— finding more specific automatic instruments to encourage
innovation and the identification and marketing of new
substances.

4.6
The Committee stresses the need for a more detailed
impact assessment, in particular as regards indirect costs, the
costs for some key downstream user sectors, and the potential

Brussels, 31 March 2004

impact on the acceding countries, with a view to ascertaining
whether the criticisms made of the studies conducted to date
are justified.

Lastly,

4.7
the Committee calls for a vigorous political
campaign to promote the provisions of the REACH system
worldwide, pressing home their essential role in protecting
public and worker health and the environment and, last but
in defending the competitiveness of the European
not least,
chemicals industry.

the pilot

The Committee welcomes

4.8
implementing
schemes and practical trials already being conducted in some
Member States and involving regional authorities and other
interested parties, with a view to simplification and a more
concrete impact assessment. The Committee also welcomes the
work being done by the Commission and the European Chemi-
cals Bureau, together with stakeholders, to draw up sectoral
the REACH
guidelines for the practical
system. The Committee thinks that when drawing up the final
legislative instruments, all the EU institutions should make use
of the experience obtained during this interim stage. It reserves
the right to issue an additional opinion assessing the results of
the present exercise.

implementation of

The President

of the European Economic and Social Committee

Roger BRIESCH

APPENDIX

to the opinion

(Rule 39 of the Rules of Procedure)

The following amendments, which received at least one quarter of the votes cast, were defeated in the course of the
debate:

Add a new point 3.4.4, as follows:

‘In order to ensure the reliability of the information made available in respect of registered chemical substances, it
is, in the EESC's view, vital to have an appropriate system of quality assurance. Such a system can be established (a)
by means of internal quality assurance measures introduced by the economic players, backed up by external certifi-
cation or (b) by independent experts. This will enable data and supporting documentation to be qualitatively
comparable and useable throughout Europe, thereby making it possible for the authorities to hand over to the
enterprises part of their responsibility for carrying out checks.’

Vote:

For: 27 Against: 64 Abstentions: 13