Opinion of the European Economic and Social Committee on Chemicals legislation — REACH
Date: 2005-07-13
Institutions: European Economic and Social Committee
Subjects: administrative formalities, chemical industry, chemical product, economic consequence, environmental risk prevention, marketing, product safety, scientific report

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Opinion of the European Economic and Social Committee on Chemicals legislation — REACH

(2005/C 294/08)

On 14 December 2004 the Bureau of the European Economic and Social Committee, acting under the
implementing provision for Rule 29 of the Rules of Procedure, decided to draw up an opinion on ‘Chemi-
cals legislation — REACH’.

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 16 June 2005. The rapporteur was
Mr Braghin.

At its 419th plenary session, held on 13 and 14 July 2005 (meeting of 13 July), the European Economic
and Social Committee adopted the following opinion by 52 votes to two with two abstentions.

1. Background

1.1
Since the publication of the proposal for a regulation
establishing a European Chemicals Agency and a procedure for
the registration, evaluation, authorisation and restriction of
chemicals (REACH) (1), there has been a wide-ranging debate
involving the EU institutions, national authorities, the chemical
industry, other industrial sectors, trade union organisations,
and numerous NGOs.

1.2
A number of suggestions which the Committee made in
its earlier opinion (2) have received interesting follow-up in the
ongoing debate, particularly as regards:

— the need for a series of

the proposal's impact on certain sectors;

further studies to assess the
following:
the
scale and consequences of any withdrawal of critical
substances from the market; the establishment of strategic
implementation projects; and the
partnerships for pilot
impact on the new Member States;

— the need to simplify the obligations placed on companies,
and to reduce costs in order to avoid loss of competitive-
ness or company relocations, whilst
safeguarding the
priority objective of safeguarding health and the environ-
ment;

— the case for fine-tuning and strengthening the role of the
Agency, and ensuring adequate representation of all the
interested players.

1.3
Two studies undertaken in the context of the Memor-
andum of Understanding between the Commission and UNICE-
CEFIC have given a clearer picture of the problems faced by
particular
studies
showed that although some of the fears voiced initially were
excessive, concerns still remain and further efforts are needed
to make the system more effective and coherent.

sectors. These further

industrial

impact

The main findings of the Business Impact Case Study
1.3.1
undertaken by KPMG Business Advisory Services (3) are as
follows:

— There is limited evidence that higher volume substances are
vulnerable to withdrawal following the REACH registration
requirements. Lower volume substances (under 100 tonnes)
are most vulnerable to being made less or non-profitable by
the 152 substances
the REACH requirements. Out of
assessed in detail, only 10 substances were found to be
vulnerable to commercial withdrawal as they became less
or non-profitable.

— There is limited evidence that downstream users will be
faced with a withdrawal of substances of greatest technical
importance to them. These substances will be registered,
sometimes in spite of commercial vulnerability.

— The one-off costs of registration for chemicals suppliers can
in some cases be significant and may result in the rationali-
sation of portfolios by chemicals suppliers. This effect
would mainly relate to substances which are not considered
by chemical suppliers to be technically critical
to their
customers.

— If a substantial withdrawal of substances occurred,

the
extent and costs of reformulation and re-engineering could
be significant (not least because of the need for studies,
tests and user validation).

— The costs will mainly be absorbed or passed on, but may be

more difficult for SMEs.

— The impact of REACH on innovation is uncertain. There is
no evidence, for the cases investigated in the study, that
research and development (R&D) resources will automati-
cally be diverted due to REACH, nor are increases in R&D
expected.

(1) COM(2003) 644 final of 29.10.2003.
(2) OJ C 112 of 30.4.2004.

(3) KPMG, Business Impact Case Study REACH, presented on 28 April

2005.

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— Companies have recognised some business benefits from
REACH which include: better information about substance
properties and dangerous components in preparations,
easier risk management and rationalisation of substance
portfolio.

more per year) and for substances currently classified as
CMR (5) category 1 or 2; a six-year phase-in period for
substances manufactured or imported in quantities of 100
tonnes or more; and an 11-year phase-in period for those
manufactured or imported in quantities of one tonne or more.

— Concerns were expressed about specific workability and
confidentiality problems. Some concerns were expressed by
formulators and downstream users that chemical producers
might not want to include certain uses in their registration
dossier.

— Users of inorganic substances (and of raw materials in par-
ticular) need further clarifications about the REACH regis-
tration provisions.

The study on new Member States (4) shows that aware-
1.3.2
ness of REACH remains limited and identifies the following key
points:

— Substantial increases in costs are only anticipated in a few

cases.

— The direct costs to be borne in specific cases could be high
in relation to turnover or in terms of erosion of profit
margins.

— A few substances are felt to be vulnerable as they already

have limited profit margins.

— Companies depending on non-EU eastern markets will be

the hardest hit.

1.4
The findings of these studies and the ongoing debate
have highlighted various aspects which the economic operators
involved feel are of critical importance. The Committee wishes
to make a further contribution to this debate, in close coordina-
tion with the work being done at the Council and the European
Parliament.

2. Registration criteria and timeframes

The proposed regulation removes the current artificial
2.1
distinction between ‘existing substances’ (those already declared
to be on the market in September 1981) and ‘new substances’
(those put on the market after that date). Article 5 establishes
an obligation to register substances on their own or in prepara-
tions which are manufactured or imported in quantities of one
tonne or more per year (second paragraph of Article 5(1)). The
regulation also establishes the principle that substances may
not be manufactured in the Community or imported unless
they have been registered (Article 19(1)).

2.2
Transitional provisions are laid down for the 30 000 or
so substances currently manufactured or put on the internal
market, which are to be phased in to the registration system
according to the quantities produced or imported by the indivi-
dual company (Article 21). The transitional provisions establish
a three-year phase-in period for the registration of substances
manufactured or imported in larger volumes (1 000 tonnes or

(4) JRC-IPTS, Contribution to the analysis of the impact of REACH in
the new European Member States, presented on 28 April 2005.

(5) Carcinogenic, mutagenic or toxic for reproduction.

This volume-based approach has been questioned on a
2.3
number of grounds, first and foremost that registrations cannot
be distributed over time according to the actual risks of the
individual substance concerned. A risk-based priority would be
more justified in scientific and economic terms, but defining
the priority substances would require an iterative procedure to
identify the intrinsic hazard and the risks related to exposure in
order to arrive at an assessment and thus to manage the risk.

2.4
The Committee therefore considers that although a
prioritisation system based on volume is rather rough (as noted
in its earlier opinion (6)), it provides the most practical way of
attaining the desired objectives and replacing the present
system, which is universally agreed to be inefficient. The
proposed system also covers substances of very high concern
such as CMR category 1 and 2. The approach adopted by the
Commission, which is based on volume (a rough indicator of
potential exposure) but which also considers intrinsic hazard,
should thus prove easier to apply, more transparent and better
able to guarantee operators sufficient legal certainty.

3. Regulatory simplification

3.1
The Committee thinks that the concerns (if not fears) of
many operators stem at least partly from the highly complex
and rather opaque structure of the proposed regulation. This
comment applies particularly to operators in sectors which do
not produce chemicals in the strict sense of the term, and to
importers, SMEs and downstream users who sometimes lack
the technical facilities and expertise to describe, when required
to do so, their particular uses and the management of the
related risks. The length of the technical annexes is a further
barrier to a full understanding and application of the REACH
system.

The Committee therefore hopes that, in the light of the
3.2
opinions and amendments taken on board during the first
reading, the Commission will also strive to make the regulation
more reader-friendly and consider reordering its chapters and
articles. Firstly, more precise definitions are needed in order to
clarify the scope of the regulation and the category exemptions,
as well as the registration deadlines and the different require-
ments for different tonnages.

Once the obligations incumbent on manufacturers and
3.3
importers according to production volume and processes have
been clarified, other more complex aspects will also become
clearer (e.g. mechanisms for data sharing, information responsi-
bilities and arrangements along the supply chain, and the
commitments and responsibilities of downstream users).

(6) OJ C 112 of 30.4.2004, point 3.3.2

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3.4
The Committee also suggests that a distinction should
be made regarding those annexes which by their very nature
do not form part of the legislative provisions (e.g. Annex X).
These annexes should still receive explicit mention and thus
provide a practical point of reference, but should be drawn up
jointly by authorities and experts from the sectors concerned,
using the model of the BAT and BREF (7) systems under the
IPPC directive. Making this daunting body of technical informa-
tion simpler and clearer will help to secure an accurate evalua-
tion of the efforts and costs facing companies. Such a distinc-
tion would also speed up adaptations to technical and scientific
progress and simplify procedures.

3.5
The Committee appreciates the Commission's effort to
draw up practical guidelines in its REACH Implementation
Projects (RIPs). It believes that such instruments are crucial for
the practical feasibility of the proposal, as they will enable
operators and authorities to become fully conversant with the
mechanisms of the system.

3.6
The Committee asks for a further effort to involve indus-
trial associations, trade unions and other sectoral organisations
with a view to securing effective cooperation on the ground
between authorities, businesses, professional organisations and
trade unions. This should help to ensure effective implementa-
tion of the system. In this context, the Committee advocates
the development of support structures such as the national
help desks which the Commission is considering at present.

4. Pre-registration

Article 26 establishes a duty to pre-register: each poten-
4.1
tial registrant of a substance coming under the REACH system
must submit the specified information to the Agency at least
18 months before (a) the three-year deadline set for quantities
of 1 000 tonnes or more, or (b) the six-year deadline for quan-
tities of one tonne or more. Downstream users and manufac-
turers/importers of quantities of
less than one tonne may
contribute to the sharing of data if they so wish.

4.2
The information required under Article 26(1) provides a
sufficient basis for encouraging the sharing of data about indi-
vidual substances, and thus possible agreements for the joint
submission of data and of the tests to be carried out (thereby
reducing costs). However, the Committee considers that this
information is not sufficient for assessing the potential risk of a
substance and hence for devising new prioritisation criteria for
registration purposes. This would require a more complicated
set of data involving more time, more costs and more red tape,
which could prove too much for small producers and impor-
ters, and for the Agency that would have to deal with them.

(7) BAT (Best Available Techniques) and BREF (BAT reference docu-
ments): these are documents drawn up by the EU office in Seville
which is responsible for implementing Directive 96/61/EEC on inte-
grated pollution prevention and control (IPPC). The documents are
drawn up jointly by Community experts and stakeholders.

4.3 When considering the various proposals under discus-
sion, the Committee thinks that preference should be given to
those which safeguard the basic objectives and the currently
proposed deadlines (thereby avoiding uncertainty and confu-
sion among the operators involved) and those which the case
studies suggest will be less burdensome for the most vulnerable
operators.

5. Recommendations for an effective, manageable REACH

system

In order to work effectively, the registration mechanism must
specify clearly:

1. the substances covered by the proposed system;

2.

its scope,
in particular by specifying the criteria and the
categories to be exempted (at present these are mentioned
in several different articles of the regulation;

3. the obligations regarding the flow of information between
(both

importers and downstream users

manufacturers,
industrial and professional) of the same substance;

4. the mechanisms and incentives for forming consortia.

Definition of the term ‘substance’. The case studies have
the

5.1
confirmed that
substances (especially inorganics) covered by REACH.

there is considerable uncertainty about

The Committee is pleased that a specific REACH Implementa-
tion Project (RIP) is being conducted to clarify for authorities
and businesses the substances which will in fact come under
the REACH system.

5.2
Scope. It would be useful to draw up a summary in table
form to provide operators with precise details of the exempted
categories, particularly of those which are already regulated by
existing Community legislation; this would help to guarantee
attainment of REACH's health and environmental protection
objectives. The Committee agrees that overlaps and duplication
of obligations must be avoided, and trusts that precise indica-
tions will remove any lingering doubts on this matter.

5.3
Flow of information. The REACH system can only work
effectively if there is an adequate flow of information between
upstream and downstream operators. Without this two-way
flow, which should also take place between different manufac-
turing sectors,
it would be impossible to take the right
measures to manage risk and protect workers, consumers and
the environment. The Committee agrees that the manufacturer/
importer should assess the exposure scenarios and risks for
‘identified uses’, when required, acting in good faith and with
‘due diligence’; these are clear concepts that are firmly estab-
lished in legislation and case law.

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5.3.1
The Committee stresses that the Agency's data on the
substances registered, and later on those that have been
assessed, should be made available to economic operators in
general (currently they are only to be provided for manufac-
turers,
importers and users of a specific substance, for that
substance alone), and to workers' representatives and other
categories who might find them useful (medical, security, emer-
gency services, etc.). Any confidential or commercially sensitive
information should be removed before these data are passed
on.

5.4
Data sharing. The proposal states that a substance infor-
mation exchange forum (SIEF) may be set up for manufacturers
and importers of the same phase-in substance, to enable them
to pool their information. The Committee supports this, and
the underlying objective of minimising duplication of tests,
including non-animal testing.

5.5
The Committee stresses the need to avoid duplication of
tests, not only in the case of experiments on animals. A
concerted effort should be made to develop QSAR-type (Quan-
titative Structure-Activity Relationship) screening and assess-
ment models, and alternative methods and tests that do not
involve animals, devising procedures for speeding up their vali-
dation and, if possible, enabling them to be used before the
competent bodies give definitive formal approval.

5.6
Cost effectiveness. The application of the system must
expressly strive to reduce the costs borne by companies, so as
to be consistent with the objectives of the Lisbon strategy and
sustainable development, which the Committee has always
supported. The fundamental challenge of REACH is to marry
the goal of competitiveness with that of health and environ-
mental protection. In particular, care must be taken to ensure
that registration costs do not weigh excessively on particular
segments of the supply chain or on sectors that face particu-
larly stiff competition or are structurally weak.

5.7
It has been calculated that 60 % of the direct costs of
registration relate to the tests. The Committee therefore stresses
the great importance of mechanisms to encourage companies,
on a voluntary basis, to conduct tests jointly and share their
results. A fair, harmonised system to ensure that those who use
previously or jointly collected data bear their share of the costs
is also very important.

5.8
the
The Committee therefore suggests that some of
guidelines on costs should be amended, as they do not appear
sufficient or fair, particularly as regards:

by several firms belonging to a consortium. A more signifi-
cant reduction would be desirable;

— the sharing of the costs of animal testing between forum
members (second paragraph of Article 28(1), and Article
50(1)). It does not seem fair to share the costs equally,
without considering their respective production volume.
The Committee thinks that it would be fairer to use criteria
related to turnover of
the substance concerned or the
volumes sold over the preceding three years;

— the 50 % share of the animal-testing costs sustained by
previous registrants (Article 25(5) and (6)) seems even more
unjust. For a late registrant, such a threshold could prove
an insurmountable barrier to market entry.

6. Comments on the proposals being discussed at the

Council

Among the proposals under discussion,

the OSOR
6.1
system (‘one substance, one registration’) proposed by the UK
and Hungary has received some backing and has been widely
debated within the Council. The principle can be supported, as
such a system would radically reduce the number of tests
needed and avoid a lot of duplicate studies, but doubts remain
about the scope for its practical application.

6.1.1
problems in this system as regards:

The Committee notes some weaknesses and unsolved

— safeguarding of confidentiality (which is difficult to guar-
antee without assigning the task to third parties working on
behalf of a pool of companies), given the proposed obliga-
tion to share data (it is the sharing that is obligatory, not
the establishment of consortia);

— the intrinsic complexity of a system that seeks to cover all
operators who handle a given substance, if only because it
would include operators in all Member States and would
thus inevitably pose language problems;

— the number of companies taking part in several SIEF, even
if this difficulty is allayed by the scheduling of three pre-
registration phases based on tonnage;

— the long time that it will presumably take for the designated
experts to reach an agreement on what data are to be
passed on from the various sets of shared ‘core data’, not
least because the inclusion of one test rather than another
could have significant economic consequences for
the
company by virtue of the cost-sharing mechanism;

— the reduction of the registration fee; this fee is modest in
the case of small volumes but becomes considerable for
larger ones. Article 10(2) currently proposes that the fee be
reduced to one-third when the same set of data is submitted

— the joint submission of the dossier (or the reference to a
joint dossier), which could lead to a shedding of responsi-
bility on the part of the individual operators involved.

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6.1.2 Moreover, the OSOR system makes no provision for
(and offers no guarantee of the possibility of) the sharing of
work to ascertain exposure and risk characterisation and
management, when required, as this would be difficult if not
impossible for different types of operator to agree on. This
would suggest a need for partly separate registrations, which
runs counter to the principle underpinning OSOR.

6.2
The recent proposal by Malta and Slovenia regarding
substances in the 1 to 10 tonne category is designed to simplify
the system and reduce costs for firms (often SMEs) concerned
with this tonnage band. It does not alter basic features of the
regulation such as the tonnage brackets and deadlines, and
proposes operating arrangements that appear simple and flex-
ible.

6.2.1

The main proposals are:

— simplification of the registration requirement, based on the
information available on the substance and its use, with a
simple basic set of essential information (including physico-
chemical and (eco)toxicological data);

— simple mechanisms for describing exposure:

— main categories of use (industrial/professional/consu-

mers),

— main conditions of exposure;

— the quantities of dangerous substances released, even unin-
tentionally, may be very high, and their release may vary
significantly depending on how the articles are processed or
used, or when they are discarded;

— identifying which substances released may ‘adversely affect
human health or the environment’ (Article 6(2)) would be
difficult in the absence of a specific risk assessment;

— the presence of CMR, PBT or vPvB substances (listed in
Annex XIII) is not necessarily reported to the authority or
subject to registration;

— EU manufacturers of articles who are subject to the REACH
system throughout the supply chain will be at a disadvan-
tage vis-à-vis their direct competitors outside the EU, who
will only be subject to it as regards dangerous substances
released in articles;

— information on the content of dangerous substances in arti-
cles is important in the purchase and marketing of the arti-
cles themselves, not least for consumers, but the proposed
regulation makes no provision for this.

6.3.1 With a view to securing the health and environmental
objectives of the system without unduly increasing red tape
and costs, the Committee endorses the following proposed
measures:

— nature of exposure (accidental/infrequent; occasional;

continuous/frequent);

— obligation to provide information downstream in the
supply chain, to professional users and users/consumers of
articles;

— prioritisation criteria (defined by the Agency) to apply auto-
matically if two or more of the conditions listed in the rele-
vant annex occur together;

— regular (five-yearly)

flexible review,

to take account of

experience acquired with previous applications.

6.2.2
The Committee is pleased that this proposal retains
the same volume-based deadlines as the Commission proposal,
and that supplementation of the information provided and/or
of that on the tests scheduled under Annex V is only required
when the Agency suggests that this is advisable. The presence
of the prioritisation criteria triggers a check which may lead
the Agency to ask for further information and tests about
specific aspects or, if there are serious concerns about the risks
posed by the substance, to begin the evaluation procedure.

6.3
The Swedish proposal on substances contained in arti-
cles deserves particular attention, if only because of the wide-
spread concern about the practical application of Article 6. It
highlights a number of important points:

— the definition of the term ‘article’ is too vague to allow a

distinction between different types of article;

— registration of substances of particular concern,

indepen-
dently of the quantities included in articles, and registration
of dangerous substances if they are present in quantities of
more than one tonne, if they are added intentionally and
are identifiable as such in the article;

— obligation for the Agency to provide structured information
on the use of substances in articles, and its right to ask for
further information to manufacturers/importers of articles
regarding unregistered substances or
those covered by
Article 54(f);

— a right to know the dangerous chemicals contained in an

article, also for professional users;

— a ‘guiding list’

released unintentionally,
under observation.

for dangerous substances which can be
identifying the types of article

The Committee also supports the proposal to bring
6.3.2
forward the application of Article 6 if a series of phases and
voluntary agreements are respected which demonstrate its prac-
tical applicability, as suggested by the sector's stakeholders.

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6.4
Lastly, the Committee reiterates the need to strengthen
the role of the Agency, as noted in its earlier opinion (8). It
therefore endorses the French proposal (Shape the Agency for
Evaluation — SAFE), and particularly the idea of making the
Agency responsible for the three types of evaluation (of the
testing proposals, of
the
the dossiers
substances themselves) envisaged in the draft regulation, and
giving it direct responsibility for the ‘rolling plan’ covering
substances that need priority evaluation.

submitted, and of

a registration obligation, but it is not known which substances
will be involved and in what volumes, or, therefore, the related
registration commitments and deadlines. The most
recent
impact studies show that the registration costs could signifi-
cantly affect these firms' competitiveness and the continued
market presence of some substances. The Committee hopes
that this aspect will be carefully monitored, not least bearing in
mind the likely adverse impact downstream.

7. Impact on the supply chain

7.1
The Committee thinks that further study is needed of
the supply chain and of the differing consequences for its
various parts. The substances covered by the regulation are
used cross-sectorally, and the same firm may be both a manu-
facturer and downstream user. In other words, a firm may have
more than one REACH role, as manufacturers/importers and
downstream users.

7.1.1
Chemical substances and preparations are used in all
production processes. However, the registration burden rests
with the direct supplier, or is transferred up the supply chain,
unless the downstream user puts the substance to an unenvi-
saged use and has not given the supplier prior notification of
this.

7.2
In order to try to pinpoint the different kinds of diffi-
culty facing operators, it is helpful to single out six main types
of operator, with different roles in the supply chain:

— manufacturers/importers of basic chemicals;

— large non-chemical manufacturers;

— SMEs that manufacture chemicals requiring registration;

— formulators;

— non-chemical manufacturing SMEs;

— importers of chemicals or articles.

7.3 Manufacturers/importers of basic chemicals (e.g. ethy-
lene and butadiene) are relatively few in number and handle
large volumes. They are thus likely to come under the first
registration deadline, but the costs will have a relatively minor
impact on their turnover.

7.4
Large non-chemical firms (particularly the iron and steel,
paper and cement industries) are both downstream users —
using a host of substances and preparations in the manufac-
turing process — and manufacturers/importers, according to
the current definition of substances. In the absence of a more
precise definition of exempted substances (which would be
desirable), they will mainly be involved in registrations for the
first deadline.

During the drafting of

7.5
the
Committee has obtained new data regarding SMEs which
manufacture chemicals and compounds requiring registration.
Despite this, available data do not give a full or detailed picture
of the situation. It is clear that several thousand SMEs will face

the present opinion,

(8) OJ C 112 of 30.4.2004, point 3.2.

Formulators (i.e.

7.6
the firms that blend the individual
substances) use a number of substances to make a single
preparation, and are involved in the registration of substances
that have not been purchased on the internal market. The
studies conducted have confirmed that formulators are particu-
larly concerned about the disclosure of data and information
that could reveal manufacturing secrets; more particularly, indi-
cation of the code for each substance used in a preparation
would reveal its formulation, jeopardising competitiveness. The
Committee suggests that this requirement should only apply to
substances that are classified as dangerous.

7.6.1
Formulators are therefore likely to be the main down-
stream users concerned by Article 34(4), which requires down-
stream users to prepare a chemical safety report (Annex XI) for
any use not envisaged in the exposure scenario communicated
to them in the safety data sheet provided by the supplier of the
raw materials used in their preparations. Formulators will also
have to meet the obligation (contained in the existing legisla-
tion) to prepare a safety data sheet for the preparations they
market, when these are classified as dangerous under Direc-
tive 99/45/EC.

Non-chemical manufacturing SMEs are mainly down-
7.7
stream users, likely to make only minor use of substances (the
registration burden for which in any case lies with the manu-
facturer/importer) but more frequently of preparations. They
will be able to refer to the safety data sheet or chemical safety
report
if required, which will enable them to make more
controlled use of the substances and manage the risk more
effectively. The economic burdens for this category of business
will mainly be indirect, involving substantially new administra-
tive and bureaucratic obligations.

7.8
As stated in point 3.6, the Committee hopes that indus-
trial associations, trade unions and other sectoral organisations
will be able to play an active part in monitoring and simpli-
fying the implementation processes. They can carry out an
information role that will help to ensure full compliance with
the regulation and encourage operators
to join specific
consortia.

8. Health and safety

The impact assessments conducted so far have concen-
8.1
trated mainly on the costs and feasibility of the REACH system.
There have been fewer, if any, quantitative assessments of the
benefits for health and safety in the workplace, and for health

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purposes. However,
it would like to see the development of
further instruments and measures. In particular, it suggests that
chemical research be explicitly included in the 7th framework
programme, on which discussions are now starting, and that
specific incentives for innovation and technology transfer be
considered, with a view to encouraging the development of
substances that pose fewer potential risks.

The two recent case studies do not anticipate a dramatic
9.2
diversion or reduction of R&D resources. However, some
impact will certainly be felt, in the absence of an increase in
research investment. This, in tandem with the increase in costs,
could lead to a drop in innovation capacity and hence in
competitiveness. As this could be particularly severe for SMEs,
the Member States too should support research in these compa-
nies, taking advantage of the new rules on state aid for SMEs.
The fact that the companies questioned did not appreciate the
information
anticipated
campaign is needed on REACH's potential benefits, which
could at least partially offset the inevitable burdens.

opportunities

suggests

that

an

replacement would be desirable. The

9.3
REACH's impact on the production system is likely to
bring new opportunities for those companies that are most
attentive to market developments, giving the more flexible and
efficient businesses the possibility to win new shares of the
market and offer new solutions for the most critical substances
whose
experience
acquired will also create a competitive advantage when other
areas of the world have to adjust to production standards that
are more respectful of human health and the environment. Nor
should one overlook REACH's impact on research associated
with the need for new knowledge (analytical chemistry,
computer modelling,
toxicology, new testing methods,
sampling and measuring techniques, new application software).

Lawmakers

9.4
and political decision-makers must be
mindful of these processes so as to ensure that all Community
policies are consistent with, and facilitate achievement of, both
the competitiveness/ innovation and environmental protection
objectives required under the Lisbon strategy. The Committee
hopes that a thorough, ongoing debate between the competent
authorities and stakeholders will help to frame effective policies
and instruments that will work alongside market mechanisms
to promote an innovative chemicals industry that is also atten-
tive to protection of health and the environment.

The President

of the European Economic and Social Committee

Anne-Marie SIGMUND

environment

and the
in general. Many operators have
complained that REACH will be excessively onerous, and have
called for substantial changes. However, some sectors and large
commercial chains have welcomed the proposal, despite the
costs and the administrative work it will demand.

8.2
The Committee's earlier opinion mentioned the added
value of the system in terms of the quality and safety of
production processes and products. It recommends that these
aspects be pursued further, not least in relation to the Environ-
ment and health action plan (9). The Committee is pleased that
some specific studies have been scheduled on this, such as the
Trade Union Technical Bureau for Health and Safety's study on
the impact of REACH on occupational health (skin diseases,
respiratory diseases).

8.3
The directive on the safety of workers already contains
provisions for establishing exposure scenarios and the safe
its practical application is
handling of substances. However,
sometimes less than satisfactory. In extending the information
available, REACH marks a step forward for protecting the
health and safety of workers in all production sectors. The
availability of more detailed and better documented safety data
sheets and chemical safety reports for dangerous substances
will certainly help to improve the situation, bearing in mind
that they will cover a larger number of substances and will be
more widely disseminated among economic operators.

Another neglected aspect which deserves serious atten-
8.4
tion concerns the training and skills needs of
the various
members of the supply chain (operators and workers), and the
implications in terms of
transparency and information for
consumers. The Committee calls for an active policy on this,
with training schemes for workers and mechanisms for making
non-confidential
information available, as suggested above.
Implementation of REACH will undoubtedly lead to develop-
ments on these fronts, but specific measures should be planned
with a view to ensuring maximum effectiveness.

9. Innovation

One of the aims of the REACH system is to stimulate
9.1
treatment
innovation. The Committee welcomes the equal
given to new substances,
five-year
the
(renewable) exemption from registration for substances in the
research stage and the increase in the volumes for notification

and especially

Brussels, 13 July 2005.

(9) OJ C 157 of 28.6.2005.