Opinion of the European Economic and Social Committee on the Proposal for a Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 COM(2007) 355 final — 2007/0121 COD
Date: 2008-03-12
Institutions: European Economic and Social Committee
Subjects: approximation of laws, dangerous substance, environmental protection, health policy, labelling, packaging

9.8.2008

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Official Journal of the European Union

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Opinion of the European Economic and Social Committee on the Proposal for a Directive of the
European Parliament and the Council on reciprocal recognition of navigability licences for inland
waterway vessels (Codified version)

COM(2008) 37 final — 2008/0021 (COD)

(2008/C 204/12)

On 13 February 2008, the Council decided to consult the European Economic and Social Committee, under
Article 80(2) of the Treaty establishing the European Community, on the

Proposal for a Directive of the European Parliament and the Council on reciprocal recognition of navigability licences for
inland waterway vessels (Codified version)

Since the Committee unreservedly endorses the proposal and feels that it requires no comment on its part,
it decided, at its 443rd plenary session of 12 and 13 March 2008 (meeting of 12 March) by 121 votes in
favour and 6 abstentions, to issue an opinion endorsing the proposed text.

Brussels, 12 March 2008.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS

Opinion of the European Economic and Social Committee on the Proposal for a Regulation of the
European Parliament and of the Council on classification, labelling and packaging of substances and
mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006

COM(2007) 355 final — 2007/0121 COD

(2008/C 204/13)

On 13 July 2007 the Council decided to consult the European Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the

Proposal for a Regulation of the European Parliament and of the Council on classification, labelling and packaging of
substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006

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 26 February 2008. The rapporteur was
Mr David Sears.

At its 443rd plenary session, held on 12 and 13 March 2008 (meeting of 12 March), the European
Economic and Social Committee adopted the following opinion by 124 votes in favour with 2 abstentions.

1. Summary and recommendations

trade and to assist less developed economies in their efforts to
protect the safety and health of workers and consumers.

The UN, acting on behalf of its member countries, has
1.1
proposed a model for a ‘globally harmonised system’ (GHS) for
the criteria and processes used in the ‘classification, packaging
and labelling of chemicals’. This is intended to support world

1.2
The EESC strongly supports this aim of global harmoni-
sation, the form and legal basis of the implementing legislation

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hereby proposed by the Commission, and the timetable
proposed for implementation by manufacturers and suppliers to
coincide with the first major deadline for the registration of
‘substances’ under Regulation (EC) 1907/2006 (REACH).

1.3
The EESC also agrees with the Commission's assessment
that, although the changes to the system developed in the EU
over the last 40 years are both inevitable and widely supported,
the short term benefits within the EU are likely to be negligible
and the costs potentially high. The EESC therefore believes that
greater attention should have been paid to these, quite unusual,
circumstances in the original impact assessment. In the absence
of any significant overall benefit, any addition or modification
to existing legislation that is not absolutely essential to imple-
menting the UN proposal should be accompanied by a separate
health, safety or economic justification. Above all, every effort
must be made to ensure that existing standards are not compro-
mised during the inevitably long transition period between
these two largely equivalent systems. Education at the point of
purchase will be a key requirement.

1.4
The EESC also believes that, given the very tight time-
table, and the need to contain start-up costs, there is scope for
flexibility in the proposal and in its immediate application. It
has taken many years to develop the current system to a point
where it properly protects the health and safety of workers and
consumers across the EU and it is likely to be the same for the
new globally harmonised system. What is key, however, is to
commit sufficient long term resources at both the UN and in
the Commission to ensure that the process of harmonisation
continues — and that this eventually extends to the actual clas-
sification and labelling of widely traded goods as opposed to
merely the criteria upon which these classifications are based.

the length of

The EESC notes, with concern,

1.5
this
proposal, by itself and in conjunction with recent proposals
such as REACH, the many other pieces of EU legislation with
which these both interact, and the ever growing volume of
guidance notes now deemed necessary. A new approach is
essential if European industry (let alone the processes of moni-
to be irretrievably
toring or amending legislation)
damaged. It is simply not reasonable to assume that everyone,
from the owner of the smallest SME to the typically larger
groups of responsible officials in a national competent authority
should have to routinely refer to more than 20 000 pages of
interlinked documentation on these topics alone. A better way
has to be found.

is not

uncontentious in content. It provides a great opportunity to
correct mistakes at the detail level. This is already happening in
the technical appendices. The provision of a standard set of defi-
nitions, applicable across all the related legislation should be
tackled forthwith,
leading eventually to a glossary of the key
words in all languages, identifying those that mean the same
(presumably ‘chemical’, ‘chemical substance’ and ‘substance’) and
those that either have different meanings or are unrelated
for instance.). Cultural confusions or
(‘article’ and ‘product’,
associations,
in some languages, with the words ‘substances’
(taken to mean drugs, alcohol or tobacco) and ‘chemicals’ (as
indications of terrorist or other illegal activities) should also be
identified and avoided.

1.7
The EESC also notes the twin dangers of over-classifica-
tion and over-labelling which eventually diminish the impact of
warnings that are absolutely essential, and of relying on labels
as the only sources of information for workers and consumers
alike. Certainly the key information must be included. Links to
other readily available sources are also important. The growing
use of internet purchasing and online research on both benefits
and risks of specific products suggests that further work on this
is necessary. The needs of emergency responders and poison
centres are not best served by long lists of standardised and
unfamiliar names for components of complex mixtures. Indica-
tions of overall hazard and safety treatment, combined with
contact data for round-the-clock follow-up offer the best protec-
tion for anyone affected.
In specific circumstances where
proprietary formulation technology is involved, the manufac-
in existing legislation, by this
turer
approach.

is also protected, as

The EESC notes that there is no label proposed for the
1.8
often very small quantities transferred between laboratories for
the purposes of academic study or business R&D. This could be
added to the array of labels proposed by the UN without diffi-
culty and is to be preferred to the extremely restrictive, dispro-
portionate and costly exemption currently proposed.

Finally the EESC notes that there will be a growing need
1.9
to review the quality of the data used and the decisions made
under the different jurisdictions world wide. The pressure to
agree the outcomes of classification, not just the criteria and
processes leading to them, will surely continue. The global
needs and benefits of this are rather easier to understand.

2. Introduction

1.6
Under this same heading the EESC regrets the absence of
key definitions and, in particular, the shift from the use of the
word ‘preparations’, which has specific toxicological significance,
to ‘mixtures’, which does not. The continuing absence of any EU
definition of ‘chemical’ as either a noun or adjective continues
to give rise to confusion for workers, consumers, managers and
is intended to be neutral and
legislators alike. This proposal

2.1
This proposal is designed to align existing EU legislation
with a recently agreed UN model for a ‘globally harmonised
labelling and packaging of raw
system’ for the classification,
materials,
intermediate and finished products defined to be
‘dangerous’ or ‘hazardous’ and variously described as ‘chemicals’,
‘mixtures’ or ‘preparations’. European legislation
‘substances’,

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dating back to 1967 will be replaced. Many other directives and
including Regulation (EC) 1907/2006 (REACH),
regulations,
currently being implemented, will
require amendment. The
longer term effects within the EU are intended to be positive,
provided that costs can be contained and some rather minor
benefits realised. Overall the proposal should facilitate world
trade whilst maintaining high standards of protection for
human health and the environment.

The 40-year old directive to be replaced is the Dangerous
2.2
Substances Directive 67/548/EEC. This is generally regarded as
the first piece of pan-European ‘chemicals’ legislation aimed, in
particular, at protecting worker safety. It, and its many amending
directives and adaptations to technical progress, now provide
manufacturers and marketers, workers, distributors and consu-
mers, in and outside the EU, with a harmonised system for the
classification of ‘dangerous substances’, using specified tests against
agreed end points and hazard criteria; for their proper labelling,
via a limited set of pictograms and standardised phrases to iden-
tify possible risks and to recommend procedures for safe hand-
ling; and for their packaging, to protect regular users and vulner-
able groups, in particular, young children.

the

after

Twenty-one years

2.3
adoption of Directive
67/548/EEC, the Dangerous Preparations Directive 88/379/EEC,
extended the process from ‘substances’ (a relatively finite list of
‘elements and their compounds’) to the theoretically infinite list
of ‘preparations’ (‘mixtures of two or more substances’). Recog-
nising that animal testing was undesirable or impossible on
such a scale, the directive introduced into European law for the
first time a theoretical relationship between the known or deter-
minable hazards of the component substances and the most
probable hazard of the eventual mixture. This could then be
used to classify, label and package the preparation without the
need for further testing.

Given that the vast majority of products sold to consu-
2.4
mers are indeed ‘preparations’
(or even ‘articles’); this was an
important step towards ensuring consumer safety for products
not already covered by specific and more restrictive directives,
for instance those applying to the sale of pesticides, detergents
or cosmetics. The 1988 directive was significantly amended in
1999 by Directive 1999/45/EC.

2.5
The above directives, together with the supporting Safety
Data Sheet Directive 91/155/EEC, also subsequently modified,
have, for many years, provided the cornerstones of worker and
consumer protection across the EU. They interact with, and
provide input to, virtually all other EU legislation aimed at
protecting human health, safety and the environment. Constant
updating is required to reflect changes in scope, manufacturing
technology and test methods, product availability and possible
usage, and to reflect the latest scientific understanding of the
consequences of all of these and of ways to mitigate any unde-
sired effects.

‘pursue

these directives

Equally important,

2.6
internal
market objectives’ in that they seek to establish a Single Market
in the EU for the various products affected. Products, whether
they be raw materials, natural or synthetic products, intermedi-
ates or waste streams, finished products or articles, can be safely
imported to or traded within and between Member States
provided that they conform to these and other relevant pieces
of EU legislation.

In 2001 the European Commission launched a White
2.7
Paper entitled ‘A Strategy for a Future Chemicals Policy’. This
culminated last year
in the adoption of Regulation (EC)
1907/2006, otherwise known as REACH, for the ‘registration,
evaluation, authorisation and restriction of chemicals’. An
accompanying Directive 2006/121/EC, published and agreed at
the same time, provided further amendments to Directive
67/548/EEC to bring the two into line. This process will
presumably continue as more data become available or as legis-
lative needs change.

2.8
All of the above refer to and affect the manufacture,
distribution and marketing of specified products within the EU
and trade between the EU and its importing and exporting part-
ners. Similar but not identical systems have,
inevitably, been
developed over the same time-frame in a number of other
economies worldwide with whom the EU regularly trades, via
the multiplicity of large, medium and small enterprises estab-
lished in and outside its borders.

2.9
A number of other countries, generally less well-devel-
oped in terms of their economies and/or legislative structures,
have recognised the need for such a system for classification,
‘dangerous substances’ but await
labelling and packaging of
agreement on a globally recognised model to implement at local
level.

2.10
Recognising, in the early 1990s, that these locally devel-
oped national or regional systems, whilst essential to the protec-
tion of human health, safety and the environment, could also
form barriers to world-wide trade, the United Nations sought
authority to develop a proposal
for a Globally Harmonised
System (GHS) for the ‘classification, packaging and labelling of
chemicals and for the provision of safety data sheets’. Models
for this harmonisation already existed in the transport sector, in
particular for physical hazards and acute toxicity.

2.11
Approval to develop this wider approach was given in
Chapter 19 of Agenda 21 adopted at the United Nations Confer-
ence on Environment and Development
in 1992.
Technical input would be gathered from the Organisation for
Economic Cooperation and Development (OECD), the Interna-
tional Labour Organisation (ILO) and the United Nations Sub-
Committee of Experts on the Transport of Dangerous Goods
(UNSCETDG).

(UNCED)

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2.12
After nearly a decade of work, representatives of the
160 or so contributing UN member states reached agreement
on the technical content of the new GHS in December 2002.
in
The World Summit on Sustainable Development (WSSD)
Johannesburg in September of the same year encouraged its
signatory countries ‘to implement the GHS as soon as possible
with a view to having the system fully operational by 2008’.
The UN GHS, which now included the 2008 target date for
implementation, was adopted by the UN Economic and Social
Council in July 2003. These agreements were signed by repre-
sentatives of all 27 member states of the, by now, enlarged EU.

2.13
A number of amendments to the original UN proposal
were adopted in 2004 and included in the recommendations for
‘a globally harmonised system of classification and labelling of
chemicals (GHS)’ published by the UN in 2005. This 540 page
document, and its subsequent revisions, has become generally
known as the ‘Purple Book’, following the colour adopted for its
printed cover. Details of progress towards the 2008 target date,
for 65 countries, including 27 from the EU, are available on the
relevant UN website.

Further technical amendments were agreed by the UN
2.14
in 2006 and included in a revised edition of the Purple Book
published in 2007. The proposals include, inevitably for such an
extended and complex process of global harmonisation of
existing systems, a mixture of old and new test criteria and end
points, pictograms, approved phrases and label designs. A
‘building block’ approach was introduced to allow different
views to co-exist and to make it possible for an agreement to be
reached between the participating countries (although excessive
use of this would of course remove many of the intended bene-
fits.)

The UN proposed model does not however have the
2.15
necessary force of law and implementing legislation is required
for those countries wishing to follow its recommendations. For
the member states of the EU, this requires a proposal from the
Commission.

2.16
The Commission started work in 2004 on an imple-
menting proposal, publishing a first draft for an EU system in
line with the GHS in 2006. Impact assessments were under-
taken and published during this same period. A stakeholder
consultation on the internet in the 3rd Quarter of 2006, together
with a series of concerns expressed by the Commission's Legal
Services, led to a major re-drafting of the original proposal. This
was finally agreed and published by the Commission in June
2007. Technical reviews have already started in the appropriate
working group of the Council. Opinions are now expected as
ever from the European Parliament, the European Economic and
Social Committee (EESC), and the Committee of the Regions.

There is a widespread desire that the current reviews
2.17
neither delay nor significantly amend the harmonising propo-
sals. The benefits are generally accepted as being diffuse, are
related primarily to world trade, and will diminish if harmonisa-

tion is not achieved. Costs within the EU (or for those trading
with the EU) will increase sharply if the implementation time-
table differs from that already agreed for REACH. Any benefits
for health, safety or the environment will be felt largely outside
the EU, in countries not at present having effective systems of
their own.

Implementation of

for particular uses,

2.18
the GHS will have consequential
effects for EU transport legislation and for a raft of associated
‘downstream’ EU legislation affecting consumer products, the
handling of chemicals
the control of
dangerous or hazardous chemicals, occupational health and
safety, waste and end-of-life products. Further proposals will be
introduced to cover these where necessary over the coming
years. A full list of legislation likely to be affected was published
by Commission Services in August 2006. Amendments to
Regulation (EC) 1907/2006 (REACH) are included in the
current proposal.

3. Summary of the Commission's Proposal

The proposal is set out in 3 ‘Volumes’ and 7 ‘Annexes’.
3.1
In the English language version, these total
just over 2 100
pages. Although the main elements of the proposal are confined
to the relatively short, 64 page, Volume I, new material, or new
or revised interpretations of old material, are present throughout
the document. The proposal must therefore be considered in its
entirety as an essential piece of primary EU and national legisla-
tion affecting regulators, manufacturers, suppliers, distributors,
traders, workers and consumers, in and outside the EU.

3.2
Volume II, comprising Annex I, sets out the detailed clas-
sification and labelling requirements for hazardous substances
and mixtures (154 pages).

Volume III, comprising Annexes II to VII, provides a
3.3
series of special rules for certain substances and mixtures; lists
of new hazard and precautionary statements; new hazard picto-
grams; detailed harmonised classification and labelling for
certain hazardous substances; and a translation table intended to
assist users to show the changes from the classification and
labelling requirements under Directive 67/548/EEC to the new
requirements and hazard statements of the proposed Regulation
(430 pages). A ‘Legislative Financial Statement’ for the proposal
as a whole, which is required for the proper evaluation of the
proposal but has little enduring value or interest as primary
legislation,
is included, or perhaps buried, at the end of this
Volume.

3.4
Volumes IIIa and IIIb comprise Tables 3.1 and 3.2 as
components of Annex VI, as set out in Volume III above. These
together comprise a translation into the new regulatory frame-
work of Annex 1 of the existing Directive 67/548/EEC — close
to 1 500 pages recording decisions on the classification and
labelling of specific hazardous substances accumulated over 40
years of product assessment in the EU.

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3.5
The Commission's impact assessment, which must be
read in conjunction with the above, is based on reports prepared
by consultants RPA and London Economics and is relatively
brief (34 pages).

products (either ‘substances’ or ‘mixtures’) already in the supply
chain at the time that the relevant legislation comes into force.

The proposal is presented as a Regulation under Article
3.6
95 of the EC Treaty ‘to ensure a level playing field for all
suppliers of substances and mixtures in the internal market, as
well as a high level of protection of health, safety, environment
and consumers’.

3.7
The proposal recognises that the scope of existing EU
legislation and the scope of the UN GHS proposal are not iden-
tical. Both differ in detail from the already largely harmonised
transport regulations on classification and labelling. Changes
under this proposal have, as far as possible, been kept to a
minimum. In some cases further proposals will be required, in
particular during the implementation phases of REACH.

3.13 Member States will be required to appoint authorities
for the application and enforcement of the Regulation — and to
establish ‘appropriate sanctions for non-compliance’. It is noted
‘good cooperation between all competent authorities is
that
essential’.

3.14
The Regulation will in principle apply to all substances
and mixtures, except where other Community legislation lays
down more specific rules. Cosmetics, flavourings, food additives,
animal food and veterinary products, certain medical devices;
products governed by rules relating to civil aviation, road or rail
transport, and ammunitions
‘explosive products
marketed for decorative effects’, i.e. fireworks) are all excluded
from the effects of this Regulation.

(but not

3.8
The proposal adopts some new terms and definitions
from the UN GHS, most noticeably the use of ‘mixture’ in place
of ‘preparation’.

3.15 Waste as defined by Directive 2006/12/EC cannot,
according to this proposal, be classified as either a ‘substance’ or
a ‘mixture’ or an ‘article’ as defined by this Regulation and is
therefore excluded from its effects.

The proposal recognises that any new system of classifi-
3.9
cation could lead to the extensive use of laboratory animals.
Alternative methods should be used wherever possible. Experi-
ments on humans and other primates for the purposes of this
classification appear to be expressly forbidden (depending on
in the various
the unresolved legal and linguistic distinction,
official
languages of the EU, between ‘should not’ and ‘shall
not’)
in the Commission's proposal (although such testing is
permitted in the UN GHS model).

3.10
The problems associated with classifying ‘mixtures’ are
recognised. ‘Bridging principles’ are provided which aim to facil-
itate read-across from products likely to have similar effects.

3.16
Alloys are however defined to be ‘mixtures’ in line with
point 41 of Article 3 in Regulation (EC) 1907/2006 (REACH)
and are therefore included in this regulation, as presumably are
true ‘mixtures’ (but not, in any useful sense,
‘preparations’) of
naturally occurring substances such as metal ores, minerals and
plant extracts.

3.17
Labelling requirements are changed in both layout and
content from the existing EU system. Some existing pictograms
are replaced; others are added for
time. Existing
permitted standardised ‘risk’ and ‘safety’ phrases are replaced
with new ‘signal words’, ‘hazard statements’ and ‘precautionary
statements’.

the first

3.11
The proposal provides for the possibility of providing
shorter common names for substances alone or as components
of mixtures where the formal names as defined by the Interna-
tional Union of Pure and Applied Chemistry (IUPAC) exceed
100 characters
identifiers
(numbers and names) supplied by the Chemical Abstracts
the American Chemical Society (CAS) will also
Service of
continue. The controlled use of generic names which correctly
identify the likely hazard without putting at risk any associated
intellectual property associated with the precise composition of
a mixture is maintained from existing legislation.

in length. The use of product

3.18
All of the above approved words and statements are
defined in all of the official languages of the EU and must be
used as necessary on each label, depending upon the country in
which the product is eventually sold. Multiple languages may be
used, although the space available is becoming increasingly
limited. (In some special cases additional translation of labels
and supporting documentation may of course be required into
legally necessary but not ‘official’ languages such as Welsh, or
into other languages required,
for instance Russian, Turkish,
Arabic and Hindi, to meet the needs of specific indigenous or
immigrant groups).

The necessary period of

3.12
transition between the two
systems is discussed in detail. It is clearly recognised that the
new criteria must be applied first to ‘substances’ and later to
‘mixtures’. To avoid unnecessary burdens on enterprises, there
will be no obligation for an enterprise to reclaim or re-label

3.19
The proposal recognises that the process of classifica-
tion, and therefore of labelling and packaging, is one of contin-
uous update within the EU as new information or under-
standing becomes available or as test methods or legislative
requirements change. Changes requiring action and the proce-
dures then to be followed are set out in the text.

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3.20
It is intended that the Regulation will come into force
20 days following its eventual publication in the Official
Journal. Substances should be classified, labelled and packaged
under existing legislation until no later than 1 December 2010
(to coincide with registration deadlines for REACH). Mixtures
should be classified, labelled and packaged under existing legisla-
tion until no later than 1 June 2015. From then onwards, only
the new legislation will apply.

4. General comments

4.1
The UN, acting on behalf of all its member countries, has
proposed a model for a ‘globally harmonised system’ for the
criteria and processes of classification, packaging and labelling
of ‘chemicals’. The member states of the EU have agreed that
the model
ideally by 2008. The
Commission has proposed implementing legislation in the form
of the Regulation now under discussion.

should be implemented,

4.2
The EESC strongly supports the aim of global harmonisa-
tion, the form and legal basis of the legislation proposed, and
the timetable proposed for implementation to coincide with the
first major deadline for the registration of substances under
Regulation (EC) 1907/2006 (REACH).

4.3
The EESC also notes that there must be flexibility to run
the two systems in parallel, in particular for ‘mixtures’ which in
many cases are themselves ‘mixtures’ of ‘mixtures’, each with a
definable and sometimes long shelf life, measured in months or
even years. The transition is unlikely to be fully within the time-
frame proposed — but fortunately that does not mean that the
process will be ineffective. In the absence of such flexibility, the
start-up costs will increase and the intended long term benefits
may not be realised.

4.4
The EESC also notes and agrees with the introductory
comments of the Commission's impact assessment that ‘in the
long term, the GHS implementation seems worthwhile ... as
cost savings will ultimately overcome the one-off costs of imple-
mentation’ … although … ‘implementation costs need to be
kept in check so as to arrive at net benefits … in the foreseeable
future and to avoid unnecessary costs and administrative
burdens for SMEs’.

4.5
The EESC also notes the views expressed by the Commis-
sion in its Legislative Financial Statement that ‘the legislative
proposal relates to the implementation of an international agree-
ment. Even a negative ex-ante evaluation would not result in the
Commission not putting forward a legislative proposal since
other policy options do not exist. A negative ex-post evaluation
induce the Commission to withdraw from its
would not
commitment to implement the internationally agreed system of
Classification and Labelling.’

4.6
Simply put, the Commission believes it had no choice
but to put forward the proposal, whatever the calculated or
actual balance of costs and eventual benefits. The EESC agrees

consultants

that this is realistic under the circumstances but regrets that the
impact assessment, even if not key to the decision making, did
not explore further the likely costs of implementation, with a
view to mitigating these effects during drafting. The fact that the
(RPA) have prepared a detailed (and
same
conflicting) analysis
(certain
just one affected sector
consumer products) suggests that this could have been done
more widely and certainly more effectively if the money, time
and will had been made available. As with all processes of
harmonisation, the dangers of escalating costs and vanishing
benefits are all too obvious.

for

4.7
It is, for instance, difficult to see why there should be
any benefits at all for health, safety and the environment inside
the EU as a direct consequence of this swap from one long-
established and fully functioning system to another equally valid
but unfamiliar system. In the short-term, consumer protection
could even suffer as the two systems, with differing words,
run in parallel. A coordinated
phrases
programme of education and training, focused on the retail
sector, would go some way to reduce this risk.

and pictograms,

4.8
There are also conceptual difficulties in understanding
how the benefits to world trade will be fully realised with coun-
tries implementing the UN proposal on different time frames
the basic requirements.
and with differing interpretations of
Early implementation by Japan and New Zealand has already
given rise to concerns in Europe. Implementation in the US,
with 4 or 5 systems currently running in parallel, is far from
completion. Different language versions will of course continue
to be required for globally traded goods, however the required
labels and safety data sheets are harmonised.

4.9
The best that can be said therefore is that this is the start
of a process of global harmonisation which mirrors what has
already occurred across the member states of the EU and which
will now require the same level of resources, supporting systems
and processes to maintain on a global basis. This will be an
unfamiliar role for the Commission and it will be important
that
it dedicates sufficient resources to allow the inevitable
changes, updates and adaptations to technical progress to the
current proposal to be made in a timely and effective manner. It
is unclear that either the financial statement or the proposals
for comitology and subsequent scrutiny are adequate in this
respect.

Similar comments should be directed to the UN, to
4.10
ensure that full harmonisation of not only the criteria for classi-
fication, but of the actual classifications determined and used as
a basis for subsequent
for globally
traded high volume ‘basic chemicals’
(and eventually for the
majority of globally traded high volume consumer products is
achieved as quickly as possible. In both cases, close and conti-
nuing cooperation between the manufacturers of the products
and the relevant regulators will be essential.

labelling and packaging,

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4.11
In the EU the Commission still needs to address the
twin problems of dealing with the many only partially defined
interactions with its own ‘downstream’
legislation — and of
recognising and accommodating the needs of specific sectors, in
particular for consumer products. Given that both systems are
supposed to be equally effective, some flexibility should be
possible to ensure that the broad framework of the proposal
can be agreed as soon as possible.

On a similar theme,

4.12
‘workers’ (in the workplace) and
‘consumers’ (in a retail store, when shopping on line or subse-
quently at home) should of course all continue to be given the
highest possible protection with respect to their health and
safety. However the two environments and the information
needs and support services available to those concerned are
quite different. This is only partially recognised in this proposal.
There is no need for a one-size fits all approach. Recent devel-
opments in consumer shopping patterns, in particular via the
internet, should be recognised. The professional needs of emer-
gency responders, first line health services and poison centres
should also be taken into account with regard to the content of
the labels and the relevance of the information specified.

4.13
The availability and value of other information sources
apart from the label should also be recognised, in particular for
consumers, where informed choices can be made using advice
from consumer organisations or on-line from most manufac-
turers or suppliers. The bald statement by the Commission that
‘the label is the only tool for communication to consumers’ is
therefore an over-simplification. For those reliant on the label
alone, perhaps long after initial purchase, the need for clearly
focused, understandable and relevant information is paramount.
For others, additional
information is readily obtainable under
existing EU law or good commercial practice for anyone
wishing to delve deeper. The many individual purchasing
choices made solely on the basis of brand loyalty work both
ways — a product may be assumed to be safe simply because it
is made by Company X — and the value of that customer
loyalty to Company X ensures that its products are indeed kept
safe, reformulated, re-made or withdrawn if this is not the case.
(Some recent and undoubtedly expensive voluntary global
recalls of toys and other consumer goods due to the failure of
internal quality controls illustrate this point quite clearly.)

which, in an earlier (February 2005) EESC Information Report
on REACH, was quoted as having 1.4 million Material Safety
Data Sheets available, now has in excess of 3.5 million — and
claims to be adding around 10 000 per day. Safety data sheets
formatted for the EU and in the appropriate national languages
for both substances and preparations are available from most
manufacturers and suppliers and from some centralised sources
— and must of course be provided to customers in Europe
before any delivery of a product can be made. As these must be
provided in all relevant languages and by all manufacturers and
suppliers for all their products, a very large number of indivi-
dual data sheets are required — and must be updated on a
regular basis or as new legislation, such as this, demands.

4.15
Complementing the above, a newly launched (June
2007) OECD eChemPortal gives easy access to a range of data-
bases maintained by its member governments and agencies,
including for the EU, the European Chemicals Bureau. These
databases provide data on many tens of thousands of individual
substances manufactured and marketed in the EU and rejoice in
a range of acronyms including ESIS (EU), CHRIP (Japan), OECD
HPV (OECD), SIDS HVPC (UNEP), HPVIS (US EPA), INCHEM
(IPCS), as well as better known and regularly used EU resources
such as IUCLID, ORATS, HPVCS, LPVCS, ELINCS and EINECS,
together with sector specific sites such as SEED, EUROPHYT,
PHYSAN and
supporting
and cosmetovigilance
programmes
ensure that any adverse effects of specific products are centrally
and speedily recorded. The extension of these joint industry and
regulator early warning programmes to other products in wide
consumer use should be encouraged.

CAT. Globally
such as pharmacovigilence

coordinated

4.16
It is clearly good news that these data sources exist and
are readily available — and even better if all of the above can
indeed be updated, safety sheet by safety sheet, product record
by product record, to reflect detailed changes required under the
different national and regional
the GHS
without
to all concerned —
although it is again unclear whether this has been fully consid-
ered in the impact assessment.

incurring unacceptable costs

implementations of

For workers, and for everyone entering a workplace,
4.14
where exposures are generally greater and/or more prolonged
and where the need to maintain the highest standards of health
and safety is a daily priority for all concerned, the packages and
quantities contained therein are generally larger and the labels
can be more detailed. Once again, there is no shortage of addi-
tional
information, much of which must be made available
under EU or other law at or before delivery of a raw material or
further processing. A US website
intermediate product

for

This wealth of on-line information, combined with the
4.17
length of the implementing legislation,
is however becoming
burdensome, as well as legally and intellectually challenging, to
regulators and users alike. Regulation (EC) 1907/2006 (REACH)
was,
in its final published form in English, 850 pages long.
REACH Implementation Projects (RIPs) and guidance notes, not
yet finalised, are said to exceed 10 000 pages. Their final forms
and eventual legal status are not yet known. The GHS proposal
now under discussion exceeds 2 000 pages. Guidance notes will
again be required — to this Regulation and to assist implemen-
tation in the 20 or so major pieces of downstream legislation,

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including Directive 1996/82/EC (Seveso II), that it will affect.
Thus the responsible institutions and bodies of the EU will
shortly have produced or reviewed close to 20 000 pages of
legislation or supporting material in this one area alone. It is
difficult to see this as a model for better regulation — or as the
ideal way to support the Lisbon objectives — or to endear the
idea of a listening and supportive centrally administered EU to
the citizens of Europe.

tion’ of the requirements which at the moment would lie, unsa-
tisfactorily, with the responsible Commission services. The fact
that this process is reported to be highlighting many errors in
in particular with the introduction of
the current legislation,
many new languages where ‘translation’, in its normal linguistic
sense, is all important, brings only a small degree of comfort.
Given the volume of data, it has to be assumed that new errors
are being introduced at the same time which only the manufac-
turer or supplier of that product will discover in due course.

if

However,

4.18
these essential communication problems
can in due time be surmounted (probably by breaking down the
legislation into the essential components of definitions, clearly
set out and agreed; test methods; end points; outcomes; required
processes and procedures and so on; all separately published
and updated on appropriate but different timetables, and not all
requiring simultaneous publication as primary legislation) then
great benefits will indeed be achieved. The data-based and gener-
ally applicable GHS should eventually affect and guide all those
commenting on the best ways to protect human health, safety
and the environment — and the benefits of this may be far
greater than the rather small associated increases in world trade
or in local employment currently used as the economic justifica-
tion for the proposal.

5. Specific comments

5.1
The EESC notes the tight timetable for the adoption of
this proposed Regulation, so that implementation can follow the
same deadlines as defined by REACH in order to contain the
once-off start-up costs. The EESC also notes that this is just the
beginning of a global process which will require continuing
change by all the participating regulatory bodies and by the
businesses and others directly affected. There is therefore an
obvious need to understand and rectify as many of the perceived
problems as possible — and to implement the core of the
proposal as flexibly as possible. Given that one good and well-
tried system is being replaced by another, hopefully equally
good, system, the risks attached to any specific derogations to
allow time for problems to be solved, are slight.

5.2
As an example of this, the preparation and inclusion of a
‘translation table’, by Commission staff and national experts, of
Appendix 1 of the existing Directive into Annex VI of the new
Regulation whilst useful as a guide to the transposition from the
old to the new requirements, has bypassed all the due processes
of review and consent on which the more than 1 000 pages of
decisions were originally built. If this is to become law with
immediate effect, then resources must be devoted to checking
this in detail, at a time when the majority of enterprises are fully
stretched fulfilling the registration requirements of REACH. As it
is often the case that EU legislation is adopted with some or all
the Annexes still empty, a similar course could be followed here,
so that the overall timetable is maintained. This also removes
the problems of liability for incorrect ‘translation’ or ‘transposi-

Similar comments apply to all instances where the new
5.3
GHS will, without due consideration,
increase the severity of
current classifications, and hence labelling, packaging and
possibly other impacts under any associated transport or down-
stream legislation. This could be the case, for instance, for some
widely used consumer products such as, household detergents,
where the new GHS appears to require quite nonsensical over-
‘on spilling a
labelling. An example frequently quoted that,
commonly used detergent, the user should then remove all their
clothes — and wash them in the same detergent’ would merely
bring the system, and those applying it,
It
certainly would not lead to the highest standards of protection
for human health, safety and the environment. Careful use of
the derogation under Article 30(1) where ‘clearly unnecessary
statements … may be omitted from the label’ seems essential.

into disrepute.

Also of concern are requirements to over-classify — a
5.4
practice in some jurisdictions designed to limit the liability of
manufacturers but again not really conducive to the proper
protection of workers or consumers. Specifically the current
proposal fails to distinguish adequately between products that
(i.e., they can in certain cases cause
are potentially ‘irritants’
temporary and reversible redness or swelling to the skin) and
those that are ‘corrosive’ (i.e., they are likely to cause a perma-
nent and possibly irreversible eating away of
for
instance by a strong acid or alkali or by the effects of oxygen).
The potential for ‘eye damage’ alone is of course rather more
frequent and in some cases is potentially more severe, with the
risk of causing blindness, and should be identified whenever
present by an appropriate and easily recognised symbol. All of
this is aggravated by imposed or voluntary limitations on the
use of animals for testing of products which now find them-
selves close to a revised end point and where both the labelling
and packaging for consumer sales depend on the classification
adopted. As the products affected in this way are likely to be
exceptions rather than the rule, short term derogations would
allow the proposal as a whole to be introduced without delay.

the skin,

5.5
Over-labelling also has an undesired knock-on effect with
regard to packaging, with child-resistant closures proving
equally resistant to opening by older or infirm users. Advice on
careful handling and storage of products in daily life is generally
more valuable than devices that make them inaccessible to users

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C 204/55

or lead to containers being left open or the contents being
transferred to less safe alternatives. Consumers, with the support
of helpful labelling and normal common sense and daily obser-
vation, do understand that products such as oven and drain
cleaners must be treated with great respect; they are also,
in
most cases, quite capable of handling washing powder or solid
dishwasher pellets without injury. Labelling them all as ‘corro-
sive’ with the key word ‘DANGER’ serves no good purpose and
again puts the entire process at risk.

only for ‘performance fluids’ such a lubricating oils and other
high-technology preparations where consumer exposure is
generally limited and the general hazards obvious irrespective of
the specific components present.

to improve clarity. The loss of

5.6
The above examples also put in question to what extent
the various new (and old) pictograms, key words and phrases
have been tested against the perceptions of different publics
around the world. Although it is too late to change the existing
UN GHS proposals, some additional words might be helpful, or
amendments proposed,
the
widely recognised ‘St Andrews cross’ symbol, rendered in black
on orange, is particularly regretted. It will take a considerable
time for replacement symbols to be properly recognised and
there will be increased risks to consumers in particular until the
new symbols are fully established.
In store communication
programmes to help all those making routine retail purchases
should therefore be implemented (and centrally funded) as soon
as possible. The needs of all
those purchasing consumer
products on-line, where a label is rarely visible at the time of
purchase, require further study.

5.7 With regard to identifying the components of a prepara-
tion or mixture, the proposal reasonably requires the use of
CAS numbers (which currently embrace more than 32 million
organic and inorganic substances with partially or wholly
defined structures, of which some 13 million are classified as
being commercially available, often in very small quantities) and
the use of IUPAC, CAS or other names to complete the identifi-
cation. It is right to note however that these names are designed
to define structures, not to identify hazards or risks. They are
rarely of use to emergency responders or poison centres in that
specific antidotes generally do not exist. The choice between
inducing vomiting or neutralising in the stomach may however
be critical to the first-aid treatment of an affected user. Subse-
quent contact with the manufacturer, at any time of day or
night, seven days a week, for more specific advice is also likely
to prove critical. It is this information, rather than the formal
chemical name and molecular structure of one or more compo-
nents of a complex mixture, which should be included on the
label for use in the case of an emergency.

5.8
It follows that where the naming of a specific compo-
nent, to the extent of defining its absolute chemical structure,
has value only to a competitor, with the consequential loss of
intellectual property rights for the original manufacturer, that
the safeguards contained in the existing General Preparations
Directive should be maintained. In general this is a problem

5.9
The above also raises the problem of the proposed use of
the word ‘mixture’, which should refer only to a system of
substances that can be separated by physical means, to distin-
guish it from being a ‘compound’ or ‘substance’ (which cannot
be so separated). The definition here seems to lump together a
series of quite different material systems (naturally occurring
ores, minerals, concentrates and plant extracts) with ‘prepara-
tions’ which contains
idea of a deliberately
the essential
constructed mixture of known components from which the
hazard of
the final product can be reasonably determined.
Alloys (and glasses) of course are neither of these and should be
separately and more appropriately regulated, both here and in
REACH. It is equally unclear why waste streams are excluded as
a category, despite being included in some cases in the EINECS
inventory as ‘substances’ under ‘slimes’ and ‘sludges’. This would
seem to imply that a mixed ore in its natural state must be clas-
sified (to no obvious purpose, as there is no likelihood of
contact with consumers and no possibility of finding any repla-
cement) whereas scrap iron or mixed paper waste, which must
all be treated ‘as is’
in continuous processing and recycling
operations, are excluded. All of the above must be handled
safely in the workplace, but this is not the prime thrust of classi-
fication, and, indeed, these products are rarely either labelled or
packaged. Sector or workplace specific legislation normally
provides better protection.

5.10 Whatever the definitions are, they should be included
in this proposal, not merely taken from the GHS or
in full
requiring reference to other documents. This would be a useful
opportunity to define ‘chemical’ for the first time — both as a
noun and as an adjective. If it is equivalent to ‘substance’, which
presumably is the case, this should be made clear. This would
also make more clear the scope of this and other directives and
regulations which apply far more widely than to the products of
the, more precisely defined ‘chemical’
industry. It would also
make clear that the translation of the word ‘chemical’ as a noun
into ‘chemical substance’ in languages lacking a single equivalent
word does not imply the existence of alternative (and presum-
ably non-toxic?)
‘non-chemical substances’. This might also
hopefully diminish the use of well meaning but meaningless
statements such as ‘most articles include chemicals’ (1) (what do
the rest contain?) or ‘chemicals are used in almost every work
place’ (2) (whatever do they use in the other work places?). The
EESC of course understands that any definitions used must be
legislation. However the EESC does not
consistent across all
accept that any one piece of
legislation is any more ‘funda-
mental’ than any other (or if it is, then this proposal clearly

(1) From Commission ‘frequently asked questions’ on REACH.
(2) From UK DEFRA guidance notes to MEPs on this proposal.

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important as

translation into different

qualifies) and certainly does not accept that all the related legis-
lation should be read in its entirety by all those involved, merely
to determine what a word does or does not mean. This
languages
becomes
creates differences that did not exist in the original — or obliter-
ates distinctions which were vital. For example,
the word
‘product’ is used here in a neutral sense for any goods likely to
be purchased or used in the workplace or by a consumer. It
absolutely is not intended to be synonymous with the word
‘article’ which has a special meaning under EU and other legisla-
tion. This is clear enough in English but may be less clear in
other languages. Whatever the situation, the distinction must be
maintained. Other linguistic and cultural confusions should also
be identified and avoided. For instance, a ‘substance-free envir-
onment’ in Europe would be taken to refer, perhaps, to outer
space. In the US it means a school where drinking and smoking
In the popular press in many cultures,
are not permitted.
‘chemicals’ on their hands or
anyone found with traces of
clothing is assumed to be a terrorist.

the word ‘danger’

In every case it must be made clear

5.11
to everyone,
including the general public, what particular significance the
various words used are intended to convey. The prohibition on
the use of
in association with the word
‘warning’ may be of interest to experts in labelling although the
two words are frequently used together in other communica-
tions aimed at reducing risk. If the word ‘dangerous’ means
anything different to the word ‘hazardous’, in all the languages
of the EU (and its trading partners) this should be made clear.
Certainly it is difficult to distinguish between them in English.
The use of abbreviations such as ‘m-factor’ which are mean-
ingful only where local
language translations of ‘multiplying’
indeed begin with the letter ‘m’ should be avoided. (The fact that
under existing legislation there is constant reference to ‘R’ and
‘S’ phrases, for risk and safety respectively, merely shows that
the legislation has been drafted in English, with little regard for
the needs of other language users.)

5.12 With regard to the overall scope of this proposal, and
to avoid drowning the process in data on the many millions of
substances transferred in small or even minute quantities, a cut
off point, based on sales per year, package size or weight, or
known toxicity, would be helpful. Equally a label appropriate to
the transfer, generally between laboratories, of very small quanti-
ties as samples for R&D to indicate that the ‘product has not
been tested or classified’ and ‘is for professional use only’ would
be a useful addition to the range of labels currently available.

Brussels, 12 March 2008.

(The alternative new proposal
to exclude ‘substances and
mixtures for scientific research and development’ but only if
used under conditions which assume that they are ‘carcinogenic,
germ cell mutagenic or toxic to reproduction’ is inappropriate
and should be deleted. There is no evidence brought forward to
suggest that laboratory hazards require priority treatment or,
contrary to normal expectation,
that anyone working in a
laboratory is at risk from lack of knowledge. If this is however
shown to be the case, amendments to EU legislation on good
laboratory practice would be a better route.)

5.13
Care should also be taken to ensure that the proposed
classification and labelling process fully reflects, as now, the
inherent hazardous properties of the individual substances and
preparations or mixtures as placed on the market. Any exten-
sion to informal or unregulated mini-risk assessments by manu-
facturers or suppliers to cover possible or expected future use
should be deleted as being inconsistent with both existing EU
law and the UN GHS proposal.

5.14 With regard to enforcement, reporting and penalties for
non-compliance, the proposal passes responsibility, quite reason-
ably, to the Member States, with the requirement that the provi-
sions for this must be ‘effective, proportionate and dissuasive’
and that they shall be notified to the Commission within 18
months of entry into force of the Regulation. The EESC notes
however that this proposal is designed, as in the existing legisla-
tion, to harmonise the criteria and processes used in any classifi-
cation but not to harmonise the outcomes of this classification.
Thus the penalties are likely to be minor in their size, effect and
enforceability compared to the desire of manufacturers to fully
and properly protect the workers and consumers upon whom
their businesses depend. This being so, the workability of the
overall proposal, in conjunction with other legislation such as
REACH, remains critical.

Finally there will be a need to evaluate the quality of
5.15
data received under different jurisdictions, to ensure that these
are comparable and relevant to determining intrinsic hazards of
novel and complex substances, including those of ‘unknown or
variable composition’. Ranking systems for this do exist, for
instance from the Society of Chemical Hazard Communications.
Peer reviewed data are also available in the Register of Toxic
Effects of Chemical Substances. The proper process for this,
presumably at the UN, does not seem to be fully defined or the
resources and budgets put in place.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS