Opinion of the European Economic and Social Committee on the Proposal for a Directive of the European Parliament and of the Council amending, for the twenty-ninth time, Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (substances classified as carcinogen, mutagen or toxic to reproduction — c/m/r) (COM(2004) 638 final — 2004/0225 (COD))
Date: 2005-04-06
Institutions: European Economic and Social Committee
Subjects: approximation of laws, dangerous substance, market approval

14.10.2005

EN

Official Journal of the European Union

C 255/33

Opinion of the European Economic and Social Committee on the Proposal for a Directive of the
European Parliament and of the Council amending, for the twenty-ninth time, Council Directive
76/769/EEC on the approximation of the laws, regulations and administrative provisions of the
Member States relating to restrictions on the marketing and use of certain dangerous substances
and preparations (substances classified as carcinogen, mutagen or toxic to reproduction — c/m/r)

(COM(2004) 638 final — 2004/0225 (COD))

(2005/C 255/05)

On 28 October 2004, the Council decided to consult the European Economic and Social Committee,
under Article 95 of the Treaty establishing the European Community, on the abovementioned communica-
tion.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the
Committee's work on this subject, adopted its opinion on 16 March 2005. The rapporteur was Mr Sears.

At its 416th plenary session (meeting of 6 April 2005), the European Economic and Social Committee
adopted the following opinion by 126 votes to 2, with 6 abstentions.

1. Introduction

substances

European Community proposals to protect public health
1.1
and the environment currently centre around three long-
standing legislative instruments on the classification, packaging
and labelling of dangerous
(Council Directive
67/548/EEC of 27 June 1967), on the classification, packaging
and labelling of dangerous preparations (Council Directive 88/
379/EEC of 7 June 1988 as replaced by Directive of the Euro-
pean Parliament and Council Directive 99/45/EEC of 31 May
1999), and on the marketing and use of certain dangerous
substances and preparations (Council Directive 76/769/EEC of
27 July 1976).

1.2
Each of these has been maintained and extended over
the intervening years by further EEC and EC Directives
amending the legislative content of the instruments and by
adapting to technical progress the various annexes which set
out, amongst other technical points, the laboratory tests to be
followed, the details of the risk and safety phrases to be used,
and the chemical identities, CAS, EC and Index Numbers and
applications, of the substances affected.

1.3
The directives, as amended, also seek to preserve the
Internal Market for the substances and preparations affected
and therefore must remain consistent with each other and with
other legislative instruments affecting specific sectors (e.g. pesti-
cides or cosmetics) or supporting particular action programmes
(e.g. EU action plans to combat cancer).

1.4
The current proposal is the twenty-ninth amendment to
Council Directive 76/769/EEC. It implements and is a logical
consequence of the (coincidentally) twenty-ninth adaptation to
technical progress of Council Directive 67/548/EEC by
Commission Directive 2004/73/EC of 29 April 2004.

set out

The adaptations

to technical progress

in
1.5
Commission Directive 2004/73/EC include updates to Annex I
of Council Directive 67/548/EEC for specific substances relating
to their classification, packaging and labelling to reflect the
latest scientific data, and to Annex V of the same Directive, to
amend the methods for the determination of physiochemical
properties, toxicity and ecotoxicity of substances and prepara-
tions in order to reduce to a minimum the number of animals
used for experimental purposes.

teratogenic

1.6
these
Commission Directive 2004/73/EC setting out
changes was published in April 2004 (OJ L152 1-311). A
number of substances were classified or reclassified as being
carcinogenic, mutagenic or
c/m/r
substances). The measures provided for were stated to be in
accordance with the opinion of the Committee on the Adapta-
tion to Technical Progress of the Directives for the Elimination
of Technical Barriers to Trade with Dangerous Substances and
Preparations.
In such cases, there is no requirement for an
earlier Opinion on the proposal from the Commission from
either the European Parliament or the European Economic and
Social Committee.

(CMRs or

1.7
Under another Council Directive 94/60/EC (an earlier,
fourteenth, amendment to Council Directive 76/769/EEC), c/m/
r substances may not be used in substances or preparations
placed on the market for sale to the general public. It follows
that an implementing measure is required,
the current
proposal, to add these substances to Annex 1 of Council Direc-
tive 76/769/EEC. In compliance with Article 95 of the Treaty,
in this case the co-decision procedure has to be followed with
the European Parliament and the Economic and Social
Committee has to be consulted.

i.e.

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1.8
In the course of 2004, the Commission consulted a
number of organisations representing the relevant stakeholders,
including CEFIC, CONCAWE, Eurometaux and BLIC (repre-
industries in
senting the chemical, oil, metal and rubber
Europe)
in Europe),
and BEUC (representing consumers
together with experts from the Member States.

very large number, of unrelated substances. These include
petroleum hydrocarbon streams, pesticides and fungicides,
general
industrial chemicals and inorganic and organic raw
materials and intermediates.

2. Summary of the Commission's proposal

The proposal will

insert 346 entries

2.1
containing
substances newly classified or re-classified under Commission
Directive 2004/73/EC in the Appendix of Annex I to Council
Directive 76/769/EEC. However, of
these, 304 are already
subject to restrictions on sale to the general public due to their
earlier classification as c/m/r substances of category 1 or 2.
Thus only 42 substances will be restricted for sale to the
general public for the first time.

2.2
Of the 42 substances restricted for the first time, a large
number are used as raw materials or intermediates in organic
synthesis or for specific professional applications. No evidence
was produced during consultation to suggest that they are used
in substances or preparations placed on the market for sale to
the general public or that any derogations are required.

2.3
Of the 304 substances now reclassified, 145 will move
from being classified as carcinogenic category 2 to category 1.
This will require two corrections for each substance, adding the
substance to its new category and deleting it from its existing
category. A number of changes are also required to the ‘Notes’
accompanying each entry.

2.4
The proposal is intended to preserve the Internal Market
and at the same time ensure a high level of protection for
health of consumers and for the environment. The costs are
estimated to be low, due to the limited use of these substances
by the general public. However, as usage of c/m/r substances
by the general public cannot be properly controlled by other
measures, the proposed restriction on sale is the only available
approach.

2.5 Member States will have twelve months from the date of
entry into force of this Directive to adopt and publish the laws,
regulations and administrative provisions necessary to comply
with the Directive.

3. General comments

3.1
As with the previous amendments to Council Directive
76/769/EEC, this proposal deals with a number, in this case a

3.2
Unlike other recent amendments, however, this is not
the primary legislation affecting these products. This proposal
is merely a necessary consequence of changes to their classifica-
tion and labelling as already proposed and implemented under
Council Directive 2004/73/EC. Any concerns over the validity
of the classification should therefore have been resolved earlier
and cannot be re-opened at this stage.

their

classification or

3.3
The Commission has however verified as far as possible
that consequent restrictions on sale to the general public as a
result of
c/m/r
substances will not add significantly to the costs of manufac-
turers. Direct enquiries to CONCAWE for the oil industry in
respect of the petroleum hydrocarbon streams listed and to
CEFIC for the chemicals industry in respect of the two phtha-
lates listed (BBP and DIPP) support this conclusion.

reclassification as

3.4
Confirmation of this lack of impact is more difficult for
the pesticides and fungicides shown here under their proprie-
tary names (Benomyl, Azafenidin, Dinocap, Linuron) or as inor-
ganic chemicals (cadmium chloride) due to the absence of
information on current manufacturers,
in Europe.
Internet searches suggest that in most cases the hazards are
already well known and again it must be assumed that the
products can be withdrawn from sale to the general public
without negative impacts on users,
i.e. suitable replacements
are readily available.

if any,

3.5
The proposal also highlights some general difficulties in
understanding and following existing EU law with respect to
so-called ‘substances’. Many of the ‘substances’ listed here and
contained within the original EINECS inventory of ‘existing
substances’, are properly classified as ‘UVCB substances’
i.e.
complex mixtures of known or unknown composition as
defined in an academic paper published in 1999 and subse-
quently referred to in a footnote on page 18 of the ‘Manual of
Decisions for Implementation of the Sixth and Seventh Amend-
ments to Directive 67/548/EEC’ published by the European
Chemicals Bureau in 2002. Certainly they are not simple
substances as generally understood, and in addition, in this par-
ticular case, few are currently marketed. This supports the view
of the Commission when the EINECS list was first published

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that ‘EINECS overstated the number of commercially significant
substances by a factor of four’,
i.e. there were then around
25 000 ‘substances’ actually on the market in significant quanti-
ties. Presumably some of these have now been replaced by the
5 000 or so ‘new substances’ listed in ELINCS — with similar
problems of definition and identification — to give a round
total of 30,000 substances actually on the market in 2005.
This is more containable that
the 100 000 number often
quoted but still raises questions of public and professional
access to the data already collected (but not regularly updated)
on at least half of these and to the problems for the competent
authorities in Member States in defining whether or not a
substance is ‘existing’ or ‘new’ and if so which regulatory proce-
dure should be followed.

3.6
Given that the proposal known as REACH incorporates,
depends upon and interfaces with this existing legislation, these
concerns should be addressed as soon as possible. It is likely
that additional resources will be required and these should be
put in place as soon as possible.

4. Specific comments

4.1
The EESC supports the limitations on marketing and use
contained in this proposal. These are necessary and desirable
consequences of decisions on classification, packaging and
labelling already taken by the Commission services in conjunc-

Brussels, 6 April 2005

tion with experts from the Member States and after discussion
with suppliers and other stakeholders.

However, as with previous amendments to Council
4.2
Directive 76/769/EEC, the EESC regrets the linking of unrelated
products in a single text which might, in other circumstances,
require specific and continuing amendments to match external
realities. This does not support good, timely, effective and,
above all, transparent, governance.

4.3
The complex and seemingly random nature of the lists
of substances provided in the Annex to this proposal and to
Council Directive 2004/73/EC suggest that attention should
now be paid to improving the quality and availability of the
data currently held, before adding massively to that currently
stored. If an improved system can be demonstrated, using the
best of modern technology and techniques for data dissemina-
tion, then the benefits of REACH in respect of accumulating
and sharing data relevant to the protection of human health
and the environment will be more evident.

4.4
REACH is also intended to simplify the existing system,
and in so doing bring benefits to all the stakeholders involved.
Certainly there seems to be some scope for this. Above all,
REACH, however formulated, must not add to an already
complex and, on this occasion at
least, somewhat opaque
process.

The President

of the European Economic and Social Committee

Anne-Marie SIGMUND