Opinion of the Economic and Social Committee on the 'Proposal for a Directive of the European Parliament and of the Council amending for the seventh time Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products'
Date: 2000-09-20
Institutions: European Economic and Social Committee
Subjects: animal experimentation, approximation of laws, consumer protection, cosmetic product, labelling, toxic substance

20.12.2000

EN

Official Journal of the European Communities

C 367/1

II

(Preparatory Acts)

ECONOMIC AND SOCIAL COMMITTEE

Opinion of the Economic and Social Committee on the ‘Proposal for a Directive of the European
Parliament and of the Council amending for the seventh time Council Directive 76/768/EEC on
the approximation of the laws of the Member States relating to cosmetic products’

(2000/C 367/01)

On 26 May 2000 the Council decided to consult the Economic and Social Committee, under Article 95
of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for the Single Market, Production and Consumption, which was responsible for preparing
the Committee’s work on the subject, adopted its opinion on 1 September 2000. The rapporteur was
Mr Braghin.

At its 375th plenary session 2000 (meeting of 20 September), the Economic and Social Committee
adopted the following opinion by 87 votes to one with one abstention.

Foreword

1.

Introduction

The main aim of the basic directive (Directive 76/768/EEC) is
to protect consumer health. An assessment of the current
market situation shows beyond any doubt that the directive
has improved the quality of cosmetic products. The subsequent
Council Directive 93/35/EC of 14 June 1993 (known as the
‘sixth amendment’ of Directive 76/768/EEC) set the additional
priority aim of reducing the suffering of animals used in tests
necessary for consumer safety. This was to be achieved by the
use of alternative validated methods. So far, however, only
three alternative methods have been validated, despite all
endeavours.

It should be pointed out that animals used in cosmetics testing
form a very small percentage of the total number of animals
used to guarantee product safety. Independent authoritative
estimates based on the second Commission report to the
Council and the European Parliament on the number of
animals used for experiments in the EU suggest that only 0,3 %
of experiments concern tests for cosmetic products. It must
also be borne in mind that the tests do not involve killing the
animal, and that particular suffering is not inflicted on it. The
main species used are guinea pigs, rats, rabbits and fish; in no
cases are primates used.

The proposed seventh amendment to Council Directive

1.1.
76/768/EEC has four key objectives:

— to introduce a permanent and definitive prohibition on
the performance of experiments on animals for finished
cosmetic products in the territory of the European Union;

— to amend the prohibition on the marketing of cosmetic
products containing ingredients or combinations of
ingredients tested on animals as soon as validated alterna-
tive methods become available (postponing the current
the
deadline to three years after implementation of
directive by the Member States);

— to revise current legislative provisions so as to make them
WTO (World Trade Organisation) compliant and legally
and practically enforceable;

— to regulate the use of information indicating that neither
a product nor its ingredients have been tested on animals,
in order to improve consumer information and ensure
that consumers are not misled.

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The definition of

‘cosmetic products’

1.2.
in Directive
93/35/EEC covers a range of products not restricted to those
generally known as beauty products. Article 1 of the directive
states that ‘a “cosmetic product” shall mean any substance or
preparation intended to be placed in contact with the various
external parts of the human body (...) or with the teeth and the
mucous membranes of the oral cavity with a view exclusively
or mainly to cleaning them, perfuming them, changing their
appearance and/or correcting body odours and/or protecting
them or keeping them in good condition’.

1.2.1.
Annex 1 of Directive 76/768/EEC defines the types
of products covered. Examples range from toilet soap, bubble
bath, shampoo and toothpaste to sun-tan lotion, moisturisers,
skin food, perfumes and make-up products.

1.2.2.
Since these cosmetic products are for everyday use
throughout life, they must not be harmful, either immediately
(e.g. allergic reactions) or in the long term (e.g. leading to
cancer or birth defects). To protect human heath, the safety of
the finished product and its ingredients must be assessed,
taking into consideration the general toxicological profile
of each ingredient,
its chemical structure and the level of
exposure.

For reasons of consumer protection, it is not possible
1.3.
to abandon safety testing. The directive contains lists of
prohibited substances, substances subject to restrictions and
requirements, and authorised substances. These lists are regu-
larly adapted to take account of technical progress, after the
Scientific Committee on Cosmetic Products and Non-Food
Products (SCCNFP) has delivered its opinion.

on animals after 30 June 2000 does not become a form of
discrimination contrary to WTO rules and in particular the
provisions of Article III (4) of the GATT.

For finished cosmetic products, the Commission there-
1.6.
fore proposes to ban animal experiments in the Member States
from the date of implementation of the directive by the
Member States. For ingredients, the ban on animal experiments
should be introduced within three years, subject to publication
in the Official Journal of alternative methods that have been
scientifically validated and officially endorsed by the European
Centre for the Validation of Alternative Methods (ECVAM) and
deemed applicable to cosmetic products by the SCCNFP,
provided those alternative methods offer ‘an equivalent level
of protection for the consumer’ [Article 4a 1(b)]. This ban on
experiments does not mean a ban on marketing cosmetic
products tested on animals, in order to prevent discrimination
between products of different geographical origin, which
would infringe current marketing rules and international law.

To improve the information supplied to the consumer,
1.7.
the proposal also offers the manufacturer or person responsible
for placing the cosmetic product on the market the possibility
to claim that no animal tests have been carried out (either
its prototype or its
directly or indirectly) on the product,
ingredients. Guidelines will be provided containing specific
provisions designed to ensure that common criteria are used,
that only one interpretation is possible, and above all, that
consumers cannot be misled.

1.8.
Finally, the draft directive includes formal measures,
adjusting the names of the Scientific Committee on Cosmetic
Products and Non-Food Products intended for Consumers
(SCCNFP) and the Standing Committee on Cosmetic Products,
and establishing decision-making procedures following the
adoption of Council Decision 1999/468/EC of 28 June 1999,
laying down procedures for the exercise of implementing
powers conferred upon the Commission.

1.4.
Ethical concerns regarding respect for life have been
raised by public opinion and are shared by the scientific
community and by many public authorities and institutions,
as well as by the parties concerned. These demand a reduction
in the number of tests and animals used, and in the duration
of tests and the suffering caused and, wherever possible and as
soon as possible, the elimination of all animal testing, provided
that consumer safety is guaranteed.

2. General comments

1.5.
For the measures adopted to be effective and enforce-
able, account must be taken of the constraints arising from
international trade rules, in particular those of the World Trade
Organisation (WTO), ensuring that the prohibition of the
marketing of cosmetic products containing ingredients tested

2.1.
The Committee endorses the aims and objectives of
the draft directive which, as part of its primary purpose of
protecting public health by means of toxicological tests to
evaluate the safety of cosmetic products for human health,
also aims to progressively abolish animal experiments, insofar
as this is possible, and clarifies the practical procedures and
timetables for making the prohibition of such experiments
effective on the territory of the Member States.

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2.2.
The draft directive gives a clear outline of the scope of
the ban on ingredients and their combinations, an area that
had previously been subject to divergent interpretations and
applications. It also lays down deadlines for implementing the
ban: three years from the date on which the Member States
put the directive into effect, possibly extended by two years
where alternative methods scientifically validated as offering
an equivalent level of consumer protection have not been
developed.

2.5.
The Committee approves of the innovative approach
of using regulatory acceptance at European level as a means of
opening the door to the legal acceptance of alternative
experimentation methods. The Union is thus leading the way
in the legal acceptance of harmonised alternative methods,
removing the need for acceptance by all OECD members,
which can take several years.

The Committee is aware that

2.2.1.
the development,
validation, standardisation and regulatory acceptance of alter-
native methods is a complex, difficult process, as acknowledged
in the Commission’s proposal, which notes that only three
alternative methods have been validated to date in spite of the
efforts made since the adoption of Directive 93/35/EEC (the
‘sixth amendment’ of Directive 76/768/EEC). The Commission
also suggests that the prospects are less promising for research
into long-term effects and certain acute effects to the skin and
eyes (difficulty in standardising certain types of in vitro tests,
e.g. for skin sensitivity and eye irritation).

2.2.2.
The Committee agrees that clear objectives should
be set for the progressive reduction and eventual prohibition
of animal testing, and hopes that every effort will be made to
comply with the dates indicated, provided that consumer
safety is not compromised. The Committee however proposes
that the deadline be extended if it proves impossible to secure
the expected results.

2.3.
The moral objective of applying the ‘three “R”s rule’
(replacing the use of animals, reducing their number, and
refining techniques) will require an additional research effort
on the part of the Joint Research Centres, private and university
research establishments and national research bodies. The
Committee calls on the Commission to do all it can to locate
appropriate resources, especially under the fifth framework
programme and for the ECVAM.

2.6.
The Committee also welcomes the Commission’s
undertaking to step up negotiations within the OECD to
ensure genuine acceptance of alternatives to animal testing on
a global scale, and to secure mutual recognition of data
demonstrating the safety of products and ingredients by
means of alternative validated and standardised methods (thus
preventing the repetition of studies using animal models).

The Committee is concerned about the additional cost
2.7.
to industry — SMEs in particular — that the ban on animal
tests will entail, especially in terms of global competitiveness if
third countries do not promptly apply the methods that are
validated and accepted in the EU.

2.7.1.
The Committee urges the Commission to ensure that
the new European legislation does not create distortions in the
single market and in trade flows with other regions to the
detriment of European products.

Commission intervention,

2.8.
in conjunction with the
Member States, is needed to draw up guidelines for better and
more comprehensive consumer information, with a view to
preventing confusion, abuse, and the risk of consumers being
misled. Experience shows that finished cosmetic products
often claim not to have been tested on animals but give no
information on ingredients, and that there is a tendency to
present ‘natural’
ingredients as if they were exempt from
testing requirements. The Committee recognises the validity of
the relevant work being carried out by the Commission, and
suggests that precise rules and guidelines for labelling in this
area be applied as soon as they become available, irrespective
of the stage reached by the present draft directive in the
legislative process, which could be very lengthy.

2.4.
The Committee fully endorses the Commission’s com-
mitment to publish details of alternative methods that have
been validated at Community level immediately (approved by
the ECVAM and given a positive assessment by the SCCNFP as
to their applicability in the cosmetics industry) with a view to
guaranteeing the safety of the ingredients and combinations of
ingredients used, providing those methods offer an equivalent
level of consumer protection to animal experiments. Such
methods should be disseminated using all available means, and
the industry should apply them as speedily as possible.

Article 4a(3) states that until the entry into force of the
2.9.
prohibition referred to under paragraph 1(b) of Article 4(a),
the Commission is to present an annual report to the European
Parliament and the Council on progress in the development,
validation and legal acceptance of alternative methods to those
involving animal experiments. This report should contain not
only accurate data on the number and type of animal
experiments relating to cosmetic products, but also infor-
mation on the adverse reactions encountered (as laid down by
Directive 93/35/EEC, which has not been fully implemented
by the Member States) and the risks to human health
demonstrated.

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2.10.
The information which the Member States must
forward to the Commission regarding the sector covered by
Directive 76/768/EEC and subsequent amendments, particu-
larly the sixth amendment under Directive 93/35/EEC,
is
sometimes late or inaccurate. The Committee calls upon the
Commission to be more vigilant in this respect and to prepare
a general framework on the national legal provisions adopted
in the meantime by the Member States, and on how they are
applied.

3.

Specific comments

3.1.
Consumer safety must be the primary focus, especially
for certain sections of the population, such as children under
the age of three. An assessment should therefore be made as
to whether broader restrictions (e.g. regarding fragrances)
should apply to the lists of ingredients allowed in products
destined for infants.

3.2.
The continued growth of allergic diseases and the
massive rise in allergies, linked to air pollution and foodstuffs,
would suggest that the range of methods used should be
widened beyond toxicological tests to include the study of
possible side-effects, and that these should be mentioned on
the label.

3.3.
Aromatic and perfumed substances of a highly com-
plex nature — sometimes unknown or concealed by industrial
secrets — are widely used through the entire range of cosmetic

Brussels, 20 September 2000.

products: this structural complexity makes it impossible to
specify each individual ingredient on product labels. However,
such substances should be indicated by an appropriate term
on the label, at least when they have a proven capacity to
produce allergic reactions.

3.4.
The use of substances which are carcinogenic, muta-
genic or toxic to reproductive organs, under the list of
dangerous substances referred to in Directive 67/548/EEC,
should be prohibited, as should more generally, the use of
substances which have been shown to produce significant
allergic reactions, given the length of time that consumers use
cosmetic products.

3.5.
The producers and suppliers of ingredients and inter-
mediates for cosmetic products should provide the Member
States and the Commission with information on toxicity
studies already included in the Safety Dossier and Material
Safety Data Sheet, so that they can, if necessary, act more
effectively and swiftly to protect public health.

3.6.
Clear and comprehensive labelling should include the
use-by date, subject to the verification of data on the stability
of the finished product, which the producer should provide in
the dossier.

3.7.
The alternative methods mentioned in point 2.2 of the
explanatory memorandum do not specifically include tests
based on human or animal cell culture. These should be
considered for possible use in toxicological tests as regards
both short- and long-term effects.

The President

of the Economic and Social Committee

Beatrice RANGONI MACHIAVELLI