Amended 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 (presented by the Commission pursuant to Article 250(2) of the EC Treaty)
Date: 2001-11-22
Institutions: European Commission
Subjects: animal experimentation, approximation of laws, consumer protection, cosmetic product, marketing

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Amended 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 (1)

(2002/C 51 E/32)

COM(2001) 697 final (cid:151) 2000/0077(COD)

(Submitted by the Commission pursuant to Article 250(2) of the EC Treaty on 22 November 2001)

1. Background

Transmission of the Proposal to the Council and the European
Parliament (COM(2000) 189 final (cid:151) 2000/0077 (COD))
in
accordance with Article 175(1) of the Treaty: 6 April 2000

Opinion of the Economic and Social Committee: 20 September
2000

Opinion of the European Parliament (cid:151) first reading: 3 April
2001.

2. Objective of the Commission proposal

the initial proposal was

The main objective of
to settle
definitively the question of animal
testing in the cosmetic
legislative provisions providing the
current
sector. The
prohibition on the marketing of cosmetic products containing
ingredients or combinations of ingredients tested on animals
after 30 June 2000 (30 June 2002 following the second post-
ponement by Commission Directive 2000/41/EC) shall be
amended so as to make them WTO-compliant,
legally and
practically enforceable, thereby offering a genuine benefit to
animal welfare.

The main elements of the initial proposal were:

(cid:151) the introduction of a permanent and definitive prohibition
finished

tests on animals

for

on the performance of
cosmetic products;

(cid:151) a switch from a marketing ban to a testing ban WTO
compliant for ingredients and combinations of ingredients
used in cosmetic products. The date of implementation of
this ban is foreseen three years after the date of implemen-
tation of the proposed Directive. However,
it should be
postponed for no more than two years if there has been
insufficient progress in developing satisfactory methods to
replace animal testing scientifically validated;

(cid:151) a commitment

that EU will
national acceptance of alternative methods,
through the
adoption of
negotiations at OECD level;

take the lead in the inter-
in particular
and

agreements

bilateral

(cid:151) to allow the use of claims indicating that animal testing has
not been performed. However, to ensure that such claims
do not mislead the consumer, the Commission, in consul-

(1) OJ C 311 E, 31.10.2000, p. 134.

tation with the Member States, will publish guidelines in
order to clarify their use.

In its amended proposal, the Commission has incorporated
many suggestions of the European Parliament, which aim to
improve health and consumer protection.

3. Commission opinion on the amendments adopted by

the Parliament

3.1. Amendments accepted in part or principle by the Commission: 1
(1st part), 2, 4, 5, 7 (2nd part), 9 to 12, 14 (2nd and 3rd
parts), 15 (2nd part (cid:151) with the exception of the suggested
consultation of the European Parliament), 16 to 19, 23 (2nd
part), 26, 30, 32 and 49 (2nd part)

in principle the first part of
The Commission can accept
amendment 1 and amendment 2 which propose
the
inclusion of a reference to Directive 86/609/EEC relating to
the protection of animals used for experimental and other
suggested in
scientific purposes. However,
amendment 2 would be more relevant
in recital 2 (as
suggested by amendment 1) than recital 3 which relates to
the testing ban for finished products. To this end, recital 2
should be amended as follows:

reference

the

laws, regu-
(cid:145)Directive 86/609/EEC on the approximation of
lations and administrative provisions of
the Member States
regarding the protection of animals used for experimental
and other scientific purposes aims to ensure that the number
of animals used for experimental purposes is reduced to a
minimum. In accordance with Directive 93/35/EEC amending
for the sixth time Directive 76/768/EEC, it is essential that the
aim of abolishing animal experiments be pursued and that the
prohibition of such experiments becomes effective on the
territory of the Member States.(cid:146)

The Commission can accept in principle amendments 4 and 5
subject to the following rewording:

tests,

in particular

(cid:145)In order to facilitate the rapid development of non-animal
alternative
are
commonly used by other sectors and specified as regulatory
requirements in the Community, more coordinated action is
needed at
including
funding of relevant scientific research.(cid:146)

the Community and national

tests which

levels,

those

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(cid:145)The Commission has earmarked EUR 17,5 billion for the new
framework programme for research and innovation in Europe
over the period 2003-2006.
the policy of
reduction, refinement and replacement of animal tests will be
continued.(cid:146)

In this context,

in principle the 2nd part of
The Commission can accept
amendment 7, as all
including the NGOs,
interested parties,
are consulted in the drafting of the guidelines, subject to the
following rewording:

The date of minimum durability of a cosmetic product shall be
the date until which this product, stored under appropriate
conditions, continues
in
particular, remains in conformity with Article 2.

function and,

to fulfil

initial

its

The date of minimum durability shall be indicated by the date
itself followed by the symbol (cid:147)+(cid:148). The date shall be clearly
expressed and shall consist of either the month and year or
the day, month and year in that order.

(cid:145)In developing such guidelines, the Commission will consult all
interested parties, including the relevant NGOs.(cid:146)

If necessary,
indication of
guarantee the stated durability.(cid:146)

this information shall be supplemented by an
the conditions which must be satisfied to

Directive 76/768/EEC already requires the safety assessment of
products based on their intended and foreseeable use. However,
the Commission can accept the principle of amendment 9
aiming to specify the
cosmetic
products
to the following
rewording:

intended for children,

safety requirements

subject

for

(cid:145)Special
concerning the safety of products intended for children.(cid:146)

should be provided by

guidance

the SCCNFP

The Commission can accept in principle amendment 10 and
the third part of amendment 14, dealing with substances which
are carcinogenic, mutagenic and toxic for the reproduction
under the Dangerous substances Directive. Under Directive
76/768/EEC, cosmetic products are already required not
to
the mandatory safety
cause any harm to human health,
including potential
assessment provided by Article 7a(1)
mutagenic, carcinogenic or reprotoxic effects. Furthermore,
this issue is already taken into account by the Commission
on a horizontal basis in the proposed White Paper on the
new chemical policy which plans to ban the use of substances
classified in categories 1 or 2 as carcinogenic, mutagenic or
toxic for reproduction under Annex 1 of Directive 67/548/EEC,
except by following a procedure of authorisation providing that
companies show their safe use for certain purposes. Therefore,
there is no need for a specific provision in Directive
76/768/EEC.

The Commission can accept in principle the suggestions of
amendments 11, 32 and 30 aiming at improving information
provided to consumers regarding the minimum durability of
cosmetic products, subject to the following rewording:

The Commission can accept in principle amendment 12, the
second part of amendment 23 and amendment 49 which
require the information on the presence in cosmetic products
of fragrance ingredients with well-recognised potential to cause
contact
allow consumers,
allergy. This
to avoid cosmetic products
sensitive to these substances,
unsuitable to them. The labelling of such ingredients through
an amendment of the current Article 6(1)(g) would answer the
concerns. To this end, the following rewording is proposed:

information will

(cid:145)Certain substances have been identified as an
In the recital:
important cause of contact-allergy reactions
in fragrance-
sensitive consumers. In order to ensure that these consumers
are adequately informed, it is therefore necessary to amend the
provisions of the Directive so as to require the mention of
these substances in the list referred to Article 6(1)(g), regardless
of their source or function. This information will improve the
diagnosis of contact allergies in this population and will enable
sensitised consumers to avoid products they may not tolerate(cid:146).

Article 6(1)(g) should be amended as follows:

(cid:145)(g) a list of ingredients in descending order of weight at the
time they are added. That list shall be preceded by be the
word (cid:147)ingredients(cid:148). Where that is impossible for practical
tape or card must
reasons, an enclosed leaflet,
contain the ingredients to which the consumer is referred
either by abbreviating information or the symbol given in
Annex VIII, which must appear on the packaging.

label,

The following shall not, however, be regarded as ingredients:

In the recital: (cid:145)In order to improve the information provided to
consumers, cosmetic products should bear more precise indi-
cations concerning the durability of their use.(cid:146)

(cid:151) impurities in the raw materials used,

Article 6(1)(c) should be amended as follows:

(cid:151) subsidiary technical materials used in the preparation but

not present in the final product,

(cid:145)(c) the date of minimum durability.

(cid:151) materials used in strictly necessary quantities as solvents or

as carriers for perfume and aromatic compositions.

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Perfume and aromatic compositions and their raw materials
shall be referred to by the word (cid:147)parfum(cid:148) or
(cid:147)aroma(cid:148).
However, the presence of substances, the mention of which
is
and
requirements(cid:148) of Annex III, Part 1, shall be indicated in the
list, irrespective of their function in the product.

required under

column (cid:147)other

limitations

the

Ingredients in concentrations of less than 1 % may be listed in
any order after those in concentrations of more than 1 %.

Colouring agents may be listed in any order after the other
ingredients,
in accordance with the colour index number or
denomination adopted in Annex IV.

For decorative cosmetic products marketed in several colour
shades, all colouring agents used in the range may be listed,
provided that the terms (cid:147)may contain(cid:148) or the symbol (cid:147)–(cid:148) are
added.

restricted to existing ingredients should be reviewed to be
implemented in a non-discriminatory manner.

The Commission can accept
in principle amendment 16
regarding the definition of finished products, subject to the
following rewording:
shall
mean the cosmetic product in its final composition, as placed
on the market and made available to the final consumer(cid:146).

(cid:145)A (cid:147)finished cosmetic product(cid:148)

The Commission can accept in principle the second part of
amendment 14, amendments 17, 18 and 19, which require
additional
information to be included in the Annual Report
made by the Commission, taking into account that the work
done at OECD level
is already part of the existing Annual
Report. However, in order to ensure a substantive evaluation
of the progress made and the collection of appropriate data, it
is proposed to present
the report on a three-year basis.
Therefore, the following rewording of the provision dealing
with the Report is proposed:

An ingredient must be identified by the common name referred
to in Article 7(2) or, failing that, by one of the names referred
to in Article 5a(2), first indent.

(cid:145)Every three years the Commission shall present a report to the
European Parliament and the Council. That
shall
contain:

report

for

In accordance with the procedure laid down in Article 10, the
the criteria and conditions under
Commission may adapt
which a manufacturer may,
trade secrecy,
apply not to include one or more ingredients on the above-
mentioned list provided by Commission Directive 95/17/EC of
19 June 1995 laying down detailed rules for the application of
Council Directive 76/768/EEC as regards the non-inclusion of
one or more ingredients on the list used for the labelling of
cosmetic products.(cid:146)

reasons of

The Commission would accept the principle of the listing of
the recognised fragrance allergens in the Annex III according to
the modalities suggested in amendment 49 (setting of threshold
levels suggested by the SCCNFP),
in line with the proposed
amended Article 6(1)(g). However, according to Article 8(2)
of Directive 76/768/EEC, the proposed adaptation of Annex
III, part 1, has to be done via a Commission Directive
such
adopted under
technical adaptation should be done after the final adoption
of the Directive amending Article 6(1)(g), which would give the
legal basis for such a technical adaptation.

the comitology procedure. Therefore,

The Commission can accept to consider the principle of an
introduction of a derogation to the full testing ban for safety
reasons proposed by the second part of amendment 15 (with
the exception of the suggested consultation of the European
consumer
Parliament),
the
protection and public health,
expected progress
to
replace animal testing. However, the system of such derogation

taking into account of
in developing satisfactory methods

the key objectives of

to ensure

(a) an account of the progress in the development, validation
and legal acceptance of alternative methods
to those
involving experiments on animals. It shall contain precise
data on the number and type of experiments relating to
cosmetic products carried out on animals. The Member
information in
States
addition to collecting statistics as laid down by Directive
86/609/EEC on the protection of animals used for experi-
mental and other scientific purposes;

shall be obliged to collect

that

(b) an account of the progress made by the Commission in its
efforts
to obtain acceptance by the Organisation for
Economic Cooperation and Development (OECD) of alter-
native methods validated at Community level, and to
obtain, within the framework of bilateral agreements with
third countries, recognition of the results of tests carried
out in the Community using alternative methods so as not
to obstruct the export of cosmetic products for which such
methods have been used;

(c) an account of the progress made in international fora, in
particular the World Trade Organisation, to enhance the
protection of animal welfare;

(d) an explanation of how the economic and competition
needs, of small and medium enterprises in particular,
have been taken into account in the implementation of
Article 4a.(cid:146)

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in

and

intimate

children
can

for
Commission

the safety for human health of

accept
to the following rewording:

the Directive already require the safety
The provisions of
assessment of cosmetic products based on their intended and
to give particular attention to
foreseeable use. However,
hygiene
products
cosmetic
principle
the
products,
amendment 26 subject
(cid:145)(d)
the finished
assessment of
product. To that end,
take into
consideration the general toxicological profile of the ingredient,
its chemical structure and its level of exposure. He shall, in
particular, take into consideration the specific exposure charac-
teristics of the areas on which the product will be applied or of
the population for which it is intended. In particular, there
shall be a specific assessment for cosmetic products intended
exclusively for use on children under the age of three and for
cosmetic products intended exclusively for use in intimate
hygiene.(cid:146)

the manufacturer

shall

3.2. Amendments not accepted by the Commission: 1 (2nd part), 3,
7 (1st part), 13 and 14 (1st part), 15 (1st part), 20 and 21,
23 (1st part), 27 and 28, 36 and 37, 39, 43, 47 and 49 (1st
part)

The Commission cannot accept the second part of amendment
1 and amendment 36, which request
the Commission to
present other proposals, being contrary to the right of initiative
of the Commission.

The Commission cannot accept amendment 3 and the first part
of amendment 15 dealing with the EU testing ban for
ingredients. The Commission cannot accept
the deletion of
the postponement which aims to ensure the key objectives of
consumer protection and public health, taking into account the
expected progress in developing satisfactory methods to replace
animal testing scientifically validated as offering an equivalent
level of protection for the consumer. The Commission has to
ensure a high level of consumer protection and therefore to
keep the possibility to postpone in case of lack of validation of
key alternative methods for this sector.

testing. These are contrary to the intention of

The Commission cannot accept the first part of amendment 7
and amendment 47 dealing with the use of claims relating to
animal
the
Commission proposal to avoid the use of such claims that
mislead consumers by giving them the impression that none
of the ingredients contained in the products have been tested
on animals whilst such tests have necessarily been performed
on almost every ingredient at least once by someone. The aim
of
the Commission is to avoid misleading claims and give
complete information to consumers. The details should be
dealt with in the production of guidelines where all interested
parties will be involved.

The Commission cannot accept amendments 13, 21 and 28
aiming at publishing all data concerning each cosmetic

in the Inventory. Such information is part of
information required for

the
product
product
the effective in-market
control system established by the 6th amendment to ensure
free movement of goods while ensuring consumer safety.
the Inventory of cosmetic
This
ingredients published by the Commission. Furthermore, such
a proposal would raise concerns in terms of industry property
rights and trade secrecy, and could lead to unfair competition,
while not improving consumer information.

the purpose of

is not

The Commission cannot accept amendment 20 and the first
part of amendment 23, which aim to achieve a full ingredient
listing, including for perfume composition. Such a full labelling
of all fragrance ingredients would neither be feasible or helpful
to sensitised consumers or dermatologists and would be dispro-
these
portionate
anticipated risks.
amendments are in contradiction with amendment 12,
the
second part of amendment 23 and amendment 49, aiming at
introducing a labelling system for the fragrance ingredients
with well-recognised potential to cause contact allergy, that
the Commission has accepted in principle.

Furthermore,

to the

The Commission initial proposal provided a switch from the
marketing ban to an EU testing ban WTO-compliant, legally
and practically enforceable, thereby offering a genuine benefit
to animal welfare. The Commission cannot accept amendment
37 and the first part of amendment 14 reintroducing the
marketing ban as and when alternatives are available, with a
definitive date after which no products can be marketed if
tested on animals, whether or not there are validated alter-
natives. It is not in conformity with WTO rules and likely to
be challenged. As already stated in recital 5 of
the initial
proposal, the Commission will pursue its effort to promote
rapid international acceptance of alternative methods at
OCDE level. Having noticed the concerns of
the public
it will stimulate discussions on trade and animal
opinion,
welfare in a multilateral forum. A unilateral Community ban
on marketing would be contrary to the policy of a multilateral
approach to animal welfare trade issues. The Community has
taken a position that discussions on trade and animal welfare
(and other PPMs issues) should be done in a multilateral forum.
A unilateral action by the Community such as the proposed
marketing ban would undermine this multilateral approach.
The Commission underlines its commitment to the use of inter-
national standards as a basis for measures which have a trade
impact. The Community would be in contradiction with its
tests
international commitments
carried out on animals in third countries because of
the
mutual acceptance of data agreement. Furthermore, considering
the development of alternatives, the time scale suggested for its
implementation is not realistic. It should take into account the
and international
development
alternative
safety would not be
methods
to ensure that consumer
endangered. Only a co-ordinated approach at
international
level would improve animal welfare, and on a wider scale.

the results of

acceptance of

to accept

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The Commission cannot accept amendment 27, suggesting
additional data on animal tests performed to be included in
the product information required for each cosmetic product
put on the market. This additional requirement obliging the
the ingredients used have
manufacturer to check if any of
been once tested on animals somewhere in the world is
impossible to fulfil, and could raise concerns under the TBT
agreement (Article 5.2.3).

The Commission cannot accept amendment 43 aiming to avoid
use of fragrances in some categories except when they fulfil
specific purposes. The suggested ban would be contrary to the
principles of necessity and proportionality. The Commission
for
has already accepted to reinforce safety requirements
some categories of products such as products for children
and intimate hygiene products, as suggested by amendment 26.

labelling

The Commission cannot accept the additional requirement of a
compulsory
by
amendments 37 and 39. Such amendment is not proportionate
the TBT
and may raise concerns, among others under
agreement, as most
this
mention.

imported products would bear

required

animals(cid:146)

(cid:145)tested

on

3.3. Amended proposal

Having regard to Article 250, paragraph 2, of the EC Treaty,
the Commission amends its proposal as indicated above.