14. 10. 91 Official Journal of the European Communities No C 269/15 
Opinion on the proposal for a Council Directive amending for the sixth time Directive 
76/768/EEC on the approximation of the laws of the Member States relating to cosmetic 
products (!) 
(91/C 269/04) 
On 22 February 1991 the Council decided to consult the Economic and Social Committee, 
under Article 100a of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The section for Protection of the Environment, Public Health and Consumer Affairs, which 
was responsible for preparing the Committee's work on the subject, adopted its Opinion on 
4 June 1991. The Rapporteur was Mr Proumens. 
At its 288th plenary session (meeting of 4 July 1991) the Economic and Social Committee 
adopted the following Opinion unanimously. 
The Committee approves in principle the proposal for 
a sixth amendment, subject to the following consider­
ations and comments. 
1. Background 
1.1. Since its publication, Cosmetics Directive 
76/768/EEC has been amended five times (Council 
Directives) and adapted thirteen times (Commission 
Directives). 
1.1.1. The text has also been the subject of a proposal 
for a Council Directive [SEC(90) 1985 final] consolidat­
ing the basic Directive and all existing amendments and 
adaptations in order to make the document easier to 
read and use. This latest proposal [SEC(90) 1985 final] 
has still to be approved. 
1.2. Since 1983 the Commission, the competent 
authorities of the Member States and the industries 
concerned have all called for a major reform of the 
Cosmetics Directive. 
1.3. In this general context a symposium, attended 
not only by the Commission, the Member States and 
industry, but also by representatives of the scientific 
community, was organized in Belgium in March 1984 
under the title of 'Biotechnologie et Objectivation des 
Produits Cosmetiques'. 
1.4. The conclusions reached at this symposium have 
led to an in-depth study of Directive 76/768/EEC. 
1.5. The final outcome of this study has been a 
Commission proposal amending the Directive for a 
sixth time. Some of the provisions of the sixth amend­
ment differ from the symposium's conclusions. 
1.6. The consumer lobby has also urged that more 
information be made available, notably via labelling. 
(!) OJ No C 52, 28. 2. 1991, p. 6. 2. General comments 
2.1. The Commission considers it important to 
amend Directive 76/768/EEC for a sixth time in order 
to harmonize the conditions under which its provisions 
are applicable in all the Member States. 
2.2. The basic Directive had already been published 
by the time Greece, Spain and Portugal joined the EEC. 
2.3. It must also be remembered that in 1975, i.e. 
one year before publication of the basic Directive, 
France had already adopted a number of national pro­
visions. These French provisions, which have not been 
changed, are not always compatible with the Articles 
of Directive 76/768/EEC. 
2.4. Although, at the request of the Commission or 
industry, legal proceedings were instituted before the 
Court of Justice in an attempt to obtain harmonization, 
coercive measures were halted when the Court was 
informed that work had begun on the sixth amendment. 
The Court rulings have subssequently been held over. 
3. Scope of the amendments 
3.1. The sixth amendment changes the original pro­
visions in the following areas: 
a) the definition of cosmetics (Article 1 of Directive 
76/768/EEC); 
b) the safety of cosmetics (Article 2); 
c) the inclusion of an inventory of ingredients; 
d) information to appear on containers and packaging 
(Article 6); 
e) the labelling of products; 
f) amendments to Article 7 with medical treatment in 
mind; 
g) the introduction of a provision concerning the mak­
ing available of a 'dossier'; 
No C 269/16 Official Journal of the European Communities 14. 10. 91 
h) amendments to Article 8(2). 
3.2. Comments on these various points are to be 
found below. 
ANALYSIS OF THE AMENDMENTS 
4. Definition of the product 
4.1. The Commission thought it necessary to amend 
this definition to make it more consistent. 
4.2. Even if the existing definition has not posed any 
particular problems, there seem to be no difficulties in 
accepting the new wording. 
5. The safety of cosmetics 
5.1. Firstly, the new text is more precise about the 
notion of 'damage,' the words 'liable to cause damage' 
being replaced by 'cause damage'. 
5.2. Secondly, the Commission adds the concept 
'reasonably foreseebale'. According to the Commission 
this does not include improper or deliberate misuse of 
the product. 
5.3. The Commission has amplified Article 2 by 
referring to the need to take into account communi­
cations made by the manufacturer. 
5.3.1. The aim of these provisions is to encourage 
the manufacturer to supply information, even if this is 
not mandatory. 
5.3.2. Such information will help consumers and 
users such as hairdressers and/or beauticians to avoid 
making mistakes. 
5.3.3. By providing information, manufacturers, 
authorized agents or others responsible for placing cos­
metics on the market will be showing a greater sense 
of responsibility. 
5.4. However, it is necessary to bear in mind that 
cosmetic products for babies, however well-thought-
out their formulation, should carry special warnings 
drawing the attention of parents to the need to avoid 
accidents resulting, for example, from ingestion by 
infants. 5.5. As already happens in some Member States, 
those responsible for selling cosmetic products to pro­
fessional users should also be under an obligation to 
systematically point out that protective gloves must be 
worn with certain products, depending on the number 
of applications per day (shampoos; perm liquids and 
their neutralizers; oxidizing colouring agents). 
5.5.1. As far as professional users of cosmetic prod­
ucts are concerned (hairdressers and beauticians), the 
Committee considers that the Commission should re­
commend that the Member States make it obligatory 
that vocational training comprises fundamental know­
ledge about health and safety risks and how to avoid 
them. 
Furthermore it should be recommended that students 
of vocational training establishments know about the 
demands that must be fulfilled in establishing a hair­
dresser's shop or beauty parlor with proper health 
and safety conditions. This of course also comprises 
knowledge about how to choose the right products and 
how to use them in such a way that risks can be 
avoided. 
6. Compilation of an inventory of ingredients 
6.1. The Commission proposes to insert an 
Article 5a which introduces a new idea, namely the 
requirement to compile an 'inventory'. 
6.2. The inventory is intended to form the basis for 
a common nomenclature of ingredients. 
6.3. The common nomenclature is the central pillar 
of the labelling provisions discussed under point 8 of 
this Opinion. 
6.4. The notion of a common nomenclature is also 
referred to in the second recital of the proposal under 
discussion. 
The Committee would urge the Commission to do 
everything in its power to ensure that the common 
nomenclature is drawn up within as short a time as 
possible. 
6.5. The Commission should nevertheless say pre­
cisely what it means by 'common nomenclature'. Unless 
it does so, producers as well as those responsible for 
its compilation at national or Community level, might 
arrive at different interpretations. 
6.6. In this connection, and assuming once more a 
precise definition of the notion of common nomencla­
ture, it is clear that the information to be included in 
the inventory can only be provided by the producers 
themselves and, in a subsidiary capacity, by the sup-
14. 10. 91 Official Journal of the European Communities No C 269/17 
pliers of the substances in question, in accordance with 
the provisions of other existing Directives. 
6.7. It must be remembered however that the inven­
tory is indicative and is not intended to constitute an 
exhaustive list of substances used in cosmetic products 
[second recital and Article 5a (3)]. 
6.7.1. Since the inventory is no more than indicative 
and is basically intended for the purpose of drawing up 
the common nomenclature, it is accepted that firms are 
not likely to provide Member States with information 
about one or more of the ingredients it uses. 
6.7.2. However, since the labelling must indicate the 
common nomenclature, firms are required to provide 
information in the interest of ensuring that any new 
ingredient or ingredients is included. 
6.73. It goes without saying that firms should not 
be required to wait until the Commission has consulted 
the Scientific Committee on Cosmetology before being 
able to use the ingredient or ingredients in question. 
Any other measure, including mention in one of the 
Community languages other than that used for the 
common nomenclature, would be tantamount to a 
registration procedure, which is out of the question 
besides being incompatible with the scope of the inven­
tory as defined in Article 5a(3). 
6.7.4. Nevertheless it is clear that a producer who 
uses a new substance can be questioned by the Scientific 
Committee on Cosmetology with a view to providing 
all necessary information to enable the latter, as a last 
resort and on the basis of hard scientific evidence, to 
restrict or even ban the use of the substance in a 
cosmetic product. 
6.8. Since 'perfumes and aromatic compositions' will 
simply be referred to by the general word 'perfume' in 
the labelling, it would appear, ipso facto, that ingredi­
ents forming part of perfume and aromatic compo­
sitions do not have to be mentioned in the inventory. 
6.9. Article 5(a)(2) describes in some detail the infor­
mation to be recorded in the inventory. 
Various forms of presentation have been envisaged, 
including the dictionary of the CTFA (Cosmetics, Toil­
etries and Fragrances Association, USA) or the 
UNIPRO inventory (Italian Association for Cosmetic 
Products), currently at an advanced stage of prep­
aration. 
6.9.1. The two methods, the CTFA dictionary and 
the UNIPRO inventory, have advantages and disadvan­
tages. It will be up to the cosmetics industry itself to decide what method to use. It could be a hybrid sol­
ution, combining the advantages of both systems to 
become a purely European system linked in particular 
to the EINECS inventory set up by the Commission to 
cover all chemical substances. 
6.10. The Committee wonders whether it is necess­
ary to make special mention of the function or functions 
of ingredients not already included in existing positive 
lists (which the Commission intends to maintain in 
full). 
6.11. Furthermore, the restrictions, conditions of use 
and warnings could be replaced by a reference to the 
text of the Directive which sets out the relevant stipu­
lations in its Annexes. 
6.11.1. It also goes without saying that where 
ingredients are not included in the said Annexes, the 
onus is on the manufacturer to communicate—if 
necessary and in the obvious interests of all parties— 
all the restrictions, warnings and conditions of use he 
considers should be included in the labelling in the 
widest sense of the term, having particular regard to 
the new Article 2 (cf. point 5.4). 
6.12. Given the indicative nature of the inventory, it 
is clear that there can be a great deal of flexibility 
regarding the frequency of its updating. 
6.13. The Committee wonders to what extent con­
sumers, and even family practitioners or doctors 
engaged in occupational medicine, will find the termin­
ology of a precisely-defined common nomenclature easy 
to understand. 
Deciding on the type of language to be used will cer­
tainly pose problems. 
The Committee therefore wonders whether consumer 
associations, working in close conjunction with cos­
metics trade associations and the relevant medical 
circles, could not draw up some sort of vade mecum in 
the national language or languages. 
In this respect it is worth noting that a Consumer's 
Dictionary of Cosmetic Ingredients exists in the United 
States. Consumer's associations could doubtless draw 
on this Dictionary whilst taking into account the par­
ticular situation in the European Community. 
7. Information appearing on containers and packaging 
7.1. The amendments to Article 6 referred to in 
paragraphs 4 and 5 do not pose any specific problems 
for the Committee. 
7.2. The Committee takes good note of the inclusion 
of an Annex VIII showing the pictorial symbol to be 
No C 269/18 Official Journal of the European Communities 14. 10. 91 
used to refer the consumer to an enclosed leaflet. The 
pictogram nevertheless needs to be improved if it is to 
be comprehensible and helpful to consumers. 
8. Labelling of products 
8.1. The Committee considers that the presentation 
(as opposed to the description) of a product may obviate 
the need to mention the product's function. For exam­
ple, 'toothpaste' does not require explanations for the 
consumer. 
8.2. The Committee is in favour of mandatory label­
ling, as described, in order to preclude distortions of 
competition and technical barriers; but this can only 
be achieved after the Commission has drawn up the 
common nomenclature. 
8.3. The requirements regarding the composition of 
cosmetic products to be included in the labelling should 
be spelt out carefully and in detail so that Member 
States are not tempted, at national level, to call for 
information over and above that which is envisaged 
under the Directive. 
9. Medical information 
9.1. In the French version of the new Article 7(3) of 
Directive 76/768/EEC, the requirement becomes absol­
ute not conditional ['exige (require) not 'peut exiger' 
(may require)]. 
9.2. According to the Commission, 'made available' 
means the preliminary gathering of information so that, 
in the event of an accident, the competent authorities 
can take action within the shortest possible time. 
9.2.1. However, the Committee wonders whether, 
before complex information is provided, the Com­
mission should not encourage the Member States to 
harmonize arrangements whereby a 'competent autho­
rity' would be asked to deal with cases of poisoning. 
Such an arrangement is still a long way from having 
been achieved. 
9.2.2. From a practical point of view, the simple 
procedure of submitting packages containing the infor­
mation required by the Directive could give the com­
petent authorities enough to go on to solve any prob­
lems of poisoning. 
Firms might of course also provide qualitative formulae 
instead of packages. 
9.3. As far as quantitative aspects are concerned, any 
change would entail a great deal of updating work by firms and competent authorities, even though the 
practical value would be virtually nil and even though 
it is an open secret that cases of poisoning due to 
cosmetic products are rare and in nearly all instances 
without serious consequences. 
9.4. Steps must be taken to ensure that an overcom­
plicated administrative system does not impose an 
excessive work-load on existing Poison Centres, thereby 
decreasing their efficiency. 
10. Compilation of a dossier 
10.1. France has had a dossier system since 1975. 
Greece and Portugal had dossier systems when they 
joined the EEC and Spain has set one up in the mean­
time. 
10.1.1. The contents of the dossier are not the same 
in all the four Member States mentioned above so it is 
important to align them. 
10.1.2. The various consultations held by the Com­
mission reveal that a dossier such as this is a vital 
element in monitoring cosmetics placed on the Com­
munity market. 
10.2. It is important to remember that the dossier is 
kept available for the competent authorities of the 
Member States concerned at the place of manufacture 
or place of importation designated by the manufacturer. 
10.2.1. The Commission should specify what is 
meant by 'place of manufacture'. 
In big firms the dossier may be kept at head office or 
in a research centre whilst there may be several places 
of manufacture where no dossiers are kept. 
11. Specific comments 
11.1. The Committee wonders to what extent the 
principle of monitoring cosmetic products has been 
jettisoned by the Commission. 
11.2. The introduction of such a system would 
appear to be premature. 
11.2.1. The Council has recently adopted a Resol­
ution on improving the prevention and treatment of 
acute human poisoning (OJ No C 329, 31 December 
1990). The data to be gathered from poison centres in 
accordance with this Resolution could deal explicitly 
with the relatively minor problems of poisoning due to 
cosmetic products. 
14. 10. 91 Official Journal of the European Communities No C 269/19 
12. Animal experiments 
12.1. With regard to the use of laboratory animals, 
the Commission confirms that it has held consultations 
with animal protection societies of various persuasions. 
12.2. Some associations go to extremes and impose 
an immediate ban on the use of animals for laboratory 
experiments involving cosmetic products. 
Other associations, on the other hand, who are trying 
to stop or at any rate significantly cut back on the use 
of laboratory animals would like to know or at least 
have some idea of what the real situation is regarding 
cosmetics tested in laboratories. 
Reasonably detailed information should be provided 
and industry should report on the so-called alternative 
solutions now available. 
12.3. It is also important for the Scientific Committee 
on Cosmetology, in carrying out its essential functions, 
not to systematically call for more testing, possibly 
involving alternative methods, in addition to the testing 
already done. 
12.4. In this respect it would be worthwhile forging 
an official link with Directorate-General XI which cur-
Done at Brussels, 4 July 1991. rently centralizes information on the testing of chemical 
products. 
12.5. The Commission should support research into 
alternative, effective methods so that tests on animals 
can be avoided; this is being looked into. 
13. Amendment to article 8(2) 
13.1. This amendment extends the 'Committee pro­
cedure' to Annex 1. The Committee queries this exten­
sion which seems, a priori, to be unnecessary. 
14. Implications for small and medium-sized enter­
prises (SMEs) 
14.1. The Committee would draw the Commission's 
attention to the increased costs which will be generated 
to SMEs both by the new labelling provisions and by 
the need to employ a production representative, even 
though the latter may work part-time and offer his 
services to other SMEs at the same time. The qualifi­
cations required must be specified (ambiguity of the 
term 'natural sciences') and adequate professional 
experience must also be regarded as an equivalent quali­
fication. 
The Chairman 
of the Economic and Social Committee 
Francois STAEDELIN