Opinion of the Advocate General — ECLI:EU:C:1998:333
Date: 1998-07-02
Language of the case: German
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Free movement of goods;Measures having equivalent effect;Approximation of laws;Quantitative restrictions
Procedure: Reference for a preliminary ruling
Origin: Austria

Summary 
I — Introduction I - 434 
II — F a a s I - 4 3 4 
III — The question referred I - 436 
IV — Is 'Odol-Med 3 (Samtweiss)' toothpaste a medicinal product or a cosmetic 
product? I - 436 
A — The Community provisions I - 437 
B — Arguments of the parties I - 438 
C — My views on the question I - 440 
(a) Community definition of 'medicinal product' and the Court 's 
case-law I - 442 
(b) Community-law definition of 'medicinal product' and 'Odol-Med 3 
(Samtweiss)' toothpaste I - 445 
V — National restrictions on the marketing of cosmetic products and Community 
law I - 4 4 8 
A — The relevant provisions of secondary Community law I - 449 
B — The arguments of the parties I - 451 
C — My views on the preliminary question I - 453 
(a) The harmonisation brought about by Directive 76/768 I - 453 
(b) National measures restricting the free movement of cosmetic products 
from the viewpoint of Directive 76/768 I - 460 
VI — Conclusion I - 464 
* Original language: Greek. 
I - 433 
OPINION OF MR COSMAS — CASE C-77/97 
I — Introduction 
1. In this case the Court has been asked by 
the Handelsgericht Wien to give a prelimi­
nary ruling on a question concerning the 
interpretation of Article 30 of the EC Treaty 
and Council Directive 76/768/EEC of 27 July 
1976 on the approximation of the laws of the 
Member States relating to cosmetic prod­
ucts. 1 The proceedings pending before the 
national court concern the marketing in Aus­
tria of toothpaste which is manufactured and 
marketed without restriction in Germany. 
II — Facts 
2. The parties to the main proceedings are 
Österreichische Unilever GmbH ('Unilever'), 
the plaintiff, and Smithkline Beecham Marke­
nartikel GesmbH ('Smithkline'), both of 
whom market cosmetic products, including 
toothpaste, in Austria. The defendant sells in 
Austria the toothpaste 'Odol-Med 3 (Samt-
weiss)' which is made in Germany by Lingner 
& Fischer. According to the order for refer­
ence, it is stated on the toothpaste tubes and 
in television advertising that 'Odol-Med 3 
(Samtweiss)' is a preventive against parodon­
tosis, contains or produces threefold prophy­
laxis, gives threefold protection against caries, 
plaque and parodontosis and removes plaque 
or reduces the formation of tartar. 2 Unilever 
specifically seeks the discontinuance of these 
statements on the ground that they are con­
trary to national law. 
3. Smithkline claims, and the national court 
agrees, that the marketing in Austria of prod­
ucts such as 'Odol-Med 3 (Samtweiss)' tooth­
paste is subject to the Law on Foodstuffs 
('LMG'), 3 Paragraph 5 of which provides that 
certain products for the care and cleaning of 
human teeth, e. g. toothpaste, are cosmetic 
products 'which are subject to certain restric­
tions and prohibitions. In particular, Para­
graph 26 of the LMG prohibits the marketing 
of cosmetic products which contain pharma­
cologically active substances not authorised, 
not conforming to the conditions of authori­
sation or in prohibited quantities, or are 
wrongly described or contain misleading ref­
erences to physiological or pharmacological 
effects. If a toothpaste contains pharmaco­
logically active substances it is also subject to 
the Regulation of the Federal Minister for 
Health and Consumer Protection on the 
authorisation of pharmacologically active 
substances in cosmetic products ('the Cos­
metics Regulation'). 4 That regulation, which 
was issued on the basis of the power con­
ferred by Paragraph 27(2) of the LMG, has 
two annexes. Annex 1 specifies seven groups 
of active substances, including substances with 
keratinising effect, substances which inhibit 
caries and substances which inhibit plaque. 
Annex 2 gives an exhaustive list of the phar­
macologically active substances which may be 
1 — OJ 1976 L 262, p. 169. 
2 — Order for reference of 20 December 1996, p. 2. 
3 — Bundesgesetz über den Verkehr mit Lebensmitteln, Verzehr­
produkten, Zusatzstoffen, kosmetischen Mitteln und 
Gebrauchsgegenständen, 23 January 1975, BGBl. 86. 
4 — Published on 12 April 1996 in BGBl. 1996, No 166. 
I - 4 3 4 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
used in the individual groups of active 
substances listed in Annex 1, the maximum 
quantities of authorised pharmacologically 
active substances, and the warning statements 
which must accompany them. In so far as 
toothpastes are, according to the Cosmetics 
Regulation, cosmetic products which come 
into contact with the mucous membranes, 
Annex 2 to the regulation applies to them and 
consequently they may contain the specified 
pharmacologically active substances only in 
the maximum quantities laid down in the 
Annex. 5 
4. According to Unilever, the problem with 
marketing Odol-Med 3 (Samtweiss)' in Aus­
tria arises from the fact that it contains only 
sodium monofluorophosphate of the per­
mitted pharmacologically active substances 
shown in the 'positive list' in Annex 2 of the 
Cosmetics Regulation, which describes the 
said substance as inhibiting caries, but it con­
tains none of the substances listed there which 
are described as preventing the formation of 
tartar or preventing paradontosis. In Uni­
lever's opinion, the statements concerning the 
toothpaste in television advertising and on 
the packaging, that the product has the effect 
5 — For the sake of completeness, I think it would be appropriate 
to set out here the national legislation ín full: 
Paragraph 5 of the LMG: 
Cosmetic products are substances which are intended for the 
cleaning, care or perfuming of human beings, for producing 
effects on their external appearance, for protecting the skin, 
or for the cleaning and care of prostheses or improving their 
use. 
Paragraph 9(1) of the LMG: 
In the marketing of foodstuffs, products for consumption and 
additives, it shall be prohibited 
(a) to refer to the prevention, relief or cure of illnesses or 
symptoms of illnesses or to physiological or pharmaco­
logical effects, particularly any which maintain a youthful 
appearance, inhibit signs of ageing, promote slimming or 
maintain health, or to create the impression of any such 
effect; 
(b) to refer to case histories, medical recommendations or 
expert reports; 
(c) to use health-related, pictorial or stylised representations 
of organs of the human body, pictures of members of the 
medical or nursing professions or of sanatoria, or other 
pictures or illustrations referring to treatment activities. 
Paragraph 26 of the LMG: 
(1) It shall be prohibited to market cosmetic products which 
(a) are detrimental to health when used for the intended pur­
pose or when used in a way which may be foreseen; 
(b) contain pharmacologically active substances or colouring 
agents which are unauthorised, do not conform with the 
conditions of authorisation or are in impermissible quanti­
ties; 
(c) have become unfit for use; 
(d) are wrongly described; 
(e) do not conform with the requirements pursuant to Para­
graph 27, 
(2) Paragraph 8(a), (b) and (0 apply mutatis mutandis, and 
Paragraph 9 applies with the proviso that non-misleading ref­
erences to physiological or pharmacological effects and illus­
trations for explaining the range of application are permitted. 
If such effects are claimed, the authorities shall be notified of 
the active ingredients on demand. 
Paragraph 17 of the LMG: 
(1) The Federal Minister for Health and the Protection of the 
Environment shall, where necessary for the protection of 
consumers against damage to health or against deception, 
taking account of the current sute of scientific knowledge 
and technology after obtaining the opinion of the Codex 
Commission, lay down by decree that certain substances are 
to be excluded or restricted in the marketing of cosmetic 
products and he shall make orders by analogy with Paragraph 
10(1), Nos. 1 to 3. For the protection of consumers against 
damage to health the Minister shall also make orders by 
analogy with the other provisions of Paragraph 10(1). In this 
connection Paragraph 10(2) applies by analogy. 
(2) The Federal Minister for Health and the Protection of the 
Environment shall, where this is compatible with the protec­
tion of consumers against damage to health and against 
deception, taking account of the current sute of scientific 
knowledge and technology after obtaining the opinion of the 
Codex Commission, authorise by decree certain substances 
with pharmacological effects and colouring agents, lay down 
conditions for their use, prescribe the requisite degree of 
purity and specify the maximum permitted quantities m cos­
metic products. 
(3) The Federal Minister for Health and the Protection of the 
Environment shall, where this is compatible with the protec­
tion of consumers against damage to health and against 
deception, taking account of the current sute of scientific 
knowledge and technology, on application authorise by decree 
unauthorised substances with pharmacological effects and 
colouring agents, lay down conditions for their use, prescribe 
the requisite degree of purity and specify the maximum per­
mitted quantities in cosmetic products. The decree must be 
subject to a time limit, but the period shall not exceed three 
years. The decree shall be rescinded if the conditions for 
authorisation are no longer fulfilled. The application for 
authorisation must be accompanied by all the ¿doumentation 
which enables the substance to be assessed. 
Paragraph 1 of the Cosmetics Regulations: 
Of the groups of active substances specified in Annex 1, only 
the pharmacologically active substances specified in Annex 2 
shall be authorised for cosmetic products in accordance with 
Paragraph 5(1) of the LMG 1975. 
The groups of active substances specified in Annex 1 are as 
follows: 
1. Substances with kerarinising effect. 
2. Substances with astringent effect. 
3. Substances which counteract irritation of the gums. 
4. Substances which inhibit caries. 
5. Substances which inhibit plaque. 
6. Substances which have a toning effect and promote blood 
circulation. 
7. Substances which have a deodorant effect. 
I - 4 3 5 
OPINION OF MR COSMAS — CASE C-77/97 
of inhibiting tartar, removing plaque and pre­
venting or inhibiting paradontosis are mis­
leading and therefore incompatible with the 
Cosmetics Regulation and the LMG. 
5. Smithkline replies that, firstly, these provi­
sions of national law are incompatible 'with 
Article 30 of the EC Treaty as they are an 
obstacle to trade within the Community and, 
secondly, they are not covered by the excep­
tions provided for in Article 36. Directive 
76/768 achieved the complete harmonisation 
of national laws on the marketing of cosmetic 
products. Therefore Article 30 of the Treaty 
must be interpreted as meaning that the mar­
keting of cosmetic products which meet all 
the requirements of Directive 76/768 is per­
mitted without restriction and that the adver­
tising ban enacted by Austria is contrary to 
Community law. Smithkline concludes that, 
as the toothpaste in question is lawfully mar­
keted in Germany, Paragraphs 9 and 26 of the 
LMG are contrary to Article 30 of the EC 
Treaty as measures having equivalent effect. 
6. The national court observes that it would 
be possible for the court, in accordance with 
Unilever's application, to prohibit the tooth­
paste in question on the basis of the relevant 
provisions of Austrian domestic law, but this 
would affect trade within the Community. 
Therefore the national court decided to refer 
the question of the interpretation of Article 
30 of the Treaty and of Directive 76/768 to 
the Court of Justice for a preliminary ruling, 
so that a final decision could be given on the 
compatibility of the national legislation with 
the abovementioned provisions of Commu­
nity law. 
III — The question referred 
7. The question is worded as follows: 'Does 
Article 30 of the EC Treaty in conjunction 
with Council Directive 76/768/EEC of 27 
July 1976 on the approximation of the laws 
of the Member States relating to cosmetic 
products preclude a national provision which 
contains prohibitions of statements in con­
nection with the marketing of cosmetic prod­
ucts which go beyond the restrictions con­
tained in the Directive?' 
IV — Is 'Odol-Med 3 (Samtweiss)' tooth­
paste a medicinal product or a cosmetic 
product? 
8. In the observations which it has submitted 
in this case, the French Government adds a 
further dimension to the legal problem before 
the national court, by reason of which the 
I - 4 3 6 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
question was referred. The French Govern­
ment contends that in Community law it 
would be more correct to regard the tooth­
paste in question as a medicinal product and 
not a cosmetic product, so that the question 
of the free movement of the product in the 
internal market in accordance with Article 30 
of the EC Treaty would have to be deter­
mined by reference to the secondary legisla­
tion concerning the approximation of national 
laws relating to medicinal products. In the 
French Government's opinion, therefore, 
Directives 65/65/EEC, 92/27/EEC and 
92/28/EEC are applicable, and not Directive 
76/768, to which the national court refers, 
9. The Court took the view that, in order to 
answer the question referred to it, it had to 
decide first whether the toothpaste in ques­
tion was a medicinal product or a cosmetic 
product within the meaning of Community 
law, and therefore wrote to the parties on 24 
March 1998 asking them to give an opinion 
on whether the product should be regarded 
as a medicinal product in accordance with the 
relevant secondary legislation. 
10. The correct choice of the appropriate 
measures of Community law governing the 
product is of crucial importance to the out­
come of the proceedings before the national 
court. If 'Odol-Med 3 (Samtweiss)' tooth­
paste is a medicinal product within the 
meaning of Council Directive 65/65/EEC, as 
correctly construed, its marketing is subject 
to very stringent requirements. A medicinal 
product may be placed on the market in a 
Member State only when the competent 
authority of that State has issued an authori­
sation. 6 Authorisation depends on strict 
formal requirements and is subject to con­
stant monitoring by the national administra­
tive authorities. In addition, Council Direc­
tive 92/27 lays down detailed rules on labelling 
and package leaflets for medicinal products 
for human use. The Community rules on the 
advertising of such products, laid down by 
Council Directive 92/28, are also especially 
strict. There is no doubt that the Community 
measures on cosmetic products, as set out in 
Council Directive 76/768, are less onerous 
for those products than the corresponding 
requirements for medicinal products. 
A — The Community provisions 
11. Article 1 of Council Directive 76/768 
defines cosmetic products as follows: 
'(1) "Cosmetic product" means any substance 
or preparation intended for placing in contact 
6 — Directive 65/65, Article 3. 
I - 4 3 7 
OPINION OF MR COSMAS — CASE C-77/97 
with the various external parts of the human 
body (epidermis, hair system, nails, lips and 
external genital organs) or with the teeth and 
the mucous membranes of the oral cavity with 
a view exclusively or principally to cleaning 
them, perfuming them or protecting them in 
order to keep them in good condition, change 
their appearance or correct body odours. 
(2) The products to be considered as cosmetic 
products within the meaning of this defini­
tion are listed in Annex I.' 
Annex I is entitled 'Illustrative list by cat­
egory of cosmetic products'. It includes 'prod­
ucts intended for care of the teeth and the 
mouth'. 7 
Article 1 of Council Directive 65/65 8 is 
worded as follows: 
'For the purposes of this Directive, the fol­
lowing shall have the meaning hereby assigned 
to them: 
1. Proprietary medicinal product 
Any ready-prepared medicinal product placed 
on the market under a special name and in a 
special pack. 
2. Medicinal product 
Any substance or combination of substances 
presented for treating or preventing disease in 
human beings or animals. 
Any substance or combination of substances 
which may be administered to human beings 
or animals with a view to making a medical 
diagnosis or to restoring, correcting or modi­
fying physiological functions in human beings 
or in animals is likewise considered a medicinal 
product.' 
B — Arguments of the parties 
12. In their observations, the French Gov­
ernment and the Government of the United 
Kingdom contend that 'Odol-Med 3 (Samt-
weiss)' should be classified as a medicinal 
product. The French Government refers to 
the Court's Upjohn judgment of 16 April 
1991, 9 which found that a product with the 
characteristics of a medicinal product is sub­
ject only to Directive 65/65 and the measures 
amending it. If the toothpaste in question is 
advertised as a means of treatment, i. e. as 
7 — See Annex I of Directive 76/768. 
8 — Directive on the approximation of provisions laid down by 
law, regulation or administrative action relating to proprietary 
medicinal products (OJ, English Special Edition, 1965-1966, 
p. 20). 9 — Case C-112/89 [1991] ECR I-1703. 
I - 4 3 8 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
having the effect of inhibiting parodontosis, it 
must be regarded as a medicinal product in 
accordance with the definition in Article 1 (2), 
subparagraph 1, of Directive 65/65. Further­
more, according to the French Government, 
it is possible that the product in question is 
also a medicinal product by virtue of func­
tion in accordance with Article 1 (2), subpara­
graph 2, if the fluorine concentration exceeds 
0.15%. The reasoning of the Government of 
the United Kingdom follows the same lines. 
13. The reply given to the Court's question 
by the parties to the main proceedings and 
the Commission is in the negative. Unilever 
refers firstly to the national law, which states 
that toothpastes are cosmetic products, which 
is why the abovementioned provisions of the 
LMG and the Cosmetics Regulation prohibit 
cosmetic products such as toothpastes from 
carrying statements to the effect that they 
prevent, relieve or treat symptoms of illness. 
Unilever concludes that toothpastes (other 
than pharmaceutical toothpastes, which may 
be regarded as medicinal products) are not a 
means of treating or preventing disease in 
human beings and are therefore not in fact 
medicinal products by virtue of presentation 
within the meaning of Directive 65/65. Fur­
thermore, toothpastes do not meet the second 
criterion of Directive 65/65 for classification 
as a medicinal product because their compo­
sition makes them unsuitable for administra­
tion 'with a view to making a medical diag­
nosis or to restoring, correcting or modifying 
physiological functions in human beings'. 10 
14. In contrast, Smithkline contends that cos­
metic products such as 'Odol-Med 3 (Samt-
weiss)' toothpaste are covered only by Direc­
tive 76/768. The product in question obviously 
falls within the scope of that directive so that 
there can be no question of another directive, 
e. g. Directive 65/65, being applicable at the 
same time. The directive on cosmetic prod­
ucts was adopted after the directive on medic­
inal products precisely in order to lay down 
rules for products which, unlike products 
with pharmaceutical properties, are intended 
exclusively or principally for the external 
cleaning of the body. The main purpose of a 
toothpaste of the type in question is to clean 
the teeth, whereas its other properties, 
including possibly pharmaceutical properties, 
depend directly on the main purpose (i. e. 
external cleaning) and cannot therefore alter 
the legal classification of the product as a cos­
metic product. In addition, there is no ques­
tion of misleading consumers because they do 
not regard toothpaste as a medicinal product. 
15. The Commission begins by stating that 
'Odol-Med 3 (Samtweiss)' is clearly a cos­
metic product within the meaning of Direc­
tive 76/768, but then concedes this is not a 
sufficient answer to the question because, if 
the same product were also covered by Direc­
tive 65/65, its nature as a cosmetic product 
would be secondary to its nature as a medicinal 
product. However, the Commission considers 
that the toothpaste in question is not a medic­
inal product by virtue of presentation or of 
function. According to the Commission, the 
abovementioned statements on the packaging 
of the toothpaste and in the television adver­
tising do not make it a product which is pre-10 — Article 1(2), second subparagraph. Directive 65/65. 
I - 4 3 9 
OPINION OF MR COSMAS — CASE C-77/97 
sented to consumers as 'treating or preventing 
disease in human beings'. The so-called 'pre­
ventive' effect of 'Odol-Med 3 (Samtweiss)' 
could not be interpreted as a claim that the 
product is for 'treating or preventing disease 
in human beings' within the meaning of Article 
1(2), subparagraph 1, of Directive 65/65. Con­
sequently there was no question of classifying 
the product as a medicinal product by virtue 
of presentation and it could not be treated as 
a medicinal product by virtue of function 
because it does not restore, correct or modify 
physiological functions in human beings. The 
Commission refers to the observation in the 
Upjohn judgment that 'substances such as 
certain cosmetics which, 'while having an effect 
on the human body, do not significantly affect 
the metabolism and thus do not strictly modify 
the way in which it functions' cannot be 
included in the category of medicinal prod­
ucts. 11 
C — My views on the question 
16. The national court has not asked whether 
the product in question must be classified 
under Community secondary legislation as a 
medicinal product or a cosmetic product. 
However, it must be borne in mind that 'the 
Court, which is competent under Article 177 
of the Treaty to provide courts of the Member 
States with the elements of interpretation of 
Community law, may deem it necessary to 
consider provisions of Community law to 
which the national court has not referred in 
its question'. 12 
17. I should like to add that it is clear from 
the Act on the Accession of Austria to the 
Community that all the abovementioned 
directives 13 form part of the acquis commu­
nautaire within the meaning of Article 2 of 
the Act of Accession and therefore take full 
effect in the Austrian legal system. 
18. At first sight there can be no doubt, in 
my opinion, that in principle a product such 
as the toothpaste in question falls within the 
definition of 'cosmetic product' given by 
Directive 76/768, i. e. it is a cosmetic product 
within the meaning of Article 1(1) of the 
Directive. Toothpastes are in fact preparations 
which are intended for 'placing in contact 
with the teeth and the mucous membranes of 
the oral cavity with a view exclusively or 
principally to cleaning them, perfuming them 
or protecting them in order to keep them in 
good condition, change their appearance or 
correct body odours'. That is also the main 
11 — See the Upjohn judgment cited in footnote 9, paragraph 22. 
12 — See the judgments in Case C-241/89 SARPP [1990] ECR 
I-4695, paragraph 8, and Case C-315/92 Verband Sozialer 
Wettbewerb [1994] ECR I-317, paragraph 7. 
13 — That is to say, Directives 76/768 (cited in paragraph 1 above), 
65/65 (cited in footnote 8), Council Directive 92/28/EEC of 
31 March 1992 (OJ 1992 L 113, p. 13), Council Directive 
92/27/EEC of 31 March 1992 (OJ 1992 L 113, p. 8), Council 
Directive 84/450 of 10 September 1984 (OJ 1984 L 250 p, 
17) and Directive 89/552/EEC of 3 October 1989 (OJ 1989 
L 298, p. 23), which was amended by Directive 97/36/EC 
of the Parliament and the Council (OJ 1997 L 202, p. 60). 
I - 4 4 0 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
object of 'Odol-Med 3 (Samtweiss)' tooth- 20. In the Upjohn judgment the Court stated: 
paste. 
19. However, the assumption that the product 
in question is by definition a cosmetic product 
within the meaning of Directive 76/768 does 
not necessarily mean that it falls within the 
legislative ambit of that Directive. If a product 
is presented as having not only cosmetic but 
also medicinal properties (however ancillary 
or supplementary the latter may be in rela­
tion to the former), it is necessary to deter­
mine whether it is subject to the Community 
secondary legislation on medicinal products. 
It is clear from the Court's case-law that, 
where a product has the characteristics of a 
medicinal product and also those of another 
type of product (foodstuff, cosmetic product, 
etc.), it is necessary to apply the provisions 
concerning medicinal products which, being 
more stringent and offering better protection 
to health and to consumers, take precedence 
over all others. 14 
'... while a comparison between the defini­
tions of a cosmetic product and a medicinal 
product is not to be ruled out in doubtful 
cases ... a product which has the characteris­
tics of a medicinal product or a proprietary 
medicinal product still does not fall within 
the scope of Directive 76/768; it is subject 
only to the provisions of Directive 65/65 and 
the directives amending it. 
That is, moreover, the only conclusion con­
sistent with the aim, pursued by both direc­
tives, of protecting public health, since the 
legal rules governing proprietary medicinal 
products are stricter than those governing 
cosmetic products, in view of the particular 
risks to public health which the former may 
represent and which are generally not dis­
played by cosmetic products. 
Consequently, even though it may fall within 
the definition in Article 1(1) of Directive 
76/768, a product must nevertheless be treated 
as a "medicinal product" and subjected to the 
relevant rules if it is presented for treating or 
preventing disease or if it is intended to be 
administered with a view to restoring, cor­
recting or modifying physiological func­
tions.' 15 
14 — The Court has on several previous occasions considered the 
problem of choosing the most appropriate measures in 
Community law for classifying preparations which are in 
the borderline area between medicinal products and other 
types of product. See, for example, the following judgments: 
Case 227/82 Van Bennekom [1983] ECR 3883, concerning 
health foods, vitamins and mineral products; 
Case C-369/88 Delattre [1991] ECR I-1487, concerning 
slimming products, a product presented as facilitating diges­
tion, a product presented as stimulating blood circulation, an 
anti-itching product, an anti-fatigue product, a product for 
pains in the joints and a method for stopping smoking; 
Case C-60/89 Monteil and Sananani [1991] ECR I-1547, 
concerning 70% modified alcohol and 2% eosin; 
the Upjohn judgment, cited in footnote 9, concerning a lotion 
for preventing alopecia androgenetica, i. e. natural loss of 
hair, 
Case C-219/91 Ter Voort [1992] ECR I-5485, concerning 
dried plants for teas, which were presented as products with 
therapeutic qualities or as supplements to medicinal prod­
ucts; 
Case C-290/90 Commission v Germany [1992] ECR I-3317, 
concerning lotions, imported from another Member State, 
for cleansing the eyes. 15 — See the Upjohn cited in footnote 9, paragraphs 30 to 32. 
I - 441 
OPINION OF MR COSMAS — CASE C-77/97 
21. It is therefore necessary to determine how 
far 'Odol-Med 3 (Samtweiss)' meets the cri­
teria of Directive 65/65, so that conceptually 
it could be regarded as both a cosmetic product 
and a medicinal product. If that is so, the 
Community law on medicinal products will 
apply (contrary to Smithkline's arguments), 
and not that relating to cosmetics. 
(a) Community definition of 'medicinal 
product' and the Court's case-law 
22. The cases already decided by the Court 
give the necessary guidance for answering the 
question whether a product is covered by 
Directive 65/65. The starting point is always 
that the Directive gives two definitions of 
'medicinal product': one by reference to pre­
sentation and one by reference to function; a 
product is a medicinal product if it satisfies 
either of those definitions. 16 In my view, the 
determining factor in deciding the present 
case is the criterion of the 'presentation' of 
the product. 17 The Court takes the view that 
'the concept of the "presentation" of a product 
must ... be broadly construed' 18 in order to 
ascertain the true meaning of the first sub­
paragraph of Article 1(2) of Directive 65/65. 
Furthermore, the fact that the Directive does 
not define 'disease' gives even greater scope 
for determining its ambit. This is also how 
the Court appears to interpret it, as may be 
seen from the Delattre judgment, cited above. 
After observing that the Directive 'gives no 
definition of illness or disease', the Court 
immediately adds that 'the only possible defi­
nitions for those terms are those most com­
monly accepted on the basis of scientific 
knowledge'. 19 
23. In addition, a product which in some 
Member States is regarded as a foodstuff or 
cosmetic product is regarded in others as a 
medicinal product. On this point the Court 
observes that 'at the present stage of develop­
ment of Community law, it is difficult to 
avoid the continued existence, for the time 
being and, doubtless, so long as harmonisa­
tion of the measures necessary to protection 
of health is not more complete, of differences 
16 — This was the meaning attached to Article 1(2) of Directive 
65/65 by the judgments in the cases Monteil and Sammani, 
Ter Voort and Commission v Germany, cited in footnote 14. 
17 — I fail to sec how this product could be regarded as a medicinal 
product by virtue of function. As the Commission correctly 
argues, the composition of the preparation does not permit 
the properties specified in Article 1(2), second subparagraph, 
of Directive 65/65 to be ascribed to i t . Moreover there can 
be no question that the use of the toothpaste here 'signifi-
cantly affects the metabolism' (see the Court's observations 
in the Upjohn judgment, footnote 9 above, and paragraph 20 
of this opinion). Finally, the French Government's statement 
that the fluorine content in the composition of 'Odol-Med 
3 (Samtweiss)' exceeds normal values and therefore the 
toothpaste is a medicinal product by virtue of presentation 
has in no way been proved. 
18 — See the Van Bennekom judgment cited in footnote 14, para­
graph 17, and the Upjohn judgment cited in footnote 9, 
paragraph 16. 
19 — See the Delattre judgment cited in footnote 14, paragraph 
12. 
I -442 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
in the classification of products as between 
Member States ...'. 20 
24. Consequently, this survey of the case-law 
shows that, to determine the true meaning of 
Article 1(2), subparagraph 1, of Directive 
65/65, the Court has chosen the interpreta­
tion which ensures the greatest possible pro­
tection for health and for consumers. This is 
why the Court observes in the Van Bennekom 
judgment that 'the directive, by basing itself, 
in the first Community definition of a medic­
inal product, on the criterion of the produc­
er's "presentation", is designed not only to 
cover medicinal products having a genuine 
therapeutic or medical effect but also those 
which are not sufficiently effective or which 
do not have the effect which consumers would 
he entitled to expect in view of their presenta­
tion. The directive thereby seeks to preserve 
consumers not only from harmful or toxic 
medicinal products as such but also from a 
variety of products used instead of the proper 
remedies.' 21 This approach to interpretation 
is followed and confirmed in later judgments 
of the Court. 22 
25. It follows that Directive 65/65 is designed 
not only to regulate preparations suitable for 
preventing or treating disease in human beings 
and animals or which are poisonous or dan­
gerous to health, but also to regulate the mar­
keting of products which do not have thera­
peutic effects but which, for a commercial 
purpose, are described (i. e. 'presented' within 
the meaning of the Directive) by the manu­
facturer or the seller as producing certain 
effects. 23 This is the interpretation to be given, 
according to the true intention of the Com­
munity legislature, to the Community defini­
tion in Directive 65/65 of medicinal products 
'by virtue of presentation'. 24 
26. In principle the national authorities are 
responsible for applying this definition to the 
products in question in any particular case. 
As the Court observed in its judgment in 
Commission v Germany, 'it is for the national 
authorities to determine, subject to review by 
the courts, for each product, whether or not 
it constitutes a medicinal product, having 
regard to all of its characteristics, in particular 
its composition, its pharmacological proper­
ties ..., the way in which it is used, the extent 
20 — See the Commission v Germany judgment, cited in footnote 
14, paragraph 16. See also the Monteil and Samanni judg­
ment (paragraph 27 et seq.) and the Delattre judgment (para­
graph 28 et seq.), cited in footnote 14. 
21 — See the Van Bennekom judgment, cited in footnote 14, para­
graph 17 (emphasis added). 
22 — See the Upjohn judgment, cited in footnote 9, paragraph 16, 
and the Ter Voort judgment, cited in footnote 16, paragraph 
14. 
23 — See the Ter Voort judgment, cited in footnote 14, paragraph 
25. 
24 — Avoidance of the risk that consumers may mistakenly assume 
that a product is a means of treatment is clearly and directly 
addressed by Council Directive 80/777/EC of 15 July 1980 
on the approximation of the laws of the Member States 
relating to the exploitation and marketing of natural mineral 
waters (OJ 1980 L 229, p. 1). Article 9(2)(a) of this directive 
provides that 'all indications attributing to a natural mineral 
water properties relating to the prevention, treatment or 
cure of a human illness shall be prohibited'. This provision 
does not apply to the present case, but it shows the impor­
tance attached by the Community legislative authority to 
preventing the use of statements of a pharmacological nature 
in the marketing of a product which (by nature) is not a 
medicinal product. 
I - 443 
OPINION OF MR COSMAS — CASE C-77/97 
to which it is sold, its familiarity to consumers 
and the risks which its use may entail'. 25 
27. Particularly in relation to products such 
as the toothpaste in question, which at first 
sight are cosmetics or foodstuffs, but which 
could be regarded as medicinal products by 
virtue of presentation because of the special 
way in which they are sold, the Court has 
taken the 'averagely well-informed consumer' 
as its criterion when it has to give a decision 
on such products. This approach consists in 
assessing the impression which the consumer 
forms of the specific product. In the Van 
Bennekom case the Court observed that 'a 
product is "presented for treating or pre­
venting disease" within the meaning of Direc­
tive 65/65 not only when it is expressly "indi­
cated" or "recommended" as such, possibly 
by means of labels, leaflets or oral representa­
tion, but also whenever any averagely well-
informed consumer gains the impression, 
which, provided it is definite, may even result 
from implication, that the product in question 
should, regard being had to its presentation, 
have an effect such as is described by the first 
part of the Community definition'. 26 In the 
Ter Voort judgment the Court went on as fol­
lows: 'the conduct, action and approaches of 
the manufacturer or seller which disclose his 
intention to make the product he markets 
appear to be a medicinal product in the eyes 
of an average well-informed consumer may 
therefore be conclusive for the purposes of 
deciding whether a product should be regarded 
as a medicinal product by virtue of its pre­
sentation'. 27 
28. A second criterion for the correct classi­
fication of preparations which are on the bor­
derline between medicinal products and other 
types of product is their external form. The 
Court regards this criterion as important, but 
not decisive. In the Van Bennekom judgment 
the Court observes that 'the external form 
given to the product in question — such as 
that of a table, pill or capsule — may ... serve 
as strong evidence of the seller's or manufac­
turer's intention to market that product as a 
medicinal product. Such evidence cannot, 
however, be the sole or conclusive evidence, 
since otherwise certain food products which 
are traditionally presented in a similar form 
to pharmaceutical products would also be 
covered'. 28 
29. The Delattre judgment offers a typical 
example of the combined application of the 
criteria of external form and 'averagely well-
informed consumer'. The Court began by 
observing that the definition of 'medicinal 
product' in Directive 65/65 must be construed 
fairly broadly for the following reasons: 
'In the first place, "form" must be taken to 
mean not only the form of the product itself 
25 — See Commission v Germany, cited in footnote 14. paragraph 
17. 
26 — See the Van Bennekom judgment, cited in footnote 14, para­
graph 18 (emphasis added). 
27 — See the Ter Voort judgment, cited in footnote 14, paragraph 
26. In paragraph 32 of the same judgment the Court states 
that it is for the national court to assess whether there is 'an 
intention on the part of the manufacturer or seller to make 
the product appear to be a medicinal product in the eyes of 
an average well-informed consumer'. 
28 — Sec the Van Bennekom judgment, cited in footnote 14, para­
graph 19. 
I - 4 4 4 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
(tablets, pills or capsules) but also that of the 
packaging of the product, which may, for rea­
sons of marketing policy, tend to make it 
resemble a medicinal product. In the second 
place, account must be taken of the attitude 
of an averagely well-informed consumer, in 
whom the form given to a product may inspire 
particular confidence similar to that normally 
inspired in him by a proprietary medicinal 
product, having regard to the safeguards nor­
mally associated with the manufacture and 
marketing of the latter type of product. 
In those circumstances, a product may be 
regarded as a medicinal product by virtue of 
its presentation if its form and the manner in 
which it is packaged render it sufficiently 
similar to a medicinal product ..." 29 
30. Finally, it should be observed that, in 
cases of doubt where products appear at first 
sight to be foodstuffs or cosmetics, but could 
be medicinal products by virtue of presenta­
tion, the Court refrains from applying to the 
facts of the case the rules of Community law 
which it is asked to interpret. In other words, 
the Court constantly proceeds on the basis 
that it is for the national courts to decide, by 
reference to the facts of the particular case, 
whether the product in question must be 
regarded as a medicinal product by virtue of 
presentation. This is logical in so far as the 
national court is the more appropriate and 
competent for deciding what sort of impres­
sion the average consumer forms of a product 
and how it is presented on the national market 
concerned. 30 
(b) Community-law definition of 'medicinal 
product' and 'Odol-Med 3 (Samtweiss)' tooth­
paste 
31. I now wish to consider 'Odol-Med 3 
(Samtweiss)' toothpaste from the two legal 
viewpoints mentioned above. 
32. Firstly, the doubts as to whether the 
toothpaste in question must be classified as a 
cosmetic product or a medicinal product do 
not arise from the fact that it is presented or 
described in advertising as preventing only 
tartar and caries, which is usual for every 
toothpaste on the market, but from the claim 
that it has a protective or preventive effect 
against disorders of the gums. Some of these, 
particularly paradontosis, are more important 
and dangerous than others for the health of 
29 — See the Delattre judgment, cited in footnote 14, paragraph 
40 et seq. 
30 — Therefore in the Van Bennekom, Upjohn, Delattre, Monteil 
and Samanni, and Ter Voort judgments, cited in footnotes 9 
and 14, the Court left the final decision to the respective 
national court after finding that the products in question 
could possibly fall within the Community definition of 
'medicinal product' if the conditions laid down by Article 1 
of Directive 65/65 were fulfilled. 
I - 4 4 5 
OPINION OF MR COSMAS — CASE C-77/97 
the teeth. 31 It seems to me that this is a very 
important factor in view of the Commission's 
assertion at the hearing that Odo l -Med 3 
(Samtweiss)' is presented to consumers, like 
other toothpastes in free circulation on the 
market, only as a preventive against caries 
and tartar and therefore there can be no ques­
tion of presentation as a medicinal product. I 
take the view that 'Odol-Med 3 (Samtweiss)' 
could not be subsumed under Directive 65/65 
if its presentation referred only to the preven­
tion of caries and tartar because the average 
consumer is not misled by statements of that 
kind, which he is accustomed to see on almost 
all equivalent products on the market. How­
ever, as the French Government correctly 
points out, the possibility that the toothpaste 
in question may fall within the ambit of 
Directive 65/65 arises from the claims in its 
presentation that it is effective against gum 
disorders. 
33. The Court has not been informed of the 
exact wording on the packaging of 'Odol-Med 
3 (Samtweiss)' or of the exact statements made 
in advertising. The order for reference made 
by the Handelsgericht Wien states that the 
toothpaste is presented as 'a preventive against 
paradontosis'. 32 The French Government 
bases its argument concerning the presenta­
tion of 'Odol-Med 3 (Samtweiss)' as a medic­
inal product on the fact that it is advertised 
as having a 'paradontosis-»»A¿¿t'íiwg' effect. 
However, the court is not in a position to 
decide, by reference to the facts of this case, 
how the product in question is to be classi­
fied according to Community law. 33 
34. In any case there are, as the Commission 
rightly observes, significant pointers indi­
cating that the toothpaste in question should 
be classified as a cosmetic product. Firstly, 
there is the usual impression which the average 
consumer appears to have, in abstracte, of 
toothpastes, namely that they are products 
which improve the appearance of the teeth 
and promote their health, without having a 
therapeutic effect which would mean that 
they could be regarded as medicinal products. 
Secondly, as the documents before the Court 
show, 'Odol-Med 3 (Samtweiss)' is marketed 
primarily as a product which has the object 
and the effect of cleaning the teeth and making 
them whiter, and the advertisements for the 
toothpaste are only supplemented by the state­
ment that, while ensuring complete preserva­
tion of the teeth, the product prevents certain 
disorders. The advantageous consequences for 
dental health complement the main purpose 
of the toothpaste as a product for beauty and 
cosmetic care and for cleaning, and therefore 
it does not differ from the other toothpastes 
on the market. Thirdly, the product in ques­
tion is marketed in the form of a toothpaste 
31 — Paradontopatbie: any complaint characterised by a disorder 
of the periodontium. Such complaints are the main cause of 
the loss of teeth after the age of 30 (Larousse Médical, 
p. 761, Larousse-Bordas 1998). 
32 — The Commission uses the same words in the account of the 
facts in its written observations, which were received by the 
Court on 23 May 1997. 
33 — It is only in exceptional cases that the facts are made clear 
to the Court in such a way that it can classify a product 
according to the appropriate Community definition. This 
occurred in the judgment in Case C-315/92, cited in foot­
note 12, and I shall revert to this in the following paragraph 
of my opinion. 
I - 4 4 6 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
in a presentation which does not differ from 
that of other toothpastes. Consequently the 
form and the presentation of the product 
which, as I have shown, are 'strong evi­
dence' 3 4 of presentation as a medicinal 
product, are likely to give the average con­
sumer the impression that he is buying an 
ordinary toothpaste. Furthermore, as I have 
also mentioned, ordinary toothpaste is not, in 
the mind of the average consumer, a medicinal 
product. 
35. In my opinion, these arguments, on which 
the Commission bases its conclusion that 
'Odol-Med 3 (Samtweiss)' should not be clas­
sified as a medicinal product, are weighty, but 
not sufficient to justify that conclusion. Firstly, 
the fact that the advertising of the product as 
having favourable effects for the prevention 
of paradontosis only complements its presen­
tation on the market as having primarily and 
principally cosmetic and cleaning effects is 
not in itself sufficient to justify the conclu­
sion, when Community law is applied, that 
the average consumer will not regard the 
toothpaste concerned as a specific (albeit ancil­
lary or supplementary) means of preventing 
disease within the meaning of the first 
Community-law definition of 'medicinal 
product' in Article 1 of Directive 65/65. 3 5 
Secondly, the fact that the product in ques­
tion, like the other toothpastes on the market 
which are sold elsewhere than in chemists' 
shops, is a toothpaste must in fact be regarded 
as evidence which indicates that 'Odol-Med 3 
(Samtweiss)' should be classified as a cosmetic 
product, but it is not a decisive criterion. As 
the Court expressly observed in the Ter Voort 
judgment, for the sake of the widest possible 
protection of health and of consumers, 'a 
product recommended or indicated as having 
prophylactic or therapeutic properties is a 
medicinal product within the meaning of the 
first subparagraph of Article 1(2) of Directive 
65/65, even if it is generally regarded as a 
foodstuff and even if in the current state of 
scientific knowledge it has no known thera­
peutic effect'. 3 6 
36. Therefore, in addition to what has been 
said above, it is also necessary to consider the 
criterion of the 'average consumer', namely 
how the average buyer regards 'Odol-Med 3 
(Samtweiss)' toothpaste, taking account of 
how the product is presented and advertised. 
This question must be answered by the 
national court, which is aware of the exact 
facts of the case, trade customs and consumer 
habits in Austria, and can therefore make a 
proper assessment of these factors. However, 
I think I must point out here that, to classify 
'Odol-Med 3 (Samtweiss)' as a medicinal 
product within the meaning of Directive 65/65, 
it is not sufficient merely to have regard to 
the reference, in the presentation of the tooth­
paste concerned and in the advertising, to its 34 — See the Van Benntkom judgment, cited in footnote 14, para­
graph 19. 
35 — Factors which could induce the average consumer to ascribe 
pharmaceutical properties to the product in question are, in 
addition to the reference to 'prevention of paradontosis' and 
the inclusion of 'Med' in the name of the toothpaste, the 
words 'clinically tested', all of which appear on the tube. For 
the last-menāoned, see the Delattre judgment, paragraph 41. 
36 — See the Ter Voort judgment, cited in footnote 14, paragraph 
21 (emphasis added). 
I - 4 4 7 
OPINION OF MR COSMAS — CASE C-77/97 
positive preventive effect in relation to the 
health of the teeth and the prevention of dis­
ease, including paradontosis. 
37. When Community law is applied to this 
case, it will be necessary to distinguish and to 
choose between two possibilities. Does the 
presentation or advertising of 'Odol-Med 3 
(Samtweiss)' toothpaste on the Austrian 
market clearly ascribe preventive effects to 
the product in relation to disorders of the 
gums in such a way that the average con­
sumer may take the view that it falls outside 
the general category of toothpaste and can, as 
a 'medicinal product', give him comprehen­
sive and effective protection? Or is it pre­
sented as a product which gives only general 
protection against tooth decay and gum dis­
orders, in other words, a form of protection 
which the average consumer can expect from 
the mere use of a toothpaste as a product 
which is not regarded as a medicinal product, 
but only as a cosmetic product with positive 
effects on health? In the first case, 'Odol-Med 
3 (Samtweiss)' must be classified as a medicinal 
product by virtue of presentation and it will 
be covered by Directive 65/65, which makes 
it unnecessary to reply to the question referred 
by the national court. In the second case, that 
is to say, if it is found that, because of the 
way in which it is presented on the Austrian 
market and the resulting impression in the 
mind of the average consumer concerning its 
properties, the product in question cannot be 
regarded as a medicinal product by virtue of 
presentation, the directives on cosmetics must 
be applied and it will be appropriate to reply 
to the question from the national court. This 
is what I now propose to do. 
V — National restrictions on the marketing 
of cosmetic products and Community law 
38. The question referred by the national 
court concerns the validity of the prohibition 
under national law which goes further than 
the provisions of Directive 76/768. First, it 
must be observed that, in the context of a ref­
erence for a preliminary ruling, the Court 
cannot give a ruling on the compatibility of 
national provisions with Community law. It 
can, however, provide the national court with 
all appropriate material on the interpretation 
of Community law to enable it to determine, 
when giving its decision, whether the national 
provisions are compatible with Community 
law. 37 
39. In the present case it is characteristic that, 
although the parties which have submitted 
written observations or have appeared before 
the Court take differing views of the law, 
ultimately they do not propose replies which 
contradict each other or are totally incompat­
ible with each other. Apart from Unilever, the 
parties appear to agree in principle that a 
national prohibition which exceeds the limits 
laid down by the relevant Community law, 
particularly Directive 76/768, is contrary to 
Community law. However, this does not mean 
that they have the same ideas on the scope of 
37 — Sec the Verband Sozialer Wettbewerb judgment, cited in 
footnote 12, Opinion of Advocate General Gulmann, para­
graph 9. 
I-448 
ÖSTERREICHISCHE UNILEVER y SMITHKLINE BEECHAM MARKENARTIKEL 
the discretion, if any, which the Community 
legislature has granted to the national authori­
ties in Directive 76/768. It is the scope of that 
discretion which the question referred to the 
Court seeks to establish. 
A — The relevant provisions of secondary 
Community law 
40. Article 2 of Directive 76/768 provides: 
'A cosmetic product put on the market within 
the Community must not cause damage to 
human health when applied under normal or 
reasonably foreseeable conditions of use, 
taking account, in particular, of the product's 
presentation, its labelling, any instructions for 
its use and disposal as well as any other indi­
cation or information provided by the manu­
facturer or his authorised agent or by any 
other person responsible for placing the 
product on the Community market. 
The provision of such warnings shall not, in 
any event, exempt any person from compli­
ance with the other requirements laid down 
in this directive.' 
Article 4 of Directive 76/768 is worded as 
follows: 
'Without prejudice to their general obliga­
tions deriving from Article 2, Member States 
shall prohibit the marketing of cosmetic prod­
ucts containing: 
(a) substances listed in Annex II; 
(b) substances Usted in the first part of Annex 
III, beyond the limits and outside the 
conditions laid down; 
...'. 
Article 6 of Directive 76/768 provides as fol­
lows: 
' 1 . Member States shall take all measures nec­
essary to ensure that cosmetic products may 
be marketed only if the container and pack­
aging bear the following information in indel­
ible, easily legible and visible lettering; the 
I - 4 4 9 
OPINION OF MR COSMAS — CASE C-77/97 
information mentioned in point (b) may, how­
ever, be indicated on the packaging alone. 
(a) ... 
(g) ... 
2. For cosmetic products that are not pre­
packaged, are packaged at the point of sale at 
the purchaser's request, or are pre-packaged 
for immediate sale, Member States shall adopt 
detailed rules for indication of the particulars 
referred to in paragraph 1. 
3. Member States shall take all measures nec­
essary to ensure that, in the labelling, putting 
up for sale and advertising of cosmetic prod­
ucts, text, names, trade marks, pictures and 
figurative or other signs are not used to imply 
that these products have characteristics which 
they do not have. 
Furthermore, any reference to testing on ani­
mals must state clearly whether the tests car­
ried out involved the finished product and/ 
or its ingredients.' 
Article 7(1) of Directive 76/768 is worded as 
follows: 
' 1 . Member States may not, for reasons related 
to the requirements laid down in this Direc­
tive and the annexes thereto, refuse, prohibit 
or restrict the marketing of any cosmetic 
products which comply with the require­
ments of this directive and the annexes 
thereto.' 
Article 12 of Directive 76/768 provides as fol­
lows: 
' 1 . If a Member State notes, on the basis of a 
substantiated justification, that a cosmetic 
product, although complying with the require­
ments of the directive, represents a hazard to 
health, it may provisionally prohibit the mar­
keting of that product in its territory or sub­
ject it to special conditions. It shall immedi­
ately inform the other Member States and the 
Commission thereof, stating the grounds for 
its decision. 
2. The Commission shall as soon as possible 
consult the Member States concerned fol­
lowing which it shall deliver its opinion 
without delay and take the appropriate steps. 
...'. 
I -450 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
B — The arguments of the parties 
41. Unilever contends that the national laws 
on cosmetic products were not completely 
harmonised by Directive 76/768 as it does 
determine exhaustively which substances may 
be contained in such products and when state­
ments for the purpose of health protection 
may or may not be placed on them. In Uni­
lever's submission, a national legislation of 
the kind in question, which aims to protect 
health, does not fall within the ambit of sec­
ondary Community legislation, particularly 
Directive 76/768. With regard to Article 30 of 
the EC Treaty, Unilever contends that the 
national measures in question fall within the 
exceptions permitted by Article 36 of the 
Treaty to the general prohibition of obstacles 
to the free movement of goods as they con­
cern the protection of health and of con­
sumers. 
42. Smithkline contends that Article 6(3) of 
Directive 76/768 constitutes a complete har­
monisation of national laws on the packaging, 
labelling and advertising of cosmetic products 
and lays down the restrictions on trade which 
are necessary to protect health. By virtue of 
that provision the Member States can pro­
hibit only advertising which attributes to cos­
metic products characteristics which they do 
not possess. On the other hand, national rules 
such as those of Austrian law, which would 
excessively restrict advertising for cosmetic 
products and generally their market presenta­
tion beyond the limits laid down by Article 
6(3) of the Directive are not compatible with 
Community law. Furthermore, under Article 
7(1) the Member States cannot prohibit or 
restrict the marketing of cosmetic products 
which comply with the directive. 
43. The Austrian Government contends, 
firstly, that Directive 76/768 does not regulate 
exhaustively the composition and the manda­
tory ingredients of cosmetic products. In any 
case, Article 6(3) has fully harmonised the 
national laws concerning their packaging and 
labelling. This provision was implemented in 
national law by Paragraph 26 in conjunction 
with Paragraph 9 of the LMG, thus prohib­
iting, firstly, the use of statements relating to 
health (with the exception of non-misleading 
references to the physiological or pharmaco­
logical effects of cosmetic products and figu­
rative representations for explaining their 
range of application). Secondly, it is prohib­
ited to market products bearing false state­
ments. 38 In addition, for avoiding misleading 
advertising Austria has a system of 'positive' 
lists, which permits claims concerning certain 
characteristics and statements to promote sales 
of cosmetic products only if the products in 
question contain substances which, according 
38 — For the actual wording of the Austrian provisions, see foot­
note 5 of this opinion. 
I - 4 5 1 
OPINION OF MR COSMAS — CASE C-77/97 
to the Cosmetics Regulation, are proved to 
have the respective positive effects in human 
beings. Only in this way can consumers be 
given complete protection against the risk of 
misleading statements concerning cosmetic 
products. The Austrian Government adds 
that, under Paragraph 27(3) of the LMG, spe­
cial authorisation may be given, upon appli­
cation, for the use of statements concerning a 
cosmetic product even if it does not contain 
any substances which, according to the posi­
tive list of the Cosmetics Regulation, con­
form with such statements. Finally, the Aus­
trian Government stresses that the provisions 
in question of the LMG do not prohibit the 
marketing of cosmetic products which con­
tain none of the substances Usted in the Cos­
metics Regulation. Those provisions merely 
prohibit the use of statements which have 
been shown to be incorrect, so as to provide 
consumers with the widest possible protec­
tion. Consequendy there can be no question 
of restricting the free movement of goods. 
44. The Government of the United Kingdom 
contends that under Article 6(3) of Directive 
76/768 the Member States have not only a 
right, but also an obligation to adopt mea­
sures to protect consumers against misleading 
advertising for cosmetic products. Therefore 
a national measure which is enacted for that 
purpose cannot be contrary to the Directive. 
If it were found that the measure in question 
was not within the scope of the Directive, it 
would in any case be covered by the grounds 
of justification set out in Article 36 of the EC 
Treaty. 
45. The French Government proposes that, if 
the Court finds that the Community law on 
medicinal products is not applicable, it should 
rule that the national provisions laying down 
suitable measures to prevent misleading adver­
tising are justified not only by Article 6(3) of 
Directive 76/768, but also by Articles 4 and 6 
of Council Directive 84/450/EEC relating to 
the approximation of laws, regulations and 
administrative provisions of the Member States 
concerning misleading advertising. 
46. The Commission begins by observing that 
the main problem of interpretation in this 
case is bound up with the question whether 
Directive 76/768 regulates the permitted com­
position of cosmetic products and thus har­
monises the national law on that subject. The 
Commission points out that the Directive has 
the object of protecting health and therefore 
prohibits the marketing of cosmetic products 
containing dangerous or harmful substances. 
Provision is made for the annexes of the 
Directive listing the prohibited substances to 
be constantly updated and amended. As the 
Community legislature has drawn up a nega­
tive list of unauthorised substances and has 
thereby prohibited the sale and advertising of 
products containing such substances, it must 
be presumed that cosmetic substances con­
taining none of those substances can be mar­
keted and advertised freely. Moreover, to give 
consumers the greatest possible protection, 
Article 12 lays down an exceptional proce­
dure whereby the marketing of cosmetic 
I - 4 5 2 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
products which contain none of the prohib­
ited substances listed in the annexes may be 
prohibited. Therefore a national provision 
which is based on a positive list of permitted 
substances and which by that means prohibits 
the marketing and advertising of cosmetic 
products containing substances other than 
those on such list is not compatible with 
Directive 76/768. Regarding the system for 
applying Articles 30 and 36 of the EC Treaty, 
the Commission contends that the Directive 
exhaustively lays down the conditions for 
unrestricted trade in cosmetic products in the 
Community and takes account of all the fac­
tors in the protection of the public interest, 
which includes the protection of health and 
of consumers. Consequendy it is unnecessary 
to examine the national law in question by 
reference to Articles 30 and 36 of the Treaty. 
C — My views on the preliminary question 
47. I propose first to consider Directive 
76/768 in order to determine the extent and 
degree to which it has harmonised national 
laws (a), and then I shall look more closely at 
the precise limits laid down by the directive 
to the validity of the national rules (b). 
(a) The harmonisation brought about by 
Directive 76/768 
48. Although the provisions of Directive 
76/768 are sufficiently clearly worded, the 
parties construe them in quite different ways. 
In particular, they have divergent opinions on 
interpretation regarding the scope of the 
subject-matter of the respective provisions 
and the degree of harmonisation of national 
laws which they bring about. 
49. I would first observe that the Court has 
been very cautious in the wording of its judg­
ments concerning Directive 76/768 and has 
avoided any general formulation to the effect 
that the Directive brought about a complete 
harmonisation of national laws, from any 
point of view whatever, to cosmetic prod­
ucts. 39 The Court 's circumspection in deter­
mining the scope and the nature of the Direc­
tive is understandable because cosmetic 
products constitute a very wide category of 
goods 'which is constantly being developed. 
39 — This is the contrary inference from the judgments in Case 
C-150/88 Parfumerie-Fabrik Glockengasse [1989] ECR 3891, 
paragraph 28; Case C-246/91 Commission v France [1993] 
ECR I-2289, paragraph 7, and the Verband Sozialer Wet­
tbewerb judgment, cited in footnote 12, paragraph 11. These 
judgments assume that Directive 76/768 led to complete har­
monisation (only) of the national provisions on the pack­
aging and labelling of cosmetic products. Subsequently it 
became apparent that the Directive on its own had not 
achieved the complete harmonisation of all national provi­
sions concerning these products. 
I - 4 5 3 
OPINION OF MR COSMAS — CASE C- 77/97 
An over-simplified approach whereby a single 
source of Community law which, like the 
Directive, has 15 articles and a number of 
annexes, covers exhaustively all the problems 
connected with trade in cosmetic products 
could jeopardise the protection of health and 
consumers. In other words, if the Directive 
were deemed to have a wide scope, which in 
fact it cannot have, this could frustrate the 
achievement of its aims, which expressly 
include the protection of health and of con­
sumers. However, this does not mean that the 
Directive has not brought about complete 
harmonisation of the national laws on certain 
matters connected with the sale of cosmet­
ics. 40 
50. After these preliminary remarks, I now 
wish to consider the relevant provisions of 
the Directive in relation to the case-law. As 
the Commission rightly observes, the main 
aim of the Community legislature is to ensure 
the free movement of cosmetic products within 
a system which permits them to be marketed 
irrespective of prior approval of their com­
position, provided they do not contain 
substances harmful to human beings, dan­
gerous substances or dangerous quantities of 
substances. That is the purpose of the so-called 
negative list. The directive has two annexes, 
one listing substances which are not permitted 
in cosmetic products, the other listing 
substances the use of which is subject to cer­
tain restrictions. Article 4 of the directive 
requires the Member States to prohibit the 
marketing of cosmetic products the composi­
tion of which does not conform with the 
prohibitions and restrictions of the negative 
list. This is also the only restriction to which 
such products are subject 'with regard to their 
composition', apart from the possibility of 
the exceptional procedure provided for in 
Article 12. 41 
51. Therefore the safeguarding of the free 
movement of cosmetic products not con­
taining prohibited (by reason of being Usted 
in annexes II and III of the Directive) 
substances or quantities of substances is a 
fundamental principle of the Directive. Con­
sequently, the Member States must not impose 
on cosmetic products any restrictions con­
cerning their composition other than those 
laid down by the Directive. 
52. In addition, Article 6 of Directive 76/768 
lays down provisions on the packaging and 
labelling of cosmetic products. The Court has 
consistently held that these provisions con­
stitute a complete harmonisation of national 
laws on the packaging and labelling of such 
products. It did so first in the Parfumerie-
Fabrik Glockengasse judgment 42 and was fol­
lowed later in the Commission v France 43 and 
the Verband Sozialer Wettbewerb judg­
ments. 44 Consequently, it is no longer open 
to the Member States to keep in force or to 
40 — See paragraph 52 below. 
41 — According to this procedure, if a Member State finds that a 
cosmetic product, although complying with the require­
ments of the directive, represents a hazard to health, it may 
provisionally prohibit the marketing of the product or sub­
ject it to special conditions on marketing. At the same time 
the Commission and the other Member states must be 
informed and the Member State concerned must state the 
grounds for its decision. 
42 — See the judgment cited in footnote 39, paragraph 28. 
43 — See the judgment cited in footnote 39, paragraph 7. 
44 — See the judgment cited in footnote 12, paragraph 11. 
I - 4 5 4 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
apply national provisions concerning the pack­
aging and labelling of cosmetic products if 
those provisions go further than the condi­
tions directly laid down by the Directive. This 
is the reason why the Community legislature 
expressly provides in Article 7 of the Direc­
tive that 'Member States may not, for reasons 
related to the requirements laid down in this 
directive and the annexes thereto, refuse, pro­
hibit or restrict the marketing of any cos­
metic products which comply with the 
requirements of this directive and the annexes 
thereto'. 
53. But is Article 6 of the Directive the only 
Community-law provision applying to the 
packaging and labelling of cosmetic products, 
or should Articles 30 and 36 of the EC Treaty 
also apply? In principle I consider that the 
reply to this question is that Article 6 of the 
Directive alone applies. This was also the 
conclusion reached by the Court in the 
Parfumerie-Fabrik Glockengasse judgment, 
where it states that 'since the directive has 
provided exhaustively for the harmonisation 
of national rules on the packaging and label­
ling of cosmetic products, it is not necessary 
to give a ruling on the interpretation of Article 
30 of the Treaty as requested by the national 
court.' 45 The same view is taken in the present 
case by Smithkline, the Commission, the 
French Government and the Government of 
the United Kingdom. 
54. However, it can be argued that in the 
Verband Sozialer Wettbewerb judgment, 
which is the most recent decision on the 
interpretation of the provisions in question, 
the Court cast doubt on the conclusion it 
reached in Parfumerie-Fabrik Glockengasse. 
In particular, although the Court accepts that 
Directive 76/768 provided exhaustively for 
the harmonisation of national rules on the 
packaging and labelling of cosmetic products, 
it adds that 'this directive must, like all sec­
ondary legislation, be interpreted in the light 
of the Treaty rules on the free movement of 
goods'. 46 Pursuing this line of reasoning, the 
Court goes on to consider whether the national 
legislation implementing the provision of the 
Directive which require the Member States to 
take all the appropriate measures for pre­
venting misleading advertising of cosmetic 
products conforms not only with the limits 
and conditions laid down by that provision 
of secondary Community legislation, but also 
with Articles 30 and 36 of the Treaty, as inter­
preted by the Court. 47 
55. In any case, it is of some practical impor­
tance whether the question of the extent to 
which a national measure on the packaging 
and labelling of cosmetic products is compat­
ible with Community law is assessed only by 
reference to Article 6 of Directive 76/768 or 
also in the light of Articles 30 and 36 of the 
EC Treaty. Let me explain: 
— On the one hand, Article 6 of the Direc­
tive calls upon the Member States to take 
45 — See the Parfumerie-Fabrik Glockengasse judgment, cited in 
footnote 38. paragraph 28. 
46 — See the Verband Sozialer Wettbewerb judgment, cited in 
footnote 12, paragraph 12. 
47 — Ibid., paragraph 17. 
I -455 
OPINION OF MR COSMAS — CASE C-77/97 
action in two areas. First, they must take 
all necessary measures to prevent the mar­
keting of cosmetic products which do not 
bear the information and statements pre­
scribed in Article 6(1). Secondly, under 
Article 6(3), the national authorities must 
take all necessary measures to ensure that, 
'in the labelling, putting up for sale and 
advertising of cosmetic products, text, 
names, trade marks, pictures and figura­
tive or other signs are not used to imply 
that these products have characteristics 
which they do' . As the Government of 
the United Kingdom correctly observes, 
the Member States have not only a right, 
but also an obligation to take appropriate 
measures to prevent misleading adver­
tising of cosmetic products. The limits of 
that obligation constitute the main focus 
and also the difficulty of the question 
referred by the national court. 
— On the other hand, the protection of con­
sumers against the risk of deception also 
falls in fact within the ambit of primary 
Community law on the free movement of 
goods, namely Article 30 et seq. of the 
EC Treaty. In the Yves Rocher judgment 48 
the Court observed that 'the protection of 
consumers against misleading advertising 
is a legitimate objective from the point of 
view of Community law'. 49 Similarly in 
Mars 50 the Court stated that 'it is settled 
law that obstacles to intra-Community 
trade resulting from disparities between 
provisions of national law must be accepted 
in so far as such provisions may be justi­
fied as being necessary in order to satisfy 
overriding requirements relating, inter alia, 
to consumer protection ...'. 51 Conse­
quently, the prohibition of the misleading 
presentation or misleading advertising of 
a cosmetic product, which is in substance 
referred to by Article 6(3) of Directive 
76/768, has the direct object of consumer 
protection which, as I have already said, is 
a ground justifying restricting the free 
movement of goods guaranteed by Article 
30 of the Treaty. Moreover, such prohibi­
tion is also directly connected with the 
protection of health, which is expressly 
recognised by primary Community law as 
justifying restrictions on the free move­
ment of goods (Article 36 of the EC 
Treaty). 
56. However, the assessment of a national 
measure concerning advertising for a cosmetic 
product and its presentation generally, by ref­
erence to Article 6(3) of Directive 76/768 and 
Article 30 et seq. of the Treaty gives rise to 
two serious problems: 
— Firstly, the assessment of a national mea­
sure of that kind in the light of the objec-
48 — Case C-126/91 [1993] ECR I-2361. 
49 — Cited in footnote 48, paragraph 15. 
50 — Case C-470/93 [1995] ECR I-1923. 51 — See the judgment cited in footnote 50, paragraph 15. 
I - 4 5 6 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
tives of the relevant provisions of primary 
Community law does not lead to clear 
answers, but rather to ambiguous and even 
contradictory conclusions. 52 
— Secondly — and this seem to me more 
important — the examination of a national 
provision by reference to Article 6(3) of 
the Directive and also to Article 30 et seq. 
of the Treaty may lead to different con­
clusions. In particular, the national legis­
lature's options when implementing 
Article 6(3) are very limited. The national 
measure may only have as its purpose and 
subject-matter the prohibition of any pre­
sentation of cosmetic products on the 
market which implies a characteristic 
which the products in question do not 
actually have. On the other hand, a national 
provision prohibiting certain forms of 
advertising would exceed the limits of the 
power conferred by the said 
Community-law rule if that advertising 
does not imply that the cosmetic products 
in question have characteristics which they 
do not have within the meaning of Article 
6(3) of the Directive. It is possible, how­
ever, that the same national provision, 
when examined only from the angle of 
Article 30 et seq. of the Treaty, would be 
regarded as compatible with Community 
law. More specifically, it might be classi­
fied, on the one hand, as a mere 'method 
of sales promotion' and would therefore 
fall outside the scope of Article 30; 53 on 
the other hand, it might be regarded as a 
measure necessary for the protection of 
health, in which case it would fall under 
the grounds of justification set out in 
Article 36. 54 
52 — There are two trends in the Court's case-law. Originally it 
was decided that legislation which restricts or prohibits cer­
tain forms of advertising and certain methods of sales pro­
motion may, although it does not directly affect imports, be 
such as to restrict their volume because it affects marketing 
opportunities for the imported products. It may therefore 
constitute an obstacle to imports and fall within the scope 
of Article 30 of the EC Treaty even if the legislation in ques­
tion applies to domestic products and imported products 
without distinction (see the judgments in Case 286/81 Oost­
hoek's Uitgevermaatschappij [1982] ECR 4575, paragraph 
15; Case 382/87 Buet and Others [1989] ECR 1235, para­
graph 7; Case C-362/88 INNO [1990] ECR I-667, para­
graph 7; Joined Cases C-1/90 and C-176/90 Aragonesa de 
Publicidad Exterior and Publivía [1991] ECR I-4151, para­
graph 10, and the Yves Rocher case, cited in footnote 48, 
paragraph 10). 
In other cases, however, the Court has found that restric­
tions on promotion and advertising are mere 'selling arrange­
ments' within the meaning given to this term in the Keck 
and Mithouard judgment and that therefore they do not fall 
within the ambit of Article 30 of the EC Treaty. In these 
cases the Court reasoned as follows: 'by contrast, contrary 
to what has previously been decided, the application to 
products from other Member States of national provisions 
restricting or prohibiting certain selling arrangements is not 
such as to hinder directly or indirectly, actually or poten­
tially, trade between Member States within the meaning of 
the Dassonville judgment so long as those provisions apply 
to all relevant traders operating within the national territory 
and so long as they affect in the same manner, in law and in 
fact, the marketing of domestic products and of those from 
other Member States. Provided that those conditions are ful­
filled, the application of such rules to the sale of products 
from another Member State meeting the requirements laid 
down by that State is not by nature such as to prevent their 
access to the market or to impede access any more than it 
impedes the access of domestic products. Such rules there­
fore fall outside the scope of Article 30 of the Treaty' (see 
the judgment in Joined Cases C-267/91 and C-268/91 Keck 
and Mithouard [1993] ECR I-6097, paragraphs 16 and 17). 
The Court has applied the foregoing judgment to find that 
the following national provisions are compatible with Com­
munity law: provisions prohibiting, firstly, advertising for 
quasi-pharmaceutical products outside the pharmacy (see 
the judgment in Case C-292/92 Hünermund [1993] ECR 
I-6787), secondly, the broadcasting of television advertising 
for the distribution sector by television companies (sec the 
judgment in Case C-412/93 Leclerc-Siplec [1995] ECR I-179) 
and, thirdly, television advertising aimed at children under 
12 (see the judgment in Joined Cases C-34/95 to C-36/95 
De Agostini and TV-Shop [1997] ECR I-3843). 
Consequently it is not easy to determine whether a national 
law restricting or prohibiting advertising falls within Article 
30 of the Treaty or not. 
53 — See the judgments cited in footnote 52. 
54 — See the judgment in Case C-320/93 Ortscheit [1994] ECR 
I-5243, where a prohibition on advertising for certain medic­
inal products was found to be justified on grounds of the 
protection of health within the meaning of Article 36. 
I - 4 5 7 
OPINION OF MR COSMAS — CASE C-77/97 
57. For these reasons — and also to clarify 
the case-law — I think it preferable for the 
Court not to embark on the tricky task of 
judging a national provision concerning the 
packaging, labelling and advertising of cos­
metic products by reference to both Direc­
tive 76/768 and the Treaty. In so far as the 
Court has held that the relevant rules of sec­
ondary Community legislation, contained in 
Article 6 of the Directive, provided exhaus­
tively for the harmonisation of national rules 
on the packaging and labelling of cosmetic 
products, those rules are, in my opinion, the 
only legal basis for determining how far the 
national provision in question is compatible 
with Community law. Therefore any refer­
ence to Article 30 et seq. of the Treaty must 
be avoided, particularly with regard to the 
packaging and labelling of cosmetic prod­
ucts. 55 
58. I also consider that in the Verband Sozialer 
Wettbewerb judgment the Court did not 
intend to depart from its initial case-law and 
to reject the exclusive application of Article 6 
of Directive 76/768 for the sake of Article 30 
et seq. of the Treaty. The Court merely wished 
to emphasise that national measures imple­
menting the obligation under Article 6(3) of 
the Directive to take steps against misleading 
advertising for cosmetic products are compat­
ible 'with Community law only if they are 
necessary and conform to the objective pur­
sued, that is to say, they do not unreasonably 
impede the free movement of goods. In other 
words, in the Verband Sozialer Wettbewerb 
judgment the Court rightly made it clear that, 
in enacting national measures to implement 
the provisions of the Directive which provide 
for comprehensive harmonisation in the field 
of the packaging and labelling of cosmetic 
products, the national legislature still has an 
obligation to observe the principle of propor­
tionality and to choose the restriction which 
will have the least effect on the free move­
ment of goods. The national legislature would 
be under the same obligation if there were no 
special provision of secondary Community 
legislation and it were a question of applying 
Article 30 et seq. of the Treaty directly. 
59. Before concluding this part of my exami­
nation, I think two further observations are 
necessary: 
— First, the fact that the Court has hitherto 
accepted that Directive 76/768 constitutes 
exhaustive harmonisation of the national 
55 — Otherwise conflicts may arise. See, for example, the judg­
ment in Case C-349/95 Loendersloot [1997] ECR I-6227, in 
which the Court stated that 'it has been suggested that the 
national court's questions should be answered within the 
framework not of Article 36 of the Treaty but of the First 
Council Directive 89/104/EEC ...', but then went on to 
observe that 'Article 7 of that directive, like Article 36 of the 
Treaty, is intended to reconcile the fundamental interest in 
protecting trade mark rights with the fundamental interest 
i n the free movement of goods, so that these two provisions, 
which aim to achieve the same result, must be interpreted in 
the same way' (paragraphs 17 and 18, with further references 
to the case law). 
I -458 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
laws on the packaging and labelling of 
cosmetic products must not be construed 
so narrowly that the advertising of those 
products would be excluded from the 
ambit of such harmonisation. In other 
words, the advertising of cosmetic prod­
ucts is also the subject of complete har­
monisation brought about by Article 6(3) 
of Directive 76/768. This means that the 
only measures in relation to consumer 
protection which the national authorities 
may take with regard to such advertising 
are those which they are authorised by 
the Community legislature to take under 
Article 6(3) of the Directive. 
— Secondly, it would be wrong to assume 
that national measures for restricting or 
prohibiting the advertising and, generally, 
placing of cosmetic products on the 
market, provided they are enacted for the 
purpose of protecting health, are not con­
trary to Article 6(3) even if they impose 
restrictions going beyond the limits laid 
down by that provision. Neither the actual 
wording of that provision nor the Court's 
case-law provided support for interpreting 
it to mean that national measures banning 
the advertising of cosmetic products in 
order to protect health fall outside the 
ambit of Article 6(3). In other words, it 
cannot be claimed that the protection of 
health is a ground permitting the adop­
tion of national measures restricting the 
presentation, placing on the market and 
advertising of cosmetic products so as 
automatically to remove such measures 
from the scope of Article 6(3) and to bring 
them within the more general ambit of 
Article 30 et seq. of the Treaty (particu­
larly Article 36). As there is no doubt that 
complete harmonisation of the rules 
relating to labelling, advertising and, gen­
erally, the presentation of cosmetic prod­
ucts has been achieved, Article 30 et seq. 
can no longer be invoked in order to gain 
acceptance for a national measure as com­
plying with the requirements of Commu­
nity law if that measure relates to the same 
subject-matter as the Directive and con­
flicts with it. 
60. It is now necessary to examine more 
closely, on the basis of the foregoing inter­
pretation, the scope for action accorded to 
the national legislature by the relevant provi­
sion of secondary Community law in the 
form of Article 6(3) of Directive 76/768. 
I - 459 
OPINION OF MR COSMAS — CASE C-77/97 
(b) National measures restricting the free 
movement of cosmetic products from the 
viewpoint of Directive 76/768 
61. The limits within which the national leg­
islature may regulate the cosmetic sector are 
clear from the foregoing observations. As I 
have said, the fundamental purpose of the 
Directive is to ensure the free movement and 
marketing of cosmetic products which do not 
contain substances or quantities of substances 
dangerous or harmful to the health of human 
beings. Consequently, the Member States 
cannot in principle impose restrictions 'with 
regard to their composition' which differ from 
those exhaustively provided for in the Direc­
tive. At the same time, however, the Member 
States must take the necessary measures to 
prevent misleading advertising for cosmetic 
products. Therefore a national measure is 
compatible with Community law if it pro­
hibits the marketing of such products with 
false, untrue or misleading statements and, in 
any case, with a presentation such as to 
attribute to them characteristics which they 
do not have. 
62. However, what happens where, in order 
to prevent consumers from being misled, that 
is to say in the context of implementing 
Article 6(3) of Directive 76/768, the national 
authorities take measures which infringe the 
first fundamental rule of the Directive? In 
other words, what becomes of a national 
measure which, to prevent misleading adver­
tising, interferes with the free movement of 
cosmetic products goods irrespective of their 
composition? In my opinion, such a measure 
is not compatible with the letter or the spirit 
of the Directive. Otherwise, that is to say, if 
it were accepted that the adoption of mea­
sures to prevent misleading advertising neces­
sarily entail setting aside the regime of free 
movement of cosmetic products irrespective 
of their composition, this would amount to a 
recognition that there are fundamental con­
tradictions in the Directive and therefore that 
the Community legislature had failed com­
pletely in its work of regulation. However, 
not only is there no conflict between the two 
basic aims of the Directive, namely ensuring 
the free movement of cosmetic products and 
preventing their being placed on the market 
with untrue or misleading statements or adver­
tising, but those two aims can be achieved 
simultaneously. That is the true intention of 
the Community legislature, and the Member 
States are required to comply with it when 
adopting measures to implement Article 6(3) 
of the Directive. 
63. In addition, according to the prevailing 
interpretation, the scope for action of the 
I - 460 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
national authorities with a view to preventing 
misleading advertising for cosmetic products 
is particularly limited. As the Court observed 
in the Parfumerie-Fabrik Glockengasse judg­
ment, the obligation under Article 6(3) of the 
Directive to take all necessary measures 'does 
not authorise Member States to require infor­
mation not provided for in the directive on 
the labelling or packaging of those prod­
ucts'. 56 In the same judgment the Court 
indeed took the view that the aim of pro­
tecting consumers 'may be achieved by means 
less restrictive of Community trade'. 57 The 
Court also made the following important 
observation: 'it appears from a comparison of 
the national provisions adopted for that pur­
pose that certain Member States have laid 
down a general prohibition of any indication 
likely to mislead the consumer. There is 
nothing to suggest that such a general prohibi­
tion is inadequate to achieve the desired end'. 58 
64. Exactly the same reasoning can be applied 
to national measures which, to prevent mis­
leading advertising, set up a system which 
hinders the free movement of goods and the 
presentation of cosmetic products by means 
of restrictions on their composition. To be 
more precise, national legislation which, for 
cosmetic products to claim certain character­
istics (in connection with labelling, presenta­
tion and advertising), requires such products 
to contain certain substances listed in national 
sources of law (according to national law, 
these are the only substances which scientifi­
cally correspond to those characteristics) is 
directly contrary to the intention of the Com­
munity legislature that the marketing of a 
cosmetic product is not to depend on prior 
authorisation of its composition by the 
national authorities. In national legislation of 
this kind the principle of the free movement 
of cosmetic products containing none of the 
dangerous of harmful substances exhaustively 
listed in the Directive is relegated to the status 
of a mere exception. Conversely, where cos­
metic products are free from restrictions under 
national law only if their composition con­
forms with the relevant national provisions, 59 
this means in reality that a system of prior 
authorisation for those products has been 
introduced, contrary to the aim of the Direc­
tive. 
65. Accordingly, a national system such as 
that described above is contrary to the require-
56 — See the Parfumerie-Fabrik Glockengasse judgment cited in 
footnote 39, paragraph 19. 
57 — Ibid., paragraph 20. 
58 — Ibid., paragraph 20. 
59 — This applies particularly in cases where national law permits 
(but only after authorisation has been granted for a speci­
fied period) the marketing of a product which contains none 
of the substances corresponding, according to the existing 
positive list, to the characteristics which it is claimed to pos­
sess. 
I -461 
OP I NI ON OF MR COSMAS — CASE C-77/97 
ments of the Directive. The ratio of a posi­
tive list of substances which cosmetic prod­
ucts must contain (although it is justified by 
the aim of improved protection for con­
sumers) in order that certain characteristics 
may be ascribed to them goes beyond the 
enabling power conferred by Community law. 
In a system of this kind, there is no examina­
tion in each individual case to establish 
whether the product produces the effects 
which are supposed to result from using it. 
The product must 'automatically' contain the 
substances which, in the opinion of the 
national authorities, produce the effects in 
question. Furthermore, a manufacturer who 
claims to have found a new substance capable 
of producing certain effects must obtain a 
special authorisation before marketing the cos­
metic product. 
66. The situation which thus arises thus clearly 
constitutes an obstacle to the free movement 
of goods even though the national system 
does not directly hinder such movement but 
prohibits advertising or generally presenting 
products as possessing the characteristics in 
question if the products contain substances 
not included in the national positive list. The 
marketing of a product is directly linked to 
the possibility of making it as attractive as 
possible to consumers. Accordingly, the free 
movement of goods also means the freedom 
to advertise a product. To avoid any misun­
derstanding, the Community legislature has 
in its wisdom furthermore expressly prohib­
ited misleading presentation as the sole restric­
tion on the freedom to advertise cosmetic 
products. 60 
67. From what I have said it follows, in my 
opinion, that national legislation such as that 
described above, which is not confined to a 
general prohibition of misleading advertising, 
but goes further and sets up a system with a 
positive list of permitted substances which 
60 — It should also be observed that Article 6(3) of Directive 
76/768 is in a way a forerunner of Council Directive 
84/450/EEC of 10 September 1984 on misleading adver­
tising. A system as strict as that introduced by the Austrian 
legislature does not appear to be justified by anything in this 
later directive, the importance of which has been clearly 
acknowledged by the Court (see the De Agostini and 
TV-Shop judgment cited in footnote 52, paragraph 37). On 
the contrary, national supervision is based on examining the 
accuracy of advertisements in individual cases and not on 
the automatic exclusion of an advertisement by a provision 
to the effect that everything which is not expressly provided 
for by law may be prohibited. In particular, Article 6 of 
Directive 85/450 provides as follows: 
'Article 6 
Member States shall confer upon the courts or administra­
tive authorities powers enabling them in the civil or admin­
istrative proceedings provided for in Article 4: 
(a) to require the advertiser to furnish evidence as to the 
accuracy of factual claims in advertising if, taking into 
account the legitimate interests of the advertiser and any 
other party to the proceedings, such a requirement 
appears appropriate on the basis of the circumstances of 
the particular case; and 
(b) to consider factual claims as inaccurate if the evidence 
demanded in accordance with (a) is not furnished or is 
deemed insufficient by the court or administrative author­
ity.' 
I - 4 6 2 
ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL 
determines whether a cosmetic product can 
be marketed freely, is contrary to Directive 
76/768. 
68. Finally, for the sake of completeness, it 
seems to me necessary to point out that 
national legislation which completely pro­
hibits advertising for cosmetic products by 
means of statements relating to health which 
are not misleading likewise goes beyond the 
limits of the legislative power conferred upon 
the national authorities by Article 6(3) of 
Directive 76/768. On this point I can confine 
myself to the following observations. If a 
cosmetic product is advertised in such a way 
that, in the eyes of consumers, it is connected 
with the protection of health, there are two 
possibilities. Either it creates that impression 
that it is a medicinal product, with the result 
that the question of the application of Direc­
tive 65/65 arises, 61 or the consumer still 
regards it as an ordinary cosmetic which actu­
ally has some connection with human health. 
In the latter case, provided the advertising is 
not misleading, the product will not fall within 
the prohibitions in Article 6(3) of Directive 
76/768 and will consequently come within 
the scope of the freedom of action granted by 
the Community legislature. A national pro­
hibition of that kind unduly restricts the 
freedom to trade in cosmetic products and is 
contrary to Community law. I am led to this 
conclusion by merely interpreting and 
applying the relevant provisions of Directive 
76/768 which have exhaustively harmonised 
the law concerning the advertising of cos­
metic products, and it is unnecessary to search 
for legal solutions on the basis of Article 30 
et seq. of the EC Treaty. 62 
61 — See paragraph 16 et seq. above. 
62 — I think it is appropriate, although not absolutely necessary, 
to observe that, if Directive 76/768 did not exist and if the 
problem were examined in the light of Articles 30 and 36 of 
the EC Treaty, it would not be clear whether a national mea­
sure banning advertising for cosmetic products with state­
ments referring to health would be in conformity with 
Community law. As I said above (see footnote 52), the 
assessment of national bans on advertising by reference to 
Article 30 et seq. does not always lead to the same conclu­
sion. 
In any case, if the national measure is to be deemed compat­
ible with Community law, it must not restrict advertising 
generally. In the Hünermund judgment cited in footnote 52, 
the Court stated that a rule of professional conduct prohib­
iting pharmacists from advertising quasi-pharmaceutical 
products outside the pharmacy does not fall within the scope 
of Article 30 of the EC Treaty. However, the Court first 
observed that 'the prohibition does not affect the right of 
traders other than pharmacists to advertise those products' 
(paragraph 19). Likewise in the Leclerc-Siplec judgment cited 
in footnote 52 the Court found that a law or regulation pro­
hibiting televised advertising in the distribution sector is not 
an obstacle to trade within the Community. This conclusion 
was reached on the basis that 'such a prohibition does not 
prevent distributors from using other forms of advertising' 
(paragraph 19). 
In fact, the distinction between a total and a partial ban on 
advertising is not always adhered to in the case-law. In the 
De Agostini and TV Shop judgment it was held that a com­
plete ban on advertising aimed at children under 12 did not 
fall within the scope of Article 30 of the EC Treaty. 
I - 4 6 3 
OPINION OF MR COSMAS — CASE C-77/97 
VI — Conclusion 
69. On the basis of all the foregoing considerations, I propose that the Court reply 
to the question from the national court as follows: 
(1) A toothpaste is to be regarded as a cosmetic product within the meaning of 
Community law and is covered by Council Directive 76/768/EEC of 27 July 
1976 on the approximation of the laws of the Member States relating to cos­
metic products unless the averagely well-informed consumer may infer with 
certainty, from the statements on the packaging of the product, from adver­
tising and generally from its presentation for sale, that it is a substance pre­
sented for treating or preventing disease within the meaning of Council Direc­
tive 65/65/EEC of 26 January 1965 on the approximation of provisions laid 
down by law, regulation or administrative action relating to proprietary 
medicinal products. 
(2) National legislation which, in order to give consumers improved protection 
against misleading advertising, and for the sake of protecting health, on the one 
hand, prohibits advertising of cosmetic products by means of misleading state­
ments concerning health and, on the other hand, introduces a national control 
system on the basis of which a cosmetic product cannot be presented on the 
market as producing certain effects if its composition does not include the 
substances which, in the view of the national legislature, alone justify and con­
firm the claim that it has such effects, it being necessary in that case to obtain 
special prior authorisation to advertise and to market the product, goes further 
than the restrictions authorised by Article 6(3) of Directive 76/68 and is there­
fore incompatible with Community law. 
I - 464