Judgment;Summary — ECLI:EU:C:2022:781
Date: 2022-10-13
Language of the case: German
Court formation: Second Chamber
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary C-616/20 – 1 
Case C-616/20 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
19 November 2020 
Referring court: 
Verwaltungsgericht Köln (Germany) 
Date of the decision to refer: 
27 October 2020 
Applicant: 
M2Beauté Cosmetics GmbH 
Defendant: 
Federal Republic of Germany 
  
Subject matter of the main proceedings 
Classification of a cosmetic product to promote eyelash growth as a medicinal 
product by function within the meaning of Paragraph 2(1), point 2(a), of the 
German Arzneimittelgesetzes (Law on Medicinal Products), which transposes 
Article 1(2)(b) of Directive 2001/83 on the Community Code relating to medicinal 
products for human use. 
Subject matter and legal basis of the reference 
Interpretation of EU law, Article 267 TFEU 
Questions referred 
1. Is a national authority, when classifying a cosmetic product as a medicinal 
product by function, within the meaning of Article 1(2)(b) of Directive 
2001/83/EC of 6 November 2001, and, in so doing, examining all the 
characteristics of that product, entitled to base the necessary scientific assessment 
EN 
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of the pharmacological properties of that product and the risks associated with it 
on a ‘structural analogy’, in a case where the active substance used has only 
recently been developed, is comparable in its structure to pharmacological active 
substances which are already known and studied, but no comprehensive 
pharmacological, toxicological or clinical studies of the new substance in relation 
to its effects and its dosage, which are necessary only if Directive 2001/83/EC is 
applicable, have been submitted by the applicant? 
2. Is Article 1(2)(b) of Directive 2001/83/EC of 6 November 2001 to be 
interpreted as meaning that a product which is placed on the market as a cosmetic 
and which significantly modifies physiological functions by producing a 
pharmacological effect is to be regarded as a medicinal product by function only 
in the case where it has a specific positive health-promoting effect? Is it sufficient 
in this regard even that the product has on a person’s appearance a predominantly 
positive effect which, by increasing self-esteem or wellbeing, is of indirect benefit 
to health? 
3. Or is that product also a medicinal product by function in the case where its 
positive effect is confined to an improvement in a person’s appearance, without 
being of direct or indirect benefit to health, but where it does not have properties 
that are exclusively harmful to health and is not therefore comparable to a 
narcotic? 
Provisions of EU law relied on 
Directive 2001/83/EC of the European Parliament and of the Council of 
6 November 2001 on the Community code relating to medicinal products for 
human use, in particular Article 1(2)(b) and Article 2(2) 
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 
30 November 2009 on cosmetic products, in particular recital 7 and Article 2(1)(a) 
Provisions of national law relied on 
Gesetz über den Verkehr mit Arzneimitteln (Law on the Marketing of Medicinal 
Products) (Arzneimittelgesetz (Medicinal Products Law) – AMG), in particular 
Paragraph 2 
Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch (Food, 
Commodities and Feed Code) (Lebensmittel- und Futtermittelgesetzbuch (Food 
and Feed Code) – LFGB), in particular Paragraph 2 
Neue-psychoaktive-Stoffe-Gesetz (Law on New Psychoactive Substances) 
(NpSG), in particular Paragraph 2, point 1, and Paragraphs 3 and 4 
M2BEAUTÉ COSMETICS 
 
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Brief presentation of the facts and the proceedings 
1 The applicant has developed the product ‘M2 Eyelash Activating Serum’ and 
placed it on the market as a cosmetic product. The product consists of a gel-like 
liquid containing, inter alia, an active substance known as ‘methylamide-dihydro-
noralfaprostal’ (MDN) in a concentration of 0.02%. This is a new synthetic active 
substance which is structurally related to the human tissue hormone prostaglandin 
and is known as a prostaglandin derivative or prostaglandin analogue. 
2 Prostaglandins make up a group of substances which, when needed, are produced 
by biosynthesis from fatty acids in various organs of the body and control 
numerous physiological processes by binding to specific receptors. They are 
involved, in particular, in the regulation of reproduction (e.g. the initiation of 
contractions), the cardiovascular system, respiration, pain and the ocular and 
sensory system. Pharmaceutical research has led to the development of some 
synthetic prostaglandins which are structurally related to human prostaglandins 
and have effects which are deployed therapeutically. 
3 Prostaglandin derivatives of the type PGF2alpha, for example, are used in 
ophthalmology as an ingredient in eye drops for the treatment of glaucoma (‘green 
star’). They lower intraocular pressure by increasing the outflow of intraocular 
fluid. A known side effect which has come to light in clinical studies is increased 
eyelash growth. For example, a prostaglandin derivate by the name of 
‘bimatoprost’ (BMP) has been authorised as a medicinal product in Germany in its 
capacity as an active ingredient in eye drops for the treatment of glaucoma. In the 
USA, moreover, bimatoprost has been authorised as a medicinal product to 
promote eyelash growth (‘Latisse’) in the treatment of ‘eyelash hypotrichosis’. 
These products contain BMP in 0.03% solution. 
4 According to the current state of scientific knowledge, bimatoprost works by 
prolonging the growth phase of eyelashes and delaying the subsequent transition 
phase. This leads to an increase in the number of hair shafts, which form thicker 
and longer eyelashes. A regeneration of hair follicles does not take place. 
5 The substance MDN that is used in the product at issue is largely identical in its 
molecular structure to the active substance bimatoprost used in medicinal 
products. The only difference between the two substances lies in a single group of 
molecules.  
6 The applicant advertises the product as an innovative beauty product which 
promotes the natural growth and density of eyelashes by up to 50% on average. 
The serum is contained in an elongated bottle with an integrated brush that 
resembles a mascara or eyeliner container. The liquid is to be applied once a day, 
with the brush, to the base of the upper eyelashes, like an eyeliner. 
7 By decision of 29 April 2014, the Bundesinstitut für Arzneimittel und 
Medizinprodukte (Federal Institute for Drugs and Medical Devices) (BfArM) held 
that that product was not a cosmetic but a medicinal product requiring 
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authorisation. the institute stated that that product has the characteristics of a 
medicinal product by function. 
8 Following completion of the administrative objection proceedings, the applicant, 
on 9 November 2017, brought before the referring court an action seeking the 
annulment of that decision. 
Essential arguments of the parties to the main proceedings 
9 In the view of the BfArM, the product at issue is a medicinal product by function. 
The reason is that the effects of MDN and BMP, which is used as an ophthalmic 
medicine, are comparable. The molecular structure of the two substances is 
comparable from the point of view of their characteristic components. Because of 
the known relationships between the structure and effect [of substances], it can 
therefore be assumed that the effects of those substances are comparable too. This 
is confirmed by the applicant’s finding in its own trials that use of the active 
substance MDN has the same effect of increasing eyelash growth as BMP is 
known to produce. MDN has a pharmacological effect because – like BMP – it 
interacts with the prostamide receptor. The lengthening and thickening of 
eyelashes also has a significant impact on physiological functions. What is more, 
the product’s classification as a medicinal product by function is supported by the 
fact that a risk to health from its use cannot be excluded. Because of the structural 
similarity of the two, its side effects are likely to be similar to those of ‘Latisse’, 
too. 
10 The applicant takes the view that its product and the active substance MDN do not 
have a pharmacological effect. The in-vitro comparative studies conducted by the 
manufacturer of the active substance show that, notwithstanding their structural 
similarity, the substances MDN and BMP are not comparable from the point of 
view of their biological and chemical properties. MDN is likely to work in the 
same way as the group of substances known as ceramides, and its effects, like 
those of ceramides, are not therefore pharmacological either. What is more, the 
promotion of eyelash growth does not constitute a significant modification of 
physiological functions. The health risks assumed to be present by the BfArM 
were drawn from experience in the use of medicinal products and have not been 
proved to apply in the case of the product at issue. Finally, the applicant takes the 
view that classification of the product at issue as a medicinal product by function 
is contrary to the case-law of the Court of Justice of the European Union 
concerning products which are consumed not for therapeutic purposes but 
exclusively for the purposes of relaxation or intoxication and, as such, are harmful 
to health (Court of Justice, judgment of 10 July 2014, C-358/13 and 
C-181/14, Markus and G., concerning, inter alia, ‘legal highs’). 
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Brief presentation of the grounds for the reference 
11 The decision on the lawfulness of the BfArM’s finding that the eyelash growth 
product at issue is a medicinal product by function is dependent on the 
interpretation of the concept of medicinal product under EU law and, therefore, on 
the answers to the questions referred. The reason for this is that the national 
definition of a medicinal product by function given in Paragraph 2(1), point 2(a), 
of the AMG corresponds almost verbatim to the provision contained in 
Article 1(2)(b) of Directive 2001/83. 
12 The finding that a product has a pharmacological effect, upon which its 
classification as a medicinal product by function is contingent, is possible only if 
the active substance used, MDN, is found to be structurally analogous to BMP, as 
the BfArM considers it to be. The reason is that no conclusive pharmacological 
studies have been carried out into the pharmacological effects of MDN at a 
particular dosage. 
13 The capacity to be of direct or indirect benefit to health, [note: this criterion is a 
reference to Joined Cases C-358/13 and C-181/14, cited above.  See the operative 
part and paras 36 and 38 of that judgment, German being the language of  the 
case. The French ‘des effets bénéfiques, immédiats ou médiats, sur la santé 
humaine’ is translated as ‘der menschlichen Gesundheit unmittelbar oder mittelbar 
zuträglich’ (DE); beneficial effects, either immediately or in the long term, on 
human health (EN); ευεργετικά αποτελέσματα, άμεσα ή έμμεσα, για την 
ανθρώπινη υγεία (EL); efectos beneficiosos, mediatos o inmediatos, sobre la salud 
humana (ES); effetti benefici, immediati o mediati, sulla salute umana (IT); 
nyttige virkninger, direkte eller indirekte, på menneskers sundhed (DA): the EN 
translation appears to be an outlier] upon which classification as a medicinal 
product by function is also contingent, is dependent on how that unwritten 
criterion for the application of Article 1(2)(b) of Directive 2001/83 – which has 
been developed in the case-law of the Court of Justice – is to be interpreted. In 
particular, the question is whether a cosmetic too must have an additional positive 
effect on health in order to be a medicinal product. 
14 Since the product at issue is marketed as a ‘cosmetic product’ and does not claim 
to be a means of curing, alleviating or preventing human disease, it is not a 
‘medicinal product by presentation’ within the meaning of Article 1(2)(a) of 
Directive 2001/83/EC. 
15 The BfArM takes the view, however, that, because of the ingredient MDN, that 
product is a medicinal product by function within the meaning of Article 1(2)(b) 
of Directive 2001/83. This is doubtful, however. First, it is unclear how far the 
obligation incumbent on the national authorities and the courts to establish the 
pharmacological effects of the product and the risks associated with it extends, in 
the absence of adequate scientific evidence on the active substance used at the 
dosage in question and its use on the eyelid (see section I below). 
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16 Secondly, it is open to question whether cosmetic products which alter a person’s 
appearance by means of a pharmacologically active substance have an effect as a 
medicinal product by function which is of direct or indirect benefit to health (see 
section II below). 
17 In accordance with the settled case-law of the Court of Justice, the competent 
national authority must make the decision as to whether a product falls within the 
definition of a medicinal product by function on a case-by-case basis, taking into 
account all of the characteristics of the product, in particular its composition, its 
pharmacological, immunological or metabolic properties, in so far as these can be 
established in the present state of scientific knowledge, the manner in which the 
product is used, the extent of its distribution, its familiarity to consumers and the 
risks which its intended use may entail.  
18 In this regard, it is not sufficient for a product to contain a physiologically active 
substance. The pharmacological, immunological or metabolic properties of a 
product are the factor on the basis of which it must be ascertained, in the light of 
the potential effects of the product, whether it may be used in or on the human 
body with a view to restoring, correcting or modifying physiological functions. 
19 However, products cannot be classified as a medicinal product by function in the 
case where, although they have an effect on the human body, they do not 
significantly affect physiological functions and thus do not actually modify the 
way in which it functions. 
20 Neither is it sufficient, in and of itself, that the use of a product presents a risk to 
health. This is an autonomous factor in the classification of a product as a 
medicinal product by function. Risks to health are not, however, indicative of the 
presence of the necessary pharmacological effects (see Court of Justice, judgment 
of 30 April 2009, Bios Naturprodukte, C-27/08, paragraph 18 et seq.). 
21 Finally, the concept of a medicinal product by function does not cover substances 
the effects of which merely modify physiological functions and which are not 
such as to entail direct or indirect beneficial effects for human health. In 
particular, substances which are consumed solely to induce a state of intoxication 
and are, as such, harmful to human health (see Court of Justice, judgment of 
10 July 2014, C-358/13 and C-181/14, Markus and G., inter alia, paragraphs 38 
and 50). 
I. Pharmacological effect of the ingredient MDN 
22 In the light of the foregoing, it is doubtful whether the BfArM has scientifically 
substantiated, to a sufficient extent, its finding that the ingredient MDN has a 
pharmacological effect on the basis of the dosage, form of administration and 
particular mode of use (application to the rim of the eyelid) present here. 
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23 According to the definition given in the ‘Borderline Guideline’, MEDDEV 2.1/3, 
rev. 3, a pharmacological effect is present where there is an interaction between 
the molecules of the substance concerned and a cell component usually described 
as a receptor. 
24 The substance used here is a newly developed one the pharmacological effects of 
which have not been the subject of sufficient scientific study. The applicant has 
submitted an in-vitro study to establish the affinity of MDN to known 
prostaglandin receptors which was able to establish only a weak binding to those 
receptors and could not therefore confirm any relevant pharmacological effect. In 
the estimation of the Institut für Risikobewertung (Institute of Risk Assessment) 
of July 2018, however, it is unclear whether that testing regime is physiologically 
relevant, that is to say whether it is transposable to the rim of the human eyelid. 
The applicant has not, however, been able to substantiate its assertion that the 
effect is based on a similarity with another group of substances (ceramides) and is 
non-pharmacological in nature.  
25 The proposition put forward by the BfArM that MDN has a pharmacological 
effect by interacting with an as yet unidentified prostamide receptor has likewise 
not been the subject of any study that would support that assumption. For that 
reason, the BfArM falls back on a so-called structural analogy with previously 
known prostaglandin analogues, in particular BMP. From the fact that the two 
substances, MDN and BMP, have a largely identical molecular structure and 
produce the same effect on eyelash growth, the conclusion is drawn that they also 
have a comparable pharmacological mode of operation and comparable side 
effects. There is as yet no positive evidence to support that proposition. However, 
not even the comparative studies of the hydrolysis and binding behaviour of MDN 
and BMP are capable of refuting the structural analogy proposition, since, in the 
BfArM’s assessment, those studies show that the substances in question exhibit 
not identical but similar properties. The referring court concurs with that 
assessment. 
26 The precise mode of operation of BMP is also as yet unknown and scientifically 
contentious. There is general agreement, however, that BMP has a 
pharmacological effect because it is a prostaglandin analogue and, like that class 
of substances, controls physiological functions via certain receptors, even though 
the receptor in question has not yet been identified. 
27 MDN can therefore be said to have a pharmacological mode of operation in the 
product at issue only if it is confirmed that its effect is comparable to that of BMP 
because it is structurally analogous to that substance and to other prostaglandin 
analogues. 
28 The referring court wishes to ascertain whether a scientific finding of 
pharmacological properties on the part of a new unknown substance may be 
reached even on the basis of a structural analogy, that is to say the fact that that 
substance belongs to a particular known group of substances, or whether, given 
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that substance-specific study is largely lacking, it must be concluded that that 
substance does not have a pharmacological effect. 
29 The conclusion that the pharmacological properties of a new, slightly modified 
substance cannot be established on the basis of a structural analogy would mean 
that products that may have pharmacological effects could be placed on the 
market as a medicinal product without a marketing authorisation because there is 
no way of establishing those effects in the absence of any scientific studies in this 
regard. The referring court is therefore inclined to endorse the permissibility of 
adducing the necessary proof of pharmacological effects on the basis of a 
structural analogy in the case where the manufacturer cannot unequivocally refute 
those effects by reference to its own conclusive studies. After all, the 
manufacturer decides on the composition of the product and its properties. He is 
responsible for placing the product on the market in a legal manner. If, in so 
doing, he uses a substance the molecular structure of which is indicative of a 
pharmacological mode of operation, he must rebut this if he does not wish to place 
the product on the market as a medicinal product. Currently, he would not have 
been able to do this in the present case, because the limited affinity to known 
prostaglandin receptors does preclude that affinity being sufficient for the 
purposes of the established effect of promoting eyelash growth in vivo or the 
substance in question binding to another as yet unidentified receptor.  
30 If it is found that the product at issue does have a pharmacological mode of 
operation, the referring court will assume, in accordance with the foregoing 
considerations, that that product, when used as intended, has a significant effect 
on the body’s physiological functions (Court of Justice, judgment of 15 November 
2007, Commission v Germany C-319/05, paragraph 68). 
31 By comparison with products to combat hair loss and dandruff, which, 
notwithstanding their effect on physiological functions, are not perceived by the 
general public as being medicinal, the product at issue here is applied to the rim of 
the eyelid and thus in the vicinity of the eye, that is to say near a particularly 
sensitive and important organ. Since that product is effective only if applied over a 
prolonged period and the active substance used is likely to have a broad range of 
effects in its capacity as a tissue hormone, there would appear to be good reason to 
assume that the product at issue here has a significant impact on the body’s 
physiological functions. 
II. Capacity of the product to be of direct or indirect benefit to human health 
32 The character of the product at issue as a medicinal product by function therefore 
depends on whether its effect on eyelash growth is of direct or indirect benefit to 
human health (Court of Justice, judgment of 10 July 2014, C-358/13 and 
C-181/14,  Markus and G., paragraphs 38 and 46). 
33 Whether the product is objectively capable of being used for therapeutic purposes 
is not decisive from the point of view of its character as a medicinal product. The 
M2BEAUTÉ COSMETICS 
 
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finding that a product has the objective capacity to be used for therapeutic 
purposes is tantamount to proof that it is therapeutically effective. However, its 
capacity to do so is a component not of the definition of a medicinal product by 
function but of the downstream examination of a positive risk-benefit ratio that 
forms part of the procedure for authorising medicinal products. The Court of 
Justice confirmed this in the judgment of 15 December 2016, C-700/15, LEK 
Farmacevtska Družba, paragraph 35. 
34 Accordingly, it is not necessary for a product to be capable of being used to treat a 
disease. That said, a product would automatically be regarded as having a 
significant pharmacological effect if it were proven to be therapeutically 
efficacious (Court of Justice, judgment of 30 November 1983 Leendert van 
Bennekom, C-227/82). 
35 That is not the case with the product at issue, however. In the European Union, 
there is no medicinal product authorisation for the active ingredient MDN and 
there are no clinical efficacy studies either.  
36 Even if a structural analogy were found to be permissible, BMP is likewise not the 
subject of any efficacy studies that could be transposed to the product at issue. It is 
true that the active ingredient BMP is authorised in the USA for the indication of 
‘eyelash hypotrichosis’. It is open to question, however, whether this constitutes a 
medical condition. The registration trials – in so far as these have been presented 
[to the court] – were carried out on healthy volunteers. Even in the 2014 study 
submitted, carried out on Japanese volunteers, the only indications examined were 
eyelash loss after chemotherapy and ‘idiopathic hypotrichosis’, which is to say 
impaired eyelash growth for no recognisable cause. After chemotherapy, 
eyelashes and hair usually grow back on their own. Whether the product is 
efficacious even in the case where natural hair growth does not resume was not 
examined. The study therefore focused on strengthening natural eyelash growth, 
and thus on an aesthetic benefit. 
37 In so far as hypotrichosis has a pathological cause, such as hair loss, nutritional 
deficiencies or autoimmune diseases, it is open to question whether the product at 
issue, even assuming a structural analogy to be permissible, will be therapeutically 
effective so long as the cause is not treated. There are no clinical studies on 
pathological eyelash loss.  
38 Whether the product at issue – like ‘Lumigan’ – could be used to reduce 
intraocular pressure and thus to treat glaucoma is open to question and has not 
been proved. It has a lower concentration, is applied not to the conjunctival sac 
but to the eyelid, is not a liquid but in a gel-like form and is, as such, bioavailable 
in a much smaller quantity in the eye. 
39 Finally, the defendant has not adduced any evidence to show that the 
psychological stress brought on by sparse eyelash growth is so serious as to 
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warrant classification as pathological and can be cured with an eyelash growth 
product.  
40 If, therefore, no demonstrable therapeutic efficacy can be established, what 
matters here is whether the promotion of eyelash growth is an effect which has 
direct or indirect health benefits (Court of Justice, judgment of 10 July 2014, 
C-358/13 and C-181/14, Markus and G., paragraph 38). 
41 That examination depends on how that unwritten criterion is to be interpreted. If 
health must be specifically and identifiably promoted in the sense of being 
improved or maintained, the product at issue would not be a medicinal product by 
function. 
42 The reason is that the positive effect of the product in this case is confined to 
strengthening eyelash growth, and thus to aesthetics. The improvement of a 
person’s appearance by longer and thicker eyelashes is an effect which has no 
bearing on health. It is an effect typical of cosmetics but not of medicinal 
products. 
43 Nor can it be established that strengthened eyelashes have a significant positive 
effect on the protective function of eyelashes as protection against foreign bodies, 
dust or sunlight. The form taken by eyelashes in different individuals varies within 
a natural range which is determined largely by genetics. No evidence is available 
to indicate that eyelashes have a diminished protective effect if there are fewer of 
them or they are shorter. That protection is probably of little importance to the 
individuals in the product’s target market nowadays anyway, most of whom enjoy 
a modern urban lifestyle that takes place largely indoors. One study even 
suggested that artificially lengthened eyelashes may even be counterproductive. 
44 If, on the other hand, an improvement in a person’s appearance were regarded as 
having a positive effect on self-esteem, personal wellbeing or the quality of social 
relations, and as thus indirectly promoting health, the product could be a 
medicinal product by function. 
45 Even if it is found that a product has health benefits as soon as it produces an 
effect which is in any way positive and is not exclusively harmful to health, a 
cosmetic which simply brings about a positive change in a person’s appearance 
and whose effects are not therefore confined to being harmful, as intoxicants are, 
for example, could also be a medicinal product by function. 
46 The decisions of the Court of Justice concerning the definition of the concept of 
medicinal product by function do not offer a clear interpretation for the purposes 
of the cosmetic product at issue. 
47 The judgment of the Court of Justice of 16 April 1991, C-112/89, Upjohn 
paragraphs 19 and 21, points rather towards a broad interpretation of the concept 
of medicinal product by function. On this interpretation, cosmetic products 
intended to combat hereditary and non-pathological hair loss are also medicinal 
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products if they significantly modify physiological functions. In that judgment, the 
Court of Justice did not at that stage require that a medicinal product by function 
must, as an unwritten characteristic, have an effect that is beneficial to health. 
That decision could therefore be interpreted as meaning that, in the case of 
cosmetic products at least, classification as being in the nature of a medicinal 
product is subject only to the requirement that the product’s pharmacological 
properties should significantly modify physiological functions, and that a more 
extensive positive effect on health is not necessary.  
48 The decision of the Court of Justice of 10 July 2014, C-358/13, and C181/14, 
Markus and G., paragraphs 38 and 50, points rather towards a narrower 
interpretation of the concept of medicinal product by function. According to this 
interpretation, ‘legal highs’, that is to say intoxicants containing cannabinoids, are 
not medicinal products because, although they significantly modify physiological 
functions, they are of neither direct nor indirect benefit to health, but serve only 
relaxation purposes. That decision could be construed as meaning that cosmetic 
products too are subject to the further requirement that the product must be of 
direct or indirect benefit to health. That construction is supported by the Court’s 
reference to the schematic connection with the concept of a medicinal product by 
presentation mentioned in Article 1(2)(a) of Directive 2001/83/EC and to the 
objective of health protection referred to in recital 3 of amending Directive 
2004/27. In that regard, the Court is silent on the matter of what it understands by 
an indirect positive effect on health. This might also include a positive effect on a 
person’s appearance the health benefits of which are not direct but indirect, in the 
form of an improvement in an individual’s wellbeing or self-esteem. 
49 That said, the judgment of 10 July 2014 cited in the preceding paragraph related to 
narcotics, not to cosmetics. The earlier decision of 16 April 1991 (Bios 
Naturprodukte, C-27/08) on cosmetic products for hair loss was mentioned but not 
abandoned. The requirement that a product must be of direct or indirect benefit to 
health might therefore serve only to exclude products whose effects on health are 
exclusively harmful, such as the synthetic cannabinoids referred to above, from 
the concept of medicinal product, without introducing the need for the further 
positive characteristic of having a health-promoting effect. If that were the case, 
nothing about the decision of 16 April 1991 would have changed and the cosmetic 
product at issue would be a medicinal product by function even in the absence of a 
positive finding in relation to its health-promoting effect.  
50 It is mentioned only for the sake of completeness that the presence of health risks 
is unlikely to have a decisive bearing in the matter of the classification of products 
as medicinal products. If the answer to the questions referred is that the product at 
issue can be said to have both a pharmacological mode of operation and a health-
promoting effect, that product would be a medicinal product by function. The 
danger of the health risks posed by prolonged use of that product would serve only 
to confirm that classification. In the event that the product at issue cannot be said 
to have a pharmacological mode of operation or a health-promoting effect, that 
product would be a cosmetic product irrespective of the risks associated with it. In 
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that event, Regulation No 1223/2009 makes available a procedure, for which it 
provides in Annex 2 thereto, for prohibiting substances which present risks to 
health.