Judgment;Summary — ECLI:EU:C:2023:143
Date: 2023-03-02
Language of the case: German
Court formation: Second Chamber
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Austria

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: 
10 December 2021 
Referring court: 
Verwaltungsgericht Wien (Austria) 
Date of the decision to refer: 
26 November 2021 
Complainant: 
Kwizda Pharma GmbH 
Respondent authority: 
Landeshauptmann von Wien (Head of government of the Land of 
Vienna) 
  
Subject matter of the main proceedings 
Food for special medical purposes – Dietary management – Nutrient – To be used 
under medical supervision – Medicinal products – Distinction  
Subject matter and legal basis of the request 
Interpretation of EU law, Article 267 TFEU 
Questions referred for a preliminary ruling 
1(a) In order to be categorised as a food for special medical purposes, must a 
product be demonstrably capable of achieving the claimed disease- or condition-
specific results solely in the context of the dietary management indicated by that 
disease or condition with respect to the food-intake requirements of that condition 
or disease? 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-760/21 
 
2  
1(b) In that context, is dietary management to be assumed only in the case where 
a person changes his or her diet in such a way as to consume other or additional 
nutrients which are absorbed by the body by way of digestion? 
1(c) For the purposes of categorisation as a food for special medical purposes, is 
it also necessary that the condition or disease for which the product is intended 
requires dietary management in order to ensure that the patient ingests the 
nutrients contained in the product which cannot be absorbed through the normal 
diet? 
1(d) Must the food for special medical purposes achieve its medical effect solely 
by virtue of the fact that it contains some or all of those nutrients which cannot be 
absorbed through the normal diet but are absolutely necessary or required in order 
for the patient to maintain his or her vital functions? 
If those questions are answered in the negative: What type of ingredients must a 
product contain in order to meet the requirements for a food for special medical 
purposes? 
2(a) Does the categorisation of a product as a food supplement preclude the 
possibility of that product also being categorised as a food for special medical 
purposes? 
2(b) If that question is answered in the negative: What criteria should be used to 
determine that a particular food supplement cannot be categorised as a food for 
special medical purposes? 
2(c) Can the use of ‘food supplements’ within the meaning of Directive 
2002/46/EC on the approximation of the laws of the Member States relating to 
food supplements constitute, in itself, ‘dietary management’ within the meaning of 
Article 2(2)(g) of Regulation (EU) No 609/2013? 
2(d) Does a food already become a food for special medical purposes if it 
contains nutrients which can also be ingested by way of food supplements or other 
foods, but which are formulated specifically for a particular disease or condition? 
3. What criteria should be used as a basis for distinguishing a medicinal 
product from a food for special medical purposes or, alternatively, is it possible to 
draw a distinction between them? 
4. Is the requirement in Article 2(2)(g) of Regulation (EU) No 609/2013, 
according to which the ingredients relevant to categorisation as food for special 
medical purposes must produce their effect in the context of dietary management 
which cannot be achieved by modification of the normal diet, to be interpreted as 
meaning that a patient in respect of whose disease or condition the food for special 
medical purposes is placed on the market is not able to meet his or her nutritional 
requirements adequately via the intake of generally available foods? 
KWIZDA PHARMA 
 
3 
5(a) Is the phrase ‘whose dietary management cannot be achieved by 
modification of the normal diet alone’ in Article 2(2)(g) of Regulation (EU) 
No 609/2013 relative in nature in so far as fulfilment of that requirement is also to 
be assumed in the case where the nutrient intake required in the context of the 
disease or condition in question can be achieved by means of generally available 
foods (in particular, food supplements) only in a particularly burdensome manner? 
5(b) If that question is answered in the affirmative, what criteria should be used 
to determine that the burden associated with the intake of generally available 
foods meets the requirement ‘whose dietary management cannot be achieved by 
modification of the normal diet alone’ in Article 2(2)(g) of Regulation (EU) 
No 609/2013? In particular, is it to be assumed that that requirement is met in the 
case where a patient would be required to take several generally available food 
supplements separately? 
6(a) What is to be understood by a ‘nutrient’ within the meaning of 
Article 2(2)(g) of Regulation (EU) No 609/2013? 
6(b) What criteria should be used to determine whether a certain ingredient of a 
product is to be categorised as a nutrient within the meaning of Article 2(2)(g) of 
Regulation (EU) No 609/2013? 
7(a) Is the requirement ‘to be used under medical supervision’ in Article 2(2)(g) 
of Regulation (EU) No 609/2013 already met in the case where that product is 
supplied in a pharmacy without the need to obtain beforehand a doctor’s 
prescription? 
7(b) What criteria should be used to determine whether the requirement of use 
under medical supervision within the meaning of Article 2(2)(g) of Regulation 
(EU) No 609/2013 is met with regard to a certain product? 
7(c) What is the consequence of the eventuality that that requirement of use 
under medical supervision within the meaning of Article 2(2)(g) of Regulation 
(EU) No 609/2013 is not met in a specific case, or even in general? 
8(a) Is the existence of a food for special medical purposes to be assumed only in 
the case where it is NOT possible to use that food without medical supervision? 
8(b) If that question is answered in the affirmative, what criteria should be used 
in order to determine whether a food can also be used without medical 
supervision? 
Provisions of EU law cited 
Regulation (EU) No 609/2013 of the European Parliament and of the Council of 
12 June 2013 on food intended for infants and young children, food for special 
medical purposes, and total diet replacement for weight control and repealing 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-760/21 
 
4  
Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 
2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European 
Parliament and of the Council and Commission Regulations (EC) No 41/2009 and 
(EC) No 953/2009 
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 
2002 on the approximation of the laws of the Member States relating to food 
supplements 
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 
28 January 2002 laying down the general principles and requirements of food law, 
establishing the European Food Safety Authority and laying down procedures in 
matters of food safety 
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 
Provisions of national law cited 
Lebensmittelsicherheits- und Verbraucherschutzgesetz (Austrian Law on food 
safety and consumer protection; ‘the LMSVG’) 
Succinct presentation of the facts and procedure in the main proceedings 
1 Four sets of administrative-complaint proceedings are pending before the 
Verwaltungsgericht Wien (Administrative Court, Vienna), each of which concerns 
the question of whether a product placed on the market is to be categorised as a 
food for special medical purposes. The products in question contain cranberry and 
D-mannose, which prevent bacteria from adhering to the mucous membrane of the 
efferent urinary tract in cases of urinary tract infections, and therefore have an 
‘anti-adhesive effect’. 
2 Those products were registered with the competent ministry as food for special 
medical purposes but have not been categorised as such by the competent 
authority. As justification for that decision, it was stated that the ingredients 
cranberry and D-mannose achieve their effect not by being absorbed in the 
gastrointestinal tract, but rather as a result of their influence on renal excretory 
activity. They therefore cannot be categorised as nutrients, as is required for food 
for special medical purposes. 
3 In each case, an administrative complaint was lodged against that refusal to 
categorise the products as food for special medical purposes. 
KWIZDA PHARMA 
 
5 
Succinct presentation of the reasoning in the request for a preliminary ruling 
Question 1 
4 The authority proceeds on the assumption that a food can be said to be for special 
medical purposes only in the case where the product (food) in question achieves 
the claimed medical effect upon realisation of the dietary management which is 
desired from a health perspective and which the person consuming that food seeks 
to achieve. 
5 The term ‘dietary management’ is not defined in Regulation (EU) No 609/2013 
and is interpreted by the authority on the basis of nutritional science. In that sense, 
‘dietary management’ refers to a change in nutritional intake brought about by 
health reasons. This implies a change in the nutrients previously ingested, 
nutrients being understood as substances which are absorbed by the body by way 
of digestion and are relevant for ensuring bodily functions. 
6 Accordingly, dietary management must be required by reason of a condition or 
disease and, as a consequence of the condition or disease, it must be necessary that 
the dietary management is intended to ensure that the patient absorbs nutrients 
which cannot be absorbed through the normal diet. The food for special medical 
purposes can achieve its medicinal effect solely by virtue of the fact that it 
contains nutrients that cannot be absorbed through the normal diet. 
7 If Article 2(2)(g) of Regulation (EU) No 609/2013 requires that such a food must 
be demonstrably capable of achieving the claimed effects, this would be restrictive 
in so far as the food would then have to be demonstrably capable of achieving the 
claimed effects exclusively via a food-intake regime in the context of the dietary 
management indicated for health reasons. 
8 Those who place the products in question on the market understand the term 
‘dietary management’ to mean that such management exists where a disease or 
condition makes the intake of a certain nutrient appear advisable. 
9 Neither cranberry nor D-mannose produce their effects by being consumed as a 
result of a required change in diet or by being ingested by way of digestion. Their 
sole effect is a particular increase in renal excretory activity, which is beneficial 
for the healing process in urinary tract infections. Therefore, they can be 
categorised as a food for special medical purposes only if the complainant’s 
interpretation is accepted. 
Questions 2(a) to 2(d) 
10 The fact that the concept of food supplements and their placing on the market, on 
the one hand, and the concept of food for special medical purposes and its placing 
on the market, on the other hand, are regulated separately by various provisions of 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-760/21 
 
6  
EU law suggests that a product cannot be simultaneously both a food supplement 
and a food for special medical purposes. 
11 However, the complainant takes the position that a combination of several food 
supplements can already lead to categorisation of a food as being food for special 
medical purposes. 
Question 3 
12 In accordance with the third paragraph of Article 2 of Regulation (EC) 
No 178/2002, a food for special medical purposes cannot be a medicinal product.  
13 According to the complainant, a substance can also be categorised as a food for 
special medical purposes if it is not merely intended for nutrient intake in the 
context of dietary management but is also capable of having a beneficial effect on 
the course of a disease or on recovery. In that case, the only difference vis-à-vis a 
medicinal product is that the healing effect is not expressly extolled on the 
packaging. Accordingly, a distinction between medicinal products and food for 
special medical purposes no longer seems possible. 
14 The products at issue in the present proceedings are intended to increase the 
excretion of harmful substances in the urinary tract, and that effect combats 
urinary tract infections. It is difficult to distinguish the products at issue from a 
medicinal product, as the latter potentially has the same effect and pursues the 
same purpose. 
15 Article 9(5) of Regulation (EU) No 609/2013 concerns the labelling and 
presentation of food covered by the regulation. However, it remains unclear 
whether food for special medical purposes must be distinguished from medicinal 
products only with regard to their labelling and presentation, or whether, in 
addition, a product may not be categorised as a food for special medical purposes 
even if it has an effect that supports and shortens the process for the healing of a 
disease. Clarification is therefore required as to the point at which cases of doubt 
within the meaning of Article 2(2) of Directive 2001/83/EC exist, in which a 
product which can be both a medicinal product and another product is categorised 
as a medicinal product. 
Questions 4 and 5 
16 The complainant takes the view that a product is a food for special medical 
purposes if its ingredients are also contained in common foods or food 
supplements but the intake of those ingredients by way of those common foods or 
food supplements is difficult for the patient. It submits that it is only with a 
comparatively large amount of effort that the patient can absorb the active 
substances of the products at issue via the normal diet, with the result that 
modification of the normal diet alone is not sufficient for dietary management. 
KWIZDA PHARMA 
 
7 
17 The question therefore arises as to which criteria are to be used to determine that 
the intake of the required nutrients is not feasible by way of a ‘normal’ diet. 
Questions 6(a) and 6(b) 
18 Different definitions of the term ‘nutrient’ can be found in various provisions of 
EU law. The complainant takes the view that virtually every food and every 
substance that may also constitute at least part of a food or food supplement is to 
be categorised as a nutrient for the purposes Regulation (EU) No 609/2013. 
19 The authority relies on a narrower definition of a nutrient, according to which it is 
a substance that is metabolised by way of digestion and has an importance 
relevant to the maintenance or ensuring of bodily functions. Moreover, only that 
nutrient may be the cause of the effect attributed to the food for special medical 
purposes. 
20 The products in question are not absorbed by the body by way of digestion and the 
active ingredients cranberry and D-mannose contained in them do not serve to 
maintain or ensure bodily functions. If the authority’s interpretation is taken as the 
basis, the ingredients are not to be categorised as nutrients and the products could 
not be categorised as food for special medical purposes. Clarification of that 
question is therefore necessary for the purposes of the present proceedings. 
Questions 7 and 8 
21 The complainant interprets the phrase ‘to be used under medical supervision’ as 
meaning that that requirement is already met in the case where a service provider 
in the healthcare sector supplies the food in question to the patient. That 
circumstance, it is argued, obtains in the case of a sale in a pharmacy and also 
corresponds to the implementation practice in Austria. 
22 However, such an approach constitutes a fundamental departure from the literal 
meaning of the phrase ‘medical supervision’, with the result that the referring 
court has doubts as to whether such a broad interpretation is permissible. 
23 Furthermore, the question arises as to whether the circumstance of whether that 
requirement of use under medical supervision is met is relevant for the 
categorisation of a product as a food for special medical purposes. If that is the 
case, with the result that mere distribution in pharmacies is not sufficient to make 
categorisation as food for medical purposes possible, the products at issue could 
not be categorised as food for special medical purposes for that reason (also).