Judgment;Summary — ECLI:EU:C:2020:693
Date: 2020-09-10
Language of the case: Swedish
Court formation: Tenth Chamber
Subject matter: Agriculture and Fisheries;Foodstuffs;Consumer protection;Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Sweden

Summary C-363/19 — 1 
Case C-363/19 
Summary of the request for a preliminary ruling made pursuant to 
Article 98(1) of the Rules of Procedure of the Court of Justice 
Date lodged:  
7 May 2019 
Referring court:  
 Patent- and marknadsdomstolen (Sweden) 
Date of the decision to refer a request for a preliminary ruling:  
2 May 2019 
Claimant:  
Konsumentombudsmannen (KO) 
Defendant:  
Mezina AB 
  
Subject matter of the proceedings before the national court 
Action for an injunction prohibiting, the use of certain health claims in the 
marketing of food supplements, non-compliance with which is punishable by a 
fine. 
Purpose and legal basis of the request for a preliminary ruling 
Interpretation of EU law. Article 267 TFEU. 
Questions referred for a preliminary ruling 
1. Do Articles 5 and 6, read in conjunction with Articles 10(1) and 28(5) of 
Regulation No 1924/2006, regulate the burden of proof when a national court is 
determining whether unpermitted health claims have been made in a situation 
where the health claims in question correspond to a claim covered by an 
application under Article 13(2) of Regulation No 1924/2006, but where the 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING — CASE C-363/19 
 
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application has not yet led to a decision on authorisation or non-authorisation, or 
is the burden of proof determined according to national law? 
2. If the answer to question 1 is that the provisions of Regulation 
No 1924/2006 regulate the burden of proof, does the burden of proof lie with the 
trader making a given health claim or with the authority requesting the national 
court to prohibit the trader from continuing to make the claim? 
3. In a situation such as that described in question 1, do Articles 5 and 6, read 
in conjunction with Articles 10(1) and 28(5) of Regulation No 1924/2006, 
regulate the evidentiary requirements when a national court is determining 
whether unpermitted health claims are being made, or are the evidentiary 
requirements determined according to national law? 
4. If the answer to question 3 is that the provisions of Regulation 
No 1924/2006 regulate the evidentiary requirements, what are the evidentiary 
requirements imposed? 
5. Is the answer to questions 1–4 affected by the fact that Regulation 
No 1924/2006 (including Article 3(a) of the regulation) and Directive 2005/29 can 
be applied together in the proceedings before the national court? 
Provisions of EU law and case-law of the Court of Justice relied upon 
Regulation (EC) No 1924/2006 No 1924/2006 of the European Parliament and of 
the Council of 20 December 2006 on nutrition and health claims made on foods 
(OJ 2006 L 404, p. 9), point (a) of the second paragraph of Article 3, 
Articles 5(1)(a), 5(1)(b), 5(1)(d), 6, 10(1) and 28(5). 
Directive 2005/29/EC of the European Parliament and of the Council of 11 May 
2005 concerning unfair business-to-consumer commercial practices in the internal 
market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 
98/27/EC and 2002/65/EC of the European Parliament and of the Council and 
Regulation (EC) No 2006/2004 of the European Parliament and of the Council 
(OJ 2005L 149, p. 22), recitals 10, 18 and 21 and Articles 3(4) and 12. 
Judgment of 23 November 2017, Bionorica and Diapharm v Commission 
(C-596/15 P and C-597/15 P, EU:C:2017:886) 
Judgment of 15 October 2015, Nike European Operations Netherlands (C-310/14, 
EU:C:2015:690) 
Judgment of 21 January 2016, Eturas and Others (C-74/14, EU:C:2016:42) 
Judgment of 16 July 2015, Abcur (C-544/13 and C-545/13, EU:C:2015:481)  
Judgment of 16 March 2016, Dextro Energy v Commission (T-100/15, 
EU:T:2016:150) 
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Judgment of 8 June 2017, Dextro Energy v Commission (C-296/16 P, 
EU:C:2017:437) 
National provisions relied upon 
Marknadsföringslagen (2008:486) (Law (2008:486) on marketing practices; 
‘MFL’) which transposes Directive 2005/29 into Swedish law: 
Paragraph 5 Marketing shall be consistent with good marketing practice. 
Paragraph 6 Marketing that violates good marketing practice on the basis of 
Paragraph 5 shall be deemed to be improper if, to a significant extent, it affects or 
is likely to affect the recipient’s ability to make a well-founded business decision.  
Paragraph 8 Marketing that is misleading on the basis of any of the provisions in 
Paragraphs 9, 10 or 12 to 17 shall be deemed to be improper if it affects or is 
likely to affect the recipient’s ability to make a well-founded business decision. 
Paragraph 10 In marketing, a trader may not make use of incorrect claims or other 
statements that are misleading in relation to the trader’s own or someone else’s 
business activity. 
The first paragraph shall apply especially in respect of statements relating to:  
1. the product’s presence, nature, quantity, quality and other distinctive 
properties, 
2. the product’s origin, use and risks such as the impact on health and the 
environment. 
Brief presentation of the facts and procedure in the case before the national 
court 
1 Mezina AB (Mezina) is engaged in the development, evidence-gathering, research 
and marketing of natural remedies, medicines and food supplements. 
2 Mezina has marketed the products Movizin complex, Macoform and Vistavital. 
Those products are classified as food supplements and contain plants or plant 
extracts, known as botanicals (referred to below as ‘botanical substances’). The 
products come within the definition of food. Movizin complex contains ginger, 
rose hip and boswellia. Macoform contains artichoke and dandelion. Vistavital 
contains blueberries. In its marketing, Mezina has made certain claims to the 
effect that the products in question or the botanical substances they contain have 
positive effects on, inter alia, joints in the body, digestion and function of the 
intestines as well as eyesight and the eyes. The parties agree that those claims are 
health claims. 
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3 The Konsumentombudsmannen (Swedish Consumer Ombudsman (KO)) has 
brought proceedings against Mezina before the Patent- and marknadsdomstolen 
(Patent and Market Court). KO has requested the Patent- och marknadsdomstolen 
(Patent and Market Court) to issue an injunction, non-compliance with which to 
be punishable by a fine, ordering Mezina to refrain, in the marketing of the 
products at issue, from using the abovementioned claims or other claims having 
essentially the same content. 
4 Mezina has objected to the injunction being issued. 
5 KO and Mezina agree that the claims about the botanical substances are what are 
known as specific health claims, all of which also are to be deemed to be 
consistent with the claims covered by relevant applications submitted to the 
European Commission for a statement of its adopted position with regard to 
Article 13(2) of Regulation No 1924/2006. 
6 The Commission has not adopted a position on any of the abovementioned health 
claims and EFSA [European Food Safety Authority] has assessed only one of 
them and has concluded that the scientific evidence that EFSA has had available 
to it has not shown a link between the substance and the claim made about it.  
7 KO and Mezina disagree as to whether the claims about the products as such are 
specific or non-specific health claims. Unlike the claims about the botanical 
substances, those claims do not appear in any of the applications submitted to the 
Commission. 
Principal arguments of the parties 
8 KO asserts that the claims about the products as such are primarily specific health 
claims which are contrary to Article 10(1) of Regulation No 1924/2006. The 
claims are not permitted, since there are no authorised claims on the Community 
list of authorised health claims concerning the products Movizin complex, 
Macoform and Vistavital. Nor are there any applications involving health claims 
about the products Movizin complex, Macoform and Vistavital. Since the claims 
are contrary to the regulation, they are also contrary to Paragraph 5 of the MFL. 
9 KO makes the following submissions in regard to Mezina’s claims made about the 
botanical substances. The claims are to be deemed to be consistent with the claims 
covered by relevant applications submitted to the European Commission for its 
adopted position. The claims do not, however, otherwise satisfy the requirements 
laid down in Article 28(5) of Regulation No 1924/2006, as they are contrary to 
point (a) of the second paragraph of Article 3 and Articles 5 and 6 of the 
regulation, and also to Paragraphs 5 and 10 of the MFL. The claims may therefore 
not be used. 
10 KO submits that the health claims about the botanical substances are not permitted 
since they do not fulfil the requirements laid down in Article 5(1)(a), 5(1)(b) and 
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5(1)(d) of Regulation No 1924/2006. Since Mezina has not submitted evidence 
showing that the regulation’s requirements are satisfied, the company has failed to 
show that it has based the health claims on generally accepted scientific evidence 
in accordance with Article 6 of the regulation. 
11 Under Article 6, it is incumbent upon Mezina to demonstrate that its claims are 
authoritative (that is to say, are not inaccurate, ambiguous or misleading) under 
point (a) of the second paragraph of Article 3. As the company has not submitted 
any evidence at all, either previously to the Konsumentverket (Swedish Consumer 
Agency)/KO or now to the Patent- och marknadsdomstolen (Patent and Market 
Court), in support of its claims, Mezina has failed to demonstrate that the claims 
are authoritative. The claims are therefore misleading under point (a) of the 
second paragraph of Article 3 of the Regulation. 
12 As Mezina has not substantiated the claims as authoritative, they are also 
misleading and not permitted under Paragraph 10 of the MFL. 
13 Given that the claims are not permitted under the Regulation, they are also 
contrary to Paragraph 5 of the MFL. 
14 In the alternative, KO submits, with regard to the claims about the products as 
such, that they are general, non-specific health claims under Article 10(3) of 
Regulation No 1924/2006. The claims are not permitted, as they are not 
accompanied by either authorised health claims under the regulation or by specific 
claims about the botanical substances, which are permitted under the transitional 
provisions laid down in Article 28(5) of the regulation. Should the Patent- och 
marknadsdomstolen (Patent and Market Court) conclude that the claims about the 
botanical substances are permitted under Article 28(5) of the regulation, KO 
submits that those health claims are not accompanied by specific claims. 
15 KO takes the view that the marketing target group cannot be deemed to have 
detailed knowledge about the health aspects discussed in the marketing materials. 
Nor can people in the target group be deemed to be accustomed internet users or 
well-informed with regard to self-care. The average consumer does not have 
detailed knowledge about the health aspects discussed in the marketing materials. 
16 Mezina, for its part, has emphasised that the Commission has not yet adopted a 
position on the applications concerning the claims about the botanical substances. 
The Commission might conclude that the requirements on which EFSA took as its 
basis for its assessment were too stringent. This is one of the reasons why the 
assessment has been put on hold, that is to say, a determination is being made as 
to whether so-called botanicals are to be assessed in the same manner as vitamins 
and minerals and/or whether the substances are to be covered by separate 
legislation. Those circumstances must be taken into account in the assessment of 
the requirements relating to the responsibility of food operators provided for in 
Article 28(5) of the regulation. 
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17 Mezina takes the view that it is unreasonable and goes beyond what is covered by 
‘the responsibility of food operators’ as provided for in Article 28(5) of the 
regulation to require Mezina to be able to present self-produced evidence as proof 
that the presence of the substance to which the claim relates has a nutritional or 
physiological effect on the basis of generally accepted scientific evidence and that 
the substance is present in a quantity that gives the nutritional and physiological 
effect which is claimed. There is a transitional period under Article 28(5) and 
legislation is not in place. The Commission has not assessed the basis used by 
EFSA basis in accordance with the regulation or adopted a decision on the claims 
in question. Nor has it been decided that botanicals are to be covered by any other 
legislation with different requirements. Accordingly, it must be sufficient for 
Mezina to be able to rely on the information submitted to EFSA and to use the 
health claims in question in a wording that is compatible with the application 
made in respect of the claim. That standpoint must be viewed in the light of the 
fact that food operators are not allowed to use their own scientific evidence in 
support of permitted health claims but are bound by the evidence submitted to 
EFSA. 
18 The requirement for generally accepted scientific evidence under Articles 5 and 6 
of the regulation refers to that evidence which is relied upon in support of the 
health claim for which authorisation is sought. Therefore, in Mezina’s submission, 
the veracity assessment under point (a) of the second paragraph of Article 3 and 
Articles 5 and 6 of the regulation should be conducted with reference to the 
requirements laid down in the regulation and be based on the scientific evidence 
submitted in support of the claims for which authorisation is sought. 
19 As Mezina understands KO’s action, KO considers that Mezina should present 
self-produced evidence in support of the claims for which authorisation is sought 
in order to comply with the requirements of the responsibility of food business 
operators and generally accepted scientific evidence. 
20 KO’s position means that more stringent requirements are placed on food business 
operators with regard to the use of health claims covered by the transitional 
provisions under Article 28(5) of the regulation than for the use of health claims 
authorised by the Commission, since, under the regulation, food business 
operators are not allowed to refer to studies other than those forming the basis for 
an authorised health claim. In that light, it is unreasonable to require food business 
operators to present scientific support for the claims in question for which 
authorisation is sought and which are covered by the transitional provisions other 
than that which forms the basis of the application. That would also lead to food 
business operators’ use of the claims for which authorisation is sought being 
assessed differently in the various Member States, which is contrary to the 
purpose of the regulation. A corresponding requirement of ‘generally accepted 
scientific evidence’ imposed by the regulation in respect of authorised health 
claims should also apply to claims covered by the transitional provisions laid 
down in Article 28(5) of the regulation in order for the ‘the responsibility of food 
business operators’ to be deemed to be fulfilled. 
KONSUMENTOMBUDSMANNEN 
 
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21 In any event, Mezina considers that the requirement of ‘the responsibility of food 
operators’ as provided for in Article 28(5) of the regulation is fulfilled, since 
Mezina followed what must be regarded as good practice in the food supplement 
industry in terms of how the transitional provisions laid down in Article 28(5) are 
to be applied. The claims about botanicals for which authorisation is sought 
should be able to be used until the Commission adopts a decision thereon, 
irrespective of whether or not they have been assessed by EFSA and irrespective 
of what EFSA’s assessment of a claim has been. That is particularly so given that 
these are botanicals that have been used for a very long time with good results, 
both for the individual substances in themselves and the products at issue in the 
present case. Mezina’s burden of proof should accordingly be deemed to have 
been satisfied for the purposes of Article 28. 
22 That follows from the Commission’s having put on hold all applications relating 
to botanicals on the grounds that a discussion is ongoing between the Member 
States concerning whether EFSA’s stringent assessment should actually be used 
for botanicals or whether they should instead be covered by separate legislation, 
as is the case for traditional plant-based medicines. Since EFSA’s 
recommendation is not binding on the Commission and may be changed, no legal 
rules have been adopted for food business operators to work with until such time 
as the Commission adopts a final decision and a potential transitional period, 
which is determined by the Commission, has expired. 
23 Mezina’s position is not that it is sufficient merely to refer to EFSA in order to 
meet the responsibility of food operators requirement under Article 28(5) of the 
regulation. Instead, Mezina is of the view that it is inherent in that requirement 
that the claims in question must be drafted in accordance with the regulation, for 
example, in such a manner that the claims do not become medicinal or intensify 
the effects which form the basis of the application. Responsibility also 
encompasses an assessment of the evidence submitted as a basis for the 
application to EFSA in order to determine whether the evidence substantiates 
those claims for which the application for authorisation is being made. However, 
each individual food business operator cannot also be required to produce its own 
studies substantiating the health effects. 
24 Mezina further considers that the claims about the products as such are non-
specific. Those claims are accompanied by claims corresponding to health claims 
for which authorisation is sought in relation to the products’ content of ginger, 
rose hip, boswellia, artichoke, dandelion and blueberries, respectively, for which 
transitional rules apply under Article 28(5) of the regulation. The marketing in 
question is therefore compatible with Article 10(3) of the regulation and is not 
contrary to good marketing practice under Paragraph 5 of the MFL. 
25 Mezina considers that the target group for the marketing in question consists of 
health-conscious consumers who are interested in supplementing their usual diet 
with food supplements and are well informed about self-care. Since the marketing 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING — CASE C-363/19 
 
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occurs on Mezina’s website it can be assumed, according to Mezina, that the 
target group is made up of accustomed internet users. 
Brief presentation of the grounds for the request for a preliminary ruling 
26 The case before the Patent- och marknadsdomstolen (Patent and Market Court) 
concerns the application of provisions of Regulation No 1924/2006 by a national 
court in a situation where national legislation transposing Directive 2005/29 is 
applied at the same time. The question is whether the burden of proof and 
evidentiary requirements in connection with the application of point (a) of the 
second paragraph of Article 3, and Articles 5(1)(a), 5(1)(b), 5(1)(d), 6, 10(1) and 
28(5) of the regulation are to be determined according to national law or 
according to EU law in a situation such as the one in the present case. Should it be 
held that EU law prevails or has an influence on questions about the burden of 
proof and evidentiary requirements in connection with the application of those 
provisions before a national court, follow-up questions arise about the more 
detailed implications of EU law. 
27 Under Article 13 of Regulation No 1924/2006, certain health claims made on 
foods may be made without a prior application procedure for authorisation. This is 
the case of health claims describing or referring to the role of a nutrient or other 
substance in growth, development and the functions of the body. In order to be 
covered by the provision, the claims must be included in a Community list 
adopted by the Commission. Further conditions are that the health claims must: 
– be based on generally accepted scientific evidence, and 
– be well understood by the average consumer. 
28 Under the scheme for these types of health claims, the Member States were to 
provide the Commission with lists of health claims by 31 January 2008. The lists 
were to be accompanied by the conditions applying to them and by references to 
the relevant scientific justification. After consulting with EFSA, the Commission 
was to adopt a Community list by 31 January 2010. 
29 Following the adoption of Regulation No 1924/2006, the Commission received a 
total of around 44 000 health claims from the Member States. The Commission 
requested a scientific opinion from EFSA. Given the high number of applications, 
the Commission requested EFSA to put on hold temporarily the assessment of the 
health claims about botanical substances and instead focus on the assessment of 
other claims referred, so that a list including those claims could be adopted as 
soon as possible. 
30 On 16 May 2012, the Commission authorised a partial list of health claims. At the 
same time, the Commission compiled a list of over 2000 health claims for which 
EFSA’s or the Commission’s assessment had not yet been completed and 
published it on its website. According to the Commission, the assessment of those 
KONSUMENTOMBUDSMANNEN 
 
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claims, which inter alia referred to effects of botanical substances, was still on 
hold, which meant that they could still be used in accordance with the transitional 
provisions laid down in (in so far as is currently relevant) Article 28(5) of 
Regulation No 1924/2006. 
31 The Court of Justice has stated, inter alia, the following concerning the transitional 
provisions of Regulation No 1924/2006 (judgment of 23 November 2017, 
Bionorica and Diapharm v Commission (C-596/15 P and C-597/15 P, 
EU:C:2017:886, paragraphs 87–89). Both permitted health claims and health 
claims the assessment of which is on hold may be used in connection with the 
marketing of food, but the requirements and the prerequisites are different for 
those two types of claims. Health claims the assessment of which is on hold are 
covered by the transitional provisions and, under Article 28(5) and 28(6) of the 
regulation, must be compatible, inter alia, with the regulation and with applicable 
national law provisions. Furthermore, health claims the assessment of which is on 
hold must also meet the requirements imposed under each Member State’s 
national provisions. 
32 The Patent- och marknadsdomstolen (Patent and Market Court) takes the view 
that the wording of Article 6 of Regulation No 1924/2006 clearly suggests that it 
is the food business operators or the party placing a product on the market who 
have the burden of proving that a health claim is based on scientific evidence 
(‘shall be based on and substantiated by’, ‘a food business operator making a 
nutrition or health claim shall justify the use of the claim’, ‘the competent 
authorities of the Member States may request a food business operator or a person 
placing a product on the market to produce all relevant elements and data 
establishing compliance with this regulation’). This does, in any event, seem to be 
implied (see, by analogy, judgment of 15 October 2015, Nike European 
Operations Netherlands (C-310/14, EU:C:2015:690), paragraph 25). 
33 The wording of Article 5(1)(a) of Regulation No 1924/2006 also suggests that EU 
law regulates the burden of proof (‘has been shown to’), even though the 
provision does not state clearly who has the burden of proof. 
34 Several references are made in Articles 5, 6 and 13 of Regulation No 1924/2006 
to ‘generally accepted scientific evidence’. The expression can be construed as 
meaning that the legislation regulates the evidentiary requirements. 
35 On the one hand, there are passages that can give the impression that EU law 
regulates the burden of proof and the evidentiary requirements. 
36 On the other hand, Regulation No 1924/2006 does not contain specific provisions 
about the regulation’s application before national courts, such as provisions on, 
inter alia, the taking of evidence, what evidence is admissible before national 
courts, or which principles are to be applied in connection with the national 
court’s examination of the probative value of the evidence submitted. According 
to the Patent- och marknadsdomstolen (Patent and Market Court), that indicates 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING — CASE C-363/19 
 
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that the issues of burden of proof and evidentiary requirements fall to be 
determined according to national law. 
37 In the absence of harmonisation of such rules under EU law, it is for the national 
legal order of each Member State to establish them in accordance with the 
principle of procedural autonomy. Those rules must not, however, be less 
favourable than those governing similar domestic situations (principle of 
equivalence) and must not make it excessively difficult or impossible in practice 
to exercise the rights conferred by EU law (principle of effectiveness) (see 
judgment of 15 October 2015, Nike European Operations Netherlands (C-310/14, 
EU:C:2015:690, paragraph 28). 
38 The principle of effectiveness precludes, first, the application of national rules of 
procedure which would make reliance on EU law impossible or excessively 
difficult by providing for rules which are too onerous, especially in connection 
with proof of the negative, namely that certain circumstances do not exist. Second, 
that principle precludes national rules of evidence which are not sufficiently 
rigorous, the application of which would, in practice, have the effect of shifting 
the burden of proof laid down in EU law (see judgment of 15 oktober 2015, Nike 
European Operations Netherlands (C-310/14, EU:C:2015:690, paragraph 29); for 
similar reasoning, see also the judgment of 21 January 2016, Eturas and Others 
(C-74/14, EU:C:2016:42). 
39 Directive 2005/29 does not contain any rules on evidentiary requirements, which 
thus fall to be provided for under national law. 
40 The Patent- och marknadsdomstolen (Patent and Market Court) is of the view that 
there is a need for clarification of the interpretation of Articles 5 and 6 of 
Regulation No 1924/2006, read in conjunction with Articles 10(1) and 28(5) of 
the regulation. The need for interpretation concerns where the burden of proof lies 
and whether the regulation regulates the evidentiary requirements in a situation 
such as that in the case before the Patent- och marknadsdomstolen (Patent and 
Market Court). 
41 There is also a need for interpretation in relation to the interaction between 
Regulation No 1924/2006 and Directive 2005/29 with regard to the burden of 
proof and evidentiary requirements. The Patent- och marknadsdomstolen (Patent 
and Market Court) takes the view that, since Regulation No 1924/2006 contains 
specific provisions on nutrition and health claims made on foods, it constitutes a 
special rule as compared with the general rules concerning protection of 
consumers against unfair commercial practices by undertakings towards them, 
such as those provided for in Directive 2005/29. That, in turn, could lead to the 
conclusion that, in the event of conflict between the provisions of Directive 
2005/29 and those of Regulation No 1924/2006, the regulation’s provisions take 
precedence and apply to those specific aspects of unfair commercial practices 
(judgment of 16 July 2015, Abcur (C-544/13 and C-545/13, EU:C:2015:481, 
paragraphs 80 and 81)). 
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42 In the case before it, the Patent- och marknadsdomstolen (Patent and Market 
Court) must apply the provisions of Regulation No 1924/2006 and, at the same 
time, provisions of national legislation (the MFL) transposing Directive 2005/29. 
43 According to consistent national practice, the trader has the burden of proving the 
veracity of marketing-related claims. In national practice, evidentiary 
requirements have been set relatively high in relation to nutritional and health 
claims. The Patent- och marknadsdomstolen (Patent and Market Court) seeks to 
know whether the application of Regulation No 1924/2006, particularly point (a) 
of the second paragraph of Article 3, means that there are grounds to contemplate 
approaches in considering the burden of proof and evidentiary requirements other 
than those resulting from national practice. 
44 The Patent- och marknadsdomstolen (Patent and Market Court) has also noted that 
a health claim that is based on and can be substantiated by generally accepted 
scientific evidence can also give rise to a conflicting and confusing message and 
therefore not be permitted (judgment of 16 March 2016, Dextro Energy v 
Commission, T-100/15, EU:T:2016:150 and, on appeal, judgment of 8 June 2017, 
Dextro Energy v Commission C-296/16 P, EU:C:2017:437). Against that 
background, and in the light of the judgment of the Court of Justice of 
23 November 2017, Bionorica and Diapharm v Commission (C-596/15 P and 
C-597/15 P, EU:C:2017:886), it seems that the Patent- och marknadsdomstolen 
(Patent and Market Court) cannot assume that health claims covered by the 
transitional rule in Article 28(5) of Regulation No 1924/2006 are compatible with 
the regulation’s provisions and with those of Directive 2005/29. Instead, a 
determination must be made as to whether the health claims are compatible with 
the regulation and with applicable national provisions, and whether the health 
claim fulfils the requirements laid down in national provisions. The issues of 
burden of proof and evidentiary requirements are of great importance to that 
assessment.