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one with regard to the EU Charter of Fundamental. Rights of the European Union. III. Health. Article 2(2)(5) NHCR defines the concept of health claims.14 In ...
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“Through the Wine Gate” First Steps towards Human Rights Awareness in EU Food (Labelling) Law Bernd van der Meulen and Eva van der Zee* Reflections on Case C-544/10, Deutsches Weintor eG v Land Rheinland-Pfalz1

I. Introduction “The food label is the arena in which many of the most intense disputes over food take place, for the label provides the most public face for controversies over food. It is also one of the most highly valued and competitively sought after communication channels in the marketplace. As the battle for space on the label has intensified, the often competing interests of consumers, industry and government come to the fore”.2 As a consequence the food label may well be the single most regulated communication channel in the world. Legislatures mandate information that must be provided in minute detail whether the business responsible for the labelling likes it or not, and ban information that may not be provided no matter how strongly the business wishes to share it with consumers. A telling example of government interference in the EU with communication through food labels is the total ban on health claims on alcoholic beverages.3 In a ruling of 6 September 2012 the EU Court of Justice shed some light on the extent of this ban and on its compatibility with human rights.

* E.L. van der Zee LL.M is PhD-researcher at the Law and Governance Group at Wageningen University, the Netherlands . Prof. Dr. B.M.J. van der Meulen is Professor of Law and Governance at Wageningen University. He is director of the European Institute for Food Law and member of the editorial board of this journal. Comments are welcome at: [email protected]. Many thanks to Dominique Sinopoli for constructive comments on an earlier draft. 1 Judgment of 6 September 2012, Third Chamber, n.y.r. 2 There is nothing specifically European here. The quote has been taken from: Neal Blewett AC (Chair), Nick Goddard, Simone Pettigrew, Chris Reynolds and Heather Yeatman, Labelling Logic. Review of Food Labelling Law and Policy, Commonwealth of Australia 2011.

The Bundesverwaltungsgericht, the German supreme court for administrative law issues, provided the Court of Justice of the EU (hereinafter ECJ or the Court) with an opportunity to move the development of EU food law two important steps forward. It asked for an interpretation of the concept of health in the context of health claims and for the meaning of human rights in food law. We will herein discuss both issues within the context of the ECJ’s ruling. Although we will initially focus on health and health claims, the emphasis will be on the second issue, the place of human rights in EU food law.4 This topic is particularly important because to date human rights awareness in EU food law is virtually absent. In our analysis we compare the situation in the EU with the situation in the USA5 where human rights law has established itself as a full part of food labelling law. We conclude that the Weintor-case opens the gate to human rights awareness in food labelling law in the EU as well, but as yet no more than a crack.

II. Background Deutsches Weintor eG (Weintor literally means: Wine gate; hereinafter Weintor) is a German wine growers cooperative. The reference for a prelimi-

3 Another example of similar magnitude is the ban on medicinal claims, i.e. the claim that a food has medicinal properties. According to the ECJ, many foods do have such properties. ECJ 15 November 2007, Case C-319/05 (Garlic); “there are many products generally recognised as foodstuffs which may also serve therapeutic purposes.” This means that the ban on medicinal claims implies that in such cases it is forbidden to speak a truth established by the ECJ itself. 4 For a thorough analysis (in the German language) of the health claims aspect, see: Andreas Meisterernst, „Der Begiff der gesundheitsbezogenen Angabe – Abgrenzung und Definition auf dem Prüfstand“, Zeitschrift für das gesamte Lebensmittelrecht 6/2012, p. 652–663. 5 The comparison between EU and USA leads in quotes to a mix in spellings, British and American. Also, in manner of referencing, we will follow the European style when addressing EU law and the American style when addressing US law.

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nary ruling was made in proceedings between Weintor and the department responsible for supervising the marketing of alcoholic beverages in the Land of Rhineland-Palatinate concerning the description of a wine as ‘bekömmlich’, indicating reduced acidity levels.6 ‘Bekömmlich’ is a concept that cannot be translated into the English language. The Advocate General (AG) describes the concept as ‘digestible, wholesome, nourishing’,7 and the Court further pinpoints its meaning as ‘easily digestible’.8 This may well be the closest approximation in the English language, but ‘easily digestible’ has a much more definite meaning. If ‘bekömmlich’ is a health claim, it is one of the softest imaginable,9 which is probably the reason why the controversy arose over this statement in the first place. The Court faced the following question: Does ‘bekömmlich’ constitute a health claim within the meaning of the ban on health claims contained in Article 4(3) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (the Nutrition and Health Claims Regulation, hereinafter NHCR) that ‘[b]everages containing more than 1.2 % by volume of alcohol shall not bear health claims’? The AG’s opinion makes clear that the referring court, as the court of appeal on a point of law, is bound by the findings of fact made at first instance in relation to the descriptor ‘bekömmlich’, i.e. that the wines at issue are said to be particularly bekömmlich (wholesome) because, as the result of a special process for reducing acidity, their acidity is ‘gentle’. For consumers, the emphasis is thus placed on the particularly gentle effect that the wines have

on the stomach.10 Furthermore, the AG points out that the Court is not called upon to make a final determination as to whether the description at issue amounts to a ‘health claim’ for the purposes of the Regulation.11 Unfortunately, the ECJ seems to seek to make precisely this determination of fact instead of focussing on the questions of law placed before it.12 The referring court asked three questions:13 two with regard to the concept of health claims and one with regard to the EU Charter of Fundamental Rights of the European Union.

6 ECJ 6 September 2012 Case C-544/10 Weintor (hereinafter: ECJ Weintor), paragraph 2.

15 In Article 2(2)(1) NHCR: ‘claim’ means any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics.

7 Advocate General Mazák Opinion 29 March 2012 Case C-544/10 Weintor, (hereinafter: AG Weintor), paragraph 2. 8 ECJ Weintor, paragraph 2.

III. Health Article 2(2)(5) NHCR defines the concept of health claims.14 In particular, it elaborates the element ‘claim’ in detail; however, this is not the case for the element ‘health’.15 As far as this latter element is concerned, the definition does not provide more than the truism that a health claim is a claim regarding health. It is not uncommon, indeed unavoidable, that legislation employs concepts that to a certain degree remain vague or open to interpretation. Such concepts acquire meaning through their interpretation in practice16 and judicial case law. Here, the ECJ holds a key responsibility.17 From our understanding, with its first question the referring court sought clarification of the concept of ‘health’. Such clarification would potentially bring resounding consequences. ‘Health’ does not only constitute a core element of the concept of health claim, it also forms a core element of the objectives of food law as such (Article 5 Regulation 178/2002, hereinafter: GFL)18 and of the key provision in food

11 AG Weintor, paragraph 36.

16 This adds great importance to the obligation to give reasons in provisions such as Article 41(2)(c) of the EU Charter and Article 296 of the Treaty on the Functioning of the European Union from which an obligation can be derived for authorities to be explicit also about the interpretations they use of legal concepts.

12 It must place the Bundesverwaltungsgericht in an awkward position to receive an answer it cannot itself give, instead of the legal instruments it asked for to be able to fulfil its task.

17 In the words of the second sentence of Article 19(1) of the Treaty on European Union: “It shall ensure that in the interpretation and application of the Treaties the law is observed.”

13 See ECJ Weintor, paragraph 26 and AG Weintor, paragraph 30.

18 On the objectives of food law, See: Bernd van der Meulen, The function of food law. On objectives of food law, legitimate factors and interests taken into account, EFFL 2010, pp. 83–90.

9 Certainly, in explicitness it is far removed from the claims that have been approved by the European Commission. 10 AG Weintor, paragraph 21.

14 ‘Health claim’ means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health.

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law, Article 14 GFL banning unsafe food, i.e. food that is injurious to health.19 It is by no means certain that in these different contexts ‘health’ carries the same meaning,20 but clarifying the meaning of ‘health’ in one context could elicit a deeper understanding of this fundamental concept. The first question reads as follows: “Does the reference to health in a claim within the meaning of the first sentence of Article 4(3) of Regulation (EC) No 1924/2006 ..., as amended by Commission Regulation (EU) No 116/2010 ... (“the Regulation”), read in conjunction with Article 2(2)(5) or Article 10(3) thereof, require there to be a beneficial nutritional or physiological effect aimed at a sustained improvement of physical condition, or is a temporary effect, limited in particular to the time taken by the intake and digestion of the food, sufficient?” [emphasis added] We understand this question to ask whether ‘health’ is a structural condition or includes fleeting sensations. The referring court is of the former opinion. This discussion is summarised in paragraphs 22, 23 and 24 of the ruling: “22 The referring court has reservations about the broad interpretation of the concept of ‘health claims’ adopted by the lower courts. In its view, given the function common to all foods, which is to provide the human body with nutrients and other substances, a description relating to the merely temporary maintenance of bodily functions or to general health-related well-being cannot be sufficient to establish a link with health for the purposes of Article 2(2)(5) of Regulation No 1924/2006. 19 On the concept of unsafe food, see: Bernd van der Meulen, The Core of Food Law. A Critical Reflection on the Single Most Important Provision in All of EU Food Law, EFFL 2012, pp. 117–125. 20 Indeed, it might be highly problematic to apply the broad concept of health implicit in the Weintor-ruling to Article 14 GFL. It might necessitate ‘unhealthy’ fast food to be regarded as unsafe. Wouldn’t such interpretation turn the EU policy on nutrition upside down, where unlike in food safety responsibility is not placed with businesses (Article 17(1) GFL), but with the individual (European Commission, White Paper on A Strategy for Europe on Nutrition, Overweight and Obesity related health issues, Brussels, 30.5.2007 COM(2007) 279 final, p. 3)? 21 Emphasis added. 22 AG Weintor, paragraph 41. 23 AG Weintor, paragraph 45. 24 ECJ Weintor, paragraph 27.

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23 In the opinion of the Bundesverwaltungsgericht, certain factors appear, on the contrary, to indicate that the reference is to a ‘health claim’ only where longer-term, sustained effects on physical condition or well-being are referred to, not just fleeting effects on metabolic processes which leave the constitution and, therefore, the actual state of health unaffected.21 24 The reference to the digestibility of the wines marketed by the applicant in the main proceedings merely amounts therefore, according to the referring court, to the assertion that, on being digested, the wine does not cause stomach complaints, or causes fewer than would normally be expected of a wine of that kind and quality. Furthermore, the Bundesverwaltungsgericht queries whether the mere fact that a food is less harmful than similar products of the same category is sufficient for a beneficial effect on health to be acknowledged.” The Advocate General gives some consideration to the concept of health: “the term generally refers to the physical and mental condition of a person, both – and, arguably, with a certain measure of ambiguity – in the sense of a certain level of functioning or well-being of the human body and mind”.22 Reference to duration is made only with regard to the effect of the food, not with regard to the concept of health as such: “the length or sustainability of the (beneficial) effect on the physical condition or bodily functions would be, or should be, constitutive of the notion of ‘health claim’ for the purposes of the Regulation.”23 The ECJ roundly refuses to address the concept of health as such. It takes the two first questions together and rephrases them as the following: “whether the first subparagraph of Article 4(3) of Regulation No 1924/2006 must be interpreted as meaning that the words ‘health claim’ cover a description such as ‘easily digestible’ that is accompanied by a reference to the reduced content of substances frequently perceived by consumers as being harmful.” 24 The ECJ also distances itself from the referring court’s presentation of the factual meaning of the claim at issue as relating to the time of intake and digestion only: “39 In the present case the description at issue, which suggests that the wine is readily absorbed and digested, implies, inter alia, that the digestive

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system – and thus a part of the human body – will not suffer, or will suffer little as a result, and that the digestive system will remain relatively healthy and intact even after repeated consumption, and thus accumulated amounts, over an extended period of time, given that that wine is characterised by reduced acidity. 40 In that, the claim in question might suggest a sustained beneficial physiological effect consisting in the preservation of a healthy digestive system, contrary to other wines, which are presumed to result, after being consumed a number of times, in sustained adverse effects on the digestive system and, consequently, on health.” These considerations relate to recital 1 in conjunction with recital 10 in the preamble to the NHCR. The Court observes that it follows from these recitals that by indicating a nutritional, physiological or any other health advantage over similar products, claims promoting the foods on which they appear guide the choices made by consumers. Those choices directly influence the total intake of individual nutrients and other substances, thereby warranting the restrictions imposed by that regulation in relation to the use of those claims.25 By qualifying a message regarding a food as a health claim, the ECJ apparently moves beyond the claimed effect of the consumption of the food at issue to the actual effect of repeated consumption of the food at issue. The Court then concludes “that the first subparagraph of Article 4(3) of Regulation No 1924/ 2006 must be interpreted as meaning that the words ‘health claim’ cover a description such as ‘easily digestible’ that is accompanied by a reference to the reduced content of substances frequently perceived by consumers as being harmful.”26 In conclusion, the Court does not give an interpretation of the concept of ‘health’ and does not explicitly answer the question whether an effect limited to the time of intake and digestion can be categorised as an effect on health. However, the Court seems to regard virtually any claim promoting the consumption of an alcoholic beverage as a forbidden health claim. It thus seems that the Court regards any claim to a fleeting effect of a food on bodily functions (be this effect positive or less negative than the effect of a comparable food) as a health claim. If we maintain that a health claim is a claim regarding health then it must follow that the action of any bodily function, no matter how fleet-

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ing, is included in the concept of health, making this a very broad concept indeed, at least in the context of health claims. It remains to be seen whether the Court will reach a similar interpretation outside the scope of the ban on health claims for alcoholic beverages. The Court construes the ban on health claims for alcoholic beverages in accordance with its broadest possible meaning. Accordingly, it limits to the greatest possible degree the freedom of businesses27 to say anything positive about an alcoholic beverage in advertisement and labelling. With its last question, the referring court queries whether this limitation complies with fundamental rights.

IV. Human rights and food labelling The Bundesverwaltungsgericht places its finger on a sore spot in EU food law. Despite the emphasis the EU places on adherence to human rights when it comes to evaluating candidate members, among its own institutions dealing with food law, human rights awareness is disturbingly absent. Nowhere do they show any realisation that food law may contribute to the realisation of the human right to adequate food,28 nor do they stop to consider the limits they place on the exercise of human rights. Neither the new Regulation on food information to consumers (Regulation 1169/2011) nor the Nutrition and Health Claims Regulation hold a recital addressing the limits these regulations place on the freedom of expression of food business operators, much less the justification of these limits.29 A

25 ECJ Weintor, paragraph 27. 26 ECJ Weintor, paragraph 41. 27 And maybe third parties. See: Susie Staerk Ekstrand and Jann Haagaard, Who can Speak freely? Can independent parties be held liable for their statements, and to what extent can a company make use of third party testimonials?, EFFL 3/2009, pp. 192–195, discussing ECJ Case C-421/07 of April 2009 (Damgaard). 28 As recognised in a variety of international documents (for an inventory, see: Bart Wernaart, “The plural wells of the right to food”, in Otto Hospes and Irene Hadiprayitno, Governing food security. Law, politics and the right to food, Wageningen: Wageningen Academic Publishers, 2010), first among which the International Covenant on Economic Social and Cultural Rights to which all EU member states are state party. On the right to food see for example: Otto Hospes, “Overcoming Barriers to the Implementation of the Right to Food”, EFFL 2008, pp. 246–261. 29 As human rights compatibility has not been considered, the likelihood seems considerable that the human rights requirements have not been fully met in each and every instance.

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search of the Eur-Lex database of official EU documents on combinations of human rights, freedom of expression, free speech and the like, on the one hand, with food, food information, food labelling and the like, on the other, yields only a handful of hits. A resolution of 1 November 2001 by the ACP-EU Joint Parliamentary Assembly considers the right to food, but only in the context of hunger in Africa, not as a right of EU citizens.30 In an answer to written questions from the European Parliament31 about food labels (on Italian wine) showing pictures of Mussolini and Hitler, the European Commission “roundly condemn[ed] all forms of racist, xenophobic or anti-Semitic behaviour, which constitutes an intolerable violation of the human rights and fundamental freedoms on which the Union is based and which are common to all the Member States.” The Commission does not show any realisation that banning such despicable labels would itself constitute a limitation – though undoubtedly a justified one – of the freedom of expression of the business using these labels. On the other side of the Atlantic the situation is fundamentally different. In struggles over several aspects of food labelling, the courts have defined subtle limits to the power of regulators to restrict the speech of food businesses on food labels.

V. Free speech on food labels in the USA The Constitution of the United States of America dates back to 1787, and has since been amended 27 times. The first ten amendments, ratified in 1791, are collectively known as the Bill of Rights. It may well be the oldest human rights document still in force today. Article 1 of the Bill of Rights, or the First Amendment, reads as follows:

30 No reference. Available at Eur-Lex. 31 Written question E-2578/02. “We fairly regularly receive reports from citizens shocked about bottles of wine being sold in shops in Italy. The bottles concerned carry labels with pictures of Hitler and Mussolini and slogans such as Ein Volk, ein Reich, ein Führer!, Blut und Ehre and Führerwein.”

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“Congress32 shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; of the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.”33 In the 18th Century, the concept of limitation clauses was as yet unknown. Case law has made up for this by developing certain ‘tests’ that must be met in order to legitimately limit a right protected by the First Amendment. These tests place requirements on the aim pursued by the legislature as well as the fitness of the instrument chosen to achieve this aim.34 Certain types of expression, such as obscenity and fraud, have categorically been placed outside the scope of protection. This is not the case with types of speakers. Initially, in the 19th Century, corporations were denied constitutional protection.35 Today,36 corporations enjoy protection of the First, Fourth, Fifth, Sixth and Fourteenth Amendments.37 Not all types of speech receive the same level of protection. Political speech is highly protected, commercial speech less so. The US Supreme Court has formulated two definitions of commercial speech: first, “expression[s] related solely to the economic interest of the speaker and its audience,” and then later, “speech proposing a commercial transaction”.38 Although the exact scope of commercial speech remains under discussion in the US, there is little doubt that product labelling falls within its ambit. Truthful advertising related to lawful activities is entitled to the protection of the First Amendment.39 The US Supreme Court found in the Central Hudson case that the content of non-misleading commercial speech can be constitutionally “regulated”

35 See, e.g., Slaughter-House Cases, 83 U.S. (16 Wall.) 36, 99 (1872). 36 Starting in 1886, with Santa Clara County v. Southern Pacific Railroad Co. 118 U.S. 394 (1886). See in particular Citizens United v. Federal Election Commission 130 S. Ct. 876 (2010); 558 U.S. 50 (2010).

33 Emphasis added.

37 See, Anne Tucker, Flawed Assumptions: A Corporate Law Analysis of Free Speech and Corporative Personhood in Citizens United, Case Western Reserve Law Review [Vol. 61:2 2001], p. 495–548 (and sources quoted there).

34 These tests may well have provided the model for the limitation clauses in the later human rights treaties.

38 Central Hudson Gas & Electric Corporation v. Public Service Commission of New York, 447 U.S. 557 (1980).

32 Via another amendment this provision applies to the legislatures in the states as well [footnote added].

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The issue of mandated speech has been discussed over the use of recombinant Bovine Somatotropin (rBST, also known as recombinant Bovine Growth Hormone rGBH), a synthetic growth hormone that increases milk production by cows. The US Food and Drug Administration (FDA) approved the use of rBST in 1993 when it determined that “rBST is safe and effective for dairy cows, that milk from rBSTtreated cows is safe for human consumption, and that production and use of the product do not have a significant impact on the environment”.42 In addition, the FDA found that “there was no significant difference between milk from treated and untreated cows”.43 Therefore, the FDA declined to require the labelling of products derived from cows receiving rBST.44 With regard to voluntary labelling the FDA stated that dairy processors may label that their milk is not from cows supplemented with rBST, provided that “any statements made are truthful

and not misleading”.45 According to the FDA, because of the presence of natural rBST in milk, no milk is “rBST-free”; therefore, a composition claim on a label stating that the milk is “rBST-free” would be false and misleading. Consequently, the FDA indicated that the dairy processors should better use a production claim, e.g. that the milk is “from cows not treated with rBST”. However, the FDA asserted that a production claim also has “the potential to be misunderstood by consumers”, namely that consumers might think that “milk from untreated cows is safer or of higher quality than milk from treated cows”, which would be a false and misleading implication.46 Therefore, the FDA believes that such misleading implications can be avoided by the use of accompanying information putting the production claim in the proper context. The FDA proposes to add statements like “No significant difference has been shown between milk derived from rBST-treated and non-rBST treated cows”.47 The state of Vermont took matters into its own hands and enacted a statute in 1994 requiring that “[i]f rBST has been used in the production of milk or a milk product for retail sale in this state, the retail milk or milk product shall be labeled as such”.48 The International Dairy Association (IDA) filed a law suit against the state of Vermont in April 1994, asserting that the statute infringed, amongst others, their protected rights under the First Amendment. The case was appealed in 1996. The United States Court of Appeals, Second Circuit, used the Central Hudson test to reach its conclusion. In International Dairy Association v. Amestoy, the Court held that Vermont had failed to establish that its interests were substantial.49 The Court deemed it insufficient to argue that strong consumer interests

39 In re R.M.J. 455, U.S. 191, 203 (1982).

44 Ibid.

40 Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626, 673 (1985) at 638.

45 Ibid.

41 Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626, 673 (1985).

47 Ibid.

(the American expression for “limited”) only when a substantial government interest is at stake, the regulation directly advances that interest, and the regulation is no more extensive than is necessary to serve that interest. This Central Hudson test also provides food labels with a measure of First Amendment protection. However, the government is “free to prevent the dissemination of commercial speech that is false, deceptive or misleading”.40 In this respect, commercial speech enjoys less protection under the First Amendment than non-commercial speech.41 With regard to food labelling, two forms of limiting free speech – mandated speech and restricted speech – have been addressed in case law.

VI. Mandated speech

42 Interim Guidance on the Voluntary Labeling of Milk and Milk Products from Cows that Have Not Been Treated with Recombinant Bovine Somatotropin, 59 Fed. Reg. 6279, 6279–80 (Feb. 10, 1994), available on the Internet at (last accessed on 26 January 2013). 43 Ibid.

46 Ibid.

48 International Dairy Foods Assocation v. Amestoy, 92 F.3d 67 (2nd Cir. 1996) at 69. The hormone rBST is a genetically-engineered ‘bovine growth hormone’ sold by Monsanto to dairy farmers. The possible changes in the milk, and the potential human health consequences of such changes, have been the subject of intense national debate for about 3 years. 49 International Dairy Foods Association v. Amestoy, 92 F.3d 67 (2nd Cir. 1996) at 73.

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and the public’s ‘right to know’ justified “compromising protected constitutional rights”. The Court held that although it “is sympathetic to the Vermont consumers who wish to know which products may derive from rBST-treated herds, their desire is insufficient to permit the State of Vermont to compel the dairy manufacturers to speak against their will. Where consumer interest alone is sufficient, there is no end to the information that states could require manufacturers to disclose about their production methods (...) Absent, however, some indication that this information bears on a reasonable concern for human health or safety or some other sufficiently substantial governmental concern, the manufacturers cannot be compelled to disclose it.” 50 However, 14 years later, in 2008, dairy processors who labelled their non-use of rBST voluntarily encountered problems in Ohio. The Ohio Department of Agriculture (ODA) adopted a regulation in May 2008 prohibiting dairy processors from making claims about the absence of artificial hormones, like rBST, in their milk products. In line with the guidance provided by the FDA, the regulation stipulated that a dairy label that contains a so-called production claim51 stating that “this milk is from cows not supplemented with rBST” (or a substantially equivalent claim) may be considered misleading on the basis of such language. However, according to the Regulation, such a dairy label does not mislead when (1) the labelling entity has verified that the production claim is accurate, and proper documents to support the production claim are made available to ODA for inspection, and (2) the label contains the additional (or substantially equivalent) statement that “[t]he FDA has determined that no significant difference has been shown between milk derived from rBST-supplemented and non-rBST-supplemented cows”.52 Clearly, this regulation compels producers to ‘speak’ when they voluntarily make a production claim.53

50 Ibid., at 69. 51 Production claims refer to the manner in which the product is produced. 52 Such statement should be in the same label panel, in exactly the same font, style, case and colour and at least half the size (but no smaller than seven point font) as the foregoing representation. 53 The regulation also stipulated that so-called ‘composition claims’ regarding the composition of milk with respect to hormones, such as “No Hormones”, “Hormone Free”, “rBST Free”, “rbGH Free”, “No Artificial Hormones”, and bST Free”, are false and misleading per se. While this is also a very interesting claim,

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The International Dairy Food Association (IDFA) and the Organic Food Association (OFA) filed suit, claiming that the Ohio regulation violates their rights under the First Amendment. However, in Boggs v. Ohio the Court of Appeals for the Sixth Circuit used a standard of review other than the Central Hudson test used by the Court of Appeals for the Second Circuit in Amestoy. In Boggs the Court used Zauderer to assess whether the Ohio rule, which compelled producers to disclose information about a production claim, was in conflict with the First Amendment.54 In Zauderer, the US Supreme Court articulated a lighter standard than the Central Hudson test to use when disclosure requirements are at issue. In this case, the Supreme Court explained that “because disclosure requirements trench much more narrowly on an advertiser’s interests than do flat prohibitions on speech, warnings or disclaimers might be appropriately required in order to dissipate the possibility of consumer confusion or deception”.55 The Supreme Court held that disclosure requirements do not violate an advertiser’s First Amendment rights where the requirements “are reasonably related to the State’s interest in preventing deception of consumers”.56 However, such requirements cannot be “unjustified or unduly burdensome”.57 In Boggs v. Ohio the Court concluded that the Ohio regulation’s disclosure requirement was “reasonably related to the State’s interest in preventing consumers from being deceived by production claims”, since there is a possibility that production claims are misleading regarding what substances are (or are not) in the milk consumers purchase.58 However, the Court held that the disclosure requirement could not be met by including such information beside an asterisk, something Ohio prohibited.59 Furthermore, the Court held that the rule was not unduly burdensome as long as the disclo-

such claims fall outside the scope of this study, because they do not concern compelled speech. 54 Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626 (1985). 55 Ibid., at 651. 56 Ibid. 57 Ibid. 58 International Dairy Foods Association and Organic Trade Association v. Boggs, 622 F.3d 628 (6th Cir. 2010) at 19. 59 Ibid., at 20.

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sure requirement could also be satisfied through the use of an asterisk.60 These cases illustrate that in the United States, the power of the legislature to require businesses to provide certain labelling information against their will is not an uncontested power, but that the legislature has to carefully consider the First Amendment rights of food businesses and that these businesses can seriously contest legislative limitations on their constitutional rights in a court of law.

VII. Limited speech

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On the other side of the spectrum, the struggle has been just as severe. In this sense, businesses are not compelled to speak against their will, but are forbidden to say what they want. This, of course, is particularly the case in the area of nutrition and health claims. The Federal Food, Drug and Cosmetic Act (FFDCA) has been amended twice to allow health claims for foods and dietary supplements in the USA: first, in 1990, by the Nutrition Labeling and Education Act (NLEA),62 and second, in 1997, by the Food and Drug Administration Modernization Act.63 The amended FFDCA granted the FDA the authority to promulgate regulations that authorized health claims if “based on the totality of scientific evidence (…) there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.” Claims supported by significant scientific agreement and approved by the FDA are also known as SSA claims. In Pearson v. Shalala (Pearson I) the Plaintiff challenged a refusal of a claim on the basis of the SSA standard as an impairment of First Amendment rights among other things.64 The US Court for the District of Columbia applied the Central Hudson test to determine whether the FDA’s restriction of commercial speech was justified. As indicated above, in Central Hudson the Supreme Court set forth a four-part test to evaluate prophylactic bans on commercial speech.65 First, it must be decided whether the commercial speech is lawful and not misleading (step 1). Unlawful and misleading claims are not entitled to First Amendment protection. However, lawful and non-misleading claims must be further analyzed starting with a determination whether the government interest to be served

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by the restriction on commercial speech is substantial (step 2). If this inquiry yields a positive answer, it must be decided whether the regulation directly advances the governmental interest (step 3), and whether the regulation is not more extensive than is necessary to serve that interest (step 4).66 In Pearson I, the FDA argued that claims not supported by SSA are inherently misleading and thus fail the first element of the Hudson test.67 The Court, however, determined that such claims are only potentially misleading and, therefore, passed the first part of the test.68 Moving onto the next step, the Court agreed that the FDA had a substantial interest in protecting against consumer fraud (step 2) and that the SSA standard advanced this interest (step 3).69 However, the SSA standard failed the fourth step because the Court considered it to be more extensive than necessary.70 As a result, the FDA’s regulations impermissibly restricted commercial speech. The Court emphasized that under the First Amendment, disclosure is preferable to outright suppression of speech. Therefore, instead of simply denying proposed health claims that lack SSA, the FDA must consider the use of clarifying disclaimers to negate the potential misleading nature of the claim. Claims could be banned outright only when evidence in support of the claim is qualitatively weaker than evidence against the claim and when evidence in support of the claim is outweighed by evidence against the claim.71 It took a lengthy legal battle before the FDA ultimately accepted the Court’s ruling. In Pearson v. Shalala 60 Ibid., at 20. 61 This section is largely based on: Diana B. McColl and Christine P. Bump, Qualified Health Claims: Creatures of Case Law, FDLI Update November/December 2005, p. 33-36. See also: Edward M. Basile and Melanie Gross, The First Amendment and Federal Court Deference to the Food and Drug Administration: The Times They Are A-Changin’ 1, 59 Food Drug L.J. 31 (2004). 62 Pub. L. No. 101-535, 104 Stat. 2253 (1990). 63 Pub. L. No. 105-115, 111 Stat, 2296 (1997). 64 Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), rehearing den., 172 F.3d 72 (D.C. Cir. 1999) (“Pearson I”). 65 Central Hudson Gas & Electric Corporation v, Public Service Commission, 447 U.S. 557 (1980). 66 Ibid., at 561-6. 67 Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), rehearing den., 172 F.3d 72 (D.C. Cir. 1999) (“Pearson I”), at 5. 68 Ibid. 69 Ibid., at 6. 70 Ibid., at 7. 71 Pearson v. Shalala, 164 F.3d at 659.

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(Pearson II) the Court noted that under Pearson I, when ‘credible evidence’ supports a claim, the claim cannot be prohibited:72 “The mere absence of significant affirmative evidence in support of a particular claim (…) does not translate into negative evidence ‘against’ it.”73 In Whitaker v. Thompson (Whitaker I)74 the Court interpreted Pearson I as identifying the narrow circumstances under which a complete ban of a health claim as inherently misleading would be reasonable: (1) when the FDA determines that no evidence supports the claim, or (2) when the FDA determines that evidence in support of the claim is qualitatively weaker than evidence against the claim and the FDA demonstrates with empirical evidence that disclaimers would bewilder consumers and fail to correct for deceptiveness. Health claims allowed under the First Amendment with a disclaimer remedying the potentially misleading character of a claim are known as qualified health claims (QHC). Forced by the courts, the FDA has started to formulate disclaimers such as “scientific evidence suggests but does not prove” and the “FDA concludes that it is highly unlikely”. The commercial value of health claims with such disclaimers may be debatable; however, the victory, in terms of the rule of law, is that the government cannot implement a law preventing businesses from speaking a truth if less intrusive measures suffice. In EU food law this level of rule of law is emerging at best.

VIII. Human Rights in the EU

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Rights of the European Union and to the European Convention for the Protection of Human Rights and Fundamental Freedoms.75 Both documents establish rights and freedoms, on the one hand, and provide a limitations clause(s), on the other. In the European Convention the limitations clauses are tailored to each provision separately. The EU Charter provides in the first paragraph of Article 52 one general limitations clause applicable to all rights and freedoms: Article 52: Scope and interpretation of rights and principles 1. Any limitation on the exercise of the rights and freedoms recognised by this Charter must be provided for by law and respect the essence of those rights and freedoms. Subject to the principle of proportionality, limitations may be made only if they are necessary and genuinely meet objectives of general interest recognised by the Union or the need to protect the rights and freedoms of others. Implicit in this provision is a five-step approach:76 1) There is a limitation on the exercise of rights and freedoms recognised by the Charter; 2) This limitation must be provided for by law; 3) The limitation must respect the essence of the rights and freedoms at issue; 4) The limitation must be necessary; 5) The limitation must genuinely meet either, a. objectives of general interest recognised by the Union, or b. the need to protect the rights and freedoms of others.

Compared to the battles raging in the USA, the Weintor-case provides only timid first steps towards bringing EU food labelling law up to human rights standards. We will provide a brief overview over the EU human rights system and then address Weintor. Article 6 of the Treaty on European Union grants EU treaty status both to the Charter of Fundamental

It is mystifying that the Bundesverwaltungsgericht focuses on the freedom to choose an occupation and the freedom to conduct a business77 rather than on the freedom of expression:

72 Pearson v. Shalala, 130 F. Supp. 2d 105 (D.D.C. 2001) (“Pearson II”).

76 Showing a little resemblance to the Central Hudson test in the USA.

73 Ibid., at 23.

77 The more so as the EU Court of Justice already in case C-234/85 Keller [1986] ECR 2897 judged that ‘whereas the Community rules on the labelling of wines place certain restrictions within a clearly defined sphere on the business activity of the traders concerned, they in no way impinge on the actual substance of the freedom to pursue that activity.’ (paragraph 9).

74 Whitaker v. Thompson 248 F. Supp. 2d 1 (D.D.C. 2002). 75 In this contribution we will not address the European Convention.

IX. The Court of Justice of the EU in Weintor

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“Is it compatible with the first subparagraph of Article 6(1) of the Treaty on European Union, as amended on 13 December 2007 (OJ 2008 C 115, p. [1]), read in conjunction with Article 15(1) (freedom to choose an occupation) and Article 16 (freedom to conduct a business) of the [Charter], as amended on 12 December 2007 (OJ 2007 C 303, p. 1), for a producer or marketer of wine to be prohibited, without exception, from making in its advertising a health claim of the kind at issue [in the main proceedings], even if that claim is correct?” The explicit reference to the situation where the claim is correct is reminiscent of the American thinking on truthful speech. On the basis of its own reading of the facts, the ECJ rejects this delineation of the question:78 51 However, in a case such as that in the main proceedings, even if the claim at issue can be regarded as being substantively inherently correct in that it indicates reduced acidity levels, the fact remains that it is incomplete. The claim highlights a certain quality that facilitates digestion, but is silent as to the fact that, regardless of a sound digestion, the dangers inherent in the consumption of alcoholic beverages are not in any way removed, or even limited. 52 Thus, the European Union legislature was fully entitled to take the view that claims such as that at issue in the main proceedings are ambiguous or even misleading where they relate to an alcoholic beverage. By highlighting only the easy digestion of the wine concerned, the claim at issue is likely to encourage its consumption and, ultimately, to increase the risks for consumers’ health inherent in the immoderate consumption of any alcoholic beverage. Consequently, the prohibition of such claims is warranted in the light of the requirement to ensure a high level of health protection for consumers. The Court deals with the Treaty structure somewhat sloppily. No reference is made to the limitations clause in Article 52 of the Charter. The Court glosses over the first question: are we dealing with a limitation of the exercise of human rights? The Court hurries ahead by pointing out that we are not only dealing with the freedom to choose an occupation and the freedom to conduct a business but also with the right to health which it derives from Article 35 of the Charter.79

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The Court thereby fashions a yardstick for assessing the lawfulness of the measure different from that provided in Article 52 of the Charter. According to the Court, a fair balance must be struck between the various fundamental rights protected by the Union legal order. It claims to derive this yardstick from the Promusicae case: “It follows from this that such an assessment must be carried out in accordance with the need to reconcile the requirements of the protection of those various fundamental rights protected by the Union legal order, and striking a fair balance between them (see, to that effect, Case C-275/06 Promusicae [2008] ECR I-271, paragraphs 65 and 66).” 80 It seems dubious to derive such a yardstick from the Promusicae case. First of all, this case predates the Lisbon Treaty, and at that time the Charter represented principles of EU law, not rock solid treaty obligations. Further, the case addresses member state obligations in implementing EU directives, not the legitimacy of EU law itself. The Promusicae case addresses the tension in the information society between the need to protect intellectual property rights (as part of property protected in Article 17 of the Charter) and the protection of personal data. The Court considers that the directives at issue do not preclude nor compel member states to lay down an obligation to disclose personal data (in the context of civil proceedings). One of the questions for a preliminary ruling asks whether such obligation may nevertheless follow from the Charter’s protection of (intellectual) property and the right to effective judicial protection. The Court underscores that the protection of personal data and hence of private life is also a fundamental right. The Court then recalls that the directives at issue seek to respect the fundamental rights set out in the Charter and the European Convention on the protection of personal data. Paragraph 65 of the Promusicae case,

78 ECJ Weintor, paragraphs 51 and 52. 79 Article 35: Health care: Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities. 80 ECJ Weintor, paragraph 47.

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to which the Court points in the Weintor case, reads: “The present reference for a preliminary ruling thus raises the question of the need to reconcile the requirements of the protection of different fundamental rights, namely the right to respect for private life on the one hand and the rights to protection of property and to an effective remedy on the other.” Far from providing a yardstick, the Court here formulates a problem statement. The answer the Court ultimately provides in Promusicae is the following (paragraph 70): “In the light of all the foregoing, the answer to the national court’s question must be that Directives (…) do not require the Member States to lay down, in a situation such as that in the main proceedings, an obligation to communicate personal data in order to ensure effective protection of copyright in the context of civil proceedings. However, Community law requires that, when transposing those directives, the Member States take care to rely on an interpretation of them which allows a fair balance to be struck between the various fundamental rights protected by the Community legal order. Further, when implementing the measures transposing those directives, the authorities and courts of the Member States must not only interpret their national law in a manner consistent with those directives but also make sure that they do not rely on an interpretation of them which would be in conflict with those fundamental rights or with the other general principles of Community law, such as the principle of proportionality.” Thus, far from presenting fair balancing as a yardstick for respecting fundamental rights, the Court places the need to balance and the need to respect fundamental rights on equal footing. The Court’s approach in Weintor based on a fair balancing of provisions of the Charter such that one right cancels out the other risks coming into conflict with Article 53 of the Charter: Article 53: Level of protection Nothing in this Charter shall be interpreted as restricting or adversely affecting human rights and fundamental freedoms as recognised, in

81 Case 152/78 Commission v. France [1980] ECR 2299, paragraph 17; Joined Cases C-1/90 and C-176/90 Aragonesa de Publicidad Exterior and Publivía [1991] ECR I-4151, paragraph 15; Case C-262/02 Commission v France [2004] ECR I-6569, paragraph 30; and Case C-429/02 Bacardi France [2004] ECR I-6613, paragraph 37. See ECJ Weintor paragraph 49.

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their respective fields of application, by Union law and international law and by international agreements to which the Union or all the Member States are party, including the European Convention for the Protection of Human Rights and Fundamental Freedoms, States’ constitutions. The key to reconciling the Court’s ruling in Weintor with the Charter is Article 52 of the Charter. We, therefore, need to place the Court’s considerations in that context. As indicated above, five steps need to be taken: 1) There is a limitation on the exercise of rights and freedoms recognised by the Charter; 2) This limitation must be provided for by law; 3) The limitation must respect the essence of the rights and freedoms at issue; 4) The limitation must be necessary; 5) The limitation must genuinely meet either, a. objectives of general interest recognised by the Union, or b. the need to protect the rights and freedoms of others. While the Court glosses over the first element, the ruling can be understood as an implicit acknowledgement that indeed a limitation of human rights is at issue. The Court starts with the last element (paragraph 49). It considers that measures restricting the advertising of alcoholic beverages in order to combat alcohol abuse reflect public health concerns and that the protection of public health constitutes, as follows also from Article 9 TFEU, an objective of general interest justifying, where appropriate, a restriction of a fundamental freedom. The Court underpins this consideration with reference to cases in which the Court ruled that limitations on advertisement for alcoholic beverages set by member states constitute barriers to the free movement of goods, but that these barriers are justified.81 Apparently, for the Court, the grounds that can justify a member state’s limitation of the free movement of goods can also justify the EU legislator to limit human rights. In the next three paragraphs (50-52 quoted above) the Court builds an argument that any claim made with regard to an alcoholic beverage is misleading. This leads the Court to the conclusion in paragraph 53 that “the total prohibition of any claim of the kind at issue in the main proceedings

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may be regarded as being necessary to ensure compliance with the requirements that stem from Article 35 of the Charter”. Thus, according to the Court, the fourth element – necessity – is fulfilled. Unlike the US Courts and unlike the ECJ itself in free-movement-of-goods cases, the Court does not consider whether this misleading character can be remedied by adequately informing the consumer. Apparently, the ECJ here applies a more lenient concept of necessity. The next paragraphs can be understood to address whether the essence of the rights at issue has been respected. The Court concludes that (paragraph 57) far from prohibiting the production and marketing of alcoholic beverages, the legislation at issue merely controls, in a very clearly defined area, the associated labelling and advertising; and (paragraph 58) thus, in a case such as that in the main proceedings, the prohibition at issue does not in any way affect the actual substance of the freedom to choose an occupation or of the freedom to conduct a business. The second requirement, that the limitation is provided for by law, is given in a case where the question is whether the legislature has infringed on human rights. In the Promusicae case the legislation explicitly took human rights into account. While explicit reference to human rights is not made anywhere in EU food law, the court points out in paragraph 55 “that the legislation at issue is designed to protect health, which is an objective recognised by Article 35 of the Charter.” It follows that the Court’s ruling, while making no reference to the applicable limitations clause, can be interpreted as complying with this clause. The Court dutifully takes all the steps required under Article 52’s limitations clause, but if we read the body language of this ruling correctly, the ECJ does not position itself here as a staunch defender of human rights as the EU’s most sacred values. It remains an open question if the case would have turned out differently if it were not about alcohol or if the rights regarding free enterprise had not been invoked, but rather the freedom of expression. After all, a full-fledged ban on expressing messages with certain content undeniably touches upon the essence of this right.

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X. Discussion Undoubtedly, EU food (labelling) law is in its infancy when it comes to human rights awareness. The value of the Weintor ruling is that while, on the one hand, it gives the ban on health claims on alcoholic beverages its broadest conceivable scope, and on the other hand, it takes the first tentative steps towards bringing the human rights discussion into EU food law. Taking human rights seriously does not mean that the legislature can no longer outlaw expressions on food labels unsympathetic to current political majorities, such as Nazi-slogans and pro-alcohol statements. Neither does it mean that in the search for truth it can no longer give priority to current scientific majority thinking. Also, it does not mean that under no circumstance can it be mandated to label the use of synthetic hormones (or of genetic modification). However, if human rights matter mainly to those who are not favoured by the majorities (political or scientific), it does mean, at the very least, that before we silence the voices we prefer not to hear, we must give due regard to their rights, follow the proper procedures and do not go beyond what is necessary. Experience in the United States shows that human rights can leave a mark on food labelling. However, this result can materialize in the EU only if businesses are willing to invoke this instrument and if courts are open to scrutinise the human rights compatibility of legislative measures with full respect for minority rights. 82 Such as the landmark ECJ 20 February 1978 Case C-120/78 (Cassis de Dijon) paragraph 13. “As the commission rightly observed, the fixing of limits in relation to the alcohol content of beverages may lead to the standardization of products placed on the market and of their designations, in the interests of a greater transparency of commercial transactions and offers for sale to the public. However, this line of argument cannot be taken so far as to regard the mandatory fixing of minimum alcohol contents as being an essential guarantee of the fairness of commercial transactions, since it is a simple matter to ensure that suitable information is conveyed to the purchaser by requiring the display of an indication of origin and of the alcohol content on the packaging of products.” Later on, the test if the objective can be achieved by informing a consumer enabling her or him to make an informed choice has become the ECJ’s litmus test to judge the necessity of member state trade barriers. Examples are: Case 178/84 Commission v. Germany, [1987] ECR 1227; Case 347/89, Freistaat Bayern v. Eurim-Pharm GmbH, [1991] ECR I-1747.