Nutrient Profiles

Nutrient Profiles

Advertising Ban Violates the Law of the European Union Prof. Dr. Alfred Hagen Meyer

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Nutrient Profiles Advertising Ban Violates the Law of the European Union Alfred Hagen Meyer*

The so called “nutrient profiles” are still under discussion (in the versions of an undated draft and a draft of 17.3.2009 at the latest concerning a Commission Regulation (EC) “establishing nutrient profiles provided for in Article 4(1) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council” 1).

The author is assuming that the advertising ban that the use of nutrient profiles entails is not consistent with Art. 11 of the European Charter of Fundamental Rights, read in conjunction with Art. 10 of the European Convention for the Protection of Human Rights and Fundamental Freedoms and in this respect violates the law of the European Union.

I. Nutrient Profiles Without Objective Justification The requirements of nutrient profiles and their application in practice would lead to advertising bans that lastingly restrict the freedom to advertise, since foods that do not satisfy the requirements could not be advertised using health claims or, as regards claims relating to nutrients, only with a stigmatizing disclaimer in certain cases.

The Commission Regulation establishing nutrient profiles provided for in Article 4(1) of Regulation No. 1924/2006 [HCR]2 would also lastingly restrict the freedom of information of an economic nature. But the EU legislature would have to prove that it had “reasonable grounds of public interest” for adopting this measure. Specifically, the legislature would have to produce convincing proof that the measure does in fact achieve the aim in the public interest as cited and that less restricting measures would not have had an equivalent * Prof. Dr. Alfred Hagen Meyer, lawyer, meyer.rechtsanwaelte Munich, lecturer on food law at Technical University Munich.

Thanks to Dr. Marion Gebhart and Walther Michl, LL.M.

effect.3 Thereby the legislature has to incorporate the proportionality principle; one of the general principles of EU law, this requires that the means deployed by an EU regulation in order to achieve the intended objective be appropriate and remain within the bounds of what is necessary to this end.

The grounds for nutrient profiles do not necessarily have to be based on “hard” scientific studies, but may also be produced on the basis of evidence of a social scientific nature that is based on past behaviour and future responses of consumers, and predicts reduced advertising activities.4 In his final opinion in the tobacco advertising case, Advocate General Fennelly stated however that freedom of expression would not be sufficiently respected if the legislature were permitted to restrict the exercise of that right without any clear evidence that such restriction is likely to lead to changes in behaviour which, in turn, are likely to benefit public health.5

Conflict of interest: the expert opinion is sponsored by third parties.

3 Opinion of Advocate General Fennelly delivered on 15 June 2000 in cases C-376/98 (Federal Republic of Germany v European Parliament and Council of the European Union) and C-74/99 (Imperial Tobacco, [2000] ECR I-8419, No. 145), paragraph 158.

1 Please note: Unless explicitly mentioned this opinion relates to the undated draft of the Commission; if reference is made to the latest draft of the Commission dated 17 March 2009, this will be named expressly.

4 Opinion of Advocate General Fennelly delivered on 15 June 2000 in cases C-376/98 (Federal Republic of Germany v European Parliament and Council of the European Union) and C-74/99 (Imperial Tobacco, [2000] ECR I-8419, No. 145), paragraph 160.

2 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, abbreviated as the Health Claims Regulation (OJ EC L 12/3 of 18 January 2007).

5 Opinion of Advocate General Fennelly delivered on 15 June 2000 in cases C-376/98 (Federal Republic of Germany v European Parliament and Council of the European Union) and C-74/99 (Imperial Tobacco, [2000] ECR I-8419, No. 145), paragraph 161.

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The nutrient profiles are however devoid of any objective justification. Renate Sommer, member of the European Parliament, formulated the issue concisely in the grounds for amendment motion 124 of her report on the draft regulation put forward by the European Parliament and the Council on consumer information on foods: ‘Nutrient profile’ is a political term, not a scientifically tenable concept. It is a form of indoctrination, not a means of providing information“.6

II. Nutrient Profiles – Unscientific Approach 1. Requirements Made of Nutrient Profiles The term ‘nutrient profile’ refers to the nutrient composition of a food or diet. ‘Nutrient profiling’ is the classification of foods for specific purposes based on their nutrient composition. The purpose in the sense of the Health Claims Regulation [HCR] is solely for the regulation of nutrition and health claims made on foods.

According to Article 4 HCR, the nutrient profiles shall be based on scientific knowledge about diet and nutrition, and their relation to health. They should be based on “generally accepted scientific evidence”.

Hence the same requirements applicable to health claims also apply to nutrient profiles (Article 5 HCR).

2. Opinion Issued by EFSA Therefore the European Food Safety Authority (EFSA) has been asked by the Commission to provide scientific advice on the establishing of nutrient 6 European Parliament, Committee on the Environment, Public Health and Food Safety, Rapporteur: Renate Sommer, 2008/0028(COD), 7 November 2008, DRAFT REPORT on the proposal for a regulation of the European Parliament and of the Council on the provision of food information to consumers (COM(2008)0040 – C6-0052/2008 – 2008/0028(COD)).

7 EFSA, The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006, Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Request Nº EFSA-Q-2007-058), adopted on 31 January 2008, The EFSA Journal (2008) 644, 1–44.

8 EFSA, Scientific and technical Guidance for the preparation and presentation of the application for authorisation of a Health Claim, Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Request Nº EFSA-Q-2007-066), adopted on 6 July 2007, The EFSA Journal (2007) 530, 1–44.

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profiles as indicated in Article 4 of the Regulation in February 2007. The opinion dealing with the terms of reference provided by the Commission was adopted on 31 January 2008.7 However, the EFSA opinion issued on nutrient profiles has not yet led to scientifically reliable guidelines. The EFSA comes to the conclusion that there are limitations on the use of nutrient profiles, above all: – The lack of uniform data on food composition and food consumption across the EU – Differences in nutrient intake recommendations and food based dietary guidelines between Member States.

In No. 11 of the opinion – Limitations – EFSA remarks sceptically on the establishing of scientifically supported nutrient profiles: “There are limitations on the use of nutrient profiles based on the composition of foods as purchased to classify foods as eligible to bear claims.

There is an inherent difficulty in seeking to apply to individual food products nutrient intake recommendations that are established for the overall diet. Furthermore, the potential of food products as purchased to adversely affect the overall dietary balance does not take into account changes in nutrient content that occur during cooking or preparation, such as addition of fat, sugar or salt nor does it take into account the usual intake of the food (based on portion size and the frequency of intake or the pattern of consumption) or particular combinations of foods that are purchased separately but usually consumed together (such as dry cereals consumed with milk). In addition, the lack of uniform data for food composition and food consumption across the EU, as well as differences in nutrient intake recommendations and food based dietary guidelines between Member States, makes it more difficult to set nutrient profiles at EU level than at national level. The basis for expert judgements needed to address such limitations should be transparent in order to avoid variable outcomes.”

This opinion thus differs markedly from the “Scientific and technical Guidance for the preparation and presentation of the application for authorisation of a Health Claim”,8 in which EFSA explained in detail what data is required so that a claim can be consid-

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ered sufficiently scientifically supported. In the Guidance EFSA also describes the handling of the data and the type of presentation in order to achieve the best possible transparency. In addition, in Commission Regulation (EC) No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006,9 among other things the general principles for scientific underpinning are listed (e.g. human studies on the target group, criteria comparable with evidence based medicine). It is on that basis alone that health claims can presently be assessed validly and transparently.

The question then is why merely epidemiological data (with, if any, a significantly lower scientific level) suffices for restrictions on advertising using health claims based on nutrient profiles, whereas proof based on intervention studies is required for health claims although – as seen – the same requirements are made of nutrient profiles as are of health claims?

As regards the nutrient profiles, with the assistance of the Inter Service Steering Group, the Commission is holding various consultations with EFSA, the Member States and stakeholders. A first report with a proposal of nutrient profiles was presented to the Impact Assessment Board (IAB) on 15 December 2008,10 which asks for improvement of certain aspects of the report and its resubmission. The new report from 28 January 2009 has been subject to a further opinion with recommendations for improvements from 9 February 2009.11 The recommendations of IAB show that there is still no comprehensible and transparent scientific evidence for nutrient profiles: – The justification for the proposed approach to nutrient profiling still needs to be significantly strengthened.

9 Regulation (EC) No. 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council (OJ L 109/11 of 19 April 2008).

10 Commission, Working Document on the Setting of Nutrient Profiles, 16/12/2008-1; Commission, Note for the Attention, Sanco/E4/CD/cp (2009) D/540114.

11 Commission, Impact Assessment Board, Impact Assessment on a Commission Decision on the Setting of nutrient profiles, Resubmission (draft version of 28 January 2009), 09-02-2009, D(2009) 1016.

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– It is not explained why only sodium, sugars and saturated fat are considered and not wider options.12 – More explicit arguments why certain categories of foods were awarded exemptions while this was not the case for others that were suggested by stakeholders.

– The report still needs to explain more convincingly why the relevant data is not available, and provide more qualitative and illustrative evidence of the impacts of the proposed option.

3. Draft Regulation on Nutrient Profiles in 2009 a. Fundamental Criticism Despite this criticism to which the EU Commission has not yet responded, the Commission prepared a draft Regulation on nutrient profiles in 2009.13 Recital No. 7 of the draft Regulation states: “It emerges that it is appropriate to set up a system of nutrient profiles for food in general, from which adjustments and exemptions should be allowed for a limited number of categories of foods or of specific foods that have important dietary roles.”

Hence the present draft is not based on the results of a well-founded scientific/statistical evaluation, contrary to what was called for.

The following fundamental criticism is directed at the draft: The basic data and impact on the development of the nutrient profile for “other foods” as food in general has not been discussed in any of the reports or the EFSA-opinion. There is only a vague respectively no link to the WHO recommendations dating from 2003.14

12 Wider options would be the incorporation of different nutrients with a benefit; f.ex. 37 nutrients – form Beta-Carotine to Zinc – are mentioned in the so called „Referenzwerte für die Nährstoffzufuhr“ [reference value for nutrients], D-A-CH Referenzwerte der DGE, ÖGE, SGE/SVE [D-A-CH reference value, inter alia German Ass. For Nutrition].

13 Draft Commission Regulation (EC) establishing nutrient profiles provided for in Article 4 (1) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council, Annex 2 to FCP/110/09E. 14 WHO (World Health Organisation) (2003). Diet, nutrition and the prevention of chronic diseases. Report of the WHO(FAO Joint Expert Consultation. WHO Technical Report Series 916, Geneva.

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Furthermore it is unclear if certain topics have been considered and it seems they have not: – different conditions for children, adults and the elderly – certain risk groups as mentioned in Article 4 HCR – food consumption per day (absolute amount or calorie-based) – The main energy supplier are staple foods [largely exempted in the new draft dated 17.3.2009]. In contrast the energy absorption for confectionary is only 8 % (men) respectively 9 % (women).15 The main focus of the draft lies on the certain food categories profiting from adapted nutrient profiles.

In comparison to the preferred options for threshold values from 16 December 2008 and 9 February 2009 (unchanged) there have been some interesting modifications in the draft: – (In the undated draft of the Commission) breads (source of fibre) have been added to the cereal and cereal product category as a new sub-category with a relatively high sodium content (to be reduced after six years of adoption).

Meanwhile the latest draft of the Commission dated 17 March 2009 exempts bread (source of fibre).

– (In the undated draft of the Commission) crustaceans and molluscs have been added to the category fish and fishery products and the threshold for sodium has been elevated.

15 German Studies on Nutrition [Nationale Verzehrsstudie II = NVS II).

16 EFSA, The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006, Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Request Nº EFSA-Q-2007-058), adopted on 31 January 2008, The EFSA Journal (2008) 644, 1–44.

17 Commission, Draft, Commission Staff Working Document, Impact Assessment Report accompanying the Commission Decision on the setting of nutrient profiles pursuant article 4(1) of Regulation No 1924/2006 of the European Parliament and the Council of 20 December 2006 on Nutrition and Health Claims made on foods, Annex 3 to FCP/110/09E. 18 Food Standard Agency: Commission Working Group, 16 February 2009: Nutrient profiles, Article 13 health claims update and authorisation of claims under Article 13(5) and 14, IP Letter CWG 16 Feb 2009. Commission Working Group, 12 January 2009: Nutrient profiles, Article 13 health claims update and authorisation of claims under Article 13(5) and 14, IP Letter CWG 12 Jan 2009. Standing Committee on the Food Chain and Animal Health, 18 December, SC and CWG 18–19 Dec 2008. Interested Parties’ letter: Commission Working Group on Nutrition and Health Claims, 21 November 2008, Ref. CPD/0016.

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Meanwhile the latest draft of the Commission dated 17 March 2009 exempts fish and crustaceans, molluscs and other aquatic invertebrates. It has to be questioned if these products (apart from fish) are really “important basic elements of traditional diets across Europe” as mentioned in Recital No 5.

– Nuts have been separated from fruits and vegetables with a higher threshold for saturated fats.

But they have not been exempted in the latest draft of the Commission dated 17 March 2009.

Even this would be a category that is an important basic element of traditional diets across Europe included in some national dietary guidelines.

– For most categories specific conditions have been introduced. These refer mainly to the ratio of that category in rather complex (convenience) food.

The initiative for these adoptions comes mainly from the discussion with the different stakeholders/industry. The aim behind these changes is to allow certain products/categories of food to bear claims at all.

On no account is this procedure based on scientific data relating to nutrition and health as required in Article 4 HCR. It is obvious that the Commission pursue the policy to make the proposal capable of winning a majority.

In contrast, a valid scientific route has been shown by the EFSA. The EFSA discussed in its paper16 several possibilities to develop thresholds such as using the average or median value of the nutrient content of foods in a given food group.

Alternatively, when starting from a selection of products, which have been identified by experts as eligible to bear claims, statistical approaches could be used.

The present discussion behind this unscientific setting of thresholds is documented in the impact assessment report17 and information from the working group meetings provided by the British FSA.18 This procedure is not consistent with the postulated robustness of the nutrient profiles by EFSA. b. Criticism in Detail Regarding the single categories and their thresholds, there are some aspects that are not at all transparent and/or plausible.

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Some examples: – Oils and spreadable fat: There is some confusion regarding the units; the proposal referring to saturates changed from 30 kcal/100 g (which was said to be an error) to 30 g/100 g.

– The high threshold of sodium in meat and meat products is set to allow some cooked ham with low levels of salt to bear claims at all.

– The impact of crustaceans and molluscs on European nutrition has been considered important enough to elevate the sodium threshold for fish and fish products from 500 to 700 mg/100g. The justification is not at all transparent. Even sodium intakes of populations in Europe are well in excess of recommended intakes.

– Cheese: It has been discussed to elevate the threshold of saturated fat from 10 g/100g to 12 or 12.5 g/100 g. The Commission noted that most (working group members) would not oppose this.

Scientific arguments, if there are any, have not been made transparent.

– Ready meals, sandwiches and soups: The setting of the special criteria (200 g serving size, minimum of two times 30 g of food of other categories) is not transparent. This category with quite complex foods in a broad range of types of products (convenience) cannot be subject to a valid scientific assessment.

Furthermore it has to be questioned if this last category even will fit in the approach of setting nutrient profiles only for food groups with an important dietary role and a significant contribution to the overall diet of the population19.

The “non alcoholic beverages” are discussed to be defined as “liquid foods” which would include gravies and sauces.20 In the primary intention mainly products such as soft drinks were in the focus, leading to a single threshold for sugar. With the new definition concerns arise due to the lacking thresholds for sodium and saturated fatty acids.

Meanwhile in the new draft dated 17.3.2009 thresholds for sodium and saturates have been added; they are the same as for other foods. This equality in treating solid and liquid foods with partly completely different consumption patterns does not seem plausible.

The exemptions of food or food categories from compliance with the nutrient profiles include besides fruits and vegetables, food supplements, table top sweeteners and some dietetic foods such

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as “honey,” the only directly named food. However, in the draft Impact Assessment report21 it is clearly stated that typical daily intakes of honey can lead to significant or frequent consumption of sugars. This is a privilege compared to other foods such as, e.g., confectionary.

The intention of this sudden change that is not scientifically based has not yet been made public.

The comparison to nuts which are not exempted but even included in some national dietary guidelines does not seem to be plausible.

According to the specific categories, certain conditions have been set. These define special ratios of ingredients in more complex (convenience) food.

The setting of these specific conditions for the food categories has not been made transparent except for dairy products. The minimum of 50 % required by Codex Standards has been transferred to all the other categories only by consideration. It is not based on composition data of concrete and relevant products.

Furthermore, when selecting the relevant nutrients the calorie content/energy density and the quantity of consumption were not taken into account. The argument that the calorie content is already covered by the obligatory labelling of nutrient values is not tenable in view of the present draft. The nutrients now planned, saturated fatty acids, sugar and sodium are all components of the broadened labelling of nutrient value under Art. 7 HCR. This unequal treatment is not plausible from a scientific point of view.

The present mode of procedure which is based more on general considerations and discussions with the associations and food enterprises affected, overlooks several issues which were addressed in the run-up (especially by EFSA). This discussion demonstrates the weaknesses in the concept of

19 EFSA, The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006, Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Request Nº EFSA-Q-2007-058), adopted on 31 January 2008, The EFSA Journal (2008) 644, p. 2.

20 Food Standard Agency: Commission Working Group, 16 February 2009: Nutrient profiles, Article 13 health claims update and authorisation of claims under Article 13(5) and 14, IP Letter CWG 16 Feb 2009.

21 Commission, Draft, Commission Staff Working Document, Impact Assessment Report accompanying the Commission Decision on the setting of nutrient profiles pursuant article 4(1) of Regulation No 1924/2006 of the European Parliament and the Council of 20 December 2006 on Nutrition and Health Claims made on foods, Annex 3 to FCP/110/09E, p. 23.

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nutrient profiles in general and with regard to the specific issues outlined above. c. Nutrients in Detail Body weight is a factor with convincing evidence related to multiple diet-related chronic diseases.

Weight loss and physical activity are therefore desired factors. But the evidence relating high intake of sugars, compared to high intakes of starch, to weight gain is inconsistent. There is only some evidence that high intakes of sugars in the form of sugar-sweetened beverages might contribute to weight gain. Even the evidence for an association of micronutrient dilution with added sugar intake is limited and inconsistent.22 Nevertheless there are thresholds for sugar in most categories. In contrary EFSA suggested that total sugar content might only be included for particular food groups.

The nutrient „saturated fatty acids“ is mentioned in Art. 4 of the Health Claim Regulation 1924/2006 as possible substances for restriction. Meanwhile there is scientific evidence that saturated fatty acids cannot be treated uniformly from the nutritional point of view. The wide-spread saturated stearic acid (18: 0) does not increase risk as well as the medium-chain triglycerides.23 This differentiation has not yet been taken into account. This is mainly important for the category vegetable oils and spreadable fats where products relatively high in stearic acid such as cocoa butter could be favoured to other solid fats. d. Single Foodstuffs in the Context of the Overall Dietary Habits The present draft on nutrient profiles disregards completely one of the essential leitmotifs behind 22 EFSA, The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006, Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Request Nº EFSA-Q-2007-058), adopted on 31 January 2008, The EFSA Journal (2008) 644, p. 14.

23 Schweizer D (2008): Nährwertprofile – Zugangsvoraussetzung für nährwert- und gesundheitsbezogene Angaben, Deutsche Lebensmittel-Rundschau 104, 4, 157–160.

24 Commission: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on nutrition and health claims made on foods, COM(2003)424 final; 2003/0165 (COD), 16.7.2003, recital 14.

25 EFSA, The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006, Scientific Opinion of the Panel on Dietetic

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the Health Claims Regulation No. 1924/2006: “There are no good and bad foods but rather good and bad diets” (draft Health Claim Regulation). Nevertheless the setting of nutrient profiles was already in the focus, but should only be adopted “after careful and adequate consideration”. At that time the proposals for nutrient profiles were “far from meeting the required consensus”. 24 One main limitation is an inherent difficulty in seeking to apply to individual food products nutrient intake recommendations that are established for the overall diet. The nutrient profile of a balanced diet is already defined on a well established scientific base.25 The role of the food in a person’s diet or the fact that the consumption of a food can be compensated by the consumption of another food with different nutritional properties cannot be taken into account by overall nutrient profiles26.

The decisive WHO report on diet, nutrition and the prevention of chronic diseases (2003)27 also focuses always on the effect of the daily diet or special nutrients and their thresholds but not on individual food products. A comprehensive evaluation of foods as such is not possible according to the German Association for Nutrition [in German: “Deutsche Gesellschaft für Ernährung”]. This association takes the view that precise figures for an exact evaluation of foods cannot be derived on a correct scientific basis, since the requisite scientific evidence is lacking.28 e. General Criticism No direct effect of nutrient profiles arises on the diet of individual consumers, since the nutrient profiles are not communicated to consumers. Nutrient profiles do not change, let alone exercise a favourable influence on (incorrect) dietary behaviour. At Products, Nutrition and Allergies (Request Nº EFSA-Q-2007058), adopted on 31 January 2008, The EFSA Journal (2008) 644, p. 1.

26 Commission, Draft, Commission Staff Working Document, Impact Assessment Report accompanying the Commission Decisison on the setting of nutrient profiles pursuant article 4(1) of Regulation No 1924/2006 of the European Parliament and the Council of 20 December 2006 on Nutrition and Health Claims made on foods, Annex 3 to FCP/110/09E, p. 18.

27 WHO (World Health Organisation) (2003). Diet, nutrition and the prevention of chronic diseases. Report of the WHO(FAO Joint Expert Consultation. WHO Technical Report Series 916, Geneva.

28 German Association for Nutrition [Deutsche Gesellschaft für Ernährung DGE] (2008): „1 plus 4“ Modell – Stellungnahme der DGE e.V. zur erweiterten Nährwertinformation, p.2.

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the most nutrient profiles reach those consumers who select products bearing health and nutrition claims. The actual proportion of products currently bearing such claims is unknown. According to the Impact Assessment Report, it was not possible to obtain exact data on the number of products bearing nutrition or health claims (IAR, p. 1829).

The question whether it is possible to influence public health via nutrient profiles remains undecided. A healthy way of life alone combined with sufficient physical activity is what has a proven effect. The WHO report30 provided convincing evidence for weight loss and physical activity for all important diseases (except dental disease); in comparison: the positive effects of consumption of fruit is only partly convincing, only “probable” evidence was obtained with regard to Type 2 diabetes and cancer.31 The WHO set certain criteria for the strength of evidence in the field of dietary/nutrition practice and risk factors. The highest level “convincing evidence” is based on a substantial number of epidemiological studies showing consistent associations.

WHO is aware that evidence based on the gold standard with intervention studies is often not available.

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In the following section we will focus on the aspects of scientific based nutrient profiling which were identified by the EFSA consultation and have not hitherto been considered. The present draft does not achieve the scientific level required by EFSA as regards the various terms of reference pursuant to Art. 4 HCR. Nutrient profiles should consider nutrients that often exceed recommended levels. Yet data on

dietary intakes are only available for 22 European Member States. The methods used for estimating dietary intake vary among Member States and even within countries.

There is no common scientific evidence on which nutrients and to which extent exceed the recommendations in the European population. The Health Claim Regulation requires that the variability of dietary habits and traditions in the EU be taken into account. Yet the local differences are reflected in the varying role and contribution of different food groups and of individual foods to the diet as listed in the EFSA-opinion [see Annex 2].32 There is still no scientific approach on how to deal with this aspect.

The EFSA considers that a nutrient profile for food in general with exemptions from the general profile, if necessary, for a limited number of food groups as a kind of mixed concept might be a good agreement. The category-based scheme is said to have several advantages such as the general comparability of portion size, the frequency of intake and the pattern of consumption.33 However, in the same context is stated that there are no EU-standardised food groups that are based on their nutrient contribution (the existing EuroFir food classification system focuses more on the origin of foods.) Hence the data basis for comparability is even less available. Therefore a valid statistical approach is not possible at the current stage.

In its position paper the German Federal Institute for Risk Assessment (German abbr. “BfR”) was only able to refer to food categories based on the data of the Federal nutrient database [in German so called “Bundeslebensmittelschlüssel”, abbr. “BLS”] and to foods that are (only) frequently consumed in Germany.34 Certainly the whole consumption in other Member States would be entirely different.

29 Commission, Draft, Commission Staff Working Document, Impact Assessment Report accompanying the Commission Decision on the setting of nutrient profiles pursuant article 4(1) of Regulation No 1924/2006 of the European Parliament and the Council of 20 December 2006 on Nutrition and Health Claims made on foods, Annex 3 to FCP/110/09E, p. 18.

32 EFSA, The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006, Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Request Nº EFSA-Q-2007-058), adopted on 31 January 2008, The EFSA Journal (2008) 644, p. 12. – see Table 2.

30 WHO (World Health Organisation) (2003). Diet, nutrition and the prevention of chronic diseases. Report of the WHO(FAO Joint Expert Consultation. WHO Technical Report Series 916, Geneva.

Annex.

33 EFSA, The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006, Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Request Nº EFSA-Q-2007-058), adopted on 31 January 2008, The EFSA Journal (2008) 644, p. 2.

f. Scientific Based Nutrient Profiling

31 WHO (World Health Organisation) (2003). Diet, nutrition and the prevention of chronic diseases. Report of the WHO(FAO Joint Expert Consultation. WHO Technical Report Series 916, Geneva. p. 54–55.

34 Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung – BfR): Nutrient Profiles – The Precondition for Health Claims, Updated BfR Position Paper, 12 March 2007.

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EFSA mentioned differences in consumption patterns across Members too.35 Furthermore, the increasing complexity of the food supply is mentioned as a disadvantage. In this light the setting of specific conditions for food categories that requires a minimum of 50 % in the finished product seems to further contribute to the existing complexity. A clear distinction between two categories can no longer be justified (e.g. combination of 51 % fruits with 49 % dairy). A differentiation between the food-based categories and the category “ready meals” also becomes difficult without further explanation. It will not be possible to attribute foods unequivocally to the category of “ready meals” if they fall within one of the other categories at the rate of at least 50% (e.g. for meat dishes a higher salt content would be allowed in the “meat” category than in the category of “ready meals”).

Result: The proposed separations lead to arbitrary categories and in the practical feasibility to allocation problems. g. Further Topics aa. Reference Quantity In the draft of the Regulation on nutrient profiles36 it has been decided to refer to 100 g/100 ml as reference quantity instead of serving size/portion or energy. This is mainly based on pragmatic considerations, but not on scientific base. The only approach that is directly related to the quantity of food typically consumed, expressing the nutrient content per serving, has not been considered. bb. Threshold or Scoring System This decision in favour of setting thresholds is also only a pragmatic, but not a scientific decision. In the absence of a gold standard methodology to evaluate nutrient profiles, advantages and drawbacks can only be analysed from a narrow theoretical point of view.

35 EFSA, The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006, Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Request Nº EFSA-Q-2007-058), adopted on 31 January 2008, The EFSA Journal (2008) 644, p. 12. – see Table 2.

36 Draft Commission Regulation (EC) establishing nutrient profiles provided for in Article 4(1) of Regulation (EC) No 21924/2006 of the European Parliament and of the Council, Annex 2 to FCP/110/09E. 37 EFSA, The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC)

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This is demonstrated by various working groups which compared the use of different systems on the same food panel and demonstrated that they lead to discrepancies. EFSA judged the proposed threshold system as possibly being too simplistic.37 Apart from the thresholds for the special categories (due to the conditions complex enough), this applies mainly to the general category “other foods”. cc. Testing For testing of a nutrient profile scheme according to Article 4 para.1 Health Claim Regulation, a wellestablished database of energy and nutrient contents of a range of foods is required. But actually there is still a lack of uniform data on food composition and food consumption across the EU. A stepwise testing and evaluation of the results with possible refining and retesting as proposed by EFSA38 is limited.

The dietary role and importance of the food must also be taken into account, allowing for the variability in dietary habits and traditions across different EU countries. The classification of foods as being eligible to bear nutrition and/or health claims should be consistent with food based dietary guidelines established in Member States, although it is recognized that such guidelines are not uniform across countries.

It is therefore questionable whether this topic can be solved consistently for the European Community. In the White Paper on a strategy for Europe on nutrition, overweight and obesity the regional and local aspect is highlighted: “The variance in diet across Member States, and the difference in policy approaches, is important. Moreover it is essential that actions continue to be developed at regional and local levels as these are closer to the EU citizens. Interventions at these levels are vital to tailor designed and validated general approaches to specific local contexts”.39

No 1924/2006, Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Request Nº EFSA-Q-2007058), adopted on 31 January 2008, The EFSA Journal (2008) 644, p. 24.

38 EFSA, The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006, Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Request Nº EFSA-Q-2007-058), adopted on 31 January 2008, The EFSA Journal (2008) 644, p. 25.

39 Commission: White paper on a strategy for Europe on nutrition, overweight and obesity related health issues, COM(2007) 279 final, 30.5.2007, p. 9-10.

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dd. Feasibility In the discussion on the selection of relevant nutrients, EFSA specifies as a prerequisite that the nutrients have to be easily available in charts or databases or easy to analyse.40 As a rule, however, charts such as EuroFir41, the German nutrient database [BLS]42 or data deriving from collections of literature43 indicate an area of fluctuation in addition to a median value. In view of the clear thresholds set (in the draft on nutrient profiles), on the one hand, and the natural fluctuation in the composition of foods, especially of processed or composite products, on the other hand, the question as to tolerance in the face of divergences does arise. This issue, which plays an important role e.g. where the risk assessment of substances is concerned, has not been taken into account so far in the draft on nutrient profiles, yet it is of practical relevance for implementation and monitoring (under the heading of “feasibility”). For example, the German Chemical Society recommends in nutrition labelling tolerances of up to 20% for sodium or of up to 1.5 g for sugar and saturated fatty acids (less than 10g/100g).44

III. Legal Aspects 1. Examination Criterion: Art. 11 EU Charter of Fundamental Rights and Freedoms The requirements of nutrient profiles and their application in practice would lead to advertising bans that lastingly restrict the freedom to advertise, since foods that do not satisfy the requirements could not be advertised using health claims or, as regards claims relating to nutrients, only with the stigmatizing disclaimer “high […(*)] content.”

This restriction on commercial advertising affects and/or violates the scope of protection of Art. 11 EU Charter of Fundamental Rights (hereinafter: CFR), read in conjunction with Art. 10 of the European Convention on Human Rights.

Art. 6(1) of the Treaty of the European Union (TEU) provides that the CFR has the same legal status as the Treaties, i.e. the Charter is part of EU primary law. Art. 51(1) CFR adds that its provisions are chiefly addressed to the bodies and institutions of the Union so that legislative acts adopted by Council and Parliament have to be judged according to

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the requirements of Art. 11 CFR. The latter has to be interpreted applying the principles enshrined in Art. 52 CFR which lays down general rules on the scope of guaranteed rights. Above all, Art. 52(3), 1st sentence CFR stipulates: “Insofar as this Charter contains rights which correspond to rights guaranteed by the Convention for the Protection of Human Rights and Fundamental Freedoms, the meaning and scope of those rights shall be the same as those laid down by the said Convention.“ The explanations relating to the Charter of Fundamental Rights45, which must be given due regard to when interpreting the Charter (Art. 52(7) CFR), contain a list of articles covered by Art. 52(3) CFR which include Art. 11 CFR. Consequently, the content of said provision is largely determined by Art. 10 ECHR whose scope and limitations are unilaterally incorporated into EU law. As the European Court of Justice (ECJ) has pointed out in its recent case law, the reference to the ECHR in Art. 52(3) CFR includes the case law of the European Court of Human Rights (ECtHR).46 Art. 52(3), 2nd sentence rounds the legal framework off by stipulating that Union law is not prevented from providing more extensive protection. This entails that the Union courts may only deviate from the Convention standards in favour of the applicant, never to his detriment.

Therefore, the guarantee of freedom of expression enshrined in Art. 10 ECHR has to be the starting point of the present legal analysis. Additionally, the case law of the ECJ has to be taken into consideration to verify whether there are autonomous, further-reaching standards in EU law.

40 EFSA, The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to Article 4 of the Regulation (EC) No 1924/2006, Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Request Nº EFSA-Q-2007-058), adopted on 31 January 2008, The EFSA Journal (2008) 644, p. 26.

41 European Food Information Resource Network EuroFir, http://www.eurofir.net/public.asp?id=4210 42 Bundeslebensmittelschlüsssel, http://www.bls.nvs2.de.

43 Souci-Fachmann-Kraut: Nutrition Tables/Die Zusammensetzung der Lebensmittel/Nährwerttabellen: 6. Aufl.-Stuttgart: medparm Scientific Publ., 2000.

44 The German Chemical Society (DGE): Empfehlungen zu Toleranzen für Nährstoffschwankungen bei der Nährwertkennzeichnung, Lebensmittelchemie, 52, 25, 1998 und Ergänzungen 52, 132–133, 1998; 53, 69, 1999.

45 OJ 2007 C 303/17.

46 ECJ decision of 22 December 2010 (C-279/09, nyr, paragraph 35); of 5 October 2010, J. McB./L. E. (C-400/10 PPU, nyr, pararaph 53).

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2. Freedom to Advertise as Part of the Scope of Art. 11 CFR As the European Court of Human Rights (ECtHR) has clarified in its Casado Coca judgement of 24 February 1994, the right to freedom of expression has to be construed in a very broad manner, thus making no distinction as to the type of information imparted: “35. [...] Article 10 (art. 10) does not apply solely to certain types of information or ideas or forms of expression, in particular those of a political nature; it also encompasses artistic expression, information of a commercial nature – as the Commission rightly pointed out – and even light music and commercials transmitted by cable.“47 Having regard to Art. 52(3) CFR, this finding of the ECtHR puts the EU courts under an obligation to integrate commercial advertising, e.g. for food, into the scope of protection of Art. 11 CFR.48

3. Restriction on Advertising According to Art. 10(2) ECHR, this right may only be restricted under the conditions provided for in Art. 10(2) ECHR, which reads: “the exercise of these freedoms, since it carries with it duties and responsibilities, may be subject to such formalities, conditions, restrictions or penalties as are prescribed by law and are necessary in a democratic society, in the interests of national security, territorial integrity or public safety, for the prevention of disorder or crime, for the protection of health or morals, for the protection of the reputation or the rights of others, for preventing the disclosure of information

47 ECtHR judgement of 24 February 1994, Casado Coca (15450/89, Series A, No. 285-A, paragraph 35; internal quotations omitted).

Cf also ECtHR judgement of 20 November 1989, Markt Intern/Germany (Series A, No. 165, paragraph 25-26).

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received in confidence, or for maintaining the authority and impartiality of the judiciary.”

According to the Court of Human Rights, those limitations must however be interpreted restrictively.

The adjective ‘necessary‘ involves, for the purposes of Article 10(2), a ‘pressing social need‘ and, although ‘[t]he contracting States have a certain margin of appreciation in assessing whether such a need exists‘, the interference must be ‘proportionate to the legitimate aim pursued‘ and ‘the reasons adduced by the national authorities to justify it‘ must be ‘relevant and sufficient‘.49 Furthermore, any prior restriction requires particular consideration.50 With regard to the particular situation of advertising bans, the ECtHR set up the following principles in its judgement Stambuk/Germany of 17 October 2002: “39. The Court recalls that, for the citizen, advertising is a means of discovering the characteristics of services and goods offered to him. Nevertheless, it may sometimes be restricted, especially to prevent unfair competition and untruthful or misleading advertising. In some contexts, the publication of even objective, truthful advertisements might be restricted in order to ensure respect for the rights of others or owing to the special circumstances of particular business activities and professions. Any such restrictions must, however, be closely scrutinised by the Court, which must weigh the requirements of those particular features against the advertising in question; […]”51 The key element, therefore, lies in the assessment of the proportionality of the restriction of a right (here: freedom to advertise) which in the words of Advocate General Jääskinen ‘requires that the measures

(Kühn, C-177/90, [1992] ECR I-35), of 15 April 1997 (Irish Farmers Association et al, C-22/94, [1997] ECR I-1809), and of 10 July 2003 (Hydro Seafood GSP Ltd, C-20/00 and C-64/00, [2003] ECR I-7411).

48 Cf the express reference to the aforementioned ECtHR judgements in Advocate General Jääskinen’s opinion of 19 October 2010 (case C-249/09, Novo Nordisk, nyr, paragraph 44) concerning advertisements for medicinal products.

50 ECJ decision of 6 March 2001, case C-274/99 P, paragraph 41 – Connolly, with reference to ECtHR decision Wingrove/UK of 25 November 1996, Reports of Judgements and Decisions, 1996-V, p. 1957, paragraphs 58 and 60.

49 ECJ decision of 6 March 2001, case C-274/99, paragraph 41 – Connolly, with reference to ECtHR Vogt v Germany, paragraph 52; and Wille v Liechtenstein judgement of 28 October 1999, no 28396/95, paragraphs 61- 63). See also ECJ decisions of 13 July 1989 (Wachauf, 5/88, [1989] ECR 2609), of 10 January 1992

51 ECtHR, judgement of 17 October 2002, application no.

37928/97, Stambuk v Germany, paragraph 39 (emphasis added); reiterated in the decisions of 23 October 2007, application no.

7969/04, Brzank v Germany, and application no. 2357/05, Heimann v Germany.

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concerned satisfy criteria of aptitude, necessity and proportionality stricto sensu‘.52 When these requirements are scrutinized by a court, a broad scope of discretion has to be awarded to the EU legislator in an area such as the one presently under discussion, in which political, economic and social decisions are needed and in which the legislative bodies have to undertake complex evaluations.53 Moreover, the ECtHR’s standing case law shows that advertising can generally be subject to stricter restrictions than the expression of political ideas.54 The ECJ seconded this stance in its Karner judgement by stating: “When the exercise of the freedom does not contribute to a discussion of public interest and, in addition, arises in a context in which the Member States have a certain amount of discretion, review is limited to an examination of the reasonableness and proportionality of the interference.

This holds true for the commercial use of freedom of expression, particularly in a field as complex and fluctuating as advertising’.55 The sequentiality of ‘reasonableness’ and ‘proportionality’ implies that the latter should be read as ‘proportionality stricto sensu’. The most up-to-date analysis of the functioning of that requirement in the material context can be found in Advocate General Jääskinen’s opinion of 19 October 2010 in the case of Novo Nordisk: “49. In my view, the principle of proportionality stricto sensu does not apply to the balancing of two fundamental freedoms, namely, the right to health and freedom of expression, if it is conceived as a requirement to minimise the former and maximise the latter. Here, the purpose of the application of the principle of proportionality is

52 Jääskinen, Opinion of 19 October 2010 (case C-249/09, Novo Nordisk, nyr, paragraph 48).

53 ECJ decision of 12 December 2006, C-380/03, paragraph 145.

54 ECtHR judgement of 5 May 1979 in case 7805/77, X and Church of Scientology v Sweden, Decisions and Reports 16 (1979), 68, 73. Frowein, in: Frowein/Peukert, Europäische Menschenrechtskonvention (3rd ed. 2009), Art. 10 margin No. 9 with further references; Grabenwarter, Europäische Menschenrechtskonvention (4th ed. 2009), § 23 margin No. 34; van Dijk/van Hoof, Theory and practice of the European Convention on Human Rights (2nd ed. 1990), Art. 10 margin No. 8, p. 425.

55 ECJ decision of 25 March 2004, C-71/02, [2004] ECR I-3025, paragraph 51, with reference to the decision of 23 October 2003 in case C-245/01, RTL Television, paragraph 73, and ECtHR judgements in the case Markt Intern Verlag GmbH and Klaus

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to attach weight to the relative importance of the two fundamental rights rather than to minimise the obstacles to freedom of commercial expression caused by the measures relating to the advertising of medicinal products adopted by the Union legislature in order to safeguard public health. Public health must be safeguarded in order to guarantee the fundamental rights, human dignity, the right to life and the right to physical and mental integrity referred to in Articles 1 to 3 of the Charter.

50. In the system of fundamental rights, the right to life is the foremost and must take precedence over the fundamental rights of freedom of action.

Freedom of commercial expression is not at the heart of that fundamental right. Therefore, the Union legislature has a wide discretion with regard to the level of protection granted to public health and it is therefore not required to restrict itself to the minimum necessary to protect freedom of expression. The argument that the principle of proportionality requires the adoption of a restrictive approach with regard to the interpretation of the limitations on the advertising of medicinal products is therefore, in my view, unfounded.“56 Despite this wide margin of appreciation for the legislator, there remains the aforementioned criterion of ‘reasonableness’. The ECJ continuously uses the formula that a measure adopted in an area of large legislative discretion will only be deemed unlawful if it is ‘manifestly inappropriate having regard to the objective which the competent institutions are seeking to pursue‘.57 The ECtHR likewise verifies if the reasons adduced by the national authorities can ‘be said to be arbitrary’.58 As Advocate General

Beermann of 20 November 1989, Reports of judgements and decisions, Series A, Nr. 165, paragraph 33, and VGT Verein gegen Tierfabriken/Switzerland of 28 June 2001, Reports of judgements and decisions 2001-VI, paragraphs 69-70. Cf also the recent ECJ (Second Chamber) decision of 2. April 2009, Case C-421/07, Frede Damgaard, paragraphs 26, 27.

56 Advocate General Jääskinen, opinion of 19 October 2010 (case C-249/09, Novo Nordisk, nyr, paragraphs 49–50).

57 ECJ decision of 12 December 2006, C-380/03, paragraph 145 – Directive 2003/33/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products, with extensive references.

58 ECtHR, decision of 23 October 2007, application no. 2357/05, Heimann v Germany.

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Fenelly put it in his opinion in the case of the Directive on Tobacco Advertising, again with reference to the ECtHR’s judgement in “Markt Intern”, limits on commercial expression ‘are acceptable where the competent authorities, on reasonable grounds, had considered the restrictions to be necessary‘.59 In the particular case of areas where there is a lack of unanimity in scientific circles as to the effectiveness of a measure, however, the Advocate General considered it ‘insufficiently respectful of freedom of

59 Opinion of Advocate General Fennelly delivered on 15 June 2000 in cases C-376/98 (Federal Republic of Germany v European Parliament and Council of the European Union) and C-74/99 (Imperial Tobacco, [2000] ECR I-8419, No. 145), paragraph 158 (emphasis added).

61 Ibid, paragraph 161.

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expression […] to permit the legislator to restrict the exercise of that right without any clear evidence that such a restriction is likely to result in changes in behaviour which, in turn, were likely to benefit public health.‘ 60 Drawing on the conclusions of part 2 of the present opinion, there is no doubt that the nutrient profiles are devoid of any objective justification and can accordingly be proven to lack the necessary reasonableness. Notably, there are no indications at all that any possible changes in consumer behaviour will lead to factually healthier lifestyle choices and thus benefit public health.

Therefore, the draft commission regulation establishing nutrient profiles provided for in Article 4(1) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council violates Art. 11 CFR, read in conjunction with Art. 10 ECHR.

Prof. Dr. Alfred Hagen Meyer Prof. Dr. Meyer ist Partner der meyer.rechtsanwälte Partnerschaft.

Schwerpunkte seiner Tätigkeit sind das Lebensmittel- und Bedarfsgegenständerecht mit allen seinen Facetten wie Produktentwicklung, Kennzeichnung und health claims, Risk Assessment und Krisenmanagement sowie Lobbyarbeit auf nationaler und europäischer Ebene.

Honorarprofessur an der TU München; er unterrichtet seit dem Wintersemester 1995/1996 das Fach Lebensmittelrecht am Institut für Lebensmittelchemie an der TU München.

Seine wissenschaftlichen Leistungen belegt er durch über 200 Veröffentlichungen, darunter die Kommentierung der „Lebensmittelwerbung“ in Fezer (Hrsg.), UWG – Lauterkeitsrecht, Kommentar (C.H.Beck-Verlag, 2009) sowie der 2007 erschienene, mit Prof. Streinz herausgegebene Kommentar zur BasisVO 178/2002 und zum LFGB (C.H.Beck). Er ist des Weiteren Herausgeber der bei C.H.Beck publizierten Textsammlung „Meyer - Lebensmittelrecht“, Mitherausgeber der bei Behr´s erscheinenden

Handbücher „Functional Food“ und „Verkehrsauffassung im Lebensmittelrecht“ sowie Themenverantwortlicher und Autor bei Römpp Lexikon Lebensmittelchemie (Thieme).

Herausgeber der Deutschen Lebensmittel Rundschau (DLR).

Geschäftsführender Vorstand des Fördervereins der Forschungsstelle für deutsches und europäisches Lebensmittelrecht in Bayreuth, zudem Vorsitzender des Verwaltungsrats der Deutschen Gesellschaft für Ernährung (DGE), Mitglied des Stiftungsrats der Deutschen Forschungsanstalt für Lebensmittelchemie (DFA) und im Wissenschaftlichen Beitrat des Milchindustrieverbands (MIV).

Korrespondierendes Mitglied der Arbeitsgemeinschaft „Fragen der Ernährung“ der Lebensmittelchemischen Gesellschaft in der GDCh und Mitglied des Rechtsausschusses des Bundes für Lebensmittelrecht und Lebensmittelkunde (BLL).

Meyer leitet regelmäßig deutsche und internationale Veranstaltungen und referiert in deutscher und englischer Sprache.

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