[2006] 5 Env. Liability : Food supplements and fortified foods : Hanekamp, Bast 181
Food supplements and fortified foods: the EC’s
patriarchal precautionary perspectives on public health
Maastricht University, Department of Pharmacology and Toxicology Rejoinder context
1. Where there are not yet scientifically established In a ‘Discussion Paper on the Setting of Maximum and numerical tolerable upper intake levels for several Minimum Amounts for Vitamins and Minerals in Foodstuffs’ nutrients, what should be the upper safe levels for those (DP), issued in June 2006, the European Commission (EC) nutrients that should be taken into account in setting seeks advice on micronutrients added to food and present in
food supplements.2 The DP looks at two regulatory 2. For some vitamins and minerals the risk of adverse instruments, a directive and a regulation, both of which address effects, even at high levels of intakes, appears to be the use of vitamins, minerals and ‘other substances’ as extremely low or non-existent according to available supplements to conventional diets: the Common Position data. Is there any reason to set maximum levels for these (EC) No 2/2006 regarding the Regulation on Fortified Foods (FFR) and the 2002 Food Supplement Directive (FSD).3 In 3. Where we set maximum levels, do we inevitably also the DP, the EC invites stakeholders to provide answers to its have to set maximum amounts for vitamins and minerals questions, in particular regarding the execution of Article 5 separately for food supplements and fortified foods in of the FSD and the similarly worded Article 6 of the FFR. In order to safeguard both a high level of public health both articles, the EC has undertaken the actual management protection and the legitimate expectations of the various of risk (the separate and further step to risk assessment) by food business operators? Are there alternatives? setting minimum and maximum levels of vitamins and 4. Taking into account all the above-mentioned minerals for fortified foods and food supplements. These considerations, how far should PRIs/RDAs (population key articles concern a number of issues which we will address reference intakes/recommended daily allowances) be
with the aid of the following questions, as formulated in the taken into account when setting maximum levels for DP. We have numbered the questions for ease of reference: To put the questions asked by the DP and the answers we putforward in this paper in perspective, we will first address theimplementation possibilities of a food supplements policy 1 Correspondence should be addressed to hjaap@xs4all.nl, and show some key inconsistencies generated by the tel +31 (0)793 460304. The information herein is dated to precautionary perspective the EC usually takes on regulation.
29 September 2006. The authors would like to thank the International Nutrition Company BV in Loosdrecht, The This will clarify the embedded presuppositions behind the Netherlands for providing a grant towards the writing of this questions asked in the DP. We then propose a new approach 2 http://ec.europa.eu/food/food/labellingnutrition/ to policy in view of current scientific knowledge. In this article, supplements/discus_paper_amount_vitamins.pdf#search=% the term micronutrients refers not only to vitamins and 22%22Discussion%20Paper%20on20the%20setting%20of% minerals but also to ‘other substances’ (as referred to in the 20maximum%20and%20minimum%20amounts%20for%20vitamins% FSD as well as in the FFR), such as amino and fatty acids, carotenoids, and polyphenols, that are all part of the human 3 http://europa.eu.int/eur–lex/lex/LexUriServ/site/en/ oj/2006/ce080/ce08020060404en00270042.pdf#search=% diet. Although bioactive food compounds such as polyphenols 22Common%20Position%20(EC)%20No%202%2F2006%22 are usually not categorised as micronutrients, and although (28 September 2006). Council Directive 2002/46/EC of 10 they are not placed within the framework of the classical June 2002 on the Approximation of the Laws of the Member States Relating to Food Supplements [2002] OJ L183 51–57.
deficiency symptoms (as is the case with vitamins and certain ENVIRONMENTAL LIABILITY PUBLISHED BY LAWTEXT PUBLISHING LIMITED 182 Food supplements and fortified foods : Hanekamp, Bast : [2006] 5 Env. Liability
minerals), consumption may well be advantageous in terms intended to provide a framework within which consumers of long-term health benefits (eg in relation to the incidence can make informed decisions about safe intake limits.
of cancer, inflammatory responses and ageing).
Separation of assessment (EFSA) and management (EC), as abasic approach of European regulation, governs the broadercontext of the FSD/FFR construct against the background Inconsistencies in the DP, FSD and FFR
of what is presented as an ‘adequate and varied diet’ . Some of The FSD, the oldest (10 June 2002) of the two regulatory the relevant parts from the FSD are cited below and pertinent instruments addressed here, concerns food supplements marketed as foodstuffs and presented as such for the purposeof supplementing the human diet.4 We define food (3) An adequate and varied diet could, under normal supplements similarly to the FSD. By definition, food circumstances, provide all necessary nutrients for normal supplements are marketable finished products that are development and maintenance of a healthy life in quantities, explicitly presented to the public for supplementation of the which meet those established and recommended by generally diet. Food supplements cannot be presented as medicines or acceptable scientific data. However, surveys show that this as substitutes for medicines. The recommended dosages of ideal situation is not being achieved for all nutrients and by the micronutrients contained in food supplements may or all groups of the population across the Community. may not exceed the average intake of food-endogenous (5) In order to ensure a high level of protection for consumers and facilitate their choice, the products that will be put on to the As the DP shows, the central issues revolve around safety market must be safe and bear adequate and appropriate (see also FSD (13) below). Safety in the FSD and the FFR is, roughly, defined in terms of trying to prevent, by way of risk (9) Only vitamins and minerals normally found in, and management, over-exposure to micronutrients and ‘other consumed as part of, the diet should be allowed to be substances’ by taking into consideration safe upper limits present in food supplements although this does not (SULs) previously established by way of risk assessment.
mean that their presence therein is necessary.
SULs are doses of vitamins and minerals that potentially Controversy as to the identity of those nutrients that susceptible individuals could take daily on a life-long basis in could potentially arise should be avoided. Therefore, it reasonable safety, without medical supervision. The European is appropriate to establish a positive list of those vitamins Food Safety Authority (EFSA) defines the SUL as the ‘tolerable upper intake level’. In EFSA terminology, this means: (13) Excessive intake of vitamins and minerals may result in adverse effects and therefore necessitate the setting of The maximum level of total chronic daily intake of a maximum safe levels for them in food supplements, as nutrient (from all sources) judged to be unlikely to pose appropriate. Those levels must ensure that the normal a risk of adverse health effects to humans. ‘Tolerable intake’ use of the products under the instructions of use in this context connotes what is physiologically tolerable provided by the manufacturer will be safe for the and is a scientific judgment as determined by assessment of risk, ie the probability of an adverse effect occurring at (14) When maximum levels are set, therefore, account some specified level of exposure. It is an estimate of the should be taken of the upper safe levels of the vitamins highest level of intake which carries no appreciable risk and minerals, as established by scientific risk assessment based on generally acceptablescientific data, and ofintakes of those nutrients from the normal diet. Due These ‘maximum levels’ are provided by the EFSA, and the account should also be taken of reference intake ensuing politically-oriented risk management process amounts when setting maximum levels.
established by the EC will set these ‘maximum levels’ for theactual micronutrient content in products, such as food The reference to an adequate and varied diet as a primary supplements and fortified foods. These maximum levels are source of all necessary nutrients in (3) is intriguing. The truismthat we can obtain everything we need from a balanced dietonly holds if we eat such a balanced diet consistently. Thepoint made here by the EC is tautological: adequate is by 4 Council Directive 2002/46/EC (n 3).
5 Scientific Committee on Food Scientific Panel on Dietetic default adequate. How this adequacy can be achieved, and Products, Nutrition and Allergies ‘Tolerable Upper Intake Levels what such an adequate diet would consist of, are not discussed.
for Vitamins and Minerals’ (European Food Safety Authority Moreover, factors impinging on individual nutritional status ENVIRONMENTAL LIABILITY PUBLISHED BY LAWTEXT PUBLISHING LIMITED [2006] 5 Env. Liability : Food supplements and fortified foods : Hanekamp, Bast 183
are only partly related to the dietary intake on which the EChas its focus. Malabsorption (genetic or otherwise) and Is it the case that the EC, four years after issuing the FSD, is increased nutritional requirements (eg during a period of confident that a varied diet now guarantees intake of all disease) greatly affect the nutritional status of individuals.
necessary nutrients? Yet, in stark contrast to this newest However, these aspects are not considered in the FSD. So, the conviction, the closing line of (7) states that the addition of EC’s reference to an adequate and varied diet erroneously micronutrients to food rendered a positive contribution to assumes average physiological health in the individual overall intakes, which thus seem to be lower than required when considering an ‘adequate and varied’ diet lacking this The EC’s opinion also assumes some kind of natural (or fortification. The EC seems to be aware of the fact that in traditional) ‘true background value’ optimised for healthy relation to, for instance, pregnancy, an adequate and varied living in an otherwise undefined ideal diet that encompasses diet does not provide micro-nutritional sufficiency when folic ideal quantities of ‘all necessary nutrients’ in bio-available acid is considered.7 In addition, the diet of the lower socio- qualities. However, it is unlikely that such a ‘true background economic classes is known to be of a lower nutritional value’ actually exists. Conversely, the phraseology of (3) standard on average than would be required for a diet intended implies that even this adequate and varied diet could well be to provide the basis for a healthy life.8 Food selection is an insufficient source of all necessary nutrients. The question constrained by economic and socio-cultural considerations, then is whether this European diet is or is not a sufficient compromising healthy eating patterns and resulting in source of all necessary nutrients. The relevance of this is clear, nutritional inadequacies. For most micronutrients, as the opinion expressed in (3) implies that fortified foods amplification of the cost-constraint results in a progressive and/or food supplements are superfluous against the decrease in the nutrient density of the diet.9 Moreover, as a background of this ‘EU-diet’. In this context, the FFR makes recent survey in the Netherlands shows, the incidence of under-nourishment in hospitals and other care institutions ishigh, suggesting that even in professional environments, (7) An adequate and varied diet can, under normal maintaining an ‘adequate and varied diet’ can be a problem.10 circumstances, provide all necessary nutrients for The final sentence (in italics) of (8) reveals the issue we normal development and maintenance of a healthy life addressed in our previous article on food supplements in in quantities as those established and recommended by this journal.11 It has become increasingly clear that RDAs are generally acceptable scientific data. However, surveys too restrictive an approach to micronutrients. The long-term show that this ideal situation is not being achieved for all effects of micronutrients, such as reducing cancer and cardio- vitamins and minerals and by all groups of the vascular incidences and decelerating premature ageing, seem population across the Community. Foods to which to be more important than their role in preventing the well- vitamins and minerals have been added appear to make an known acute deficiency diseases. To reiterate, RDAs do not appreciable contribution to the intake of these nutrients and assuch may be considered to make a positive contribution tooverall intakes. 7 MRC Vitamin Study Group ‘Prevention of Neural Tube (8) Some nutrient deficiencies, although not very frequent, Defects: Results of the Medical Research Council Vitamin can be demonstrated to exist at present in the Study’ (1991) 338 Lancet 131–37. See further M Lucock ‘Is Community. Changes in the socio-economic situation Folic Acid the Ultimate Functional Food Component for Disease Prevention?’ (2004) 328 Brit Med J 211–14.
prevailing in the Community and the life styles of 8 S Shohaimi and others ‘Residential Area Deprivation Predicts different groups of the population have led to different Fruit and Vegetable Consumption Independently of Individual Educational Level and Occupational Social Class: A Cross nutritional requirements and to changing dietary habits.
Sectional Population Study in the Norfolk Cohort of the This in turn has led to changes in the energy and nutrient European Prospective Investigation into Cancer (EPIC– requirements of various groups of the population and to Norfolk)’ (2004) 58 J Epidemiol Community Health 686–91.
9 N Darmon and others ‘A Cost Constrained Alone Has intakes of certain vitamins and minerals for these Adverse Effects on Food Selection and Nutrient Density: An groups that would be below those recommended in Analysis of Human Diets by Linear Programming’ (2002) 132 J different Member States. In addition, progress in scientific 10 J Meijers and others ‘Prevalentie van Ondervoeding: de knowledge indicates that intakes of some nutrients for Landelijke Prevalentiemeting Zorgproblemen’ [‘Prevalence of maintaining optimal health and well-being could be higher Under–nourishment: the National Prevalence Survey Care Problems’] (2005) 60(1) Nederlands Tijdschrift voor Diëtisten 11 J C Hanekamp ‘The Precautionary Principle: A Critique in the Context of the EU Foods Supplements Directive’ [2006] 2 6 Common Position (EC) no 2/2006 (n 3).
Env. Liability 43–51. See this article for further references.
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define an optimal level of any nutrient, as they are focused on Slippery slopes
the prevention of disease caused by nutritional deficiencies.
Furthermore, they are designed to meet the needs of healthy The approach chosen by the EC to establish maximum levels people and do not take into account special needs arising (not SULs!) for food supplements, in relation to which other from infections, metabolic disorders, or chronic disease.12 sources of micronutrient intake (food, including fortification) These are important constraints to consider in any policy are balanced, is hampered by a number of problems, among which the regulatory dilemma mentioned above is only of In relation to the to-be-established maximum levels for minor concern. First, when maximum levels for food food supplements, intake of micronutrients from dietary supplements need to be correlated to the total overall intake sources other than food supplements needs to be taken into of food and food products, this can generate a slippery slope account, therefore needs to be known. Article 5 of the FSD situation. Does this approach imply that other sources of states the following (see also (14) above): micronutrients, including conventional fresh and processedfoods (and their fortified variants), need to be regulated as 1. Maximum amounts of vitamins and minerals present in well? Micronutrient-intake as such, in the view of the FSD food supplements per daily portion of consumption as and the FFR, needs to be capped, implying (perhaps recommended by the manufacturer shall be set, taking unwittingly) that all food and food-products need to be regulated. Modern plant-breeding technology (developed (a) upper safe levels of vitamins and minerals established over the past hundred years at least!), in which micronutrient by scientific risk assessment based on generally accepted content is specifically enhanced, also then comes into scientific data, taking into account, as appropriate, the regulatory focus. When one looks at the latest research on varying degrees of sensitivity of different consumer the optimisation of nutrients in whole foods and its beneficial health effects,13 the FSD/FFR construct seems to generate a (b) intake of vitamins and minerals from other dietary legislative culture of full-blown regulatory control of all food- sources. Consequently, even conventional foods rich inmicronutrients become a regulatory target. These dilemmas This then must include fortified foods as a source of are not clarified in the DP. The FSD/FFR approach, with the micronutrients. However, the regulation on fortified foods, aid of the precautionary principle, generates an open-ended which is still a draft (proposal) lacking the force of law, does compulsory regulatory structure relating to all food- contain a list of allowed micronutrients, although their products, not just food supplements and fortified foods. This content-levels in different types of fortified foods still need unrestrained licence to define is created by the fact that the to be established. In paragraph 28 of the DP, the Commission FSD and FFR embrace the whole of micronutrient intakes comments on the complexities created by the task of from all foods in order to regulate food supplements and simultaneously setting maximum amounts for two different food sources of micronutrients, knowing full well that thesetting of a maximum in one category of products will workas a variable in the other and vice versa. So, the Commissionwrites (italics added): 13 V M Ursin ‘Modification of Plant Lipids for Human Health: Development of Functional Land-based Omega-3 Fatty Acids’ (2003) J Nutr 4271–74. F Fumagalli and others ‘Form Field to Although food supplements and foods to which vitamins Health: A Simple Way To Increase the Nutraceutical Content of and minerals are added are covered by different measures Grape As Shown by NO-Dependent Vascular Relaxation’ (2006) 54 J Agric Food Chem 5344–49. J A Napier and others the considerations for setting maximum levels for vitamins ‘Progress Towards the Production of Very Long-chain and minerals are inevitably interrelated. In particular, the Polyunsaturated Fatty Acid in Transgenic Plants: Plant Metabolic distribution of these nutrients in the two broad categories Engineering Comes of Age’ (2006) 126 Phys Plantarum 398– 406. I L F Nielsen and others ‘Bioavailability Is Improved by of food products, food supplements and fortified foods, Enzymatic Modification of the Citrus Flavonoid Hesperidin in have to be considered together if we are to have a clear picture Humans: A Randomised, Double-Blind, Crossover Trial’ (2006) 136 J Nutr 404–408. D Rein and others ‘Tansgenic Flavonoid Tomato Intake Reduces C-Reactive Protein in Human C- Reactive Protein Transgenic Mice Than Wild-Type Tomato’ (2006) J Nutr 2331–37. As stated in this article: ‘Genetic enhancement of valuable dietary components in plant foods, such as specific flavonoids in tomatoes, may allow us to optimise human food composition and may help to reduce the 12 T M Devlin (ed) Textbook of Biochemistry with Clinical Correlation burden of cardiovascular disease.’ See also: ‘Boosting Vitamin C (Wiley-Liss New York 2002) pp 1137–65.
Content in Blackcurrants’ (2006) July BBSRC Business 12–13.
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As the Commission itself has observed, the regulatory regulatory capabilities, regardless of the public funding call for insight into the intake of micronutrients in Europe is available, this would certainly be a sensible approach towards complicated by the fact that survey costs are high and the micronutrients. Parenthetically, an MTR-approach applied reliability and accuracy of the estimates of intake vary widely.
in the context of the FSD/FFR construct would be likely to As surveys are expensive they are not conducted frequently, instigate regulatory action to try to ameliorate the problems and they have become available only in a limited number of caused by micronutrient deficiency rather than excess.
Member States. Moreover, when they are available, they can Fourthly, a focus on the risks of excessive micronutrient be obsolete and may not reflect current intakes of vitamins intake could frighten the public away from health-enhancing and minerals.14 So, although intake of micronutrients from diets, which might well include fortified foods and food supplements and fortification should be balanced, by supplements, considering the uncertainties about the means of maximum limits with the intake from conventional nutritional adequacy of a diet consisting of conventional foods.
diets, the actual possibilities of doing so are severely hampered Indeed, the need to educate the public about the crucial importance of nutrition and the potential health benefits of a Secondly, the FSD/FFR approach is preoccupied with simple and affordable daily multivitamin/mineral supplement the risk of excess, although the risks in relation to the intake contrasts starkly with the present regulatory focus.19 Through of micronutrients are on both side of the equation. We dealt the implementation of the FSD and FFR, the existing bias with this in our previous article on the FSD.15 Micronutrients towards negative information about the possible health risks differ from other chemical substances in foods in that they of products or activities could well be increased, which is are essential/beneficial to the human physiology, so that counter to the maxim of a ‘high level of protection for human various adverse (toxicological) effects can result from intakes life and health’.20 In conclusion, striving to guarantee public that are too low (the typical acute deficiencies or chronic safety from excess toxicity through the stringent regulation diseases) as well as too high. Therefore, with its focus on of micronutrient levels in food supplements and fortified excess toxicity, the FSD contradicts its own legal basis of foods may adversely affect the opportunity to reduce cost- public health regulation; a ‘high level of protection for human effectively the short and long-term health problems caused life and health’. This FSD/FFR construct lacks the overarching scope required to weigh deficiencies (minimum levels) andexcess toxicity (maximum levels) even-handedly.
An unmanageable succession of events
Thirdly, the terms ‘high’ and ‘protection’ are not defined, although they must be understood within a precautionary The EC has a tendency to regard techno-science21 with context.16 For instance, does ‘high’ mean ‘no risk’ (that is suspicion, as something that could potentially lead to guaranteeing absolute safety)?17 Is ‘high’ defined in disastrous consquences. This dystopic premise is widespread environmental legislation in terms of the widely-used MTR in EC regulation, including the FSD and FFR discussed here.
(maximum tolerable risk level of, say, one extra case of (A dystopia is a society where everything is as bad as possible.) morbidity or mortality within a population of 1,000,000)? The European Environment Agency, in its well-known yet ‘Protection’ against what and to what extent? In Dutch policy, deeply flawed report on the precautionary principle, states when a potential risk does not exceed the MTR level, generally with regard to new technology that ‘[its] very novelty might no further policy action is required.18 Considering the limited be taken as a warning sign’.22 The precautionary principle is 19 B N Ames and others ‘Are Vitamin and Mineral Deficiencies a Major Cancer Risk?’ (2002) 2 Nature 694–704.
20 M Siegrist and others ‘Better Negative than Positive? 16 Regulation (EC) 178/2002 of the European Parliament and Evidence of a Bias for Negative Information about Possible of the Council of 28 January 2002 laying down the general Health Dangers’ (2001) 21(1) Risk Analysis 199–206.
principles and requirements of food law, establishing the 21 The word techno-science contracts the terms techne – European Food Safety Authority and laying down procedures in instructional or prescriptive (‘how’) knowledge usually applied matters of food safety [2002] L32 OJ Eur Comm 1–24. This in devising and constructing machines – and episteme – regulation on the establishment of the European Food Safety propositional (‘what’) knowledge about natural phenomena and Authority specifically refers to the precautionary principle as a regularities usually applied to in science. I take this term from the Belgian philosopher Gilbert Hottois (see below).
17 For the problems of proving safety see I D Bross ‘Why Proof See J Mokyr The Gifts of Athena. Historical Origins of the Knowledge of Safety Is Much More Difficult Than Proof of Hazard’ (1985) Economy (Princeton University Press Princeton 2002).
22 P Harremoës, D Gee, M MacGarvin, A Stirling, J Keys, B 18 ‘Nuchter omgaan met risico’s’ [‘Coping Rationally with Wynne, S Guedes Vaz Late lessons from early warnings: the Risks’] (2003) RIVM rapport 251701047/2003 Bilthoven The precautionary principle 1896–2000 Environmental Issue Report No 22 (European Environment Agency 2001) p 170.
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frequently used to address this perceived danger. We have and the individual’s capacity for independent judgment. Its criticised the precautionary approach on other occasions, underestimation of the value of available knowledge makes it including in our previous article in this journal.23 The eminent prone to assuming ‘worst-case’ scenarios, which Hottois Belgian philosopher Gilbert Hottois, in his critique of the pinpoints as one of the main drivers to impose definitive and Convention for the Protection of Human Rights and Dignity massive prohibitions. Regulatory risk management is of the Human Being with Regard to the Application of Biology consequently carried out in line with this dystopic worldview, and Medicine, describes this dystopic vision as follows: generating by default a precautionary-biased outcome in termsof preferred hypotheses and selected underpinning data.
This argument postulates that once man has engaged in a Implementation of the principle, consequently, is self-evident.25 direction that might lead to deep errors, he will no longer The fact that excess toxicity is the predominant consideration in be able to stop or choose the good aspects and resist the the FSD and the FFR is a typical example of this.
bad. This argument is deeply antihumanist, for it supposes When the EC is developing policies to regulate the that individuals lose their capability to judge and decide micronutrient content of all food sources for the benefit of freely, after reflection and deliberation, as soon as they European citizens, as is implied by the FSD and the FFR, it have made one – fatal – step in a direction that might lead assumes a ‘true value’ of human health and the means to to evil. One may wonder what direction is perfectly ‘safe’ acquire it through a varied and adequate diet, and this is and ‘pure’ and what choice is totally free from ambiguities subsequently laid down in regulation. The idea of a ‘true value’ and ambivalent possible consequences. The ‘slippery of health, however, carries utopian overtones that are slope’ argument, according to which individuals are forced paternalistic and even anti-humanist, as it cannot, if taken into an irresistible concatenation of actions (succession seriously by the EC, be challenged or ignored.26 Indeed, a (of actions); authors)…, is anti–humanist …. It is the ‘true value’ cannot be anything but adhered to, as disagreement belief in irresistible concatenations, entailing the negation is by definition regarded as irresponsible.
of human freedom and of any positive contribution of The subsequent danger is that part of society, primarily rational analysis that leads the supporters of the ‘slippery assembled within Europe’s bureaucracy, defines its concept slope’ argument to want to impose definitive and massive of human health and the maintenance thereof and then prohibitions. Such absolute prohibitions suppress, from imposes this concept on others, with selective reference to the very beginning, freedom of choice …, since this scientific research and its results.27 Although the FSD suppression of freedom is thought to be the only way to specifically refers to facilitating the choice of consumers in (5), the reference to and understanding of ‘a high level ofprotection’ demonstrates that the EC does not feel As Hottois points out, the subtle yet far reaching influence of comfortable with consumer freedom. This consumer the ‘slippery slope’ argument ‘that once man has engaged in a freedom has effectively been curbed through politicisation direction that might lead to serious errors, he will no longer of the European consumer. Through the institutionalisation be able to stop or choose the good aspects and resist the bad’, of mistrust, regulation of an essentially free and deregulated raises serious doubts about the EC’s perspective on the value market is established. The insistence, with the aid of the of knowledge, information, education, ethics, responsibility precautionary principle, on advance proof that products aresafe galvanises consumer suspicion even further.28 Peculiarly, the EC believes itself to be immune from and 23 See also I Forrester, J C Hanekamp ‘Precaution, Science and able to oversee the ‘irresistible concatenation of actions’, from Jurisprudence: a Test Case’ (2006a) 9(4) J Risk Res 297–311.
which individuals and economic parties need to be protected, Hanekamp ‘Precaution and Cholera: A Response to Tickner and Gouveia-Vigeant’ (2006b) 26(4) Risk Analysis 1013–19.
with the aid of the precautionary principle. It is a mystery 24 G Hottois ‘A Philosophical and Critical Analysis of the how the EC obtained this ‘immunity’ and overseeing capability.
European Convention of Bioethics’ (2000) 25(2) J Med Phil Indeed, ‘one may wonder what direction is perfectly “safe” 133–46. The quote does not end there. Hottois adds the following thoughts: ‘Once again, we are not saying that the fears and “pure” and what choice is totally free from ambiguities suggested through the “slippery slope” discourse have no psychological or sociological relevance at all. On the contrary, the unconscious is very real. But what must be clearly stated is that when one is claiming to have an ethical position, one should not support solutions imposing dogmatic prohibitions in reaction to irrational temptations (in Freudian terms: the 26 H Achterhuis De erfenis van de utopie [The Legacy of Utopia] repression of the unconscious – the id – by the superego), but solutions encouraging the slower and more difficult work of developing the conscious self: the personal ability to decide in 28 A Burgess ‘Flattering Consumption. Creating a Europe of the Consumer’ (2001) 1(1) J Consumer Culture 93–117.
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and ambivalent possible consequences’, as Hottois poignantly Within the perspectives we outline in this paper, the setting of remarks. The illusion of guidance towards safety is supposed maximum levels in food supplements and/or fortified foods for to be supported by precaution, yet precaution will fail to do micronutrients that have barely any adverse effects irrespective so, as it condemns the very steps the guidance requires. The of known dose is superfluous, as it does not contribute to the regulation required by the principle gives rise to risks of its protection of public health. Question 2 therefore can be answered own; hence the principle bans what it simultaneously Politically, however, precaution does give guidance to the Bearing in mind the problems of setting maximum implementing government bodies, as it best addresses micronutrient levels for supplements and fortification in the secondary risk-management strategies.30 The increasingly context of total dietary intake and the RDA/PRI dominant regulatory culture of risk-aversion engenders (recommended daily allowances/population reference micronutrient policies primarily focused on excess toxicity intakes) addressed in questions 3 and 4, it is obvious that risks, while simultaneously lecturing Europeans on ‘an European regulation cannot control, through the FSD/FFR adequate and varied diet’. Therefore, the FSD/FFR construct construct, individual consumption in relation to both fortified avoids responsibility for the health of European citizens.
foods and food supplements. As a seemingly forthright numerical Toxicity as a result of intake of food supplements, encouraged approach, through the setting of maximum levels, trying to by the bias towards negative information about the possible balance the micronutrient-content of food supplements and health risks of products or activities,31 is a considerably more food fortification in relation to the ‘average’ conventional food visible, if infrequent, phenomenon, than deficiency diseases consumption of the European populace will not control that are not and cannot be related to any regulatory activities.
individual food consumption. Indeed, as stated above, the We now turn to the DP questions, and propose a novel limited availability and value of surveys will make the balancing approach to the regulation of micronutrients.
exercise exceedingly difficult, if not impossible.
Nevertheless, RDAs are habitually presented on the labels and/or packaging of food supplements and foods containing A rejoinder to the European Commission
added micronutrients. In view of this practice, we propose Our view in relation to any (newly discovered) micronutrient that SULs should also be presented, where these are available is that the recommended amount should maximise a healthy and only when specific and serious safety concerns have been lifespan (which in the case of a number of the classical demonstrated.34 This is in conformity with the observations micronutrients appears to be higher than the amount needed made in the Draft Opinion by Alexander Stubb on the proposal to prevent acute deficiency diseases).32 Policies in relation to of the European Parliament and of the Council for a regulation food supplements should primarily be focused on enhancing on the addition of vitamins and minerals and of certain other health. This is in line with state-of-the-art scientific substances to foods.35 When SULs are mentioned on food knowledge, and addresses the basic European precautionary labels and/or packaging, these can best be presented in policy tenet of a ‘high level of protection for human life and absolute numbers (x mg or µg per day) unrelated to the food health’, which is habitually and erroneously understood in (supplement) product in question. The consumer will thus the negative. It is also along the lines of the Healthy Life Years be informed that the micronutrient in question, at a specific (HLY) Structural Indicator (ie the number of years a person consumption level, could pose health risks – either of can expect to live in good health), as put forward in the deficiency under the RDA or adverse effects above the SUL Communication from the Commission entitled ‘Healthier, – in relation to his/her entire consumption habits. This allows Safer, More Confident Citizens: a Health and Consumer the consumer to decide how much of which food Protection Strategy’.33 Therefore, in view of the above, and to (supplement) product he or she should consume. This approach informs consumers about SULs on a ‘total dietaryintake’ basis, and leaves consumers free to choose how to‘add up’ levels of micronutrients consumed in combinationwith their own individual choices of conventional foods.
29 C R Sunstein Laws of Fear: Beyond the Precautionary Principle (Cambridge University Press Cambridge 2005).
30 M Power The Risk Management of Everything. Rethinking the Politics of Uncertainty (Demos UK 2004).
34 J C Hanekamp and others ‘Chloramphenicol, Food Safety and 32 M Fenech ‘Recommended Dietary Allowances (RDAs) for Precautionary Thinking in Europe’ [2003] 6 Env Liability 209–19.
Genomic Stability’ (2001) 480–81 Mut Res 51–54.
35 http://www.europarl.europa.eu/meetdocs/2004_2009/ 33 http://ec.europa.eu/health/ph_overview/Documents/ documents/pa/553/553919/553919en.pdf (28 September com_2005_0115_en.pdf (28 September 2006).
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On a product, the SULs should be presented next to the market). Even if scientific facts on the risks of food- RDAs, so that consumers can easily calculate the ‘total dietary endogenous compounds are available – scientific knowledge intake’ bandwidth between RDA and SUL. In brief, our of the health impact of a growing number of all sorts of food- endogenous chemicals will undoubtedly increaseconsiderably during the coming years – the inescapability of RDAs should play a primary role in the presentation next to such compounds contextualises such knowledge. Whether SULs with specific and serious safety concerns on the packaging consciously or not, people have always been exposed to a of both food supplements and fortified foods. Both the RDAs and certain degree of chemical risk in their daily lives through the SULs should be presented in x mg or µg per day. intake of food-endogenous compounds, of which acrylamidehas gained quite some notoriety. Acrylamide, a non-nutrient, When considering the future of the FSD and FFR, it seems is present in foods that are fried or baked at a high temperature, that the well-known vitamins and minerals do not pose a such as potato chips, French fries, and crispbreads. Acrylamide major regulatory problem. Scientific knowledge of risks and is known to cause nerve damage and is a suspected human benefits is readily available, and can be used for guidance.
carcinogen at certain exposure levels. However, most Things become a lot more complicated when considering regulatory agencies are reluctant to ban the processing of ‘other substances’ for which limited scientific knowledge is starchy foods in which acrylamide is generated. Many agencies available, and for which RDAs and SULs, and thereby simply alert the public and suggest a balanced and varied diet maximum and minimum levels, cannot readily be obtained.
including plenty of fruit and vegetables.36 This is probably the As these substances are usually not defined as essential, although they might demonstrably improve human health, However, individuals make a choice to consume food deficiency cannot be established as in the case of vitamins and supplements, rather than being unconsciously and minerals. It seems then that future regulatory demands will involuntarily exposed to them as they are to food-endogenous increase when ‘other substances’ come into focus. Below, we compounds such as acrylamide. Therefore individuals making propose a novel regulatory framework for micronutrients a conscious purchase of food supplements and to a lesser that include other substances. As we did not elaborate on the degree of fortified foods, expect those products to be safe, maximum and minimum levels of micronutrients in the and rightly so.37 Food supplements and fortified foods that recommendations in response to the DP, we address this issue come to market need to be safe eg in terms of carrying clear and simple indications for normal recommended intake. Evenwithout the present regulatory context, this is a crucialexigency that food business operators and other economic The broader context of the rejoinder
parties must take seriously in view of issues of trust, liability, Question 1 has to do with the perspective – in terms of product safety and consumer protection. In view of this, how innovation and public health – that regulation should or should micronutrients best be regulated, if at all? should not have on newly developed products that come to In terms of risks of excessive exposure, a recent analysis market and/or products that are already on the market but in the Netherlands by the RIVM suggests that, on average, about which few scientific facts are publicly available. Food is there seems to be no need for concern about high intakes of chemistry, and the mixture of chemicals that food represents vitamins or minerals38 (which, in any case, are dwarfed by is estimated to consist of many hundreds of thousands of drug toxicity).39 When the ‘high level of protection for human different chemicals. All these food-borne chemicals have their life and health’ is taken seriously, first, the breadth and depth own specific nutritional benefit(s) and toxicological profile, (in other words integrity) of scientific knowledge in this field both individually and interactively (eg synergism andantagonism). Ongoing scientific research will augment ourknowledge of ever-increasing numbers of bioactive food- 36 T Kasamatsu and others ‘Balancing Risks’ (2006) 46 Reg Tox An unremitting regulatory imposition of full toxicological 37 C Starr ‘Social Benefit Versus Technological Risk’ (1969) assessment of increasing numbers of micronutrients (both as 38 M C Ocké and others Dietary Supplement Use in the Netherlands. food supplements and fortification in foods) that will come Current Data and Recommendations for Future Assessment RIVM report to market, in combination with positive lists, will prove to be 350100001/2005 (Bilthoven The Netherlands 2005). See also B N Ames ‘The Metabolic Tune-Up: Metabolic Harmony and prohibitive in terms of cost, limited (toxicological oriented) Disease Prevention’ (2003) 133 J Nutr 1544S–1548S.
research facilities and resources, scientific and public 39 J Lazarou and others ‘Incidence of Adverse Drug Reactions in Hospitalised Patients. A Meta-analysis of Prospective Studies’ interests, and so on, and will slow innovation (no-data-no- ENVIRONMENTAL LIABILITY PUBLISHED BY LAWTEXT PUBLISHING LIMITED [2006] 5 Env. Liability : Food supplements and fortified foods : Hanekamp, Bast 189
needs to be taken seriously both by governments and When micronutrients are projected to be presented for economic parties. This is in line with a full-weight-of-evidence medicinal use, then these products automatically fall outside approach, ideally expounded in well-balanced risk-benefit the scope of our proposed policy format.41 It is noteworthy, assessment procedures, as a result of which a precautionary however, that over-the-counter (OTC) medicines – bias towards excess toxicity is eliminated. Not following this medication that can be obtained without a doctor’s balanced approach is, in our view, contradictory to the scientific prescription, yet has been authorised through the proper method.40 Secondly, therefore, a realistic regulatory approach regulatory authorities – have traditionally been used to treat to micronutrients cannot be founded on precautionary self-limiting minor ailments. These medicinal compounds thinking as understood by the European Commission. Thirdly, need only be taken for a limited amount of time and are easy any rational regulatory approach has to decide on the level of to obtain and relatively safe. The scope for treating such self- public intervention that is justified: risks, benefits, and policy diagnosed conditions has been broadened by the trend away intervention potential need to be balanced.
from prescription-only medication (POM) to OTC We propose the following tenets to compose a realistic medicines, and this is likely to continue.42 The global trend is policy for marketable food supplements: (i) cost-benefit towards the encouragement of increased self-care, not only context; (ii) ex post orientated; (iii) benefit orientated, (iv) in the treatment of minor ailments, but also in the self- innovation oriented, and (v) market oriented (level playing- management of long-term conditions. Ironically, these field). The flow-chart below describes the policy-direction policies, which encourage consumers to take and demonstrate their responsibility for health, is altogethercounter to the approach taken in the FSD/FFR.
Figure 1: Flow-chart for food supplements and food
The scheme presented above concerns micronutrients fortification regulation
that are explicitly intended by the prospective producer tobe used for supplementation of the diet and/or as additionsto conventional foods. We stipulate that the term‘micronutrient’ must be understood in the broadest possibleway (see above). A priori, the scheme places all thesemicronutrients, including vitamins and minerals, in an ex postapproach. In this approach, the essential ordering principle isthe intended normal use (INU, the recommended dailydosage), as unambiguously clarified and presented by themanufacturer on the product’s packaging. This approach isborne out by the fact that, until now, the risk of over-exposureto micronutrients has seemed limited.43 In fact, taking intoconsideration the issue of household economics, people ingeneral will not be capable of or indeed willing to invest infood supplements containing excessive quantities ofmicronutrients, as the costs would be prohibitive. Maximumlevels therefore are superfluous in view of the fact that risksare minimal.
41 For a study on herbal medicinal products see eg E Ernst ‘Risks of Herbal Medicinal Products’ (2004) 13 Pharmacoepi 42 ‘Over-the-counter Medication’ (2005) British Medical Association Board of Science. This report can be downloaded from http://www.bma.org.uk/ap.nsf/AttachmentsByTitle/ OTC0505/$FILE/OTC0505.pdf (28 September 2006).
43 See (n 38). See also A Shao and others ‘Risk Assessment for Creatine Monohydrate’ (2006) 45 Reg Tox Pharm 242–51. J N Hathcock and others ‘Risk Assessment for Carnitine’ (2006) Reg Tox Pharm doi:10.1016/j.yrtph.2006.06.007.
40 R C Barnard ‘Scientific Method and Risk Assessment’ (1994) A Shao and others ‘Risk Assessment for the Cartenoids Lutein and Lycopene’ (2006) 45 Reg Tox Pharm 289–98.
ENVIRONMENTAL LIABILITY PUBLISHED BY LAWTEXT PUBLISHING LIMITED 190 Food supplements and fortified foods : Hanekamp, Bast : [2006] 5 Env. Liability
We therefore propose that through the system of intended at large. Positive listing through the no-data-no-market normal use (INU) of micronutrients, as established and strategy will counteract innovation, as increasing regulatory presented by the relevant food business operator, food demands, fuelled by precautionary deliberations, will hinder supplements and fortified foods should be allowed on the entry to the market, and continuing presence in it. This is market without setting maximum and/or minimum levels.
illustrated in the EC communication on the precautionary RDAs, if applicable, should play a primary role in the principle, which states that the provisional nature of presentation next to SULs with specific and serious safety precautionary measures, which is usually a ban, ‘is not bound concerns. The roles played by science and the history of safety, up with a time limit but with the development of scientific established as a result of long-term widespread use (tacit knowledge’.48 As mistrust in science is widespread (see eg knowledge),44 are different yet complementary and need to the discussion of Hottois, above), scientific knowledge is be internalised and explicated by the producer, whether hardly deemed sufficient to overcome the knowledge-barrier, through experimental scientific research, desk-top studies, so any precautionary ban will have an ‘enduring temporality’.49 or both. We envision that the quality, purity (when applicable), An effective way of counteracting this, therefore, would consistency and stability of products will be guaranteed consist of a preventive negative list of compounds proved to through GMP (good manufacturing practice) and/or other industry standards that match today’s safety requirements and Analogously, as is feared with the implementation of the concerns. This is an important aspect of the safety-guarantee European REACH chemicals policy (an acronym that stands that producers need to assess, manage and communicate. In for Registration, Evaluation, and Authorisation of Chemical addition, compounds of long-standing widespread use – Substances), consistent regulatory ex ante demands on new whether inside or outside the EU45 – could in principle be chemical products could hamper small and medium-sized regarded as generally safe (GRAS). Tea, for example, has been businesses significantly, as fully-fledged toxicological research consumed for literally thousands of years, and it is this long requires considerable funding.51 There are evidently good record of tea consumption that makes the potentially reasons to take a preventive regulatory approach with regard beneficial compounds which it contains an attractive target to safety, when confronted with products with only a very limited local or traditional use, and of which limited if any In order to stimulate a level playing-field and innovative (scientific) knowledge is available. This reflects the overall developments within the field of food, we propose this ex approach, that manufacturers need to be sure of the food- post approach to micronutrient compounds, whereby the safety of their product in relation to the recommended dosage aspect of safety is not tackled on the basis of politically dominated precautionary thinking,47 but rather on the basis In the absence of RDAs and/or SULs, issues of safety can, of prevention, ie on the basis of objective, verifiable scientific for instance, be tackled by the highest observed intake (HOI) data concerning safety. Contrary to the precautionary approach, when there are no known adverse effects.52 The approach, such an approach to safety would support and HOI is the highest level of intake observed or administered, sustain innovative industry and thus, eventually, public health as reported within studies of acceptable quality.53 Monitoring and the economies of the Member States and the Community of public health in relation to the intake of micronutrientfood supplements (analogous to the pharmaco-vigilancesystem for pharmaceuticals) is a further part of the proposedscheme. This is of interest to both governments and 44 Tacit knowledge, opposite to codified (usually scientific) knowledge, is part and parcel of our daily lives and is transmitted through interpersonal contact, not through schoolbooks or scientific publications. Skills and traditions formed in laboratories, for instance, are utilised extensively, yet 48 Communication from the Commission on the Precautionary are not part of the codified output, such as journal publications Principle (Commission of the European Communities Brussels and books. Therefore, even scientific knowledge in the public domain needs to be found, interpreted by specialists, and reprocessed for actual use. See n 21.
45 Council Regulation (EC) 258/97 of 27 January 1997 51 L Bergkamp, J C Hanekamp ‘The Draft REACH Regime: concerning Novel Foods and Novel Ingredients [1997] L43 OJ Costs and Benefits of Precautionary Chemical Regulation’ Eur Comm 1–7. In fact, this regulation defines a novel food or [2003] 5 Env Liability 167–80. B Durodié ‘The True Cost of ingredient as novel as one without a history of use in the EU Precautionary Chemicals Regulation’ (2003) 23(2) Risk Analysis 46 See eg D S Wheeler and others ‘The Medicinal Chemistry of 52 ‘A Model for Establishing Upper Levels of Intake for Tea’ (2004) 61 Drug Dev Res 45–65.
Nutrients and Related Substances’ (2006) Report of a Joint 47 J C Hanekamp and others ‘The Historical Roots of FAO/WHO Technical Workshop on Nutrient Risk Assessment Precautionary Thinking: the Cultural Ecological Critique and (WHO Headquarters Geneva Switzerland 2–6 May 2005).
“The Limits to Growth”’ (2005) 8(4) J Risk Res 295–310.
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manufacturers, as it will reveal patterns of intake, potentialbenefits and associated risks. Assessment and managementoptions remain wide open to governments and producers ifmonitoring studies reveal potential risks associated with intakeof micronutrient food supplements (beyond a certain level).
Communicating benefits and risks within this context is aviable strategy.
In view of the growing knowledge of food components other than vitamins and minerals that have subsequentlybecome and will become available as food supplements and/or as components of fortified foods, issues of benefits andrisks are becoming increasingly important. However, bioactivefood compounds such as certain polyphenols that may wellbe advantageous in terms of long-term health benefits, arenot as yet placed within the framework of the classicaldeficiency symptoms (as is the case with vitamins and certainminerals), and thereby lack RDAs. This then, in the light ofthe latest scientific knowledge, necessitates a new approachto the RDA, in which the ‘survival’ approach of the preventionof deficiency (as in the current RDAs) is transformed into a‘health’ approach, that is the optimisation of a healthy lifespan.
In our view, a switch from the current deficiency-related RDA,limited to vitamins and minerals, to a health-related RDA,extended to other substances known to have beneficial effectson health, is essential in order to understand and address theoptimisation of the public’s nutrient requirements. To reiterate,RDAs do not define an optimal level of any nutrient. Theproposed switch will simultaneously address issues of safety,as new RDAs will give guidance to consumers in terms ofbeneficial consumption levels, both with regard tosupplements, fortified foods, and, ultimately, conventionalfoods. It is not so much new regulation that is needed in thefield of food supplementation and fortification, butgovernments that delegate to citizens the freedom to makechoices, and to economic parties the freedom to create newmarkets in which responsibility for health and safety is takenseriously.54 ‘True (regulatory) perspectives’ on health andsafety dampen down innovative insights, both scientificallyand democratically.

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