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[2006] 5 Env. Liability : Food supplements and fortified foods : Hanekamp, Bast 181
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Food supplements and fortified foods: the EC’s
patriarchal precautionary perspectives on public health
Dr Jaap C Hanekamp1
CEO HAN
Professor Dr Aalt Bast
Maastricht University, Department of Pharmacology and Toxicology
Rejoinder context
In a ‘Discussion Paper on the Setting of Maximum and
Minimum Amounts for Vitamins and Minerals in Foodstuffs’
(DP), issued in June 2006, the European Commission (EC)
seeks advice on micronutrients added to food and present in
food supplements.2 The DP looks at two regulatory
instruments, a directive and a regulation, both of which address
the use of vitamins, minerals and ‘other substances’ as
supplements to conventional diets: the Common Position
(EC) No 2/2006 regarding the Regulation on Fortified Foods
(FFR) and the 2002 Food Supplement Directive (FSD).3 In
the DP, the EC invites stakeholders to provide answers to its
questions, in particular regarding the execution of Article 5
of the FSD and the similarly worded Article 6 of the FFR. In
both articles, the EC has undertaken the actual management
of risk (the separate and further step to risk assessment) by
setting minimum and maximum levels of vitamins and
minerals for fortified foods and food supplements. These
key articles concern a number of issues which we will address
with the aid of the following questions, as formulated in the
DP. We have numbered the questions for ease of reference:
1. Where there are not yet scientifically established
numerical tolerable upper intake levels for several
nutrients, what should be the upper safe levels for those
nutrients that should be taken into account in setting
their maximum levels?
2. For some vitamins and minerals the risk of adverse
effects, even at high levels of intakes, appears to be
extremely low or non-existent according to available
data. Is there any reason to set maximum levels for these
vitamins and minerals?
3. Where we set maximum levels, do we inevitably also
have to set maximum amounts for vitamins and minerals
separately for food supplements and fortified foods in
order to safeguard both a high level of public health
protection and the legitimate expectations of the various
food business operators? Are there alternatives?
4. Taking into account all the above-mentioned
considerations, how far should PRIs/RDAs (population
reference intakes/recommended daily allowances) be
taken into account when setting maximum levels for
vitamins and minerals?
To put the questions asked by the DP and the answers we put
forward in this paper in perspective, we will first address the
implementation possibilities of a food supplements policy
and show some key inconsistencies generated by the
precautionary perspective the EC usually takes on regulation.
This will clarify the embedded presuppositions behind the
questions asked in the DP. We then propose a new approach
to policy in view of current scientific knowledge. In this ar ticle,
the term micronutrients refers not only to vitamins and
minerals but also to ‘other substances’ (as referred to in the
FSD as well as in the FFR), such as amino and fatty acids,
carotenoids, and polyphenols, that are all part of the human
diet. Although bioactive food compounds such as polyphenols
are usually not categorised as micronutrients, and although
they are not placed within the framework of the classical
deficiency symptoms (as is the case with vitamins and certain
1 Correspondence should be addressed to hjaap@xs4all.nl,
tel +31 (0)793 460304. The information herein is dated to
29 September 2006. The authors would like to thank the
International Nutrition Company BV in Loosdrecht, The
Netherlands for providing a grant towards the writing of this
review.
2 http://ec.europa.eu/food/food/labellingnutrition/
supplements/discus_paper_amount_vitamins.pdf#search=%
22%22Discussion%20Paper%20on20the%20setting%20of%
20maximum%20and%20minimum%20amounts%20for%20vitamins%
20and%20minerals%20in%20foodstuffs%22%22
(28 September 2006).
3 http://europa.eu.int/eur–lex/lex/LexUriServ/site/en/
oj/2006/ce080/ce08020060404en00270042.pdf#search=%
22Common%20Position%20(EC)%20No%202%2F2006%22
(28 September 2006). Council Directive 2002/46/EC of 10
June 2002 on the Approximation of the Laws of the Member
States Relating to Food Supplements [2002] OJ L183 51–57.
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minerals), consumption may well be advantageous in terms
of long-term health benefits (eg in relation to the incidence
of cancer, inflammatory responses and ageing).
Inconsistencies in the DP, FSD and FFR
The FSD, the oldest (10 June 2002) of the two regulatory
instruments addressed here, concerns food supplements
marketed as foodstuffs and presented as such for the purpose
of supplementing the human diet.4 We define food
supplements similarly to the FSD. By definition, food
supplements are marketable finished products that are
explicitly presented to the public for supplementation of the
diet. Food supplements cannot be presented as medicines or
as substitutes for medicines. The recommended dosages of
the micronutrients contained in food supplements may or
may not exceed the average intake of food-endogenous
micronutrients.
As the DP shows, the central issues revolve around safety
(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
management, over-exposure to micronutrients and ‘other
substances’ by taking into consideration safe upper limits
(SULs) previously established by way of risk assessment.
SULs are doses of vitamins and minerals that potentially
susceptible individuals could take daily on a life-long basis in
reasonable safety, without medical supervision. The European
Food Safety Authority (EFSA) defines the SUL as the ‘tolerable
upper intake level’. In EFSA terminology, this means:
The maximum level of total chronic daily intake of a
nutrient (from all sources) judged to be unlikely to pose
a risk of adverse health effects to humans. ‘Tolerable intake’
in this context connotes what is physiologically tolerable
and is a scientific judgment as determined by assessment
of risk, ie the probability of an adverse effect occurring at
some specified level of exposure. It is an estimate of the
highest level of intake which carries no appreciable risk
of adverse health effects.5
These ‘maximum levels’ are provided by the EFSA, and the
ensuing politically-oriented risk management process
established by the EC will set these ‘maximum levels’ for the
actual micronutrient content in products, such as food
supplements and fortified foods. These maximum levels are
intended to provide a framework within which consumers
can make informed decisions about safe intake limits.
Separation of assessment (EFSA) and management (EC), as a
basic approach of European regulation, governs the broader
context of the FSD/FFR construct against the background
of what is presented as an ‘adequate and varied diet’ . Some of
the relevant parts from the FSD are cited below and pertinent
passages are highlighted in italics:
(3) An adequate and varied diet could, under normal
circumstances, provide all necessary nutrients for normal
development and maintenance of a healthy life in quantities,
which meet those established and recommended by generally
acceptable scientific data. However, surveys show that this
ideal situation is not being achieved for all nutrients and by
all groups of the population across the Community.
(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
market must be safe and bear adequate and appropriate
labelling.
(9) Only vitamins and minerals normally found in, and
consumed as part of, the diet should be allowed to be
present in food supplements although this does not
mean that their presence therein is necessary.
Controversy as to the identity of those nutrients that
could potentially arise should be avoided. Therefore, it
is appropriate to establish a positive list of those vitamins
and minerals.
(13) Excessive intake of vitamins and minerals may result in
adverse effects and therefore necessitate the setting of
maximum safe levels for them in food supplements, as
appropriate. Those levels must ensure that the normal
use of the products under the instructions of use
provided by the manufacturer will be safe for the
consumer.
(14) When maximum levels are set, therefore, account
should be taken of the upper safe levels of the vitamins
and minerals, as established by scientific risk assessment
based on generally acceptablescientific data, and of
intakes of those nutrients from the normal diet. Due
account should also be taken of reference intake
amounts when setting maximum levels.
The reference to an adequate and varied diet as a primary
source of all necessary nutrients in (3) is intriguing. The truism
that we can obtain everything we need from a balanced diet
only holds if we eat such a balanced diet consistently. The
point made here by the EC is tautological: adequate is by
default adequate. How this adequacy can be achieved, and
what such an adequate diet would consist of, are not discussed.
Moreover, factors impinging on individual nutritional status
4 Council Directive 2002/46/EC (n 3).
5 Scientific Committee on Food Scientific Panel on Dietetic
Products, Nutrition and Allergies ‘Tolerable Upper Intake Levels
for Vitamins and Minerals’ (European Food Safety Authority
2006) p 9.
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are only partly related to the dietary intake on which the EC
has its focus. Malabsorption (genetic or otherwise) and
increased nutritional requirements (eg during a period of
disease) greatly affect the nutritional status of individuals.
However, these aspects are not considered in the FSD. So, the
EC’s reference to an adequate and varied diet erroneously
assumes average physiological health in the individual
(population) concerned.
The EC’s opinion also assumes some kind of natural (or
traditional) ‘true background value’ optimised for healthy
living in an otherwise undefined ideal diet that encompasses
ideal quantities of ‘all necessary nutrients’ in bio-available
qualities. However, it is unlikely that such a ‘true background
value’ actually exists. Conversely, the phraseology of (3)
implies that even this adequate and varied diet could well be
an insufficient source of all necessary nutrients. The question
then is whether this European diet is or is not a sufficient
source of all necessary nutrients. The relevance of this is clear,
as the opinion expressed in (3) implies that fortified foods
and/or food supplements are superfluous against the
background of this ‘EU-diet’. In this context, the FFR makes
for noteworthy reading (italics added):6
(7) An adequate and varied diet can, under normal
circumstances, provide all necessary nutrients for
normal development and maintenance of a healthy life
in quantities as those established and recommended by
generally acceptable scientific data. However, surveys
show that this ideal situation is not being achieved for all
vitamins and minerals and by all groups of the
population across the Community. Foods to which
vitamins and minerals have been added appear to make an
appreciable contribution to the intake of these nutrients and as
such may be considered to make a positive contribution to
overall intakes.
(8) Some nutrient deficiencies, although not very frequent,
can be demonstrated to exist at present in the
Community. Changes in the socio-economic situation
prevailing in the Community and the life styles of
different groups of the population have led to different
nutritional requirements and to changing dietary habits.
This in turn has led to changes in the energy and nutrient
requirements of various groups of the population and to
intakes of certain vitamins and minerals for these
groups that would be below those recommended in
different Member States. In addition, progress in scientific
knowledge indicates that intakes of some nutrients for
maintaining optimal health and well-being could be higher
than those currently recommended.
Is it the case that the EC, four years after issuing the FSD, is
confident that a varied diet now guarantees intake of all
necessary nutrients? Yet, in stark contrast to this newest
conviction, the closing line of (7) states that the addition of
micronutrients to food rendered a positive contribution to
overall intakes, which thus seem to be lower than required
when considering an ‘adequate and varied’ diet lacking this
fortification. The EC seems to be aware of the fact that in
relation to, for instance, pregnancy, an adequate and varied
diet does not provide micro-nutritional sufficiency when folic
acid is considered.7 In addition, the diet of the lower socio-
economic classes is known to be of a lower nutritional
standard on average than would be required for a diet intended
to provide the basis for a healthy life.8 Food selection is
constrained by economic and socio-cultural considerations,
compromising healthy eating patterns and resulting in
nutritional inadequacies. For most micronutrients,
amplification of the cost-constraint results in a progressive
decrease in the nutrient density of the diet.9 Moreover, as a
recent survey in the Netherlands shows, the incidence of
under-nourishment in hospitals and other care institutions is
high, suggesting that even in professional environments,
maintaining an ‘adequate and varied diet’ can be a problem.10
The final sentence (in italics) of (8) reveals the issue we
addressed in our previous article on food supplements in
this journal.11 It has become increasingly clear that RDAs are
too restrictive an approach to micronutrients. The long-term
effects of micronutrients, such as reducing cancer and cardio-
vascular incidences and decelerating premature ageing, seem
to be more important than their role in preventing the well-
known acute deficiency diseases. To reiterate, RDAs do not
6 Common Position (EC) no 2/2006 (n 3).
7 MRC Vitamin Study Group ‘Prevention of Neural Tube
Defects: Results of the Medical Research Council Vitamin
Study’ (1991) 338 Lancet 131–37. See further M Lucock ‘Is
Folic Acid the Ultimate Functional Food Component for
Disease Prevention?’ (2004) 328 Brit Med J 211–14.
8 S Shohaimi and others ‘Residential Area Deprivation Predicts
Fruit and Vegetable Consumption Independently of Individual
Educational Level and Occupational Social Class: A Cross
Sectional Population Study in the Norfolk Cohort of the
European Prospective Investigation into Cancer (EPIC–
Norfolk)’ (2004) 58 J Epidemiol Community Health 686–91.
9 N Darmon and others ‘A Cost Constrained Alone Has
Adverse Effects on Food Selection and Nutrient Density: An
Analysis of Human Diets by Linear Programming’ (2002) 132 J
Nutr 3764–71.
10 J Meijers and others ‘Prevalentie van Ondervoeding: de
Landelijke Prevalentiemeting Zorgproblemen’ [‘Prevalence of
Under–nourishment: the National Prevalence Survey Care
Problems’] (2005) 60(1) Nederlands Tijdschrift voor Diëtisten
12–15.
11 J C Hanekamp ‘The Precautionary Principle: A Critique in
the Context of the EU Foods Supplements Directive’ [2006] 2
Env. Liability 43–51. See this article for further references.
184 Food supplements and fortified foods : Hanekamp, Bast : [2006] 5 Env. Liability
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define an optimal level of any nutrient, as they are focused on
the prevention of disease caused by nutritional deficiencies.
Furthermore, they are designed to meet the needs of healthy
people and do not take into account special needs arising
from infections, metabolic disorders, or chronic disease.12
These are important constraints to consider in any policy
focused on public health.
In relation to the to-be-established maximum levels for
food supplements, intake of micronutrients from dietary
sources other than food supplements needs to be taken into
account, therefore needs to be known. Article 5 of the FSD
states the following (see also (14) above):
1. Maximum amounts of vitamins and minerals present in
food supplements per daily portion of consumption as
recommended by the manufacturer shall be set, taking
the following into account:
(a) upper safe levels of vitamins and minerals established
by scientific risk assessment based on generally accepted
scientific data, taking into account, as appropriate, the
varying degrees of sensitivity of different consumer
groups;
(b) intake of vitamins and minerals from other dietary
sources.
This then must include fortified foods as a source of
micronutrients. However, the regulation on fortified foods,
which is still a draft (proposal) lacking the force of law, does
contain a list of allowed micronutrients, although their
content-levels in different types of fortified foods still need
to be established. In paragraph 28 of the DP, the Commission
comments on the complexities created by the task of
simultaneously setting maximum amounts for two different
food sources of micronutrients, knowing full well that the
setting of a maximum in one category of products will work
as a variable in the other and vice versa. So, the Commission
writes (italics added):
Although food supplements and foods to which vitamins
and minerals are added are covered by different measures
the considerations for setting maximum levels for vitamins
and minerals are inevitably interrelated. In particular, the
distribution of these nutrients in the two broad categories
of food products, food supplements and fortified foods,
have to be considered together if we are to have a clear picture
of the overall food offering.
Slippery slopes
The approach chosen by the EC to establish maximum levels
(not SULs!) for food supplements, in relation to which other
sources of micronutrient intake (food, including fortification)
are balanced, is hampered by a number of problems, among
which the regulatory dilemma mentioned above is only of
minor concern. First, when maximum levels for food
supplements need to be correlated to the total overall intake
of food and food products, this can generate a slippery slope
situation. Does this approach imply that other sources of
micronutrients, including conventional fresh and processed
foods (and their fortified variants), need to be regulated as
well? Micronutrient-intake as such, in the view of the FSD
and the FFR, needs to be capped, implying (perhaps
unwittingly) that all food and food-products need to be
regulated. Modern plant-breeding technology (developed
over the past hundred years at least!), in which micronutrient
content is specifically enhanced, also then comes into
regulatory focus. When one looks at the latest research on
the optimisation of nutrients in whole foods and its beneficial
health effects,13 the FSD/FFR construct seems to generate a
legislative culture of full-blown regulatory control of all food-
sources. Consequently, even conventional foods rich in
micronutrients become a regulatory target. These dilemmas
are not clarified in the DP. The FSD/FFR approach, with the
aid of the precautionary principle, generates an open-ended
compulsory regulatory structure relating to all food-
products, not just food supplements and fortified foods. This
unrestrained licence to define is created by the fact that the
FSD and FFR embrace the whole of micronutrient intakes
from all foods in order to regulate food supplements and
fortification.
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
Health: A Simple Way To Increase the Nutraceutical Content of
Grape As Shown by NO-Dependent Vascular Relaxation’ (2006)
54 J Agric Food Chem 5344–49. J A Napier and others
‘Progress Towards the Production of Very Long-chain
Polyunsaturated Fatty Acid in Transgenic Plants: Plant Metabolic
Engineering Comes of Age’ (2006) 126 Phys Plantarum 398–
406. I L F Nielsen and others ‘Bioavailability Is Improved by
Enzymatic Modification of the Citrus Flavonoid Hesperidin in
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
burden of cardiovascular disease.’ See also: ‘Boosting Vitamin C
Content in Blackcurrants’ (2006) July BBSRC Business 12–13.
12 T M Devlin (ed) Textbook of Biochemistry with Clinical Correlation
(Wiley-Liss New York 2002) pp 1137–65.
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As the Commission itself has observed, the regulatory
call for insight into the intake of micronutrients in Europe is
complicated by the fact that survey costs are high and the
reliability and accuracy of the estimates of intake vary widely.
As surveys are expensive they are not conducted frequently,
and they have become available only in a limited number of
Member States. Moreover, when they are available, they can
be obsolete and may not reflect current intakes of vitamins
and minerals.14 So, although intake of micronutrients from
food supplements and fortification should be balanced, by
means of maximum limits with the intake from conventional
diets, the actual possibilities of doing so are severely hampered
for lack of data.
Secondly, the FSD/FFR approach is preoccupied with
the risk of excess, although the risks in relation to the intake
of micronutrients are on both side of the equation. We dealt
with this in our previous article on the FSD.15 Micronutrients
differ from other chemical substances in foods in that they
are essential/beneficial to the human physiology, so that
various adverse (toxicological) effects can result from intakes
that are too low (the typical acute deficiencies or chronic
diseases) as well as too high. Therefore, with its focus on
excess toxicity, the FSD contradicts its own legal basis of
public health regulation; a ‘high level of protection for human
life and health’. This FSD/FFR construct lacks the overarching
scope required to weigh deficiencies (minimum levels) and
excess toxicity (maximum levels) even-handedly.
Thirdly, the terms ‘high’ and ‘protection’ are not defined,
although they must be understood within a precautionary
context.16 For instance, does ‘high’ mean ‘no risk’ (that is
guaranteeing absolute safety)?17 Is ‘high’ defined in
environmental legislation in terms of the widely-used MTR
(maximum tolerable risk level of, say, one extra case of
morbidity or mortality within a population of 1,000,000)?
‘Protection’ against what and to what extent? In Dutch policy,
when a potential risk does not exceed the MTR level, generally
no further policy action is required.18 Considering the limited
regulatory capabilities, regardless of the public funding
available, this would certainly be a sensible approach towards
micronutrients. Parenthetically, an MTR-approach applied
in the context of the FSD/FFR construct would be likely to
instigate regulatory action to try to ameliorate the problems
caused by micronutrient deficiency rather than excess.
Fourthly, a focus on the risks of excessive micronutrient
intake could frighten the public away from health-enhancing
diets, which might well include fortified foods and
supplements, considering the uncertainties about the
nutritional adequacy of a diet consisting of conventional foods.
Indeed, the need to educate the public about the crucial
importance of nutrition and the potential health benefits of a
simple and affordable daily multivitamin/mineral supplement
contrasts starkly with the present regulatory focus.19 Through
the implementation of the FSD and FFR, the existing bias
towards negative information about the possible health risks
of products or activities could well be increased, which is
counter to the maxim of a ‘high level of protection for human
life and health’.20 In conclusion, striving to guarantee public
safety from excess toxicity through the stringent regulation
of micronutrient levels in food supplements and fortified
foods may adversely affect the opportunity to reduce cost-
effectively the short and long-term health problems caused
by micronutrient deficiencies.
An unmanageable succession of events
The EC has a tendency to regard techno-science21 with
suspicion, as something that could potentially lead to
disastrous consquences. This dystopic premise is widespread
in EC regulation, including the FSD and FFR discussed here.
(A dystopia is a society where everything is as bad as possible.)
The European Environment Agency, in its well-known yet
deeply flawed report on the precautionary principle, states
with regard to new technology that ‘[its] very novelty might
be taken as a warning sign’.22 The precautionary principle is
14 See the DP 32 (n 2).
15 Hanekamp (n 11).
16 Regulation (EC) 178/2002 of the European Parliament and
of the Council of 28 January 2002 laying down the general
principles and requirements of food law, establishing the
European Food Safety Authority and laying down procedures in
matters of food safety [2002] L32 OJ Eur Comm 1–24. This
regulation on the establishment of the European Food Safety
Authority specifically refers to the precautionary principle as a
guiding principle of law.
17 For the problems of proving safety see I D Bross ‘Why Proof
of Safety Is Much More Difficult Than Proof of Hazard’ (1985)
41 Biometrics 785–93.
18 ‘Nuchter omgaan met risico’s’ [‘Coping Rationally with
Risks’] (2003) RIVM rapport 251701047/2003 Bilthoven The
Netherlands.
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?
Evidence of a Bias for Negative Information about Possible
Health Dangers’ (2001) 21(1) Risk Analysis 199–206.
21 The word techno-science contracts the terms techne –
instructional or prescriptive (‘how’) knowledge usually applied
in devising and constructing machines – and episteme –
propositional (‘what’) knowledge about natural phenomena and
regularities usually applied to in science. I take this term from
the Belgian philosopher Gilbert Hottois (see below).
See J Mokyr The Gifts of Athena. Historical Origins of the Knowledge
Economy (Princeton University Press Princeton 2002).
22 P Harremoës, D Gee, M MacGarvin, A Stirling, J Keys, B
Wynne, S Guedes Vaz Late lessons from early warnings: 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
criticised the precautionary approach on other occasions,
including in our previous article in this journal.23 The eminent
Belgian philosopher Gilbert Hottois, in his critique of the
Convention for the Protection of Human Rights and Dignity
of the Human Being with Regard to the Application of Biology
and Medicine, describes this dystopic vision as follows:
This argument postulates that once man has engaged in a
direction that might lead to deep errors, he will no longer
be able to stop or choose the good aspects and resist the
bad. This argument is deeply antihumanist, for it supposes
that individuals lose their capability to judge and decide
freely, after reflection and deliberation, as soon as they
have made one – fatal – step in a direction that might lead
to evil. One may wonder what direction is perfectly ‘safe’
and ‘pure’ and what choice is totally free from ambiguities
and ambivalent possible consequences. The ‘slippery
slope’ argument, according to which individuals are forced
into an irresistible concatenation of actions (succession
(of actions); authors)…, is anti–humanist …. It is the
belief in irresistible concatenations, entailing the negation
of human freedom and of any positive contribution of
rational analysis that leads the supporters of the ‘slippery
slope’ argument to want to impose definitive and massive
prohibitions. Such absolute prohibitions suppress, from
the very beginning, freedom of choice …, since this
suppression of freedom is thought to be the only way to
prevent future wrong uses of freedom.24
As Hottois points out, the subtle yet far reaching influence of
the ‘slippery slope’ argument ‘that once man has engaged in a
direction that might lead to serious errors, he will no longer
be able to stop or choose the good aspects and resist the bad’,
raises serious doubts about the EC’s perspective on the value
of knowledge, information, education, ethics, responsibility
and the individual’s capacity for independent judgment. Its
underestimation of the value of available knowledge makes it
prone to assuming ‘worst-case’ scenarios, which Hottois
pinpoints as one of the main drivers to impose definitive and
massive prohibitions. Regulatory risk management is
consequently carried out in line with this dystopic worldview,
generating by default a precautionary-biased outcome in terms
of preferred hypotheses and selected underpinning data.
Implementation of the principle, consequently, is self-evident.25
The fact that excess toxicity is the predominant consideration in
the FSD and the FFR is a typical example of this.
When the EC is developing policies to regulate the
micronutrient content of all food sources for the benefit of
European citizens, as is implied by the FSD and the FFR, it
assumes a ‘true value’ of human health and the means to
acquire it through a varied and adequate diet, and this is
subsequently laid down in regulation. The idea of a ‘true value’
of health, however, carries utopian overtones that are
paternalistic and even anti-humanist, as it cannot, if taken
seriously by the EC, be challenged or ignored.26 Indeed, a
‘true value’ cannot be anything but adhered to, as disagreement
is by definition regarded as irresponsible.
The subsequent danger is that part of society, primarily
assembled within Europe’s bureaucracy, defines its concept
of human health and the maintenance thereof and then
imposes this concept on others, with selective reference to
scientific research and its results.27 Although the FSD
specifically refers to facilitating the choice of consumers in
(5), the reference to and understanding of ‘a high level of
protection’ demonstrates that the EC does not feel
comfortable with consumer freedom. This consumer
freedom has effectively been curbed through politicisation
of the European consumer. Through the institutionalisation
of mistrust, regulation of an essentially free and deregulated
market is established. The insistence, with the aid of the
precautionary principle, on advance proof that products are
safe galvanises consumer suspicion even further.28
Peculiarly, the EC believes itself to be immune from and
able to oversee the ‘irresistible concatenation of actions’, from
which individuals and economic parties need to be protected,
with the aid of the precautionary principle. It is a mystery
how the EC obtained this ‘immunity’ and overseeing capability.
Indeed, ‘one may wonder what direction is perfectly “safe”
and “pure” and what choice is totally free from ambiguities
23 See also I Forrester, J C Hanekamp ‘Precaution, Science and
Jurisprudence: a Test Case’ (2006a) 9(4) J Risk Res 297–311.
Hanekamp ‘Precaution and Cholera: A Response to Tickner and
Gouveia-Vigeant’ (2006b) 26(4) Risk Analysis 1013–19.
24 G Hottois ‘A Philosophical and Critical Analysis of the
European Convention of Bioethics’ (2000) 25(2) J Med Phil
133–46. The quote does not end there. Hottois adds the
following thoughts: ‘Once again, we are not saying that the fears
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
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
an enlightened and deliberate way.’
25 Hanekamp (2006b) (n 23).
26 H Achterhuis De erfenis van de utopie [The Legacy of Utopia]
(Ambo Amsterdam 1998).
27 Hanekamp (2006b) (n 23).
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
remarks. The illusion of guidance towards safety is supposed
to be supported by precaution, yet precaution will fail to do
so, as it condemns the very steps the guidance requires. The
regulation required by the principle gives rise to risks of its
own; hence the principle bans what it simultaneously
authorises.29
Politically, however, precaution does give guidance to the
implementing government bodies, as it best addresses
secondary risk-management strategies.30 The increasingly
dominant regulatory culture of risk-aversion engenders
micronutrient policies primarily focused on excess toxicity
risks, while simultaneously lecturing Europeans on ‘an
adequate and varied diet’. Therefore, the FSD/FFR constr uct
avoids responsibility for the health of European citizens.
Toxicity as a result of intake of food supplements, encouraged
by the bias towards negative information about the possible
health risks of products or activities,31 is a considerably more
visible, if infrequent, phenomenon, than deficiency diseases
that are not and cannot be related to any regulatory activities.
We now turn to the DP questions, and propose a novel
approach to the regulation of micronutrients.
A rejoinder to the European Commission
Our view in relation to any (newly discovered) micronutrient
is that the recommended amount should maximise a healthy
lifespan (which in the case of a number of the classical
micronutrients appears to be higher than the amount needed
to prevent acute deficiency diseases).32 Policies in relation to
food supplements should primarily be focused on enhancing
health. This is in line with state-of-the-art scientific
knowledge, and addresses the basic European precautionary
policy tenet of a ‘high level of protection for human life and
health’, which is habitually and erroneously understood in
the negative. It is also along the lines of the Healthy Life Years
(HLY) Structural Indicator (ie the number of years a person
can expect to live in good health), as put forward in the
Communication from the Commission entitled ‘Healthier,
Safer, More Confident Citizens: a Health and Consumer
Protection Strategy’.33 Therefore, in view of the above, and to
keep regulation as simple as possible:
Within the perspectives we outline in this paper, the setting of
maximum levels in food supplements and/or fortified foods for
micronutrients that have barely any adverse effects irrespective
of known dose is superfluous, as it does not contribute to the
protection of public health. Question 2 therefore can be answered
in the negative.
Bearing in mind the problems of setting maximum
micronutrient levels for supplements and fortification in the
context of total dietary intake and the RDA/PRI
(recommended daily allowances/population reference
intakes) addressed in questions 3 and 4, it is obvious that
European regulation cannot control, through the FSD/FFR
construct, individual consumption in relation to both fortified
foods and food supplements. As a seemingly forthright numer ical
approach, through the setting of maximum levels, trying to
balance the micronutrient-content of food supplements and
food fortification in relation to the ‘average’ conventional food
consumption of the European populace will not control
individual food consumption. Indeed, as stated above, the
limited availability and value of surveys will make the balancing
exercise exceedingly difficult, if not impossible.
Nevertheless, RDAs are habitually presented on the labels
and/or packaging of food supplements and foods containing
added micronutrients. In view of this practice, we propose
that SULs should also be presented, where these are available
and only when specific and serious safety concerns have been
demonstrated.34 This is in conformity with the observations
made in the Draft Opinion by Alexander Stubb on the proposal
of the European Parliament and of the Council for a regulation
on the addition of vitamins and minerals and of certain other
substances to foods.35 When SULs are mentioned on food
labels and/or packaging, these can best be presented in
absolute numbers (x mg or µg per day) unrelated to the food
(supplement) product in question. The consumer will thus
be informed that the micronutrient in question, at a specific
consumption level, could pose health risks – either of
deficiency under the RDA or adverse effects above the SUL
– in relation to his/her entire consumption habits. This allows
the consumer to decide how much of which food
(supplement) product he or she should consume. This
approach informs consumers about SULs on a ‘total dietary
intake’ basis, and leaves consumers free to choose how to
‘add up’ levels of micronutrients consumed in combination
with 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).
31 Siegrist (n 20).
32 M Fenech ‘Recommended Dietary Allowances (RDAs) for
Genomic Stability’ (2001) 480–81 Mut Res 51–54.
33 http://ec.europa.eu/health/ph_overview/Documents/
com_2005_0115_en.pdf (28 September 2006).
34 J C Hanekamp and others ‘Chloramphenicol, Food Safety and
Precautionary Thinking in Europe’ [2003] 6 Env Liability 209–19.
35 http://www.europarl.europa.eu/meetdocs/2004_2009/
documents/pa/553/553919/553919en.pdf (28 September
2006).
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On a product, the SULs should be presented next to the
RDAs, so that consumers can easily calculate the ‘total dietary
intake’ bandwidth between RDA and SUL. In brief, our
recommendation is as follows:
RDAs should play a primary role in the presentation next to
SULs with specific and serious safety concerns on the packaging
of both food supplements and fortified foods. Both the RDAs and
SULs should be presented in x mg or µg per day.
When considering the future of the FSD and FFR, it seems
that the well-known vitamins and minerals do not pose a
major regulatory problem. Scientific knowledge of risks and
benefits is readily available, and can be used for guidance.
Things become a lot more complicated when considering
‘other substances’ for which limited scientific knowledge is
available, and for which RDAs and SULs, and thereby
maximum and minimum levels, cannot readily be obtained.
As these substances are usually not defined as essential,
although they might demonstrably improve human health,
deficiency cannot be established as in the case of vitamins and
minerals. It seems then that future regulatory demands will
increase when ‘other substances’ come into focus. Below, we
propose a novel regulatory framework for micronutrients
that include other substances. As we did not elaborate on the
maximum and minimum levels of micronutrients in the
recommendations in response to the DP, we address this issue
below.
The broader context of the rejoinder
Question 1 has to do with the perspective – in terms of
innovation and public health – that regulation should or
should not have on newly developed products that come to
market and/or products that are already on the market but
about which few scientific facts are publicly available. Food is
chemistry, and the mixture of chemicals that food represents
is estimated to consist of many hundreds of thousands of
different chemicals. All these food-borne chemicals have their
own specific nutritional benefit(s) and toxicological profile,
both individually and interactively (eg synergism and
antagonism). Ongoing scientific research will augment our
knowledge of ever-increasing numbers of bioactive food-
endogenous chemicals.
An unremitting regulatory imposition of full toxicological
assessment of increasing numbers of micronutrients (both as
food supplements and fortification in foods) that will come
to market, in combination with positive lists, will prove to be
prohibitive in terms of cost, limited (toxicological oriented)
research facilities and resources, scientific and public
interests, and so on, and will slow innovation (no-data-no-
market). Even if scientific facts on the risks of food-
endogenous compounds are available – scientific knowledge
of the health impact of a growing number of all sorts of food-
endogenous chemicals will undoubtedly increase
considerably during the coming years – the inescapability of
such compounds contextualises such knowledge. Whether
consciously or not, people have always been exposed to a
certain degree of chemical risk in their daily lives through the
intake of food-endogenous compounds, of which acrylamide
has gained quite some notoriety. Acrylamide, a non-nutrient,
is present in foods that are fried or baked at a high temperature,
such as potato chips, French fries, and crispbreads. Acrylamide
is known to cause nerve damage and is a suspected human
carcinogen at certain exposure levels. However, most
regulatory agencies are reluctant to ban the processing of
starchy foods in which acrylamide is generated. Many agencies
simply alert the public and suggest a balanced and varied diet
including plenty of fruit and vegetables.36 This is probably the
correct approach.
However, individuals make a choice to consume food
supplements, rather than being unconsciously and
involuntarily exposed to them as they are to food-endogenous
compounds such as acrylamide. Therefore individuals making
a conscious purchase of food supplements and to a lesser
degree of fortified foods, expect those products to be safe,
and rightly so.37 Food supplements and fortified foods that
come to market need to be safe eg in terms of carrying clear
and simple indications for normal recommended intake. Even
without the present regulatory context, this is a crucial
exigency that food business operators and other economic
parties must take seriously in view of issues of trust, liability,
product safety and consumer protection. In view of this, how
should micronutrients best be regulated, if at all?
In terms of risks of excessive exposure, a recent analysis
in the Netherlands by the RIVM suggests that, on average,
there seems to be no need for concern about high intakes of
vitamins or minerals38 (which, in any case, are dwarfed by
drug toxicity).39 When the ‘high level of protection for human
life and health’ is taken seriously, first, the breadth and depth
(in other words integrity) of scientific knowledge in this field
36 T Kasamatsu and others ‘Balancing Risks’ (2006) 46 Reg Tox
Pharm 100–104.
37 C Starr ‘Social Benefit Versus Technological Risk’ (1969)
165 Science 1232–38.
38 M C Ocké and others Dietary Supplement Use in the Netherlands.
Current Data and Recommendations for Future Assessment RIVM report
350100001/2005 (Bilthoven The Netherlands 2005). See also
B N Ames ‘The Metabolic Tune-Up: Metabolic Harmony and
Disease Prevention’ (2003) 133 J Nutr 1544S–1548S.
39 J Lazarou and others ‘Incidence of Adverse Drug Reactions
in Hospitalised Patients. A Meta-analysis of Prospective Studies’
(1998) 279(15) JAMA 1200–05.
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needs to be taken seriously both by governments and
economic parties. This is in line with a full-weight-of-evidence
approach, ideally expounded in well-balanced risk-benefit
assessment procedures, as a result of which a precautionary
bias towards excess toxicity is eliminated. Not following this
balanced approach is, in our view, contradictory to the scientific
method.40 Secondly, therefore, a realistic regulatory approach
to micronutrients cannot be founded on precautionary
thinking as understood by the European Commission. Thirdly,
any rational regulatory approach has to decide on the level of
public intervention that is justified: risks, benefits, and policy
intervention potential need to be balanced.
We propose the following tenets to compose a realistic
policy for marketable food supplements: (i) cost-benefit
context; (ii) ex post orientated; (iii) benefit orientated, (iv)
innovation oriented, and (v) market oriented (level playing-
field). The flow-chart below describes the policy-direction
we envision:
Figure 1: Flow-chart for food supplements and food
fortification regulation
When micronutrients are projected to be presented for
medicinal use, then these products automatically fall outside
the scope of our proposed policy format.41 It is noteworthy,
however, that over-the-counter (OTC) medicines –
medication that can be obtained without a doctor’s
prescription, yet has been authorised through the proper
regulatory authorities – have traditionally been used to treat
self-limiting minor ailments. These medicinal compounds
need only be taken for a limited amount of time and are easy
to obtain and relatively safe. The scope for treating such self-
diagnosed conditions has been broadened by the trend away
from prescription-only medication (POM) to OTC
medicines, and this is likely to continue.42 The global trend is
towards the encouragement of increased self-care, not only
in the treatment of minor ailments, but also in the self-
management of long-term conditions. Ironically, these
policies, which encourage consumers to take and
demonstrate their responsibility for health, is altogether
counter to the approach taken in the FSD/FFR.
The scheme presented above concerns micronutrients
that are explicitly intended by the prospective producer to
be used for supplementation of the diet and/or as additions
to conventional foods. We stipulate that the term
‘micronutrient’ must be understood in the broadest possible
way (see above). A priori, the scheme places all these
micronutrients, including vitamins and minerals, in an ex post
approach. In this approach, the essential ordering principle is
the intended normal use (INU, the recommended daily
dosage), as unambiguously clarified and presented by the
manufacturer on the product’s packaging. This approach is
borne out by the fact that, until now, the risk of over-exposure
to micronutrients has seemed limited.43 In fact, taking into
consideration the issue of household economics, people in
general will not be capable of or indeed willing to invest in
food supplements containing excessive quantities of
micronutrients, as the costs would be prohibitive. Maximum
levels therefore are superfluous in view of the fact that risks
are minimal.
40 R C Barnard ‘Scientific Method and Risk Assessment’ (1994)
19 Reg Tox Pharm 211–18.
41 For a study on herbal medicinal products see eg E Ernst
‘Risks of Herbal Medicinal Products’ (2004) 13 Pharmacoepi
Drug Safety 767–71.
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.
A Shao and others ‘Risk Assessment for the Cartenoids Lutein
and Lycopene’ (2006) 45 Reg Tox Pharm 289–98.
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We therefore propose that through the system of intended
normal use (INU) of micronutrients, as established and
presented by the relevant food business operator, food
supplements and fortified foods should be allowed on the
market without setting maximum and/or minimum levels.
RDAs, if applicable, should play a primary role in the
presentation next to SULs with specific and serious safety
concerns. The roles played by science and the history of safety,
established as a result of long-term widespread use (tacit
knowledge),44 are different yet complementary and need to
be internalised and explicated by the producer, whether
through experimental scientific research, desk-top studies,
or both. We envision that the quality, purity (when applicable),
consistency and stability of products will be guaranteed
through GMP (good manufacturing practice) and/or other
industry standards that match today’s safety requirements and
concerns. This is an important aspect of the safety-guarantee
that producers need to assess, manage and communicate. In
addition, compounds of long-standing widespread use –
whether inside or outside the EU45 – could in principle be
regarded as generally safe (GRAS). Tea, for example, has been
consumed for literally thousands of years, and it is this long
record of tea consumption that makes the potentially
beneficial compounds which it contains an attractive target
for research and marketing.46
In order to stimulate a level playing-field and innovative
developments within the field of food, we propose this ex
post approach to micronutrient compounds, whereby the
aspect of safety is not tackled on the basis of politically
dominated precautionary thinking,47 but rather on the basis
of prevention, ie on the basis of objective, verifiable scientific
data concerning safety. Contrary to the precautionary
approach, such an approach to safety would support and
sustain innovative industry and thus, eventually, public health
and the economies of the Member States and the Community
at large. Positive listing through the no-data-no-market
strategy will counteract innovation, as increasing regulatory
demands, fuelled by precautionary deliberations, will hinder
entry to the market, and continuing presence in it. This is
illustrated in the EC communication on the precautionary
principle, which states that the provisional nature of
precautionary measures, which is usually a ban, ‘is not bound
up with a time limit but with the development of scientific
knowledge’.48 As mistrust in science is widespread (see eg
the discussion of Hottois, above), scientific knowledge is
hardly deemed sufficient to overcome the knowledge-barrier,
so any precautionary ban will have an ‘enduring temporality’.49
An effective way of counteracting this, therefore, would
consist of a preventive negative list of compounds proved to
be damaging to public health.50
Analogously, as is feared with the implementation of the
European REACH chemicals policy (an acronym that stands
for Registration, Evaluation, and Authorisation of Chemical
Substances), consistent regulatory ex ante demands on new
chemical products could hamper small and medium-sized
businesses significantly, as fully-fledged toxicological research
requires considerable funding.51 There are evidently good
reasons to take a preventive regulatory approach with regard
to safety, when confronted with products with only a very
limited local or traditional use, and of which limited if any
(scientific) knowledge is available. This reflects the overall
approach, that manufacturers need to be sure of the food-
safety of their product in relation to the recommended dosage
(INU).
In the absence of RDAs and/or SULs, issues of safety can,
for instance, be tackled by the highest observed intake (HOI)
approach, when there are no known adverse effects.52 The
HOI is the highest level of intake observed or administered,
as reported within studies of acceptable quality.53 Monitoring
of public health in relation to the intake of micronutrient
food supplements (analogous to the pharmaco-vigilance
system for pharmaceuticals) is a further part of the proposed
scheme. 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
are not part of the codified output, such as journal publications
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
concerning Novel Foods and Novel Ingredients [1997] L43 OJ
Eur Comm 1–7. In fact, this regulation defines a novel food or
ingredient as novel as one without a history of use in the EU
(sic).
46 See eg D S Wheeler and others ‘The Medicinal Chemistry of
Tea’ (2004) 61 Drug Dev Res 45–65.
47 J C Hanekamp and others ‘The Historical Roots of
Precautionary Thinking: the Cultural Ecological Critique and
“The Limits to Growth”’ (2005) 8(4) J Risk Res 295–310.
48 Communication from the Commission on the Precautionary
Principle (Commission of the European Communities Brussels
2000) p 11.
49 Forrester (n 23).
50 Hanekamp (n 34).
51 L Bergkamp, J C Hanekamp ‘The Draft REACH Regime:
Costs and Benefits of Precautionary Chemical Regulation’
[2003] 5 Env Liability 167–80. B Durodié ‘The True Cost of
Precautionary Chemicals Regulation’ (2003) 23(2) Risk Analysis
389–98.
52 ‘A Model for Establishing Upper Levels of Intake for
Nutrients and Related Substances’ (2006) Report of a Joint
FAO/WHO Technical Workshop on Nutrient Risk Assessment
(WHO Headquarters Geneva Switzerland 2–6 May 2005).
53 See n 43.
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manufacturers, as it will reveal patterns of intake, potential
benefits and associated risks. Assessment and management
options remain wide open to governments and producers if
monitoring studies reveal potential risks associated with intake
of micronutrient food supplements (beyond a certain level).
Communicating benefits and risks within this context is a
viable strategy.
In view of the growing knowledge of food components
other than vitamins and minerals that have subsequently
become and will become available as food supplements and/
or as components of fortified foods, issues of benefits and
risks are becoming increasingly important. However, bioactive
food compounds such as certain polyphenols that may well
be advantageous in terms of long-term health benefits, are
not as yet placed within the framework of the classical
deficiency symptoms (as is the case with vitamins and certain
minerals), and thereby lack RDAs. This then, in the light of
the latest scientific knowledge, necessitates a new approach
to the RDA, in which the ‘survival’ approach of the prevention
of 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 effects
on health, is essential in order to understand and address the
optimisation of the public’s nutrient requirements. To reiterate,
RDAs do not define an optimal level of any nutrient. The
proposed switch will simultaneously address issues of safety,
as new RDAs will give guidance to consumers in terms of
beneficial consumption levels, both with regard to
supplements, fortified foods, and, ultimately, conventional
foods. It is not so much new regulation that is needed in the
field of food supplementation and fortification, but
governments that delegate to citizens the freedom to make
choices, and to economic parties the freedom to create new
markets in which responsibility for health and safety is taken
seriously.54 ‘True (regulatory) perspectives’ on health and
safety dampen down innovative insights, both scientifically
and democratically.
54 B M Friedman The Moral Consequences of Economic Growth
(Alfred A Knopf New York 2005).