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Transcript
European Journal of Clinical Nutrition (1999) 52, 786±791
ß 1999 Stockton Press. All rights reserved 0954±3007/99 $15.00
http://www.stockton-press.co.uk/ejcn
Approach of the US Food and Nutrition Board to daily nutrient
requirements: `A useful basis for the European discussion on
risk assessment of nutrients?'
Report on a Workshop organized by the European Academy of Nutritional
Sciences (EANS) and TNO Food and Nutrition Research Institute,
11 December 1998, Brussels
JH Brussaard1*, H van den Berg1, RJJ Hermus2 and P Walter3
1
TNO Nutrition and Food Research Institute, Zeist, The Netherlands; 2Vice President of EANS, TNO Nutrition and Food Research
Institute, Zeist, The Netherlands; and 3President of EANS, University of Basel, Switzerland
Objective: To discuss the approach of the US Food and Nutrition Board (FNB) to daily nutrient requirements
and its relevance for Europe.
Setting: A workshop for experts from academia and regulatory bodies, together with members from the FNB
Dietary Reference Intakes Subcommittee on Upper Reference Levels of Intake, and from the B-vitamins Expert
panel. The workshop was organised by the European Academy of Nutritional Sciences and TNO Nutrition and
Food Research Institute (The Netherlands).
Conclusions: Classical approaches to recommended dietary allowances (RDA) are no longer satisfactory,
because they do not take into account newly emerging science with regard to intakes beyond the RDA. There is
an urgent need for global harmonisation of criteria used for assessing adequacy of intake and for harmonisation
of terminology. For sound advice to consumers, the development of tolerable upper intake levels is necessary.
The discussion of principal issues relating to criteria for nutrient adequacy should be pursued on an international
level.
Sponsorship: Roche Vitamins Europe Ltd, Birsfelden, Switzerland
Descriptors: nutrient requirements; dietary reference intakes; recommended dietary allowance; tolerable upper
intake level
Introduction
In 1992, the Scienti®c Committee on Food (SCF) of the
European Community expressed its opinion on nutrient and
energy intakes for the European Community, at that time
twelve Member States. The report provided nutritional
recommendations to be used for different goals, including
nutrition labelling and community programs on research
and nutritional aspects. Excessive intakes were only discussed brie¯y. Experts of several Member States did not
share the recommendations expressed by the SCF. National
recommendations for daily nutrient requirement were
issued by Member States in 1993 and thereafter, for
example by Italy, Spain, the Nordic countries, while at
present national recommendations are in preparation (for
example, Germany, Austria, Switzerland, France, The
Netherlands). However, the development of a (new) concept and of guidelines with respect to the safety and upper
levels of intake of these nutrients was found to be necessary
because the current activities regarding harmonisation on
EU food legislation for vitamin and mineral supplements,
and the addition of these essential nutrients to food. There*Correspondence: Dr JH Brussaard, TNO Nutrition and Food Research
Institute, Dept of Consumer Research and Epidemiology, P.O. Box 360,
3700 AJ Zeist, The Netherlands.
Received 31 March 1999; accepted 8 April 1999
fore, the European Communities may consider a new
assessment of the 1992 recommendation timely and
appraise new scienti®c evidence and insight in nutrients
and their function. A similar discussion had already started
in the US and Canada. After preparatory workshops organised by the Food and Nutrition Board (FNB) (Anonymous,
1994; Lachance, 1994), the Institute of Medicine (National
Academy of Sciences, USA) installed a Standing Committee on the Scienti®c Evaluation of Dietary Reference
Intakes (DRIs), chaired by V. Young. Expert panels were
charged to review the scienti®c development regarding
groups of nutrients, and two additional subcommittees
were formed, one on Upper Reference Levels of Nutrients
(chaired by I. Munro) and one on the Use of DRIs (chaired
by S. Murphy). The ®rst two panels have issued prepublication reports: `Vitamin D, calcium and related minerals' (1997) and `Folic acid and other B-vitamins' (1998).
To understand and discuss the concepts and rationale
behind the FNB approach and to facilitate discussions
between European experts from academia, industry
and regulatory authorities, the European Academy of
Nutritional Sciences (EANS) and TNO Nutrition and
Food Research Institute organised this workshop (December 1998). In this workshop members of the FNB DRI
Subcommittee on Upper Reference Levels of Intake, and
from the B-vitamins Expert panel gave an overview on the
European risk assessment of nutrients
JH Brussaard et al
concepts and activities in the USA, while European experts
presented an overview on the past and current activities in
Europe. In this paper, the presentations and resulting
discussions are summarised.
possible to deliberate more comprehensively and deeply,
and slashing criticism afterwards is prevented.
General concept and approach of the US Food and
Nutrition Board
(introduced by Prof. Vernon Young)
Key issues in the development of a model to derive
tolerable upper intake levels (UL) are the concept of
safety versus risk, the limitations of traditional models
and the unique characteristics of nutrients. The LJL refers
to the maximum level of long-term daily nutrient intake
that is unlikely to pose a risk of adverse health effects to
almost all individuals in the speci®ed life-stage and gender
group. It refers to all pathways of (oral) exposure combined, and is based on an evaluation conducted using the
methodology for risk assessment. It is not intended to be a
recommended level of intake, as there is no established
bene®t for healthy individuals associated with nutrient
intakes above the recommended dietary intake.
In the USA, the main reason for a revision of the recommended dietary allowances (RDAs) (latest revision 1989)
was the apparent evolution in the application of RDAs.
RDAs are those levels of intakes judged by the FNB to be
adequate to meet the known nutrient needs of practically all
healthy persons. Thus, RDAs were to be applied to groups
of healthy people and not individuals, and therefore set at
levels that exceed the needs of most individuals to encompass the individual variability in nutrient requirements.
However, RDAs are often considered to be the level of
an essential nutrient that a healthy individual should consume on average over a period of time to ensure adequate
and safe intake. It was felt that future RDA documents
needed to provide more details about the actual derivation
of the recommendations and give more explicit guidance in
using the values for nutrition policy and other de®ned uses.
Furthermore, suf®cient new knowledge has accumulated
for selected nutrients and for certain subgroups, that would
support an update and extension of the RDAs. Finally, the
evolution of concepts for intake recommendations played a
role. Especially, the consideration of reduction of risk of
chronic disease as a criterion for adequacy of intake is new
provided suf®cient data exist on ef®cacy and safety. However, incorporating the latter criterion appeared rather
dif®cult because of lack of suf®cient data on several
topics, such as the speci®city of effects as related to the
intake of a single nutrient, dose-response relationships,
information on the variability of the effective dose and
the interaction between nutrients. Another problem
appeared to be the insuf®cient information available for
several subgroups such as adolescents and children. In
developing DRIs,** the criteria to assess adequacy are of
paramount importance. When international harmonisation
of recommended intakes is pursued, this is one of the
essential elements to agree upon. For example, in assessing
the requirement for folate, reduction of risk for chronic
disease was evaluated as criterion for adequacy. However,
insuf®cient data were available for a quantitative assessment and the committee reverted to other classical indicators for adequacy such as the erythrocyte folate
concentration. On the other hand, in the assessment of the
calcium requirement, the scienti®c evidence was judged to
be strong enough to use desirable calcium retention during
growth and minimising bone loss during adulthood as a
criterion for adequacy. An essential element of the FNB
approach is given by the transparency of the process. After
review of the available database and comments from
experts, further advice is being solicited through workshops, meetings and correspondence; ®nally, the National
Research Council reviews all information. In this way, it is
** [In the new FNB reports on nutrient requirements, the term DRI is used
as a collective term for estimated average requirement (EAR),
recommended dietary allowance (RDA), adequate intake (AI) and
tolerable upper intake level (UL) (Anonymous, 1997a)]
A model for development of tolerable upper intake
levels
(introduced by Dr. Ian Munro)
Safety and risk
Munro emphasised the important difference between safety
and risk. Safety can be seen as an intellectual concept, not
an inherent biological property. A safe level refers to a
point on a continuum, and is affected by economic, political, and cultural in¯uences. Risk on the other hand, is
de®ned as the probability of an adverse effect occurring at
some speci®ed level of exposure. Risk assessment is
viewed as a scienti®c exercise, less in¯uenced by value
judgments. It is a systematic means of evaluating the
probability of occurrence of adverse health effects in
humans from excess exposure to a nutrient (Anonymous,
1997b).
Limitations of traditional models
Traditional models for the development of upper levels of
intake focus on establishing safe, rather than tolerable
upper intake levels, and rely heavily on animal data
following the concept of establishing an acceptable daily
intake (ADI). Typical documents required for approval of
ingredients include studies on acute and sub-chronic and
long-term toxicity, on carcinogenicity, multi-generation
teratology and genotoxicity, as well as studies on absorption, distribution, metabolism and excretion. From this
database a no-observed-adverse-effect-level (NOAEL) is
derived and the ADI (mg=kg human body weight) is
calculated by dividing the NOAEL (mg=kg animal body
weight) by the appropriate safety factor. This factor is
usually set at 100, to compensate for the extrapolation
from animal to man, `intra-human sensitivities' (children,
elderly, gender) and differences in test population size.
Sporadic intake in excess of the ADI is not considered a
risk in view of the cautious principles used in setting such
levels of intake.
If the same concept were applied to essential nutrients, it
is not unlikely that for some nutrients the ADI might come
down to an intake below the RDA, as has been shown for
zinc. Therefore, for essential nutrients other procedures
have to be followed.
Unique characteristics of nutrients
For nutrients no, or insuf®cient, dose-response data are
actually available. There are only very few clinical studies
on the relation between dose and biomarkers of adverse
787
European risk assessment of nutrients
JH Brussaard et al
788
effects and the relevance of animal data obviously is rather
limited.
Case reports on medical applications of nutrients
describe high intakes of nutrients, but the resulting data
should not be applied to the general population. Furthermore, only few chronic studies and few surveillance studies
with nutrients are available in man and animals to have a
NOAEL evaluated. Besides, the quality of many of the
available animal studies can be criticised, due to lack of
published details, for example on age and weight of the
animals, and the composition of the diet.
Another drawback is that available databases often
concentrate on supplement intake, but not on total intake.
Finally, there are signi®cant differences in bioavailability
of nutrients from different sources and mode of application.
Risk assessment for nutrients
Risk assessment models are essentially a way of organising
data. A risk assessment model widely used in public health
and regulatory decision making is that proposed by the
National Research Council (NRC, 1983a,b) Using this
approach the steps of risk assessment as applied to nutrients
are as follows.
Step l. Hazard identi®cation. This involves the collection, organisation and evaluation of all information pertaining to the adverse effects of a given nutrient in humans. It
investigates causality, the relevance of experimental data,
mechanism of toxic action, quality and completeness of the
database and identi®cation of distinct and highly sensitive
population groups. The result is a summary of the evidence
concerning the capacity of the nutrient to cause one or more
types of toxicity in humans.
Step 2. Dose-response assessment. In this step, the
relationship between nutrient intake (dose) and adverse
effect (in terms of incidence and severity) is determined.
It involves data selection, including critical endpoints
and identi®cation of NOAEL or, where the NOAEL cannot
be determined, the lowest-observed-adverse-effect-level
(LOAEL). Also other sources of uncertainty have to be
evaluated such as inter-individual variation in sensitivity,
extrapolation from animal data to humans, and the use of
subchronic NOAEL to predict chronic NOAEL. As a result
of this step, the UL is calculated, possibly different ULs for
various life-stage groups, by dividing the NOAEL by the
relevant uncertainty factor (UF). The range between UL
and NOAEL may be smaller or wider, depending on the
level of uncertainty. The UF for nutrients is typically less
than 10 depending on the quality and nature of the data and
the observed adverse effects involved. Also a smaller UF
may be used when the adverse effects are extremely mild
and reversible.
At this moment, extrapolation from adults to children is
mostly done on a body weight basis, while obviously a
function related basis would be better. This is one of the
issues still under discussion. Another open discussion at
this stage of the process is whether it is necessary to have
ULs for all nutrients, or whether for some nutrients it may
be suf®cient to de®ne another value based on a speci®c
physiological indicator.
Step 3. Exposure assessment, that is an evaluation of the
distribution of total daily nutrient intakes among members
of the general population.
Step 4. Risk characterisation. This step summarises the
conclusions from steps 1 through 3 and evaluates the risk.
Generally, the risk is expressed as the fraction of the
exposed population having nutrient intakes in excess of
the estimated UL. Where possible, the magnitude of the
excess is identi®ed and scienti®c uncertainties are
described. It should be noted that risk is assessed as such
and not weighed against possible bene®ts. Also, a discussion of recommendations for reducing risk is not part of the
risk assessment process, but belongs to risk management.
Case illustrations for upper tolerable levels of intake ±
vitamin B6, folic acid and niacin
(introduced by Prof. Robert Russell)
The `NRC format' for risk characterisation for nutrients has
recently been applied to the B-vitamins. For vitamin B6,
the critical effect level on which the tolerable upper intake
was based was sensory neuropathy. For this critical end
point, a NOAEL of 200 mg=day was identi®ed and an
uncertainty factor of 2 was selected because of the small
number of studies available which used doses of pyridoxine
less than 500 mg=day. Thus, an upper tolerable level of
intake of 100 mg=day was obtained for vitamin B6. As with
all nutrients, the upper levels for children and adolescents
were calculated based upon the upper levels of adults,
adjusted for body weight. The highest mean intake of
vitamin B6 (including supplements) according to
NHANES III was 9 mg=day and the highest reported
intake at the ninety-®fth percentile was 21 mg=day (in
pregnant women). Therefore, it can be concluded that the
risk of adverse effects resulting from excess intake of
vitamin B6 from food and supplements appears to be
very low at the highest intakes noted above.
For (synthetic) folic acid, the critical adverse effect
indicator used was precipitation or exacerbation of neuropathy by folic acid in vitamin B12 de®cient individuals,
although there is only limited, but suggestive evidence. It is
important to note, that the upper tolerable level of intake
was set not for food folate but rather for synthetic folic
acid. Due to lack of data from the literature, the LOAEL
rather than the NOAEL was used as a basis. A lowest
observed effect level of 5 mg of folic acid was derived from
100 reported cases of folic acid treatment in dosages of
5 mg or more causing neurologic progression in patients
with vitamin B12 de®ciency. However, the masking of a
vitamin B12 de®ciency state by folate must be considered
as lack of appropriate neurological examination of the
patient. An uncertainty factor of 5 was used based on the
severity of the possible neurologic complications (erring on
the side of safety) and because of the fact that a LOAEL
rather than a NOAEL was used. Thus, the tolerable upper
level of intake for adults was set at 1 mg=day for synthetic
folic acid. It could be argued, that this level may not be
compatible with levels of folic acid possibly associated
with bene®cial effects on cardiovascular risk. Presently, the
conclusion of the FNB is that there is no dose-response
relation for the association between dietary folate and blood
concentrations of folic acid or homocysteine. However,
ongoing studies on cardiovascular risk prevention use daily
supplements of 2.5 mg folic acid, which is higher than the
present UL. In the case where the results of these studies
are positive, the UL for folic acid will certainly need to be
re-considered and potential solutions such as addition of
vitamin B12 to food along with folate might have to be
addressed. For the moment, however, the UL remains at
1 mg=day. The highest ninety-®fth percentile for total folate
intake was found to be 983 mg=day (non pregnant women);
European risk assessment of nutrients
JH Brussaard et al
from food alone it was 438 mg=day, indicating a low level
of risk. Another approach to risk characterisation in this
case is to start from the level of food forti®cation. Mandatory folic acid forti®cation in grain cereals in the USA is
currently 140 mg=100 g cereal. According to the food guide
pyramid the upper level of cereal consumption is 11
servings=day, leading to a supplemental intake of folic
acid of 440 mg=day. Therefore, the intake of synthetic
folic acid is likely to exceed 1 mg=day only in combination
with supplement use. Another consideration is that among
those groups where a high intake of cereals is likely, for
example, adolescents, the prevalence of vitamin B12 de®ciency is extremely low.
Most of the data on adverse effects from niacin are from
studies involving patients with high lipid levels who were
treated with pharmacological preparations of nicotinic acid.
The FNB panel considered that the generic name niacin
might be interchangeable with nicotinic acid. The most
sensitive but benign adverse effect reported is ¯ushing,
resulting either in withdrawal from treatment or a change in
the dosing pattern. Using this critical effect, a LOAEL of
50 mg=day was derived from the available database. However, the uncertainty factor chosen was small (1.5) because
of the transient and rather benign nature of the ¯ushing
effect; thus, the tolerable upper level of intake for niacin
was de®ned as 35 mg=day. The highest mean intake of
niacin found was 39 mg=day among men aged 31 to 50,
with on average 28 mg from food and 11 mg from supplements. The conclusion therefore is that a small percentage
of the population is likely to exceed the upper tolerable
level of intake for niacin.
The situation in Europe
(introduced by Prof. Ruud Hermus and Dr A Somogyi)
Contrary to the situation in the USA, European countries
usually have their own national intake recommendations
for energy and nutrients apart from the SCF recommendations expressed in 1992 (SCF Report, 1993). As illustrated
in Table 1, there are large differences in recommendations
between countries. This can be explained ®rst by differences in the conceptual framework for recommendations
which are an element of nutrition policy, originally aimed
at providing enough food for the population. More qualitative aspects of nutrition policy such as the risk reduction
of chronic diseases have only recently been discussed as
possibly important in establishing recommendations. The
recommended intake values from different countries are
sometimes based on original scienti®c data reviewed by
expert committees, in other cases on a review of the
recommendations from other national or international
expert groups, or on a combination of both approaches.
Table 1 RDAs for adults of selected nutrients in various countries
(mg=day)
European Commission, 1992
France, 1992
Germany, 1991
The Netherlands, 1989
Nordic countries, 1996
UK, 1991
Vitamin C
(men and
women)
men
women
Calcium
(men and
women)
45
80
75
70
60
40
9.1
10
10
9
10
8.7
19.6
18
15
15
12 ± 18
14.8
700
900
900
700 ± 900
800
700
RDA ˆ Recommended dietary allowance.
Iron
Secondly, the starting point for setting recommendations
generally is an assessment of the physiological requirement
of a nutrient, plus margins for variability, uncertainty and
bioavailability. This leads to several differences as, for
example, the width of the safety margins chosen differs
between countries. Another factor of uncertainty is that the
period over which a requirement is established is seldom
de®ned. The most important cause of differences, however,
form the criteria used to de®ne adequacy, depending on
whether they are based on prevention of de®ciency, tissue
saturation, body stores, the maximisation of a physiological
effect (for example, enzyme activity) or the minimisation
of the risk of a chronic disease. Furthermore, there are
differences with respect to classi®cation into age groups,
for which the scienti®c reason is often less clear.
Finally, application of the recommendations is different
in the various countries. This can be illustrated by comparing the situation in three European countries, The Netherlands, the UK and the Nordic countries, respectively
(Netherlands Food and Nutrition Council, 1992;
DHSS,1991; Nordic, 1996). There are more or less explicit
differences in the de®nition of values, the criteria for
adequacy used, the utilisation aimed at, and the time
period concerned.
In the Netherlands, RDAs were developed for use in
food supply planning and for the evaluation of food consumption. Based on data on the individual minimum
requirement of a nutrient, its bioavailability and the metabolic interactions of nutrients, an average minimum
requirement was assessed. This average minimum requirement together with data on the variations in the minimum
requirement (usually 2 s.d. of the average minimum
requirement) was used for the de®nition of the adequate
level or range of intake. These values (average minimum
requirement and adequate level of intake) are suitable for
the evaluation of food consumption data. RDAs, especially
in view of food supply planning, were based on the
adequate level=range of intake, combined with data on
dietary habits, acceptance, etc. In this way, RDAs ful®l
the nutritional needs of practically all healthy persons in a
population. In the UK, the Panel on Dietary Reference
Values recognised that earlier de®nitions of recommended
dietary intake values gave rise to a lot of misunderstanding.
In trying to reduce the chance of misunderstanding it was
decided to introduce new terms and to set a range of
reference values (not recommendations!) based on the
distribution of requirements for each nutrient. These reference values are to be used in a variety of ways such as the
evaluation of dietary surveys, or for food labelling or to
provide guidance on diet composition and meal provision
for groups and individuals. The dietary reference values
(DRVs) are de®ned as follows: the estimated average
requirement (EAR) indicating the mean requirement, the
reference nutrient intake (RNI) indicating that level above
which intakes will be almost certainly adequate and the
lower reference nutrient intake (LRNI), indicating the level
below which intakes will be almost certainly inadequate for
most individuals.
In the UK, as well as The Netherlands, prevention of
clinical signs of de®ciency, maintaining nutrient balance
and allowing for a certain level of nutrient storage were
used as criteria of adequacy. The claimed bene®cial effects
of higher intakes of some nutrients were considered to be
not suf®ciently scienti®cally based to be acceptable as
criteria for adequacy.
789
European risk assessment of nutrients
JH Brussaard et al
790
The Nordic countries followed a slightly different
approach. In 1996, they published a set of Nordic nutrition
recommendations (NNR) to be understood as basis for the
planning of a diet which satis®es the nutritional needs (that
is, covers the physiological requirement for growth and
function) and is a prerequisite for overall good health and
contributes to risk reduction of diet-associated diseases.
The criteria for these guidelines were de®ned for each
nutrient separately, which allows reassessment when new
scienti®c knowledge emerges. NNR are to be used in
several ways: as guidelines for planning of diets, as the
basis for teaching and information, as the basis for food and
nutrition policy and as the basis for evaluation of intake.
Recommendations are given several levels: (1) `recommended intakes of nutrients' expressed as average daily
intake over time, for use at planning of diets for groups;
stating that the requirement is lower for almost all individuals; (2) `recommended nutrient density' to be used for
planning of diets for groups of individuals over 7 y of age
with a heterogeneous age composition, the values being
adapted to the person with the highest requirement; (3)
`lower limits' of average daily intake of nutrients, to be
used only for the evaluation of results from dietary surveys.
It is indicated that prolonged intake below these levels may
induce a risk of de®ciency, while a higher intake is no
guarantee against de®ciency symptoms in single individuals. Finally, upper limits for average daily intake of
nutrients for adults were de®ned, stating that if the supply
from the diet and vitamin and=or mineral supplements
exceed these values there is a risk of undesirable effects.
These values are to be used for the evaluation of intake of
single individuals.
In principle, the EU Scienti®c Committee on Food
(SCF) used a very similar approach as the UK Panel on
dietary reference values (moving away from single RDA
values towards three values to indicate the spread of needs)
with different names: average requirement (AR) corresponding to the UK EAR and population reference intake
(PRI), corresponding to the UK RNI. The PRI (SCF) and
the RNI (UK) correspond conceptually with the traditional
RDA, and when diets are being designed or food supplied it
should contain nutrients at this level over a period of time
to ensure negligible risk of nutrient de®ciency in any
person. Recommendations by the EU serve the same
purposes as in all other countries, but besides have different
objectives: they must be suitable for use in all Member
States, regardless of the national nutritional policy or dietary habits, and they must enable free circulation of foodstuffs, which is an important principle. The use of these
recommendations in labelling is therefore an important
aspect.
Risk management is becoming of more importance for
the EU. In this respect, two steps are considered of
importance. First, the establishment of upper safe levels
and the assessment of risk. Second, evaluation of available
risk management. The de®nition of upper safe levels of
intake is a topic presently discussed by a sub-committee of
the Scienti®c Committee for Food. To coordinate EU
efforts in the ®eld of risk assessment, the Unit Evaluation
of Health Risk was established in 1998. Although regulations should be based on scienti®c evidence it is clear that
in trade disputes economic consideration also have a role.
However, food safety and consumer protection have always
been viewed as cornerstones of regulatory policy in the
EU. Bene®cial effects of high intakes can be seen as the
counterpart of risk and among some parts of the society
there is a demand to allow health-related claims for (food)
products with high levels of certain nutrients. However, at
present, claims on medical issues are forbidden in the EU
and this is unlikely to change in the foreseeable future.
Conclusions
(by Prof. Paul Walter)
The discussion on nutrient recommendations or nutrient
intake values relates to safety, scienti®c, regulatory and
political issues. Several challenges can be identi®ed and it
seems clear that the classical RDA approach is no longer
satisfactory, because it does not take into account newly
emerging science with regard to intakes beyond the RDA.
In the USA, the attempt to include new science on risk
reduction of chronic diseases in establishing new intake
recommendations is courageous, but dif®cult to achieve.
The results of the Panel on Dietary Antioxidants will be
very important in this respect (expected by September
l999). There is an urgent need for global harmonisation
of criteria used for assessing adequacy of intake and for
terminology.
A recent development is the increasing importance of
forti®ed foods and food supplements. This necessitates
open and understandable information for the consumer.
The consumption of a healthy, balanced diet may turn out
to be dif®cult for several segments of the population, such
as the aged, adolescents, or pregnant women, and selected
consumption of food enriched with some nutrients may
become a necessary tool. This may require permission to
use health-related claims for forti®ed=functional foods.
However, combined use of forti®ed food and food supplements might lead to safety considerations. Therefore, it is
important to develop tolerable upper intake levels, in order
to advise the consumer that beyond a certain intake of the
respective nutrient the risk of an adverse effect will be
increasing. There is a rather broad public interest for these
topics and informing for the consumers is of paramount
importance.
The discussion of principal issues relating to criteria for
nutrient adequacy should be pursued. The formation of a
special working group led by the European Academy of
Nutritional Sciences (EANS), preferably in close cooperation with the Food and Nutrition Board or the American
Society for Nutritional Sciences (ASNS) in the USA, might
deliver an important contribution to progress in this area.
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Thiamin, Ribo¯avin, Niacin, Vitamin B6 Folate, Vitamin B12, Pantothenic Acid, Biotin and Choline. National Academy Press, Washington, DC.
FSCT Report (1993) Reports of the Scienti®c Committee on Food (Thirty®rst series): Nutrient and energy intakes for the European Community.
Commission of the European Communities, Directorate ± General
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Appendix
European Academy of Nutritional Sciences (EANS) and
TNO Nutrition and Food Research Institute Workshop,
11 December l998, Brussels. Approach of the US Food
and Nutrition Board to daily nutrient requirements: `A
useful basis for the European discussion on risk assessment
of nutrients?'
Scienti®c Programme Committee
P Walter, President of EANS, University of Basle, Basle,
Switzerland
RJJ Hermus, Vice-president of EANS, TNO Nutrition and
Food Research Institute, Zeist, the Netherlands
H van den Berg, TNO Nutrition and Food Research
Institute, Zeist, the Netherlands
JH Brussaard, Scienti®c Secretary, TNO Nutrition and
Food Research Institute, Zeist, the Netherlands
Speakers
RJJ Hermus, Vice-president of EANS, TNO Nutrition and
Food Research Institute, Zeist, the Netherlands
I Munro, Chair of Sub-committee on upper reference levels
of nutrients, Mississauga, Ontario, Canada
RM Russell, Member of B-vitamin Panel of FNB, Tufts
University, Boston, USA
A Somogyi, Head of Unit Evaluation of health risks, DG
XXIV, European Commission, Brussels, Belgium
VR Young, Chair DRI Standing Committee on the Scienti®c Evaluation of Dietary Reference Intakes, Massachusetts Institute of Technology, Cambridge, MA, USA
P Walter, President of EANS, University of Basle, Basle,
Switzerland
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