November 1996: (11)s1994201

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Functional Foods-The Future: How to Regulate These Hoods
Gkm-dPascal, M.S.,Engineer in Biochemistry

Answering the question of how to regulate functional
foods is one of the most difficult challenges the author has
faced. The approaches adopted in countries that have ana-
lyzed this issue are so diverse and closely linked to the
cultures of the countries concerned that summarizing them
is impossible. A description of all these approaches would
make tedious reading. This paper therefore presents a
strictly personal point of view that draws on views ex-
pressed in regulatory documents, minutes, conference pro-
ceedings, and documents published by producers of func-
tional foods.’-’
Defining Functional Foods
Legislators need a precise definition of the subject to be
regulated. This is the first hurdle to overcome. Let us begin
by examining definitions that have been proposed or
adopted in Australia and Japan.
The National Food Authority of Australia has adopted
the following preliminary definition of functional foods:
“Functional foods are similar in appearance to conven-
tional foods and are intended to be consumed as part of a
normal diet, but have been modified to serve physiological
roles beyond the provision of simple nutrient require-
ment~.”~
In the Quick Guide to Foodfor SpeciJiedHealth Use
published by the Japan Health Food and Nutrition Food
Association under the supervision of the Japanese Minis-
try of Health and Welfare, functional foods are described
as “food to which some ingredients to help get into shape
are added; from which allergens are removed; [for which]
the result of such addition or removal is scientifically evalu-
ated;.and to which the Ministry of Health and Welfare has
given permission to indicate the nature of effectiveness to
the health.”
The first common element in these definitions is that
functional foods are foods. This might suggest that the
definition excludes dietary supplements in the form of a
pill, tablet, or capsule. The position adopted in the recent
U.S. regulation on dietary supplements supports this view,
because of the safety problems involved. This view has
Dr. Pascal is Chairman, European Union Scientific
Committee for Food, CNERNA-CNRS, France.
been adopted by certain European countries in which spe-
cific legislation concerning dietary supplements has been
or soon will be adopted. It is not clear, however, whether
this point of view can be accepted in all countries
Another common theme in the two definitions is the
need for a food to be modified (through the addition or
removal of ingredients) to be considered a functional food.
Obviously, some countries will not agree on this point. In
the United States, even if functional foods are not legally
recognized, foods for which health claims are allowed can
be considered functional foods. Provisions of the Ameri-
can regulation precisely address usual constituents of food
(calcium), current foods rich in certain constituents (fiber-
containing fruits, vegetables, or grain products; fruits and
vegetables that contain vitamins A or C), or types of diets
(low-fat diet, low-cholesterol diet, diet rich in fruits and
vegetables). The claim bears on a substance, the word
substance indifferently meaning a food or a food compo-
nent.
Some interesting concepts have emerged from the
Australian consultative procedure, such as “where the
functionalityof a food is derived from a particular nutrient,
such as calcium or fibre, the regulatory structure must en-
sure that all foods with sufficient levels of the particular
nutrient are equally able to make the particular claim unless
otherwise disqualified.’%This point of view is widely shared
in France, where the Institut Franqais de la Nutrition (French
Nutrition Institute) recently proposed allowing the use of
“generic” functional/physiologicalor health claims in a
positive list (similar to the U.S. position) and “new” claims.
The generic claimswould mainly be appliedto normal food-
stuffs and the new claims to more sophisticated products
designed on the basis of new scientific knowledge.
Within the framework of sound competition between
non- or slightly transformed raw material producers and
food industries, any food for which a functional effect in-
ducing a possible action on the maintenanceof good health
has been demonstrated might benefit from functional/
physiological or health claims.
Categorizing Functional Foods
Functional foods are foods and fall under food legislation.
This raises the question of whether functional foods must
be considered current or particular foods or dietary or spe-

Nutrition Reviews, Vol. 54, No. l l s199

cia1 nutritive foods. The Japanese regulation has chosen
to define foods for specified health use as Foods for Spe-
cial Dietary Uses in the Special Nutritive Food System (Ar-
ticle 12 ofthe Nutrition Improvement Act). By contrast, the
American regulation does not provide for the inclusion of
products that might benefit from health claims in a particu-
lar category of foods, if dietary supplements are excluded
from functional foods.
A few years ago, it seemed the intention of the Euro-
pean Commission to develop proposals in several areas of
food law that might affect functional foods: a directive on
foods for particular nutritional uses (PARNUTS directive);
claims; food supplements(if they must be considered func-
tional foods). These intentions were reviewed in the light
of the Commission’s commitment to “subsidiarity.” It now
seems that proposals on claims (other than general guide-
lines) and food supplements are either very delayed or
unlikely. However, work on PARNUTS is continuing, and
this may affect legislative control of functional foods. It is
not absolutely clear, however, that the scope of the
PARNUTS directive includes functional foods. If not, then
the only food law controls that currently apply to func-
tional foods and that are likely to be applied in the future
are controls on safety and on claims. This is close to the
opinion of the United Kingdom Ministry of Agriculture,
Fisheries and Food.
Claims
Claims lie at the heart of the problem of regulation of func-
tional foods. Discussions within both the Codex Alimen-
tarius Commission and the Codex Committee on Food La-
belling, as well as within the European Union (EU), have
emphasized different approaches between countries. Gov-
ernments and interested international organizations were
invited to comment before the 23rd session of the Codex
Committee on Food Labeling on proposed guidelines for
the use of health and nutrition claims in food products
labeling.’ In particular, they were asked to comment on the
proposal to permit two types of claims: nutrient function
claims and health claims.
Only one general agreement has been reached so far:
to refuse any medicinal claim. Regarding other types of
claims, three positions prevail.
Countries such as Denmark and Finland refuse to ac-
cept either nutrient function claims or health claims.
Countries such as New Zealand and Switzerland refuse
to accept health claims but accept nutrient function
claims.
Countriessuch as Australia, Sweden, the United King-
dom, and the United States are ready to accept both
types of claims, with very strict provisions for the
acceptance of health claims.
Arguments put forward by countries that refuse cer-
tain types of claims are very similar. For example, New
s200
Zealand considers “that nutrition messages should em-
phasize the positive, such as nutrient function claims, rather
than a negative emphasis as in health claims with diseases
and disorders. Furthermore, no one food is able to confer
health or prevent disease. Rather if is the total diet and
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other factors, such as heredity and lifestyle, that may in-
crease or decrease the risk of diet-related diseases. Be-
cause the precise role of diet has yet to be determined for
many diet-related diseases, New Zealand considers it is
premature to allow health claims. ”
The United Kingdom suggests that “all references to
disease are deleted from the definition and examples. This
would leave reference to health only and would help to
reduce the extension of acceptable claims into the unac-
ceptable area of medicinal claims....The U.K. is of the view
that the sections on ‘nutrient function claims’ and ‘health
claims’ should be merged. If the reference to disease were
removed from the health claims section, there would be
even less need for a distinction to be made between the
two. The claims would all be concerned with a food con-
tent which had some beneficial effect on health. It is con-
sidered that mentioning disease should be outside the ac-
ceptable claim definition so as to avoid consumer misun-
derstanding. ”
Within the EU, identical different points of view, as in
the Codex Committee, have emerged during the many and
long discussions aimed at harmonization of claims among
member states. These discussions concerned “physiologi-
cal claims” similar to the Codex nutrient function claims
and health claims. As no agreement has been reached con-
cerning specific claims, a proposal for a European Parlia-
ment and Council Directive on the Use of Claims Concern-
ing Foodstuffs merely proposes general guidelines and
principles. One of these general principles is the prohibi-
tion of medicinal claims: “Subject to the provisions that
apply to natural mineral waters and to foodstuffs for par-
ticular nutritional uses, a claim may not have the object or
effect of attributing to any foodstuff the property of pre-
venting, treating or curing a human disease, or refer to
such properties or suggest these properties.”
Lawyers reading the above would understand that
any reference to prevention is prohibited for a food, but
that this does not apply to an ingredient or constituent.
This is fundamental for nutritionists who consider that
including sufficient amounts of certain nutrients or food
components in a diversified and balanced diet may play a
role in preventing the development of specific diseases.
Another general principle upon which all European
countries agree is that any authorized claim should not be
false or misleading. In particular, “any claims which:
state or suggest objective characteristics which can-
not be substantiated;
are liable to reflect discredit on other foodstuffs,
whether similar or not;
Nutrition Reviews, Vol. 54, No. 1 1
 are liable to engender doubts as to the safety of simi-
lar foodstuffs, arouse fear or to exploit such feelings
in consumers; or
state, imply or suggest that a balanced diet of every-
day foodstuffs cannot provide all the nutritive sub-
stances in a sufficient quantity for the needs of the
population in general,
shall be considered as false or misleading.”
Another important point tackled in the general prin-
ciples of the draft directive is mutual respect for national
opinions as stated by the responsible authorities. “Each
Member State shall establish a centralized decision-mak-
ing system to deal with complaints relating to claims. To
this end each Member State shall designate the body or
authority responsible for deciding on the misleading na-
ture of a claim.”
Conclusions
Several common positions are found among the different
countries at the international level.
Functional foods are foods (i.e., differentiated from
dietary supplements).
Functional foods should be safe. These products can
be foods or traditional constituents that long experi-
ence has shown to be harmless. Functional foods can
also be novel foods or can contain novel ingredients.
In this case, their safety must be evaluated according
to rules established for that new category of foods.
Medicinal claims cannot be accepted.
Any authorized claim must not be false or misleading.
Claims should be for a generally recognized and ac-
cepted action or effect of a nutrient or a food compo-
nent.
Only guidelines can be subject to international agree-
ment within the scientific community. The wording of
claims that depend on the cultural and sanitary con-
text of a particular country should remain the respon-
sibility of the competent national authorities.
The most sensitive question that remains unanswered
concerns the nature of claims that may be used and the
type of proof to be put forward to assess their truthful-
ness. The following general scheme can be envisaged.
Draw up an open and positive list of generic claims.
Nutrition Reviews, Vol. 54,No. 11
The list should be set up according to a series of
concepts identifying the functions that can be modu-
lated by a diet or a food component and according to
a group of markers proving the modulation of the func-
tion. Using these claims would only assume that a
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dossier would be submitted before marketing and that
the actual control would be carried out afterward.
Possibly use new claims with very strong scientific
arguments and control before marketing. The nature
of the scientific dossier should be established by the
competent national authorities after internationaldis-
cussions to come to an agreement on general prin-
ciples.
Because of the difficulty of demonstrating that a food
Component, food, or diet can contribute to the long-term
maintenance of good health, it would be pragmatic to ac-
cept two types of claims: functional claims, whose truth-
fulness is easier to prove, and health claims, which are
more difficult to justify. This general scheme would en-
courage industry to support research in human nutrition
because it would enable the use of functional claims as a
first step before health claims can be justified.
I . Anonymous. Proposed Draft Guidelines for the Use
of Health and Nutrition Claims in Food Product La-
belling. Codex Alimentarius Commission, Doc. CW
FL 94/5 (3 appendix), 1994
2. Anonymous. The FDA’s final regulation on health
claims for foods. [editor’s note] Nutr Rev 199351:90-
3
3. Anonymous. Functional foods: focus on the technical
issues and the law. Food Manufacture 1995;April:25-
32,52
4. National Food Authority. Functional Foods: Policy Dis-
cussion Paper. Australia- Canberra: National Food
Authority, 1994
5. Federation of Swedish Food Industries.Health Claims
in the Marketing of Food Products. Stockholm, Au-
gust 1990
6. Japan Health Food and Nutrition Food Association.
Foods for Specified Health Use. Tokyo, 1995
7 . lnstitut Franqais de la Nutrition. L‘alimentation: Ses
Alldgations Sant6. Dossier scientifique de I’IFN n”6.
Paris: IFN, 1995
8. Preston C. Regulatory and legal aspects of funtional
foods: the Australian experience. Nutr Rev 1996 (this
issue)
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