FOSHU Regulation in JAPAN 2018

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Volume 5 | Issue 10 | June 2018
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3. REGULATIONS 31NUFFOODSSPECTRUM | June 2018 | www.nuffoodsspectrum.in
T
he Hippocrates doctrine “Let food be thy medicine
and medicine be thy food,” espoused nearly 2,500
years ago continue to receive interest and more so
in present times. Mankind across cultures have unique
relationship with food which goes beyond not being
just source of basic nourishment but folklores are replete
with recipes, food preparations that are known to confer
functional benefits. Ayurveda in India, TJM (Traditional
Japanese Medicine – -Kampo) in Japan orTCM (Traditional
Chinese Medicine) in China emphasize on role of food,
herbs, minerals in healing and conferring good health.
As the lifestyle and society continue to evolve, there is
an ever-expanding consumer preference toward health
enhancing role of specific foods or physiologically- active
food components, so-called functional foods (Hasler,
1998). As Institute of Food Technology (IFT) report says,
clearly all foods are functional, as they provide taste,
aroma, or nutritive value. However, the term functional as
it applies to food has adopted a different connotation—
that of providing an additional physiological benefit
beyond that of meeting basic nutritional needs.
Foodandnutritionsciencehasmovedfromidentifying
and correcting nutritional deficiencies to designing
foods that promote optimal health and reduce
the risk of disease. Sound science must underlie the
development, marketing and regulation of these new
functional foods to protect and inform consumers.
Regulatory policies must ensure the safety and efficacy
of products and the accuracy of their marketing claims
Functional foods constitute a rapidly growing focus for
research, product development and consumer interest as
well as regulatory efforts in recent years. Such products
Kiyohisa Kaneko
Director – Scientific
& Regulatory Affairs
– Coca-Cola Japan
Company Ltd.
Sunil Adsule
Director – Scientific
& Regulatory Affairs
– Coca-Cola India
and South West Asia
Shinsuke Nakagawa
Manager – Scientific
& Regulatory Affairs
– Coca-Cola Japan
Company Ltd.
FOSHU Regulation in Japan
contain bioactives that offer considerable opportunities
for reducing mounting health care costs for ailments
such as heart disease, diabetes, cancer, immune and
inflammatory disorders, mental and depression related
diseases, together with the aging process and obesity.
Although the association between health and diet and
food, including functional foods, was originally anecdotal
and based on epidemiological data, modern nutrition and
food science focus on health promotion, and have now
reached a molecular level (IFT Expert Report Functional
Foods: Opportunities and Challenges 2005).
The term "functional food" first appeared in
Nature in 1993 in an article titled "Japan Explores the
Boundary between Food and Medicine" (Swinbanks
and O’Brien, 1993) while the term “nutraceutical” was
coined by Stephen DeFelice in 1989, from “nutrition”
and “pharmaceutical” to reference “food” or “part of a
food” that provides health benefits (DeFelice, 2002). The
1984 initiative of the Ministry of Education, Science and
Culture (MESC) of Japan served as a basis to explore the
interface between food and medical sciences. As it might
be expected, Japan led the way for establishing strict
procedures for approval and marketing of functional
foods under "food for specified health uses” or “FOSHU"
which was conceptualized in 1991.
FOSHU Evolution:
With the rapid emergence in the senior population in
Japan in last few decades the chronic diseases associated
with aging such as diabetes, cardiovascular disease,
hypertension, osteoporosis, and cancer are also on the
rise. These diseases are connected not only to age but

4. REGULATIONS32 NUFFOODSSPECTRUM | June 2018 | www.nuffoodsspectrum.in
also to lifestyle factors such as diet, nutrition, and physical
exercise. The goal of functional foods is to prevent the
development of such chronic disease before treatment
requiring drugs becomes necessary. The Japanese
Ministry of Education initiated research and development
projects concerning the functionalities of food in 1984.
The projects employed researchers within the disciplines
of nutrition, pharmacology, psychology, and the medical
sciences. (Health Claim Evidence Requirements in Japan;
by Kazuhiko Yamada, Natsuko Sato-Mito, Junichi Nagata,
and Keizo Umegaki; 2008)
The outcome of these projects defined a functional
food for the first time.
Foods in general were defined to have 3 functions,
a. The primary function was identified as nutritional,
that is, essential for human survival.
b. The secondary function was identified as sensory,
or sensory satisfaction, such as‘‘deliciousness’’, flavor, and
good texture &
c. The tertiary function was physiological, such as
regulation of biorhythm, the nervous system, the immune
system, or body defense.
Functional foods were assessed as foods possessing
tertiary functions. The scientific evidence for functional
foods continues to evolve as more studies on the
health benefits and physiological functions of foods are
conducted.
How these benefits are communicated to consumers
is a key aspect. Therefore, labeling of functional foods is
playing a very critical role both consumers and producers.
Through easy to understand and simplified labeling,
consumers can understand the features, contents, and
usage of the foods and then choose the proper foods for
themselves using the information provided on the label.
As there is more information in public domain through
social media, internet, newspaper columns on health
benefits of food than ever before, consumers’ interest
in health issues has become a leading factor in their
purchasing decisions. Manufacturers can emphasize the
characteristics of their products to help consumer choose
right product through the labeling or claims made. One of
the critical and indispensable aspect which has legal and
regulatory implication is that the labeling & claim must be
truthful, clear and unambiguous to prevent any chance of
misinterpretation. The labeling of health claims on foods
should always be based on and backed up by scientific
evidence.
Positioning of Functional Foods in Japan:
The current Japanese system for regulation of health
foods can be seen from adjoining chart, this is broadly
classified in two major categories
a. Foods in General – which are conventional food
products – food in this category are prohibited from
making any functional claim
b. Foods with Health Claims – which are food aimed
at delivering targeted benefits and these are further
classified into three sub-categories as
i. Foods for Specified Health Use – FOSHU
ii. Foods with Function Claims – FFC
iii. Foods with Nutrient Function Claims – FNFC
FOSHU – Characteristics
Japan was the first country to regulate its health food
market by introducing “Food for Specified Health Uses”
(FOSHU) standardization. For a product to become
recognized as FOSHU certified, it would have to be
submitted for review to test its efficacy and safety. In
2009, FOSHU regulatory responsibilities transferred
from the Ministry of Health, Labor and Welfare (MHLW)
to the Consumer Affairs Agency (CAA). In order to make
certification more acceptable to the manufacturers the
CAA later on added more options for FOSHU certification
in form of FNFC and FFC. The new options are meant
to be faster in terms of time of approval, less in term of
investment of resources needed than the original set of
regulations.
FOSHU refers to foods containing ingredient with
functions for health benefits and officially approved
to claim its physiological effects on the human body.
FOSHU is intended to be consumed for the maintenance
/ promotion of health or special health uses by people
who wish to control health conditions, such as blood
pressure or blood cholesterol. To sell a food as FOSHU, the
assessment for the safety of the food and effectiveness of
the functions for health is required, and the claim must
be approved before its release in market by the CAA –
Consumer Affairs Agency.
FOSHU Approvals are provided in four categories
namely
I. Regular FOSHU: This involves manufacturer to
ensure
a. Effectiveness on the human body is clearly proven
(clinical study must be conducted to prove efficacy and
safety of finished product)
b. Absence of any safety issues (animal toxicity tests,
confirmation of effects in the cases of excess intake in
clinical study.)
c. Use of nutritionally appropriate ingredients other
than functional components (e.g. no excessive use of salt,
etc.)
d. Guarantee of compatibility with product
specifications
e. Well designed and established quality control
protocols, such as specifications of products and
ingredients, processes, and methods of analysis

5. REGULATIONS 33NUFFOODSSPECTRUM | June 2018 | www.nuffoodsspectrum.in
II. Qualified FOSHU:
Food with health function which is not fully
substantiated on scientific evidence that meets the level
of FOSHU, or the food with certain effectiveness but
without established mechanism of the effective element
for the function will be approved as qualified FOSHU.
III. Standardized FOSHU:
Standards and specifications are established for foods
with specific functional components having sufficient
FOSHU approvals and accumulation of scientific evidence.
Standardized FOSHU are approved when it meets the
standards and specifications.
IV. Reduction of disease risk FOSHU:
Reductionofdiseaseriskclaimispermittedforproducts
whose ingredients clinically and nutritionally established
to reduce a risk of certain disease (E.g. Calcium for
Osteoporosis and Folic acid for neural tube defects). As of
January 2018, approved products in aforesaid four FOSHU
categories are more than 1100 products with Regular
FOSHU approved products are the highest in number.
TYPE Number of Approved
Products (Jan 2018)
Regular FOSHU 1018
Qualified FOSHU 1
Standardized FOSHU 110
Reduction of Disease Risk FOSHU 14
General procedure for approval of FOSHU
ThosewhowishtoapplytheirproductsforFOSHUlabeling
are required to submit the following documentation
List of Documentation
required for FOSHU Approval:
1. Sample of the entire package with labels and
proposed health claims
2. Documentation that demonstrates clinical and
nutritional proof for the product and/or its functional
component for the maintenance of health
3. Documentation that demonstrates clinical and
nutritional proof of the intake amount of the product
and/or its functional component
4. Documentation concerning the safety of the
product and its functional component, including
additional clinical study and its usage in traditional
Japanese diet as a part of the eating experience
5. Documentation concerning the stability of the
product and its functional component
6. Documentation of the physical and biological
characteristics of the product and the functional
component
7. Methods of qualitative/quantitative analytical
determination of its functional component, and analytical
assay results of the component in the product
8. Report on the analysis of the designated nutrient
constituents and energy content of the product
9. Statement of the production method, list of factory
equipment, and an explanation of the quality control
system
Conditions for FOSHU Approval
1. Improvement of dietary habits and contribution to
health maintenance and enhancement can be expected
by consuming the product.
2. Scientific evidence for the claimed health benefit is
available.
3. Clinical and nutritional intake level of the product
and/or its functional component is established.
4. The product and/or its functional component is
safe for human consumption.
5. Following items regarding functional component
are defined: a) Physical, chemical, and biological
characterization and its methods, b) Methods of
qualitative and quantitative analytical determination
6. Nutrient constituent of same type of the food is
maintained
7. The food is intended to be consumed on a daily
basis and not on rare occasions
8. The product or its functional component is not
included in the medical drug list
The documentation of effectiveness should be
prepared on the basis of substantiation, not only by
human clinical and animal studies but also by in vitro
metabolism and biochemical data. Such data should
demonstrate statistically significant differences between
the control and intervention groups.
Basically, human studies should be conducted for
a sufficient period of time and in case of the cross over
study designed with appropriate wash-out phases, using
the food for which the claim is intended.The study should
be well designed taking in account the biomarker and
an appropriate sample size, i.e., a sufficient number of
subjects to show statistically significant difference for the
claimed health benefit. Literature supporting the relevant
functional constituents, the food carrier, and the related
function should be provided in the form of a review.
Fordocumentationofsafety,bothinvivostudiesandin
vitro studies should be carried out to develop preliminary
data to assess the safety of intake in humans. Even if the
effective component has been consumed in food by a
reasonable number of people over a certain period, safety
data regarding human consumption should be provided
using at least 3 times the amount of the effective dosage.
Literature concerning related functional components
must be reviewed and provided. If the related literature or
report implies an undesirable or adverse effect on health,
it should be accompanied by a scientific explanation or a

6. REGULATIONS34 NUFFOODSSPECTRUM | June 2018 | www.nuffoodsspectrum.in
human study that confirms safety in humans.
Documentation of the methods for analysis of the
functional components should be included in the claim
submission. These analytical determinations typically
precede clinical studies and animal studies as well
as in vitro studies and stability testing. As additional
documentation, evidence regarding the stability of
respective functional components should be provided.
If a product is to be administered in the form of tablets
or capsules, experiments should be conducted exploring
the extent of disintegration or dissolution of the bioactive
substance. It is important within the evaluation process
that both the benefit and safety of a given functional
food differ from those of a medicine. Functional foods
are designed to target healthy people or people in a
preliminary stage of a disease or a borderline condition
of at-risk groups. Therefore, the effectiveness for these
people may be reduced compared with medicine
for patients. Generally, foods with functionality have
been historically consumed by people and thus can be
regarded as safer than innovative medicine.
FOSHU Market in Japan
The introduction of FOSHU approved products in
Japan has steadily grown in last two decades asserting
acceptance and growing popularity of these products.
As per the Statistics released by Japan Health and
Nutrition Food Association, over 1000 products are
already approved by the Authorities. Though during the
initial period, products with GI health benefits dominated
product offerings in FOSHU category, the market
continues to expand further with products positioned
on regulating levels of triglyceride, body fat, cholesterol,
blood sugar, blood pressure, bone health.
Coca-Cola Plus is the latest brand to join Coca-Cola
Japan’s portfolio of Food of Specified Health Use (FOSHU)
drinks – which is a large and growing segment of the
country’s competitive beverage market. This no-calorie
beverage contains indigestible dextrin – a source of
dietary fiber. Coca-Cola Plus offers the same great Coke
taste with functional benefits, to health- and taste-
conscious consumers as a beverage to enjoy with food.
Functional benefits of drinking one Coca-Cola Plus per
day with food is, it helps suppress fat absorption and
helps moderate the levels of triglycerides in the blood
after eating.
Impact of FOSHU Certification
on Consumer Behavior
A report carried by Journal of Consumer Marketing
on Impacts of the FOSHU (Food for Specified Health
Uses) system on food evaluations in Japan found that
Japanese consumers do not rely on apparently justified
health claims, but on the symbolic logo, to evaluate
the healthfulness of specific foods. The health claims
successfully communicate messages regarding the
healthfulness when used in conjunction with the FOSHU
Seal. That implies that the FOSHU Seal has become a
symbol for high-quality food brands, in terms of nutrient
intake and health promotion, as expected by both the
Japanese government and FOSHU food manufacturers.
This also indicates high level of confidence placed by the
consumers in Institutional Processes set in such as FOSHU
Regulatory Approval process for health claims – thereby
giving clear set of guidelines to the food manufacturer.
The FOSHU system creates a win-win paradigm for
consumers and manufacturers.
Recently in India, the Food Safety and Standards
Authority of India published draft regulation on Claims
and Advertising which defines health claim as “means
any representation that states, suggests, or implies that a
relationship exists between a food or a constituent of that
food and health”.
The regulation also proposes framework for making
health claims and its approval by Food Authority. Once
finalized this regulation will enable and encourage Indian
Food manufacturers to develop products on similar lines
as FOSHU products in Japan.
FOSHU Approval
Process Flow:
The application process
for FOSHU starts
with the receipt of all
the documentation
described by the Office
of Consumer Affairs
Agency. The evaluation
process is explained in
diagram :