1) The document discusses Japan's new "Foods with Function Claims" system which allows foods to make certain health claims after notifying authorities and providing evidence of safety and effectiveness. 2) It provides an overview of international regulations on health claims in the EU, US, and Japan and compares Japan's new system to regulations for dietary supplements in the US. 3) Statistics are given on the number and types of health claims made for foods under the new Japanese system between 2015-2016, including many claims related to digestion, fat reduction, and cholesterol.

1. "Foods with Function Claims"
System in Japan
December 3rd, 2016
Shinji Hashimoto, Chief Researcher
Yakult Central Institute, Tokyo, Japan

2. International comparison of regulation on Health Claim
(EU,US,JP)
Codex Standardized Specific Notification
Nutrient Function
Claim
EU（Genric function
claim）
JP（FNFC）
Other Function
Claim,
(Structure/Functi
on Claim)
JP（Standardized
FOSHU）
EU（new function
Claim）
JP（FOSHU）
US（DSHEA：
Dietary
Supplement
Health and
Education Act）
JP（FFC）
Disease Risk
Reduction Claim
US（NLEA：Nutrition
Labelling and
Education Act)
EU（Risk Reduction
Claim)
JP（Risk Reduction
Claim）
FNFC：Foods with Nutrient Function Claims, FFC：Foods with Function Claims,
FOSHU：Foods for Specified Health Uses
2

3. EU JP USA
Collective name
of the Foods
Foods with
Health Claims*1 FOSHU
Food with
function claims
Dietary
Supplement
Specific approval/
Standardized/notif
-ication
Specific
approval
Specific
approval/
Standardized
Notification Notification
Assessment
Body
EFSA CAA/CC*2 Business
operator
Business
operator
Responsibility
Standing
Committee / EC
CAA/CC*2 Business
operator
Business
operator
Types of System
Pre-assessment
and pre-
authorized claim
system
Pre-assessment
and pre-authorized
claim system
Prior
notification
system
Ex-post
notification
system
Applicable
period
Prior to the launch
and during the
sales period
Prior to the launch
and during the
sales period
From 60 days
before the launch
and during the
sales period
After the launch
(within 30 days
after the launch)
*1 Use this name because there is no name applied for this food category in EU.
*2 CAA: Consumer Affairs Agency, CC: Consumer commission
 International comparison of Health Claims on Other
Function Claims (EU,US, JP)
3

4. Foods with Function Claims
(Japan)
Dietary Supplement (US)
Notification
system
Prior notification system
(60 days before the launch)
Ex-post notification system
(within 30 days after the launch)
Safety
Information about the safety
should be submitted and
disclosed.
Information about the safety is not
need to be submitted or disclosed.
(The authorities could request
disclosure as necessary.)
Effectiveness
Information about the
effectiveness data should be
disclosed.
Information about the efficacy is not
need to be submitted or disclosed.
(The authorities could request
disclosure as necessary.)
Functional
labeling
Conspicuously-printed on the
front of container/package
Printed in extremely small character
size on container/package
4Comparison between labeling system for Dietary Supplement (US)
and Foods with Function Claims (Japan)

5. Foods with Health Claims (FHC)
Drugs
(including quasi drug)
Foods with
Nutrient
Function Claims
(standardized)
Foods for Specified Health
Uses (standardized/product
specific)
Common food
(including so-called
“ health food “)
《Prior classification ～2015.03.31》
Foods with Health Claims (FHC)
Drugs
(including
quasi drug)
Foods with
Nutrient
Function Claims
(standardized)
Foods for Specified
Health Uses
(standardized/product
specific)
Foods with
function claims
Common food
(including so-
called “ health
food “)
Categories allowed to bear function claims
New category added
5
《Current classification 2015.04.01～》
New category of Foods with Health Claims based
on new functional labelling system

6. Basic framework for New system
Labeling system that does not mislead, but helps the
consumers to select the goods independently and rationally.
Ensuring of
Safety
Establishing
scientific evidence
required for
labeling functional
claims
Providing consumers
with information
through proper
labeling
6
“Foods with Function Claims” System in Japan

7.  What is Food with function claims?
１．The target groups of the products are persons who are
suffering from diseases or on the borderline.
２．Products label the expected specific health benefit on the
package brought about by the functional substances based
on the scientific evidence.
３．Products are all foods except Food for Specified Health
Uses (FOSHU), Food with Nutrient Function Claims (FNFC),
alcoholic drinks and food which will lead to excessive
consumption of sodium, sugars and fat.
４．Product information including wording, safety, effectiveness
data, manufacturing and quality control … etc. should be
submitted to Consumer Affairs Agency (CAA) until 60 days
prior to the targeted launch date.
7

8. Role of the authority
•Product information, scientific evidence of
safety and effectiveness and content of labeling
should be submitted to the consumer affairs
agency prior to the launch of the product.
Consumer affairs agency (CAA) should disclose
that information prior to the launch.
• The authority should operate the new
labeling system appropriately by strengthening
the market monitoring (e.g. conduct a sampling
inspection based on the Food Labeling Act)
after launch.
8

9. Safety
１．Assessment of Safety
•Evaluate the history of consumption of the food by
human based on actual intake data, which is mainly
consisted of functional substance(s). (e.g.) daily intake,
sales period, sales volume, content of ingredient,
population, form, consumption methods, consumption
frequency …
•Research of existing information on safety
•In case that the history of consumption doesn’t
secure the product’s safety sufficiently, evaluate the
results of the safety study on animals or humans.
9

10. ２．Assessment of equivalence between functional
substance(s) for notification and those used in
existing information
・Food business operator should consider (explain)
the equivalence by qualitative and quantitative
method.
３．Assessment of Interaction between functional
substance(s)
・Interaction with drugs
・Interaction among functional substance(s)
10
Safety

11. History of
consumption
51 foods
Existing information
24 foods
Safety study
5 foods
History of consumption &
Existing information
8 foods
History of consumption &
Safety study
2 foods
Evaluation of Safety
（2015.4～2015.10）
11

12. Effectiveness
１．Clinical study with a finished product
① Prior registration to UMIN clinical trials registry
② Study method which conforms to FOSHU
③ Report of peer-reviewed papers in conformity with
CONSORT statement
２．Systematic review of the clinical studies on a finished
product or functional substances
① Evaluate systematic review in terms of “Totality of
Evidence”
② Consideration of equivalence between functional
substances used in the papers and those in a finished
product in the case of systematic review regarding
functional substances
☆ Subjects of the clinical study and available papers include
persons who are mild cases as well.
12

13. Evaluation of Effectiveness
（2015.4～2015.10）
Clinical study
16 foods
Systematic review
73 foods
Both methods 1foods
“FFC”：90 foods
13

14. １．Scope of functional labeling
• Expression of maintenance and enhancement of health,
including expression that refers to certain body sites, will be
accepted as functional labeling, but those including the name
of disease will not be allowed.
• Scope of food: all foods except alcoholic drink and foods
which will lead to excessive consumption of sodium, sugars, fat,
saturated fatty acid and cholesterol.
• Substance(s): direct or indirect quantitative substance(s) that
has been examined its mechanism.
• Target group: healthy people (those who are suffering from
diseases, minors, pregnant women or lactating women would
not be the target group.)
14
Labeling and Expression

15. ２．Labeling on containers and package
• Mandatory labeling as follows (excerpt);
- safety and effectiveness is not assessed by the administrative
authority
- the product is not designed to diagnosis, treatment
or prevention of disease
- the product is not designed for those who are suffering from
diseases, minors, pregnant women… etc.
３．Disclosure of information other than label on
containers and package
• Disclosure of the result of the safety assessment,
effort of quality control (HACCP, GMP…) and the
information of scientific evidence concerning
functionality is required.
15
Labeling and Expression

16. Type of function claims
（2015.4～2015.10）
Fat/Obesity; 22
Eyes; 14
Skin; 8
Blood pressure; 7Digestive system; 8 foods
Sleep; 2
Knee joint; 2
A feeling of
tension; 1
Blood sugar
level; 5
A feeling of fatigue; 2
Discomfort
of eyes and
nose; 2
Stress; 1 Bone; 3
Cholesterol; 1
Neutral fat; 4 Multiple function; 8
16
“FFC”：90 foods

17.  “FFC” receiving the notification
number : 489 foods
 “FFC” using Bifidobacteria or
Lactic acid bacteria : 38 foods
17
The foods labeled with a notification number
(2015.4～2016.10)

18. History of
consumption
32 foods
Existing information
3 foods
Safety study
3 foods
Evaluation of Safety on the products using
Bifidobacteria or Lactic acid bacteria
（2015.4～2016.10）
18
“FFC”：38 foods

19. Evaluation of Effectiveness on the products
using Bifidobacteria or Lactic acid bacteria
（2015.4～2016.10）
Clinical study
3 foods
Systematic review
(functional subatances)
34 foods
Systematic review
(finished product)
1 food
19

20. • 『BIO, containing Bifidus
BE80, has been reported to
ease gastro-intestinal
discomfort*.』
• *Gastro-intestinal discomfort
includes flatulence, bloating,
abdominal discomfort or
rumbling in lower digestive
tract that are commonly
observed in the usual life of
healthy population.
Danone Japan Co., Ltd
20

21. Functional
substance
Functionality Function claims Foods
Bifidobacteria-
utilizing foods
Bifidobacteria
Intestinal
regulation
Health benefit
of
probiotics
28
Lactic acid
bacteria-
utilizing
foods
Lactic acid
bacteria
Intestinal
regulation 1
Reduce
visceral fat
and body fat
6
Food
materials
(indigestible
dextrin,
GABA）
Effects of
each food
material
Health benefits
of each food
materials
3
21
“FFC” using Bifidobacteria and Lactic acid bacteria

22. Thank you for your attention