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Critical Factors for the Use ofFoods with Function Claims!
■First, reconsider your dietary habits.
― It is important to have a balanced diet consisting of meals including
a staple food, a main dish and side dishes.

■Consuming more Foods with Function Claims does
not necessarily result in better outcomes.
Excessive intake may cause adverse health effects.

ForConsumers

What are "Foods with Function Claims"?
The new system of Foods with Function Claims has beenlaunched. This is different from Foods for Specified HealthUses and Foods with Nutrient Function Claims.

― Carefully check warning statements printed on the package
when consuming Foods with Function Claims.
― Carefully read the recommended daily intake, directions for use,and warnings printed on the package.

■If you feel discomfort after consuming Foods withFunction Claims, immediately stop consuming theproduct.
― Whenever you do not feel well after consuming Foods with Function
Claims, immediately stop consuming the product and consult a doctor.
― The contact phone number of the food business operator is printedon the package. When any adverse health event associated withthe use of the product occurs, contact that number.

● "Foods with Function Claims" are foods submitted to the Secretary-General of theConsumer Affairs Agency as products whose labels bear function claims based on
scientific evidence, under the responsibility of food business operators.

For more details

Contact Information● Consumer Affairs Agency http://www.caa.go.jp/foods/index23.html

Food Labelling Division, Consumer Affairs Agency
TEL: +81-(0)3-3507-8800

Revised July, 2015
(English translation December, 2015)●Before purchasing and consuming Foods with Function Claims, carefully check thewarnings on the product label and the information disclosed on the website of theConsumer Affairs Agency.

● What are "Foods with Function Claims"?

1 What are Foods with Function Claims?
● Before this system was in place, making function claims on food labels had only been
allowed for government-approved Foods for Specified Health Uses (FOSHU) and forFoods with Nutrient Function Claims (FNFC) that comply with the specifications andstandards designated by the government. These systems remain in place.
●In addition to these categories, this new type of Foods with Health Claims, called Foods
with Function Claims, was introduced in April 2015 in order to make more products
available clearly labeled with certain nutritional or health functions and to enableconsumers to make more informed choices.
● These food products are allowed to label the function of food which is thatthe specified health effects can be achieved (i.e., helpful for maintaining andpromoting health) such as "Helps maintain good GI condition" or "Slows fatabsorption."● Under the condition that the safety of the food product is ensured, the foodproduct is labeled with a function claim which is based on scientific evidence andalso under the food business operator's own responsibility※.
※Food business operator refers to food importers, food manufacturers, food producers and food retailers.

● In order to enable consumers to make a product choice without misunderstanding
the information, the information must be provided through proper labeling, etc.

［Basic Approach of the System］

Foods Labeled with Certain Nutritional or Health Functions
Foods for Specified Health Uses
Foods for Specified Health Uses (FOSHU) are scientifically recognized as helpful for
maintaining and promoting health and are permitted to bear claims such as "Slowscholesterol absorption." The government evaluates the claimed effects and safety, andthe Secretary-General of the Consumer Affairs Agency gives approval for the labellingof each food product that satisfies the requirements.

Foods with Nutrient Function Claims
Foods with Nutrient Function Claims (FNFC) can be used to supplement or complement
the daily requirement of nutrients (vitamins, minerals, etc.) which tend to be
insufficient in everyday diet. Given that the food product contains certain amounts ofnutrient whose function has already been substantiated by scientific evidence, it canbear a nutrient function claim prescribed by the Standards without submitting anotification to the government.

Foods with Function Claims
Under the food business operator's own responsibility, Foods with Function Claims canEnsuring Safety

be labeled with function claims based on scientific evidence. Information on theevidence supporting the safety and effectiveness of the product are submitted to theLabelling System Not Misleading to Consumers andPromoting Consumer’s Voluntary and Reasonable Product Choices
Establishing
Requirements for
ScientificEvidence to MakeFunction Claims

Providing
Consumers withInformation
through Proper
Labelling

Secretary-General of the Consumer Affairs Agency before the product is marketed.
However, unlike FOSHU, the product is not individually pre-approved by the SecretaryGeneral of the Consumer Affairs Agency.

Foods in General

Any food labeled as a nutritional supplement, a health supplement, ora nutrient controlling food falls under this category.

※Cannot label a function claim

Characteristics of the System
１．Foods with Function Claims are for people not suffering from any disease (excludingminors, pregnant women (and those planning a pregnancy), or lactating women).
２．
All food products including fresh produce are subject to this system.

Foods with Health Claims※Can label a function claim

３. Prior to market entry, food business operators are required to submit information,such as on food safety and effectiveness and the system in place to collect information
on adverse health effects, to the Secretary-General of Consumer Affairs Agency.
４．Unlike Foods for Specified Health Uses, the government does not evaluate the safetyand effectiveness of the submitted product.
５．The submitted information is disclosed on the website of the Consumer Affairs Agency.
2Foods for SpecifiedHealth Uses
Foods with Nutrient
Function Claims
Foods withFunction Claims

FoodPharmaceutical products
Quasi-pharmaceutical products
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● What are "Foods with Function Claims"?

2 What is written on the label of Foods with Function Claims?
Back of Package
A notification number ison the label.

The product is labeled as"Foods with Function
Claims" on the principal
display panel.

A notification number can be used tocheck information regarding theevidence on safety and effectiveness ofthe product on the website of theConsumer Affairs Agency.

Front of Package
Foods with Function Claims
Notification Number △△Name : ○○○Ingredients : ◎◎◎◎◎、△△△△、○○○○○○○○○○/▽▽▽、 ×● Recommended daily intake : 2 tablets

×××、・・・・、 (Partially includingXX・○○) NET: 90g (1 tablet 500mg×180tablets) Expiration Date : written below
Storage conditions : Keep away fromdirect sunlight, high heat and moisture.
Manufacturer: ○○○○ CO., Ltd.

of this product does not cure disease or
promote health.

XXX, ○○city, △△prefecture
Nutrition Information●●●（Product Name）〈Submitted Claim〉

This product contains ◇◇, which has
a function to □□.

Under the responsibility of a food business operator,
this product has been submitted to the SecretaryGeneral of the Consumer Affairs Agency as aproduct labeled with a statement that specified
health outcomes can be achieved. However, unlike
Foods for Specified Health Uses, this product has notbeen individually evaluated by the Secretary-Generalof the Consumer Affairs Agency.

The label bears the claim submitted to theSecretary-General of the Consumer Affairs
Agency. The submitted claim states theeffectiveness of the product or thefunctional substance(s), which is based on
the scientific evidence.
The function claim states that the specified health effect can beachieved (i.e., it is helpful for maintaining and promoting health.).

4(Per recommended daily intake (2 tablets))

EnergyProtein
Fat
Carbohydrate
Salt equivalentkcalgggg

Functional substance ◇◇ mg● Directions for use : Take withwater or tepid water.

● Warning : Consuming a large quantity● This product is not intended to diagnose,

treat, cure, or prevent any disease.

● This product is not a food developed forpeople suffering from diseases, minors,
pregnant women (including those planninga pregnancy), or lactating women.
● If you have a disease, consult a doctor. If
you are taking medicines, consult a doctor
or a pharmacist.
● If you feel discomfort after consuming thisproduct, immediately stop taking theproduct and consult a doctor.
Maintain a balanced diet including
a staple food, a main dish and side dishes.
● Contact Information : 0120-XXX-XXX

Expiration Date
Bar CodeMore detailed information such asevidence on safety and effectiveness ofthe product submitted by food business
operators is disclosed on the website of
the Consumer Affairs Agency.
http://www.caa.go.jp/foods/index23.html

Follow the recommended daily
intake and directions for use, andcheck warnings on the label.

"Foods with Function Claims" arenot pharmaceutical products.
They are not intended for use in
the diagnosis, cure, or preventionof disease. People who have a
disease or are taking medicines
should consult a doctor or apharmacist.
It is not a food developed forpeople suffering from diseases,minors, pregnant women (including
those planning a pregnancy), orlactating women.
※ Although this statement is not on the labelof fresh produce, the same approach also
applies to fresh produce.

If your meal includes a staple food,a main dish and side dishes, youare more likely to have anutritionally balanced meal.

Consumers can call a phone number
on the label to make an inquiry orcontact the food business operator.

This indicates the quantity offunctional substance per unit ofrecommended daily intake.

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● What are "Foods with Function Claims"?

3

How is the safety and effectiveness ofFoods with Function Claims ensured?
● Food business operators are required to evaluate the safety and effectivenessin accordance with certain rules prescribed by the government and toestablish systems of production, manufacturing, quality control, and collecting
information on adverse health events. They must then submit the information
to the Secretary-General of the Consumer Affairs Agency 60 days prior tomarketing the product.
● Submitted documents are disclosed on the website of the Consumer
Affairs Agency.
● Consumers can check the product information on how the safety andeffectiveness of the product is ensured before the product is placed on market.

◆ The Consumer Affairs Agency will lead the post-market surveillance.

１．How is the safety evaluated?
The safety is evaluated by one of the following methods.
● A history of consumption by humans● Research of existing information on safety● Safety testing on animals or humans
Any interactions with drugs, etc. are also evaluated.

２．How is the effectiveness evaluated？

The effectiveness is evaluated by one of the following methods.
●Clinical trial(s) with a finished product●Systematic literature review(s)※ on a finished product or functional substance(s)This reveals: types of scientific evidence substantiating the claimed effects, thetarget population, the frequency and amount of consumption, and theeffectiveness of product.

３．How are systems of production, manufacturing and quality
control managed?
Food business operators are required to establish following systems.
● For processed food, structures of sanitary control for facilities and employees● For fresh produce, sanitation control procedure for producing, harvesting, or fishing● Systems designed to prevent distribution of out-of-specification products● An analytical method for the functional substance(s)Etc.

４．How are adverse health events collected?
Food business operators should establish a system to receive information fromconsumers, health professionals, etc. The contact information of the food business
operator (a telephone number) is always printed on the product label.

Please check the website of the Consumer Affairs Agency where
the information (1～4) submitted by the food business operator
is disclosed. You can get information about the evidence on foodsafety and effectiveness, which is arranged by notification number.

※What is a systematic literature review?
A systematic literature review is one of the considered methods for providing scientific evidence
on the claimed effect.
It determines the totality of evidence on the claimed effect based on not only favorable results but
also unfavorable results.
The authors of a systematic literature review retrieve research papers by searching databasesthat contain study literature. The authors develop a search strategy such as keywords that will be
used to retrieve literature beforehand. All retrieved literature is filtered, and then the literaturethat meets the pre-determined criteria is grouped according to whether or not their results
support the effectiveness of the finished product or functional substance(s).
A food business operator is not allowed to intentionally retrieve only studies reporting favorable
results in relation to the claimed effect.

● When the scientific evidence is provided by clinical trial(s) with a finishedproduct, the product package bears a claim that the product has afunction to ○○○○.
● When the scientific evidence is provided by systematic literature
review(s), the product package bears a claim that the product/functionalsubstance(s) has been reported to have a function to ○○○○.

6① Retrieving and filtering literature according
to a pre-defined search strategy② Scientifically evaluating the claimed
effect in light of the quality of each study③ Disclosing the evaluation
process and the results

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