161201 foods with function claims system in japan

"Foods with Function Claims" System in Japan

December 3rd, 2016

Shinji Hashimoto, Chief ResearcherYakult Central Institute, Tokyo,

Japan

International comparison of regulation on Health Claim(EU,US,JP)

Codex Standardized Specific NotificationNutrient Function Claim EU（ Genric function

claim）JP（ FNFC）

Other Function Claim,(Structure/Function 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

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EU JP USACollective name

of the FoodsFoods with

Health Claims*1 FOSHU Food with function claims

Dietary Supplement

Specific approval/Standardized/notif-ication

Specific approval

Specific approval/

StandardizedNotification Notification

Assessment Body EFSA CAA/CC*2 Business

operatorBusiness operator

Responsibility Standing Committee / EC CAA/CC*2 Business

operatorBusiness operator

Types of SystemPre-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)

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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)

SafetyInformation 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.)

EffectivenessInformation 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)

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

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《 Current classification 　 2015.04.01 ～》

New category of Foods with Health Claims basedon new functional labelling system

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

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.

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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.

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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.

　　　　　

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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)

10Safety

History of consumption

51 foodsExisting in-formation24 foods

Safety study5 foods

History of con-sumption & Ex-isting informa-

tion 8 foods

History of consumption & Safety study

2 foods

Evaluation of Safety （ 2015.4 ～ 2015.10 ）

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Effectiveness１． 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.

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Evaluation of Effectiveness （ 2015.4 ～ 2015.10 ）

Clinical study16 foods

Systematic review

73 foods

Both methods 　1foods

“FFC” ： 90 foods

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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.)

14Labeling and Expression

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.

15Labeling and Expression

Type of function claims （ 2015.4 ～ 2015.10 ）

Fat/Obesity; 22

Eyes; 14

Skin; 8Blood pressure; 7

Digestive system; 8

foods

Sleep; 2Knee 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; 3Cholesterol; 1

Neutral fat; 4 Multiple function; 8

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　“ FFC” receiving the notification number : 489 foods

　“ FFC” using Bifidobacteria or Lactic acid bacteria : 38 foods

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The foods labeled with a notification number (2015.4 ～ 2016.10)

History of consumption

32 foods

Existing in-formation

3 foodsSafety study

3 foods

Evaluation of Safety on the products using Bifidobacteria or Lactic acid bacteria

（ 2015.4 ～ 2016.10 ）

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Evaluation of Effectiveness on the products using Bifidobacteria or Lactic acid bacteria

（ 2015.4 ～ 2016.10 ）

Clinical study3 foods

Systematic review (functional sub-

atances) 34 foods

Systematic review (finished

product) 　1 food

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•『 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., Ltd20

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 fat6

Food materials

(indigestible dextrin, GABA ）

Effects of each food material

Health benefits of each food

materials3

21“FFC” using Bifidobacteria and Lactic acid bacteria

Thank you for your attention