161201 foods with function claims system in japan
TRANSCRIPT
"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” : 90 foods
“ 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 )
18
“FFC” : 38 foods
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