3.the status of functional foods in taiwan 0917

1
The Status of Functional Foods
in Taiwan
Shiowwen Chen, Ph.D.
Food Industry Research & Development Institute
Hsinchu City, Taiwan
E-mail: sch@firdi.org.tw
September 21, 2018

Outlines
 Health Foods
 Definitions
 Health Food Control Act
 Material allowed
 Novel food
 Market trends
 Global
 Taiwan
 Cooperation
2

Definitions
 Nutraceutical and Functional foods
• Marketing terms, no legal status
• Food Safety and Sanitation Act
 Health Foods
• Health Food Control Act
• Legal term
 Medical Foods
• Special Dietary Food
• Food Safety and Sanitation Act
3

Health Food Control Act of Taiwan
• Promulgated on Feb. 3, 1999, and took effect on
Aug. 1, 1999. (31 articles)
To enhance the management and supervision of
matters relating to health food, protect the
health of the people of the republic and
safeguard the rights and interests of
consumers. (§1)
“Health Food”
4

• Amendments
1. 1999/12/22, §19 amended.
2. 2000/11/8, §5 amended.
3. 2002/11/30, §§7, 9, 11, 17, 22~24, 27, & 31 amended.
4. 2006/5/17, §§2, 3, 14, 15, 24, & 28 amended.
5. 2013/7/9, the competent authority was transferred from
Department of Health to Ministry of Health and.
Welfare.
6. 2018/1/24, §13 amended.
5

Definition of Health Foods
 Food with health care effects, having been labeled or
advertised with such effects.
The term “health care effects” shall mean an effect
that has been scientifically proven to be capable of
improving people’s health, and decreasing the
harms and risks of diseases.
However, it is not a medical treatment aimed at
treating or remedying human diseases;
such “health care effects” shall be announced by the
central competent authority. (§2)
6

Chapter I General Provisions (§§1-5)
Chapter II Health Food Permit (§§6-9)
Chapter III Management of Safety and Sanitation of
Health Food (§§10-12)
Chapter IV Labeling and Advertisement of Health
Food (§§13-15)
Chapter V Inspection of and Enforcement on Health
Food (§§16-20)
Chapter VI Penal Provisions (§§21-29)
Chapter VII Supplementary Provisions (§§30-31)
At: https://law.moj.gov.tw/Eng/LawClass/LawAll.aspx?PCode=L0040012
7

8
A Permit is Required for a Product to be
Claimed as “Health Food”
§ 6 No food shall be labeled or advertised as
health food unless it is registered as such in
accordance with this Act.
This Act shall govern any food that is labeled or
advertised as food furnishing specific nutrient or
specific health care effects.

A Dual System for Health Food Permits
§3 A health food permit shall be issued only if one of the
following requirements is met under the purpose of this Act.
1. Duly supported by scientific assessment of the safety
and health care effects of food that they are harmless
and carry definite, certain health care effects; if current
technology cannot identify ingredients contributing to
such effects, the ingredients with the relevant health care
effects and supporting literature shall be enumerated and
provided to the central competent authority for evaluation
and verification.
2. Ingredients conforming to the Health Food
Specification Standards set by the central competent
authority.
9

A Dual System for Health Food Permits
• Track 1: individual assessments of the safety,
stability and health care effects of the certified
product.
• Track 2: product ingredients conforming to the
Health Food Specification Standards set by the
central competent authority.
• Fish oil (DHA/EPA)
• Anka, red yeast rice, red mold rice, or Monascus spp.
10

11
Completeness of dossier
Information of applicant
Contents of label and instruction
General safety issues

§2 … accompanied by the preliminary review fee, intact product
samples, and (the) following documents and information:
(1) Application form
(2) Specifications and quantity of ingredients
(3) Safety assessment report
(4) Health care effect assessment report
(5) Identification report on ingredients with health care effect
of a product and its examination method employed
(6) Test report on the ingredient stability of a product and its
health care effect
Application for Track 1 Health Food Permits
Regulations for Application of Health Food Permit
12

• Track 1:
(7) Summary of manufacturing process
(8) Documentary evidence of good manufacturing practices
(9) Sanitary specifications and its test report
(10) General nutrients analysis report
(11) Relevant research reports and literatures
(12) Product package, label and information leaflet
(13) Registration certificate of the applicant's corporation or
business
13

§2-1 … accompanied by the preliminary review fee, intact product
samples, and (the) following documents and information:
(1) Application form
(2) Specifications of the raw materials and quantity of
ingredients of the product
(3) Ingredients specification test report of a product
(4) Test report on the ingredient stability of a product and its
health care effect
(5) Summary of manufacturing process
15

§2-1 …
(6) Documentary evidence of good manufacturing practices
(7) Sanitary specifications and its test report
(8) General nutrients analysis report
(9) Package, label and product instruction sheet
(10) Certificate of the applicant's corporation or business
registration
16

Anka, Red Rice Yeast
Health Food Specification Standards
At: https://law.moj.gov.tw/LawClass/LawAll.aspx?PCode=L0040077
17

Fish Oil
Health Food Specification Standards
At: https://law.moj.gov.tw/LawClass/LawAll.aspx?PCode=L0040076
18

The 3 Key Criteria of a Health Food
• Track 1: individual assessments of the
• safety,
• stability and
• health care effects of the certified product.
19

Safety of Health Food
• General
• Chapter IV of Food Safety and Sanitation Act
• Health Food Control Act
• Assessment methods
20
At: https://www.fda.gov.tw/TC/newsContent.aspx?id=19958&chk=bc02a081-030e-4029-
a8d6-7adb15fb8bd9&param=pn

Safety Assessment of Health Food
• 4 caterogories
• Category I –
• History of consumption as food, &
processed with traditional means
• Complete toxicological studies, record of
consumption, & (product’s) ingredients,
composition and processing means are
exactly the same as those illustrated in the
dossier.
21
At: https://www.fda.gov.tw/TC/newsContent.aspx?id=19958&chk=bc02a081-030e-4029-
a8d6-7adb15fb8bd9&param=pn

• 4 caterogories
• Category II –
• History of consumption as food,
• But, processed with non-traditional means
22
1. Ames test
2. In vitro chromosome aberration assay or
in vitro mouse lymphoma tk assay
3. Micronucleus test
4. Acute oral toxicity study
5. 28-day oral toxicity study

• 4 caterogories
• Category III –
• Has no consumption history (?)
23
1. Ames test
2. In vitro chromosome aberration assay or in vitro
mouse lymphoma tk assay
6. Teratogenesis test

• 4 caterogories
• Category IV –
• Has no consumption history
• (may) contain analogs of carcinogens
24
1. Ames test
2. In vitro chromosome aberration
assay or in vitro mouse
lymphoma tk assay
6. Teratogenesis test
7. Carcinogenicity toxicity
8. Reproduction test

Health Care Effects for Track 1 Permits
13 health care effects announced*
25
helpful for modulatingblood lipid levels
helpful for modulatingblood glucose levels
helpful for modulatingallergy
helpful for modulatingimmune functions
helpful in less proneto body fat build-up
increase endurance, anti-fatigue
good for bonehealth
helpful for slowing aging
helpful for modulatinggastrointestinal functions
helpful for resistance to liver damage (by CCl4)
good for dental health
helpful for modulatinghypertension
helpful for increasing iron absorption
Evaluation methods can
be found at:
https://www.fda.gov.tw/
TC/siteList.aspx?sid=17
60&pn=2

Stability Evaluation of a Health Food
26
At: https://www.fda.gov.tw/TC/newsContent.aspx?cid=5072&id=22317

Stability Evaluation of a Health FoodStability of a Health Food
27

Articles That Can be Used/Added in Food
28
At: https://consumer.fda.gov.tw/Food/Material.aspx?nodeID=160
§15-1

Articles That Can be Used in Foods
At: https://consumer.fda.gov.tw/Food/Material.aspx?nodeID=160
29
Department of Chinese Medicine and Pharmacy

At: https://www.fda.gov.tw/tc/newsContent.aspx?cid=3&id=24027 30
Novel food/ingredient
Non-traditional food/ingredient

31
Dossier of
reference search
Safety

Definition of Non-Traditional Food in Taiwan
32
1. Has no consumption history* as food in Taiwan; or do
have consumption history, but not long enough
2. Bred by non-traditional means, or processed by novel
technologies, leading to changes of compositions or
structure
Safety assessment is required

Classification of Toxicity of Non-Traditional
Food in Taiwan
33
Non-traditional
processing means or
consumption habit
Non-traditional food/
ingredient
Ames test
In vitro chromosome aberration
lymphoma tk assay
Micronucleus test
Acute oral toxicity study
28-day oral toxicity study
Ames test
In vitro chromosome aberration
lymphoma tk assay
Micronucleus test
Acute oral toxicity study
90-day oral toxicity study
Teratogenesis test

Taiwan
Connect Taiwan, Move business forward.
Health & Function
Foods in Taiwan
FIRDI Food Industry Research and Development Institute (TAIWAN)
INDUSTRIAL DEVELOPMENT BUREAU, MINISTRY OF ECONOMIC AFFAIRS
IMPLEMENTED BY
SPONSORED BY
Li-Ting, Chen
Research Scientist
FIRDI, Food Industry Research and Development Institute (TAIWAN)
34

Topics
Go with Global Trends
Health & Function Food in Taiwan
Connect Taiwan
Taiwan
Health & Function Food

Emerging Global Trends in Functional Foods:
the ongoing change in the market
Consumer
(Informationasymmetry)
Manufacturer
(Thrivingindustry value
chain )
Policy
(Regulationand
limitation)
Market
(Increasein sales)
Health
Environment:
ageing population
increased risk of infection diseases
popularity of functional ingredients
differences in regional development
changes in policy
Incentives:
consumer awareness
increased medical costs
R&D abilities
application of innovative technologies
“borderless” nature of internet
Source: ITIS Group of FIRDI (2018/05)
37

Trend 5: Another Choice
2018
Global FoodIndustry Trends
Viewpoints of FIRDI ITIS
An incredibly fine-tuned piece of handmade
workmanship comes from talent with extreme self-
discipline.
Plant-based food gets bonus points from images of
“health improving, mind power enhancing, widened
selection or deepening food value”.
Cutting-edge food service resembles an enjoyable
moment made of on fleek food and service with
perfect sensational and high-tech atmosphere.
Live your busy life the smart way! Let it take care of
everything and be ready to be spoiled.
An unstoppable trend of finding ways to better health,
more convenience and satisfaction has opened the
door to endless possibilities.
Speed-to-market and faster-paced production is
shortening the product life cycle. Convincing
products will change habits!
Is eco-friendly a cliché? Go green is a trend to bring
customers onboard.
Here comes a new trend in which food is not only
soothing your stomach but also comforting your life
and soul.
Precision medical development and information
diffusion is at the core of a trend seeking to optimize
one's gut environment and lead you to a healthy body.
Trend 10：New Solutions to Every
Old Problem
A change of behaviour and lifestyle, a change of
mindset towards perceived value and efficiency.
Trend 6: Your Second Mom
Trend 7: Enrich Your Life
Trend 8: Gut Lucky
Trend 9: Caring for The Earth
Trend 1: Plant Power
Trend 2: A Strong Sense of
Modernity
Trend 3: Salute the Spirit of Artisan
Trend 4: Always Want to Do better
38

Health & Function
Foods in Taiwan
39

Taiwan FDA approves 13 functional claims
that can be used for track 1 health foods
40
helpful for modulatingblood lipid levels
helpful for modulatingblood glucose levels
helpful for modulatingallergy
helpful for modulatingimmune functions
helpful in more resistant to body fat build-up
increase endurance, anti-fatigue
good for bonehealth
helpful for anti-aging
helpful for modulatinggastrointestinal functions
helpful for resistance to liver damage (by CCl4)
good for dental health
helpful for modulatinghypertension
helpful for increasing iron absorption

Health Food of Taiwan
Form of products
food
dietary
supplement
Industry
food biotech
Function
ingredient carrier
41
Source:TFDA (2018/02)，ITIS Group of FIRDI (2018/05)
Hypertension
Slowing aging
Iron absorption
Dental health
Anti-fatigue
Body-fat buildup
Allergy
Blood glucose
Bone health
Liver protection
Immune system
Gastrointestinal
functions
Blood lipid

Product Types of Health Food
0
7 12 16 22 27
43 51 68 87 100 108
115 126 131 142 154 164
1
5 9 13 18 25
32 36 43 57 73 81 89 99 110 123 140 151
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
traditional foods type dietary supplements
Sources:TFDA(2018/02), ITIS Group of FIRDI (2018/05)
42

Market Size and Segments of Taiwanese
Functional Foods
(billion
NTD)
Based on researches of FIRDI ITIS project, it’s estimated that
market size of Taiwanese functional food to be about 121 billion
NTD in the year of 2016.
Source: Food IndustryAlmanac 2016, FIRDI (2016/07)
Traditional
food-form
Dietary
supplements
43

The Ecosystem and Value Chain of
Functional Foods Industry in Taiwan
44
Value-creating
activities
Application
of products
Upstream Downstream
Access
Supply
chain
Virtual path
(Network mall
E - commerce
Physical path
Prepared foods
Milk powder
Dietary supplements
Snack food
Feed
Cleansing skin care
Fermented milk
Medical products
Consumer
Domestic
International
Culture Bank
Strain screening & identification
Large-scale fermentation
Collection oflocal strains
Optimization of fermentation production
Functional strains
Quality testing
(security/stability/functionality)
Brand value
Cost-controlling
Drying
Marketing & trade
Preservation
Strain LAB material
Safety &security
Strain improvement
Strain supply & trade
Healthfoodcertification
Related
industries
Raw material Culture-equipment testing
Domestic/Import Domestic/Import
Domestic/Import
Downstream processing equipment
(e.g. centrifugal, drying, packaging)
Beverages
Storage/coating
Direct
marketing path
Source: ITIS Group of FIRDI
44

Diverse Functional Foods/Ingredients
Diverse functional ingredients, diverse business opportunities
45
Functional
Food
Microbial Plant
Animal
VitaminMineral
Other
Bacteria: lactic acid bacteria
Fungi: black yeast, red yeast rice …
Medicinal mushrooms: Antrodia, Ganoderma
lucidum, Cordyceps sinensis …
Algae: green algae, cyanobacteria, spirulina
Fermented food: brown rice enzyme,
vinegar, fermented foods …
Root: ginseng ..
Stems: garlic …
Leaves: wheat grass, ginkgo leaves, aloe vera
Flowers: pollen, flower buds
Fruit: date, plum, mulberry
Seeds: barley, black soybeans, azuki beans,
quinoa, Camellia kissi seeds
Vegetable fat: Avocado oil, evening primrose
oil, wheat germ oil, coconut oil
Shellfish: oyster extract, clams
Insect by-products: royal jelly,
propolis
Animal fat: fish oil, cod liver oil
Bones, shark cartilage
Other organs: placenta, chicken
Other products: bird's nest, egg yolk
Vitamin A, C, E, D, BCalcium, iron, zinc, chromium
Carbohydrates: dietary fiber,
oligosaccharides, polysaccharides
Protein: soy protein, immunoglobulins,
collagen, enzymes
EPA, DHA, lecithin, linoleic acid
Others: nucleic acids …
Source: ITIS Group of FIRDI
EvergreenTraditionalNovel
Super Food

Major Raw Materials Used
by Taiwanese Functional Food Companies
Remarks: Survey was conducted in May, 2017.
Raw material type Description Percentage
Plant-based
Root (e.g., ginseng, acanthopanax), stems (e.g., garlic), leaves
(e.g., wheat leaf, aloe), flowers (& pollen), fruits (e.g., mulberry,
plums), seeds (e.g., barley), cereals (e.g., oats …
32%
Animal-based
Shellfish (freshwater clam, marine clams, oysters, etc.), insect
products (royal jelly, honey, propolis, etc.), animal (essence of
chicken or eel or …, fish oil, cod liver oil, etc.), viscera (internal
organs, placenta, etc.), bones (cartilage, bones, etc.), eggs, saliva
(bird’s nest, etc.) …
18%
Microorganism-based
Lactobacillus, Bifidobacterium, yeast, red yeast rice, Ganoderma
spp., Antrodia camphorata, Ophiocordyceps sinensis, green algae,
blue-green algae, spirulina …
47%
Others Water (sea water, mountain spring), soil, organic compounds 3%
The raw material of Taiwanese functional food products is diverse, and can be grouped into
four types: plant, animal, micro-organism and others. The focuses of research on raw material are
on plants and micro-organisms.
46

Uni-
President
Grape
King Bio
ViatlonNamchow
Biozyme
Agriculture
associations
Chatzutang
Standard
Foods
Bing-han
TCI-bio
AGV
Diversity and flexibility of Taiwanese food companies -
Operation models in response to environmental changes
…
47

Case 1: Explore Health Benefits of Tea to Engage
Target Customers
48
Three ‘Chai Li Won’ tea drinks being certified for “blood lipid
regulation”, and 1 of them is “double” w/ “less prone to body fat
buildup”.
Uni-president Chai Li Won
“Its aftertaste is just like freshlybrewedtea”
 Health benefit exploring Health FoodPermits
 Technology advanced low-temperature extractiontechnology
 Brand image advertising strategy: wittyand humorous＋office
workers as spokesperson
Sources:Uni-president, ITIS Group of FIRDI (2018/05)
Advanced
technology
Featured
Ingredients
Functional
Supplemnt
Ingredients
Products
Operation
Models＊＊＊＊

Case 2: Focus on Product Positioning and Develop
Specific Health Products
Sources: sfworldwide , ITIS Group of FIRDI (2018/05)
Quaker Oat (& other grain powder) + functional supplement
beverages
 Builda strongholdfor its core products  Health Food Permits
 Technology grain processing technologies + patents
 Products oat-related+ functional beverages
 Brand image professionof nutrition and health + advertising
strategy: love for family
49

Case 3: Focus on Fermentation Techniques and Seek
Cooperation in Product Developments
Sources:Grape King Bio , FIRDI (2018/09)
Grape King Bio
Fermentationtechnologies + Ingredients R&D + OBM/ODM/OEM
 Builda strongholdfor its core technologies  1st infermentation-based
products + Health Food Permits
 Technology fermentation + Ingredients R&D + patents
 Products LAB+ medicinal fungi
 Brand image Professionof fermentation + cooperationpartners
50

Case 4: Focus on R&D and Seek International
Cooperation in Product Developments
51
TCI-bio
dietary supplement + functional ingredients development +
international cooperation
 Featured ingredients source ingredients locally(e.g.
bananas) and around the world
 Technology  integrated bioscience design+ patents
 Operation models international boutique cooperation
partners + industry/media interaction+ product awards
Sources:tci-bio, ITIS Group of FIRDI (2018/05)

Case 5: Focus on Value Creation of “Enzymes”
52
Sources:biozyme, ITIS Group of FIRDI (2018/05)
Biozyme
choice of vegetables and fruits combination+ fermentation
 Functional benefits exploration find new functions
 Technology  processing ofvegetables and fruits (secure) +
fermentation
 Products  enzyme-related
 Brand image  Professionofnutritionand health + brand
image + high-price marketing

Case 6: Make a Difference by Integrating Local
Products, Culture, and Tourism
53
Featured plants in Taitung
functional value development + tourism culture connection
 Functional benefits exploration “certified” functional ingredients +
explore new functions
 Technology  cooperate withindustry, academia, and research
institutes + new product development
 Products  “Community spirit”
 Brand image  tourism + targetedconsumer groups + integrated
marketing
Sources:taitung.gov.tw, toyugimal, ITIS Group of FIRDI (2018/05)

Product Development Trend of Functional
Foods in Taiwan
54
Plants
Microbes
Animals
Advanced
technology
Featured
ingredients
Functional
supplement
ingredients
Products
Operation
models
Current Market
(Carriers)
 Food
types
 Capsules
or
lozenges
(Functions)
 Features of
functions
 Proving
functions
 Labelling
functions
(Creation)
 Extraction
technology
 Fermentation
technology
 Product
development
(Features)
 Predominant
ingredients
 Developing
functions
 Food culture
 Local features
 Safety
assurance
 Standards and
specifications
＊＊＊＊
(Integration)
 Target consumer
groups
 Shopping
experiences
 Channel
changing
 Social media
 Trends and
environment
 Trans-industrial
technology
Future Market
Keep Exploring

1. Technology
2. Integration
3. Innovation
Global
Cooperation
Taiwan GlobalClean Label
Transparency
Regulation
Compliance
Forming
Industrial
Chain
Intelligent
Manufactuting
Utilizing
Resources
Modernizing
Traditional Diets
Focus of International Cooperation
Ex. Communicating and
converging product
standards
Ex. Developing new
values of functional diets
Ex. Developing multiple
high values of raw materials
Ex. International
division of labor
on developing
functional materials
Ex. Automation of
manufacturing processes
Health&
Functional Food
56

Safety + Deliciousness
Health
Convenience
Pleasure
Enviorment
Jointly creating a healthy, secure, happy and sustainablelife
Consumer Demands
Living wisely
Local
Brand
Cost/Performance
Culture
Story
Certification
Experience
1. Technology
2. Integration
3. Innovation
Taiwan
Discovering & Creating New Demands
in ASEAN and Global Wide
Health& FunctionalFood
57

Taiwan
What We Do
Business Matching
Market Analysis
Regulatory Consultation
R&D Services
Training
Taiwan58

Taiwan
FIRDI
Contact Us │Address:331 Shih-PinRoad, Hsinchu, 300 TaiwanR.O.C.
│FAX:886-35-214016│
│TEL: 886-35-223191 EXT. 233
│E-MAIL: yfc@firdi.org.tw
│TEL: 886-35-223191 EXT. 704
│E-MAIL: cla@firdi.org.tw
Chen,Yu-Fen
DEPUTY DIRECTOR
Chen, Lei-An
ASSOCIATE RESEARCH SCIENTIST
59

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3.the status of functional foods in taiwan 0917