Regulation and Ingredient Registration Masterclass

Health claims in Southeast
Asia
Speaker: Dr. Iain Brownlee, Director of Operations for Food & Human Nutrition, Newcastle
University International Singapore, Singapore
Health claims in Southeast Asia
Dr Iain Brownlee
iain.brownlee@ncl.ac.uk
Overview of presentation
• An introduction to the idea of food-related

claims
– Background
– Scientific basis
• The current situation in Southeast Asia
– ASEAN free market
– Existing regulations and frameworks
– Stakeholder perpsectives
Who am I?
• Academic in Singapore since 2011
• Research interests overlap with health claims
– Wholegrain food interventions
– Dietary fibre and health
– Development of anti-obesity products
• Strong track record of industry collaboration
– Food
– Pharmaceutical
– Biotech
Acknowledgements
What is a health claim?
• Broadly, a claim made in relation to the

composition of a food or its impact on health
status
– Various definitions used around the world
Company Regulatory agency Outcome
Accept
Application Evaluation Reject
Reconsider
Claims timeline
AVA Singapore (2010)
MoH Malaysia (2010)
FSANZ Australia/
FDA The Philippines (2007) New Zealand (2013)
Codex (International)
1997 2009
1990 2017
FOSHU (Japan)
1991 2001 NADFC Indonesia (2011)
MoPH Thailand (2011)
EFSA (Europe)
1996 2006
MoH Vietnam (2014)
FDA (US)
1990 2003
Adapted from K. Tan thesis (2017)
Southeast Asia
• Association for Southeast Asian Nations
(ASEAN) formed in 1967
– 2009 ASEAN Trade in Goods Agreement
– Aimed at ASEAN economic community
• Each country currently manages it own food
standards
• Subsequent impact on:
– Import and export
– Food labelling
The spectrum of food-
related claims
• Nutrient-function claims
– Based on existing cut-offs for compositional content
– e.g. Product X contains Y units of nutrient Z
• Associated/other claim
– Can be related to health outcomes
– e.g. “Free from…”, “organic”
• Disease-related claim
– Reduction of disease risk
– Disease amelioration
– e.g. “Product X [contains y units nutrient Z and] has been
shown to reduce [a specific disease] risk”
Codex Alimentarius (2013) Guidelines for use of nutrition and health claims
Dietary fibre and
health
• Consumption of plant-based foods historically
linked to health
• “Dietary fibre hypothesis” linked low intake to

incidence of non-communicable diseases
– Burkitt: diet and disease Europe vs East Africa
– Cleave: added bran to refined flour for constipation
• In-depth research on dietary fibre and health

commenced in the ‘70s Cleave (1941) British Medical Journal 1
Burkitt (1952) East African Medical Journal 29
Health claims and
evidence
Panel consensus or meta-analyses?
Intervention studies
Weighting of evidence
Randomised controlled studies
Other randomised studies (non-controlled)
Controlled, non-randomised studies
Other intervention studies
Observational studies
Cohort studies
Case-control studies
Cross-sectional studies
Other observational studies (e.g.: case reports)
Other studies
Animal and mechanistic studies
Historical observation
EFSA health claim guidelines

Stakeholders in health claims
Government
(regulators)
The Industry
(applicants)
Academics public
(advisors/
evaluators)
Example: composition
Source of fibre High in fibre

≥3 g per 100 g ≥6 g per 100 g
≥1.5 g per 100 kcal ≥3 g per 100 kcal
≥10% daily reference value ≥20% daily reference value
per serving (US) per serving (US)
Codex Alimentarius (2013) Guidelines for use of nutrition and health claims
Example: plant-based foods
• “Low fat diets rich in fiber-containing grain products,
fruits and vegetables may reduce the risk of some
types of cancer, a disease associated with many
factors.”
• “Development of cancer depends on many factors.
Eating a diet low in fat and high in grain products, fruits
and vegetables that contain dietary fiber may reduce
your risk of some cancers.”
• The food must:
– Be, or contain, a grain product, fruit, or vegetable.
– Qualify as “low fat”
– Qualify, without fortification, as a “good source” of dietary
fiber Food & Drug Administration Guidance for Industry: A
Food Labeling Guide (11. Appendix C: Health Claims)
Example: bioactive ingredient
• Oat β-glucan and LDL cholesterol reduction

– “… >3 g of oat beta-glucan per day… [in] adults
who want to lower their blood cholesterol
concentrations”.
• Glucomannan (konjac fibre) and body weight
reduction
– “… >3 g of glucomannan … in 3 doses of >1 g
each… [as part of] an energy-restricted diet [in]
overweight adults”.
EFSA Journal (2010) 8:1885
EFSA Journal (2010) 8:1798
Comparison across ASEAN
Standards
Member Reference
(National Agency of Drug and Food Control of the
Indonesia
Republic of Indonesia, 2011)
Malaysia (Ministry of Health Malaysia, 2010)
(Agri-Food & Veterinary Authority, 2010 (with
Singapore
amendments to 2016))
Thailand (Ministry of Public Health Thailand, 2011)
(Codex Alimentarius, 1997 (last amended in 2013 –
The Philippines
via Food & Drug Administration Philippines)
Vietnam (Ministry of Health Vietnam, 2014)
Tan et al., (2015) Nutrition Reviews 73
Claim types/definitions
Member Definition of health claim Types of claim Associated
Indonesia “…states the relationship of Nutrient function N
food/food substances to health” Other function
Reduction of disease risk
Malaysia N N Nutrient function
Other function
Singapore “… states, suggests, or implies … a Nutrient function N
relationship … between a Other function
food/food constituent and health” Reduction of disease risk
Thailand “Image … or any statements Nutrient function N
appeared on the label in connection Other function
with food, food component, or Reduction of disease risk
nutrient that are associated directly
and indirectly with health”
The “… states, suggests, or implies … a Nutrient function N
Philippines relationship … between a Other function
food/food constituent and health” Reduction of disease risk
Vietnam N N “Functional
food”
Claim scope/objectives
Member Scope Objectives
Indonesia Processed foods with claim declaration To protect the public from misleading claims on
Includes labels and advertisements labels and advertising of processed foods
Malaysia Unavailable Unclear

Singapore Food labels and advertisements Provide food importers, manufacturers and
retailers with a better understanding of the
labelling requirements of the Food Regulations,
as well as the permitted and prohibited claims
for use in food labels and advertisements
Thailand Unavailable Unavailable
The All foods To provide truthful and non-misleading
Philippines Food labels information to aid consumers in choosing
Advertisement (if required by local healthful diets
authorities)
Vietnam Functional foods (supplemented food, Regulate activities of manufacture, trade,
health supplement, medical food and product announcement, labelling and
food for special dietary uses) instruction for use

Comparison to Codex principles
Member Consistent Scientific Provide Not associated Do not lead Contribute

with national evidence to truthful/non- with to wrong to … a
health substantiate misleading treatment/ consumption balanced
policy? the claim? information to prevention of patterns? diet?
aid consumers … diseases?
Indonesia Y Y Implied Y Y Y
Malaysia N Y N Y N N
Singapore N Y Implied Y N Implied
Thailand N Y N Y N Y
Vietnam N Implied N N N N

Scientific comparability
Member Study types Publication Researchers Supporting

knowledge
Indonesia Human studies e.g. Published in Conducted by independent In vitro
RCT scientific journals researchers or institutions Animal studies
Observational studies
if not possible
Malaysia Human intervention Published in peer- Should include studies Epidemiological
trials reviewed journals from other organisations Experimental
or institutions Review papers
Singapore Well designed human ≥5 peer-reviewed None Observational

interventions reports, ideally Animal models
published in last Ex vivo
10 y In vitro
Thailand ≥2 appropriately None None Unknown
designed interventions
with adequate
samples…
Stakeholders in health claims
Government
(regulators)
The Industry
(applicants)
Academics public
(advisors/
evaluators)
Study design
• Comparative study in mothers (n=48) in urban Indonesia,
Thailand and Singapore
• Data collected via focus groups
– Knowledge
– Understanding
• Evaluated perceptions for 3 micronutrients
– Calcium
– Iron
– Vitamin A
• Compared 3 types of claim statement
– Approved
– Derived (short) version
– Contrived (inappropriate)
Tan et al., (2016) Appetite 105

Examples
Nutrient Approved Derived Inappropriate
Calcium… … plays a role in the … makes strong … helps you to grow
formation and bones and teeth taller
maintenance of
bone density and
teeth
Iron… … is a component … helps your body … helps build strong
of haemoglobin in to produce energy muscles
red blood cells that
carried oxygen to all
parts of the body
Vitamin A... … can help to Antioxidants like Antioxidants like
maintain the carotenes and carotenes reduce
integrity of the vitamin E support the chance of your
surface layer your child’s child from falling
immune system sick

Major findings
• High degree of trust in health claims

– Trust in government bodies
– Trust in manufacturers
• Limited understanding of health claims process
– Sourced information via public domain and
commercial sector
• More confident of understanding on Ca claims
– Concerns with “scientific” terminology

Further developments
• ASEAN Agreement on Traditional Medicines

• ASEAN Agreement on Health Supplements
– Annex VII ASEAN Guidelines on Claims and
Claims Substantiation for Traditional Medicines
and Health Supplements
– Suggests “traditional”, “nutritional”, ‘functional”
and “health” claims
– Suggests definitions and delineations
Take-home messages
• Food-related health claims are developing in
the region
• Nutrient-based claims tend to be easier to

substantiate
• There is currently no cross-ASEAN standard for

food-based health claims
• Consumer understanding of claims is key

APAC (Regional Food Regulation &
Registration: Comparative legal and
regulatory update)
Speaker 1: Alan Adcock, Partner, Deputy Director, IP and RA, Tilleke & Gibbins, Member,
Lifesciences Asia Pacific Network (LAN), Thailand and Vietnam
Speaker 2: Nick Beckett, Managing Partner, Beijing Office, CMS, Member, Lifesciences Asia
Pacific Network (LAN), China
Speaker 3: Charles Fisher, Principal, Food Legal, Australia and New Zealand
Speaker 4: Nicholas Lauw, Partner, Rajah & Tann, Member, Lifesciences Asia Pacific Network
(LAN), Singapore and Malaysia
Bangkok • Hanoi • Ho Chi Minh City
Jakarta • Vientiane • Yangon
Asia (Regional) Food Regulation &

Registration : Comparative
Regulatory and Legal Update
Alan Adcock
Presented at: Vitafoods Asia 2017
@ Marina Bay Sands
6 September 2017
Thai Food Industry
Thailand—hugely attractive and lucrative market for both
foreign and local food manufacturers
Number of Enterprises Cumulative Investment Employment
7,742 USD 20 billion 1.1 million
**S=Small enterprises, M=Medium enterprises, L=Large enterprise

Reference: National Food Institute Ministry of Industry
30
Overview of Food Industry
Production
GDP BY INDUSTRY SECTORS

Food Manufacturing Production
21.8% Index
Others 1.1% yoy
40.9%
Electricity
Capacity Utilization
and
Electronic
55.28%
21.8%
Apparels
/Textiles Autovehicles
Chemicals
5% 10.4%
7.1%
31
Overview of Food Industry
Consumption
Average monthly Spending of Thailand Food Market in World

Thai Householding 2016 Market Share between 2006-2016
Food & Beverages 33.7%

Housing/Maintenance 19.7%
Transportation 17.4%
Person/Closing/Shoes 5.2%
Communication 3.4%
Others 20.6%
32
Food Act 1979
 The Food Act is applicable to the manufacture and
importation of food for sale in Thailand. Manufacturers
and importers are required to obtain licenses prior to
manufacturing and/or importing food into Thailand.
 Place of Business Registration (an establishment
license) either as a manufacturer or an importer (renew
license every three years)
 Food Product Registration (valid lifelong subject to
variation updates)
 Distribution and/or sale of foods do not require a license
under the Food Act
33
Food Act 1979
 Definition of "food" means edible things or things required for the
sustenance of life:
 all kinds of substances eaten, drunk, held in the mouth or taken
into the body by human beings irrespective of the means or
manner in which they are consumed, excluding medicines,
psychotropic substances or narcotics which may be governed by
other laws; or
 substances aimed to be used, or used as ingredients, in the
manufacturing of foods, including food additives, colors and
flavorings.
Although the Act does not mention food packaging, the Act also covers
their specification and standard (e.g. baby bottle milk for infants).
34
Importation of food products into
Thailand
 For foreign food manufacturers, their first
interaction with FDA too often ends with a firm
rebuttal, as their products are rejected for
registration or they face significant delays.
 Although FDA obstacles can be frustrating,
companies can achieve success by
familiarizing themselves with Thai FDA
practices and preparing for potential pitfalls.
35
License Holding in Thailand
- When overseas manufacturers of FDA / MoA regulated
products have no locally established businesses in
Thailand…
- …and who do not wish for their Thai authorized
distributors to have knowledge of/access to their
confidential and proprietary product formulations/efficacy
data…
- …they may choose to engage a license holding
consultancy to serve as their product license holder for
purposes of registration at the relevant authority and
import clearance through Thai Customs.
36
Type of Food Products
 Type 1 - Specific controlled food (food standard, specifications,
packaging and labeling)
 Type 2 - Standardized food (quality and labeling)
 Type 3 - Labeled food
 Type 4 - General food (do not require FDA number, optional for
registration)
37
Trends in Food Supplement
NUTRACEUTICALS
Isoprenoids Phenolic Protein/ Fatty acids Vitamins/ Microbial

(Terpenoids Compounds Amino acid Struct. Lipids Mineral Probiotics
)
carotenoids flavonoids amino acids n-3 PUFA vitamins
terpenes isoflavones allyl-S-cpd. CLA Zn/ Fe/ Ca
Mg/ Cu
Co Q10 anthocyanin indoles lecithin
microelements
tannin (V, Cr)
About 1,000 applications per month
38
Food Registration
 Application form
 Copy of manufacturing license/import license
 Power of Attorney
 Technical documents: formula, production flow
chart, ingredient specification, finished product
specification, packaging material, GMP
Certificate from manufacturer, Certificate of
Free Sales from country of origin, Label
 Product analysis report
39
Registration Problems
 Insufficient number of FDA officers (14 persons) to review
high volume of applications (avg: 71 applications / officer /
month)
 FDA officers have high backlog
 More Junior FDA officers than Senior FDA officers
 100% manual work
 Applicants are not familiar with the law
 A limitation of the consultation process for acceptability of
ingredients – phone calls or one-on-one meetings
 No public Positive or Negative lists for Food Supplement
Ingredients
40
Keys to success: food registration
 New Food Ingredients: A company must first determine whether

all its ingredients have already been approved by the Thai FDA.
An ingredient that is commonly registered in another country
may not necessarily have been registered with the Thai FDA.
 For New Food Ingredients, the FDA will request additional
supporting documents. For example, a product used in food
consumption must be able to show a history of use for more than
15 years in a foreign country and/ or safety data.
 Strategic decision whether to retain the New Food Ingredient in
a formula. New ingredient can be helpful in differentiating the
product from competitors. But companies face an extended
registration process when new ingredients are included.
41
Keys to success: food registration
 Misclassification of food
 Vitamins & Minerals, which are classified as Food
Supplement, can be classified as a Drug in Thailand
 Prior to FDA submission, an applicant must be fully aware
of (1) the ingredient list for its product; (2) the source of the
ingredients; (3) the manufacturing process; (4) the
objectives of use; and (5) the targeted consumer group.
These factors will allow the company to:
 Preliminary classify the product; and
 Assist in answering registration question from the FDA.
42
Food Product Name
 Trademarks are regulated by both Department of Intellectual Property
(DIP) of Ministry of Commerce and the Health Surveillance Agency—
Food and Drug Administration (FDA) of Ministry of Public Health
 Both agencies have different rules to each other
 Yet the FDA approval process can cause frustration because there are
limited legal arguments available and the rationale for refusal is not
always given.
 The name of the food must not “cause
any misunderstanding in the essential
part, must not be false, must not be
deceitful, must not me misleading,
must not be against the good culture of
Thailand, or must not reflect a destruction
of Thai language value.”
43
Food Product Name
 Recent tendency of the FDA has been to reject
names that include specific descriptive words,
such as “slim”, “lean”, “white”, “boost”, and
“cure” among others.
 FDA examiners have also rejected any
wording that has a different spelling or
appearance to these descriptive words with a
similar sound, such as “linn” used in place of
“lean.”
44
FDA Number
Type of business (manufacturer or
importer) Business number
Province code
e.g. 10 Bangkok (specific for each
company)
XX – X – XXX XX – Y – YYYY
No. of registered
Year of approval
product
(B.E.)
Authorized by FDA or
Health Provincial Office
45
Licensing Facilitation Act to enhance
food registration procedures
 Thai laws usually give the authorities broad discretion in granting
licenses, which ends up affecting business, because the costs, time
and outcome are unpredictable.
 A new law called the Licensing Facilitation Act B.E. 2558 (2015),
which came into effect on July 21 2015.
 The act requires government authorities to prepare a 'public
manual.‘ The act aims to solve these issues by requiring the
authorities (e.g. FDA) to publish public manuals disclosing the rules,
procedures, requirements, costs and periods of time for granting the
relevant licenses.
 As required under the act, the Food Bureau of FDA has published
33 public manuals.
 E-Submission effective on August 10, 2016
46
Example of Timeframe according to
Public Manual
Procedure time
Food Supplement 35 days
Supplementary Food for Infant and Young Children 35 days
Food for Weight control (e.g. sweetener) 35 days

Modified Milk (Other than Milk for Infant and Young Children) 35 days
Food Additives 35 days

Cow’s milk, Flavored milk, Fermented milk, Other Milk Products, 25 days
Ice-cream, beverages in Sealed Container, Food in Sealed
Container
Food Advertising 10 days
47
FDA Service Fees
FDA Reviewing Fee Government Fee
List
(Baht) (Baht)
- Formal Product Classification 1,000 Free
- E - Submission for Standardized food and
200 Free
Food with label (no formula approval)
- E - Submission for Standardized food and
2,000 Free
Food with label (formula approval required)
- Reprocess of 7 food categories (Fast Track) 2,000 Free
- Food Additive (already listed in Codex/FDA
3,000 5,000
database)
- Specially Controlled Food 4,000 5,000
- Medical Food Product 4,000 5,000
- Food Supplement (SorBor 5) 2,000 Free
- Food Supplement (SorBor 3) 3,000 Free
- Food Advertisement 2,000 5,000
License Variations 200 - 1,000 Free
48
Meeting with the FDA and Handling
with the official action
Meeting preparation
 Be persuasive, but open & honest

 Focus on Q&A
Avoid broad & open-ended questions
Be specific & answerable
 Do not speculate
 Precaution: Do not stress commercial concerns
over science!
49
FDA inspections – Typical scenario
 A food importer/manufacturer is inspected by the

Thai FDA and receives a fine because their
advertising contains over-claims and unapproved
advertising. Variations not notified.
 Control Inspection Report. Do not sign until facts
verified.
 Liaise with FDA before police/Customs are alerted.
 Urgent audit of products and promotional materials.
 Developing Action Plan going forward.
50
Alan Adcock
Tilleke & Gibbins | Supalai Grand Tower, 26th Floor, 1011 Rama 3 Rd.,
Chongnonsi, Yannawa, Bangkok 10120, Thailand
D: +66 2056 5871 | T: +66 2056 5555 | F: +66 2056 5678 |
Email: alan.a@tilleke.com
For more information please visit our website:
www.tilleke.com
51
APAC FOOD REGULATION & REGISTRATION: COMPARATIVE
REGULATORY AND LEGAL UPDATE (SINGAPORE)
Vitafoods Asia 2017
6 September 2017
SUMMARY
• Food regulation issues arising out of the investigation into the sale
of infant milk formula in Singapore.
• Other areas that may be subject to further regulation in future.
53 Not to be reproduced or disseminated without permission.

INFANT MILK POWDER IN SINGAPORE
• Average price has risen from S$25 to S$56 outstripping the increases in
other dairy products and household staples.
• Families can spend around S$150 to S$200 a month on just milk
formula for 1 child.

INFANT MILK POWDER IN SINGAPORE: THE ISSUES
• The CCS investigation found that manufacturers primarily engaged

in non-price competition in Singapore.
• Strategies were adopted to build a premium image for their milk
formula products in order to entrench consumer brand loyalty.
• Premium formulations were being imported into Singapore.
• Manufacturers were providing sponsorship and/or payments to
private hospitals for participation in their milk rotation systems.

INFANT MILK POWDER IN SINGAPORE: CCS
RECOMMENDATIONS
• Improving Consumer Awareness

• Encouraging Entry
• Review of Sponsorship

INFANT MILK POWDER IN SINGAPORE: HPB RECOMMENDATIONS
• Adjust guidelines and regulations on advertising, labelling and the

importation of Formula Milk
• Strengthen Public Education efforts

INFANT MILK POWDER IN SINGAPORE: ACTIONS TO BE TAKEN
• Amendment of the Sale of Infant Food Ethics Committee Singapore

Code (SIFECS).
• To be extended to applying to formula milk for infants up to 12
months (previously to 6 months).
• Full review to be completed by the end of the year

INFANT MILK POWDER IN SINGAPORE: IMPROVING CONSUMER
AWARENESS
Under the current SIFECS code

• Labels cannot imply that formula milk products are superior to breast
milk.
• Must meet regulations under the Sale of Food Act.
• Point of sale materials, can inserts or stickers are not permitted.
• Can only provide information on the appropriate use of the product,
and cannot encourage progression to follow-on formulas.
• A notice stipulating that breast milk is best has to be provided.

INFANT MILK POWDER IN SINGAPORE: IMPROVING CONSUMER
AWARENESS
• Adjusting the Guidelines and Regulations

on the advertising, labelling and import of
formula milk.
• Discourage manufacturers from incurring
costs on advertising and marketing
activities.

INFANT MILK POWDER IN SINGAPORE: ENCOURAGING ENTRY
• Difficulties of parallel importing milk formula.

• SIFECS labelling requirements prevent the parallel importation of
milk formula from countries where labels do not comply with local
regulations.
• Parallel importers must obtain various import documentation from
the manufacturer or the distributors in the country of export (Import
Requirements of Specific Food Products.
• The nutritional requirements in our Food Regulations, Sale of Food
Act, are arguably less stringent than the Codex Alimentarius.

INFANT MILK POWDER IN SINGAPORE: ENCOURAGING ENTRY
• Changes may be made to SIFECS and other regulations to make

the parallel importation of milk products easier.
• Has to be balanced with the need to maintain food safety
standards.

INFANT MILK POWDER IN SINGAPORE: REVIEW OF
SPONSORSHIP & PUBLIC EDUCATION
• Hospitals may be encouraged to carry brands or products that are

available commercially at lower prices.
• Parents will be made aware that all infant formula regardless of
price meets Singapore’s nutritional requirements for healthy infants.
• Promotion of breast feeding.
• Promotion of cows milk for children above 12 months of age.

OTHER AREAS OF INTEREST: REDUCTION OF SUGAR
• Diabetes Prevention and Care Taskforce studying measures to

reduce the level of sugar in beverages.
• Agreement by 7 major soft drink manufacturers to reduce sugar
content to 12% and below by 2020.
• Sugar Tax?
• Warning Labels?
• Advertising Restrictions?

OTHER AREAS OF INTEREST: PROMOTION OF BROWN RICE
• Not clear if any legislative steps will be taken in this area.

DISCLAIMER
The material in this presentation is prepared for general information

only and is not intended to be a full analysis of the points
discussed. This presentation is also not intended to constitute, and
should not be taken as, legal, tax or financial advice by Rajah &
Tann. The structures, transactions and illustrations which form the
subject of this presentation may not be applicable or suitable for
your specific circumstances or needs and you should seek
separate advice for your specific situation. Any reference to any
specific local law or practice has been compiled or arrived at from
sources believed to be reliable and Rajah & Tann does not make
any representation as to the accuracy, reliability or completeness of
such information.

THANK YOU
Rajah & Tann Singapore LLP

9 Battery Road #25-01
Singapore 049910
+65 6535 3600
nicholas.lauw@rajahtannasia.com
www.rajahtannasia.com

Labelling and advertising of food in China
Nick Beckett
Managing Partner, CMS Beijing
Global Co-Head of CMS Life Sciences Sector Group
Labelling and advertising of food in China | 6 September 2017

Overview - China
 Labelling food
• Requirements
• Common Pitfalls
• Liabilities for non-compliance
 Advertising food
• Requirements
• Common Pitfalls
• Liabilities for non-compliance
 Comments on best practice
• Beware “professional shoppers”
Labelling and advertising of food in China | 6 September 2017 CMS

69
Food Labelling
 Main obstacle to importation

 Targeted by “professional shoppers”
 Fragmented legal regime:
• Law
 Food Safety Law
• Regulations
 Measures on the Supervision and Administration of Inspection of
Labels for Import and Export of Prepacked Food
• National Standards (GB):
 GB7718-2011 General Rule for the Labelling of Prepacked Food
 GB1535-2003 Soya Bean Oil
• Notices
 Announcement on Approving Ginseng (Artificial Planting) as New Raw
Food Materials
 Reply on Issues regarding Labels of Prepacked Food

70
Food Labelling – General Rules
 Approved before importation

 Principles:
• Prominent, legible, understandable, true, accurate, in Chinese etc.
 Required information
• Name of food, specification, net weight, list of ingredients, production date
and shelf life, storage conditions, nutrient label
 Imported products
• Also country of origin; contact information of importer/distributor
 Recommended information
• Allergens; Batch number; Method for eating
 Prohibited content
• Medical related claims; deceptive or misleading claims, false claims etc.

71
Food Labelling – Example
Name of food
List of ingredients Squeezed or leached
Raw material producing country

Country of origin
Production date
Shelf life
Storage condition
Responsible person in China

Net weight and
specification
Nutrition label

72
Food Labelling - GMOs
 Approved before importation

 Only applicable for specific listed products, irrespective of the
proportion
 Standard terms:
• Transgenic XX
• Manufactured from Transgenic XX
• Raw material is Transgenic XX
• This product is manufactured by transgenic XX, but this product no longer
contains genetically modified ingredients
• The raw materials processing the product contain the transgenic XX, but
this product no longer contain genetically modified ingredients
 Must be prominent and in Chinese

73
Food Labelling – GMOs - Example
Name of food
List of ingredients
“Raw material is Transgenic XX”
Production date
Shelf life
Raw material producing country
Storage conditions
Net weight and specification Responsible person in China

74
Food Labelling - Infant Food
 Approved together with the product

 Required specific clarification
• Nutrient content per 100kJ;
• Product category and type;
• Applicable infant age and standard terms for different ages;
• Directions for use, proper preparation and illustration;
• Warning on the health risks of incorrect preparation or application
 Prohibited content:
• Images of infants or women;
• Expressions such as “like human milk” or “like breast milk”;
• Medical or health claims
• Functional claims
 Printed directly on the package before importation.

75
Food Labelling - Infant food - Example
The ideal food for
infants aged 0 - 6
months is breast milk;
when breast milk is Nutrition label
absent or deficient, (Nutrient or
this product can be nutritional component
Storage conditions used. Name of food content as per 100kJ) List of ingredients
Directions for use, proper

Product Applicable Users Country of origin
preparation and
illustration category &
type
Warning on the health risks as
Responsible person in China
a result of incorrect Net weight and specification
preparation or application. Production date
Labelling and advertising of food in China | 6 September 2017life
Shelf CMS
76
Food Labelling - Health Food
 Approved together with product

• Product name, raw materials, function, suitable/unsuitable population,
health functions, etc.
 Mandatory claim
• “THE PRODUCT CANNOT REPLACE MEDICINES”
• Medical claims

77
Food Labelling - Health Food - Example
Health food logo

Product name
Raw materials
Functional ingredients & content
Health functions
Suitable population
Unsuitable population
Dosage and directions
Specifications
Shelf life
Storage conditions
Precautions
The product cannot replace medicines

78
Food Labelling – Common Pitfalls
 Missing information
 Non-standard terms
 “Ingredient List”
X “Main Ingredients”
 Non-standard style
• Not standardised format
• Not consistent with different language
• Not prominent enough
 Misleading or false claims
• Not indicating the true nature of the product
• Superlatives
• Medical claims
• Non-approved health claims
79
Food Labelling - Liabilities for Non-compliance
 Non-compliance found before importation

• Key issues - destroyed or returned
• Other issues - imported after remedial measures
 Non-compliance found during distribution
• Recall, may be sold after remedial measures
• Civil liabilities
 First asking responsibility system
 Additional compensation (10 times of price or 3 times of loss)
• Administrative liabilities
 Order to amend labels;
 Confiscation or destruction of non-compliant products;
 Seizure of illegal revenue;
 Fines of up to 50,000 RMB or 10 times of product value;
 Suspension of business;
 Revocation of licences
80
Food Advertising
 Strictly regulated
 Highly risky
 Targeted by “professional shoppers”
 Special programme in operation until 30 June 2018

81
Food Advertising – General Rules
 Principle
• True, lawful, culturally acceptable, readily identifiable etc.
• Information shall be accurate, clear and explicit.
• Not false or misleading
• National symbols
• Official symbols
• Superlatives
• Unhealthy
• Illegal
• Medical claims
• Name or image of doctors, medical institutions.

82
Food Advertising – Example
‘‘State-level’’ is prohibited.
‘‘Disease prevention’’ is prohibited.
‘‘State-level’’ is prohibited.

83
Food Advertising - GMOs
 Food with no approved GMO equivalents or similar

• “Non-GMO” statement prohibited
 Food which has approved GMO equivalents or similar
• “Non-GMO” statement allowed
• Misleading statement prohibited

84
Food Advertising - GMOs - Example
‘‘Non-GMO’’
is prohibited
for peanut oil

85
Food Advertising – Infant Food
 Images of breastfeeding mothers and

infants
 Claims of full or partial substitution of

breast milk

86
Food labelling - Infant food – Example
‘‘Expressly or impliedly indicating

that the product can substitute breast
milk’’ is prohibited.

87
Food Advertising – Health Food
 Approved before publication

• Name of the health food product, licence number, advert license number,
logo and unsuitable population
• “THIS PRODUCT CANNOT REPLACE MEDICINES".
• Medical claims
• Certain statements like “scientific and research finding” or “latest
technology” etc.
• Assertions or guarantees of efficiency or safety
• Comparison with pharmaceuticals or other healthcare food
 Restrictions on publication
• News form, disguised form, targeting minors.

88
Food Advertising – Health Food – Example 1
Health food logo
Health food license number
Name of the health food

product
Unsuitable population
Health food advert
license number
‘‘The product cannot replace drugs’’

89
Food Advertising – Health Food – Example 2
‘‘Disease prevention or treatment’’ is

prohibited.
‘‘False or misleading information’’ is

prohibited.
‘‘The product cannot replace drugs’’

shall appear for the whole duration
of TV advertising.

90
Food Advertising - Common Pitfalls
• Superlatives
• Name or images of medical institutions or doctors
 False information
• Claim must be evidenced
 Medical claims
• Strictly prohibited
 Health claims
• Normal food
• Health food

91
Food Advertising - Liabilities for Non-compliance
 Civil liabilities
• Advertiser shall be liable
• Joint liabilities for other involved parties
 Administrative liabilities
• Cessation of advertising
• Eliminate illegal effect
• Fine up to 2 million RMB or a multiple (3-10) of total advertising fees
• Revocation of business licence.
• Revocation the approval for advertisement.
• Prohibition from publishing advertising for one year.
 Criminal liabilities
• Crime of "false advertising"
• ≤ 2 years’ imprisonment or criminal detention
• Fine
92
Comments on Best Practice – Beware Professional Shoppers
 Professional and organised

 Relatively friendly environment
 Attracted by higher compensation
 Focusing on label and advertisement
 Counter measures
• Ensure compliance
• Closely follow new rules
• Lobby legislators
• Build internal response team
• Proactively cooperating with local authorities
• Seek support from professional lawyers

93
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94 Labelling and advertising of food in China | 6 September 2017 CMS

www.foodlegal.com.au
KEY REGULATORY CONCERNS

FOR AUSTRALIA
FOODLEGAL
Level 6, 313 Latrobe Street
Melbourne VIC 3000
Phone (03) 9606 0022
95
Who is FoodLegal?
 Legal experts in food

regulation and compliance
 Experienced in negotiating
with regulators
 Recall crisis managers &
advisors
 Publishers
 Online compliance tools
 And educators
© 2017 FoodLegal, All rights reserved 96

Why import food into Australia?
 Lots of natural ingredients not grown in

Australia
 Lots of refined ingredients not made in
Australia
 High labour costs… and profit margins
 Increasing natural disasters
 Australian consumers are early adopters

But very strict regulations!
 Strict biosecurity and

customs laws
 Health claims
 Food fortification
 Country of origin

GETTING FOOD
ACROSS THE BORDER

Biosecurity vs Regulatory compliance
 A product that may pose no

biosecurity (and even no health or
safety threat) can be refused entry if
label or recipe is non-compliant
 A product that poses no threat to
public health and safety and
complies with all of Australia’s food
regulations can be refused entry

In Australia…
 <20ppm gluten means low

gluten…
 Not gluten free…
 As is the case in the rest of the
world.
 In Australia, gluten free must
contain non-detectable gluten

Importing into Australia key learnings
1. Both biosecurity concerns and regulatory

compliance must be assessed
2. Imported foods must be perfect
– Higher stakes
– Stricter standards
– In contrast with locally produced product

HEALTH CLAIMS

The envy of the world
 Our health claims system is one of the

most flexible in the world
 This could lead to Australia/New
Zealand becoming a testing ground for
new health claims

How does it work?
 Any product that meets a nutritional

profile…
– E.g Low fat milk yes, full fat milk no
 Can make a general level health claim…
– No serious diseases or biomarkers
 So long as you have a systematic scientific
review substantiating the claim
 No government pre-approval
 Reviews are being reviewed

Risk for importers of health products
 In most other countries around the world, dietary

supplements and complementary medicines (including
Chinese traditional medicine) are not made to
medicinal standards
 Thus, when imported into Australia, many overseas
health products risk being:
– Non-compliant therapeutic goods; or
– Non-compliant food products

Food fortification is highly restricted
 Regulatory triggers: Vitamins, minerals, amino acids,

innovative health ingredients and nutritive substances
 Prohibited unless expressly permitted
 Product classification becomes vital

Special Purpose Foods
Classification Pros Cons

Formulated Beverage Additional Vitamin and Mineral Limits on sugar, CO2 and
fortifications caffeine
Cannot be mixed with other
foods
Formulated Can add caffeine, nutritive Mandatory warnings
Caffeinated Beverages substances and B Vitamins Maximum daily consumption
Formulated Meal Many vitamin and mineral options Strict macronutrient ranges
Replacement/ No format requirement Lots of labelling warnings
Supplementary Foods Nutrition minimums
Formulated No compositional minimums Cannot be marketed to children
Supplementary Sports No format requirement or pregnant/lactating women
Food Many fortification permissions
Foods for Special Can add almost anything More that 50% must be sold
Medical Purposes You MUST state the name of the through a pharmacy or doctor or
disease hospital

There’s always New Zealand…
 Under Trans Tasman Mutual Recognition

Agreement, any product lawfully sold in
New Zealand can be lawfully sold in
Australia
 Products between food and medicine
– Supplemented food (e.g. vitamins and
minerals in sweets)
– Dietary supplement (pills, capsules or liquids)
– Natural health products?

Beware the Red Bull decision

Health claims key learnings
1. Health claims are flexible in Australia

2. Exceeding Australian fortification limits
for food could result in products being
refused entry
3. New Zealand presents scope to access
the Australian market

COUNTRY OF ORIGIN
LABELLING CHANGES

As of 1 July 2018…
 For priority foods, a logo must declare:

– Whether produced, grown or made in Australia;
– Whether packed in Australia but made elsewhere; and
– Percentage of Australian grown/produced ingredients
 Non-priority foods must declare where produced,
grown, made or packed and whether from single or
multiple countries of origin
 Priority food declarations must be in a box
Made in China Packed in Singapore from
Packed in Australia ingredients of multiple origins

Country of origin key learnings
1. Have to assess whether your product is

priority or not
2. Know where it was last substantially
transformed
 Get the kangaroo graphic!
3. Know exactly how much Australian
content is in there


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Health claims in Southeast

• An introduction to the idea of food-related

• Broadly, a claim made in relation to the

Application Evaluation Reject

• “Dietary fibre hypothesis” linked low intake to

• In-depth research on dietary fibre and health

EFSA health claim guidelines

Source of fibre High in fibre

• Oat β-glucan and LDL cholesterol reduction

Malaysia Unavailable Unclear

Tan et al., (2015) Nutrition Reviews 73

Member Consistent Scientific Provide Not associated Do not lead Contribute

Tan et al., (2015) Nutrition Reviews 73

Member Study types Publication Researchers Supporting

Singapore Well designed human ≥5 peer-reviewed None Observational

Tan et al., (2016) Appetite 105

Tan et al., (2016) Appetite 105

• High degree of trust in health claims

Tan et al., (2016) Appetite 105

• ASEAN Agreement on Traditional Medicines

• Nutrient-based claims tend to be easier to

• There is currently no cross-ASEAN standard for

• Consumer understanding of claims is key

Asia (Regional) Food Regulation &

Number of Enterprises Cumulative Investment Employment

7,742 USD 20 billion 1.1 million

**S=Small enterprises, M=Medium enterprises, L=Large enterprise

GDP BY INDUSTRY SECTORS

Average monthly Spending of Thailand Food Market in World

Food & Beverages 33.7%

Isoprenoids Phenolic Protein/ Fatty acids Vitamins/ Microbial

About 1,000 applications per month

 New Food Ingredients: A company must first determine whether

Food for Weight control (e.g. sweetener) 35 days

Food Additives 35 days

 Be persuasive, but open & honest

 A food importer/manufacturer is inspected by the

 Urgent audit of products and promotional materials.

 Developing Action Plan going forward.

For more information please visit our website:

53 Not to be reproduced or disseminated without permission.

54 Not to be reproduced or disseminated without permission.

• The CCS investigation found that manufacturers primarily engaged

55 Not to be reproduced or disseminated without permission.

• Improving Consumer Awareness

56 Not to be reproduced or disseminated without permission.

• Adjust guidelines and regulations on advertising, labelling and the

57 Not to be reproduced or disseminated without permission.

• Amendment of the Sale of Infant Food Ethics Committee Singapore

58 Not to be reproduced or disseminated without permission.

Under the current SIFECS code

59 Not to be reproduced or disseminated without permission.

• Adjusting the Guidelines and Regulations

60 Not to be reproduced or disseminated without permission.

• Difficulties of parallel importing milk formula.

61 Not to be reproduced or disseminated without permission.

• Changes may be made to SIFECS and other regulations to make

62 Not to be reproduced or disseminated without permission.

• Hospitals may be encouraged to carry brands or products that are

63 Not to be reproduced or disseminated without permission.

• Diabetes Prevention and Care Taskforce studying measures to

64 Not to be reproduced or disseminated without permission.

• Not clear if any legislative steps will be taken in this area.