Regulatory Harmonization in

Hong Kong

Date: 4 September 2014 Thursday

Presented by

Mr. Calvin Chan

Vice President

Hong Kong Location

Hong Kong is a small-sized island covering 1,095 sq. km (423 sq. miles).

Hong Kong’s stock market was the sixth largest in the world and the second largest in Asia in terms of market capitalisation as at the end of July 2013*. Hong Kong was the most active market for initial public offering (“IPO”) funds raised globally in 2009, 2010 and 2011. Per capita GDP at current market price = USD36,590

Population 7,153,519 (July 2012 est.)

Median age total: 43.9 years male: 43.3 years female: 44.4 years (2012 est.)

Population growth rate 0.421% (2012 est.)

Birth rate 7.54 births/1,000 population (2012 est.)

Death rate 7.23 deaths/1,000 population (July 2012 est.)

Hong Kong Demographics

Sex ratio at birth: 1.07 male(s)/female under 15 years: 1.09 male(s)/female 15-64 years: 0.93 male(s)/female 65 years and over: 0.88 male(s)/female total population: 0.94 male(s)/female (2011 est.)

Life expectancy at birth total population: 82.12 years male: 79.39 years female: 85.05 years (2012 est.)

Hong Kong Demographics

• Population of over 7M people

• Fast pace and high pressure at work

79

86

60

65

70

75

80

85

90

平均壽命

男 女

歲

Hong Kong Environment

• Crowded environment with tall buildings and jammed traffic and unfavorable air pollution in city

• Lack of proper food balance and sufficient exercise create different health problems in the population

Hong Kong Environment

• The population of Hong Kong is currently ageing at a moderate pace. The proportion of population aged 65 and over has increased from 9.8% in 1995 to 12.1% in 2005.

• The proportion of population aged 65 and over is projected to

increase to 26.8% in 2033. An ageing population will have an impact on the labour force as the number of persons in working ages will grow slower than the overall population growth.

Aging Population

Hong Kong Common Cancers – 2011

Colon Cancer

• DOH survey revealed 27% working men and 12% working women have regular exercise.

• 64% working man has lunch outside home and women is 50%.

• Cases of diabetes and cardiovascular disease are increasing

These phenomenon reflects the demand for large Healthcare service

requirements in Market

Hong Kong Health Condition

Hong Kong Health Food Association

Our Vision

• HKHFA strives to become an authorative and publicly trusted organisation with wide industry representation and international perspective.

Our Mission:

• HKHFA mission is to campaign for the equitable rights and stature of its members, to foster a viable business environment for the industry and to provide consumers with the knowledge of the safe use of health food products.

The Hong Kong Health Food Association

• Established in 2005

• A non-profit organization

• Aims at fostering the well-being of the public & encourages the industry to exercise self-discipline

• More than 65 Ordinary Members

- including manufacturers, distributor, wholesaler and retailer

- with more than 1,000 product items

- with more than 1,000 retail shops in Hong Kong

• Services include:

• Issue Free Sale Certificate

• Voluntary Listing

• www.hkhfa.org

The Hong Kong Health Food Association

Certificate of Free Sale

Voluntary Listing http://www.hkhfa.org/en/products.php

[Health Food] refers to products taken orally in recommended dosing regimen, such as pills,

capsules, tablets, granules, powders, liquids or semi-solids with health claims. They are neither

conventional food nor products classified as pharmaceutical products (drugs) or pCm (proprietary

Chinese Medicine).

They contain nutrients or other health-enhancing substances whose purpose to supplement the

normal diet or adjust physiological functions of human body, but not for therapeutic uses in

treatment of diseases.

[保健食品]*是指具建議服用量和保健功能聲稱的口服產品，包括丸狀、膠囊狀、片狀、 粒

狀、粉狀、液體或半固體的保健產品，但不包括傳統食品、西藥和中成藥。它們含有營養

素或其他保健成分，能補充日常膳食供給的不足或調節人體機能，但不以治療疾病為目的。

Definition of Health Food

Health Food Market Survey

• HKHFA appointed HKU Social Science Research Centre to conduct telephone survey on Health Food/Supplements issues in September 2008

– The market survey has contacted 1062 people and the overall response rate is 69.3%。The objectives are to find out the habit of taking health food, the importance of different concerns and opinion towards the regulations of health food/supplements

– The projected Hong Kong Health Food/Supplement retail market size is USD1.3B

–New survey result to be ready by end of 2014

Health Food Market Survey

• 52% of respondents get the product information from friends and relatives;

• Around 24% health food/supplements users are influenced by advertisements;

• Less than 15% buy the health food/supplement products because of the prescription of medical practitioners;

• Higher education, average income of USD2,500/month, executives/employers take health food/supplements more often than others;

• Female is a better purchaser than male.

Health Food Market Survey

• Result showed that 35% of interviewee has taken health food/ supplements in past 6 months. This is projected to be about 2M of total population, estimating the total turnover of the Hong Kong health food is approximately HK $ 10 billion.

• About 40% believed that the health food/supplements they are currently taking can benefit their health including increase of immune strength, keep healthy, more energetic, and supplement nutrition for the body etc.

• 66.7% and 31.5% strongly agree and agree that health food/supplements should provide precise and accurate information of functions on the label

Health Products Market Survey

How to Enter into Hong Kong

Explore product potentiality and competitiveness

Understand the product classification and testing requirements and registration

requirements

Decide on whether to set up local company or deploy local distributors

Beware of high operating expenses in HK esp. for rental and labour as compared with

China etc.

Key Factors of Entering into Hong Kong

• Drug (Pharmaceutical Products, e.g., Vitamins, Glucosamine) - Pharmacy and Poisons Ordinance (Chapter 138)

• Proprietary Chinese Medicine (e.g., Traditional Chinese Medicine Herbs) - Chinese Medicine Ordinance (Chapter 549)

• Food (e.g., Natural Food / Fruit Extract, Fish Oil, Omega-3) - Public Health and Municipal Services Ordinance (Chapter 132)

- Food Safety Ordinance (Chapter 612)

Regulatory Environment of Health Food in Hong Kong

Refs.: The Hong Kong Department of Health; The Chinese Medicine Council of Hong Kong; Centre for Food Safety & Department of Justice Hong Kong.

Pharmaceutical Products - Classification

Examples of “medicinal” claims “this product helps prevent heart disease” “this product lowers high cholesterol” “this product may lower blood sugar” “prevents osteoporosis” “relieves premenstrual symptoms” “relieves menopausal symptoms” “treatment or management of obesity” “soothes sore throats” “this product relieves occasional constipation/diarrhoea” “prevention of travel sickness”

Classification Claims

Food - Definition

According to the Law of Hong Kong • Does not belong to Drug or pCm above are grouped under the category of Food (referring to as Health Food / Dietary Supplements by the Industry)

Health Food/Food

Refs.: The Hong Kong Department of Health; The Chinese Medicine Council of Hong Kong; Centre for Food Safety & Department of Justice Hong Kong.

Dietary Supplements • Traders should be registered as Food Importer / Food Distributor • Use permitted food additives according to Codex Alimentarius Commission and use International Numbering System (INS) where possible for label • Listing of full ingredients in descending order • Nutritional Labeling (1+7):

- Energy; i. Protein ii. Total Fat iii. Saturated Fat iv. Trans Fat v. Carbohydrate vi. Sugar vii. Sodium

Health Food/Food Related Regulations

Dietary Supplements

• Labeling of Best Before Date:

(a) 年Y 月M 日D ; (b) Y年 D日 M月 ; (c) 日dd 月mm 年yy; (d) y年 m月 d日； (e) Y年 M月 D日; (f) DD日 MM月 YY年

Health Food/Food Related Regulations

Dietary Supplements

• Use appropriate warning if contains known allergens (i) cereals containing gluten (namely wheat, rye, barley, oats, spelt, their hybridized strains and their products); (ii) crustacea and crustacean products; (iii) eggs and egg products; (iv) fish and fish products; (v) peanuts, soyabeans and their products; (vi) milk and milk products (including lactose); (vii) tree nuts and nut products, the name of the substance shall be specified in the list of ingredients

Health Food/Food Related Regulations

Undesirable Medical Advertisements Ordinance (UMAO)

不 良 廣 告 (醫 藥) 條 例

The Undesirable Medical Advertisements Ordinance (UMAO), Cap. 231

One of the major amendments of the Ordinance was to

• extend the prohibition / restriction on advertising to six groups of claims specified in a schedule (Schedule 4) which applied to all orally consumed products, (whether or not it is a medicine but does not include a product which is customarily consumed only as food or drink).

• Other major amendments included increasing the penalties for contravention of UMAO, empowering the Director of Health to appoint inspectors to enforce the Ordinance and amendments to Schedules 1 and 2.

Ref: Hong Kong Drug Office

According to the UMAO, no person shall publish, or cause to be published the following :

• Any advertisements likely to lead to the use of any medicine, surgical appliance or treatment for the purpose

of treating human beings for, or preventing them from contracting any disease or condition specified in

column 1 of Schedule 1 (except for a purpose specified in column 2 of that Schedule); or

• treating human beings for any purpose specified in Schedule 2 of the Ordinance

• Any advertisement: offering to procure a miscarriage of women; canvassing, inviting or inducing the

procuration of miscarriage of women; or referring to any thing in terms which are calculated to lead to the use

of that thing for the procuration of miscarriage of women

• An advertisement for an orally consumed product which makes for the product a claim specified in column 1

of Schedule 4, or any similar claim, except as allowed under the provisions in column 2 of that Schedule

Ref: Hong Kong Drug Office - http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/External_Guidelines_Notes_on_the_UMAO.pdf

The Undesirable Medical Advertisements Ordinance (UMAO), Cap. 231

Guidelines on Undesirable Medical Advertisements Ordinance (Cap.231)

• Guidelines on Undesirable Medical Advertisements Ordinance(Cap. 231)

• Annex A- Examples of Prohibited and Allowable Claims under Schedule 1 & 2 (in Chinese only)

• Annex B- Supplementary Guidelines on Regulation of Six Groups of Health Claims of Orally Consumed Products

Ref: Hong Kong Drug Office

Food Laws in Hong Kong

Food Laws in Hong Kong

• Food Legislations / Guideline: http://www.cfs.gov.hk/english/food_leg/food_leg_list.html#cl

• Microbiological Guideline: http://www.cfs.gov.hk/english/food_leg/files/food_leg_Microbiological_Guidelines_for_Food_e.pdf

• Pesticide Residues in Food Regulation: http://www.cfs.gov.hk/english/whatsnew/whatsnew_fstr/files/TM_May_2014_Intro_of_Regulation_e.pdf

Ref: Centre for Food Safety

Regulations of Chinese Medicine

Chinese Medicine Ordinance

• Licensing of Chinese Medicine Traders According to the Chinese Medicine Ordinance, Chinese medicines traders who wish to carry on a business in the retail of Chinese herbal medicines, wholesale of Chinese herbal medicines, wholesale of proprietary Chinese medicines or manufacture of proprietary Chinese medicines shall first obtain a licence issued by Chinese Medicines Board. Details: http://www.cmchk.org.hk/pcm/eng/#main_licen.htm

• Lists of licensed Chinese medicines traders Details: http://www.cmchk.org.hk/pcm/eng/#main_list.htm

Ref: Chinese Medicine Council of Hong Kong- http://www.cmchk.org.hk/pcm/eng/#../../eng/main_ord_cap549.htm

Useful Links

• Food and Health Bureau - http://www.fhb.gov.hk/en/index.html

• Department of Health - http://www.dh.gov.hk/eindex.html

• Drug Office - http://www.drugoffice.gov.hk/eps/do/en/level.html

• Centre for Food Safety - http://www.cfs.gov.hk/eindex.html

• Food and Environment Hygiene Department - http://www.fehd.gov.hk/english/index.html

• Legislative Council of the HKSAR - http://www.legco.gov.hk/index.html

• Consumer Council - http://www.consumer.org.hk/website/ws_en/

• Department of Justice - http://www.legislation.gov.hk/blis/eng/index.html

~ The End ~

Contact us:

Hong Kong Health Food Association Address: Morrison Hill Post Office, Wan Chai, Hong Kong Tel: (852) 2837-7920 Fax: (852) 2837-7921 Email: enquiry@hkhfa.org

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