Introduction

At the meeting of the LegCo Bills Committee on the Provision of Municipal Services (Reorganization) Bill on 23 July 1999, Members asked the Administration to provide a paper to elaborate on the division of responsibilities in respect of food and drug hygiene under the Public Health and Municipal Services Ordinance, Cap.132 (PHMSO) and other relevant legislation such as the Chinese Medicine Ordinance. The paper should also include the Administration's proposed plan to implement the regulation of Chinese medicine and whether Chinese herbal tea and health food will be included.

2. This paper outlines the existing control frameworks.

Existing Control of Food Safety and Food Hygiene

3. The basic food law is contained in Part V (Food and Drugs) of the PHMSO. The main provisions cover general protection for food purchasers, offences in connection with sale of unfit food or adulterated food, food hygiene, seizure and destruction of unfit food. Subsidiary regulations under the Ordinance elaborate on the control in specific areas such as composition and labelling, use of preservatives, presence of harmful substances, import of game, meat and poultry, milk and frozen confections, and licensing of food businesses. In addition, the Public Health (Animals and Birds) Ordinance (Cap.139) and its subsidiary legislation cover the quarantine and inspection of livestock and poultry and control of farm hygiene.

4. The responsibilities for food safety and food hygiene are mainly divided between the Health and Welfare Bureau, Department of Health, the two Provisional Municipal Councils (PMCs) and their executive departments, i.e. Urban Services Department (USD) and Regional Services Department (RSD).

5. Generally speaking, the PMCs and USD/RSD are responsible for food hygiene including the licensing and inspection of food premises and the safety of certain food products. The PMCs are empowered under PHMSO to make Bylaws applicable to their own region relating to these matters. The Director of Health is empowered under section 55 of the Ordinance to make subsidiary legislation regulating issues such as the addition or extraction of any specified substance to food, the use of any substance as an ingredient in the preparation and preservation of food, the composition of such food or the bacteriological or chemical standards and the labelling, marking and advertising of food. The Hygiene Division of the Department of Health is funded by the two PMCs. In addition to performing statutory functions relating to food safety control throughout the territory, it is also responsible for enforcing certain parts of the food safety-related bylaws under delegated authority by the two PMCs. The Division is also involved in monitoring and promoting food safety and hygiene through a food surveillance programme and health education.

6. Under section 55(1A) of PHMSO, the Secretary for Health and Welfare is also empowered to make regulations for prohibiting, restricting or regulating the importation, manufacture or sale, or consignment or delivery of food or ingredients of food which do not comply with the food safety regulations or which are or may be prejudicial to public health. In addition, the Agriculture and Fisheries Department and, indirectly, the Economic Services Bureau are also involved in the veterinary public health aspect of food safety, including quarantine and inspection of livestock and poultry, farm hygiene and the coral fish harvest zones registration programme.

7. The fragmentation of responsibilities in food safety and food hygiene among the PMCs and different agencies has adversely affected co-ordination and direction and our ability to respond to food safety crises. The proposed new structure for delivery of food safety and hygiene services aims to address this problem.

Existing Control of Drugs

8. The control of drugs is mainly provided under the following legislation:

1. the Pharmacy and Poisons Ordinance, Cap.138 (PPO);

2. Part V of the PHMSO; and

3. the Dangerous Drugs Ordinance,Cap.134 (DDO).

The Health and Welfare Bureau is reviewing the drug-related legislation including (a) and (b) above to make the relevant provisions easier to administer.

(a) Pharmacy and Poisons Ordinance

9. The PPO provides for the registration of medicines and pharmaceutical products (i.e. drugs) and the licensing of manufacturers, importers, wholesalers and retailers of these products. The Pharmacy and Poisons Board, chaired by the Director of Health and comprising relevant government officials, medical practitioners, pharmacists and academics, is responsible for overseeing the implementation of controls under the Ordinance.

(b) Part V of Public Health and Municipal Services Ordinance

10. Under the PHMSO, "drug" is defined as including medicine for internal or external use by man. The definition was extended to cover Chinese herbal medicine and proprietary Chinese medicine under the Chinese Medicine Ordinance enacted in July 1999 (see paragraph 12 below). Articles or substances used only as drugs are excluded from the definition of "food" in the same Ordinance.

11. Under section 55 of PHMSO, the Director of Health is empowered to make subsidiary legislation regulating such matters as the addition or extraction of any specified substance to drugs, the use of any substance as an ingredient in the preparation or preservation of drugs, the composition of such drugs or the bacteriological or chemical standard and the labelling, marking and advertising of drugs.. The Food and Drugs (Composition and Labelling) Regulations have been made under the Ordinance to regulate the standards of composition of drugs. Under section 55(1A) of the Ordinance, the Secretary for Health and Welfare is empowered to make regulations for prohibiting, restricting or regulating the importation, manufacture or sale, or consignment or delivery of drugs or ingredients of drugs which do not comply with the regulations made by the Director of Health or which are or may be prejudicial to public health.

(c) Dangerous Drugs Ordinance

12. Certain types of dangerous drugs which are liable to abuse are controlled under the DDO. Under the Ordinance, the Director of Health is responsible for licensing the import, export, manufacture, sale and possession of dangerous drugs.

Control of Chinese Medicines

13. The newly enacted Chinese Medicine Ordinance (Cap.549) provides for a statutory framework to regulate the practice, use, trading and manufacture of Chinese medicines (including Chinese herbal medicines and proprietary Chinese medicines) in order to protect public health and consumers' rights and to ensure the professional standard of Chinese medicine practice. It covers the registration of individual proprietary Chinese medicines, licensing of the wholesalers and manufacturers of such medicines and retailers and wholesalers of Chinese herbal medicines. Public officers authorized by the Director of Health as inspectors will be responsible for enforcement of the provisions under the Ordinance. The regulation of Chinese medicines will be introduced in phases starting from 2000.

Chinese Herb Tea

14. At present, Chinese herb tea premises are required to obtain permits from the PMCs under the Food Business By-laws (Cap. 132 sub. leg.). In addition to complying with the usual requirements for licensing of food premises, the operators are required to submit a list of Chinese herb tea to be sold together with the formulae. To better protect public health, USD and RSD seek the advice of Director of Health on the formulae before issuing a Chinese herb tea permit allowing the herb tea concerned to be sold. Sampling of Chinese herb tea is carried out by the staff of the Department of Health as necessary. We will review this arrangement following the enactment of the Chinese Medicine Ordinance.

Health Food

15. "Health food" generally refers to dietary supplements which are manufactured or sold for use in regulating the functional states of the human body. The term usually excludes pharmaceutical products and medicines. However, there is no international consensus regarding the definition and control of "health food".

16. A number of health foods currently available in the market may in fact be classified as "proprietary Chinese medicine" under the Chinese Medicine Ordinance. The latter is defined under the Ordinance as any proprietary product-

1. composed solely of the following as active ingredients -
   1. any Chinese herbal medicines; or
      
   2. any materials of herbal, animal or mineral origin customarily used by the Chinese; or
      
   3. any medicines and materials referred to in subparagraphs (i) and (ii) respectively;

2. formulated in a finished dose form; and

3. known or claimed to be used for the diagnosis, treatment, prevention or alleviation of any disease or any symptom of a disease in human beings, or for the regulation of the function states of the human body.

17. Health foods not classified as "proprietary Chinese medicine" under the Chinese Medicine Ordinance will continue to be subject to controls same as other food items under the PHMSO.

18. "Health food" is a relatively new category of products. The Administration will closely monitor international developments in this area and make necessary changes to the regulatory framework whenever appropriate.

Constitutional Affairs Bureau
3 September 1999