Legislative Council Bills Committee on
the Provision of Municipal Services (Reorganization) Bill
(8 September 1999)
Control of Food and Drugs
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:
- the Pharmacy and Poisons Ordinance, Cap.138 (PPO);
- Part V of the PHMSO; and
- 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
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.
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-
- composed solely of the following as active ingredients -
- any Chinese herbal medicines; or
- any materials of herbal, animal or mineral origin customarily
used by the Chinese; or
- any medicines and materials referred to in subparagraphs (i)
and (ii) respectively;
- formulated in a finished dose form; and
- 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