Request a DemoAs a free trade zone, Hong Kong regulates cosmetics in a very relaxed manner. There is no specific regulations regulating cosmetics and no positive/negative lists. Although cosmetics require compliance with Consumer Goods Safety Ordinance and Trade Description Ordinance the two regulations don’t make any provisions relating to cosmetics clearly. The supervision on cosmetics only appears in the post-market surveillance and random inspection when clearing customs. Due to lack of pre-market requirements, cosmetics can enter into Hong Kong almost freely.
Part 1 Regulatory Framework and Competent Authority
1.1 Existing Main Cosmetic Regulations in Hong Kong
Regulations | Effective Date | Status |
Feb 6, 2015 | In force | |
| Consumer Goods Safety Regulation (Cap. 456 Section 30 (1)(a)) | Apr 1, 1998 | In force |
Jul 25, 2025 | In force |
2 Competent Authority of Cosmetics
The Commerce and Economic Development Bureau (CEDB) is responsible for formulating and revising the Consumer Goods Safety Ordinance.
The Customs & Excise is responsible for responsible for enforcing the Consumer Goods Safety Ordinance and conducting post-market inspections.
Part 2 Cosmetic Products
2.1 Obligations
Hong Kong doesn’t define cosmetics but considers cosmetic and skin care products as consumer goods. Consumer products are subject to the regulation of the Consumer Goods Safety Ordinance. The Ordinance stipulates that manufacturers, importers and suppliers should ensure that the consumer goods they supply in the market meet "the general safety requirement". Under this requirement, the consumer goods concerned must be reasonably safe. In determining whether a particular consumer good complies with this requirement, due regard should be made to all circumstances, including:
the manner in which, and the purpose for which, the consumer goods are presented, promoted or marketed;
the use of any mark in relation to the consumer goods and instructions or warnings given for the keeping, use or consumption of the consumer goods;
reasonable safety standards published by a standards institute or similar body for a consumer goods of the description which applies to the consumer goods or for matters relating to consumer goods of that description; and
the existence of any reasonable means (taking into account the cost, likelihood and extent of any improvement) to make the consumer goods safer.
The above are all the contents in the "the general safety requirement". The Ordinance doesn’t specify any further requirements for cosmetics. In addition, there is no pre-market approval (either notification or license) for cosmetics in Hong Kong. The Customs & Excise will check if cosmetics comply with the above mentioned general requirements only at the time of clearing customs or conducting post-market inspections.
But generally speaking, if the goods can meet overseas or international safety standards (such as the standards of the Mainland, the United States, the European Union, Australia or Japan), they will be considered as meeting the requirement under the Ordinance.
2.2 Post-market Surveillance
Customs & Excise is responsible for post-market surveillance for cosmetics. For regulating the safety of cosmetics, Customs & Excise will, in accordance with the Consumer Goods Safety Ordinance, consider relevant reasonable safety standards, including the standards or requirements issued by the European Union, the United States and the Mainland.
The post-market surveillance activities include investigation of complaints from customer and spot checks on retailers to check if they put up for sale unsafe or suspected unsafe products (such as those subject to recall overseas). Customs & Excise also takes product samples for testing by the Government Laboratory, closely monitors local and overseas media reports, as well as reports published by safety organizations on potential hazards relating to cosmetic and skin care products, so that appropriate measures could be taken against suspected unsafe products. When a particular product is found to have breached the requirement under the Ordinance, Customs & Excise will require retailers to stop selling and recall that unsafe product, and will prosecute offenders. On first conviction, the penalty is a maximum fine of $100,000 and an imprisonment for one year, and on subsequent convictions, the penalty is a maximum fine of $500,000 and an imprisonment for two years.
2.3 Labeling
There are also no specific requirements for labeling, such as required information on labels or prohibited/allowed claims.
Only the Consumer Goods Safety Regulation mentions several sentences regarding labeling, which are as follows:
“(1) Where consumer goods or their packages are marked with, or where any labels affixed to or any documents enclosed in their packages contain, any warning or caution with respect to their safe keeping, use, consumption or disposal, such warning or caution shall be in both the English and the Chinese languages.
(2) A warning or caution referred to in subsection (1) shall be legible and shall be placed in a conspicuous position on-
the consumer goods;
any package of the consumer goods;
a label securely affixed to the package; or
a document enclosed in the package,
as the case may require.
(3) A person who supplies consumer goods which do not comply with subsection (1) or (2) commits an offence and shall be liable-
on first conviction, to a fine at level 6 and to imprisonment for 1 year; and
on subsequent conviction, to a fine of $500000 and to imprisonment for 2 years.”
The Commissioner of Customs & Excise has the right to require the manufacturer, importer or supplier of consumer goods, including cosmetic products, to modify their labelling, packaging or advertising to make sure that they comply with the general safety requirement.
Trade Description Ordinance supplements that it is prohibited to use false trade descriptions, false, misleading or incomplete information, false marks and misstatements in respect of goods supplied including cosmetics.
2.4 Ingredients Requiring Special Attention
Hong Kong does not maintain an official list of prohibited or restricted ingredients for cosmetics. However, certain ingredients are subject to specific regulatory requirements. If a cosmetic product contains any of these ingredients, it must comply with the applicable provisions.
2.4.1 Endangered Species
The Protection of Endangered Species of Animals and Plants Ordinance (the Ordinance), Cap. 586, is the local legislation which gives effect to CITES in Hong Kong. The Ordinance requires a license to be issued in advance by the Agriculture, Fisheries and Conservation Department for the import, introduction from the sea, export, re-export or possession of specimens of a scheduled endangered species, whether alive, dead, its parts or derivatives (including medicines).
For the list of endangered species, please refer to Appendix I, Appendix II or Appendix III of Protection of Endangered Species of Animals and Plants Ordinance (Cap. 586).
To meet its international obligations under the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988, Hong Kong regulates 54 chemicals that can be used in the manufacture of dangerous drugs or psychotropic substances.
Any person who intends to import, export, supply, procure, deal in, possess, or manufacture these controlled chemicals must apply for the appropriate licence, permit, authorization, or storage approval, as required.
Controlled chemicals (including their salts, except for those of sulphuric acid and hydrochloric acid where applicable) are classified into three categories under the schedules of the Control of Chemicals Ordinance.
2.4.3 Dangerous Drugs
Importation of dangerous drugs requires an import licence and import certificate issued by the Department of Health. A valid export authorization or diversion certificate from the exporting country will also be required.
The common types of dangerous drugs are stimulants, hypnotics, tranquilizers and sedatives. Examples are opium, morphine, heroin, cannabis, cocaine and amphetamines. A list of dangerous drugs is stipulated under First Schedule to the Dangerous Drugs Ordinance (Cap. 134).
2.4.4 Mercury
Under the Mercury Control Ordinance (Cap. 640), the import of cosmetics having a mercury content exceeding 1ppm is prohibited. Cosmetics used around the eyes are excepted if they meet all of the following conditions:
1) Mercury is used as a preservative;
2) Lack of effective and safe preservative alternatives;
3) Mercury is at levels not exceeding 70 ppm.
2.4.5 VOC
Under Air Pollution Control (Volatile Organic Compounds) Regulation (Cap. 311 sub. leg. W), the volatile organic compound (VOC) concentration in hair spray shall not exceed 55%.
2.4.6 Asbestos
Under section 80 of the Air Pollution Control Ordinance (Cap. 311), import, transhipment, supply and use of asbestos and asbestos containing material (ACM) other than goods in transit and registered proprietary Chinese medicine are banned.
Part 3 Pharmaceutical Products and Proprietary Chinese Medicines
3.1 Pharmaceutical Products
Personal care products and cosmetics that fall within the definition of “pharmaceutical products” under the Pharmacy and Poisons Ordinance (Cap. 138) (PPO) must meet the requirements of safety, quality, and efficacy, and be registered with the Pharmacy and Poisons Board before they can be legally sold in Hong Kong.
3.1.1 Definition of Pharmaceutical Product
According to the PPO, a pharmaceutical product (PP) refers to:
1) A substance or combination of substances that:
(i) is presented as having properties for treating or preventing disease in humans or animals; or
(ii) may be used or administered to restore, correct, or modify physiological functions via pharmacological, immunological, or metabolic action, or to make a medical diagnosis;
2) This definition also includes advanced therapy products.
To determine whether a product is classified as a PP, enterprises should refer to the Guidance Notes on Classification of Products as “Pharmaceutical Products”, considering both the composition and the nature of claims made about the product.
3.1.2 General Classification Criteria
A product is generally considered a PP if:
It contains a drug substance in its composition; or
It makes medicinal claims in its labeling, packaging, leaflets, brochures, wrapper, advertisements, or other promotional materials.
In evaluating whether a product is a PP, the following factors are considered:
Presence of substances;
Whether the substance is medicinal;
Pharmaceutical dosage form (e.g., tablet, capsule) and intended use;
Indications or claims on labels and promotional materials;
Availability of similar registered pp in Hong Kong;
Potential public health risks.
Cosmetics, toiletries, or disinfectants that do not contain drug substances and do not make medicinal claims are generally excluded, unless they contain ingredients commonly regarded as medicinal and indicative of a medical use.
3.1.3 Reference Materials for Classification
As each product is assessed on a case-by-case basis, there is no definitive list of substances that qualify as PP. However, when determining whether a product is PP, it is useful to consult:
1) Substances listed under Heading "A" of the Poisons List in the Pharmacy and Poisons Regulations (Cap. 138 sub. leg. A), which are primarily intended for medicinal use.
2) Appendices of the Guidance Notes on Classification of Products as “Pharmaceutical Products”, which provides:
Examples of substances generally regarded as medicinal, even if not included in the Poisons List;
Substances not considered medicinal;
Examples of medical and non-medical claims;
Case-by-case determinations on whether certain types of products are classified as PP.
3.1.4 Registration Requirements
For Locally Manufactured Products:
The licensed manufacturer or the contracting licensed wholesaler must apply for registration.
For Imported Products:
The licensed wholesaler importing the product, or the local representative (branch, subsidiary, agent, or distributor) of the overseas manufacturer is responsible for registration.
Enterprises should submit your application for registration of pp via the online Pharmaceuticals Registration System 2.0 (PRS 2.0) of Drug Office of the Department of Health at https://www.drugoffice.gov.hk/prs2-ext/client_authentication.jsp together with the application fee and required particulars in text searchable PDF file.
All registered pp must bear a registration number in the format "HK-XXXXX" on their packaging.
3.1.5 Special Note: Hair Dye Preparations
Hair dye products containing phenylenediamines, toluenediamines, alkylated benzene diamines, or their salts are classified as Part 2 Poisons under the PPO. Such products:
1) May only be sold at registered pharmacies or listed poison sellers.
2) Must comply with PPO labeling requirements, including:
The name and concentration of the poison in the formulation.
A warning statement, such as:
“Caution: This drug may cause severe skin inflammation in some individuals and must be used under the advice of a specialist.”
3.1.6 Import Licensing Control
The importation of PP is subject to licensing control. An import license issued by the Department of Health is required for imports of PP into Hong Kong.
3.2 Proprietary Chinese Medicines
Personal care products and cosmetics which fall within the definition of proprietary Chinese medicines (pCm) under the Chinese Medicine Ordinance (Cap 549) must fulfil the requirements set by the Chinese Medicine Council of Hong Kong (CMCHK) in terms of safety, quality and efficacy, and be registered with the Chinese Medicines Board under the CMCHK before they can be imported, locally manufactured and sold.
3.2.1 Definition of pCm
A pCm refers to any proprietary product that:
(a) Contains only the following as active ingredients:
(i) Chinese herbal medicines, as listed in Schedule 1 or 2 of the Chinese Medicine Ordinance (Cap. 549);
(ii) Materials of herbal, animal, or mineral origin customarily used in Chinese medicine; or
(iii) A combination of (i) and (ii);
(b) Is formulated into a finished dosage form; and
(c) Is known or claimed to be used for the diagnosis, treatment, prevention, or alleviation of any human disease or its symptoms, or for the regulation of human bodily functions.
3.2.2 Registration of pCm
An application for the registration of a pCm must be submitted:
(a) By the manufacturer, if the product is manufactured in Hong Kong; or
(b) If manufactured outside Hong Kong:
(i) by the importer, or
(ii) by the local representative or agent of the overseas manufacturer, prior to its importation into Hong Kong.
Applications must be submitted to the Chinese Medicines Board and must:
(a) Be in the form prescribed by the Board, with the required documents, information, samples, and other supporting materials;
(b) Include all necessary particulars in accordance with applicable requirements; and
(c) Be accompanied by the prescribed application fee.
If the application is approved, and upon payment of the prescribed issue fee, the Board will register the product and issue a certificate of registration in the form it determines.
The Board may impose conditions on the registration as it sees fit and may amend, vary, or revoke these conditions if necessary.
The Board may refuse registration if it deems it necessary in the public interest. The applicant will be notified in writing with reasons for the refusal.
Registered pCm must display a Hong Kong Proprietary Chinese Medicine Registration Number on their packaging, in the format “HKC-XXXXX” or “HKP-XXXXX”.
3.2.3 Import Licensing Control
The importation of pCm is subject to licensing control. An import license issued by the Department of Health is required for imports of pCm into Hong Kong.
3.3 Post Market Surveillance
To safeguard the safety and quality of pp and pCm, the Department of Health (DH) has implemented a regular market surveillance system. Under this system, product samples are routinely collected from the market for testing. DH has also established a mechanism for reporting adverse incidents related to drugs and Chinese medicines, enabling effective risk assessment, management, and reporting.
If substandard products are identified, DH may take appropriate actions, including requesting product recalls, prosecuting the responsible traders, referring cases to the relevant board or council for follow-up, and issuing public press statements.
