CMS Expert Guide on Beauty in Hong Kong

In Hong Kong, there are no laws/regulations specifically targeting on cosmetic products. There are however various legislations that have to be considered.

On one hand, cosmetic products are governed generally as consumer goods under the Consumer Goods Safety Ordinance (Cap. 456) (“CGSO”) (and its subsidiary legislation, Consumer Goods Safety Regulation (Cap. 456A) (“CGSR”)) and as goods under the Trade Description Ordinance (Cap 362) (“TDO”).

On the other hand, depending on the composition and ingredients of the cosmetic products, chances are that they may be classified as "pharmaceutical product" regulated under the Pharmacy and Poisons Ordinance (Cap. 138) (“PPO”) or as “proprietary Chinese medicines” regulated under the Chinese Medicine Ordinance (Cap. 549) (“CMO”).

While there is no express restriction on a particular substance in cosmetic products, the safety standard imposed by the respective laws and regulations as set out in Question 4 below will need to be satisfied.

PPO 
Further, if the cosmetic products are being classified as "pharmaceutical product" under PPO,  products containing any substances which fall under the Poisons List set out in Schedule 10 of the Pharmacy Poisons Regulation (Cap. 138A) (“PPR”) shall subject to the following conditions of sale:

For example, hair dye preparations containing phenylene diamines, toluene diamines or other alkylated-benzene diamines or their salts fall under Part 2 of the Poisons List.

It should be noted that unless as provided otherwise in the PPR, generally the restriction does not extend to the sale or supply of a substance for use in or in connection with an institution, or to a registered medical practitioner, registered dentist or registered veterinary surgeon for the purpose of his profession.

CMO

Similarly, if the cosmetics products are being classified as “proprietary Chinese medicines” under CMO, there are restrictions on the sale and possession of the products if they contain any substances which fall under the list of Chinese Herbal Medicines in Schedules 1 and 2 of the CMO, such as arsenic trioxide or cordyceps.

No. Please refer to Question 7 below in relation to the enforcement of the applicable legislations.

There is no laws or regulations specially addressing to cosmetic products save the general legal requirements for consumer products as explained below.

CGSO

Generally, section 4 of the CGSO imposes a safety requirement for all consumer goods, including cosmetic products. It requires consumer goods to be reasonably safe having regard to all relevant factors, such as:

• 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 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.

For instance, the Customs and Excise Department (“C&ED”), being the enforcement agency of CGSO, will consider the standards or requirements published by the European Union, the United States and the Mainland to determine whether a product is reasonably safe.

PPO & CMO

For cosmetic products being classified as "pharmaceutical product", they must satisfy the criteria of safety, quality and efficacy and be registered with the Pharmacy and Poisons Board before they can be legally sold in Hong Kong. As for cosmetic products being classified as “proprietary Chinese medicines”, they 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. 

While there is no specific packaging requirements for cosmetic products in Hong Kong, there are certain labelling requirements that must be observed.

CGSO

CGSO imposes bilingual safety labelling requirements on all consumer goods, including cosmetic products, as follows:

1. all markings or labels containing warning or caution words or phrases given in respect of the safe keeping, use, consumption or disposal of the goods shall be in both English and Chinese; and
2. any warning or caution phrases must be legibly and conspicuously shown on the goods / package of the goods / the label securely affixed to the package / a document enclosed in the package.

PPO

PPO requires the labels of cosmetic products that classified as "pharmaceutical product" to contain the following information:

1. name of the product;
2. name and quantity of each active ingredient;
3. name and address of the manufacturer;
4. Hong Kong registration number;
5. batch number;
6. expiry date;
7. product pack size and unit of quantity; and
8. storage conditions (and specific storage conditions, if any).

CMO

CMO requires the labels of cosmetic products that classified as "proprietary Chinese medicines" to contain the following information:

1. name of the medicine;
2. active ingredients;
3. registration number;
4. name of the holder of the certificate of registration of the medicine or the manufacturer (as the case may be)
5. packing specification;
6. dosage and method of usage;
7. batch number; and
8. expiry date.

There is no laws or regulations specially addressing to marketing of cosmetic products save the general legal requirements in this regard as explained below.

TDO

Generally, TDO prohibits unfair trade practices against consumers such as false trade descriptions, misleading omissions and bait advertising.  For example, it will be a case of false trade descriptions if the cosmetic products do not contain a particular substance that claimed to be contained therein.

The maximum penalty upon conviction of the offences in relation to unfair trade practices is a fine of $500,000 and imprisonment for five years.

Undesirable Medical Advertisements Ordinance (Cap. 231) (“UMAO”)

Specifically, for cosmetic products that fall under the definition of “medicine” or “orally consumed product” under the UMAO, there are certain diseases, conditions, purposes and claims prohibited or restricted to be advertised.

Code of Practice on Advertising Standards (the “Advertising Standard”)

Further, pursuant to the Broadcasting Ordinance (Cap. 562), the Communications Authority has issued various code of practice for advertisement through different media, including radio and television programme, which prohibits advertisement of certain products, such as medical preparations under Part 1 of the Poisons List or products coming within the recognised character of, or specifically concerned with, prevention or treatment for any disease of hair or scalp, except for prevention or treatment of dandruff by means of external applications.There is no laws or regulations specially addressing to marketing of cosmetic products save the general legal requirements in this regard as explained below.

TDO

Generally, TDO prohibits unfair trade practices against consumers such as false trade descriptions, misleading omissions and bait advertising.  For example, it will be a case of false trade descriptions if the cosmetic products do not contain a particular substance that claimed to be contained therein.

The maximum penalty upon conviction of the offences in relation to unfair trade practices is a fine of $500,000 and imprisonment for five years.

Undesirable Medical Advertisements Ordinance (Cap. 231) (“UMAO”)

Specifically, for cosmetic products that fall under the definition of “medicine” or “orally consumed product” under the UMAO, there are certain diseases, conditions, purposes and claims prohibited or restricted to be advertised.

Code of Practice on Advertising Standards (the “Advertising Standard”)

Further, pursuant to the Broadcasting Ordinance (Cap. 562), the Communications Authority has issued various code of practice for advertisement through different media, including radio and television programme, which prohibits advertisement of certain products, such as medical preparations under Part 1 of the Poisons List or products coming within the recognised character of, or specifically concerned with, prevention or treatment for any disease of hair or scalp, except for prevention or treatment of dandruff by means of external applications.

TDO

C&ED is responsible for enforcing the TDO, with various enforcement tools available, such as requiring the trader to give an undertaking not to continue or repeat the conduct or commercial practice of concern. Alternatively, the Commissioner of Customs and Excise (“CCE”) may apply to the court for an injunction to prohibit the concerned conduct.

Criminal Proceedings may also be initiated where there is a serious contravention of fair trading regulations and the following list of non-exhaustive factors will be considered:

• Whether the conduct continues over a long period of time;
• The number of victims and quantum of financial loss or other detriment suffered or likely to be suffered by the victim(s);
• Whether the conduct is a fabricated one with prior planning;
• Whether the victims are particularly vulnerable;
• Prevalence of the conduct and its impact on the community, including the risk posed to public health and safety or to the environment;
• Whether there are elements in the conduct which caused or were likely to cause harassment, anxiety or distress to the victims;
• Any attempt by the trader to conceal his identity, whether directly or indirectly, such that the Enforcement Agency or the victims (or both) cannot easily identify or trace the trader;
• Lack of remorse;
• The trader’s compliance history and conviction record(s); and
• Whether the trader has obstructed the Enforcement Agency in taking lawful actions during investigation.

CGSO

C&ED is also responsible for enforcing the CGSO, with various remedial measures available, and may serve on any person the following notices:

• Notice to warn — to require that person, at his own expense and by his own arrangements, to publish a warning that a product may be unsafe unless certain steps are taken.
• Prohibition notice — to prohibit that person from supplying certain consumer goods which are found to be unsafe for a specified period of time.
• Recall notice — to require the immediate removal of unsafe goods from sale and the retrieval of those goods (e.g. by an offer to buy-back or exchange) already supplied.
• Requirement notice — to require —
  • the manufacturer, importer or supplier of consumer goods to have them tested in the form and manner specified by CCE;
  • the manufacturer, importer or supplier of consumer goods to modify them or their labelling, packaging or advertising so that they comply with the general safety requirement, an approved standard or a safety standard/specification established by regulation; and
  • a person who advertises specified consumer goods to include warning notices in the advertisements or to cease the advertising.

PPO and CMO

The Department of Health (“DH”) is generally responsible for the enforcement of PPO and CMO. If any pharmaceutical products or proprietary Chinese medicines are found to be not up to required standard, DH may take actions such as requesting the traders concerned to recall the products, prosecuting the traders concerned or referring the cases to the relevant board (i.e. the Pharmacy and Poisons Board for PPO and the Chinese Medicines Board for the CMO) or council for follow-up actions.

Back in February 2017, there was discussion in the Legislative Council as to whether the existing mechanism will be reviewed and whether a single government department will be entrusted to be responsible for the prosecutions, inspections, sampling tests and handling of complaints concerning cosmetics and skin care products. However, due to the different risk profile and nature, consumer goods and drugs (of which cosmetic goods may fall under) remain to be subject to different regulatory mechanisms administered by relevant professional departments. There is no further discussion in this field thereafter.

Similar to cosmetics, supplements may fall under the aforementioned scope of “pharmaceutical products” regulated by the PPO or “proprietary Chinese medicine” regulated by the CMO.

The Guidance Notes on Classification of Products as “Pharmaceutical Products” under PPO helpfully provide a list of substances that are normally not regarded as medicinal, which includes fish oils, caffeine, amino acids and more.

If the supplement fall within the definition of "food" under the Public Health and Municipal Services Ordinance (Cap. 132) (“PHMSO”), it will be regulated thereunder instead.

If the supplement products are to be regulated by either the PPO or the CMO, the restrictions set out in Question 2 apply.

No. Please refer to Question 16 below in relation to the enforcement of the applicable legislations.

Please refer to Question 4 above.

If the supplements are regulated under PHMSO, they need to be fit for human consumption and in compliance with the relevant food safety standards.

There is no law on keeping record in relation to supplements made available to customers.

Please refer to Question 5 above.

If the supplements are regulated under PHMSO, under the Food and Drugs (Composition and Labelling) Regulations (Cap. 132W), the following information should be marked in either English or Chinese language or in both languages on the label of prepackaged food:

• Name of the Food;
• List of Ingredients;
• Indication of "use by" or "best before" Date;
• Statement of Special Conditions for Storage or Instructions for Use;
• Name and Address of Manufacturer or Packer; and
• Count, Weight or Volume of Food.

Please refer to Question 6 above.

Further, under the Advertising Standard, advertisements of claims relating to nutrition or dietary effects of products or services should be handled with care. For example, advertisements for dietary supplements, including vitamins or minerals, must not state or imply that they are necessary as additions to a balanced diet in order to avoid dietary deficiency or that they are the only means to enhance normal good health.

Please refer to Question 7 above.

The enforcement agency for PHMSO is the Centre for Food Safety under the Food and Environmental Hygiene Department. It ensures that food products are up to safety standard and conform with labelling requirements by conducting food surveillance.

The Preparatory Office for the Hong Kong Centre for Medical Products Regulation (“CMPR”) has been established in June 2024 to prepare for the establishment of he CMPR and study the potential restructuring and strengthening of the regulatory and approval regimes for drugs and medical devices.

For supplements that are not classified as drugs and medical devices, they will continue to be regulated in accordance with other legislations and arrangements currently applicable to them. 

As compared to cosmetic products, cosmetic device may be regulated under the Electrical Products (Safety) Regulation (Cap. 406G) (“EPSR”) as an electrical product instead, if it is designed for household use, supplied in Hong Kong, and using a voltage exceeding 50V alternating current or 120V direct current.

It may also be regulated under the PPO if it contains pharmaceutical products or under the Radiation Ordinance (Cap. 303) if it emits ionising radiation.

Otherwise, similar to cosmetic product, it will be regulated by the CGSO as well.

Further, there is no distinction between medical devices and cosmetic devices in terms of the regulatory regime in Hong Kong.

The following answers are provided on the assumption that the cosmetic products are regulated under the EPSR.

No. Please refer to Question 5 below of the enforcement EPSR.

Under the EPSR, the supplier shall ensure that a certificate of safety compliance has been issued before its supply, and that the cosmetic device complies with the applicable safety requirements, which could be found in Section C1 of the Guidance Notes for the Electrical Products (Safety) Regulation.

Pursuant to Para. 1 of Schedule 1 of the EPSR, the following shall be printed on the product in English, Chinese or international standard symbols, or, if this is not possible, on an accompanying notice: (1) the rated voltage and frequency; (2) rated input in terms of watts, kilowatts, amperes or milliamperes; (3) model or type reference number; and (4) manufacturer’s name or trade mark.

Further, pursuant to Schedule 3 of the EPSR, a warning label shall be fixed durably and conspicuously on the surface of the packaging of the electrical product, or on the product itself if no packaging is provided when supplied where the electrical product is designed solely for use at a voltage of less than 200V alternating current single phase.

If in the opinion of the Director of Electrical and Mechanical Services (the “Director”) an electrical product does not comply with the applicable safety requirements, the Director may serve a written notice on the supplier of the electrical product concerned requiring that supplier (or its agent) to (1) notify the purchasers the hazardous defects in the product; (2) accept a return of the product; and (3) refund the purchasers any sum paid for the product subject to a condition that a receipt for the product is surrendered; and (4) publicize the aforesaid matters set out in (1) to (3).

If a person supplies an electrical product which fails to comply with the applicable safety requirements, or fails or refuses to comply with the above notice from the Director, that person commits an offence and is liable to a fine at $100,000 and to imprisonment for 1 year on first conviction, and to a fine of $500,000 and to imprisonment for 2 years.   

This has been no new development since a report prepared back in 2019 by the Panel on Health Services and Panel on Commerce and Industry as part of the Joint Subcommittee on Issues Relating to the Regulation of Devices and Development of the Beauty Industry and published by the Legislative Council Secretariat.

The report discussed the potential implementation of pre-market control and post-market control of medical devices (including cosmetic devices) to ensure medical devices conform with the requirements on safety, quality performance and efficacy before being allowed to be placed on the market. 

While there is no regulation specifically for cosmetic (non-surgical) services, consumers of such services shall be entitled to protection under the Supply of Services (Implied Terms) Ordinance (Cap. 457) (“SSITO”).

No.

“Botulinum toxin complexes” is listed in Part 1 of the Poisons List. Therefore, it can only be sold on premises duly registered under PPO as premises of an authorized seller of poisons by a registered pharmacist or in his presence and under his supervision.

No, businesses and/or practitioners administering these services are not required to register with a centralised body.

Normally, consumers will lodge their complaints with the Consumer Council (“CC”) or the C&ED if the complaints are associated with unfair trade practices, but these bodies are not specifically responsible for non-surgical cosmetic services.

The SSITO seeks to imply terms to the contract between the consumer and the supplier that, among others, the supplier will carry out the service with reasonable care and skill. The consumer can have a civil claim against the supplier if such term has been breached.

On the other hand, if a complaint was made to CC, CC may investigate and help negotiate on the consumer’s behalf by way of conciliation.

Please see above Question 7 under the section of Cosmetics and Supplements in relation to the enforcement of C&ED.

Please see above Question 6 under the section of Cosmetics and Supplements.

In 2013, the Steering Committee on Review of Regulation of Private Healthcare Facilities published the "Report of the Working Group on Differentiation between Medical Procedures and Beauty Services", with recommendations on procedures that should be performed by registered medical practitioners or registered dentists. There is however no subsequent developments in this field.