With effect from 1 January 2008, the Health Sciences Authority (HSA) has implemented the ASEAN Cosmetic Directive (ACD) by way of the Health Products (Cosmetic Products - ASEAN Cosmetic Directive) Regulations 2007, a subsidiary legislation under the Health Products Act, which adopts similar regulatory principles and requirements as the European Union (EU) regulations on cosmetic products.
Under the current regulatory control, any person who introduces a cosmetic product into the local market must notify the HSA before the supply and/or sale of the cosmetic product. The person also has to ensure that the cosmetic product is safe for human use when applied under normal conditions of use, and does not contain any banned or restricted substances stipulated for cosmetic products as listed in the legislation.
Part 1 Regulatory Framework and Competent Authority
1 Existing Main Cosmetic Regulations in Singapore
|Health Products Act (HPA)||2008-12-31||In Force|
Health Products (Cosmetic Products - ASEAN Cosmetic Directive) Regulations 2007
|Guidelines on the Control of Singapore Cosmetic Products||2019-4-1||In Force|
|Classification Guide for Cosmetic Products||2019-1-1||In Force|
|Guidance for New Importers of Cosmetic Products||2020-04-22||In Force|
2 Competent Authority
The Health Sciences Authority (HSA), a statutory board of the Singapore Ministry of Health, has the authority for the regulation and licensing of cosmetic products intended for human use in Singapore.
The Cosmetics Control Unit (CCU), a unit in HSA, was set up in November 1995 to administer the regulatory control of cosmetic products.
Part 2 Cosmetic Products
A cosmetic product in Singapore is defined as any substance or preparation that is intended to be placed in contact with the external parts of the human body, such as the skin, hair, nails, lips or mouth (including gums, teeth and tongue), for the purpose of:
Changing their appearance
Correcting body odours
Keeping them in good condition
Cosmetic products are not:
Injections and eye-drops
Products that are consumed orally, such as tablets, capsules or beverages
Products that are intended for treatment, such as acne treatment creams
(Use the Classification Guide for Cosmetic Products to check if a product is a cosmetic or not)
In addition, HSA divides cosmetics into two categories: lower risk cosmetics and high risk cosmetics. The classification is defined only for determine the notification fees. The fee for high risk cosmetics is higher than low risk cosmetics.
Cosmetic Products deemed to be of higher risk are cosmetic products to be applied around the eyes, on the lips, hair dyes containing phenylenediamines and oral and dental care products.
Cosmetic Products deemed to be of lower risk are all other cosmetic products not listed above such as skin whitening products, moisturizers, etc.
2 Manufacturing Requirements
The ASEAN guidelines on Good Manufacturing Practice (GMP) stipulates the requirements for manufacturing cosmetics in the respects of personnel, premises, equipment, Sanitation and hygiene, etc..
Cosmetic product manufacturers in Singapore do not require a manufacturer's license. The manufacturer may apply for a voluntary Good Manufacturing Practice (GMP) certificate to facilitate the export of the cosmetic products.
Companies or individuals who intend to sell or supply a cosmetic product in Singapore are required to notify the HSA. Before submitting a notification, they shall check that the ingredients in the cosmetic product comply with the requirements of the Annexes of ASEAN Cosmetic Directive (ACD) and the labelling requirements, and apply for a Client Registration and Identification Service (CRIS) account. The notification shall be submitted by using the online Pharmaceutical Regulatory Information System (PRISM). An acknowledgement of notification email will be auto-generated and sent to the applicant's email address if notification has been submitted successfully. Only after the acknowledgement is received the product can be supplied.
Subsequent retention of the notification (re-notification) is required every year if the cosmetic product continues to be supplied in the market.
Who should submit?
A cosmetic product notification is required:
Even if the product has already been notified by another company in Singapore, and you are importing from the same manufacturer
For every different variant of the same cosmetic product, such as different shades of a lipstick and different scents of a shampoo
A cosmetic product notification is not required for the following products. However, company still need to comply with other requirements, such as labelling, ingredients and adverse event reporting:
Sample products connected with advertising, sponsorship or promotional activities
Products used for testing or trial in connection with any research or development of that product
Products manufactured by or in accordance with the specifications of a medical practitioner, and supplied solely by that medical practitioner for the use of patients under his care
Different pack sizes of the same product
What responsibilities companies shall take?
Sellers of cosmetic products are responsible for the safety and quality of their products. Cosmetic products should not contain adulterants or prohibited substances and they should not breach the limits for specified substances.
Maintain records of supply of the cosmetic products for 2 years.
Submit safety and technical information when requested by HSA.
Monitor and report adverse events and recalls to HSA.
Recall product if the product is found to have any safety concern.
Cosmetic products are prohibited to claim to modify a physiological process, such as a reversal of hair loss, or to prevent or treat a disease or medical conditions. In general, all advertising claims
must be aligned with the definition of cosmetic products, and justified by scientific data or evidence and/or by the cosmetic formulation or preparation itself.
must be in line with the ASEAN Cosmetic Claims Guidelines and fully substantiated when requested as per the Singapore Code of Advertising Practices (SCAP). Advertising activities should also comply with the principles and guidelines listed in SCAP.
5 Labeling Requirements
Cosmetic product labels should contain truthful and accurate information about the cosmetic product, its intended purpose and how it is to be used. They are required to be labelled in accordance with the Regulations before they can be sold or supplied in Singapore and to make claims that will NOT mislead the consumer about the product's contents, quality or safety.
Suppliers of cosmetic products, such as wholesalers or retailers, must ensure that the cosmetic products comply with the Regulations before they supply the product. Labels or labeling statements must be in English and legible. The following information must appear on the outer packaging or immediate container of the cosmetic products:
a. Name of the cosmetic product
b. Function of the cosmetic product
c. Instructions for use
d. Full ingredients listing
e. Country of manufacture
f. Contents (weight/volume)
g. Batch number
h. Manufacturing/ expiry date (expiry date is only required for products with less than 30 months durability)
i. Name and address in Singapore of company responsible for placing the product in the market
j. Special precautions, if any (especially those listed in Annex III, VI, VII in the ASEAN Cosmetic Directive)
An explanation of the symbol or code (e.g. colour) used in the label should be provided.
Cosmetic products that bear the label “for professional use only” or similar labelling are restricted for “professional use”.
“Professional use” means the application and use of cosmetic products by persons in the exercise of their professional activity (e.g. in hair salons, nail salons, spa salons, skin clinics etc). It also means that such cosmetic products should not be sold by a professional to the consumer.
A “professional” would have attained a certain level of expertise and experience. Therefore, they are more familiar with the risks associated with the use of the products than the consumer. They would also have the professional expertise in the correct application of the product on a consumer.
The label must be legible, permanent, indelible, prominently and conspicuously displayed on the product at the point of sale. Labels or labeling statements shall appear on the outer packaging of the cosmetic products or, where there is no outer packaging, on the immediate packaging of cosmetic products.
Where the size, shape or nature of the container or package does not permit all the required information to be specified on the container or package, the use of leaflets, pamphlets, hang tags, display panels etc placed together with the product are allowed. However, the name of the cosmetic product and the batch reference must be displayed on the immediate package or container.
Listing of Ingredients
All cosmetic products must be labeled with the ingredients contained in the product. The quantity or percentage of each ingredient in the cosmetic product need not be disclosed on the labeling.
The ingredients should be listed in descending order by weight, except for:
Ingredients (except coloring agents) in concentrations of less than 1% (by weight) listed in any order after ingredients present in concentration of 1% or more; and
Coloring agents listed in any order, after the other ingredients.
Perfume and aromatic compositions and their raw materials may be referred to by the word “perfume”, “fragrance”, “aroma” or any other similar term. Likewise, flavouring may be referred to as “flavour” or any other similar term.
Part 3 Ingredient Requirements
Companies shall refer to the Annexes of the ASEAN Cosmetic Directive for the most updated list of prohibited and restricted ingredients, including permitted colouring agents, preservatives or UV filters.
1. Annex II is a List of Substances Which Must Not Form Part of the Composition of Cosmetic Products
2. Annex III is a List of substances that cosmetic products must not contain except for the ones subject to restrictions and conditions laid down
3. Annex IV lists colouring agents allowed for use in cosmetic products
4. Annex VI lists the Preservatives Which Cosmetic Products May Contain
5. Annex VII is a list of UV Filters Which Cosmetic Products May Contain