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|
|Guidelines on the Control of Singapore Cosmetic Products||2019-4-1||In Force|
|Classification Guide for Cosmetic Products||2019-1-1||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
In accordance with the ACD, 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 e.g. skin, hair, nails, lips, or mouth including gums, teeth, tongue, for the purpose of cleaning them, perfuming them, changing their appearance, correcting body odours or protecting them or keeping them in good condition. (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 manufacturers must ensure that their manufacturing conditions comply with the GMP.
Prior to manufacturing cosmetics companies are required to apply for a GMP certificate with the HSA. The certificate shall be renewed every three years.
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. 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.
Product notification is intended for cosmetic products only. Products notified with HSA that does not meet the cosmetic product's legal definition found in the First Schedule of the Health Products Act may be removed without notice.
Notification is not required if:
a cosmetic product that is supplied solely as a sample in connection with any advertising, sponsorship or promotional activity; or
a cosmetic product that is supplied solely for testing or trial use in connection with any research or development of that product; or
a cosmetic product that is 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.
Subsequent retention of the notification (re-notification) is required every year if the cosmetic product continues to be supplied in the market.
A new product notification is required if changes are made to the following:
Company change of distribution rights
For changes to manufacturer's name and address that affect more than one product notification, submission under the “Update to Manufacturer’s Name & Address” in PRISM is sufficient to effect the change. A company may select up to a maximum of 20 affected notifications per amendment submitted.
For changes to the name and/or address of company, without change of distribution rights (i.e. no change in Unique Entity Number), the company can amend the company's name and/or address via the “amend company information” under amend@PRISM.
Responsibilities of the company
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. For the reporting form and guide, please click here.
Recall product if the product is found to have any safety concern.
4 Record Keeping
The person responsible is required to keep records relating to the supply of the cosmetic product. The records shall contain information on the name and notification number of the product, name and address of company supplied, and the batch number, date and quantity of product supplied. The records should be kept for 2 years after the date of supply.
The person responsible is required to produce records of supply, safety or technical information of the cosmetic products upon request by HSA when safety concern on the cosmetic product arises. In addition, companies may be required to submit samples of cosmetic products for laboratory testing when requested by HSA, for example to verify the safety or quality of the products. The expenses incurred in the testing will be borne by the companies.
Cosmetic products are intended for the purposes mentioned in Section 2 of this guideline. Product claims to modify a physiological process or to prevent or treat a disease/medical conditions are not permitted in cosmetic products and on advertisements for cosmetic products. In general, any claims made must be justified by scientific data/evidence and/or by the cosmetic formulation or preparation itself.
All advertising claims must be 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.
6 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 Restrictions
Companies supplying the cosmetic products are responsible to ensure the product including the ingredients are safe for use.
Cosmetic products shall not contain substances found in Part I of the Third Schedule of the Regulations. These substances are prohibited for use in cosmetic products.
Substances found in Part II of the Third Schedule of the Regulations, may only be used in cosmetic products provided the specified conditions are met. Depending on the substance, the conditions could be on the maximum concentration allowed to be used or labelling of special warning on the product packaging.
Only colouring agents, preservatives or UV filters found in Parts III, IV and V respectively of the Third Schedule of the Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations are allowed to be used in cosmetic products. The use of colouring agents, preservatives and UV filters are subject to the conditions specified, if any.