Singapore Cosmetic Regulation

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.

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Part 1 Regulatory Framework and Competent Authority

1 Existing Main Cosmetic Regulations in Singapore

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

1 Definition

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:

• Cleaning them

• Perfuming them

• Changing their appearance

• Correcting body odours

• Protecting them

• 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 Cosmetic Product Classification Guide to check if a product is a cosmetic or not)

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.

3 Notification

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.

4 Advertisement

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:

• The name of the cosmetic product and its function

• Instructions for use

• Full ingredients listing

• Country of manufacture

• The name and address of the company or person responsible for placing the product on the local market

• Contents

• Batch number

• Manufacturing/expiry date

• Special precautions, if any (especially the "Conditions of use and warnings" listed in Annex III, VI, VII in the ASEAN Cosmetic Directive)

If the size, shape or nature of the container or package does not permit the particulars above to be displayed, the use of leaflets, pamphlets, hang tags, display panel, shrink wrap, etc. is allowed. However, the name of the cosmetic product and manufacturer's batch number. shall appear on small immediate packaging.

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