|Health Products (Cosmetic Products - ASEAN Cosmetic Directive) Regulations 2007|
|Health Sciences Authority (HSA)|
|Main Supporting Rules|
|Apr 1 2019||Guidelines on the Control of Singapore Cosmetic Products|
|Apr 16 2019||Step-by-step Guide on Cosmetic Products Notification|
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.
|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|
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.
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.
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:
- Brand name
- Product name
- Product types
- 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.
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.