There are no pre-market requirements for cosmetic products in Singapore. However, before a company can make cosmetic products available to the market, it is required to submit a notification to the Health Sciences Authority (HSA) for cosmetic products.
Compliance readiness extends beyond notification for cosmetic companies, importers and regulatory bodies when they are entering into Singapore. To prevent enforcement actions or disruption to the market, companies should make sure they are using formulations that are compliant with the ASEAN Guidelines, they are correctly labelling their products, they have adverse event reporting systems in place, and they are checking for post-market compliance.
Cosmetic Product Classification in Singapore
A cosmetic product is defined as any substance or preparation intended for application to the external parts of the human body (skin, hair, nails, lips, teeth, and oral cavity) intended for the sole purpose of cleansing, fragrance, health, skin care, body care, and hair care.
In Singapore, injections, oral supplements, and products used for the treatment of medical conditions are not considered cosmetics.
HSA Notification Requirements for Cosmetics in Singapore
The HSA does not require cosmetic products to be pre-marketed and approved, as is required for pharmaceuticals in Singapore. Manufacturers/Importers, however, are required to meet “Cosmetic Product Notification” criteria.
Cosmetic Products are required to be notified to HSA via the Cosmetic Product Notification System (CPNS). This is the required notification process for the importation or manufacture of cosmetics in Singapore. Note that the HSA will not review the notification, and therefore, notified products are not “approved” by the HSA.
Cosmetics Market Entry Process in Singapore (Step-by-Step)
Before supplying to the market, companies need to adhere to the requirements of the HSA notification and the ASEAN Cosmetic Directive (ACD). The typical market entry process includes:
Step 1: Confirm Cosmetic Product Classification
Before companies can start making the product, they need to establish whether the product is considered a cosmetic under Singapore regulations. Cosmetic products that claim to have therapeutic or medicinal benefits may not be covered under the cosmetic definition and may need to be regulated differently.
Step 2: Verify Ingredient & Labeling Compliance
Prior to notification, companies should make sure formulations meet the Singapore requirements as per ASEAN Cosmetic Directive (ACD) ingredient restrictions and prohibited substances lists, as well as labeling requirements.
Step 3: Designate a Singapore Responsible Entity
The cosmetic products must be placed on the market by a local Singapore Company or importer, and any notification and compliance duties must be carried out in accordance with HSA.
Step 4: Register Access to HSA PRISM System
Companies are required to register to a Client Registration and Identification Service (CRIS) account and gain access to HSA’s PRISM system to submit cosmetic notifications.
Step 5: Compile the Product Information File (PIF)
The Product Information File (PIF) should include formulation information, safety evaluations, labeling data and technical documentation that will be available for review by regulators.
Step 6: Submit Cosmetic Product Notification
Cosmetic product notifications to the HSA must be made via PRISM and the companies will need the HSA’s acknowledgement prior to supplying the product in Singapore. HSA does not prescreen cosmetics for market entry.
Step 7: Post-Market Compliance
Post-market compliance obligations are the responsibility of companies and include adverse event reporting, product defect reporting, notification modifications, annual re-notification, and cancellation of notifications for discontinued products.
Documents Required for Cosmetic Notification in Singapore
Typical documents required include:
- Product Information File (PIF)
- Complete ingredient and formulation details
- Safety assessment data
- Product specifications
- Labeling artwork and claims support
- Manufacturer and importer details
- Adverse event and quality records
- Supporting GMP documentation, where applicable
Companies are responsible for ensuring that all documentation remains updated and available throughout the product lifecycle in Singapore.
Labeling Requirements for Cosmetics in Singapore
The labeling requirements under HSA for cosmetic notification in Singapore include:
- Product name and function
- Directions for use
- Full ingredient list
- Country of manufacture
- Net content (weight/volume)
- Batch number
- Manufacturing or expiry date (mandatory for products with durability below 30 months)
- Name and address of the Singapore responsible company
- Special precautions and warning statements, where applicable
Ingredient lists must follow recognized nomenclature standards such as INCI and be declared in descending order by weight.
Products labelled “for professional use only” are restricted to professional settings such as salons, spas, and aesthetic clinics.
GMP Requirements for Cosmetics in Singapore
Singapore does not require a manufacturing licence for cosmetic manufacturers. However, companies may apply for voluntary Good Manufacturing Practice (GMP) certification through HSA to support export activities and demonstrate compliance with ASEAN GMP standards.
Manufacturers applying for GMP certification must undergo an HSA GMP audit and prepare a Site Master File in accordance with ASEAN cosmetic GMP guidelines. Applications are submitted through the PRISM system.
Post-Market Surveillance for Cosmetics Notification in Singapore
HSA conducts post-market surveillance of cosmetic products in Singapore to monitor product safety, labeling compliance, and prohibited ingredients. This may include market sampling, product testing, and investigation of consumer complaints or safety concerns.
Companies are responsible for reporting serious adverse events and product defects associated with cosmetic products supplied in Singapore. Serious cases involving hospitalization, life-threatening reactions, or significant health risks must be reported to HSA within the prescribed reporting timelines.
Where necessary, HSA may require corrective actions, product recalls, or market withdrawal of non-compliant cosmetic products.
Timeline & Cost of Cosmetic Notification in Singapore
Cosmetic product notifications in Singapore are submitted electronically through HSA’s PRISM system. Once successfully submitted, companies receive an acknowledgment notification before supplying the product to the market.
Notification fees vary depending on product category and variants:
| Cosmetic Product Type | Fees |
| Products applied around the eyes or lips, oral/dental products, or hair dyes containing diamine compounds | SGD 28 for single product or first 3 variants |
| Fourth and subsequent variants | SGD 8 per variant |
| Other cosmetic products | SGD 13 for single product or first 3 variants |
| Fourth and subsequent variants | SGD 8 per variant |
Notifications are valid for one year and require annual re-notification to continue market supply.
Conclusion
Singapore’s cosmetics regulations are modelled after the ASEAN Cosmetic Directive (ACD) and are notification-based, administered by HSA.
Compliance with the ASEAN Cosmetic Directive (ACD) can be complicated, but Artixio is here for you. Our regulatory professionals can help with Singapore cosmetic product registration solutions to help you ensure your cosmetic product is compliant with all ACD requirements, so you can concentrate on what you do best – making exceptional cosmetic products.
Looking to simplify your ACD process? Call Artixio today at info@artixio.com.
FAQs
Is cosmetic registration mandatory in Singapore?
There are no pre-market requirements or registration for cosmetic products in Singapore. But companies have to complete cosmetic product notification with HSA prior to providing a product in the marketplace.
Who can submit cosmetic product notifications in Singapore?
The cosmetic notifications should be made by a Singapore-registered entity that must be responsible for introducing the product in the Singapore market.
Does Singapore have the ASEAN Cosmetic Directive (ACD)?
Yes. Singapore regulates cosmetic products under the ASEAN Cosmetic Directive (ACD), which covers ingredient restrictions, labelling, and safety requirements.
Do cosmetic manufacturing companies in Singapore need to be certified by GMP?
In Singapore, cosmetic manufacturers are not required to be GMP certified, but may benefit from export business and prove compliance with the ASEAN GMP standards.
