Capabilities
Regulatory support
Regulatory support from Celcode: ASEAN Cosmetic Directive checks, documentation for HSA product notification in Singapore, label review and export documents.
Cosmetic products in Singapore are regulated by the Health Sciences Authority under the ASEAN Cosmetic Directive. A product must comply with its ingredient, labelling and claims requirements, and the company placing it on the market must notify the HSA before supplying it. Celcode checks the formulation and label against these requirements, prepares the technical documentation the notification needs, and provides manufacturing documentation, including GMP certification, for export markets.
How cosmetic products are regulated in Singapore
The Health Sciences Authority (HSA) regulates cosmetic products under the Health Products Act, applying the ASEAN Cosmetic Directive. The framework has four practical consequences for a brand:
- Ingredients must comply. The Directive lists substances that are prohibited or restricted and the colourants, preservatives and UV filters that may be used, with limits.
- The product must be notified before supply. The company that places the product on the Singapore market notifies the HSA before the product is sold. Notification is a declaration of compliance, not an approval.
- Labels must carry required particulars. Product name and function, ingredients, contents, country of manufacture, batch identification, dates where required, directions and warnings, and the name and address of the company responsible.
- Claims must stay cosmetic. A cosmetic product cleans, perfumes, changes the appearance, protects or keeps in good condition; it does not treat or prevent disease. Claims must be supported.
The brand also keeps a product information file with the technical and safety information behind the notification, and is responsible for the product’s safety and claims once on the market. Consult the HSA’s regulatory overview for the current requirements; they are updated from time to time.
What Celcode provides
| Item | What it covers | When |
|---|---|---|
| Formulation compliance check | Ingredients checked against the ASEAN Cosmetic Directive annexes for Singapore and target markets | During formulation and before the benchmark sample is approved |
| Ingredient listing | Full ingredient list in the required nomenclature and order for the label and the notification | Before label artwork |
| Label review | Required particulars, claims wording, warnings and directions checked against requirements | Before artwork is finalised |
| Notification documentation | Technical documentation the brand needs to notify the product in Singapore | Before production |
| Manufacturing documentation | GMP certificate details, certificate of analysis for batches, and other documents requested by export markets | At release and on request |
| Claims support | Advice on what the formulation can substantiate and which tests would be needed for specific claims | At concept and during development |
Export markets
Celcode manufactures for Singapore and for export. Most ASEAN markets apply the same Directive but run their own notification systems and, in some cases, ask for additional documents such as a free sale certificate. Markets outside ASEAN have their own frameworks. Naming the target markets in your brief lets Celcode check ingredient restrictions and plan documentation before formulation is fixed, which avoids reformulating later.
What GMP certification contributes
Celcode’s manufacturing site holds an HSA Good Manufacturing Practice certificate for cosmetic products (certificate MCGM2500160, valid to 28 July 2027), covering receipt of materials, production, packaging, labelling, quality control, release, storage and distribution. Export markets frequently ask for evidence that a product was made under GMP; the certificate provides that evidence for products within its scope. It is a statement about the quality system, not an endorsement of any individual product, which still needs its own notification. See certifications.
Responsibilities at a glance
| Responsibility | Brand | Celcode |
|---|---|---|
| Placing the product on the market and notifying the HSA | Yes | Prepares documentation and guides submission |
| Product information file | Holds it | Supplies the manufacturing and formulation documents |
| Ingredient compliance of the formulation | Approves the formulation | Checks and formulates within the Directive |
| Label particulars | Approves artwork | Reviews against requirements |
| Marketing claims | Owns them | Advises on cosmetic scope and substantiation |
| GMP manufacturing | Selects the manufacturer | Manufactures under the certified system |
How to start
Tell us the target markets in your product brief. Regulatory checks start at the concept stage, so the earlier the markets are known, the fewer changes are needed later.
Frequently asked questions
Does Celcode submit the product notification for my brand?
The notification is submitted by the company responsible for placing the product on the Singapore market, which is normally your brand. Celcode prepares the technical documentation, ingredient listing and label review that the notification relies on, and can guide you through the submission.
Is HSA notification an approval?
No. Cosmetic products in Singapore are notified, not approved. The notifying company declares that the product complies with the requirements and remains responsible for its safety and claims. GMP certification of the manufacturer is separate and does not endorse any individual product.
What documents do export markets ask for?
Requirements vary by market. Commonly requested items include the ingredient listing, the manufacturer's GMP certificate, a certificate of analysis and, in some markets, a free sale certificate or a product information file. Tell us the markets in your brief so the documentation is planned early.
Can a cosmetic product claim to treat a skin condition?
No. Therapeutic and medicinal claims are outside the scope of cosmetic products. Claims are reviewed during the regulatory check so that the label and marketing stay within cosmetic scope and are supported by the formulation.
- Written by
- Celcode Dermal Lab
- Published
- Updated