Singapore Cosmetic Registration (HSA – Health Sciences Authority)

1. Regulatory Authority & Framework

Cosmetics in Singapore are regulated by:

• Health Products Act
• Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations
• ASEAN Cosmetic Directive (ACD) – fully adopted
• HSA – Health Sciences Authority, Cosmetic Control Unit

Key feature:
Singapore uses a post-market surveillance + notification system, NOT pre-market approval.

2. Definition of Cosmetic (ACD-Aligned)

A cosmetic is any product intended to be applied to the external parts of the body, teeth, or mucous membranes for:

• Cleansing
• Perfuming
• Changing appearance
• Correcting odour
• Skin/hair conditioning
• Protecting/maintaining condition

Products with therapeutic claims/multi-function can be classified as medical devices, therapeutic products, or medicated cosmetics, requiring other pathways.

3. Registration Type – Cosmetic Product Notification (CPN)

Singapore requires Cosmetic Product Notification, not approval.

Outcome:

• CPN Reference Number
• Notification is immediate upon successful submission
• No validity period → notification remains valid indefinitely unless product changes or is withdrawn

4. Responsible Person (RP) Requirement

Foreign manufacturers cannot submit directly.
A Singapore-based entity must be appointed as the Responsible Person (RP).

RP obligations:

• Submit the CPN via PRISM (HSA online system)
• Ensure product safety & label compliance
• Maintain Product Information File (PIF)
• Handle adverse event reporting
• Manage recalls & corrective actions
• Support post-market checks by HSA

RP name must appear on product label.

5. Cosmetic Product Notification (CPN) Requirements (PRISM System)

Documents / Information Required

1. Product details
   • Product name & category
   • Product function
   • Brand
   • Variants/shades
2. Full ingredient list (INCI)
   • Ingredient % for restricted substances (if applicable)
   • Compliance with ACD Annexes
3. Label artwork
   • Must include mandatory claims, warnings, RP details
4. Manufacturer & RP details
   • Address, contact, country of manufacture
5. Product Information File (PIF) (kept by RP, NOT uploaded)
   • Safety assessment
   • Quality data
   • GMP (ISO 22716 recommended)
   • Stability tests & microbiological limits
   • Product formula, test reports
   • Claims substantiation
6. No CFS (Certificate of Free Sale) required
   Singapore is one of the easiest ASEAN markets for cosmetic notification.

6. Ingredient Control (ASEAN Cosmetic Directive)

Singapore strictly follows ACD Annexes:

• Annex II – Prohibited substances
• Annex III – Restricted substances (AHA, SA, hair dyes, etc.)
• Annex IV – Allowed colorants
• Annex VI – UV filters
• Annex VII – Preservatives

Strict rules:

• Hydroquinone, steroids, tretinoin → prohibited
• Mercury → zero tolerance
• AHA & salicylic acid have concentration & pH limits
• Nanomaterials require RP justification and safety data
• Sunscreens must use approved UV filters

7. Labeling Requirements (Mandatory)

Singapore requires compliance with ACD & local rules.

Label must include:

• Product name & function
• Full INCI ingredient list
• Country of manufacture
• Net content
• Batch/lot number
• Manufacturing/expiry date
• Warnings for restricted ingredients
• Name & address of Responsible Person (RP)
• Directions for use
• Special warnings (e.g., AHA, hair dyes, certain UV filters)

Languages:

• English mandatory
• Additional languages allowed

Sticker labeling accepted for imported products.

8. Fees & Timelines

Government Fees

• SGD 0
  (Yes — Cosmetic Product Notification in Singapore is free.)

Review Timelines

• Submission via PRISM: Instant
• Notification active immediately
• PIF and label must be available on request
• HSA may conduct post-market inspection anytime

Singapore is the fastest & simplest cosmetic regulatory system in ASEAN.

9. Post-Market Surveillance (PMS)

HSA conducts:

• Random market sampling
• Laboratory testing (heavy metals, microbiology)
• Advertisement surveillance
• E-commerce monitoring
• PIF audits
• Rapid safety alerts system

RP obligations:

• Maintain PIF for minimum 3 years after last batch placed on market
• Report serious adverse events
• Withdraw/recall unsafe products
• Ensure label & claims remain compliant

10. Borderline Products (Important Restrictions)

The following cannot be notified as cosmetics in Singapore:

• Acne treatment products (BPO, strong SA)
• Melasma/pigmentation “treatment/cure” claims
• Hair loss therapy / hair growth agents
• Steroid-containing creams
• Antiseptics, medicated mouthwash
• Anti-inflammatory or wound-healing products
• Products with pharmaceutical-level concentrations

Such items fall under Therapeutic Product or Medical Device regulations.

11. Consulting Notes for Your Portfolio

12. Advantages of Singapore Cosmetic Market

• Fastest ASEAN entry (instant notification)
• No government fees
• Transparent ACD-based regulations
• English-language documentation
• Perfect gateway market for ASEAN due to strict PMS
• Strong consumer trust in regulated cosmetics