CIRS has compiled a list of frequently asked questions regarding market access and compliance for cosmetics in Singapore and Malaysia and has provided detailed answers respectively. This effort is designed to assist cosmetic enterprises in navigating regulatory requirements and implementing best practices effectively.
Q1: Do Singapore and Malaysia follow unified ASEAN requirements for prohibited and restricted substances in cosmetics?
Answer：Yes. Singapore and Malaysia strictly follow the ASEAN Cosmetic Directive (ACD) for prohibited and restricted substances in cosmetics. It should be noted that the Annex lists of the ACD are updated annually. Before launching any new product, it is essential to verify the latest version of the lists to avoid non-compliance due to outdated regulatory references.
Q2: Are the notification validity periods the same in Singapore and Malaysia? Is there a distinction between special-use and general cosmetics?
Answer：The notification validity periods differ between Singapore and Malaysia, and there is no distinction between "special-use" and "general" cosmetics.
- Malaysia: Validity period is 2 years
- Singapore: Validity period is 1 year
Q3: Why can sunscreen products in Malaysia not claim SPF > 50, but may claim SPF 50?
Answer：According to the Malaysian Guidelines on Control of Cosmetic Products, if a sunscreen product's tested SPF value exceeds 50, it must be labeled as "SPF 50+". For sunscreen products with a tested SPF value of exactly 50, the label may state "SPF 50".
Q4: Is animal testing required for cosmetics in Singapore and Malaysia?
Answer：Neither Singapore nor Malaysia has fully prohibited animal testing at present.
Q5: Is it mandatory to appoint a local responsible person when exporting cosmetics to Singapore and Malaysia?
Answer：Yes. Exporting cosmetics to both Singapore and Malaysia requires the appointment of a local responsible person (a local company). Overseas companies cannot file notifications directly.
- Singapore: A local Responsible Person (RP) must be appointed
- Malaysia: A local Cosmetic Notification Holder (CNH) must be appointed
Q6: What are the labeling language requirements for cosmetics in Singapore and Malaysia?
Answer：The two countries have different labeling language requirements.
- Singapore: Labels must be in English; other languages may be used concurrently
- Malaysia: Labels must be in Malay or English
Q7: How are general cosmetics and high-risk cosmetics classified in Singapore and Malaysia?
Answer：Both Singapore and Malaysia classify general and high-risk cosmetics based on risk categories under the ASEAN Cosmetic Directive (ACD), and the notification process is the same.
| General Cosmetics | High-Risk Cosmetics | |
| Singapore | Submit notification via PRISM prior to marketing | In addition to notification, additional safety data for specific ingredients must be provided (e.g., UV filters, skin-whitening agents, hair dyes, preservatives, nanomaterials) |
| Malaysia | Submit notification via QUEST prior to marketing | In addition to notification, additional clinical data, efficacy documentation, etc. must be provided (e.g., skin-whitening, sunscreen, anti-acne, children's use, hair dyeing and perming products) |
Q8: How soon can a cosmetic product be marketed after notification?
Answer：The time-to-market requirements differ slightly between Singapore and Malaysia.
- Singapore: For general cosmetics, the notification takes effect immediately upon submission, with no review period. For high-risk cosmetics, the Health Sciences Authority (HSA) may review additional safety data, taking approximately 1–4 weeks.
- Malaysia: For general cosmetics, products may be marketed upon issuance of the NOT number, typically within 1–3 working days after submission. For high-risk cosmetics, the review is slightly longer due to more stringent data requirements, taking approximately 1–2 weeks, with the issuance of the NOT number as the point of market entry.
Q9: Under what circumstances can cosmetics be exempted from notification in Singapore and Malaysia?
Answer：Exemptions from notification for cosmetics in Singapore:
- Samples associated with advertising, sponsorship, or promotional activities;
- Test or trial products associated with product research or development;
- Products manufactured by, or at the request of, a healthcare practitioner, and supplied exclusively by that practitioner to patients;
- Different pack sizes of the same product.
Exemptions from notification for cosmetics in Malaysia:
- Market sampling: Products for test marketing or aesthetic research, not for commercial sale.
- Internal evaluation: In-house R&D or production sample evaluation by the company, not for external sale.
- Export-only or re-export products: Locally manufactured products intended solely for export, or imported products processed and re-exported, subject to compliance with destination country regulations and proper record-keeping.
- Transit products: Products transiting through Malaysia to other countries, not involving domestic sale.
- Free Trade Zone products: Products sold within free trade zones or on international conveyances, subject to record-keeping for inspection purposes.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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- ASEAN Cosmetics Notification
- ASEAN Cosmetics Formula/Label Review
- ASEAN Cosmetics Regulatory Compliance Consultation
