March 07, 2025

Introduction

Malaysia has a structured regulatory framework governing cosmetic product registration to ensure consumer safety and compliance with international standards. The National Pharmaceutical Regulatory Agency (NPRA), operating under the Ministry of Health Malaysia (MOH), oversees cosmetic product notifications and post-market surveillance. All cosmetic manufacturers and importers must adhere to the Guidelines for Control of Cosmetic Products in Malaysia, which align with the ASEAN Cosmetic Directive (ACD).

Definition of Cosmetics in Malaysia

Under Malaysian regulations, cosmetics are defined as substances or preparations intended for external application to the human body for purposes such as:

  • Cleansing
  • Perfuming
  • Changing appearance
  • Correcting body Odors
  • Protecting or maintaining the skin in good condition

To qualify as a cosmetic, a product must not make therapeutic, pharmacological, or immunological claims. Items with medicinal properties may be classified as pharmaceuticals and require additional regulatory compliance.

Examples of Cosmetic Products

  • Skincare creams and lotions
  • Perfumes and fragrances
  • Deodorants
  • Makeup and color cosmetics
  • Hair care products and colorants
  • Personal hygiene products

Regulatory Authority: NPRA & ASEAN Cosmetic Directive (ACD)

The National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health Malaysia (MOH) regulates cosmetic products in Malaysia. The country follows the ASEAN Cosmetic Directive (ACD), which harmonizes cosmetic regulations across ASEAN member states. Companies must ensure compliance with ACD standards, ingredient safety guidelines, and Good Manufacturing Practice (GMP) requirements.

Halal Certification for Cosmetics in Malaysia

While halal certification is voluntary, it provides a significant advantage in Malaysia, where over 63% of the population identifies as Muslim. Halal-certified cosmetics hold strong market appeal and open export opportunities to Muslim-majority nations.

To obtain halal certification, products must comply with guidelines set by the Department of Islamic Development Malaysia (JAKIM), ensuring:

  • Ingredients are free from prohibited (haram) substances (e.g., non-halal animal derivatives, excessive alcohol content).
  • Manufacturing facilities prevent cross-contamination with non-halal substances.
  • Packaging materials conform to halal principles.

Halal certification may seem complex, but partnering with regulatory experts can streamline the process and facilitate market entry.

Steps for Cosmetic Product Registration in Malaysia

1. Appoint a Cosmetic Notification Holder (CNH)

Before manufacturing, selling, supplying, or importing cosmetics in Malaysia, companies must notify the NPRA through the QUEST3+ system. A Cosmetic Notification Holder (CNH), a locally incorporated company, must be appointed to manage product compliance and act as the liaison with regulatory authorities.

2. Ensure Compliance with Ingredient Regulations

Cosmetics must adhere to ASEAN Cosmetic Ingredient Listings, which categorize ingredients into:

  • Prohibited Ingredients (Annex II)
  • Restricted Ingredients (Annex III)
  • Permitted Colorants (Annex IV)
  • Permitted Preservatives (Annex VI)
  • Permitted UV Filters (Annex VII)

3. Fulfill Product Safety and Labeling Requirements

Cosmetic labeling must include:

  • Product name and function
  • Full ingredient list
  • Manufacturer’s details
  • Batch number
  • Expiry date (if applicable)
  • Country of origin
  • Usage instructions and precautions

4. Online Notification via QUEST3+ System

Manufacturers and importers must notify the NPRA about their cosmetic products before market entry. This involves:

  • Registering as a Cosmetic Notification Holder (CNH)
  • Submitting product details, including formulation, manufacturer details, and Responsible Person (RP) information
  • Paying the required processing fee

5. Obtain a Notification Number

Upon approval, the NPRA issues a notification number, which must be displayed on the product packaging. Unlike pharmaceuticals, cosmetics do not require pre-market approval but must comply with notification requirements.

6. Good Manufacturing Practice (GMP) Compliance

Manufacturers must comply with Good Manufacturing Practices (GMP) to ensure product safety and quality. Certification from recognized authorities such as ISO 22716 or ASEAN GMP standards demonstrates adherence to these standards.

7. Post-Market Surveillance & Compliance

The NPRA conducts routine post-market surveillance to ensure ongoing compliance. The Responsible Person (RP) must:

  • Report any adverse effects or safety concerns
  • Maintain product records and documentation
  • Ensure compliance with regulatory updates

Common Reasons for Product Rejection

Cosmetic products may be rejected if they:

  • Contain prohibited or restricted ingredients beyond the allowed limit
  • Make misleading or non-compliant claims
  • Lack proper safety documentation
  • Have microbial contamination

Importing Foreign Cosmetic Products to Malaysia

Key Import Requirements

Imported cosmetics must comply with Malaysian regulations, including:

  • Product Notification with NPRA
  • Securing an import license through the Ministry of Trade and Industry (MITI)
  • Compliant product labeling, including:
    • Product name and function
    • Full ingredient list
    • Country of manufacture
    • Notification holder details
    • Batch number and expiry date
    • Special precautions (if any)
  • Comprehensive safety assessment documentation
  • Detailed Product Information File (PIF)

Partnering with an Importer of Record (IOR)

Foreign brands can accelerate the import process by partnering with an Importer of Record (IOR). An IOR handles:

  • Customs clearance and documentation
  • Compliance with local regulations
  • Product registration and notification
  • Import duties and VAT obligations
  • Local regulatory representation

Timeline and Costs for Cosmetic Registration

  • Processing time: Typically 1-3 months after submission via QUEST3+
  • Notification fee: Varies depending on product type but is generally affordable compared to pharmaceutical registrations
  • Notification validity: 2 years, with renewal required one month before expiry

Conclusion

Registering a cosmetic product in Malaysia requires thorough compliance with NPRA regulations, ingredient safety assessments, and ASEAN guidelines. By following the correct procedures, companies can ensure successful market entry and long-term compliance.

For expert assistance with cosmetic product registration, regulatory compliance, and market access strategies, contact Maven’s regulatory experts today!