Comprehensive Guide to Registering Cosmetic Products in Malaysia
The Malaysian Ministry of Health (MOH) has recently banned five cosmetic products due to the presence of scheduled poisons. These harmful ingredients pose serious health risks to consumers, leading to the strict prohibition of their sale and distribution.
In this article, we’ll explore the banned products, the dangers of their ingredients, and what consumers should do to protect themselves.
Introduction
Malaysia’s burgeoning cosmetics market, projected to reach $3.2 billion by 2024, offers lucrative opportunities for both local and international investors. However, to capitalize on this potential, it is imperative to navigate the regulatory landscape meticulously to ensure compliance and successful market entry.
Regulatory Framework Governing Cosmetics in Malaysia
Cosmetic products in Malaysia are regulated under the Sale of Drugs Act 1952 and the Control of Drugs and Cosmetic Regulations 1984 (CDCR). The National Pharmaceutical Regulatory Agency (NPRA), operating under the Ministry of Health Malaysia (MOH), oversees the notification and regulation of cosmetic products.
Definition of Cosmetics by NPRA
The NPRA defines cosmetics as substances or mixtures intended for external application on the human body, including skin, hair, nails, lips, and external genital organs, or for oral use on teeth and mucous membranes of the oral cavity. These products are designed for:
- Cleaning
- Perfuming
- Altering appearance
- Protecting or maintaining these areas in good condition
Products with therapeutic claims fall outside this definition and are classified as pharmaceuticals, necessitating a different registration process.
Key Steps for Cosmetic Product Notification in Malaysia
Since January 1, 2008, Malaysia has implemented a notification procedure for cosmetic products. Companies must notify the NPRA before manufacturing, selling, supplying, or importing any cosmetic products.
1. Appointment of a Cosmetic Notification Holder (CNH)
The company responsible for placing a cosmetic product on the Malaysian market is referred to as the Cosmetic Notification Holder (CNH). The CNH must:
- Be a locally incorporated entity in the field of cosmetics.
- Foreign companies must appoint a third-party company in Malaysia to act as the CNH.
- Ensure all product information, including documents on quality, safety, and claimed benefits, is available and accessible upon request by the NPRA.
2. Registration with the Quest System
The CNH must register for a Quest membership through the NPRA’s online system. This involves:
- Submitting relevant information and documents (e.g., certificate of incorporation, company constitution, etc.).
- Paying a processing fee ranging from RM260 to RM335, depending on the validity period.
3. Submission of Cosmetic Product Notification
After successful registration, the CNH can submit notifications for cosmetic products through the Quest system by:
- Completing the notification form.
- Paying a processing fee of RM50 for each product and variant.
- Undergoing an NPRA compliance screening.
- If the product meets all regulatory requirements, a notification note is generated, allowing market entry.
The notification process typically takes one to two weeks. Notifications are valid for two years, and renewals should be submitted at least one month before expiration.
Safety and Labelling Requirements
1. Safety Assessment
The safety of cosmetic products is assessed based on:
- Ingredients (ensuring no prohibited substances are included).
- Chemical structure and exposure level.
- Adequate packaging and quality control.
- Procedures for addressing side effects.
2. Labelling Requirements
Proper labeling is mandatory and must include:
- Product name and function.
- Instructions for use.
- Full ingredient list (in descending order of weight).
- Country of manufacture.
- Name, address, and contact number of the CNH.
- Manufacturing batch number and manufacturing/expiry date.
- Special precautions (if applicable).
Compliance with these labeling requirements is crucial to avoid regulatory issues.
Importing Foreign-Manufactured Cosmetic Products
Foreign companies intending to export cosmetic products to Malaysia must:
- Appoint a local CNH to handle the notification process.
- Ensure compliance with Malaysian labeling regulations.
- Obtain comprehensive safety assessment documentation.
Halal Certification for Cosmetics
While halal certification is voluntary, obtaining it provides a strategic advantage in Malaysia’s market, where over 63% of the population identifies as Muslim. The Department of Islamic Development Malaysia (JAKIM) sets guidelines for halal certification, ensuring:
- Products are free from prohibited substances.
- Manufacturing processes prevent cross-contamination.
Halal-certified products resonate strongly with local consumers and facilitate export opportunities in other Muslim-majority nations.
Summary
Successfully entering Malaysia’s cosmetics market requires meticulous adherence to regulatory requirements. By:
- Appointing a qualified CNH,
- Registering with the Quest system,
- Ensuring product safety,
- Complying with labeling standards, and
- Considering halal certification,
Companies can navigate the process effectively and capitalize on the market’s growth potential.
