Definition of Cosmetics
According to the Guidelines for Control of Cosmetic Products in Malaysia, the definition of a cosmetic product is -"A substance or preparation intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition."
Cosmetic products shall not bear any therapeutic claims. The main categories of such products include:
- Skin care creams and lotions
- Perfumes
- Deodorants
- Make-up products
- Hair care products and hair dyes
- Personal hygiene products
Competent Authority
Drug Control Authority (DCA) and National Pharmaceutical Regulatory Agency (NPRA).
- Drug Control Authority (DCA): Responsible for formulating cosmetic regulatory policies, approving product notifications, and issuing licenses to manufacturers, importers, and wholesalers.
- National Pharmaceutical Regulatory Agency (NPRA): Acts as the secretariat to the DCA and is responsible for implementing cosmetic product notification, quality control, licensing, and post-market surveillance activities.
Compliance Requirements
Any company that intends to manufacture, distribute, import, or sell cosmetic products must notify the product information via the QUEST system of the National Pharmaceutical Regulatory Agency (NPRA). Manufacturing or importing of the cosmetic product may only commence upon receipt of the notification acknowledgment.
Note: Halal cosmetics must also obtain Halal certification from the Department of Islamic Development Malaysia (JAKIM).
Cosmetic Notification Process
*: The Cosmetic Notification Holder (CNH) must be a company or legal entity incorporated in Malaysia and registered with the Companies Commission of Malaysia (SSM). The company's constitution must clearly state that its business activities are related to health or cosmetic products.
Validity of Notification Number
The notification number is valid for 2 years from the date of issuance.
Note: Renewal must be submitted one month prior to the expiry date. Failure to renew within this period will result in the notification number becoming invalid, and a new notification must be submitted.
Products Exempted from Notification
- Products for market testing
- Products for internal evaluation/testing
- Products in transit
- Products manufactured in Malaysia solely for export or imported solely for re-export
- Products sold within Free Trade Zones or intended for international transshipment
Responsibilities of the Cosmetic Notification Holder (CNH)
- Liaise with the National Pharmaceutical Regulatory Agency (NPRA) for product notification and submission of any changes.
- Ensure that the notified product complies with all applicable cosmetic regulatory requirements.
- Be responsible for the safety and quality of the product.
- Maintain the Product Information File (PIF).
- Keep company contact details up to date, including company name, address, contact person, telephone number, fax number, and email address.
- Monitor, report, and manage post-market adverse events and undertake product recalls when necessary.
Documents Required for Cosmetic Notification
- Product Information: Product name, specifications, intended use, and product description.
- Manufacturer (and Assembler, if applicable): Name and address of the manufacturer (For foreign manufacturers, a valid GMP certificate (or equivalent) is required).
- Cosmetic Notification Holder (CNH): Name, address, telephone number, and email address of the CNH.
- CNH Representative: Name and telephone number of the representative employee of the CNH.
- Importer: Name and address of the importer.
- List of Ingredients: Full list of product ingredients.
- Letter of Authorization or Contract Manufacturing Agreement: A letter of authorization or a contract manufacturing agreement, where applicable.
- Product Label: A copy of the product label.
Cosmetic Labeling Requirements
Cosmetic labels may be presented in either Bahasa Malaysia or English. All statements on the label must be clear and truthful, and must not be misleading in any way that could cause significant misunderstanding about the product. The following information must be included on the label:
- Product name and function
- Directions for use
- Full list of ingredients
- Country of origin
- Name and address of the notification holder
- Net content
- Batch number / Manufacturing date / Expiry date
- Warnings and precautions
Note: If the product packaging is too small to accommodate all the required information, supplementary materials such as leaflets, brochures, or inserts may be used to provide the necessary details.
Product Information File (PIF) Requirements
The PIF may be maintained in the form of a physical file (i.e., a collection of hardcopy records stored at a designated location) or in electronic format (i.e., softcopy). It must be readily accessible and made available upon request by the National Pharmaceutical Regulatory Agency (NPRA). The PIF shall be prepared in either Bahasa Malaysia or English. The PIF must be kept up to date to reflect any changes to the notified product, such as new ingredients, manufacturers, raw material suppliers, or manufacturing processes. Where applicable, the revision date of the documents should be indicated for verification purposes.
The PIF shall consist of the following four main sections:
- Administrative Documents and a Summary of Product Description
- Quality and Safety Data of Cosmetic Ingredients
- Quality and Safety Data of the Finished Product
- Safety and Efficacy Data of the Product
Recommended Cosmetic Testing Requirements (Non-Mandatory)
- Microbiological Testing
- Heavy Metal Testing
- Stability Testing
- Preservative Efficacy Testing
- Packaging Compatibility Testing
- Other Efficacy and Toxicological Tests
About Us
The CIRS cosmetic team provides expert support to ensure that cosmetic products meet stringent global cosmetic regulations and safety standards.
We offer comprehensive, lifecycle-based solutions for personal care products, from early-stage cosmetic ingredient development, through to final product registration. Our services include:
- Cosmetic ingredient development and regulatory strategy,
- Physical/chemical and analytical tests,
- Toxicological tests (in vivo & in vitro),
- Efficacy and claim substantiation studies (in vivo & in vitro), and
- Ingredient and product registration across global markets.
With deep expertise in cosmetic regulatory compliance and safety evaluations, our team enables brands to bring products to market efficiently and with confidence.
Our Services
- Malaysia Cosmetic Notification
- Malaysia Local Company Authorization & License Holding Services
- Preparation and Compilation of Product Information File (PIF)
- Electronic Account Registration
- Formula and Packaging Review
- Product Testing Service
- Logistics and Customs Clearance
