Malaysia Cosmetics Regulations
Cosmetic products in Malaysia are regulated under the Control of Drugs and Cosmetics Regulations (CDCR) 1984 is associated with the agreement of the ASEAN Harmonized Regulatory Scheme and the regulation ASEAN Cosmetic Directive. Since 2008 January 1st, importing cosmetic products to Malaysia is required to complete a cosmetics notification procedure to the Director of Pharmaceutical Services (known as DPS) through the National Pharmaceutical Regulatory Agency (NPRA). False declaration or products do not make full compliance with the stipulated regulations and guidelines will be not allowed to sell in the market.
Cosmetic notification is submitted online via the Quest 3+ system. Notified cosmetics does not mean it is being approved. Product notification is a process that requires companies to be responsible for the product information submitted to NPRA on their products marketed in Malaysia.
Cosmetics Notification Holder
Similar to the EU responsible person, the company that notifies the products will be known as Cosmetic Notification Holder (CNH) who is responsible to ensure the products meet all stipulated regulations and guidelines for Cosmetics products. The responsibility also includes PIF holding (including updated information/document on product quality, safety and claimed benefit is available and accessible upon request.), post-market surveillance, product recall, etc.
Product Information File (PIF) and Safety Assessment
The PIF can be either in hardcopy or in an electronic format written by Bahasa Malaysia or English. Notification Holder shall keep it updated for all changes made to the notified product such as new ingredients, manufacturers, raw material suppliers, and production processes. Date of document revision, where appropriate shall be stated for verification.
Notification holder shall ensure the safety assessment has been conducted for each product to ensure the products must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use.
Since ASEAN Cosmetic Directive has similar core features as EU regulation, most of the materials can be applied to the PIF includes safety assessment if you have done the EU notification.
Please refer to Annex I, part 12 – Guideline for Product Information File (PIF) and Annex I, part 6 for Guideline for Safety Assessment of Cosmetic Product, to make sure if any difference is required.
Notification Holder shall ensure that the label of the cosmetic products complies with the labeling requirements as defined in Annex I, part 7: Cosmetic Labeling Requirements.
The information on the label shall be in Bahasa Malaysia and/or English, and the following is the list of the labeling requirements.
- The name of the cosmetic product and its function
- Instructions on the use of the cosmetic product
- Full ingredient listing
- Country of manufacture;
- The name and address of Notification Holder
- weight or volume
- batch number
- The manufacturing or the expiry date of the product
- Special precautions to be observed in use
- The valid contact number of the CNH
The CNH shall provide scientifically accepted protocols or study designs in generating technical or clinical data with justification.
More importantly, the claims on medicinal in nature or beyond the cosmetic scope are not allowed on the label.
A guidance document on the cosmetic claim is available in Annex I, part 8: Cosmetic Claims Guideline.
Good Manufacturing Practice (GMP)
All cosmetic products must be manufactured in accordance with the Guidelines for Cosmetic Good Manufacturing Practice or its equivalent. For the foreign manufacturers, documentation to prove GMP compliance is to be made available upon request by the NPRA.
Post-Market Surveillance of Cosmetic Products
It is important to notice that the Malaysian government established post-market surveillance (PMS) to ensure the compliance and safety of cosmetics after sell on its markets.
The main PMS activities for cosmetics include:
- Screening of product formulation and information to ensure that cosmetics do not contain any prohibited or harmful substances and all restricted ingredients are used within the allowable limits and conditions of use. Screening criteria also include the product name and its claimed benefits
- Sample collection and testing
- Monitoring of label compliance
- Audit of premises for compliance to the Cosmetic GMP
- Handling of product complaints
- Monitoring of advertisements
- Monitoring of adverse reactions
- Audit on the PIF
- Risk communication
- Information sharing through ASEAN Post Marketing Alert System (PMAS)
If a product is found to be non-compliant to the stipulated guidelines and regulations, the NPRA will take necessary actions such as cancellation of the product’s notification and/or recall of the product from the market.