Failure to fulfil the regulatory requirements will lead the cosmetic product to be rejected, delayed, or even pulled from the Malaysian market. Compliance is one of the more difficult tasks for companies to do before notifying the products for cosmetic registration than during notification itself in Malaysia. Having the regulations in mind from the outset can help prevent delays, comply with them easily, and ensure your product goes to the market smoothly.
In this blog, understand the complete regulations and registration process to enter the Malaysian cosmetics market.
Regulatory Authority for Cosmetics in Malaysia
In Malaysia, cosmetics are under the control of the National Pharmaceutical Regulatory Agency (NPRA), regulated by the Control of Drugs and Cosmetics Regulations (CDCR) 1984. Responsibilities of NPRA include product recalls, post-market surveillance, compliance monitoring, coloristic notifications, and enforcement action. Pre-manufacture notification with NPRA is required for the importation, marketing, or distribution of all cosmetic products in Malaysia.
Cosmetic Product Classification in Malaysia
A typical mistake made by the regulatory bodies in Malaysia is that a product is assumed to be considered cosmetic because of its formulation. NPRA evaluates:
- Intended use
- Product claims
- Mode of action
- Active ingredients
- Dosage form
Therapeutic products can be considered as drugs or intermediates rather than cosmetics. Common examples include:
- Anti-acne treatments
- Hair regrowth products
- Skin-lightening products that have medical claims
- Skin repair or healing products
The improper classification can lead to the rejection of the notification, further registration procedures, and considerable delay for entering the market.
Cosmetics Registration Process in Malaysia (Step-by-Step)
A notification-based system is adopted in Malaysia, although notification is just one of the processes for approval. The following is a list of the steps:
Step 1: Appoint a Cosmetic Notification Holder (CNH)
It should be done via a locally incorporated Malaysian company. The CNH is also responsible legally for product compliance, the maintenance of the PIF, the recall of products, adverse event reporting, and notification updates.
Step 2: Register for QUEST3+
To submit any cosmetic notification, the CNH has to get a membership with QUEST prior to making the submission. Any notifications are made through NPRA’s QUEST3+ system.
Step 3: Confirm Product Classification
Products that make “therapeutic,” “medical,” or “treatment” claims may not be considered cosmetics and may have a different regulatory pathway. Prior to notification, check with classification.
Step 4: Check Formula Compliance
Examine the formulation against:
- Annex II: Prohibited substances
- Annex III: Restricted substances – Appendix 03
- The list of “Permitted colorants” is still in Annex IV
- Annex VII: Additional colourants
- UV filters as listed in Annex VII
Ingredients restricted must meet concentration limits and conditions of use.
Step 5: Prepare the Product Information File (PIF)
The PIF should be shared prior to notification and should contain:
- Product formulation
- Safety assessment
- Manufacturing information
- GMP documentation
- Product specifications
Step 6: Label and Claim Review
Any labels and claims shall meet the NPRA requirements for cosmetic labelling and the scope of cosmetic claims. Notification rejection can be due to medicinal/therapeutic claims.
Step 7: Send Notification with QUEST3+
The CNH submits:
- Product details
- Manufacturer details
- Details of your importer (if not, left blank)
- Ingredient list
- Authorization documents
- Product label
The notification fee will be RM50 per Product & Variant.
Step 8: Create the Notification Note
Payment is confirmed and passed for the submission through compliance screening, and the Notification Note will be generated in QUEST. Marine products can then be imported and sold in Malaysia.
Step 9: Maintain Notification Compliance
The notification shall be in force for two (2) years. The CNH handles the PIF, reports serious adverse events, changes products, and must renew the notification prior to its expiration.
Compliance Requirements for Cosmetics in Malaysia
The Cosmetic Notification Holder (CNH) should ensure that:
- The safety of the product in its normal applications
- Obey the addition restrictions and concentration limit
- GMP-compliant manufacturing
- Availability of a new Product Information File (PIF)
- Determine and ensure label and claims are compliant. Label & claim compliance
- Adverse event reporting
- Product complaint handling
- When making changes to the product, you will be advised
NPRA’s post-market surveillance activities involve:
- Formula screening
- Samples of the product are to be taken and laboratory tests conducted
- Label review
- GMP audits
- PIF audits
- Advertisement monitoring
- Adverse event monitoring
If compliance is not met upon notification, then you risk cancellation of the notification, product recall, or a regulatory penalty.
ASEAN Cosmetic Directive (ACD) Requirements
Malaysia has cosmetic regulations based on the ASEAN Cosmetic Directive (ACD). Products notified in Malaysia should meet the following ASEAN requirements:
- Inherently hazardous materials, facilities, and equipment (Annex II)
- Restricted substances (Annex III)
- Allowed colourings (Annex IV)
- Preservatives that are allowed (Annex VI)
- Authorised UV filters (Annex VII)
Product formulations that meet the standards in another ASEAN market must be assessed in relation to the Malaysian standards of implementation and post-market enforcement prior to notification.
Documents Required for Cosmetic Notification in Malaysia
These are the main documents that important companies in cosmetic registration in Malaysia should have in hand prior to notification:
- Product formulation
- Product label
- Manufacturer details
- Details of your importer (if not, left blank)
- A Letter of Authorisation (LOA) or a Letter of Declaration
- All Contract Manufacturing Agreement Attachments (if applicable)
- Product Information File (PIF)
The PIF should include:
- Safety assessment
- Product specifications
- Manufacturing information
- GMP documentation
- Other manuscript measures, such as stability and quality data
- Supporting claims with evidence
Documents may be required by NPRA on an audit review, product review, or in the course of its post-market surveillance.
Labeling Requirements for Cosmetics in Malaysia
Cosmetic labels should be in the Malay language, English, or both, and have to contain the following:
- Product name
- Product function
- Information on how to use the product (if there is any)
- All the ingredients are listed in full using their INCI names
- Country of manufacture
- CNH: Name of Cosmetic Notification Holder (CNH) and their Address
- Batch number
- Data on manufacturing or expiry date (where applicable)
There should be no medicinal or therapeutic claims or misleading claims on labels. Product names or claims that contain the words treatment, cure, prevention, or medical benefit may lead to notification failure or regulatory action. Halal certification by JAKIM or a certificate body is required for the use of the ‘Halal’ designation.
NPRA Cosmetic Notification Requirements
Visitors wearing makeup can expect to see cosmetic notification of the following (NPRA screens for):
- Product classification
- Ingredient compliance
- Product claims
- Labeling compliance
- Required supporting documents
Ingredients, which in products are not compliant with European requirements or exceed the cosmetic definition, can also be denied in the notification process.
Responsible Person (RP) Requirements in Malaysia
The notification for cosmetics shall not be made directly by the foreign companies. A local applicant in Malaysia will need to be an incorporated company to become the Cosmetic Notification Holder (CNH) and become a point of contact with NPRA.
The CNH will be responsible for:
- Product compliance
- PIF maintenance
- Adverse event reporting
- Product recalls
- Changes in notifications and renewal of Notifications
- Ensuring that NPRA audits and requests are addressed
Product Safety & Ingredient Compliance Requirements
The Cosmetic Notification Holder (CNH) is responsible for making sure that the product is safe for normal use, and a safety assessment is done prior to notification.
NPRA also monitors:
- Heavy metal limits
- Microbiological quality
- Product claims
- Product safety data
Products that do not meet safety standards can undergo regulatory measures, product recall, or notice cancellation.
Good Manufacturing Practice (GMP) Requirements for Cosmetics
All cosmetic products have to be manufactured under Cosmetic GMP requirements or an equivalent GMP standard recognised by NPRA.
For local manufacturers:
- All new manufacturing sites or production lines will need GMP inspection by NPRA
- Periodic inspections for GMP will be conducted for manufacturers
For foreign manufacturers:
- Compliance with GMP documentary evidence shall be made available upon request
- Any GMP evidence must be presented or approved by a competent authority or a recognized body in the country of manufacture.
Import Requirements for Cosmetics in Malaysia
Companies’ cosmetic products need to be prepared before import based on several important requirements, such as having a valid Notification Note, a product label that is compliant with the regulatory requirements, and comprehensive documentation.
The importer/CNH is responsible for ensuring:
- Valid cosmetic notification
- It would be great to redo the development of their products in line with the requirements of NPRA.
- Will the Product Information File (PIF) be available? Will there be a Product Information File (PIF)?
- Label compliance
- Consistency of the formulation notified with the product that has been imported
The information that must be indicated in the declaration of the importation shall remain valid with each consignment of goods imported.
Halal Cosmetic Compliance Considerations in Malaysia
In Malaysia, there is no requirement for cosmetic notification to be coupled with Halal certification. The use of the Halal logo is only valid when the products are certified by the Department of Islamic Development Malaysia (JAKIM) or a JAKIM-recognized certification body.
They know certain ingredient sourcing, manufacturing controls, and certifications are important to consider prior to market entry for brands leveraging Muslim consumers or Halal-focused retail channels.
Restricted & Prohibited Ingredients in Malaysian Cosmetics
The ASEAN Cosmetic Directive (ACD) ingredient annexes are adopted by Malaysia, and there are also certain cosmetic substances being restricted.
Products contain NO:
- Substances permitted by Annex II (Permitted Substances)
- Unapproved colorants
- Unapproved preservatives
- Unapproved UV filters
The restricted ingredients listed in Annex III may only be used within certain concentrations and under specific usage guidelines.
In the event products contain prohibited substances or the levels of ingredients are exceeded, both notifications and post-market regulatory action may be rejected by NPRA.
Timeline for Cosmetic Registration in Malaysia
Once payment of the cosmetic notification Malaysia companies is confirmed, the typical time frame is 1-3 working days, when all the notification requirements are fulfilled.
Overall, however, the timeline might be longer, since the companies have to complete:
- Product classification assessment
- Formula compliance review
- PIF preparation
- Label review
- CNH onboarding
- Documentation collection
Typically, cosmetic notification projects require 1–4 weeks to complete, depending on the complexity of the product and the maturity of the documentation.
Cost of Cosmetic Registration in Malaysia
The following fees are imposed by NPRA under its cosmetic notification system:
- RM50 per item for cosmetics notification
- RM50 for each product for notification renewals
- RM50 for an amendment to the notification, which involves the re-notification of products
- RM50 per copy for a Certificate of Free Sale (CFS)
May come with extra fees such as:
- QUEST membership registration
- Cosmetic Notification Holder (CNH) services
- Product classification assessment
- Safety assessment
- PIF preparation
- GMP documentation
- Label compliance review
- Product testing (if required)
A different notification fee is suggested for each product variant.
Conclusion
The Malaysian notification system is quite simple but requires successful formulations to enter the market, complete documentation, accurate labeling, and local representation to the regulators.
At Artixio, we assist cosmetic companies in the classification of cosmetic products, compliance check of ingredients, preparation of PIF, providing Responsible Person (RP) support, and cosmetic notification for NPRA in Malaysia and the ASEAN products market.
If you have and need any assistance with cosmetic product registration in Malaysia, please contact us at info@artixio.com.
FAQs
1. Is It Possible to Submit a Cosmetic Notification Direct by a Foreign Company?
No. It should be submitted by a locally incorporated Malaysian Company, which acts as the Cosmetic Notification Holder.
2. How Much Do Cosmetics Cost in Malaysia?
NPRA requests a notification and renewal fee amounting to RM 50/ product and variant.
3. Does a Product Information File (PIF) Need to Be Prepared?
Yes. The CNH is required to keep an updated PIF and provide it to NPRA as and when requested.
