Exporting Cosmetics to Malaysia? Understand Compliance Key Points in One Article

Malaysia is one of the most attractive cosmetics markets in the Asia-Pacific region, boasting steady growth momentum. Even amid an inflationary economic environment, its beauty and personal care sector has achieved year-on-year revenue growth, demonstrating considerable market potential. This market not only attracts the layout of numerous international brands such as Colgate but also nurtures well-known local brands like Safi, jointly forming a mature and dynamic consumer market. So, how can cosmetics enterprises accurately seize the development opportunities in Malaysia’s cosmetics market? And what key compliance requirements do they need to address? Next, let’s conduct a detailed analysis together.

01 Regulatory Background of Cosmetics in Malaysia

Regulatory Authorities

The National Pharmaceutical Regulatory Agency (NPRA) is responsible for a series of tasks such as product notification, quality control, registration, and post-market supervision of cosmetics. All cosmetics intended for sale in the Malaysian market, whether imported or locally produced, must first be notified to the NPRA.

Drug Control Authority (DCA) is mainly responsible for issuing licenses to cosmetics manufacturers, importers, and wholesalers.

KeyRegulatory

• Control of Drugs and Cosmetics Regulations (CDCR)

• Guidelines for Control of Cosmetic Products in Malaysia(2022)

• ASEAN Cosmetic Directive (ACD)

CosmeticNotificationHolder（CNH）

Malaysia'sregulationsclearlystipulatethattheCosmeticNotificationHolder (CNH) bears the obligation of product notification.The CNH must complete the notification through the NPRA Quest system before commencing any activities related to the manufacture,sale,supply, import,or possession of cosmetics.

Responsibilities and Requirements for Cosmetic Notification Holder (CNH)

a.AlltransactionswithNPRAshallbeconductedbypersonneldesignatedbyCNH.

b.Notified products comply with all cosmetics regulations and guidelines.

c.Product Information Files(PIF),including the latest information/documents on product quality,

safety and claimed efficacy，shall be provided and available upon request.

d.If NPRA instructs to recall products, CNH must ensure that all affected cosmetics are recalled

from the market and sales or supply are stopped.Product distribution records must be properly kept for recall purposes. e.Changes with detailed product information have been submitted accordingly.

f.Cosmetics manufacturers (and assemblers where applicable) comply with Good Manufacturing Practices(cGMP) for cosmetics.

g. In case of serious adverse events,CNH shall report to NPRA as required.

h.The details provided in product notifications are true,and all data and information related to notification shave been provided.

i.Each shipment complies with all legal requirements and meets the stated standards and specifications of the product.

j.When a product does not meet any of the stated standards or specifications of the product,CNH cannot rely on the acceptance of the product notification in any legal proceeding.

k. Detailed information such as company name,address,contact person,telephone number,fax number and email shall be kept updated.

l. Termination of CNH authorization shall be notified to NPRA in writing.

m.Any decision to with draw a product notification shall be notified to NPRA with reasons stated.

02 Basic Cosmetic Compliance Requirements in Malaysia

Notification Process

After registering as a user in the NPRA Quest system, the Cosmetic Notification Holder (CNH) shall fill out and submit a notification form for each cosmetic product, and pay the corresponding fee.

Application Dossiers

The Cosmetic Notification Holder (CNH) shall submit the following materials for notification:

• Product details, including product name, product type, intended use, and product description

• Information of the manufacturer, assembler, and importer (name, address, etc.)

• The CNH's name, address, valid contact number (and email address)

• Detailed information of the CNH's company representative, including a valid contact number

• Complete product ingredient list (the content of restricted ingredients must be indicated, i.e., percentage (%))

• Letter of authorization/declaration letter/contract manufacturing letter (if applicable)

• Product label

 Label Requirement

ThelabelsofcosmeticsexportedtoMalaysiashallincludethefollowinginformation:

• The cosmetic's name and its function, unless clearly stated in the product description

• The cosmetic' s usage instructions, unless clearly stated in the product name or description

• A complete list of ingredients

• The country of manufacture

• The name and address of the Cosmetic Notification Holder(CNH)

• The content expressed by weight or volume,in metric units or both metric and imperial units

• The production batch number

• A clear indication of the cosmetic's production date or expiration date (e.g.,Month/Year)

• Special precautions (if any)

Over 63% of Malaysia's population is Muslim, making the halal industry an indispensable part of its economy. Looking at the local cosmetics market, while international brands dominate. local brands like Safi have won the favor of many consumers through their certified halal credentials. Therefore.if planning to export cosmetics to Malaysia, addressing and meeting halal requirements in the product R&D and compliance processes is an unavoidable step, and enterprises must incorporate this into their early-stage planning.

If you have any questions related to Cosmetics registration and filing/safety assessment, please contact us via info@enter-co.com.

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