The ASEAN Ingredient Listings would be the reference document of all ASEAN Member Countries in the review of formulations of cosmetic products. It will provide the list of ingredients that are banned or restricted for use, the positive list of colorants, preservatives and UV filters that are allowed for use in cosmetic products marketed in ASEAN. Refer to these listings during product formulation to ensure your products comply with the ASEAN Ingredient Requirements.

ASEAN | What is the Role of the Cosmetic Regulatory Authority under the Directive?

The cosmetic regulatory authority has the authority to enforce post-marketing surveillance to ensure compliance with the ASEAN Cosmetic Directive. They can visit the company anytime, with or without prior notice, to audit the Product Information File as well as take samples for analytical testings. In the event of non-compliance with requirements of the ASEAN Cosmetic Directive, the regulatory authority can impose sanctions for the violation as defined in the local laws and issue a product recall if deemed necessary to protect public health.

ASEAN | What If I Change Formulation Or Packaging Or Claims Of An Existing Product In The Market? What Do I Need To Do Under The Directive?

Check if your formula changes comply with the ASEAN Cosmetic Ingredient Listings, the ASEAN Cosmetic Labeling Requirements, the ASEAN Cosmetic Claims Guidelines. You will also need to check if the change would require a new notification or amendment and file for the change accordingly.

ASEAN | What is Post Marketing Surveillance (PMS)?

The Regulatory Authorities will conduct an on-going post-market surveillance programme on cosmetic products to ensure that they comply with the Directive’s requirements. This may involve any or all of the following activities.

ASEAN | What Are My Responsibilities Under The ASEAN Cosmetic Directive After It Has Been Implemented?

Companies will be fully responsible for the safety and quality of cosmetic products placed in the market. The following is a guide of what you will need to do when you intend to market a cosmetic product in ASEAN.

ASEAN | Who Should Prepare and Keep the PIF?

The company or person responsible for placing the cosmetic product in the market (the one who notify NPRA) shall keep the PIF readily accessible to the regulatory authority at the address specified on the label. This clearly refers to a company or person having an address in the local market and to the company or person responsible for bringing in the product into the market; whether this is an importer, a manufacturer or a distributor.

ASEAN | How Can An Overseas Company Notify And Distribute Cosmetic Products In Malaysia?

All cosmetic products must be notified with the NPRA before it can be marketed in Malaysia . A foreign company wishing to bring cosmetic products into Malaysia would first have to appoint a local agent (a company registered in Malaysia ) to be the holder. The appointed agent would then be responsible for all matters pertaining to the notification of the products.

Cosmeticlawinfo database