ASEAN Cosmetics Compliance

Cosmetics Definition

A cosmetic product means any substance or preparation intended by its manufacturer to be placed in contact with the various external parts of the human body such as the skin epidermis, hair, nails, lips and external genital organs or with the teeth or the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, per fuming them, changing their appearance, correcting body odours, protecting them or keeping them in good condition.

Core Regulations

Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS)
ASEAN Cosmetic Directive (ACD)

Regulatory Agencies

ASEAN Cosmetic Scientific Body (ACSB): Assists the ACC in reviewing technical data and safety issues related to ingredients and products.
ASEAN Cosmetic Committee (ACC): Responsible for cooperation, review, and monitoring of ASEAN integrated cosmetic regulations; responsible for revising and updating relevant regulatory documents; and discussing relevant regulatory issues.
ASEAN Cosmetic Association (ACA): A third-party organization that promotes integration among member states, facilitates cooperation with other trade organizations, and provides relevant regulatory training to businesses.

Cosmetics Notification and Review Agencies in ASEAN Countries

Basic Compliance Requirements

ASEAN Cosmetics Notification

ASEAN cosmetics product notification requirements apply to all cosmetics sold in ASEAN member states, including imported products. Notifications must include detailed technical documentation, production certificates, label samples, and safety statements. All documents must comply with language and format requirements.

After notification, approval results in one member state are mutually recognized in other member states. Any changes to the formula or function require re-notification. Applicants must maintain distribution records for review or recall purposes to ensure product compliance and consumer safety.

Note: Mutual recognition of notifications and simplified filing procedures are not currently implemented among member states! Actual notification materials, procedures, and platforms depend on the requirements of each country's regulatory agencies. (For detailed information, please contact: Enterco)

Cosmetic Notification Required Materials

For products already notified in one ASEAN country, a simplified notification can be submitted to other countries according to the following requirements. The simplified notification information includes: basic product information, packaging and labeling, information on the responsible party, and supporting documentation from the original registration notification.

ASEAN Product Information Document (PIF)

A Product Information File (PIF) is a comprehensive document required by the ASEAN Cosmetics Directive (ACD) for cosmetics sold in the market. The PIF provides documentation of the safety, quality, and efficacy of cosmetics, facilitating regulatory review and ensuring consumer health and safety.

The ASEAN Cosmetics Product Information File (PIF) is developed with reference to the framework of the EU Cosmetics Regulation (EC 1223/2009) and incorporates ISO international standards (such as ISO 22716, ISO 11930, and ISO 17516). It covers good manufacturing practices, microbiological safety limits, and preservative effectiveness assessments for cosmetics. Furthermore, some countries have adopted the chemical safety assessment requirements of the EU REACH Regulation.

Product Information File (PIF) Content Requirements

Our Services

ASEAN Local Responsible Persons
ASEAN Cosmetics Notification
ASEAN Cosmetics Formulation and Labeling Review
ASEAN Cosmetics PIF Data Compilation
ASEAN Cosmetics Safety Assessment Report
ASEAN Cosmetics Compliance Consulting