The Association of Southeast Asian Nations (ASEAN) consists of 10 countries, including:
Brunei Darussalam
Cambodia
Indonesia
Laos
Malaysia
Myanmar
The Philippines
Singapore
Thailand
Timor-Leste
The ASEAN Cosmetic Directive (ACD), which came into force in 2008, harmonized the requirements for cosmetic products among these countries to facilitate the movement of goods and reduce trade barriers.
The ACD defines a cosmetic product as follows:
A cosmetic product shall mean any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, and/or correcting body odours and/or protecting them or keeping them in good condition.
Although the FDA in several ASEAN member countries has its own category of traditional/herbal products, all products that fall within the scope of the above definition will be classified as cosmetics, regardless of whether they contain herbal ingredients.
Products outside this scope cannot be registered as cosmetics.
The ASEAN Cosmetic Directive (ACD) was fully implemented in all member states on January 1, 2008. Some provisions that have been harmonized include guidelines pertaining to product registration or notification, labeling, use of prohibited and restricted substances, and post-market surveillance.
While national regulatory agencies in each ASEAN member state have the authority to manage local notifications and required documents for product registration, the ACD helps align the major elements necessary for notification, including the Product Information File (PIF). The ACD does not mandate adherence to a specific PIF format but provides the following outline:
The qualitative and quantitative composition of the product. In the case of perfume compositions, the name, code number of the composition, and the identity of the supplier.
Specifications of the raw materials and finished product.
The method of manufacture, complying with good manufacturing practices as outlined in the ASEAN Guidelines.
An assessment of the safety for human health of the finished product, its ingredients, their chemical structure, and level of exposure.
Existing data on undesirable effects on human health resulting from the use of the cosmetic product.
Supporting data for claimed benefits of cosmetic products to justify the nature of their effect.
The ACD also specifies labeling requirements for cosmetic products. The label must include the following:
Product function
List of ingredients
Manufacturer's name and address
Details of the distributor or importer
Nominal quantity of the product
Batch number
Expiry date
Particular precautions for use
The ACD annexes provide lists of allowed substances, banned or restricted substances, and lists of permitted coloring agents, preservatives, and UV filters.
Additionally, the ACD requires cosmetic manufacturers to notify the regulatory authorities in each ASEAN member state of any changes to their products, whether minor or major. These changes, such as formula modifications or packaging updates, ensure that regulatory authorities remain aware of alterations that might affect product safety.
Formula review
Labeling and claim review
Safety assessment
