ASEAN Cosmetic Directive

ASEAN Cosmetic Directive (ACD) is a regulation that ASEAN members are agreed to harmonize the regulatory requirements for all cosmetics products in ASEAN area in order to keep the safety and quality of the products and to eliminate the trade barriers between countries.

What is ASEAN Cosmetic Directive?

The Association of Southeast Asian Nations (ASEAN) is a united trade group consists of 10 countries: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam.

As a trade group, members are agreed to harmonize the regulatory requirements for all cosmetics products in ASEAN area in order to keep the safety and quality of the products and to eliminate the trade barriers between countries. Therefore, a regulation called ASEAN Cosmetic Directive has been published and came into force in 2008.

If you have experienced EU cosmetics, the ASEAN Cosmetic Directive is quite familiar to you for the regulation is referred to as some core features from EU Cosmetic Directive and the EU Cosmetic Regulation 1223/2009. It means you are capable to apply the EU technical documents directly to ASEAN cosmetic compliance such as product information files (PIF) along with Cosmetic safety assessment report (CPSR). But there are differences, unlike the EU, the ASEAN Cosmetic Directive is not directly regulated in each member countries and it allows themselves to implement under the regulatory schema. This will be causing potential inconsistencies in the directive implementation. And more importantly, Unlike in the EU, where one notification covers all of the EU countries, products are necessary to do the notification/registration separately in each country.

What kind of products are defined as Cosmetics in ASEAN Cosmetic Directive?

The ASEAN Cosmetic Directive defines cosmetic products as: “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 odors and/or protecting them or keeping them in good condition”.

Follow the above definition, there are some examples that will be categorized as cosmetic:

• creams, emulsions, lotions, gels, and oils for the skin (such as the hands, face, and feet);
• face masks (other than chemical peeling products);
• tinted bases (liquids, pastes, and powders);
• make-up powders, after-bath powders, and hygienic powders;
• toilet soaps and deodorant soaps;
• perfumes, toilet waters, and Eaux de cologne;
• bath and shower preparations (such as salts, foams, oils, and gels);
• depilatories;
• deodorants and antiperspirants;
• hair care products, including:
• hair tints and bleaches;
• products for waving, straightening and fixing;
• setting products;
• cleansing products (lotions, powders, and shampoos);
• conditioning products (lotions, creams, and oils);
• hairdressing products (lotions, lacquers and brilliantines);
• shaving products (for example, creams, foams, and lotions);
• products for applying make-up to, and removing it from, the face and eyes;
• products intended for application to the lips;
• products for teeth and mouth care;
• products for nail care and make-up;
• products for external intimate hygiene;
• sunbathing products;
• products for tanning without the sun;
• skin-whitening products; and
• anti-wrinkle products.

ASEAN Cosmetic Directive Compliance Framework

Basic of Cosmetics regulatory requirement

• Must not cause damage to human health when applied under the normal or reasonably foreseeable condition of use
• The manufacturer has to gather the necessary technical information
• Component & finished product evaluated for the aspect of safety
• Products produced under GMP
• Safety data available
• Labeling meets requirement

ASEAN Cosmetics Notification

Cosmetic brand owners, manufacturers, and importers must follow the specific member state’s procedures for product registration and notification. In order to comply with the requirements of importing and marketing of different countries, products need to notify the products in each country.

Responsible person

Like EU cosmetic standard, each product needs to have a responsible person that cooperates with the notification and takes responsibility for the safety of products and to keep the product information file readily accessible to the regulatory authority. Again, you need to appoint the responsible person for placing the cosmetic products on the market in each individual ASEAN member country. And the company must be located in that country and must notify the local regulatory authority of that country.

Product Information Files and Safety assessment

ASEAN has issued the ‘Guidelines for Product Information Files’ and ‘Guidelines for the safety assessment of a cosmetic product’ to aid the brands to comply with the regulation. Although most of the features are consistent with EU, you still should check with your local responsible person in each country to ensure the structure or supplement has slightly different.

Labeling requirements

The following names and claims should be put on the labels of products.

1. Product name & its function
2. Use instruction
3. Ingredients listing
4. Country of manufacturer
   Eg :  Made in Malaysia
   Manufactured in USA
   Country of origin:  Thailand
5. Content (mg or ml)
6. Batch number
7. Mfg. or expiry date
8. Additional statement
9. Declaration of porcine and bovine origin.
   Eg : This product contains an ingredient of pork origin/beef origin

Animal Testing Status

Although ASEAN requires mandatory safety assessment like EU, it has no formal regulations on animal testing. The responsibility for the safety or any testing on cruelty-free or not totally relies on the company.  But each country may have its own policy regarding testing.

Access ASEAN Cosmetics Regulatory Database. ->

Reference:

HSA: ASEAN Cosmetic Directive