Marie Magnan, Cosmed’s Regulatory Affairs Manager, gives her take on the regulatory landscape between the two regions.
ASEAN cosmetics directive: overview
ASEAN is the Association of South East Asian Nations, which gathers 10 countries: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.
Directly inspired by European Regulation, the ASEAN cosmetic directive was signed September 2nd, 2003 by all member countries. It entered into force on January, 1st 2008.
What is a cosmetic product in the ASEAN region?
The ASEAN cosmetic directive follows the main lines of European regulation 1223/2009.
In the ASEAN Cosmetic Directive (ACD), a cosmetic product is defined as any substance or preparation that meets the following criteria:
It is 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 it is intended to be in contact with the teeth and the mucous membranes of the oral cavity
In either case, the product is intended to exclusively or mainly result in cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.
Main points of the ASEAN Cosmetic Directive
The product has to be notified to the competent authorities, but it is not a centralised system as in Europe: the notification must be done in each ASEAN member country.
Before placing it on the market, the responsible person must give some information on the cosmetic either via an online system (in Malaysia, Indonesia, Singapore, Vietnam and Philippines) or via a paper form (in Brunei, Cambodia, Laos, Myanmar and Thailand) sent to the regulatory body.
For every product, a Product Information File must be available to the authorities in each country in case of control.
It contains a safety evaluation for the cosmetic to confirm the product does not cause damage to human health when applied under normal or reasonably foreseeable conditions of use.
This file should also include an attestation or a demonstration that the manufacturing is made in line with ASEAN Good Manufacturing Practices Guidelines.
The common technical requirements under the ASEAN Cosmetic directive detail the ingredients that cannot be used in cosmetics as well as listings of permitted preservatives, UV absorbers and colourants.
COSMED, the professional association of the cosmetic industry in France, counts 785 SMEs members.
It is an industry stakeholder in the European Commission for the development of cosmetic regulation, as well as in national and international standardization bodies.
Its contributions and regulatory and scientific views are internationally recognized. Furthermore, Cosmed provided a regulatory monitoring to institutions and enterprises.