Applicable legislation

The Association of Southeast Asian Nations (ASEAN) consists of 10 countries: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. In 2003, these countries agreed to harmonize the requirements for cosmetic products in order to facilitate the movement of goods and decrease the trade barriers within the region. The new common cosmetics legislation came into force in 2008. This legislation is called the ASEAN Cosmetic Directive (ACD). ACD is modelled after the EU Cosmetic Directive and the EU Cosmetic Regulation 1223/2009 that followed. It is, however, not a complete copy of the EU legislation.

What type of products are cosmetics?

The ASEAN Cosmetic Directive provides the following definition: “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”.

Requirements

All products marketed in an ASEAN member country must conform to the provisions of the ACD and its Annexes and Appendices, including safety, ingredients, labelling, claims requirements and the good manufacturing practice (GMP) standards.

The ASEAN Cosmetic Directive adopted the list of prohibited and restricted substances, as well as allowed preservatives, colourants and UV filters from the EU Cosmetic Directive 76/768/EEC and the regulation that followed. However, not all of the chemicals or ingredients identified in the EU Cosmetic Regulation Annexes have been transposed to the ACD. For example, fragrance allergens have intentionally been omitted.

Much like in the EU, each product requires a product information file (PIF) that consists of four parts: (I) the administrative documents and product summary, (II) quality data of raw materials, (III) quality data of finished products and (IV) safety and efficacy data. A safety assessment is also part of the PIF.

Each product placed on the market in the ASEAN needs to have a responsible person that has to ensure that the product will not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, has to keep the product information file readily accessible to the regulatory authority and has to complete the product notification. The company or person responsible for placing the cosmetic products on the market in each individual ASEAN member country must be located in that country and must notify the local regulatory authority of that country. Unlike in the EU, where one notification covers all of the EU countries, in the ASEAN region, each country requires a separate notification. In keeping with the EU though, there is no pre-market approval requirement prior to placing products on the market; the emphasis is on post-market surveillance.

The labelling requirements are also very similar to those in the EU. Labels must be written in English and/or the national language and/or a language understood by the consumer where the product is marketed.

Although not a requirement of the ASEAN Cosmetic Directive, Certificates of Free Sale are often required at ports when cosmetics are imported.

Services offered

  • Product classification
  • Formula review to ensure compliance with the ASEAN Cosmetic Directive
  • Labelling review
  • Product Information File preparation
  • Safety assessment
  • Certificate of Free Sale

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