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.