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ASEAN Harmonized Cosmetic Regulatory Scheme

The Association of Southeast Asian Nations (ASEAN) is a regional intergovernmental organization comprising 10 countries in Southeast Asia (namely Brunei Darussalam, Cambodia, Indonesia, Malaysia, Myanmar, Lao PDR, Philippines, Singapore, Thailand and Vietnam), which promotes intergovernmental cooperation and facilitates economic, political, security, military, educational, and sociocultural integration among its members and other countries in Asia.

In order to enhance cooperation amongst Member States in ensuring the safety, quality and claimed benefits of all cosmetic products marketed in ASEAN and eliminate restrictions of trade of cosmetic products amongst Members, ASEAN Ministers signed the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) during the 35th ASEAN Economic Ministers Meeting on 2 September 2003.

The AHCRS lays down the requirements for cosmetic products for all signatory ASEAN Member Countries starting from 1 January 2008. A product produced or marketed in any signatory country and meeting the requirements of AHCRS would be able to enter other signatory countries. The most significant aspect of this harmonized scheme is that all ASEAN Member Countries will move from the traditional and preferred approach of “pre-market approval” to the new approach of “post-market surveillance” for cosmetic products, considered being more effective.

The AHCRS, which has been co-developed with the cosmetic industry, comprises the signed Agreement and its 2 Schedules as follows:

SCHEDULE A: MUTUAL RECOGNITION ARRANGEMENT OF PRODUCT REGISTRATION APPROVAL. The product registration approval in an Asean country is recognized in Member Countries, where a mutual recognition arrangement has been agreed upon.” Schedule A is a preparatory stage for Member Countries to proceed to Schedule B but a Member Country can opt to proceed directly to Schedule B.

SCHEDULE B: THE ASEAN COSMETIC DIRECTIVE: PRODUCT NOTIFICATION The manufacturer or the person responsible for placing cosmetic products on the ASEAN market, shall notify the cosmetic regulatory authority of each Member State where the product will be marketed of the place of manufacture or of the initial importation of the cosmetic product before it is placed on the ASEAN market. In most ASEAN countries, this is a transition from a pre-market approval (registration) system to post -market surveillance. All ASEAN countries are committed to implement Schedule B – The ASEAN Cosmetic Directive by January 2008.

The ASEAN Harmonized Cosmetic Regulatory Scheme Common Technical Documents are also introduced in the meantime. The documents have been the result of close collaboration between the ASEAN governments and the cosmetic industry with the objective to harmonize cosmetic technical requirements among ASEAN Member Countries for the marketing of safe and quality cosmetic products.

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