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ASEAN Cosmetic Regulations

  •   26 Aug 2019
  •    Angelita Hu
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       ASEAN Cosmetic Regulations   
    Overarching Regulation
    Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS)
    Competent Authority
    ASEAN Cosmetic Committee
    Main Supporting Rules 
    13 Jun 2007Asean Guidelines for Product Information File (PIF)
    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.

    Contents

    Part 1 Regulatory Framework and Competent Authority 

    1. Main Cosmetic Regulations

    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 following are the highlights of the ASEAN Harmonized Cosmetic Regulatory Scheme Common Technical Documents. These 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.
     
    RegulationDescription
    Appendix I (Illustrative List by Categories of Cosmetic Products)The current ASEAN’s illustrative list has been adopted with emphasis that this list is not exhaustive. Products satisfying the definition of cosmetic in the ASEAN Directive (similar to the EU definition) shall be allowed as a cosmetic.
    Appendix II (ASEAN Cosmetic Labeling Requirements)Full Ingredient Listing will become mandatory. The International Nomenclature of Cosmetic Ingredients names (INCI) would be the primary reference for ingredient names on the label. Please refer to the ASEAN labeling requirements for details
    Appendix III (ASEAN Cosmetic Claims Guidelines)There will be no negative or positive list of claims. Claims will be subject to local country control because of difference in languages, interpretations, culture and religions. The definition of a cosmetic product, llustrative List by Category of Cosmetic Products, Ingredient Lists and and the ASEAN Cosmetic Claims Guideline shall be the technical documents that will guide the countries in the review of the acceptability of a cosmetic claim.
    Appendix IV (ASEAN Cosmetic Product Registration Requirements)Repealed
    This applies to all cosmetic products that are currently required to be registered in the respective ASEAN countries that have entered into mutual recognition arrangement with another ASEAN country. Target registration processing period is 30 days maximum.
    Appendix V (Asean Cosmetic Import Export Requirements)Repealed
    All cosmetic products manufactured in or imported from non-ASEAN Member countries or ASEAN Member Countries have to comply with the ASEAN Harmonized Cosmetic Regulatory Scheme and its technical documents. Licensing and its requirements shall be regulated by each country’s regulatory authority.
    Appendix VI (ASEAN Guidelines for Cosmetic Good Manufacturing Practices)This document has been the result of close collaboration between the regulatory authorities and the cosmetic industry with the objective to provide a simple guideline on Cosmetic GMP that addresses the needs of both the industry and government.
    Annexes of the ASEAN Cosmetic DirectiveThey detail the ingredients that cannot be used in cosmetics as well as listings of permitted preservatives, UV absorbers and colorants.

    2. Competent Authority

    The ASEAN Cosmetic Committee (ACC) under the ASEAN consultative Committee on Standards and Quality (ACCSQ) has been established since 2003 to conduct the following activities:
    • Coordinating, reviewing and monitoring the implementation of the Agreement on ASEAN Harmonized Cosmetic Regulatory Scheme, including the ASEAN mutual Recognition Arrangement of Product Registration Approvals for Cosmetics and the ASEAN Cosmetic Directive;
    • Monitoring the implementation of the technical documents and reviewing and updating these documents when necessary
    • Providing a forum for discussion of issues that may arise concerning the implementation of the Agreement;
    • Considering measures to enhance the operation of the Agreement
    The ACC are composed of one official representative from each Member State's regulatory authority responsible for cosmetics and the ASEAN Cosmetic Association (ACA).

    The ASEAN Cosmetic Scientific Body (ACSB) has been established to assist ACC in reviewing the safety and technical data of ingredients and making recommendations on other technical and safety issues for adoption by the ACC. The ACSB consists of representatives from the regulatory authorities, the industry and the academe. At present, the ACSB is reviewing the ASEAN Handbook of Cosmetic Ingredients as well as additions to the annexes of the Directive.

    The ACC and ACSB meets twice a year to exchange information and draft or implement the amendments to the AHCRS and related technical documents.

    Part 2 Cosmetic Products

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