Asean

• College of Nursing Pharmacy & Allied Health Sciences

  ASEAN Cosmetic Product Notification
• A product produced or marketed in any signatory country and meeting the requirements of AHCRS would be able to enter other signatory Countries
• AHCRS


  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

  
• Harmonisation of cosmetic regulations in the ASEAN region

  • Benefit consumers - wider choice of safe cosmetic products
  • Benefit regulatory bodies - one simplified regulatory system
  • Benefit cosmetic industry - open ASEAN as one single market for manufacturers, with more than 500 million consumers
• AHCRS Coverage


  • Schedule A- Mutual Recognition Arrangement of Product Registration Approval
  • Schedule B- The ASEAN Cosmetic Directive: Product Notification

  
• Mutual Recognition Arrangement of Product Registration Approval

  A cosmetic product registration processed and issued by one country is recognised by the ASEAN countries who have signed the MRA

  
• Product Notification scheme


  Does not require registration, only post-market surveillance. The company shall file the Product Notification with the regulatory agency in the country prior to placing the cosmetic product in the market

  
• ASEAN Technical Documents on Cosmetic Regulatory Scheme

  • ASEAN Definition of Cosmetics and Illustrative List by Categories of Cosmetics
  • Cosmetic Ingredient Lists
  • ASEAN Guidelines for Cosmetic GMP
  • ASEAN Cosmetic Labelling Requirements
  • ASEAN Cosmetic Claims Guidelines
  • ASEAN Cosmetic Product Registration Requirements/Procedure (Schedule A)
  • ASEAN Requirements for Import/Export of Cosmetic Products

  
• Cosmetic Product Notification Certificate

  An authorization issued to a licensed establishment that will place a health product (cosmetics) in the market in lieu of a product registration

  
• Supporting documents for product notification

  • Full ingredient listing (as per labeling requirements) and the percentage of restricted ingredients
  • Clear & legible colour photographs or draft drawing/artwork of the product labels, package inserts, inner and outer cartons
  • Copy of the Business Licence of the registrant or company responsible for placing the product in the market
• Post-marketing Surveillance (PMS) of Cosmetic Products

  FDA conducts product verification through collection of actual products sold in the market to check if the submitted information during notification such as the ingredient listing is consistent with the label of the collected product

  
• Any subsequent changes to the information submitted in the notification, which have been verified by the FDA through PMS activities, will render the notification invalid and a new notification will have to be submitted
• Products being rendered as unnotified through these PMS activities are deemed non-compliant to existing rules and regulations
• FDA Advisories are issued to warn the general public against the purchase and use of unnotified or non-compliant cosmetic products which may pose danger to the consuming public
• ASEAN Cosmetic Labeling Requirements

  • Name of the cosmetic product
  • Immediate packaging
  • Outer packaging
  • Labeling

  
• Particulars to appear on the outer/immediate packaging of cosmetic products


  • The name of the cosmetic product and its function
  • Instructions on the use of the cosmetic product
  • Full ingredient listing
  • Country of manufacture
  • The name and address of the company or person responsible for placing the product on the local market
  • The contents given by weight or volume
  • The manufacturer's batch number
  • The manufacturing or the expiry date of the product
  • Special precautions to be observed in use

  
• Full Ingredient Listing


  The ingredients must be declared in descending order of weight at the time they are added. Perfume and aromatic compositions and their raw materials may be referred to by the word "perfume", "fragrance", "aroma" or "flavor". Coloring agents may be listed in any order after the other ingredients, in accordance with the color index number or denomination adopted in Annex IV
• The ingredients shall be specified using the nomenclature from the latest edition of standard references
• Botanicals and extract of botanicals should be identified by its genus and species. The genus may be abbreviated
• Impurities in the raw materials used, subsidiary technical materials used in the preparation but not present in the final products, and materials used in strictly necessary quantities as solvents, or as carriers, for perfume and aromatic compositions shall not be regarded as ingredients
• Labeling requirements for cosmetic products

  • The name of the cosmetic product and its function
  • Instructions on the use of the cosmetic product
  • Full ingredient listing
  • Country of manufacture
  • The name and address of the company or person responsible for placing the product on the local market
  • The contents given by weight or volume
  • The manufacturer's batch number
  • The manufacturing or the expiry date of the product
  • Special precautions to be observed in use

  
• ASEAN Cosmetic Claim Guidelines

  Products are determined to be either "cosmetic" or "drug" based on composition of the product and the proposed use. Cosmetic products typically have effects that are not permanent, and have to be used regularly to maintain their effects
• Decision process to identify cosmetic products and allowable claims

  • The product should contain only ingredients that comply with the annexes of ASEAN Cosmetic Directive (ACD), and does not contain any ingredients that are banned in the ACD
  • The product should be 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
  • The product should be applied to the permitted parts of the human body with a view exclusively or mainly to clean them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition
  • The product should not be presented as treating or preventing disease in human beings
  • Cosmetic products typically have effects that are not permanent, and have to be used regularly to maintain their effects

  
• Claims can be softened i.e. made less functional and more cosmetic in nature by the use of modifiers