ASEAN HARMONIZATION OF COSMETIC REGULATIONS OVERVIEW Objectives To achieve high quality and safe products in the market. Help the products to penetrate global markets. Encourage self compliance and self regulation. Harmonization 10 ASEAN Member States Brunei Cambodia Indonesia Lao PDR Malaysia Myanmar Philippines Singapore Thailand Vietnam ASEAN Harmonization Benefits The Consumers A wider choice of cosmetic products The Government/Regulatory Bodies One Simplified Regulatory System The Cosmetic Industry ASEAN as one single market The ASEAN Region Eliminate technical barriers to trade Facilitate flow of products across ASEAN Member Countries to boost economic growth Republic Act No. 9711 or FDA Act of 2009 General Provision: The manufacturer, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any HEALTH PRODUCT without the proper authorization from the FDA is prohibited. (Sec. 10, RA 9711) A manufacturer, owner, distributor, advertiser, and/or their agents are mandated to strictly observe the prohibitions and strictly adhere to the standards, guidelines, and rules and regulations prescribed by the FDA. Republic Act No. 9711 or FDA Act of 2009 Administrative sanctions and/or penalties: A fine of not less than Fifty Thousand Pesos (PhP50,000), but not more than Five Hundred Thousand Pesos (PhP500,000). An additional fine of not more than One Thousand Pesos (PhP1,000) shall be imposed for each day of continuing violation. Destruction and/or appropriate disposition of the subject HEALTH PRODUCT and/or closure of the establishment for any violation of the FDA Act of 2009, these Rules and Regulations, other relevant laws, and FDA-promulgated issuances. (Sec. 13, RA 9711) Definitions Under Republic Act No. 9711, otherwise known as the Food and Drug Administration (FDA) Act of 2009, here are the definitions of terms related to ASEAN Cosmetic Directive or ACD: Health Products – means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and household/ urban hazardous substances and/or a combination of and/or a derivative thereof. It shall also refer to products that may have an effect on health, which require regulations as determined by the FDA. Definitions Cosmetics – means any substance or preparation intended to be placed in contact with the 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 odor and/or protecting the body or keeping them in good condition. Definitions Cosmetic products are identified as follows: Cleansing Rubbed Beautifying Poured Promoting Sprinkled Attractiveness Sprayed Altering the appearance Applied Republic Act No. 9711 or FDA Act of 2009 There will be four (4) Centers covering the four (4) major product categories that are regulated by FDA: Food, Drug, Cosmetics and Device. Under Cosmetic Center (includes household hazardous/urban substances), there will be Risk Management and Surveillance Division, which will implement the Post-Market Surveillance System. Definitions Post-Market Surveillance – means monitoring health products and incidents of adverse events involving such products in coordination with the FDA Regional Field Offices. They will develop and maintain a system for gathering and monitoring information on health product risks and actions. And to develop standards on risk management to be followed by all manufacturers, traders, distributors, importers, exporters, wholesalers and retailers and, where applicable, users of health products. Post-Market Surveillance of Cosmetic Products Factors that warrant inspection of cosmetic establishment Company’s history of compliance Regulatory authority’s surveillance Market information and feedback from consumers Type and risk level of products Consumer Complaints Post-Market Surveillance of Cosmetic Products Subject of Audit and Sources of Samples Department Stores Supermarkets/ Public Markets/ Grocery Stores Drugstores/ Pharmacies Dermatological Clinics Mall Shops, Boutiques or Stalls Direst Selling Spas Beauty Salons Hotels/Resorts ASEAN HARMONIZED COSMETIC REGULATORY SCHEME The manufacturer/Importer/Distributor 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, using the Product Notification Form prescribed by the regulatory authority. The product can only be marketed after notification has been sent to the regulatory authority and acknowledgement has been received. ASEAN HARMONIZED COSMETIC REGULATORY SCHEME The implementation of ACD in the Philippines started January 2008. The Regulatory Agency allows the industries a 36-month grace period for compliance. Full implementation of ACD for all Member States : January 2011 Product Notification Guidelines Requirements for Product Notification: Full ingredient listing (as per labeling requirements) and the percentage of restricted ingredients. Copy of License to Operate of the company. Acceptance of a product notification does not constitute, in any way, an agreement that the product meets all the regulatory requirements. The company or person responsible for placing the product in the market has to ensure that each consignment of the product meets the requirements of the Directive and will not cause damage to human health under normal or reasonably foreseeable conditions of use. The Regulatory Authority will require the company to keep a Product Information File (PIF) and will carry out a range of post-marketing monitoring and surveillance activities to ensure compliance with the Directive. PIF Guidelines In view of the above ACD requirements, companies placing products in the market need to organize the PIF in such a way that it meets the requirements and be easily consulted by the Authorities. It is recommended that the PIF be organised into 4 parts as follows: Part I: Part II: Part III: Part IV: Administrative Documents and Product Summary Quality Data of Raw Material Quality Data of Finished Product Safety and Efficacy Data A Table of Contents should be provided for each of the 4 parts. PIF Guidelines In the fourth and final part of the PIF, the Companies are required to provide Safety and Efficacy Data, which shows detailed information on the safety assessment and data of the finished product and also relevant efficacy data to support any claims made on the product, conducted by a certified Safety Assessor and Dermatology. There are specific Test and corresponding Fees involve for the Safety and Efficacy Assessment: Dermal Patch Test (for allergic reaction/irritancy) - Php15,000 per product Clinical Study (for justification of claims) – Php35,000 per product FDA Expectations to the Cosmetic Industry Company to closely coordinate with the authority to safeguard the safety of the consumers (vise-versa) Request Industry Association to collaborate with the authority for the dissemination of new policies and updates on ACD to their members Company to policing their own brand to lessen the counterfeit products in the market FDA Expectations to the Cosmetic Industry Company to strengthen the undesirable event reporting for the welfare of the consumer Company to place their cosmetic product in accordance with the GMP and ACD Company to help BFAD reach those SMEs to participate in the ASEAN Harmonization of Cosmetic and to compete in the global market Solutions to the Cosmetic Industry There are ways to prevent and encounter these situations with FDA: Transact business with establishments that are accredited/licensed by FDA. They should have valid License to Operate and/or GMP Certificate. They should have valid authorizations/notifications issued by FDA for the products they market. They should be compliant to the Rules and Regulations of ASEAN Cosmetic Directives, e.g. PIF, SOP, etc.