FDA Advisory No. 2017-083
Guide on the Proper Accomplishment of the Product Ingredient List Section of the Cosmetic Electronic Notification (e-Notification) Version 2.0
Pursuant to the issuance of Administrative Order (A.O.) No. 2005-0015 “Adoption of the Association of Southeast Asian Nation (ASEAN) Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents” and A.O. No. 2005-0025 “Implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents,” the Food and Drug Administration (FDA), then called the Bureau of Food and Drugs (BFAD), has adopted and implemented the ASEAN Cosmetic Directive (ACD) in 2005 to eliminate technical barriers to trade of cosmetic products without compromising public health and safety. This has shifted the regulatory process from a pre-market approval to a post-marketing surveillance (PMS) system and has made way for the implementation of the cosmetic notification scheme.
In September 2015, FDA has implemented the cosmetic electronic notification (e-notification) version 2.0 through the issuance of FDA Memorandum Circular (FMC) No. 2015-011 “Guidelines for Electronic Notification of Cosmetic Products (Cosmetic E-Notification Version 2.0) using the FDA E-Portal” which aimed to further enhance the efficiency of the cosmetic notification application process and promote transparency of information.
Though the use of FDA e-Portal for cosmetic notification is new to the agency’s stakeholders, the information required to be submitted are the ones that are found in the ASEAN cosmetic notification template previously used in the manual and first version of the cosmetic e-notification system. FMC No. 2015-011 provided for a number of reminders that must be followed to ensure that cosmetic notification applications lodged with FDA will not be disapproved. One of these reminders is that “all ingredients must be specified using the nomenclature accepted in the standard references listed in the ASEAN Cosmetic Labeling Requirements. Botanicals and extracts of botanicals should be identified by its genus and species. The genus may be abbreviated. The functions and percentages of ingredients must be declared if they are substances with restrictions for use as specified in the annexes of the ASEAN Cosmetic Directive.”
However, after assessing the efficiency of the cosmetic e-notification version 2.0 as well as the proficiency of stakeholders in using the new system, statistics show that 56.11% of the disapproved applications or 5.02% of the total applications received are disapproved due to errors/incompleteness of the full ingredient list required in the application of cosmetic notification.
In order to aid compliance of cosmetic stakeholders, FDA has developed an illustrative guide reiterating how to properly fill out and accomplish the product ingredient list section of the cosmetic notification template. The guide, as annexed, is made available in both English and Filipino versions and may be downloaded via the FDA website (www.fda.gov.ph).
Dissemination of the information to all concerned is requested.