Steps for Cosmetic e-Notification v.2.0:1. Secure a CCRR User Account by sending a request to [email protected] following the format below: 2. After securing the CCRR user account, log in at the FDA e-Portal (https://ww2.fda.gov.ph) 3. Select “New Case” and accomplish the ASEAN Notification Form. 4. Download the Order of Payment and assign the task to FDA Cashier. 5. Pay the fee at any Landbank Branch or thru online Bancnet payment and wait for the Result of Application. 6. If approved, download and print the notice of acknowledgement. 7. For more information, you may download the following for your reference/guidance: FDA Memorandum Circular No. 2015-010 FDA Memorandum Circular No. 2015-011 Cosmetic e-Notification v.2.0 Booklet for Applicants Do's and Don'ts 1. Fields with red asterisk (*) are mandatory and shall not be left blank. 2. DO NOT COMMIT ANY SPELLING MISTAKE, FDA won't be liable for this. 3. For the Restricted Ingredient, make sure to provide the function of that ingredient and its corresponding percentage.
Annex II - List of Substances Which Must Not Form Part of the Composition of Cosmetic Products Annex III: Part 1 List of substances that cosmetic products must not contain except subject to restrictions and conditions laid down Annex IV: Part 1 List of colouring agents allowed for use in cosmetic products Annex VI - List of Preservatives Which Cosmetic Products May Contain Annex VII - List of UV Filters Which Cosmetic Products May Contain ASEAN Cosmetic Method (ACM 03) - Identification and Determination of Hydroquinone in Cosmetic Products by TLC and HPLC ACM 004 - Identification and Determination of of 2-Phenoxyethanol, Methyl, Ethyl, Propyl, and Butyl 4-Hydroxybenzoate in Cosmetic Products by HPLC ACM 009 - Determination of Salicylic Acid (Beta Hydroxy Acid) in Cosmetic Products by High Performance Liquid Chromatography (HPLC)
ASEAN Cosmetic Directive: Guidelines for Product Information File (PIF) ASEAN Guidelines for the Safety Assessment of a Cosmetic Product ASEAN Botanical Safety Assessment guidance Document (Adopted 21st ACSB - November 2014) ASEAN Sunscreen Guidelines Guidance Format of the Safety Assessment
ASEAN Cosmetic Methods:
Q & A on Specific Provision ACD Interpretation of ASEAN GMP Guideline for Cosmetic Cosmetic Product Notification General Information Booklet on ASEAN Harmonized Cosmetic Regulatory Scheme IMPORTANT NOTE: Schedule A of the Agreement on ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) is no longer applicable
Guidelines on the Unified Licensing Requirements and Procedure of the Food and Drug Administration (FDA)
- Revised Guidelines in Licensing Cosmetic Establishments
- Amendment to FDA Circular No. 2013-002 "Revised Guidelines in Licensing of Cosmetic Establishments"
- Checklist of Requirements for Initial, Renewal and Amendment Applications
- Site Master File Format
- Petition Form (except NCR and Region 4A)
- Joint Affidavit of Undertaking
- CAPA Plan
- FDA Memorandum Circular No. 2014-008 or "Guidelines on the Electronic Notification of Selected Household/Urban Hazardous Substances (HUHS E-Notification) System
- FDA Memorandum Circular No. 2014-008-A or "Amendment to FDA Memorandum Circular No. 2014-008 or "Guidelines on the Electronic Notification of Selected Household/Urban Hazardous Substances (HUHS E-Notification) System"
- Revised Guidelines in Licensing Household Hazardous Substances (HHS) Establishments
- Amendment to FDA Circular No. 2013-009 "Revised Guidelines in Licensing of Household Hazardous Substances (HHS) Establishments
- Checklist of Requirements for the Initial, Renewal and Amendment Applications
- Site Master File Format
- Petition Form (except for NCR and Region 4A)
- CAPA Plan