Steps for Cosmetic e-Notification v.2.0:
1. Secure a CCRR User Account by sending a request to email@example.com 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 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 Microbial Limit
- ASEAN Heavy Metal Limit
- ASEAN Guidelines on Limits of Contaminants for Cosmetics
ASEAN Cosmetic Methods:
- ACM 001 - IDENTIFICATION OF TRETINOIN (RETINOIC ACID) IN COSMETIC PRODUCTS BY TLC AND HPLC
- ACM 002 - IDENTIFICATION OF PROHIBITED COLORANTS IN COSMETIC PRODUCTS BY TLC AND HPLC
- ACM 003 - IDENTIFICATION AND DETERMINATION OF HYDROQUINONE IN COSMETIC PRODUCTS BY TLC AND HPLC
- ACM 004 - IDENTIFICATION AND DETERMINATION OF 2-PHENOXYETHANOL, METHYL, ETHYL, PROPYL, AND BUTYL 4-HYDROXYBENZOATE IN COSMETIC PRODUCTS BY HPLC
- ACM 005 - DETERMINATION OF HEAVY METALS (ARSENIC, CADIUM, LEAD AND MERCURY) IN COSMETIC PRODUCTS
- ACM 006 - ENUMERATION OF AEROBIC MESOPHILIC BACTERIA, YEAST AND MOULD
- ACM 007 - IDENTIFICATION OF STEROIDS IN COSMETIC PRODUCTS BY TLC AND HPLC
- ACM 008 - EVALUATION OF THE ANTIMICROBIAL PROTECTION OF A COSMETIC PRODUCT
- ACM 009 - DETERMINATION OF SALICYLIC ACID (BETA HYDROXY ACID) IN COSMETIC PRODUCTS BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)
- ACM 010 - DETERMINATION OF GLYCOLIC AND LACTIC ACID (AHA) BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)
Schedule A of the Agreement on ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) is no longer applicable
- 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
1. Letter of Intent
2. Photocopy of the following
- Valid LTO with attachment(s)
- Valid acknowledged notification with complete particulars
3. Proof of payment (Php 510/product/country)
Note: If the cosmetic formulation contains placenta ingredient, submit the following:
- Certificate of Origin indicating the specie, e.g. Equus caballus (horse), of the connective tissue extract, or embryo extract and/or placental protein
- Certificate of Analysis stating the composition of the placental protein or hormone free
- Certificate from Health Authority of the country of origin that the bovine is free from transmittable spongiform encephalopathy (TSE).
- 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
- ASSESSMENT CHECKLIST FOR INITIAL APPLICATION OF ACTIVE INGREDIENT REGISTRATION
- ASSESSMENT CHECKLIST FOR INITIAL APPLICATION OF HOUSEHOLD URBAN PESTICIDE REGISTRATION
- ASSESSMENT CHECKLIST FOR RENEWAL APPLICATION OF HOUSEHOLD URBAN PESTICIDE REGISTRATION
- SELF-ASSESSMENT CHECKLIST FOR VARIATION APPLICATION OF HOUSEHOLD URBAN PESTICIDE REGISTRATION