In a previous post, I wrote about the Philippine Food and Drug Administration (FDA) and the requirements and how to procure a License to Operate (LTO) for food establishments.
This post is about the Certificate of Product Registration (CPR).
For a related entry, please read Food and Drug Administration – Philippines.
- Requirements for registration are based on the requirements indicated in Administrative Order 2014-0029 and FDA Circular 2016-014:
A. Proof of payment or fees as prescribed by current FDA regulations;
B. Clear and complete loose labels or artworks, as applicable, of all packaging size, or equivalents as defined by FDA regulations except of bulk raw materials, ingredients and food additives intended for further processing or for distribution to establishments/manufacturers for further processing;
C. Pictures of the product in all angles and in different packaging sizes, and from at least two different perspectives allowing visual recognition of a product as the same with the one being registered, as applicable;
D. For food supplement, a sample in actual commercial presentation shall be submitted.
E. For food products with label claims: as applicable, documents to substantiate claims, such as technical, nutritional or health studies or reports, market research studies, Certificate of Analysis, quantitative analysis and computations, scientific report or studies published in peer-reviewed scientific journals, certificates or certification to support use of logo/seal on Sangkap Pinoy, halal, Organic, or Kosher food and in compliance with current labelling regulations.
F. Additional requirements for food supplement are the following:
*Certificate of Analysis for physico-chemical and microbiological parameters
*Shelf life study with stability data containing relevant information on the critical parameters of the finished product, period conducted, conclusion, and signed/verified by competent technical staff to support shelf life declaration.
*Safety data (Acute Oral Toxicity Test (LD-50 Test, Heavy Metals Test, other cytoxicity tests, safe history of use or other tests to assess potential toxicity as applicable)
2. All food additives must conform with the Updated List of Food Additives and/or latest General Standard for Food Additives based on Bureau Circular 2006-016 and Administrative Order 2014-0029. Food flavours must be listed in Flavors and Extracts Manufacturers Association (FEMA) or International Organization of the Flavor Industry (IOFI) Generally Recognized As Safe Lists based on B.C. 2006-016 or latest FDA Regulation on Food Additives.
3. Based on FDA Circular 2016-007, additional requirements for imported products include ANY of the following scanned copy of the original documents:
(1)Foreign Agency Agreement or (2) Certificate of Distributorship or (3) Appointment letter or (4) Proforma Invoice or (5) Memorandum of Agreement from the supplier.
AND ANY of the following documents issued by the Regulatory/ Health Authority/Internationally Recognized Certifying Body:
(1) Certificate of Registration with GMP Compliance or its equivalent or (2) Valid Sanitary Phyto-Sanitary Certificate or (3) Health Certificate or (4) ISO 22000 Certificate or (5) FSSC Certificate or (6) HACCP Certificate or (7) Certificate of Free Sale issued to the Manufacturer.
In case, the Certificate of Free Sale is issued by the Chamber of Commerce or trade association, this should be duly authenticated by the Philippine Consulate from the country of origin.
4. Food products with standards of identity should conform with the specification in the corresponding standards thru submission of Certificate of Analysis.
5. Medium and high risk food products should conform with the microbiological parameters as indicated in FDA Circular 2013-010.
6. Processed food products containing food additives with restricted levels (e.g. nitrite in meat products) should not exceed the maximum levels allowed in the Updated List of Food Additives (B. C. 2006-016) or FDA latest Regulation on Food Additives. A Certificate of Analysis on the level of such restricted food additive in the finished product must be submitted.
7. Thermally processed food products packed in hermetically sealed containers (e.g. can, bottle) should submit Tests Results for Commercial Sterility.
8. Labels of food products applying for registration should conform to the current labelling guidelines based on Administrative Order 2014-0030.
9. For food products requiring the use of salt as an ingredient, it is mandatory to use iodized salt for local food products intended for local distribution based on Republic Act 8172 (ASIN Law).
10.The following staple food products should be fortified with Vitamin A and/or iron-based on Republic Act 8976 and must submit the Certificate of Analysis and compliant label as additional requirements in the registration:
*Cooking Oil-Vitamin A *Wheat Flour-Iron and Vitamin A *Sugar-Vitamin A *Rice-Vitamin A
11.Voluntary fortification of processed food products must conform with AO 04 s. 1995.
12. The following high risk food products should conform with the corresponding Codex Standards:
Infant Formula: Codex Standard for Formula for Special Medical Purposes Intended for Infants and Infant Formula (Codex STAN 72-1981 Rev. 2006)
Follow up Formula or Milk Supplement: Codex Standard for Follow Up Formula (Codex STAN 156-1987)
Cereal-based Foods for Older Infants and Young Children: Codex Standard for Processed Cereal-based Foods for Older Infants and Young Children (Codex STAN 074-1981 Revised 2006)
Formulated Complementary Foods for Infants and Young Children (Codex GL-9-1991 Revised 2013)
Canned Baby Foods: Codex Standard for Canned Baby Foods (Codex STAN 73-1981)
Foods for Special Medical Purposes: Codex Guidelines for the Labeling and Claims of Foods for Special Medical Purposes (Codex STAN 180-1991)
Foods for Special Dietary Uses: Codex Standard for the Labeling of Prepackaged Foods for Special Dietary Uses (Codex STAN 146-1985 )
Formula Foods for Weight Control Diets: Codex Standard for Formula Foods for Weight Control Diets)
A. Application Process on How to Register Pre-Packaged, Processed Food Products (Initial/Renewal Data Capture/Amendment Data Captire/Reapplication Data Capture) Via E-Regitration
Step 1: Client enters the system through the link https://ww2.fda.gov.ph completely and accurately fills up online form. (timeline: 0 calendar day)
Step 2: Client pays the assessed fee as per the system generated Order of Payment Form through FDAC Cashier or any other means prescribed by FDA (e.g. Bancnet or Landbank Oncoll). (timeline: 2 calendar days)
Step 3: Evaluation: Evaluator evaluates the application according to encoded information in the data entry and uploaded documents with recommendation for approval or denial. (timeline: 48 calendar days)
Step 4: Checking: Checker reviews evaluated application with recommendation. (timeline: 40 calendar days)
Step 5: Issuance: the Center for Food Regulation and Research (CFFR) Director reviews and electronically signs the application. If with deficiencies, client receives the system generated Letter of Denial in the inbox of e-Registration account. (timeline: 20 calendar days)
Step 6: Printing of CPR: The assigned Administrative Staff prints the system generated Certificate of Product Registration (CPR).
- The assigned data controller updates the e-Registration system and prepares transmittal.
- The assigned Administrative Staff forwards the CPR to Releasing Section.
- The assigned Central Releasing Staff releases the CPR to client and updates database. (timeline 4 days)
Total CPR e-Registration System Processing Time: 114 Calendar Days
B. Application Process of Pre-Packaged, Processed Food Products For Export/Reapplication Via E-Registration
Step 1: Client enters the system through the link https://ww2.fda.gov.ph completely and accurately fills up online form. (timeline: 0 calendar day)
Step 2: Client pays the assessed fee as per the system generated Order of Payment Form through FDAC Cashier or any other means prescribed by FDA (e.g. Bancnet or Landbank Oncoll). (timeline: 2 calendar days)
Step 3: Evaluation: Evaluator evaluates the application according to encoded information in the data entry and uploaded documents with recommendation for approval or denial. (timeline: 25 calendar days)
Step 4: Checking: Checker reviews evaluated application with recommendation. (timeline: 16 calendar days)
Step 5: Issuance: the Center for Food Regulation and Research (CFFR) Director reviews and electronically signs the application. If with deficiencies, client receives the system generated Letter of Denial in the inbox of e-Registration account. (timeline: 10 calendar days)
Step 6: Printing of CPR: The assigned Administrative Staff prints the system generated Certificate of Product Registration (CPR).
- The assigned data controller updates the e-Registration system and prepares transmittal.
- The assigned Administrative Staff forwards the CPR to Releasing Section.
- The assigned Central Releasing Staff releases the CPR to client and updates database. (timeline 4 days)
Total CPR e-Registration System Processing Time: 57 Calendar Days
C. Application Process of CPR Automatic Renewal Application Initially Approved from E-Registration
Step 1: Client enters the system through the link https://ww2.fda.gov.ph completely and clicks the Renewal option for the application. (timeline: 0 calendar day)
Step 2: Client pays the assessed fee as per the system generated Order of Payment Form through FDAC Cashier or any other means prescribed by FDA (e.g. Bancnet or Landbank Oncoll). (timeline: 2 calendar days)
Step 3: Approval (CPR or Letter of Denial) – the CFFR Director reviews and electronically signs the application. If with deficiencies, client receives the system generated Letter of Denial in the inbox of e-Registration account. (timeline: 2 calendar days)
Step 4: Printing of CPR: The assigned Administrative Staff prints the system generated Certificate of Product Registration (CPR).
- The assigned data controller updates the e-Registration system and prepares transmittal.
- The assigned Administrative Staff forwards the CPR to Releasing Section.
- The assigned Central Releasing Staff releases the CPR to client and updates database. (timeline 4 days)
Total CPR e-Registration System Processing Time: 7 Calendar Days
Source: CFFR User Manual 2019
For more information, please visit www.fda.gov.ph.
FDA Philippines Contact Numbers: (02) 821 – 1176, (02) 821 – 1177, (02) 821 – 1159, (02) 821 – 1162, and (02) 821 – 1220
FDA Cubao Satellite Office Contact Number: (02) 294 – 8017