6. Registration Processes

General Foods
Philippines

This section provides information on any product notification or registration and manufacturing site registration processes.

6.1 Product Notification

N/A

6.2 Product Registration

All processed foods, including food additives, food supplements, and bottled water, shall first be registered with the Philippines Food and Drug Administration (FDA) before these are distributed, supplied, sold or offered for sale or use as advertised, among other marketing or promotional activities. [1]

Description of the process

One registration (and one Certificate of Product Registration (CPR)) shall be made for a product that has multiple packing sizes, multiple artwork designs, and/or multiple suggested recipes on the pack provided that it meets all the following conditions:

• The same brand name
• The same product name/variant 
• The same product formulation/ingredients in the same order of proportion
• The same label information, except for net weight 

The registration process is guided by the FDA Circular No. 2016-014 [3] and the document "Food Registration Requirement to Secure a Certificate of Product Registration" [2].

Product registration will be done online through the portal [4].

List of Mandatory required documents for product registration

1. Accomplished Integrated Application form as prescribed by current FDA regulations [1]
2. Proof of payment of fees
3. Clear and complete labels or artwork
4. Pictures of the product from all angles and in different packaging sizes, and from at least two different perspectives allowing visual recognition of a product as the same as the one being registered, as applicable. 
5. 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 reports or studies published in peer-reviewed scientific journals, certificates or certification to support the use of logo/seal on Sangkap Pinoy*, Halal, Organic, or Kosher food and in compliance with current labeling regulations. 
6. For food supplements, a sample in actual commercial presentation shall be submitted (for the initial application of food supplements only) 
7. Stability study for finished product and safety data (for food supplements only). 
8. Notification containing the list of new sources and their complete address, name and complete address of the manufacturer (in cases when the source is not directly from the manufacturer), and distributorship agreement or contract agreement, whichever is applicable, and signed by the duly authorized representative of the establishment as reflected in the record of Center for Food Regulation and Research (CFRR). 
9. Certified true copy or certified photocopy of ANY of the following valid original documents issued to the source by the regulatory or health authority from the country of origin per source: GMP certificate or equivalents, phytosanitary certificate/health certificate, ISO 22000 certificate, HACCP certificate, Certificate of Free Sale.

See reference [2] for details of the documents required.

* The Sangkap Pinoy Seal Program (SPSP) is a strategy to encourage food manufacturers to fortify processed foods or food products with essential nutrients at levels approved by the DOH. This is a program to reduce vitamin and mineral deficiency in the Philippines [6].

6.3 Other Notes or Requirements

Product Registration

The FDA may require additional documents on products that are considered high-risk food provided that the reason for the additional requirements is to address uncertainties of safety as deemed necessary through a separate issuance [1]. High-risk products include but not limited to the following: infant formula, milk supplements, food for infants and young children, foods for special medical purposes, and foods for special dietary uses. 

In addition, FDA may conduct an inspection of the manufacturing or processing plant or verification of documents submitted or may require additional documents/evidence to ascertain the safety and/or quality of the product.

Validity of Certificate of Product Registration (CPR) will be 2 - 5 years for initial application and 5 years for renewal; provided that upon the renewal, the product conforms with the pertinent standards and requirements including labeling regulation. 

Modifications to the label, packaging size, shelf life and packaging design of the product must be notified to the FDA. Change of manufacturer or repacker as well as changes to the composition require a new registration.

6.4 Manufacturing Site Registration

Requirements for manufacturing site registration 

A separate manufacturing site registration is not required for imported food. However, this shall be notified during the product registration with the following documents:

1. Notification letter containing the list of sources and their complete name and address of their manufacturer (in cases where the source is not directly the manufacturer), and distributorship agreement or contract agreement, whichever is applicable.
2. A certified true copy of any of the original documents issued to the source by the Competent Authority in the country of origin (see below or the Reference [9] for details).

Authority in charge

Philippines FDA

Estimated cost and duration

Notification on the manufacturing source for imported food can be done during product registration (i.e. this is not a separate registration).

6.4.1 Standard/Rules for Manufacturing Site [9]

For overseas food manufacturers, the Philippines requires one of following valid original documents issued to the manufacturing source by the Competent Authority in the country of origin to process the product registration:

1. GMP certificate or equivalents;
2. Phytosanitary certificate/health certificate;
3. ISO 22000 certificate;
4. HACCP certificate or Certificate of Free Sale.
   

6.4.2 Other Notes or Requirements for Manufacturing Site Registration

N/A

6.5 References

1. Administrative Order No. 2014-0029 Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and the Other Food Products, and for Other Purposes

https://www.fda.gov.ph/wp-content/uploads/2021/03/Administrative-Order-No.-2014-0029.pdf

2. Food registration requirement to secure a certificate of product registration    

https://www.fda.gov.ph/wp-content/uploads/2021/03/Food-Registration-Requirements-to-secure-Certificate-of-Product-Registration.pdf

3. FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products”

https://www.fda.gov.ph/wp-content/uploads/2021/03/FDA-Circular-No.-2016-014.pdf

4. E-Registration portal

https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

5. Administrative Order 2010-0008

https://www.fda.gov.ph/wp-content/uploads/2021/08/Administrative-Order-No.-2010-0008.pdf

6. Sangkap Pinoy Seal for added nutrients

https://nnc.gov.ph/regional-offices/luzon/national-capital-region/4327-choose-foods-with-sangkap-pinoy-seal-for-added-nutrients

7. General Regulatory fees and charges

https://www.fda.gov.ph/wp-content/uploads/2018/06/FINAL-ANNEXES-for-AO-on-INCREASE-OF-FEES.pdf

8. Philippines DOH FAQ 

https://doh.gov.ph/faqs/How-many-days-will-it-take-for-the-processing-of-the-certificate-of-product-registration

9. FDA Circular 2016-007: Notification of Sources of Raw Materials, Low Risk, Medium Risk, and High-Risk Prepackaged Processed Food Products

https://www.fda.gov.ph/wp-content/uploads/2021/03/FDA-Circular-No.-2016-007.pdf