Commodity

Commodity Details

For Imports

Regulating Agencies

Legal Basis

• Administrative Order No. 2020-0017 – Administrative Order No. 2020-0017 || Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003
• DA Administrative Order No. 9, Series of 2010 – Rules and Regulations Governing the Importation of Agricultural and Fish and Fishery/Aquatic Products, Fertilizers, Pesticides and Other Agricultural Chemicals, Veterinary Drugs and Biological Products into the Philippines
• DOH Department Circular No. 2011-0101 – DOH Department Circular No. 2011-0101 The Rules and Regulations Implementing RA No. 9711- The Food and Drug Administration Act of 2009
• Republic Act No. 10611 – Republic Act No. 10611 An Act To Strengthen The Food Safety Regulatory System In the Country To Protect Consumer Health And Facilitate Market Access Of Local Foods And Food Products And For Other Purposes
• Republic Act No. 7394 dated April 13, 1992 – Republic Act No. 7394 dated April 13, 1992 The Consumer Act of the Philippines

Permits, Clearances, Certifications

• SPS Import Clearance from Bureau of Fisheries and Aquatic Resources
• License to Operate (LTO)
• Certificate of Product Registration (CPR)
• FDA Certification/Notification/Clearance (for those not requiring LTO and/or CPR)
• Certificate of Analysis (if applicable)

Requirements & Procedures

Documentary Requirements

Bureau of Fisheries and Aquatic Resources

1. Duly accomplished form
2. Duly accomplished proposal form with emphasis on health, ecological and genetic impacts of the proposed importation
3. Import risk analysis by the IRA Panel
4. Health certificate from the competent authority of the country of origin to be presented upon arrival of the consignment at the NAIA or other designated ports of entry. On a case to case basis, BFAR may specify certification requirements for individual species and/or shipments to ensure freedom from specified diseases as deemed necessary
5. The quarantine and inspection requirements shall be based on the decision of the BFAR IRA Panel which may require a quarantine period of 24-28 days on a case to case basis after the release of the shipment from the airport to the BFAR’s quarantine facility, with costs to be borne by the importer.

Note: Risk analysis shall not be required for Low Risk Species except when there is a reported significant disease outbreak in the country of origin.

1. International Health Certificate from the Country of Origin - Fish and fishery/aquatic products coming into the Philippines intended for distribution and for further processing shall be certified by authorized or competent regulatory agency from the country of origin. The International Health certificate shall be issued on the basis that the following requirements have been met:
   1. Fish and fishery/aquatic products meet the quality of fresh fish prior to freezing shall be graded accordingly to size.
   2. The fishery products must be handled and processed hygienically in processing plants and/or freezer vessels.
   3. Frozen fishery products must be kept and maintained at -18°C or lower during transport.
   4. Fish and fishery/aquatic products must be subject to visual inspection for parasite check. Fish infested with parasites, must be removed from the batch.
   5. The International Health Certificate shall be supported with the following laboratory test results, which shall not exceed for the indicator organisms, such as:
      • Total viable count - 100/gram
      • Salmonella - absent in 25 gram sample
      • Shigella - absent
      • Vibrio Cholerae - absent
   6. The International Health Certificate shall accompany the consignment of fish and fisher/aquatic products and shall be presented as part of the documentation requirements upon arrival.
2. Print Area Health Control Requirements - Fish and fishery/aquatic products covered by the following families: Scombridae (tuna and tuna-like species and mackerel) and Clupeidae (sardines) shall be subject to chemical analysis for histamine. Examinations shall be carried out in accordance with internationally recognized methods. The results of the test shall not exceed 20 mg./100 gm. And shall be included i the Health certificate requirement.

Food and Drug Administration

The Philippine importer must use the e-registration system version using the valid user account holder . You must read carefully the new issuance of FDA Circular 2020-033 (Procedure for the use of a modified e-registration system for raw material and pre-packaged food products and its amendment 2020-033A).

There is an available video presentation on the FDA website for "Complete Guide on How to Apply for Food CPR version 2".

You may also see the Frequently Asked Questions of FDA for your other references.

Valid License to Operate (LTO) as Food Importer

Duly accomplished and notarized Integrated Application Form

Proof of Registration

1. If Single Proprietorship, valid Certificate of Business Name Registration with the DTI
2. If Corporation or Partnership, valid Registration with SEC and Articles of Incorporation or Partnership
3. If Cooperative, valid Certificate from Cooperative Development Authorities (CDA) and by laws

Proof of Occupancy

1. Valid notarized Contract of Lease/Sub-Lease/Certificate of Occupancy/ Warehousing Agreement (for third party logistics)
2. Transfer Certificate of Title (TCT)if owned and notarized Certificate of Occupancy (if owned by one of the incorporators
3. Clearance from the Condominium/ Building Administration allowing the use of the unit for business purposes - as necessary

Location Plan/Site/Google Map (indicate size, location, landmarks, immediate environment, type of building)

Floor Plan/Lay out with dimension (office and/or warehouse; manufacturing plant)

List of food products to be distributed

Sample label of product to be imported/distributed

Any of the following from each supplier

1. Foreign Agency Agreement
2. Certificate of Distributorship
3. Appointment Letter
4. Proforma Invoice
5. Memorandum of Agreement

Any one of the following documents for the status of manufacturer issued by the Regulatory/Health Authority from the country of origin

1. Certificate of Registration of Manufacturer and its conformity with GMP from Regulatory/ Health Authority or its equivalent
2. Phytosanitary Certificate/Health Certificate
3. Certificate of Free Sale
4. ISO 2200 Certification/FSSC 2200
5. HACCP Certificate as applicable

Valid Certificate of Product Registration (CPR)

Completely filled up Assessment Slip

Application Letter

Notarized Affidavit of Undertaking

Completely filled up Product List

Proforma/Sales Invoice declaring the products imported and applied for product registration

Actual loose label with sticker reflecting the complete name and address of the importer

Original copy of the Certificate of Free Sale (CFS) issued by the Government Regulatory Agency in the country of origin stating that the specific products applied for registration are freely sold in the country of origin and fit for human consumption.

Procedures

Bureau of Fisheries and Aquatic Resources

1. Receiving and Review Letter request to Import - Director's Office and Regulatory and Quarantine Division
2. Conduct Import Risk Analysis (IRA) Evaluation of Risk Factors - (Environment, Disease and Effect on Endemic Species) (Inspection of Importer’s
   Facilities) Fish Health Section
3. If approved by IRA, Processing/Tying of Sanitary and Phytosanitary Certificate (SPS) to Import Live Fishes - Regulatory and Quarantine Division
4. For Signature and Approval (Section Chief and Division Chief) Regulatory and Quarantine Division
5. Release to Applicant The SPS Certificate to Import Live Fishes - Regulatory and Quarantine Division

A Permit to Import may be issued only after an application thereof has been filed and the applicant has paid the Permit Fee of One Thousand Five Hundred (P1,500.00) Pesos, and such other charges for administrative and technical services rendered in connection with the importation.

Inspection Requirements. Upon arrival, imported fresh/chilled/frozen fish and fishery/aquatic products shall be subject to the following inspection requirements:

1. Documentation. Inspection/verification of accompanying importation documents (original copy of Permit to Import, photocopies of International Health Certificate from duly accredited laboratory and/or Sanitary and Phytosanitary Clearance/ Certificate from the competent authority of the country of origin, Airway bill/Bill of Lading and invoice) must be presented and surrendered to the inspecting Fishery Quarantine Officer). In the absence of a certified true copy by the importer of the International Health Certificate from the country of origin, the shipment shall be committed to a storage facility for a period of not exceeding ten (10) days to allow the importer to submit such documents. Failure to comply within the specified period, the shipment shall be returned to the country of origin, otherwise, forfeited in favor of the government for its proper disposition. All expenses involving storage, return to origin and disposition of the shipment shall be borne by the importer.
2. Physical Examination. Adequate sample of imported fishery product for laboratory examination shall be collected randomly by technical personnel of the Bureau for sensory/organoleptic examination. Fresh, chilled, and frozen fish and fishery/aquatic products shall meet the quality requirements based on organoleptic checks on the standards for fresh/chilled/frozen fish and fishery/aquatic products. Each batch of imported fishery products shall be subject to examination at the time of landing. The local government unit shall be responsible for the examination of fish and fishery products during distribution to markets and outlets.
3. Microbiological Analysis. All imported fishery products shall be subject to microbiological examination. After laboratory examination, if imported products does not meet the required quality standard, the whole shipment shall be committed to a storage facility while further laboratory examination shall be conducted on random samples to technically determine the quality of the products. If found unfit for human consumption or does not meet the required standard, the said container shall be returned to the country of origin. Fees and charges incidental to examination and storage of imported products shall be chargeable to the importer.
4. If upon inspection the imported fish or fishery/aquatic product does not met the quality requirements prescribed by the Bureau, or prohibited fish and fishery/ aquatic products are included in the importation, the same shall be removed immediately, and in case of the latter, confiscated, and the importer shall, in addition, be penalized in accordance with the provisions of applicable laws, rules and regulations.
5. Issuance of Fishery Sanitary and Phytosanitary (SPS) Certificate for the release of the imported fishery product.
6. Should any portion of the imported fish and fishery/aquatic products intended for non-human consumption be sold, utilized, or distributed for local human consumption, the importer shall be permanently disqualified from applying for subsequent importation of fish and fishery /aquatic products, and shall be penalized in accordance with Section 12 of this Order, Provided, However, That the imported fish or fishery/aquatic products shall be immediately confiscated and forfeited in favor of the government.
7. Should any portion of the imported fish and fishery/aquatic product intended for canning and processing plants and any portion of the importation by institutional buyers be sold or diverted to the local wet markets, the importer shall be permanently disqualified from applying for subsequent importation of fish and fishery/aquatic products, and shall be penalized in accordance with Section 12 of this Order: Provided, However, That the imported fish or fishery/aquatic products shall be immediately confiscated and forfeited in favor of the government.

Food and Drug Administration

1. Application form id downloaded from www.fda.gov.ph
   • The integrated application form in XLS or XLSX format is used for both License and Registration applications, as well as amendments and other certifications. Promos and advertisements are also now covered in the application from. Remember that a valid LTO is required for a CPR.
2. Application form is filled-up correctly.
   • The application form has six parts:
     1. General Information
     2. Establishment Information
     3. Product Information
     4. Supporting Information
     5. Sources and Clients
     6. Applicant Information
   • If the part is appropriately filled up, a green 'PROCEED' will be indicated. Required fields will appear sequentially. If the form is appropriately filled up, the composed body text (in the green box) will appear.
3. Send an email to pair at pair@fda.gov.ph
   • In the XLS application form, the worksheet 'Email' composes the subject and bosy of the email that should be sent to pair@fda.gov.ph. Copy and paste the appropriate fields onto the email. Include CCs as needed. The XLS or XLSX file should not be attached but it will be required during submission. Any attachment will lead to rejection of schedule request. Up to ten applications in a single email are acceptable.
4. Within two working days, a Document Tracking Log (DTL) is sent with a schedule for submission.
   • The FDA will determine the schedule of applications according to the priority of the Centers. A quota will be set for the total number of applications that can be scheduled in a day. Multiple applications sent in a single email may be scheduled over separate days. Requests for specific schedules will not be accommodated. Receiving will be scheduled within 10 working days of receipt of application email.
5. Fees are paid either at Land Bank branches or at the main FDA cashier.
   • Once a DTL is received, payment can be made immediately through any branch of the Land Bank of the Philippines. The main FDA cashier will only accommodate those scheduled to be received for the day. A copy of the DTL provided by FDA and a copy of the application form are required to process payment. Indicate in the application form the tracking number provided. Check that the tracking number indicated in the DTL is indicated in the proof of payment.
6. Check if all requirements are in order.
   • Be sure that you have a checklist of requirements and that you have all the necessary documents. Don't forget to have the petition or declaration form notarized. A softcopy of all requirements should be stored in a USB device to facilitate transfer. Include an XLS or XLSX copy of the accomplished application form. Please keep your USB devices free of malicious software. A copy of the OnColl Payment Slip is also required at the point of submission.
7. Application is filed on schedule.
   • Only applications scheduled for the day will be accommodated. Hard copies will no longer be required at submission. Don't forget to get back the USB devices used to transfer documents. Remember the RSN number of each application. Use the RSN to follow-up through pair@fda.gov.ph. Should you fail to complete submission on the set date, queue for another schedule through pair@fda.gov.ph using RSN.

NTMs

For Live, Fresh, Frozen, Chilled, and Uncooked:

1. BFAR – Importer Registration
2. BFAR – Import Risk Analysis
3. BFAR – SPS Import Clearance
4. BFAR – Packaging Requirements
5. BFAR – Labelling Requirements
6. BFAR – 30 Day Must Ship Out Date however 15 Days if Live Milk Fish
7. BFAR – Inspection Requirements for live fish
8. BFAR – Storage and Transport Requirements

For Salted, In Brine, Dried, Preserved, Prepared, Canned, Heated, Cured, Smoked, Dried, Marinated, and Chemically Modified:

1. FDA – License to Operate
2. FDA – Certificate of Product Registration
3. FDA – Labelling Requirement

Import Status

Regulated

For Exports

Regulating Agencies

Status

The export of this commodity is currently regulated. Please contact the regulating agency above for export requirements and procedures.

NTMs

For Fresh, frozen, chilled, Uncooked, Par-Cooked, Fermented, and Flaked

1. BFAR – Exporter Registration
2. BFAR – Export Permit
3. BFAR – Pre-shipment Inspection

For Salted, In Brine, Dried, Preserved, Prepared, Canned, Heated, Cured, Smoked, Dried, Marinated, and Chemically Modified:

1. FDA – License to Operate
2. FDA – Certificate of Product Registration
3. FDA – Export Certification

Tariff Schedules

Visit the Philippine Tariff Commission (TC) through its Philippine Tariff Finder (PTF).

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