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| Agenda Item 4.5 | Conference Room Document 19 English only |
second fao/who global forum of food safety regulators
Bangkok, Thailand, 12-14 October 2004
(Prepared by the Philippines)
The legal mandate of the Bureau of Food and Drug (BFAD) is embodied in Section 12 of the 1987 Philippine Constitution which provides that "The State shall establish and maintain an effective Food and Drug Regulatory System and undertake appropriate health manpower development and research, responsive to the country's health needs and problems. The basic law that established the Bureau of Food and Drugs, and defined its mandate and responsibility is Republic Act 3720: Food, Drugs, Devices and Cosmetics Act of 1963 as amended by Executive Order No. 175.
Assuring the public of safe and quality supply of processed foods both local and imported is a shared responsibility of the four line divisions of the Bureau. These divisions perform the mainstream or primary functions of the office. Divisions are Regulation Division I, Regulation Division II, Product Services Division and Laboratory Services Division.
Regulation Division I controls the importation, exportation, distribution and retailing of processed foods. The basis is Administrative Order No. 56 s. 1989 Revised Regulations for the Licensing of Drug Establishments and Outlets which covers imported processed food products. The division monitors and ensures safety and quality of imported processed foods through collection of samples from outlets and ports of entry. Regulation Division I issues the following: License to Operate, Certificates of Donation, Medical Mission, Release of Non -Iodized Salt (for importers) and Release of Raw Materials to be used by manufacturers in the processing of food and finished products from the Bureau of Custom. Issuances will only be upon request and the party shall comply with requirements.
Certificates of Donation are issued based on Administrative Order 54 - A s.2003 which covers all donations including imported processed food. The requesting party shall submit the following requirements/documents to be issued a Certificate of Donation:
Certificates of Release for Importers of raw materials, bulk finished products/processed food and iodized and non-iodized salt requires submission of the following: Letter of Intent, Proforma Invoice, copy of License to Operate, Certificate of Product Registration/Initial registration from Product Services Division and list of supplier with address. The port of entry and the purpose of importation shall be declared including the planned distribution and quantity of arriving shipment.
Regulation Division II takes responsibility of licensing, inspection, monitoring, and issuance of License to Operate to regulated establishments .specifically for manufacturers upon demonstration of compliance to Administrative Order. 208 s. 1974, Human Foods; Current Good Manufacturing Practice (Sanitation) in Manufacture, Processing, Packing and Holding later revised and signed into law last June 2004 under Administrative Order 153 s. 2004 Revised Guidelines on Current Good Manufacturing Practice in Manufacturing, Repacking or Holding Food. The aforementioned law has provisions which aligns with Codex and other international references for food safety standards. The Division monitors and ensures compliance of regulated establishments with requirements for Good Manufacturing Practices (GMP) and Hazard Analysis Critical Control Point (HACCP). Issuance of License to Operate is also based on compliance with documentary and technical requirements. Documentary requirements include: Petition Form duly accomplished by the applicant, list of production equipment, sketch of the production area, location plan, Fixed Assets of the Manufacturers which is used as basis for payment of fees and charges set forth by the BFAD and Certificate of Registration from Securities and Exchange Commission/Bureau of Domestic Trade. Technical requirements include: organizational chart of key personnel in production indicating their qualifications, training and experience, flow chart of the process with emphasis on the Critical Control Points, report of analysis of the finished product which shows conformance to standards, potability test results for source water used in processing , standard operating procedures enforced in the plant to ensure the safety and quality of the product being processed and the suitability of the packaging materials used. Submitted technical/documentary requirements shall be validated during inspection of the plant and facilities of the applicant. GMP Certificate can also be issued by the Division upon request of the manufacturer/establishment.
Laboratory Services Division conducts laboratory tests on finished products to determine compliance with standards of safety, efficacy, purity and quality of processed foods. It also tests foods which are subject of complaints from the public and suspected food vehicles in outbreak investigations. It can also detect additives, mycotoxins, histamines and other marine toxins, heavy metal contaminants and some of enteropathogens. The division issues Certificates of Free Sale and Health Certificates. Issuance of certificates is based on Office Memo No.4 s.1989 "Philippine Exporters Manual" which covers any person or establishments desiring to export processed food products or drugs. The certificates are issued only when products conform to safety and quality standards and/or the requirements and specifications of the importing country and this is valid for one (1) shipment only and expires within fifteen (15) days from date of issue. The requesting party shall submit Letter of Intent accompanied by the following documents: copies of Export Declaration, Letter of Credit, valid Certificate of Product Registration, Report of Analysis on the product and Packing List. Issuance will only be upon compliance with requirements.
Product Services Division is responsible for the evaluation of processed food product applications for product registration. Products being applied are categorized into Category I and Category I1. List of products under Category 1 are bakery and bakery products, nonalcoholic beverages and juices and other foods for general consumption while under Category 11 are bottled water, food supplement and food for infants and other foods serving special dietary requirements of consumers. Each of these categories has to comply with listed technical requirements. Recommendation for approval is based primarily on the conformance of the submitted technical documents with standards of BFAD, USFDA, and CODEX ALIMENTARIUS COMMISION and existing labeling regulations. Product Registration is mandatory for processed food products intended for export, import and locally processed food to be advertised. Locally processed food which are not advertised may not register the product, but the manufacturer should have the License to Operate as Food Manufacturer and the product must conform with the existing product standards and labeling regulations.
The Division issues Certificates of Product Registration based on Administrative Order No. 37 s. 1979 "Registration of Food and Food Products Intended for Import /Export with the Bureau of Food and Drugs. Issuance of certificates shall only be upon compliance with the requirements. The following are requirements the requesting party shall have to comply:
A valid License to Operate is a prerequisite for all of the certificates being issued by the Bureau of Food and Drugs wherein Current Good Manufacturing Practice (cGMP) is the basis for issuance.
The four Divisions of the Bureau of Food and Drugs responsible for the implementation of food safety measures have systems in place to carry out its mandate. Consumer confidence in imported/exported food is assured by stringent implementation of the pertinent provisions of R.A 3720 and Republic Act 7394.