In the Philippines, the Department of Agriculture (DA) regulates imported fresh and primary agricultural food products, while the Department of Health (DOH) governs processed foods. The Philippines Food and Drug Administration (PFDA), an attached agency under the DOH, oversees the manufacturing, importation, exportation, distribution, sale, transfer, promotion, advertising, sponsorship and testing of food and food/dietary supplements. It also conducts research on food safety and efficacy, and develops standards pertaining to food safety and quality.
Official Website of the Regulatory Authority: https://www.fda.gov.ph/
Certificate of Free Sale issued by the competent government authority of the exporting country.
A：The cost of applying for the LTO varies according to the application, the general food distributor (importer, exporter, wholesaler) is 8,080.00 (valid for 2 years) for the first application, and is renewed to 20,200.00 (valid for 5 years).
A：According to RA 9711 and A.O. 2014-0029, manufacture and/or distribution (i.e., import, export and/or wholesale local distribution) of all processed foods and foodstuffs for trade and/or repackaging, including food additives, food supplements and bottled water, A certificate of product registration is required prior to sale, offer for sale or use, distribution or supply, and other marketing and promotional activities.
A：Only the initial application for a food supplement is required to submit a sample consistent with the registration application.
A：The same requirements as those set out in Executive Order 2014-0029 for traditional foods, but with the addition of stability studies, Certificate of Finished Product Analysis (COA), and safety data, if applicable (e.g. LD-50 toxicity test). It is suitable for food supplements containing herbs not listed in any official pharmacopoeia and substances for which safe levels have not been determined.
A：Stability data for shelf life studies should include: Conclusion parameters and method declaration Product name, batch number, production date, analysis date, physical and chemical aspects of tabular data and results as well as the names and signatures of QA analysts and QA managers. PFDA accepts the results of actual and accelerated shelf-life studies. If a shelf-life study is ongoing, test results of at least 6 months are required.
A：If the raw material is a specific additive, reference can be made to the FAO/WHO JECFA specification on the limits of heavy metals. Also refer to the Codex Committee on Food Chemistry for raw material specifications for heavy metal limits.
A：A request for modification to CPR (Change/Add label design) is required. You will need to upload a note explaining the changes made to the label and the revised label. An administrative fee of 210.00 Pesos must be paid.
A：Agreed. Stickers are allowed, provided they are durable and not easy to tear off. The label information shall be printed on the remedial sticker of the label itself and will only be allowed to be used for 6 months from the date of approval.