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On May 3, 2023, the Philippine FDA released the draft document titled “New Rules and Regulations on the Authorizations Covering Food Business Operators and Processed Food, and Other Food Products Repealing Administrative Order 2014-0029”, aiming to repeal AO 2014-0029 and other related issuances in the licensing of food establishments and registration of food products, thus to address emerging concerns and to be abreast with internationally acceptable standards.
Major contents
Application scope
The proposed document covers all Food Business Operators (FBOs), as well as imported and locally produced, processed and prepackaged foods. However, it does not apply to certain food businesses, such as slaughterhouses, wet markets, and restaurants without prepackaging activities.
Guidelines for licensing of food establishments
All FDA-covered FBOs must secure a License to Operate (LTO) and comply with hygiene principles, standards, and laws for food quality and safety.
LTO is required before engaging in food-related activities. Only one licensed establishment is allowed at a given address or facility.
Changes in business information require prior notification and approval by FDA through amendment.
Revoked or cancelled LTO resulted from violations disallows reapplication under the same company/owner/business name for three years.
LTO has a validity period of two years for the initial license and five years for the renewal license, unless it is revoked.
Sticking additional information on labels is allowed for licensed food distributors.
Guidelines for registration of processed food products
All processed food products, food additives, food supplements, and bottled water must be registered with FDA before distribution, sale, or use.
Multiple packaging sizes or labels of a product can receive only one Certificate of Product Registration (CPR) if they meet specific conditions.
The respective distributor, trader, exporter, repacker, and manufacturer must secure a CPR for each imported and locally manufactured raw materials, ingredients, and food additives.
If a company has several plants in one or different cities/towns/provinces manufacturing the same product, each plant shall apply for separate registration of the product.
CPR is valid for five years for both initial and renewal, unless it is revoked within that period.
For medium and high-risk food products, including those for institutional use with standard of identity (e.g., infant formula, milk supplement, food supplement, FSMP, special dietary foods), Certificates of Analysis must be uploaded for the assessment of compliance with standards. These products must also meet chemical, microbiological, and nutritional requirements based on Codex standards, as well as national, and FDA regulations.
Attachments
Annex A - Definition of Terms: Notably, compared with the original version, three terms (commissary, consolidator, indentor) are newly introduced and one term (trader) is provided with amended definition.
Annex B - Processed Food Products Classification According to Microbiological Risk: Notably, prepared frozen meals are newly categorized into medium risk foods.
Annex C - Activities Allowed Under a Single License
Annex D - Requirements for Application of LTO
Annex E - Requirements for Application of CPR
Annex F - Requirements for Application of Import Permit for Samples
Annex G - Requirements for Application of Import Permit for Exhibits
Annex H - Affidavit for Exhibits
Annex I - Affidavit of Undertaking for Samples
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