Philippines to Amend Regulation on the Licensing of Food Business Operators and Registration of Processed Food

On November 18, 2024, the Philippines FDA announced a public consultation on a draft regulation entitled "New Rules and Regulations Covering the Licensing of Food Business Operators and Registration of Processed Food, and Other Authorizations Repealing Administrative Order 2014-0029 and For Other Purposes". All comments can be sent to [email protected] by December 9. Major details revealed by the draft are as follows:

Background 

Administrative Order (AO) No. 2014-0029 entitled "Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and Other Food Products, and For Other Purposes" was issued in 2014, aiming to effectively strengthen the food control system and implement risk-based food control strategies by setting rules and regulations for the issuance of License to Operate (LTO) and Certificate of Product Registration (CPR) to food establishments. With the development of the e-registration system, rules and regulations on the licensing of establishments and registration of food products need to be updated for facilitating trade in ASEAN and protecting consumer health.

Objective 

The proposed new draft was promulgated under three core objectives:

1. To update the specific guidelines of the licensing of Food Business Operators (FBOs);

2. To update the process and requirements in the registration of processed food products;

3. To align the product category and numbering system with the Codex Alimentarius Food Category System in the electronic registration.

Notable changes of the licensing of FBOs  

• The new draft provides more specific guidelines for food establishments in different roles, including manufacturer & repacker, trader, and distributor, so as to provide more targeted assistance in obtaining the LTO.

• It aligns the requirements for the issuance of LTO based on "Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of Covered Health Product Establishments with the Food and Drug Administration Repealing for the Purpose Administrative Order No. 2020- 0017", which is another draft regulation waiting for the final promulgation.

• The validity of LTO is changed as follows:

Notable changes of processed food registration 

• "From the same manufacturer and manufacturing site" becomes a new condition for exempting repeated registration of a product with multiple packaging sizes.

• In addition to the existing Codex standards and FDA regulations, Philippine National Standards (PNSs) shall also be followed as applicable.

• The registration of processed food is based on the food classification in the Philippines. Annex C of this draft provides an updated food classification.                                             

Part of changes made to the food classification table

• The new draft aligns the registration requirements for CPR with FDA Circular No. 2020-033.

• For the registration of food/dietary supplements, the draft provides more specific guidelines for stakeholders in preparing required documents. Besides, the requirement to submit actual samples of food/dietary supplements is removed.

• The validity of CPR is changed as follows:

Other notable changes 

The old regulation states general information on the grounds for the disapproval of both LTO and CPR applications. The draft further provides specific reasons for the disapproval of each application separately. Similarly, the inspection and supervision requirements for LTO and CPR, which were previously grouped together in the old regulation, are now separately detailed in the draft.