QuestionsQuestions (TRNP PARK RULES 01-08)
The text cites RA 10611 (Food Safety Act of 2013) as the mandate for FDA (via CFRR) to ensure the safety of food processing and product packaging activities and to issue authorizations (licenses/permits/registrations) covering establishments engaged in production, distribution, and related activities.
The objectives are: (1) adopt risk-based classification of food establishments and food products, (2) issue a License to Operate (LTO) for food establishments engaged in manufacture/processing and distribution-related activities, and (3) issue a Certificate of Product Registration (CPR) before processed food products are sold/used/distributed/promoted.
It covers food establishments engaged in manufacture and/or distribution (import/export/wholesale) trade and/or repacking of processed food and food products, including facilities involved in packing, holding, producing, and distribution stages within its scope.
It does not cover fresh or raw foods in primary production and post-harvest stages under DA. It also excludes activities such as slaughterhouses, poultry dressing plants, fish ports, wet markets, supermarkets, school canteens, restaurants, catering, water refilling stations, street food sale, including ambulant vending, as these are under LGUs.
The establishment must first apply for the LTO initial application. After securing the LTO, it should file the CPR initial application.
Authorization is permission embodied in a document granted by a regulatory agency to a natural or juridical person for food business operations. It may be a permit, license, certificate of registration, certificate of compliance, certificate of exemption, or similar document.
LTO is the FDA authorization to operate/establish a food business. All food establishments covered by the AO must secure LTO before manufacturing, importing, exporting, selling, offering for sale, distributing, transferring, and related activities (including promotion/advertising/sponsorship where applicable).
FDA adopts a risk-based approach to establish risk categorization of establishments and products. High-risk establishments are prioritized for inspection, and inspections/COCs depend on risk level and the complexity of production (including HACCP/GMP requirements).
A manufacturer may engage in any activity it can satisfy for, including processing. A packer/repacker may engage in any activity it can satisfy except processing. A trader may engage in any activity it can satisfy except processing or packaging.
A distributor is not allowed to engage in processing and/or packaging.
An initial LTO is valid for two (2) years. A renewed LTO is valid for five (5) years, unless revoked.
The CPR validity is 2 years minimum to 5 years maximum for initial issuance, and 5 years for renewal, provided the holder conforms with standards and labeling regulations.
For multiple packaging sizes: same brand name, same product name/variant, same formulation/ingredients (same order of proportion), and same label information except net weight. For multiple artwork design/recipes: same brand name, same product name/variant, same formulation/ingredients (same order of proportion), and same label information except net weight.
The company must secure FDA permission through notification for additional label design or other label changes prior to use in advertisement, promotion, and commercial distribution.
FDA issues a Letter of Denial. The applicant has up to six (6) months to comply and file for re-application.
Grounds include: failure to submit complete requirements or correct deficiencies; failure to meet standards/requirements on document evaluation or inspection; failure to respond to deficiency notices or submit documents on time; misrepresentations/false entries/withholding relevant data; and other analogous grounds determined by FDA.
FDA may inspect at any time (routine/spot check/post-market surveillance), and upon validation of non-compliance to safety/quality standards, it may revoke the LTO and CPR immediately following due process.
Within six (6) months after signing, FDA must streamline the national licensing and registration process with other government agencies to ensure increased protection of consumers and availability of processed food in the market.