Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 2014-0029)
The primary purpose is to establish rules and regulations on the licensing of food establishments and registration of processed food and other food products in the Philippines to ensure food safety and protect public health.
LTO is an authorization issued by the FDA to food establishments engaged in manufacturing, importing, exporting, distributing, trading, or repacking processed food before they can legally operate.
Manufacturers may engage in any activity satisfying the requirements including processing; packers/repackers can perform activities except processing; traders may engage in any activity except processing or packaging; distributors cannot process or package; and multiple facilities with different activities in a single address may have a single license.
Fresh or raw food at primary production stages under the Department of Agriculture, and businesses such as slaughterhouses, poultry dressing plants, fish ports, wet markets, supermarkets, school canteens, restaurants, catering establishments, water refilling stations, street food vendors under the purview of Local Government Units (LGUs) are excluded.
CPR is an authorization issued by the FDA for specific health products after evaluation and approval of registration requirements, allowing processed food products to be sold, distributed, or promoted.
Grounds include failure to submit required documents, failure to meet standards upon evaluation or inspection, failure to respond to notices, misrepresentations or withholding relevant data, and other analogous causes as determined by the FDA.
The FDA adopts a risk-based approach focusing on preventive strategies such as HACCP, GMP, and Good Distribution Practices, prioritizing high-risk establishments for inspection.
Yes, local manufacturers who import raw materials for their own use and further processing into registered products do not need to secure CPRs for individual ingredients if these are part of the FDA-registered product formulation.