QuestionsQuestions (Republic Act No. 10611)
RA 10611 declares it is the State’s policy to maintain a “farm to fork” food safety regulatory system that ensures a high level of food safety, promotes fair trade, and advances global competitiveness. Its objectives include: (1) protecting the public from food-borne and water-borne illnesses and unsafe foods; (2) enhancing industry and consumer confidence in the regulatory system; and (3) achieving economic growth by promoting fair trade and a sound regulatory foundation for domestic and international trade, through measures like delineating agency mandates, coordinating enforcement, establishing standards, strengthening science-based regulation, and upgrading capabilities of stakeholders.
“Food safety” is the assurance that food will not cause harm to the consumer when prepared or eaten according to its intended use. “Food business” refers to any undertaking (public or private) that carries out activities related to any stage of the food supply chain. “Food business operator” is a person engaged in the food business (including agents) who is responsible for ensuring requirements of the Act are met by the food business under the operator’s control.
Adulteration is an act leading to the production of food that: (1) contains poisonous or deleterious substances that may injure public health; (2) contains added poisonous/deleterious substances exceeding maximum limits or GMP standards; (3) contains filthy/putrid/decomposed matter unfit for human consumption; (4) was prepared/packed/held under unsanitary conditions; (5) is from diseased animals or animals that died otherwise than slaughter; (6) is in containers with poisonous/deleterious substances; (7) was intentionally subjected to radiation without conformity to regulation; (8) has omitted/abstracted valuable constituents, substituted ingredients, or mixed/packed with substances to increase bulk/weight or mislead appearance/quality; (9) not prepared per acceptable manufacturing practice; or (10) uses expired ingredients.
For “unsafe,” consider normal conditions of use, conditions maintained at each stage of primary production/processing/handling/storage/distribution, health of plants/animals, effects of feeds/crop protection chemicals/inputs, and information provided to consumers (including labels). For “injurious to health,” consider probable immediate/short-term/long-term effects including cumulative effects and particular sensitivities of intended consumer categories. For “unfit,” consider unacceptability due to contamination by extraneous matter or putrefaction/deterioration/decay according to intended use.
If unsafe food is part of a batch, lot, or consignment of the same class or description, it is presumed that all food in that batch, lot, or consignment is also unsafe.
Food compliant with specific national law or regulations is deemed safe insofar as the aspects covered are concerned. However, imported food declared unsafe by the competent authority of the exporting country after entry into the Philippines must be withdrawn from the market and distribution channels.
RA 10611 mandates that risk assessment and regulation be based on science and risk analysis (risk assessment, risk management, and risk communication), using sound scientific evidence and being independent/objective/transparent. It also encourages food business operators to implement HACCP-based systems for food safety assurance.
When relevant information is insufficient to show a food type poses no risk, precautionary measures must be adopted. Once issued, measures remain enforced pending additional scientific information; they must not be more restrictive to trade than required and should be proportionate to the level of consumer protection needed.
Under the DA: Bureau of Animal Industry (BAI), National Meat Inspection Service (NMIS), Bureau of Fisheries and Aquatic Resources (BFAR), Bureau of Plant Industry (BPI), Fertilizer and Pesticide Authority (FPA), Philippine Coconut Authority (PCA), Sugar Regulatory Administration (SRA), and National Food Authority (NFA). Under the DOH: Food and Drug Administration (FDA), Center for Food Regulation and Research, and Bureau of Quarantine (BOQ).
DA: food safety in primary production and post-harvest stages and foods locally produced or imported in this category. DOH: safety of processed and prepackaged foods, locally produced or imported in this category, plus monitoring/epidemiological studies on food-borne illnesses. LGUs: enforcement for food businesses like slaughterhouses, wet markets, supermarkets, restaurants/catering/school canteens, and water refilling stations; also street food sales and ambulant vending.
FSRCB is created to coordinate and monitor food safety regulation performance and mandates across DA, DOH, DILG, and LGUs. It identifies the correct enforcing agency where jurisdictions overlap; coordinates crisis management and planning; establishes coordination policies/procedures; evaluates effectiveness of enforcement, research, and training; submits regular reports to relevant Congressional committees; and may accept grants/donations.
The Board is chaired by the DOH Secretary and co-chaired by the DA Secretary. Alternate chair for DOH is the FDA Director General, and alternate co-chair for DA is the Undersecretary for Policy and Planning, R&D and Regulations. Members include heads of DA food safety regulatory agencies, the Director of the FDA Center for Food Regulation and Research, a DILG field operator (rank of Director), heads of leagues (barangays, municipalities, cities, provinces), and representatives from DTI and DOST (rank of Director). Other DOH agencies with food safety concerns may join when deemed necessary by DOH.
Traceability is required for foods at relevant stages (production, post-harvest handling, processing, distribution) when needed to ensure compliance, including production inputs like feeds, additives, ingredients, packaging materials, and substances expected to be incorporated. Food business operators must identify suppliers and related information and provide systems so information is available to regulators on demand, including identification of other businesses supplied. In case of a food-borne disease outbreak, traceability is established by the DOH’s National Epidemiology Center (NEC).
RA 10611 requires appropriate authorizations (permit/license/certificate of registration or compliance, etc.) covering establishments and facilities engaged in production, post-harvest handling, processing, packing/repacking, holding, or producing food, with special derogations for micro, small, and medium enterprises based on geographical location and risk assessment. It also mandates regular inspections by FSRAs or delegated bodies, with inspection frequency based on risk; inspections must consider standards, HACCP, GMP, and other regulatory requirements, and inspectors must have defined skills and be periodically evaluated.
Food testing must be carried out by laboratories accredited under international standards; those not currently accredited must apply within a specified period. Testing must use internationally approved and validated methods. Laboratories must prevent conflict of interest, be staffed with analysts having required expertise and competence, and FSRAs may recognize private laboratories accredited by the Philippine Accreditation Office (PAO) of the DTI.
RA 10611 requires regular skills training/education for food business operators (especially MSMEs), food handlers (mandatory safe food handling training), and government personnel (scientific basis and official controls). Mandatory training programs must be developed/implemented by accredited training providers. For consumer education, DA, DOH, and LGUs must develop a program in partnership with the Department of Education, carried out by DepEd.
Prohibited acts include: producing/handling/manufacturing/importing foods not conforming to standards or banned foods; refusing access to records/entry of inspectors; failing to comply with recall-related orders; adulteration/misbranding/mislabeling/false advertising or acts contrary to GMP; operating without required authorization; conniving with operators or inspectors resulting in risks; and violating IRR. Penalties vary by number of convictions and severity, including fines, suspension of authorization, and in serious outcomes (slight injury, less serious/serious injury, death) imprisonment, higher fines, and possible permanent revocation. The Act also provides special rules for unauthorized offenders, and additional sanctions for government personnel, naturalized citizens, aliens, corporate officers/directors, and foreign juridical persons.