Food Safety Act of 2013

Policy, objectives, and constitutional anchors

The State shall maintain a farm to fork food safety regulatory system that ensures a high level of food safety, promotes fair trade, and advances global competitiveness of Philippine foods and food products. Section 2.
The Act’s objectives include protecting the public from food-borne and water-borne illnesses and from unsanitary, unwholesome, misbranded or adulterated foods, enhancing confidence in the system, and achieving economic growth through fair trade and a sound regulatory foundation. Section 3.
The measures to attain these objectives include delineating and linking agency mandates; providing coordination and accountability; establishing hazard-addressing standards and control measures; strengthening the scientific basis; and upgrading capabilities of farmers, fisherfolk, industries, consumers, and government personnel. Section 3.
The Act directs food law toward a high level of food safety, protection of human life and health, and protection of consumer interests through fair practices. Section 6.

Definitions and key concepts

The Act defines “Advertising” as presenting facts/data/information to the public about food attributes/features/quality/availability to promote sale or distribution. Section 4(a).
The Act defines “Adulteration” to include numerous specific modes, including: poisonous or deleterious substances; exceeding maximum limits; filthy/putrid/decomposed substances; preparation/packing/holding under unsanitary conditions; product of diseased animals or animals that died otherwise than slaughter; contamination from containers with poisonous/deleterious substances; unauthorized radiation; omission/abstraction of valuable constituents; substitution, concealment, or inferiority/damage; adding/mixing/packing to increase bulk/weight or reduce strength; concealment practices; failure to follow current acceptable manufacturing practice; and use of expired ingredients. Section 4(b).
The Act defines “Authorization” as permission embodied in a document issued by a regulatory agency for food business operations across specified stages (primary production, post harvest handling, distribution, processing, manufacture, importation, exportation, sale/offer for sale/distribution/transfer/preparation for human consumption), taking forms such as permit, license, certificate of registration, certificate of compliance or exemption, or similar documents. Section 4(c).
The Act defines “Food Safety Regulatory Agencies (FSRAs)” as national government agencies under DA and DOH, specifically listing: DA agencies (BAI, NMIS, BFAR, BPI, FPA, PCA, SRA, NFA) and DOH agencies (FDA, Center for Food Regulation and Research, Bureau of Quarantine). Section 4(o).
The Act defines “Food business operator” as a person engaged in the food business, including agents, responsible for ensuring compliance with the Act for food under the operator’s control. Section 4(k).
The Act defines “Food hygiene” (hygiene) as measures and conditions to control hazards that could lead to food-borne illnesses and ensure fitness for consumption of food of plant or animal origin for its intended use. Section 4(l).
The Act defines “Food safety” as assurance that food will not cause harm to the consumer when prepared or eaten according to intended use. Section 4(n).
The Act defines core regulatory and scientific terms including Control measure, Crisis management, Food, Feed, Food-borne illnesses, Food law, Food supply chain, GAP, GMP, Good hygienic practices, HACCP, Hazard, Inspection, Label, MSME, Misbranding, Official control, Person, Post harvest stages, Primary production, Processing, Risk, Risk analysis (risk assessment/risk management/risk communication), Risk assessment/management/communication, Food safety standards, Traceability, Monitoring. Section 4.

Food safety standards: requirements and principles

The Act requires food safety guidelines when determining whether food is unsafe, considering normal use conditions; normal conditions at each supply chain stage; the health of plants/animals; effects of feeds/crop protection chemicals/other inputs; and information provided to consumers including labeling. Section 5(a).
The Act provides that whether food is injurious to health shall consider effects on subsequent generations; cumulative effects; and health sensitivities of a specific consumer category where food is intended for that category. Section 5(b).
The Act provides that whether food is unfit for human consumption shall consider unacceptability for intended use due to contamination by extraneous matter or through putrefaction, deterioration, or decay. Section 5(c).
The Act creates a batch-based presumption: where unsafe food is part of a batch/lot/consignment of the same class or description, all food in that batch/lot/consignment is presumed unsafe. Section 5(d).
The Act provides that food complying with specific national food safety law/regulations is deemed safe in aspects covered by those rules; imported food declared unsafe by the competent authority of the exporting country after entry must be withdrawn from the market and distribution channels. Section 5(e).
The Act clarifies that compliance with specific standards for a specific food does not prevent competent authorities from restricting market entry or requiring withdrawal where there is reason to suspect food safety risks. Section 5(f).
The Act mandates science-based risk analysis guidance: risk-based development of legislation/standards and official control activities; independent/objective/transparent risk assessment using sound scientific evidence; risk management considering local conditions/enforcement/cost; risk communication transparency and communication of risks to farmers/fisherfolk/operators and affected sectors; and encouraging food business operators to implement HACCP-based systems. Section 7.
The Act directs food law to prevent adulteration, misbranding, fraudulent practices, and misleading practices, and to prevent misrepresentation in labeling/false advertising including presentation and packaging arrangements, materials, display setting, and product descriptions. Section 8.
The Act requires the DA and DOH to set mandatory food safety standards, guided by science, risk analysis, expert advice, other countries’ standards, Philippine National Standards (PNS), and Codex Alimentarius Commission standards where applicable. Section 9(a).
The Act requires adoption of Codex standards except when in conflict with what is necessary to protect consumers and when scientific justification exists. Section 9(b).
The Act designates the current National Codex Organization (NCO) as the body for country participation at Codex and Codex incorporation; it further requires the DA and DOH to designate a third level officer as coordinator for Codex activities for their respective departments and to financially support Codex participation. Section 9(c)-(d).
The Act establishes precautionary measures: when available relevant information is insufficient to show a type of food/food product does not pose a risk, precautionary measures must be adopted; those measures remain enforced pending submission of additional scientific information and must not be more restrictive to trade than required and must be proportionate to protection level. Section 10.
The Act requires transparency through public consultation during preparation/evaluation/revision of food legislation (open/transparent/direct or through representative bodies unless urgency prevents it) and requires informing the general public when food is suspected to pose a risk to human health about nature of risk, affected foods/types, and necessary preventive/reducing/measures. Section 11.

Import, export, and trade compliance duties

Foods imported, produced, processed, and distributed for domestic and export markets must comply with requirements on import equivalence and inspection, and exported foods must comply with national and importing-country regulations. Section 12.
Food to be imported must come from countries with an equivalent food safety regulatory system and must comply with international agreements the Philippines is a party to. Section 12(b).
Imported foods must undergo cargo inspection and clearance by the DA and DOH at the first port of entry to determine compliance with national regulations. Section 12(b).
Cargo food safety inspection must always occur prior to tariff and other charges assessment by the Bureau of Customs (BOC). Section 12(b).
The BOC and the Association of International Shipping Lines (AISL) must provide the DA and DOH documents such as the Inward Foreign Manifest of Arriving Vessels to identify shipments requiring food safety inspection. Section 12(b).
Shipments not complying with national regulations must be disposed according to DA and DOH policies. Section 12(b).
Exported foods must at all times comply with national regulations and the regulations of the importing country. Section 12(c).
Returned shipments must undergo border inspection clearance using the rule on first port of entry inspection. Section 12(c).

Responsibilities across the food supply chain

Food business operators must ensure that food satisfies applicable requirements of food law relevant to their activities and that control systems exist to prevent, eliminate, or reduce risks to consumers. Section 13.
Food business operators must know specific requirements and applicable procedures, adopt and apply good practices, and receive assistance for micro and small industries to adopt such practices. Section 14(a).
If an operator considers or has reason to believe that food is not safe or not compliant, the operator must immediately initiate procedures to withdraw the food and must inform the regulatory authority. Section 14(b).
Operators must allow inspection and collaborate with regulatory authorities to avoid risks from foods they supplied. Section 14(c).
If unsafe or noncompliant food may have reached consumers, the operator must effectively and accurately inform consumers of the withdrawal reason and recall the same from the market when necessary. Section 14(d).
Government responsibilities are allocated among the DA, DOH, DILG, and LGUs according to supply chain stage and type of establishments:
- The DA is responsible for food safety in primary production and post harvest stages, and for locally produced or imported foods in this category. Section 15(a).
- The DOH is responsible for safety of processed and prepackaged foods and foods locally produced or imported under this category, including monitoring and epidemiological studies on food-borne illnesses. Section 15(b).
- LGUs are responsible for food safety in food businesses such as slaughterhouses, dressing plants, fish ports, wet markets, supermarkets, school canteens, restaurants, catering, and water refilling stations; LGUs also cover street food sale including ambulant vending. Section 15(c).
- The DILG, in collaboration with DA and DOH and other agencies, supervises enforcement of food safety and sanitary rules and inspection/compliance of establishments within its territorial jurisdiction. Section 15(d).
- LGUs may be called upon by DOH and DA to assist implementation of food laws and future relevant regulations. Section 15(e).
- DA and DOH must capacitate LGUs and provide technical assistance, including training DILG and LGUs and periodically assessing training effectiveness with coordination with DILG. Section 15(f).
- DA and DOH, cooperating with LGUs, must monitor the presence of biological, chemical, and physical contaminants in food to determine nature and sources of hazards. Section 15(g).
DA responsibilities include developing and enforcing standards and regulations for primary production and post harvest stages, monitoring and ensuring compliance by farmers/fisherfolk/operators, ensuring DA agencies’ fresh plant/animal/fisheries/aquaculture mandates are clearly defined, and monitoring contamination and formulating measures to address incidents. Section 16.
Specific DA agencies and their covered food categories must be followed:
- BAI (animals including eggs and honey), NDA (milk), NMIS (meats), BFAR (fresh fish and other seafood including aquaculture), BPI (plant foods), FPA (pesticides and fertilizers), PCA (fresh coconut), SRA (sugar cane production and marketing), NFA (rice, corn, and other grains). Section 16(a)-(i).
The BAFPS must develop food safety standards including those for organic agriculture and must establish mechanisms for science-based standards development using expertise from FSRAs, other government agencies, academe, and private sector. Section 16.
The Food Development Center (FDC) of the NFA must provide scientific support in testing, research, and training. Section 16.
When necessary and when funds allow, food safety units may be created within the stated DA agencies, using necessary personnel drawn from existing DA manpower. Section 16.
DOH responsibilities include ensuring safety of food processing and packaging activities; the FDA Center for Food Regulation and Research implementing a performance-based food safety control management system including standards/regulations development, post-market monitoring, enforcement of HACCP and other risk-based controls, Codex participation, stakeholder risk communication/exchange, laboratory establishment and strengthening, hazard database and food-borne illness database from epidemiological data, strengthening R&D on standards, and certification of food safety inspectors. Section 18(a)-(b).
The Bureau of Quarantine must provide sanitation and ensure food safety at domestic and international ports and airports of entry, including in-flight catering, food service establishments, sea vessels, and aircraft, as provided in implementing rules under Republic Act No. 9271 and Presidential Decree No. 856 (Code on Sanitation of the Philippines). Section 18(c).
DOH epidemiological study and risk assessment roles are assigned to: NEC, RITM, and NCDPC for monitoring studies on food-borne illnesses and documentation for risk-based policy formulation, with food safety risk assessment bodies established for this purpose. Section 18(d).
The National Center for Health Promotion must advocate food safety awareness, information, and education to the public. Section 18(e).
NCDPC must strategize actions to ensure food safety, reduce contamination and food-borne diseases, address double burden of micronutrient deficiencies and noncommunicable diseases, and regularly evaluate progress. Section 18(f).
DOH and FDA must be strengthened through food safety functional divisions, incremental staffing of food safety officers and experts, and funding including fees collected from services. Section 18(g).
DILG and LGUs must enforce the Code on Sanitation of the Philippines (Presidential Decree No. 856), food safety standards, and food safety regulations where food is produced/processed/prepared/sold within territorial jurisdiction, including sanitation (public markets, slaughterhouses, micro and small processing, public eating places), codes of practice for production/post harvest handling/processing/hygiene, safe use of additives/processing aids/sanitation chemicals, and proper labeling of prepackaged foods. Section 19(a).
DILG supports DOH and DA in collection/documentation of food-borne illness data, monitoring, and research; DILG and LGUs participate in trainings, standards development, and other activities by DA/DOH/national agencies. Section 19(b)-(c).

Food Safety Regulation Coordinating Board (FSRCB)

The Act creates a Food Safety Regulation Coordinating Board (FSRCB) to monitor and coordinate performance and implementation of DA, DOH, DILG, and LGUs’ mandates in food safety regulation. Section 20(a).
The Board identifies the responsible enforcement agency when jurisdiction overlaps. Section 20(b).
The Board coordinates crisis management and planning during food safety emergencies and establishes policies and procedures for coordination among agencies. Section 20(c)-(d).
The Board continuously evaluates effectiveness of enforcement and research/training programs and regularly submits reports to Congressional Committees on Health, Agriculture and Food, and Trade and Industry. Section 20(e)-(f).
The Board may accept grants and donations from local and international sources. Section 20(g).
Within thirty (30) days from the Act’s effectivity, the DA, DOH, and DILG Secretaries must organize the Board:
- The Board is chaired by the DOH Secretary and co-chaired by the DA Secretary; the alternate chair for DOH is the FDA Director General; the alternate co-chair for DA is the Undersecretary for Policy and Planning, R&D and Regulations. Section 21(a).
- Members include: heads of DA/D0H food safety regulatory agencies, FDA Center Director, a DILG field operator of rank Director, heads of Leagues (of Barangays, Municipalities, Cities, Provinces), and representatives each from DTI and DOST of rank Director; other DOH agencies with food safety concerns join when deemed necessary by the DOH. Section 21(a).
- Within twelve (12) months, the Board must submit a manual of procedures containing rules for meetings and decision-making. Section 21(b).
- The Board has administrative and technical secretariat at DOH; DOH and DA establish functional divisions and organize personnel drawn from existing manpower. Section 21(c).
- Funds for organization, participation, secretariat, experts, and working group expenses to prepare the manual must be allocated by the concerned agencies. Section 21(d).
FSRAs of DA and DOH, coordinating with LGUs, are responsible for ensuring food safety at various stages within their specified mandates. Section 22.

Crisis management and rapid alert

The FSRCB must establish a rapid alert system for notification of direct or indirect risk to human health due to food. Section 23.
When serious risk to human health is evident, the Board (coordinating with DOH and DA FSRAs) must immediately adopt one or more emergency measures depending on the situation’s gravity:
- For food of national origin: suspension of distribution/use; laying down special conditions; and other interim measures. Section 24(a).
- For imported food from another country: suspension of imports from all or parts of the third country concerned (and, where applicable, transit country); special conditions for the food from all or part of the third country concerned; and other interim measures. Section 24(b).
The Board must prepare a general plan for crisis management, specifying situations representing direct or indirect risk to human health from food that cannot be prevented, eliminated, or reduced to an acceptable level (including radiation contamination of food and food shortage requiring coordinated action, and other crisis situations compromising food safety). Section 25.

Official controls, traceability, inspections, laboratories

Official controls must be established by each agency to verify compliance with food laws and regulations. Section 26.
Official controls are implemented through regulations prepared by FSRAs in accordance with Act principles. Section 26(a).
Official control frequency must be proportionate to severity and likelihood of occurrence of the food safety risks being controlled. Section 26(b).
Official controls must use appropriate techniques; be conducted by an adequate number of qualified and experienced personnel with adequate funds, facilities, and equipment. Section 26(c).
Personnel performing official controls must meet operational criteria and procedures ensuring impartiality and effectiveness, and must conduct controls at the highest competence and integrity while mindful of conflict of interest. Section 26(d)-(e).
Agencies must document policies/procedures for official controls in a manual of operations to ensure consistency, high quality, uniformity, predictability, and transparency. Section 26(f).
Official controls may be delegated to other competent bodies with conditions, coordination, oversight, and retained accountability by the regulatory agency. Section 26(g).
Agencies must receive necessary funding and technical support out of their existing budget to perform official controls under Act principles. Section 26(h).
Traceability must be established for foods at relevant stages (production, post harvest handling, processing, or distribution) when needed to ensure compliance, and must cover production inputs like feeds, food additives, ingredients, packaging materials, and other substances expected to be incorporated into food/food product. Section 27.
Food business operators must be able to identify: the person/company from whom they were supplied food; a food-producing animal; production chemicals (pesticides and drugs); and production/post harvest handling/processing inputs (feeds, additives, ingredients, packaging, or substances expected to be incorporated into food). Section 27(a).
Operators must establish and implement systems so the above information is available to regulatory authorities on demand. Section 27(b).
Operators must establish systems to identify other businesses to which products were supplied and make that information available to regulatory authorities on demand. Section 27(c).
Traceability during a food-borne disease outbreak must be established by the National Epidemiology Center (NEC) of the DOH. Section 27.
Appropriate authorizations must be developed and issued as permits/licenses/certificates of registration or compliance covering establishments and facilities engaged in production, post harvest handling, processing, packing, holding, or producing food for consumption in accordance with mandated issuances by regulatory agencies, with special derogations after risk assessment for geographical location and for micro, small and medium-sized food business operators and health products. Section 28.
Regular inspections must be conducted by FSRAs or delegated control bodies and must follow rules:
- Inspections must account for compliance with mandatory standards, HACCP implementation, good manufacturing practices, and other regulatory requirements. Section 29(a).
- Inspection frequency must be based on risk assessment; high-risk food/high-risk activities must be inspected more frequently. Section 29(b).
- Inspectors must have defined risk-based inspection skills and be regularly evaluated to verify continuing competence. Section 29(c).
- Procedures must ensure inspection results are interpreted uniformly. Section 29(d).
Food testing laboratories must be managed under rules:
- Food testing must be carried out by laboratories accredited in accordance with international standards; those not accredited must apply for accreditation within a specified period of time. Section 30(a).
- Testing must use internationally approved procedures/methods of analysis validated. Section 30(b).
- Laboratories must be organized and managed to prevent conflict of interest in testing. Section 30(c).
- Laboratories must be staffed with analysts with required expertise and professional competence. Section 30(d).
- FSRAs may recognize private testing laboratories accredited by the Philippine Accreditation Office (PAO) of the DTI to support testing needs. Section 30(e).

Training, consumer education, and funding

The Act requires regular skills training and instructional/educational activities for food business operators, food handlers, and government personnel:
- Operators, especially micro/small/medium enterprises, must be trained on regulatory requirements; personnel must be trained on HACCP, codes of good practice, and technologies enabling compliance. Section 31(a).
- Food handlers must undergo mandatory training on safe food handling and similar courses. Section 31(b).
- Government personnel must be trained on the scientific basis of the law and on conduct of official controls. Section 31(c).
FSRAs must identify training needs and the appropriate programs; mandatory training programs must be developed and implemented by accredited training providers. Section 31.
A consumer education program must be developed by the DA, DOH, and LGUs in partnership with the Department of Education, implemented by the latter. Section 32.
Funding must be provided for development and implementation of training and consumer education programs. Section 33.

Food-borne illness monitoring, surveillance, and research

The government must implement programs in support of risk analysis:
- An integrated food-borne disease monitoring system linking sources of contamination in collaboration with DOH-NEC and NCDPC; and
- Identification of hazards in the food supply chain and assessment of exposure levels to hazards. Section 34.
The government and academe must develop and implement a research program on cost-effective technologies and codes of practice to assist farmers, fisherfolk, micro/small/medium enterprises, and other stakeholders in complying with food safety regulations. Section 35.

Fees and cost recovery

The DA, the DOH, and the LGUs (where applicable) may collect fees for inspection of food products, production and processing facilities, issuance of import or export certificates, laboratory testing of food samples, and other fees deemed necessary. Section 36(a).
Fees must be based on an officially approved procedure estimating the cost of the activity and are subject to government accounting and auditing rules and regulations. Section 36(a).

Prohibited acts and penalties

It is unlawful to produce/handle/manufacture for sale/offer for sale/distribute in commerce/import into the Philippines any food not conforming to applicable food quality or safety standards promulgated under the Act. Section 37(a).
It is unlawful to produce/handle/manufacture for sale/offer for sale/distribute in commerce/import into the Philippines any food declared as banned by a rule promulgated under the Act. Section 37(b).
It is unlawful to refuse access to pertinent records or refuse entry to inspection officers of an FSRA. Section 37(c).
It is unlawful to fail to comply with an order related to notifications for recall of unsafe products. Section 37(d).
It is unlawful to adulterate, misbrand, mislabel, falsely advertise any food product that misleads consumers, and to carry out other acts contrary to good manufacturing practices. Section 37(e).
It is unlawful to operate a food business without the appropriate authorization. Section 37(f).
It is unlawful to connive with food business operators or food inspectors in a way that results in food safety risks to consumers. Section 37(g).
It is unlawful to violate the implementing rules and regulations of the Act. Section 37(h).
Penalties for violations follow conviction tiers:
- First conviction: fine of not less than PHP 50,000 but not more than PHP 100,000, and suspension of appropriate authorization for one (1) month. Section 38(a).
- Second conviction: fine of not less than PHP 100,000 but not more than PHP 200,000, and suspension for three (3) months. Section 38(b).
- Third conviction: fine of not less than PHP 200,000 but not more than PHP 300,000, and suspension for six (6) months. Section 38(c).
- For violation resulting in slight physical injury: fine of not less than PHP 200,000 but not more than PHP 300,000 and suspension for six (6) months; offender must also pay hospitalization and rehabilitation cost. Section 38(d).
- For violation resulting in less serious or serious physical injury: fine of not less than PHP 200,000 but not more than PHP 300,000 and suspension for one (1) year; offender must also pay hospitalization and rehabilitation cost. **Section