Food Safety Act of 2013 Overview

Key terms and core food safety concepts

Section 4 defines food as any substance or product, whether processed, partially processed or unprocessed, intended for human consumption, including drinks, chewing gum, water, and other intentionally incorporated substances.
Section 4 defines food business as any undertaking, public or private, carrying out activities related to, or any stages of, the food supply chain.
Section 4 defines food business operator as the person engaged in the food business (including agents) responsible for ensuring compliance with the Act by the food business under the operator’s control.
Section 4 defines food safety as assurance that food will not cause harm to the consumer when prepared or eaten according to intended use.
Section 4 defines Food Safety Regulatory Agencies (FSRAs) as national government agencies under DA and DOH as enumerated in Section 4 (including DA bureaus/agencies and DOH bodies), and Section 4 defines food safety officers as properly qualified and trained officers appointed by agencies or LGUs.
Section 4 defines food safety regulatory system as regulations, standards, inspection, testing, data collection, monitoring, and other activities carried out by FSRAs and LGUs to control food safety risks.
Section 4 defines Official control as controls and control activities by regulatory agencies, including monitoring, inspections, verifications, audits, sampling and testing, and recall of defective products.
Section 4 defines Risk analysis as a process of risk assessment, risk management, and risk communication, and defines HACCP as a science-based system identifying, evaluating and controlling significant hazards at critical control points.

Standards, risk analysis, and market rules

Section 5 establishes food safety requirements and provides criteria for when food is unsafe, injurious to health, or unfit for human consumption, considering normal conditions of use and conditions at each supply stage, health status of plants/animals, effects of feeds/crop protection chemicals/inputs, consumer information, probable effects (including cumulative and intergenerational), and contamination, putrefaction, deterioration or decay.
Section 5 provides a presumption: when unsafe food is part of a batch, lot or consignment of the same class or description, all food in that hatch, lot or consignment is presumed unsafe.
Section 5 provides that foods complying with specific national food safety laws/regulations are deemed safe insofar as the covered aspects are concerned, but imported food declared unsafe by the exporting country’s competent authority after entry must be withdrawn from market and distribution channels.
Section 5 allows authorities to take measures or impose restrictions or require withdrawal even if a product complies with specific standards when there is reason to suspect food safety related risks.
Section 7 requires science-based risk analysis to guide development of legislation/standards and conduct of inspection and official control activities, requiring independence, objectivity, and transparency for risk assessment based on sound scientific evidence; risk management must account for local conditions and enforcement/cost; risk communication must be transparent among risk assessors/managers and must also communicate food safety risks to farmers, fisherfolk, food business operators and affected sectors.
Section 7 encourages food business operators to implement a HACCP-based system.
Section 10 mandates precautionary measures when relevant information is insufficient to show a type of food does not pose a risk to consumer health; the measure must remain enforced pending additional scientific information and must be no more restrictive than required and proportionate to the required level of protection.
Section 11 requires public consultation during preparation, evaluation and revision of food legislation to be open, transparent and direct (or through representative bodies) unless urgency prevents it, and requires authorities to inform the general public when food is suspected to pose a risk to human health.
Section 12 requires foods imported for domestic and export markets to come from countries with an equivalent food safety regulatory system and to comply with international agreements to which the Philippines is a party.
Section 12 requires imported foods to undergo cargo inspection and clearance by the DA and DOH at the first port of entry to determine compliance with national regulations, and requires that inspection to always take place prior to assessment for tariff and other charges by the Bureau of Customs (BOC).
Section 12 requires BOC and the Association of International Shipping Lines (AISL) to provide DA and DOH documents (including the Inward Foreign Manifest of Arriving Vessels) to identify shipments requiring food safety inspection, and requires disposition of shipments that do not comply with national regulations according to DA/DOH policies.
Section 12 requires exported foods to at all times comply with national regulations and the importing country’s regulations, and requires returned shipments to undergo border inspection clearance under Section 12(b).

Responsibilities across government agencies

Section 13 requires food business operators to ensure their food satisfies requirements of food law relevant to their activities in the food supply chain and to put control systems in place to prevent, eliminate or reduce risks to consumers.
Section 14 requires food business operators to: (a) know applicable food law requirements and procedures; (b) adopt and apply good practices (with assistance to micro and small industries to adopt such practices); (c) immediately initiate withdrawal procedures and inform regulatory authorities if the operator considers or has reason to believe food is not safe or not compliant; (d) allow inspections and collaborate to avoid risks; and (e) if unsafe/noncompliant product may have reached consumers, effectively and accurately inform consumers and recall if necessary.
Section 15 assigns principal government responsibilities among DA, DOH, DILG, and LGUs for distinct stages and types of activities: DA for primary production and post harvest stages; DOH for processed and prepackaged foods plus monitoring and epidemiological studies; LGUs for food businesses within territorial jurisdiction including slaughterhouses, dressing plants, fish ports, wet markets, supermarkets, school canteens, restaurants, catering, and water refilling stations, including street food sale and ambulant vending; and DILG (with DA/DOH and other agencies) for supervision of enforcement of food safety and sanitary rules and inspection/compliance.
Section 15 requires DA and DOH to capacitate LGUs and provide technical assistance, including training for DILG and LGUs and periodic assessment of effectiveness in coordination with DILG.
Section 16 requires DA to develop and enforce standards and regulations for primary production and post harvest stages, ensure farmers/fisherfolk and food operators comply, and ensure DA agencies’ food safety regulatory mandates are clearly defined; it lists DA agencies and their covered areas (including BAI, NDA, NMIS, BFAR, BPI, FPA, PCA, SRA, and NFA).
Section 16 requires the Bureau of Agriculture and Fisheries Product Standards (BAFPS) to develop food safety standards including organic agriculture and to establish mechanisms for science-based standards using experts from FSRAs, other government agencies, academe and private sector; it also assigns scientific support for testing/research/training to the Food Development Center (FDC) of the NFA.
Section 16 directs DA, in coordination with other agencies, to monitor contaminants in foods of plant, animal and fishery origin and formulate and implement measures to address contamination incidents.
Section 18 assigns DOH responsibility to ensure safety of food processing and product packaging, and it requires the FDA Center for Food Regulation and Research to implement a performance-based food safety control management system covering: development of standards/regulations; post-market monitoring; enforcement of HACCP and other risk-based controls; strong participation in Codex and international standard-setting; risk communication and stakeholder exchange; food safety laboratory establishment and capability strengthening; databases of food safety hazards and food-borne illness from epidemiological data; strengthening R&D on product/safety/quality standards; and certification of food safety inspectors.
Section 18 requires the Bureau of Quarantine (BOQ) to provide sanitation and ensure food safety in its ports/airports of entry responsibilities including in-flight catering, food service establishments, sea vessels and aircraft as provided in IRR of Republic Act No. 9271 and Presidential Decree No. 856 (Code on Sanitation of the Philippines).
Section 18 assigns epidemiological monitoring for food-borne illnesses to the National Epidemiology Center (NEC), RITM, and NCDPC, and directs establishment of food safety risk assessment bodies for this purpose; it also assigns NCHP to advocate food safety awareness to the public and requires NCDPC to strategize actions to ensure food safety, reduce contamination risk and food-borne diseases, address double burden (micronutrient deficiencies and noncommunicable diseases), and regularly evaluate progress.
Section 18 requires strengthening of DOH and the FDA Center for Food Regulation and Research by establishing food safety functional divisions, incrementally staffing food safety officers and experts, and providing funds including fees collected from services.
Section 19 requires LGUs to enforce the Code on Sanitation (Presidential Decree No. 856), food safety standards and regulations where food is produced, processed, prepared and/or sold in their territorial jurisdiction, including sanitation in public markets, slaughterhouses, micro and small food processing establishments and public eating places; codes of practice; safe use of food additives/processing aids/sanitation chemicals; and proper labeling of prepackaged foods.
Section 19 requires DILG to support DOH and DA in collecting and documenting food-borne illness data, monitoring and research, and requires both DILG and LGUs to participate in training, standards development, and other activities.

Food Safety Regulation Coordinating Board and crisis control

Section 20 creates the Food Safety Regulation Coordinating Board (FSRCB) with powers to: monitor and coordinate performance of DA, DOH, DILG and LGUs; identify the responsible enforcement agency when jurisdictions overlap; coordinate crisis management and planning; establish coordination policies and procedures; continuously evaluate enforcement effectiveness and research/training programs; regularly submit reports to Congressional Committees on Health, Agriculture and Food, and Trade and Industry; and accept grants and donations.
Section 21 requires the Secretaries of DA, DOH, and DILG to organize the FSRCB within thirty (30) days from Act effectivity, with the Board chaired by the DOH Secretary and co-chaired by the DA Secretary; it sets alternate chair and alternate co-chair and specifies membership including heads of DA/DOH food safety regulatory agencies, FDA Center director general, a DILG field operator rank director, Leagues of Barangays/Municipalities/Cities/Provinces heads, and representatives from DTI and DOST.
Section 21 requires the Board, within twelve (12) months from Act effectivity, to submit a manual of procedures for meeting conduct and decision-making.
Section 21 requires FSRCB assistance by an administrative and technical secretariat at DOH, and requires both DOH and DA to establish functional divisions and organize personnel for Board operations, funded from existing manpower and agency budgets.
Section 22 requires DA and DOH FSRAs, in coordination with LGUs, to ensure food safety across supply chain stages within their mandates.
Section 23 requires FSRCB to establish a rapid alert system to notify of direct or indirect risk to human health due to food.
Section 24 requires FSRCB, coordinating with DOH and DA FSRAs, to immediately adopt one or more emergency measures when food is likely to constitute serious risk to human health, depending on gravity and origin:
- For food of national origin: (1) suspend distribution or use; (2) lay down special conditions; and (3) adopt any other appropriate interim measures.
- For food from another country: (1) suspend imports from all or parts of the third country concerned (and, where applicable, the third country of transit); (2) impose special conditions for the food from all or part of the third country concerned; and (3) adopt any other appropriate interim measures.
Section 25 requires the Board, coordinating with FSRAs and other relevant agencies, to prepare a general crisis management plan for threats to food safety such as radiation contamination, food shortage requiring coordinated action, and other crisis situations that may compromise food safety; the plan must specify direct or indirect risk situations not likely prevented/eliminated/reduced to acceptable levels.

Official controls, traceability, licensing, inspection, laboratories

Section 26 requires official controls to verify compliance with food laws and regulations, and requires each agency to prepare regulations governing official controls consistent with Act principles, including proportionality of control frequency to severity/likelihood of risks, adequate competent personnel and adequate funds/equipment, impartiality and effectiveness operational criteria, high competence and integrity with conflict-of-interest awareness, documented procedures in a manual of operations, and delegation of official controls to other competent bodies with oversight while keeping accountability with the regulatory agency.
Section 26 requires agencies performing official controls to be provided with necessary funding and technical support out of their existing budgets.
Section 27 requires traceability for foods at relevant stages of production, post harvest handling, processing or distribution when needed to ensure compliance, and it must cover production inputs such as feeds, food additives, ingredients, packaging materials, and other substances expected to be incorporated.
Section 27 requires food business operators to: (a) identify the persons/companies supplying food, food-producing animals, production chemicals (pesticides and drugs), and production/post harvest/processing inputs including feeds/food additives/food ingredients/packaging materials or any substance expected to be incorporated; (b) implement systems and procedures enabling regulatory authorities to access the above information upon demand; and (c) establish systems and procedures to identify other businesses to which products were supplied, also available to regulatory authorities upon demand.
Section 27 requires traceability in food-borne disease outbreaks to be established by the National Epidemiology Center (NEC) of the DOH.
Section 28 requires appropriate authorizations for establishments and facilities engaged in production, post harvest handling, processing, packing, holding or producing food for consumption through permits/licenses/certificates of registration or compliance, and it requires special derogations after risk assessment especially for micro, small and medium-sized food business operators and health products.
Section 29 requires regular inspection of food business operators by FSRAs or delegated control bodies and requires inspections to consider compliance with mandatory food safety standards, HACCP implementation, good manufacturing practices and other regulatory requirements; to set inspection frequency based on risk (with more frequent inspections for high-risk foods/high-risk activities); to use inspectors with defined risk-based skills evaluated for continuing competence; and to ensure uniform interpretation procedures for inspection results.
Section 30 requires food testing laboratories to carry out testing by laboratories accredited in accordance with international standards, and it requires non-accredited laboratories to apply for accreditation within a specified period of time; it requires use of internationally approved validated analytical procedures/methods, organizational and management structures to prevent conflict of interest, staffing with analysts with required expertise and professional competence, and it authorizes FSRAs to recognize private testing laboratories accredited by the Philippine Accreditation Office (PAO) of the DTI.

Training, consumer education, monitoring, research, funding

Section 31 requires regular skills training and educational activities for food business operators, food handlers, and government personnel, requiring: training of food business operators (especially micro, small and medium enterprises) on food safety regulation requirements, HACCP, codes of good practice, and technologies for compliance; mandatory training on safe food handling for food handlers; and government personnel training on the scientific basis for the law’s provisions and conduct of official controls.
Section 31 requires each FSRA to identify training needs and implement mandatory training programs developed and implemented by accredited training providers.
Section 32 requires development of a consumer education program by DA, DOH and LGUs in partnership with the Department of Education, with implementation carried out by the latter.
Section 33 requires funding for development and implementation of training and consumer education programs.
Section 34 requires the government to implement programs supporting risk analysis including an integrated food-borne disease monitoring system linking to food contamination sources in collaboration with DOH-NEC and NCDPC, and identification of hazards in the food supply chain with assessment of exposure levels.
Section 35 requires government and academe to develop and implement a research program on cost effective technologies and codes of practice to help farmers, fisherfolk, micro, small and medium scale enterprises and other stakeholders comply with food safety regulations.
Section 36 authorizes DA, DOH, and LGUs (where applicable) to collect fees for inspection of food products, production and processing facilities, issuance of import or export certificates, laboratory testing of food samples and other necessary fees; it requires fees to be based on an officially-approved procedure estimating the cost of the activity and subject to government accounting and auditing rules and regulations.

Prohibited acts and penalties

Section 37 makes it unlawful for any person to: (a) produce, handle or manufacture for sale, offer for sale, distribute in commerce, or import into the Philippines any food not conforming to applicable food quality or safety standards promulgated under the Act; (b) do the same for any food declared banned food product by a rule promulgated under the Act; (c) refuse access to pertinent records or entry of inspection officers of the FSRA; (d) fail to comply with an order relating to notifications to recall unsafe products; (e) adulterate, misbrand, mislabel, falsely advertise any misleading food product and carry out other acts contrary to good manufacturing practices; (f) operate a food business without the appropriate authorization; (g) connive with food business operators or food inspectors in a manner resulting in food safety risks to consumers; and (h) violate the implementing rules and regulations of the Act.
Section 38 provides criminal penalties for violations of any provision of the Act with staged penalties tied to conviction number, violation consequences, and additional legal effects:
- For the first conviction, impose a fine of not less than PHP 50,000 but not more than PHP 100,000 and suspension of appropriate authorization for one (1) month.
- For the second conviction, impose a fine of not less than PHP 100,000 but not more than PHP 200,000 and suspension of appropriate authorization for three (3) months.
- For the third conviction, impose a fine of not less than PHP 200,000 but not more than PHP 300,000 and suspension of appropriate authorization for six (6) months.
- For violation resulting in slight physical injury, impose a fine of not less than PHP 200,000 but not more than PHP 300,000, suspension of appropriate authorization for six (6) months, and payment of hospitalization and rehabilitation costs of the person.
- For violation resulting in less serious or serious physical injury, impose a fine of not less than PHP 200,000 but not more than PHP 300,000, suspension of appropriate authorization for one (1) year, and payment of hospitalization and rehabilitation costs.
- For violation resulting in death, impose imprisonment of not less than six (6) months and one (1) day but not more than six (6) years and one (1) day, a fine of not less than PHP 300,000 but not more than PHP 500,000, and permanent revocation of appropriate authorization to operate a food business.
Section 38 doubles fines when the offender does not have the appropriate authorization.
Section 38 applies additional consequences: if the offender is government personnel, the personnel is subjected to appropriate civil service laws in addition to the prescribed penalty; if the offender is a naturalized citizen, the naturalization certificate and registration in the civil registry are cancelled with immediate deportation after payment of fine and service of sentence; if the offender is an alien, the alien is summarily deported after payment of fine and service of sentence and permanently barred from entering the country.
Section 38 imposes corporate liability on any director, officer or agent of a corporation who authorizes, orders or performs any act constituting in whole or in part a violation of Section 37 with knowledge or notice of noncompliance received by the corporation, subject to the penalties in Section 38.
Section 38 provides that when the violation is committed by or in the interest of a foreign juridical person duly licensed to engage in business in the Philippines, its license to engage in business is immediately revoked.

Implementing rules, separability, repeal, effectivity

Section 39 requires the DA and the DOH to jointly issue the implementing rules and regulations within ninety (90) days after Act effectivity.
Section 40 provides a separability clause: if any provision is declared invalid or unconstitutional, the other provisions remain in full force and effect.
Section 41 provides a repealing clause: all laws, presidential decrees, executive orders, rules and regulations inconsistent with the Act are repealed, amended or modified accordingly.
Section 42 provides effectivity: the Act takes effect fifteen (15) days after its publication in two (2) newspapers of general circulation.
The Act was approved: August 23, 2013 and took legal effect upon compliance with the Section 42 publication requirement.