1. General regulations on food safety
Food safety in the Philippines is mainly regulated under Republic Act No. 10611, otherwise known as the Food Safety Act of 2013 (“FSA”), and its implementing rules and regulations, Department of Agriculture- Department of Health Joint Administrative Order No. 2015-0007 (“FSA IRR”). The purpose of the regulations is to maintain a farm to fork food safety regulatory system that ensures a high level of food safety, promotes fair trade, and advances the global competitiveness of Philippine food and food products.
Aside from the FSA and the FSA IRR, food establishments4 are also subject to Presidential Decree No. 856, s. 1975, otherwise known as the Code on Sanitation of the Philippines and the Implementing Rules and Regulations of Chapter III thereof (“Sanitation IRR”). The Code of Sanitation of the Philippines and the Sanitation IRR provide the sanitation requirements for operating a food establishment in the Philippines. Currently, there are no regulations in the Philippines which specifically apply to food or food ingredients that do not have a history of safe use (commonly called “novel food”). Hence, the general regulations on food safety apply.
1.1 Definition of food
Food is defined under the FSA as any substance or product whether processed, partially processed or unprocessed that is intended for human consumption. It includes drinks, chewing gum, water and other substances which are intentionally incorporated into food during its manufacture, preparation and treatment.
Under the Sanitation IRR, food is defined as any raw, cooked, or processed edible substance, beverage or ingredient used or intended for use or for sale, in whole or part, for human consumption.
1.2 Basic Principles for Food Safety Management
The requirements imposed for food safety are expected to guide decisions made in relation to potential adverse health effects from the consumption of the food and the identification of risk management options.9 Hence, the FSA requires that food business operators (“FBO”) and the relevant government agencies are knowledgeable of the conditions under which food could become unsafe or injurious to health, including as follows:
(a) Determining whether food is unsafe
In determining whether food is unsafe, FBOs and the relevant government agencies must consider the conditions of the use of food by the consumer including (i) the normal conditions of the use of food by the consumer, (ii) the normal conditions maintained at each stage of primary production, processing, handling, storage, and distribution, (iii) the health of plants and animals from where the food is derived, (iv) the effect of feeds, crop protection chemicals, and other production inputs on otherwise healthy plants and animals, and (v) the information provided to the consumer, including information provided on the label or any information generally available to the consumer.
(b) Determining whether food is injurious to health
In determining whether food is injurious to health, regard shall be given to the (i) probable immediate, short- term, or long-term effects on subsequent generations of that food on health, (ii) probable cumulative effects, and (iii) particular health sensitivities of a specific category of consumers where the food is intended for that category.
(c) Determining whether food is unfit for human consumption
In determining whether food is unfit for human consumption, regard shall be given to the unacceptability of the food according to its intended use due to contamination by extraneous matter or through putrefaction, deterioration, or decay, The condition of the food shall be evaluated through physical, chemical, microbiological, and other tests, whenever necessary.
When unsafe food is part of a batch Where unsafe food is part of a batch, lot, or consignment of food of the same class or description, it shall be presumed that all food in that batch, lot, or consignment is also unsafe. 16 (e) Food that complies with specific national law or regulations Food that complies with specific national law or regulations governing food safety are deemed safe insofar as the aspects covered by national law and regulations are concerned. Imported food that is declared unsafe by the competent authority of the exporting country after entry into the country must be withdrawn from the market and distribution channels. 17 (f) Right of authorities to impose restrictions Compliance of a food product with specific standards applicable to a specific food does not prohibit a competent authority from taking appropriate measures or imposing restrictions on entry into the market or requiring its withdrawal from the market, where there is reason to suspect that such food product shows food safety related risks.18 FSRAs are authorized to restrict entry into the market or apply other measures to protect consumer health when food meeting specific standards is subsequently found to be a potential source of food safety related risks.19 1.3 Key Obligations of Food Industry Stakeholders The FSA imposes obligations upon food industry stakeholders: (a) Food business operators FBOs are required to ensure that food satisfies the requirements of food law relevant to their activities in the food supply chain and that control systems are in place to prevent, eliminate, or reduce risks to consumers.20 They must (i) be knowledgeable of, adopt, and apply the specific requirements of food law relevant to their activities in the food supply chain,21 (ii) immediately initiate procedures to withdraw the food from the market when it considers or has reason to believe that a food which it produced, processed, distributed, or imported is not safe or not in compliance with food safety requirements,22 (iii) allow inspection of their businesses and collaborate with the regulatory authorities on any action taken to avoid risks posed by the food product/s which they have supplied, 23 and (iv) where the unsafe or noncompliant food product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for the withdrawal, and if necessary, recall the same from the market.24 In compliance with sanitation requirements, an FBO must also ensure that (i) its employees possess a health certificate issued by the local government health officer, which the officer will only issue after physical and 16 Rule 5.2(d), FSA IRR. 17 Rule 5.2(e), FSA IRR. 18 Rule 5.2(f), FSA IRR. 19 Rule 55.1, FSA IRR. 20 Section 13, FSA. 21 Section 14(a), FSA IRR. 22 Section 14(b), FSA IRR. 23 Section 14(c), FSA IRR. 24 Section 14 (d), FSA IRR. Ⓒ Nishimura & Asahi 2022 - 4 - medical examinations and immunizations are conducted, 25 (ii) its food handlers observe good personal hygiene and practices, 26 (iii) all food is obtained from sources approved by the local health authority, 27 (iv) all food and food materials are transported in sanitary transporting facilities and approved by the local government health officer, 28 (v) all food while displayed, stored, prepared, served, or sold are protected from contamination such as dust, flies, rodents, and other vermins, 29 and (vi) it complies with the requirements on food services spaces, structural requirements, sanitary facilities requirements, sewage disposal and drainage, refuse collection, and separation, storage and disposal.30 If a person or entity is operating a food establishment for public patronage, it must secure a sanitary permit issued by the local government health officer or sanitary engineer.31 (b) Government Agencies (1) The Department of Agriculture (“DA”) is responsible for food safety in the primary production and postharvest stages of food supply and foods locally produced or imported in this category.32 It is required to ensure that all laws, standards, policies, and programs assuring the safety of primary and postharvest food, food locally produced or imported under this category are implemented.33 National agencies under the supervision of the DA are designated as food safety regulatory agencies (“FSRA”). These are the Bureau of Animal Industry, the National Meat Inspection Service, the Bureau of Fisheries and Aquatic Resources, the Bureau of Plant Industry, the Fertilizer and Pesticide Authority, the Philippine Coconut Authority, and the Sugar Regulatory Administration. 34 As FSRAs, each agency is in charge of (among others) establishing, implementing, and regulating the specific food safety regulations within the scope of their mandate. (2) The Department of Health (“DOH”) is responsible for the safety of processed and prepackaged food, food locally produced or imported under this category, and the conduct of monitoring and epidemiological studies on food-borne illnesses.35 The DOH must ensure that all health laws, standards, policies, and programs assuring the safety of processed and prepackaged foods, processed foods but not prepackaged, foods locally produced or imported under this category and the conduct of monitoring and epidemiological studies on food-borne illnesses are strictly implemented.36 25 Section 3(b)(1), Sanitation IRR. 26 Section 3(b)(5.1), Sanitation IRR. 27 Section 3(b)(5.3), Sanitation IRR. 28 Section 2.1, Sanitation IRR. 29 Section 3(b)(3.1), Sanitation IRR. 30 Section 3(d) to (k). 31 Section 3(a)(1), Sanitation IRR. 32 Section 15(a), FSA IRR. 33 Rule 15a.1, FSA IRR. 34 Rule 4(o), FSA IRR. 35 Section 15(b), FSA IRR. 36 Rule 15b.1, FSA IRR. Ⓒ Nishimura & Asahi 2022 - 5 - National agencies under the supervision of the DOH, which are designated as FSRAs, are the Food and Drug Administration, the Center for Food Regulation, and Research and the Bureau of Quarantine.37 (3) Each local government unit (“LGU”) is responsible for food safety in food businesses located and registered within its jurisdiction. These include activities in slaughterhouses, dressing plants, fish ports, wet markets, supermarkets, school canteens, restaurants, catering establishments and water refilling stations. The LGU is also responsible for street food sales, including ambulant vending (i.e. sidewalk vendors).38 1.4 Implementation of Food Safety Regulations (a) Traceability To ensure compliance with food safety requirements, FBOs are required to establish traceability for food at relevant stages of production, post-harvest handling, processing, and distribution.39 Particularly, FBOs are required to (i) be able to identify any person or company, which supplied it with food, food-producing animals, production chemicals (e.g. pesticides and drugs), and production, post-harvest handling and processing inputs such as feeds, food additives, food ingredients, packaging materials, or any substance expected to be incorporated into food or any other food product, (ii) establish and implement systems and procedures which allow the above information to be available to the regulatory authorities on demand, and (iii) establish systems and procedures to identify the other businesses, to which their products have been supplied. This information shall be made available to the regulatory authorities upon demand. 40 (b) Licensing and Registration of Establishments An FBO is required to secure the appropriate authorizations from the DA or DOH (through the appropriate FSRA) in the form of a permit, license, and/or certificate of registration to carry out its business activity. The relevant FSRA will only issue the authorization after verifying by examination or objective evidence that the product or establishment meets the specified requirements under the applicable law.41 An FBO must also secure a business permit from the LGU having jurisdiction over the place where it operates. Before issuing a business permit, the LGU is required to verify that the FBO complies with the Sanitation IRR and other food safety requirements that may apply. The business permit will authorize the FBO to market its products within the territorial jurisdiction of the LGU. (c) Inspection of FBOs FBOs are subject to regular inspections by the FSRAs. In conducting the inspections, compliance with mandatory food safety standards, the implementation of Hazard Analyses and Critical Control Points (HACCP), good manufacturing practices, and other requirements of regulations are considered.42 The frequency of inspections are based on the assessment of risks - establishments producing high risk food or carrying out high risk activities can expect more frequent inspections. 43 37 Rule 4(o), FSA IRR. 38 Section 15(c), FSA IRR. 39 Section 27, FSA IRR. 40 Section 27(a), FSA IRR. 41 Section 28, FSA IRR. 42 Section 29(a), FSA IRR. 43 Section 29(b), FSA IRR. Ⓒ Nishimura & Asahi 2022 - 6 - 1.5 Penalties under the FSA and Code of Sanitation (a) Food Safety Act of 2013 (1) The FSA 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 or food product which is not in conformity with an applicable food quality or safety standard promulgated in accordance with this law; (B) produce, handle, or manufacture for sale, offer for sale, distribute in commerce, or import into the Philippines any food or food product which has been declared as banned food product; (C) refuse access to pertinent records or entry of inspection officers of the FSRAs; (D) fail to comply with an order relating to notifications to recall unsafe products; (E) adulterate, misbrand, mislabel, falsely advertise any food product which misleads the consumers and carry out any 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, which will result in food safety risks to the consumers; and (H) violate the implementing rules and regulations of the law.44 (2) Violations under the FSA are punished as follows:45 (A) first conviction, a fine of PhP50,000.00 to PhP100,000.00 and suspension of appropriate authorization for one (1) month; (B) second conviction, a fine of PhP100,000.00) to PHP200,000.00 and suspension of appropriate authorization for three (3) months; (C) third conviction, a fine of PhP200,000.00 to PhP300,000.00 and suspension of appropriate authorization for six (6) months; (D) for violation resulting in slight physical injury of a person, upon conviction, a fine of PhP200,000.00 to PhP300,000.00 and suspension of appropriate authorization for six (6) months; the offender shall also pay the hospitalization and rehabilitation cost of the injured person; (E) for violation resulting in less serious or serious physical injury of a person, upon conviction, a fine of PhP200,000.00 to PhP300,000.00 and suspension of appropriate authorization for one (1) year; the offender shall also pay the hospitalization and rehabilitation cost of the injured person; and (F) for violation resulting in death of a person, upon conviction, the penalty of imprisonment of six (6) months and one (1) day to six (6) years and one (1) day and a fine of PhP300,000.00 to PhP500,000.00 and permanent revocation of appropriate authorization to operate a food business. If the offender does not have the appropriate authorization, the imposable fines are doubled. If the offender is an alien, said alien shall be summarily deported after payment of fine and service of sentence and perpetually barred from entering the country. If the offender is a corporation, the director, officer, or agent of the corporation who authorizes, orders or performs any of the prohibited acts, and who has knowledge or notice of noncompliance received by the corporation from the concerned department, will be subject to the above penalties. 44 Section 37, FSA. 45 Section 38, FSA. Ⓒ Nishimura & Asahi 2022 - 7 - In a violation is committed by, or in the interest of a foreign juridical person duly licensed to engage in business in the Philippines, such license to engage in business in the Philippines immediately shall be revoked. (b) Code on Sanitation of the Philippines (1) The Code on Sanitation of the Philippines punishes a person who: (A) violates any provision of the law; or (B) interferes with, hinders, or opposes any officer, agent, or member of the DOH or of the bureaus and offices under it, in the performance of his duty as such under the law, or tears down, mutilates, defaces or alters any placard, or notice, affixed to the premises in the enforcement of the law. 46 (2) Performance of any of the above acts is penalized by imprisonment for a maximum period of six (6) months or a maximum fine of PhP1,000 or both.47 2. General regulations on food additives Food additives are regulated under Administrative Order No. 88-A, s. 1984 (“AO 88-A”)48 and Department of Health Bureau Circular No. 2006-016 (“DOH 2006-16”).49 AO 88-A prescribes the guidelines on the use of food additives in all foodstuff sold in the Philippines whether manufactured or imported.50 DOH 2006-16 was established pursuant to Republic Act No. 3720, otherwise known as the Food, Drug, and Cosmetic Act, as amended by Republic Act No. 7394, otherwise known as the Consumer Act of the Philippines.51 DOH 2006-16 supplements AO 88-A and its objective is to: (a) establish a regulation prescribing the conditions for safe use of food additives and the maximum quantity of food additive which may be used or permitted to remain in or on food; (b) ensure food safety, harmonize local food regulation with international food control laws, rules, and regulations, and ensure market access opportunities; and (c) update the list of permitted food additives and prescribe guidelines for their use and application in food distributed in the Philippines.52 The Philippines has also adopted the Food Category System and Descriptor of the General Standard for Food Additives (Codex Stan 192-1995, Rev. 2018 or Latest).53 46 Section 17, Sanitation IRR. 47 Section 17, Sanitation IRR. 48 Available at https://www.fda.gov.ph/wp-content/uploads/2021/05/Administrative-Order-No.-88-A-s.-1984.pdf (last accessed 26 August 2022). 49 Available at https://www.fda.gov.ph/wp-content/uploads/2021/05/Bureau-Circular-No.-2006-016.pdf (last accessed 26 August 2022). 50 AO 88-A. 51 Available at https://www.officialgazette.gov.ph/1992/04/13/republic-act-no-7394-s-1992/ (last accessed 26 August 2022). 52 Section I, DOH 2006-16. 53 Department of Health Department Circular No. 2019-0319. Ⓒ Nishimura & Asahi 2022 - 8 - 2.1 Definition of food additive “Food additive” refers to any substance the intended use of which results, reasonably may be expected to result, or indirectly results, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of the intended use.54 2.2 General principles for the use of food additives (a) List of permitted food additives Only food additives which present no appreciable risk to the health of the consumer at the proposed level of use as found by the Joint Food Agriculture Organization/World Health Organization Expert Committee on Food Additives (“JECFA”) and/or other internationally recognized bodies are included in the list of permitted food additives in the Philippines.55 (b) When use of a food additive is justified The use of a food additive is justified only when (i) it results in an advantage on the part of the food (e.g. lengthening of shelf life, enhance nutritional quality, etc.), (ii) it does not present an appreciable health risk to consumers, (iii) it does not mislead the consumer, or (iv) it serves one or more of the technological functions as set out in DOH 2006-16, and only where these objectives cannot be achieved by other means which are economically and technologically practicable.56 (c) Permitted levels of use of food additives Permitted levels of use of food additives in various food groups are established to ensure that the intake of food additives do not exceed the acceptable daily intake. 57 The maximum levels are provided under Table 3 of DOH 2006-16 (subject to updates by the DOH). (d) Good Manufacturing Practice The use of food additives is subject to conditions of good manufacturing practices including (i) the quantity of the additive added to food must be limited to the lowest possible level necessary to accomplish its desired effect, (ii) the quantity of the additive that becomes a component of food as a result of its use in the manufacturing, processing, or packaging of a food and which is not intended to accomplish any physical or other technical effect in the food itself is reduced to the extent reasonably possible, and (iii) the food additive is of food grade quality and is prepared and handled in the same way as a food ingredient.58 54 Section 10(n), Republic Act No. 3720, otherwise known as the Food, Drug, and Cosmetic Act; Section II(5), DOH 2006-16. 55 Section III(A)(1), DOH 2006-16. 56 Section III(A)(2), DOH 2006-16. 57 Section III(A)(3), DOH 2006-16. 58 Section III(A)(4), DOH 2006-16. Ⓒ Nishimura & Asahi 2022 - 9 - (e) Specifications for the Identity and Purity of Food Additives Food additives should be of appropriate food grade quality and at all times conform with the applicable Specifications of Identity and Purity recommended by the Codex Alimentarius Commission, JECFA or, in the absence of such specifications, by responsible international regulating bodies. In terms of safety, food grade quality is achieved by compliance with the specifications as a whole and not merely with individual criteria.59 2.3 Penalties under DOH 2006-16 A person who violates DOH 2006-16 is subject to the penalties under the Consumer Act of the Philippines60 as follows: (a) a fine of PhP1,000.00 to PhP10,000.00 or imprisonment of two (2) months to one (1) year, or both; (b) if the offender is an alien, he shall be deported after service of sentence and payment of fine without further deportation proceedings; (c) in case the offender is a naturalized citizen, he shall, in addition to the penalty prescribed, suffer the penalty of cancellation of his naturalization certificate and its registration in the civil register and immediate deportation after service of sentence and payment of fine; (d) if the offender is a corporation, the director, officer or agent of the corporation who authorized, ordered or performed the violation, and who has knowledge or notice of noncompliance received by the corporation from the concerned department, shall be subject to the above penalties; and (e) in case the violation is committed by, or in the interest of a foreign juridical person duly licensed to engage in business in the Philippines, such license to engage in business in the Philippines immediately shall be revoked.61 3. General regulations on pesticides Pesticides are regulated under Presidential Decree No. 1144, s. 1977 (“PD 1144”).62 The purpose of PD 1144 is to establish the Fertilizer and Pesticide Authority (“FPA”) to assure the agricultural sector of adequate supplies of fertilizer and pesticide at reasonable prices, rationalizing the manufacture and marketing of fertilizer, protecting the public from the risks inherent in the use of pesticides, and educating the agricultural sector in the use of these inputs.63 In relation to this, the FPA has issued the Pesticide Regulatory Policies and Implementing Guidelines regulating the use of pesticides (“Pesticides IRR”). 64 Any person that intends to use a pesticide for commercial use (i.e. exporting, importing, manufacturing, formulating, distributing, supplying, repacking, storing, commercially applying, selling, marketing) must 59 Section III(A)(5), DOH 2006-16. 60 Section III(B), DOH 2006-16. 61 Article 19, Consumer Act of the Philippines. 62 Available at https://www.officialgazette.gov.ph/1977/05/30/presidential-decree-no-1144-s-1977/ (last accessed 26 August 2022). 63 Section 1, PD 1144. 64 Available at https://fpa.da.gov.ph/NW/images/FPAfiles/DATA/Regulation/Pesticide/Book2020/PoliciesandImplementingGuidelines2020- P.pdf (last accessed 26 August 2022). Ⓒ Nishimura & Asahi 2022 - 10 - register and secure a license from the FPA. Separate registration is required for each active ingredient and its possible formulations.65 3.1 Definition of pesticides Pesticide refers to any substance or product, or mixture thereof, including active ingredients, adjuvants, and pesticide formulations, intended to control, prevent, destroy, repel or mitigate directly or indirectly, any pest. The term shall be understood to include insecticide, fungicide, bactericide, nematocide, herbicide, molluscicide, avicide, rodenticide, plant regulator, defoliant, desiccant and the like.66 3.2 Policy Guidelines on Product Stewardship The FPA has adopted the principle of pesticide company product stewardship to address the hazards and risks to human health and the environment associated with the use of pesticides. Hence, pesticide companies are required to exercise product stewardship to ensure that their products are properly handled and safely used. This applies to the entire cycle from the introduction, manufacture, formulation, marketing, and application, to the use of the products, including proper waste disposal.67 In compliance with the above, a pesticide company must (i) ensure that its products are handled properly and workers are protected during the formulation, storage, transit, application, and disposal, (ii) provide the necessary training on the safe handling and use of its product (including waste disposal) to dealers and users following FPA approved modules, (iii) provide at cost, protective clothing to users of its product, (iv) provide antidotes for its product to the nearest medical facilities as determined by the FPA, (v) provide information services to the public, (vi) report to the FPA any information adversely affecting the safe use of its product within the quarter that such information has become known, and (vii) stop the sale of, and recall, its product when found or deemed unsafe for use under any use directions or restrictions by the FPA.68 A dealer of pesticides is also required to make available first aid kits to the nearest medical facilities as determined by the FPA.69 3.3 Penalties under PD 1144 (a) It is unlawful for any handler of pesticides or for any farmer, planter, or end user of pesticides to: (1) engage in any form of production, importation, distribution, storage, and sale in commercial quantities without securing from the FPA a license therefor; (2) use any pesticide or pesticide formulation on crops, livestock, and the environment in a manner contrary to good agricultural practices; (3) deal in pesticides which have not been previously registered with FPA, or which registration has expired or has been suspended or revoked; 65 Section 2.1.1, Pesticide IRR. 66 Section 3(a), PD 1144. 67 Section 5.1, Pesticide IRR. 68 Section 5.1.1, Pesticide IRR. 69 Section 5.1.1(4), Pesticide IRR. Ⓒ Nishimura & Asahi 2022 - 11 - (4) adulterate pesticides formulation; (5) impose as a condition for the purchase of fertilizer, the simultaneous purchase of pesticide for other agricultural chemical inputs and vice-versa; (6) mislabel or make claims which differ in substance from the representation made in connection with a product’s registration or from its actual effectiveness; and (7) violate such other rules and regulations as may be promulgated by FPA.70 (b) Any person who violates any of the provisions of PD 1144 or any of the rules and regulations issued by the FPA in relation to pesticide, shall be subject to imprisonment for a maximum period of one (1) year or a fine of PhP5,000.00 to PhP10,000.00. If the offender is a corporation, the penalty shall be imposed upon the guilty officials or officers of such entities.71
