Consumer product quality and standards are primarily governed by the Consumer Act ("Consumer Act"), which is a general law on consumer products. In addition, the Food and Drug Administration Act of 2009 (Republic Act No. 9711), which amends the Foods, Drugs and Devices and Cosmetics Act (Republic Act No. 3720) ("FDA Law"), specifically regulates "health products," which include food and other consumer products that may have an effect on health.
"Food" is defined as any substance, whether processed, semi-processed or raw, intended for human consumption. This includes chewing gum, drinks and beverages, and any substance which has been used as an ingredient or a component in the manufacture, preparation or treatment of food. "Food/dietary supplements" are processed food products intended to supplement the diet. These supplements generally contain one or more of the following dietary ingredients: a vitamin, mineral, amino acid, herb, or other dietary substance of botanical, animal, artificial or natural origin. Their purpose is to increase the total daily intake in an amount conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements. It is usually in the form of capsules, tablets, liquids, gels, powders or pills and is not represented for use as a conventional food or as the sole item of a meal or diet or a replacement for drugs and medicines.
The Food and Drug Administration ("FDA") is the regulatory authority under the Philippine Department of Health ("DOH") that implements the FDA Law. The FDA Center for Food
Regulation and Research ("CFRR") is tasked with regulating the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of and/or, where appropriate, the use and testing of food products and food/dietary supplements. The CFRR is also mandated to conduct research on the safety, efficacy and quality of food, and to institute standards relating to food safety and quality.
The Department of Trade and Industry ("DTI") is primarily tasked with implementing the Consumer Act. The DTI Bureau of Product Standards ("BPS") formulates Philippine National Standards for consumer products, including food.
Standards for food are prepared by the technical committees and sub-committees of the BPS and the FDA. Food standards are published as Philippine National Standards.
To ensure that product quality standards are complied with, among others, the FDA requires entities that manufacture, import, export, sell and distribute food products to obtain a License to Operate ("LTO") from the FDA for their intended activities. These entities also require a Certificate of Product Registration ("CPR") for each food product that they manufacture, import, export and market in the Philippines. An LTO covering a particular food establishment shall be prima facie evidence of the licensee's authority to engage in the activity/ies specified in the LTO. A CPR covering a food product shall be prima facie evidence of the registrant's marketing authority for the said health product in connection with the activity/ies permitted pursuant to the LTO. Only establishments with a valid LTO from the FDA may apply for a CPR.
In addition, certain food products are subject to special laws and regulations, for example, milk (Executive Order No. 51, National Code of Marketing of Breast milk Substitutes and Other Related Products, also known as the "Milk Code").
The following labeling requirements set out by the DOH in Administrative Order No. 30-2014 (“Revised Rules and Regulations Governing the Labeling of Pre-packaged Food Products Further Amending Certain Provisions of Administrative Order No. 88-B s. 1984”) (“Food Labeling
Rules”)1 apply to food products, including food supplements, whether imported or locally produced and distributed in the Philippines:
Food identification
The following information on pre-packaged food products must be placed on the label:2
Labeling of ingredients
The Food Labeling Rules provide for specific information which must be stated on food labels for each of the items above. With respect to the list of ingredients, generally, the following rules apply:
a. except for a single ingredient food, a complete list of ingredients shall be declared on the label;
b. the list of ingredients shall be headed or preceded by an appropriate title which consists of or includes the term “ingredients;”
c. the complete list shall be declared in descending order of proportion on either the principal display panel or information panel;
d. added water shall be declared in the list of ingredients, except when the water forms part of an ingredient, such as brine, syrup or broth used in the compound food and declared as such in the list of ingredients. Water or other volatile ingredients that evaporate in the course of manufacture need not be declared;
e. where an ingredient is itself the product of two or more ingredients, the compound ingredient may be declared, as such, in the list of ingredients, provided that it is immediately accompanied by a list, in brackets, of its ingredients in descending order of proportion;
f. where a compound ingredient constitutes less than 5% of the food, the ingredients, other than food additives which serve a technological function in the finished product, need not be declared;
g. a specific name, not a collective (generic) name shall be used for an ingredient unless a general class name would be more informative and not in conflict with existing regulations/standards;
h. flavors and flavoring substances shall be declared;
i. any pyroligneous acid or other artificial smoke flavors used shall be declared as artificial flavor or artificial smoke flavor;
j. coloring substances shall be declared by their common name or as “food color(s)” or “color(s)” for those derived from or identical with substances derived from plant materials, and as “artificial colors” for coal-tar dyes or other synthetic chemical compounds; and
k. food additives shall be declared by their common name and their functional categories.
Other regulations and policies of the FDA may also apply. For example, under FDA Circular No. 2, series of 1999, the labels of all food supplements shall indicate the phrase “No approved
therapeutic claim” to inform the consumers that food/dietary supplements have no approved curative effects.
Declaration of food additives
As mentioned above, food additives must be declared in the list of ingredients by their common name or their class name, which indicates their functional categories. Under the Food Labeling Rules, the provisions of the Guidelines of Codex Standard for Food Additives Labeling (General Standard for Food Labeling of Food Additives when sold as such, CODEX STAN 107-1981) are adopted.
Processing aids and food additives carried over into food (from another food that was used as an ingredient) at levels less than those required to achieve a technological function, need not be declared in the list of ingredients.
Open-date marking
The expiration/expiry date shall be printed clearly, conspicuously and legibly on all product labels (except alcoholic beverages) in the following order: Day, Month, Year.
The declaration of day and year are numerical while the declaration of month must be in words to avoid confusion (e.g., Expiry date: 01 January 2012 or 01 Jan. 12).
Consumer complaint desk address
Under Department Administrative Order No. 01, series of 2008, issued by the DTI, all manufacturers and importers of consumer products sold in the Philippines, including food, must specify their consumer complaint desk address on the label.
For milk and milk substitutes, special guidelines on labeling are provided in DOH Department Circular No. 2007-0276.
Exemptions from labeling requirements
The following are exempted from the labeling requirements under the Food Labeling Rules:
Under the Food Labeling Rules, the nutrition facts shall be presented in tabulated form (as illustrated below) through the declaration of protein, carbohydrates (including dietary
fiber and sugar), fat (including saturated fat, trans fat and cholesterol), sodium, energy value or calories.
All nutrient quantities shall be declared in relation to the average or usual serving in terms of slices, pieces or a specified weight or volume. The declaration of nutrients can also be
expressed either in units per serving or % Recommended Energy and Nutrient Intake (“RENI”) or in both, provided that all locally manufactured food products intended for local consumption
shall also indicate the corresponding RENI valued in an actual percentage, expressed in whole numbers.
a. Carbohydrates, protein, fats (cholesterol expressed in milligrams (mg)), sugar and dietary fiber shall be expressed in the nearest gram (g). Energy values shall be expressed in calories (kcal). Sodium shall be declared in mg.
b. Vitamins and minerals shall be expressed in mg or micrograms (mcg or <μg). International units (I.U.) shall be used for Vitamins A, D & E.
Below is a sample of the Nutrition Facts Declaration:
Nutrition facts Total Fat (g) *Percent RENI values are based on FNRI reference adult requirement of 19-29 years old. However, if a product is specifically intended for a different age bracket group, percent RENI values are based on the appropriate FNRI reference requirement. |
% RENI* |
Under the Food Labeling Rules, the language used for all information on the label of food products must be either English or Filipino or a combination thereof. For food products intended for export, the language acceptable to the importing country shall be used.
In the case of imported food products, labels where the information appears in a foreign language shall always carry the corresponding English translation.
In the case of a change of labels, and where it is permitted by the FDA to use up the existing labels, the use of a provisionary sticker label for the English or Filipino translation shall only be allowed for a maximum period of six months. All information should be accurate, legible and must be contained in a single sticker. The sticker must be durable, i.e., cannot be easily removed from the label or packaging.
Where the label of a food package is so small that it prevents the use of letters of the prescribed size or where it concerns secondary or optional information, letters of proportionately reduced size may be used, provided the prescribed particulars are visible and legibly shown and the designated label space is proportional to the size of the package. For other small packages that will not be able to accommodate label information, only the brand name and product name may be indicated. However, these shall not be sold separately and shall not be for retail sale.
Under the Philippine Customs Modernization and Tariff Act (“Customs Act”), every article of foreign origin imported into the Philippines shall be marked in any official language of the Philippines, being either Filipino or English. The country of origin shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or container) will permit.
Furthermore, under the Food Labeling Rules, the name and address of the manufacturer, repacker, packer, importer, trader or distributor of the food shall be declared on the label of locally manufactured products.
For imported products, the complete name and address of the importer, as well as the country of origin shall also be declared.
If a manufacturer has a plant in many cities and/or towns, the corporate head office address would suffice provided every food package has a code/mark to identify the processing plant where it was produced. In the case of products carrying foreign brands or manufactured under license by a foreign company, the name and/or address of the foreign company, if declared, shall be in letters of type size not bigger than those used for the local company.
When food undergoes processing in a second country which changes its nature, the second country in which the processing is performed shall be considered to be the country of origin for the purposes of labeling.
The existing regulations on genetically modified organisms in the Philippines are Executive Order No. 430 series of 1990, which created the National Committee on Biosafety of the Philippines, and Joint Circular No. 1 Series of 2016 of the Department of Science and Technology, Department of
Agriculture ("DA"), Department of Environment and Natural Resources, the DOH, and Department of Interior and Local Government ("DILG") ("GM Circular").
Under the GM Circular, no genetically modified plant or its products ("GM Plant") may be tested, commercially propagated and directly used without first obtaining the applicable Biosafety Permit. In case of commercial propagation of GM Plants, aside from obtaining the Biosafety Permit, it must be shown that: (i) based on field trials conducted in the Philippines, the GM Plant does not pose
greater risks to biodiversity, human and animal health than its conventional counterpart; (ii) food and feed safety studies show that the regulated article does not pose greater risks to biodiversity, human and animal health than its conventional counterpart, consistent with CODEX Alimentarius Guidelines on the Food Safety Assessment of Foods Derived from the Recombinant-DNA Plants and protocols of the DOH and BAI on feeding trials; and (iii) if the GM Plant is a pest-protected plant, its transformation event that serves as the plant incorporated protectant has been duly registered with the Fertilizer and Pesticide Authority of the Philippines. Under current policies and practices, and in the absence of unforeseen complications, the Biosafety Permit will be issued by the Bureau of Plant Industry within four months from complete submission of documentary requirements.
Furthermore, if a GM Plant is used for food and feed, or for processing, aside from obtaining the Biosafety Permit for Direct Use, the GM Circular also requires: (i) that in the case of an imported GM Plant, the GM Plant has been authorized for commercial distribution as food and feed in the country of origin; and (ii) regardless of the intended use, the regulated article does not pose greater risks to biodiversity, human and animal health than its conventional counterpart.
All importation of GM Plants, for whatever use, must be covered by a Sanitary and Phytosanitary Import Clearance ("SPSIC") issued by the Bureau of Plant Industry. No shipment of any GM Plant shall be allowed without a SPSIC.
Similarly, under the current policies of the FDA, food products derived from biotechnology are not prohibited. However, such products must pass the food safety assessment based on international standards (The UN FAO/WHO CODEX Alimentarius Risk Analysis of Food Derived From Modern
Biotechnology (CAC/GL 44-2003) and Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL45-2003)).
The FDA has yet to issue its guidelines on labeling of prepackaged foods derived from or containing ingredients derived from modern biotechnology including genetically modified foods.
The use of nutrition claims or health claims in food shall be covered by the Food Labeling Rules, and the Codex Guidelines for use of Nutrition and Health Claims under CAC/GL 23-1997
("Codex Guidelines"), including the latest amendments, as applicable. However, when any portion of the amendments to the Codex Guidelines are contrary to existing Philippine laws and their rules and regulations, in consideration of national policies and interest, the Food Labeling Rules shall apply as supplementary.
Pursuant to the Codex Guidelines, the following general claims can be made relating to health products:
Furthermore, the following information should appear on the label of the food bearing a Health Claim:
The Food Labeling Rules provide that, in addition to the provisions stipulated in the Codex Guidelines on the Use of Nutrition and Health Claims and the Codex General Guidelines on Claims, any of the following representations or suggestions, whether directly or indirectly stated, shall constitute misleading, deceptive and untruthful declarations,
and are prohibited:
Pictures of food preparations or dishes may appear on the labels of products like sauce mixes or other similar food products that are used as ingredient(s) for the preparation of such food/dishes shown in the pictures, provided the statement "Serving Suggestion" or any other statement of
similar meaning appears with the picture.
Food allergen information on the label of products containing the following ingredients, but not limited to those listed below, shall be indicated clearly, conspicuously and indelibly, located directly below the List of Ingredients (e.g., "Contains food allergen: egg;" or "Allergen Information: may contain _____"/"Manufactured using equipment that processes _____;" or a similar expression).
The following ingredients known to cause hypersensitivity shall always be declared:
The labels of all food supplements shall indicate the phrase "No approved therapeutic claim" to ensure that such products are not commercially sold or advertised with therapeutic claims. The font size for the phrase is 14, type face Arial, and must be printed in bold capital letters on the primary display panel of all labeling materials used for the food supplements. If the label is too small, the phrase shall be printed as 1/2 the size of the largest text in the primary display panel, while maintaining the other specifications.
In addition, under current FDA policies, warning labels are required for products that may cause a "reaction to [a] certain ingredient."
Under the Food Labeling Rules, the net content of food products shall be declared using the metric system of measurement or the SI (International Systems of units) on either the principal display panel or the information panel and in line generally parallel to the base of the package. The
declaration shall be made in the following manner:
Foods packed in a liquid medium normally discarded before consumption shall carry a declaration of drained weight. For the purposes of this requirement, liquid medium means water, aqueous solutions of sugar and salt, fruit and vegetable juices, in canned fruits and vegetables only, or vinegar, either singly or in combination.
For multi-unit retail packages, a statement of the quantity of contents on the outside package shall include the number of individual units, the net content of each individual unit, and, in parenthesis, the total quantity of contents of the multi-unit package.
A multi-unit retail package may thus be properly labeled:
FDA Circular 2016-012 dated 25 July 2016 ("Recall Guidelines") contains the latest Guidelines for Product Recall of health products. The Recall Guidelines state that the Market Authorization Holder ("MAH") shall be the party primarily responsible for the recall.
The Recall Guidelines contain a non-exclusive list of events which may trigger a recall. These events are:
Once a trigger event has occurred, the Product Recall Committee ("PRC") shall review and evaluate the health hazards. The following factors shall be considered in making a decision to recall a particular health product:
Once the PRC decides to move forward with the recall, it shall then determine the classifications of the product recalls as follows:
The Food Safety Act of 2013 ("Food Safety Act") requires food business operators 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.
It identifies the responsibilities of Food Safety Regulatory Agencies ("FSRAs") and other government agencies, as well as the food establishment operators.
The FSRAs are composed of the DA and its associated agencies (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, the Sugar Regulatory Administration and the National Food Authority) as well as the DOH and its associated agencies (the FDA-CFRR and the Bureau of Quarantine). The Food Safety Act also created a Food Safety Regulation Coordinating Board. The board will, among other things, monitor and coordinate the performance and implementation of the mandates of the DA, the DOH, the DILG and the local government units in food safety regulation, and establish a rapid alert system for the notification of a direct or indirect risk to human health due to food.
Under the Food Safety Act, appropriate authorizations shall be developed and issued in the form of a permit, license and certificate of registration or compliance that would cover establishments, facilities engaged in production, post-harvest handling, processing, packing, holding or producing food for consumption in accordance with the mandated issuances of regulatory agencies issuing such authorizations. Special derogations shall be provided due to geographical location and after an assessment of risks, especially for micro, small and medium-sized food business operators and health products.
Also, foods imported, produced, processed and distributed for domestic and export markets shall comply with the following requirements:
A food establishment has the following responsibilities under the Food Safety Act:
The following are prohibited acts under the Food Safety Act:
The implementing rules and regulations of the Food Safety Act, which elaborate the provisions of the Food Safety Act, were passed on 20 February 2015 and took effect on 23 March 2015.
Advertising for consumer products is governed in general by the provisions of the Consumer Act, and the Code of Ethics of the Ad Standards Council ("ASC") (which the Consumer Act requires all advertising materials to comply with).
Under the Implementing Rules and Regulations of the FDA Law ("FDA IRR"), the following are the general rules on advertisements, promotions, sponsorship and other marketing activities of any health product, including food:
The Consumer Act also contains certain provisions that regulate advertisements of consumer products, including food. Under the Consumer Act, it is prohibited to advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. The Consumer Act also prohibits the use of any reference to any laboratory report or analysis required to be furnished to the FDA unless such laboratory report is duly approved by the FDA. Furthermore, the Consumer Act requires all advertising materials to conform to the Code of Ethics of the ASC. Please note that in the Philippines, the advertising industry is self-regulating and is not specifically regulated by any
government agency.
The ASC Code of Ethics does not specifically provide for guidelines regarding advertisements for food. Under the general guidelines of the ASC, any advertisement should respect the country and the law, and should not contain messages that deride or otherwise discredit the law and its enforcement. Furthermore, advertisements must endeavor to promote the improvement of the quality of life of Filipinos, positive Filipino family values, customs and traditions. Furthermore, presentations and acts of profanity, obscenity, vulgarity or those that are offensive or indecent, as well as those which exploit or tend to promote physical, verbal or psychological violence or the use of deadly weapons, are prohibited.
The ASC Code of Ethics contains specific guidelines for advertisements involving food supplements, health supplements, alcoholic beverages and products covered by the Milk Code
The Consumer Act requires food product labels to state whether ingredients used are natural or synthetic.
Furthermore, under the Food Labeling Rules, flavors and flavoring substances, whether in any of the categories below, shall also be declared as part of the list of ingredients. Flavor as classified shall be declared as "Natural Flavor(s)," "Nature identical flavor(s)" or "Artificial Flavor(s)," respectively. In the
case of combination of Natural Flavors and Nature – identical flavor(s) where there are identical flavors – it shall be declared as such or simply as "Flavors."
Currently, the Philippines does not have regulations that are specific to health ratings.
Nonetheless, the Philippine government promotes the fortification of food with certain micronutrients so as to combat malnutrition. Under Philippine laws and regulations, fortification is mandatory for certain staple foods, and voluntary for processed food. Food products, which meet
the minimum requirements for fortification, shall use the Diamond Sangkap Pinoy Seal for staple food, and the Sangkap Pinoy Seal for processed food. The intention of these seals is to guide consumers in choosing food that is more nutritious.
Diamond Sangkap Pinoy Seal – Fortified Staple Food
Mandatory fortification is imposed by Republic Act No. 8172, otherwise known as the Asin (Salt) Law, and Republic Act 8976, otherwise known as the Food Fortification Law of 2000 (collectively, the "Food Fortification Laws"). Under these laws, the following food staples must be fortified:
Food | Micronutrients |
Salt | Iodine |
Rice | Iron |
Flour | Vitamin A and Iron |
Sugar | Vitamin A |
Cooking Oil | Vitamin A |
Under DOH Administrative Order 82 Series of 2003, food that meets the minimum standards imposed in the Food Fortification Laws shall have the Diamond Sangkap Pinoy Seal on their labels. The standards for mandatory fortification are as follows:
Prescribed level of Iodine in Salt under the Asin Law:
|
Type of Container/Package |
|
Sampling Point |
Bulk (>2 kg) |
Retail (=2 kg) |
Production Site |
70-150 mg/kg |
60-100 mg/kg |
Port of Entry |
70-150 mg/kg |
60-100 mg/kg |
Retail Site |
= 50 mg/kg |
= 40 mg/kg |
Prescribed level of micronutrients for other staple food under the Food Fortification Law of 2000:
Food |
Fortificant |
Minimum |
Maximum |
Rice |
Iron Ferrous Sulfate |
60 mg Fe/kg raw rice |
90 mg Fe/kg raw rice |
Flour |
Vitamin A Retinol palmitate/acetate |
3.0 mg/kg as retinol |
6.5 mg/kg as retinol |
Iron Elemental Iron |
70 mg Fe/kg |
105 mg Fe/kg |
|
Iron Ferrous Sulfate or Ferrous Fumarate |
50 mg Fe/kg |
75 mg Fe/kg |
|
Sugar |
Vitamin A Retinol palmitate |
5 mg/kg |
30 mg/kg |
Cooking oil |
Vitamin A Retinol palmitate |
12 mg RE/L |
23 mg RE/L |
Sangkap Pinoy Seal - Fortified Processed Food
Bureau of Food and Drugs (now known as the FDA) Administrative Order 4-A Series of 1995 ("Fortification AO") contains the Guidelines on Micronutrient Fortification of Processed Food, which encourages manufacturers of processed food to fortify the same. Fortification of processed
food is voluntary. Below are the relevant guidelines for voluntary fortification under the Fortification AO:
1. For essential nutrients that are deficient in the Filipino diet, the added nutrients shall supply at least 1/3 of the Recommended Dietary Allowances ("RDA") of the target consumer, except that vitamin C shall be supplied at not less than 100% of the RDA in fortified juices/flavored drinks. These levels shall be uniformly distributed in the total number of services likely to be consumed in a day.
2. For nutrients that are essential but have not been established to be deficient in the Filipino diet, the added nutrients shall supply at least 1/5 (or 20%) of the RDA of the target consumer.
3. For nutrients that are essential but have no established RDA, the added nutrients shall supply at least 20% of the estimated safe and adequate levels for daily intake as recommended by the Food and Nutrition Board of the US National Research Council.
4. For processed foods to be fortified with nutrient(s) with known toxicity (e.g., vitamins A, D, E, K, Zn, Se), the level of such nutrient(s) in the food shall not exceed 150% of the RDA for the target consumer per prescribed serving(s) likely to be consumed per day.
5. For essential amino acids, fortification levels shall be in accordance with the recommendations of the Joint FAO/WHO/UNU Expert Consultation on Energy and Protein Requirements (WHO TRS 724, 1985). Food manufacturers who wish to fortify their products with amino acids are required to consult a qualified professional with expertise in human nutrition and shall submit a certificate of such consultation.
6. For nutrients that have not been established as essential for humans, fortification with such nutrients shall be at a significant level above the natural state as determined by the precision of the analytical method at its lowest detection limit.
Processed food products, which comply with the standards set forth in the Fortification AO, shall include the Sangkap Pinoy Seal on their labels.