Administrative Order No. 88-B s. 1984 on labelling of prepackaged Food Products

Republic of the Philippines Ministry of Health BUREAU OF FOOD AND DRUGS Manila May 25, 1984 Administrative Order No. 88-B s. 1984 SUBJECT: Rules and regulations Governing the labeling of prepackaged Food Products Distributed in the Philippines Pursuant to the provisions of Section 26 (a) of R.A. 3720, otherwise known as the “Food, Drug and Cosmetic Act”, the following rules and regulations on the labeling of prepackaged food products, imported or locally produced are hereby promulgated for the information and guidance of all concerned: Section 1. Definition of Terms For the purpose of this labeling regulation, the term: 1.1. Container means any form of packaging material which completely or partially enclose the food (including wrappers). A container may enclose the food as a single item or several units or types of prepackaged food when such is presented for sale to the consumer. 1.2. Food means any substance, whether processed, semi-processed of raw which is intended for human consumption and including beverages, chewing gum and any substance which has been used as an ingredient or a component in the manufacture, preparation or treatment of “food”. 1.3. Food Additives means any substance not normally consumed as food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacturing, processing, preparation, treatment, packaging, transport for holding of such food results, or maybe reasonably expected to result (directly or indirectly) in its or its by – product becoming a component of (or otherwise affecting the characteristic of) such food. 1.4. Food Standard is a regulatory guideline that defines the identity of a given food product (i.e. its name and the ingredients used for its preparation) and specifies the minimum quality factors and, when necessary, the required fill of container. It may also include specific labeling requirements other than or in addition to the labeling requirements generally applicable to all prepackaged foods. 1.5. Ingredient means any substance, including a food additive, used as a component in the manufacture or preparation of food and present in the final product (in its original or modified form). 1.6. Label includes any tag, brand, mark, pictorial, or other descriptive matter, written, printed, marked, embossed or impressed on or attached to a container of food. 1.7. Labeling means any written, printed or graphic matter (1) upon any article or any of its container or wrappers or (2) accompanying the packaged food. 1.8. Lot refers to quantity of food products under essentially the same condition during a particular production schedule. 1.9. Nutrition Information means any representation which states, suggests or implies that a food has particular nutritional properties including but not limited to the energy value and to the content of protein, fat and carbohydrates, as well as vitamins and minerals. 1.10. Prepackaged means packaged or made up in advance in a container, ready for sale to the consumer. 1.11. Processing Aid means a substance or material not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of food to achieve a certain technological purpose which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product. Section 2. General Provisions 2.1 Prepackaged food shall not be described or presented on any label or in any labeling in a manner that is false, misleading or deceptive or is likely to create erroneous impression regarding its character in any respect. It shall not be described or presented on any label or in any labeling by words, pictorial or other devices which refer to or are suggestive either directly or indirectly, of any other product with which such food might be confused, or in such a manner as to lead the purchaser or consumer to suppose that the food is connected with such other product. 2.2 Food packages shall have labels that carry the necessary information about the product. 2.2.1 The “Principal Display Panel” of the label shall be that part which, either through design or general use, is presented or shown to the consumer under customary conditions of display for retail sale. 2.2.2 The “Information Panel” of the label shall be that part immediately continuous to the principal display panel and in the case of rectangular, cylindrical or four-sided (tetra-pak) containers, any of the sides adjacent to the principal display panel except the bottom side which serves as the base of package. 2.3 Every word, figure or statement required to appear on the label or labeling shall be printed legibly with such conspicuousness and in such terms as to render it likely to be understood under customary condition of purchase and use. Where the label of a food package is so small that it prevent the use of letters of the prescribed size or where it concerns secondary or optional information, letters or 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. Section 3. Mandatory Label Information The labels of all prepackaged foods shall bear the following information: 3.1. Name of the Food 3.1.1. The name shall indicate the true nature of the food and shall normally be specified and not generic. a) Where a name or names have been established for a particular food in a Food Standard, any one of these names shall be used. b) In other cases, a common or usual name, or in the absence thereof, an appropriate descriptive name shall be use. c) A “coined” or “fanciful” name may be used provided it is not misleading or confusing. 3.1.2. For the consumer’s better understanding of the true nature and condition of the food, there shall appear in the label either in conjunction with, or in close proximity to the name of the food, such additional words or phrases, as necessary, to state the type of packing medium, form or style, and the condition or type of treatment it has undergone (e.g. dried, freeze-dried, concentrated, smoke, reconstituted, etc.). However, if the form (whole, slices, diced, etc.) is visible through the container or is depicted by an appropriate vignette, the particular form need not be included in the statement of the name of the food. 3.1.3. The name of the food shall be presented in bold type letters on the principal display panel and shall be in a size reasonably related to the most prominent printed matter on such panel, e.g., trade mark or brand name. 3.2. List of Ingredients 3.2.1. A complete list of ingredients shall be declared in descending order of proportion on either the principal display panel or information panel except that when a food product is covered by a Food Standard, only the optional ingredients shall be declared unless otherwise required by such regulation. 3.2.2. Added water shall be declared in the list of ingredients if such a declaration would result in a better understanding of the product’s composition by the consumer except when the water forms part of an ingredient such as brine, syrup or broth and declared as such in the list of ingredients. 3.2.3. A specific name, not a collective (generic) name shall be used for an ingredient except that spices, flavors and food colors other than those sold as such, may be designated as spices, flavors and food color without naming the specific materials. 3.2.3.1. Spices shall refer to any aromatic vegetable substance in the whole, broken, ground or any other form, except those substances which have been traditionally regarded as food. 3.2.3.2. Flavors and flavoring substance are classified in the following categories: a) Natural flavors – flavoring substance derived through appropriate physical processes from spices, herbs, fruits or fruit juices, vegetable or vegetable juices, edible yeast, bark, bud, root, leaf of plant materials, meat, fish, poultry, eggs, dairy products or fermentation products thereof. b) Nature – identical flavoring substance – substances chemically derived from aromatic materials or obtained synthetically, which are chemically identical to substances present in natural products intended for human consumption. c) Artificial flavoring substances – substances that impart flavor but which have not been identified in natural products or natural sources of flavorings. 3.2.3.3. Flavor as classified above shall be declared as “Natural Flavor(s)”, “Nature – identical flavor(s)” or “Flavor(s)” for (a), (b) and (c) respectively. In the case of combination of Natural Flavors and Nature – identical flavors it shall be declared as such or simply “Flavors”. 3.2.3.4. Any pyroligneous acid or other artificial smoke flavors used as an ingredient in a food shall be declared as artificial flavor or artificial smoke flavor. No representation may be made, either directly or implied, that a food flavored with pyroligneous acid or other artificial smoke flavor has been smoked or has a true smoke flavor, or that a seasoning sauce or similar product containing pyroligneous acid or other artificial smoke flavor and used to season or flavor other food will result in a smoked product or one having a true smoked flavor. 3.2.3.5. Coloring substances shall be declared by their common name or as “Food Color(s)” or “Color(s)” for those that are derived from or identical with substances derived from plant materials, and as “Artificial Color(s)” for coal-tar dyes or other synthetic chemical compounds. 3.2.3.6. The specific names of vegetable oil used shall be indicated. In the case of mixture of two or more vegetable oils the declaration shall be in the following manners “vegetable oil” (name of oils in decreasing order of proportion) “or blend of vegetable oil” (name of possible oil blends). 3.2.4. Declaration of Food Additives 3.2.4.1. Food additives shall be declared by their common name or their class name which indicate their functional categories. The following class names may be used except when otherwise stated in a food standard. Anticaking Agent(s) Acidulant(s)/Food Acid(s) pH-Control Agent(s) Emulsifier(s) Firming Agent(s) Flavor Enhancer(s) Flour Treatment Agent(s) Bleaching Agent(s) Dough Conditioner(s) Maturing Agents Glazing Agent(s) Humectant(s) Leavening Agent(s) Preservative(s) Antimicrobial Agent(s) Antioxidant(s) Stabilizer(s) thickener(s) Modified Starch(es) Vegetable Gum(s) Sequestrant(s) 3.2.4.2. Vitamins and Minerals All added vitamins and minerals shall be declared individually in the list of ingredients except that when a nutrition information table is presented in the label, the collective term “Vitamins and Minerals” may be declared in the list of ingredients. Provided, however, that when the nutrition information table declares other vitamins and minerals which have not been added to the product, the added vitamins and minerals shall be specified either in the list of ingredients or in the nutrition information table. 3.2.4.3. The following substances shall be declared by their common name: a) Sodium Chlorite/Salt b) Sodium Nitrite c) Sodium/Potassium Nitrite d) Monosodium Glutamate/MSG/Vetsin e) Specific name for non-nutritive sweeteners 3.2.4.4. When the acidulant used is acetic acid or sodium diacetate in the case of dehydrated food products, e.g., soup mixes, they may be declared as such or as acidulant(s) but in no case shall the terms vinegar or vinegar powder be used to refer to these substances. 3.2.4.5. 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 achieved technological function, need not be declared in the list of ingredients. 3.3. Net Contents and Drained Weight 3.3.1. The net content shall be declared using the metric system of measurement or “SI” (International System 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: a) for liquid foods, by volume; b) for solid foods, by weight, except that when such foods are sold by number, a declaration of count may be made; c) for semi-solid or viscous foods, either by weight or volume. 3.3.2. Foods packed in a liquid medium normally discarded before consumption may carry a declaration of drained weight. 3.3.3. The declaration of contents shall appear in conspicuous and legible bold face print or type in distinct contrast to other matters on the panel where it is declared. 3.3.4. The net contents declaration shall be in letters and numerals of a type size established in relation to the height of the label of the food package and shall be uniform for all packages of substantially the same size by complying with the following type size specifications: a) Not less than 2mm in height on packages not more than 60mm or bottles not more than 200mm in height. b) Not less than 2.5mm in height on packages more than 80mm but not more than 160mm or bottles more than 200mm but not more than 400mm in height. c) Not less than 3.5mm in height on packages more than 160mm but not more than 260mm or bottles more than 400 but not more than 650mm in height. d) Not less than 5mm in height on packages more than 260mm or bottles more than 650mm in height. 3.3.5. For food packages with surface areas of less than 30cm2 the minimum type size for declaration of net contents shall be 1.5mm. 3.3.6. 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 multiunit package. A multi unit retail package may thus be properly labeled. “20 x 10 g sachets (net wt. 200 g)” or “6 x 300 ml bottles (1.8 L or 1000 ml)” However, the number of individual units in a multiunit retail package may not be declared if the number of the units can be clearly seen and easily counted without opening the package. 3.4. Name and address of Manufacturer, Packer and Distributor 3.4.1. The name and address of either the manufacturer, packer or distributor of the food shall be declared on the label. 3.4.1.1. The street, City/town and province shall be indicated except that the street address may be omitted if the company’s name, as declared on the label, is listed in a current telephone directory. 3.4.1.2. If a manufacturer with corporate headquarters in Metro Manila, has plant in many cities and towns, the name of the company as listed in a current telephone directory would also suffice provided every food package has a code/mark to identify the processing plant where it was produced. 3.4.2. If the food is not manufactured by the person or company whose name appears on the label, the name must be qualified by “manufactured for” or “Packed for” or similar expression. 3.4.3. The country of origin shall be indicated if the product is being exported or imported. 3.4.4. In the case of products carrying foreign brands or manufactured under license by a foreign company, the name or name and address of the foreign company, if declared shall be in letters of type size not bigger than those used for the local company. 3.4.5. The name and address of the importer or local distributor shall be declared in the labels of imported products except for sole legal distributors/importers. 3.5. Lot Identification The lot identification code shall be embossed or otherwise permanently marked on immediate individual packages or containers. Section 4. Nutrition Information Nutrition information may be included on the label or in the labeling provided it conforms to the requirements of this section. 4.1. The nutrition information shall be presented through the declaration of protein, carbohydrate, fat, energy value vitamin and mineral content of the food in tabulated form. 4.1.1. The declaration of nutrient quantities shall be on the basis of the food as packaged. Another column of figures may be used to declare the nutrient quantities on the basis of the food as consumed after cooking or other preparation provided the specific method of cooking or preparation shall be disclosed in a prominent statement following the information. 4.1.2. 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. 4.1.3. Protein, Carbohydrate and fat content shall be expressed to the nearest gram except that if a serving/portion contains less than one gram, the statement “contains less than one gram” or “less than one gram” may be used. 4.1.4. Energy value shall be expressed in terms of calorie, kilocalories (Kcal), joules or kilojoules (kjoules). 4.1.5. Vitamin and Mineral content shall be expressed in terms of percentage of Recommended Daily allowances (RDA) or by weight. International Units (I.U.) shall be used for Vitamins A, D and E. 4.1.6. The RDA values shall be based on the Philippine RDA except that in the absence thereof for certain nutrients, the FAO/WHO or U.S. RDA values may be cited and shall be specified. In the case of imported products, RDA values of the country of origin may be indicated. 4.1.7. The percentage of RDA shall be expressed in 2 – percent increments up to and including the 10 – percent level, 5 – percent increments above 10 – percent and up to and including the 50 percent level, and 10 – percent increments above the 50 – percent level. 4.1.8. Nutrients present in amounts less than 2 percent of the RDA shall be indicated by zero, or by the statement – “contains less than 2% of the RDA” or by an asterisk referring to this statement, or not declared at all. 4.1.9. Claims that a food product is enriched/fortified with vitamins and/or minerals shall be made only when the amount of added vitamin(s) and/or mineral(s) is in accordance with the level(s) specified in the Food Fortification Guidelines and the nutrition information shall appear on the label. 4.1.10. Fatty acid composition cholesterol content and sodium content may also be declared. 4.2. The added nutrients for fortification can be in the form of nature identical nutrients or in the form of naturally occurring food containing large amounts of the desired nutrients. 4.3. For the purpose of compliance with nutrient label declarations. a) The nutrient content of a food shall be at least equal to 80 percent of the value for that nutrient declared on the label at any point in time within the expected shelf-life of the product. Provided, that no regulatory action will be based on a determination of a nutrient value which falls below this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved. b) The carbohydrate, fat or energy value shall not exceed 20 percent of the value declared on the label. c) The sample for nutrient analysis shall consist of a composite of 12 sub-samples (consumer units) taken one from each of 12 different randomly chosen shipping cases, to be representative of a lot. Composite shall be analyzed by AOAC Methods where available or in the absence thereof, by reliable and appropriate analytical procedure. 4.4. A food labeled under the provision of this section shall be deemed to be misbranded if its labeling represents, suggest or implies: 4.4.1. That the food because of the presence or absence of certain dietary properties, is adequate or effective in the prevention, cure, mitigation or treatment of any diseases or symptoms when such claim cannot be substantiated. 4.4.2. That a balanced diet of ordinary foods cannot supply adequate amount of nutrients. 4.4.3. That the food has dietary properties when such properties are of no significant value or need in human nutrition. Ingredients or substances which have not been combined with vitamins and/or minerals, added to food labeled in accordance with this section, or otherwise used or represented in any way which states or implies nutritional benefit. Ingredients of this type may be marketed as individual products or mixtures thereof; Provided, that the possibility of nutritional, dietary, or therapeutic value is not stated or implied. 4.4.4. That a natural vitamin in a food is superior to an added or synthetic vitamin, or to differentiate in any way between vitamins naturally present those added. Section 5. Labeling of Food Additives 5.1. Food Additives, when packed in retail containers and sold either through normal distribution channels (e.g., supermarkets, grocery stores) or directly to food processors, shall be properly labeled, indicating the information required in sub-section 5.1.1. to 5.1.7. 5.1.1.a) the name shall be specific preferably the name indicated in the BFAD’s List of Permissible Food Additives or a trade/brand name may be used which shall be accompanied by a descriptive statement pertaining to the functional use of the additive. b) Color additives, when sold as such, shall be referred to as “Food Color” and immediately below these words the component(s) shall be indicated. 5.1.2. Listing of Additives components a) All substances present shall be listed in the order of decreasing proportion. When one or more of the food additive(s) is subject to a quantitative limitation as specified in the BFAD’s List of Permissible Food Additives, the quantity or proportion of the additive(s) shall be indicated in the label. b) In the case of Flavorings, each flavoring component need not be given. The generic expression “Flavor” or “Flavoring” shall be used and indicating the nature of the flavor by using the qualifying words, “natural”, “nature-identical”, “artificial” or a combination of these words, as appropriate. c) When compounded additive or flavoring preparations contain coloring substances the name of each coloring substance shall be indicated. 5.1.3. The words “For Food Use”, “Food Grade” or a statement similar thereto shall appear prominently on the principal display panel of the label, except when the word ‘food’ already appears as part of the name of the product as in “Food Color”. 5.1.4. Adequate information shall be given about the manner in which the food additive is to be used either on the label or a package insert. Whenever there are specified restrictions for any of the components, there shall be information pertaining thereto to ensure compliance with the restrictions. 5.1.5. Food additives with a limited shelf-life shall carry an open-date mark which shall signify that beyond this date the effectivity of the additive, for its intended use is diminished. 5.1.6. Storage instructions shall be indicated, particularly when the stability of the additive depends there on. 5.2. For food additives that are packed in non-retail containers and/or solely destined for further industrial processing, the required information, other than those indicated in sub section 5.1.1. and 5.1.6. may be stated in a brochure which shall be given to the buyer together with documents relating to its sale. Section 6. Other Requirements 6.1. Open – Date Marking Prepackaged food shall be open – date marked in compliance with the “Guidelines for Open – Date marking of prepackaged Foods”. 6.2. Alcoholic Beverages In addition to the labeling requirements under section 3 of this regulation, the alcohol content in terms of percentages or proof units shall be indicated on the principal display panel of the label of alcoholic beverages. 6.3. Language 6.3.1. The language used for all information on the label shall be either English or Filipino or any major dialect or a combination thereof. For food products intended for export the language acceptable to the importing country shall be used. 6.3.2. In the case of imported food products, labels where in the information are declared in a foreign language must also carry the corresponding English translation, otherwise such products shall not be permitted for local distribution. 6.4. Additional Information Additional information when stipulated in a Food Standard or any other BFAD regulation shall be indicated on the label. Section 7. Misleading Declarations/Representations The situations described in this section are example of what have been considered misleading. The BFAD reserves its right to rule against other form of misleading declaration/representations. 7.1. Any representation relative to the flavor of the food product as depicted on the label, labeling or advertising material which is inconsistent with Sections 3.2.3.2 and 3.2.3.3. 7.2. Use of Photographs and Graphic Representations 7.2.1. Photographs of fruits, vegetables, poultry, fish, meat or eggs whether fresh or cooked, whole or sliced shall not appear on the label unless the product contains such materials or substances naturally derived from them. If flavoring substances have been added to boost or reinforce the natural flavor of a given material, the words “Flavor Added” or any statement to that effect shall appear conspicuously and in close proximity to the photograph. 7.2.2. Graphic representations used to depict the above mentioned materials (fruits, vegetables, etc.) are acceptable provided these do not vividly illustrate the actual appearance of such materials. 7.2.3. Pictures of food preparations or dishes may appear on the labels of products like sauce mixes or other similar products that are used as ingredient(s) for the preparation of such food/dishes provided the statement “Serving Suggestion” or any other statement of similar import appear with the picture. 7.3 Use of Names of Places 7.3.1 Names of places may be used as part of the name of the product (a) if the product is produced in the place cited or (b) if the product contains the characterizing ingredient(s) and/or prepared in exactly the same manner as the product identified with said place. However, in the case of (b), if the place cited is in another country, it shall be qualified by the word “style” except when reference to the place is accepted as a generic term for that product. 7.3.2. Use of names of places as Brand Name is acceptable provided the presentation is not misleading, i.e., it does not appear as part of the name of the product. Section 8. Exemptions 8.1. Exemptions from the labeling requirements shall be allowed in the following situation: a) A shipment or other delivery of a food which is in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantity at establishment other than that where originally processed or packed, shall be exempt from compliance with labeling requirements during the time of introduction into the movement in commerce and the time of holding in such establishment. b) A food, while held for sale, shall be exempt from labeling requirements, if said food, having been received in bulk containers at a retail establishment, is accurately weighed, measured or counted either within the view of the purchaser or in compliance with the purchaser’s order. 8.2 Exemptions from any specific provision(s) of this labeling regulation may be granted under justifiable circumstances. Petition for such exemptions should be submitted to the Bureau of Food and Drugs for appropriate action. Section 9. Any article of food that is misbranded when introduced into domestic commerce may be seized when the director of Bureau of Food and Drugs or his duly authorized designate has probable cause to believed from facts found by him or any official or employee of the Bureau of Food and Drugs that the misbranded article is dangerous to health, or that the labeling of the misbranded article is fraudulent or would be in material respect misleading to the injury or damage of the purchaser or consumer. Section 10. Any violation of the provision of this rules and regulation shall render the article misbranded and the responsible person shall be subject to the penal provision of section 12 (a)of R.A. 3720. In addition, administrative sanctions, such as suspensions or revocation of license to operate, fines or written notice of warning, may likewise be imposed by the Bureau of Food and Drugs, in the discretion of its Director. In case of the juridical person, the penalty arising out of the criminal offense, shall be imposed upon the president, Manager or head and of the members of the Board of Directors or governing body of the firm or establishment. Section 11. All orders, regulation or guidelines or parts thereof in conflict with the provisions of this Administrative Order are hereby repealed or modified accordingly. This regulation shall take effect immediately upon approval and publication in the Official Gazette. There shall be a maximum period of 18 months from the date of effectivity to modify and consume inventories of existing prepackaged food labels which are violative of this regulation. In the case of gross violation the Bureau of Food and Drugs shall order compliance within a period shorter than 18 months. Recommending Approval: (Sgd) CATALINA C. SANCHEZ Director APPROVED: (Sgd) J.C. AZURIN Minister of Health