REPUBLIC OF THE PHILIPPINES DEPARTMENT OF HEALTH OFFICE OF THE SECRETARY MANILA RULES AND REGULATION GOVERNING THE OPERATION OF FOODJAND FOOD PRODUCTS MANUFACTURING AND PROCESSING ESTABLISHMENTS CHAPTER I—Purpose, and Definitions SECTION 1—Pursuant to Section 26(a) of Republic Act No. 3720, otherwise known as the Food, Drug and Cosmetic Act, the following rules and regulations are hereby promulgated to insure the proper operation and maintenance of food and food products manufacturing and processing establishments. SECTION 2— (a) As used in these regulations, the term “ACT” means the Food, Drug and Cosmetic Act and all amendments thereto, (b) “Manu. facturing and/or processing” shall include repacking or otherwise changing the container, wrapper or labeling of food, and/or food products in’ the furtherance of the distribution of the same from the original place of manu. facture to the person who makes the final delivery or sale to the ultimate consumer, (ec) “Invested Capital” shall mean all assets directly or in. directly used in the business and shall include the current market value of the°land, the buildings, the machineries and the equipment ‘used in the industry; provided, however, that when the land and the building in which the business is to be carried’ on is not used exclusively by the producer in his business, but mainly as a residenée, then the land:and building shall not be considered as part of the capital of the applicant; provided further, that wherr the building used in the business is rented, the rental shall not be considered an operating capital, (d) The. definitions and interpretations esntained in Section 10 of the Food, Drug and Cosmetic Act shall be applicable.to such terms when used in the regulations in this Section. CHAPTER D—Application for a Permit to Operate a Food and Food Products Manufacturing and Processing Establishments ae SECTION 3—Any person or group of persons desiring to operate or establish a food and food products manufacturing and/or processing estab- lishment shall file an application for permit to operate with the office of the Food arid Drug Administration under oath, in duplicate, signifying the name of the establishment as duly registered with the Bureau of Commerce, the - place, city or municipality, and province where it'is to be established, name, citizenship and domicile of the owner, administrator or manager, the invested capital and the class of food or food products to be manufactured, and/or processed. The application must be accompanied by a copy of the Reg- istration Certificate of the Bureau of Commerce. If the applicant is a corporation or association, the application must be accompanied by an authenticated copy of the certificate of registration with the. Securities and Exchange Commission, together with a copy of the Articles of Incorporation and the By-Laws. If the applicant is an alien, the petitio should be accompanied by an authenticated coy of the Certificate of Alien Registra. tion. o77880SECTION 4—All existing food and food products manufacturing or processing establishments shall comply with the requirements of these reg- ulations within ninety .(90) days after these regulations shall have taken effect. SECTION 5—If, after inspection, the food manufacturing and/or processing establishment was found to have failed to comply with the requirements of the regulations, the Administrator may refuse to issue the necessary permit, in which case he shall give not more than sixty (60) days to the owner, administrator or manager thereof, if the establishment is located in the City of Manila and its suburbs, cities and municipalities, and not more than ninety (90) ,days if in the province, to require the establishment to comply with such deficiencies. SECTION 6—Food and food products manufacturing and processing establishments with an invested capital of not more than five thousand (P5,000.00) pesos shall be exempted from the provisions of Section 15 hereof. However, these establishments shall not be exempted from the requirements of Section 3 of this regulations, inspection and sampling of the products produced, distributed ‘or sold for examination and analysis. SECTION 7—No food and food products manufacturing and proc- essing establishment shall operate without having first secured the proper permit from the Food and Drug Administration. SECTION 8—No food and food products manufacturing and proc- essing establishment shall transfer their location or site without first noti- fying the Food and Drug Administration of such intention. The manager or owner shall notify the Food and Drug Administration of the transfer in writing, stating the place he intends to move and establish the plant in accordance with the requirements of the regulations. CHAPTER Ul—Requirements for Food and Food Products Manufacturing and Processing Plant or Establishment SECTION 9—Bumpinc.—Buildings in which food and food products are manufactured, processed, packaged, labeled or held shall be maintained in a clean and orderly manner and shall be of suitable size, construction and location in relations to surroundings to facilitate maintenance and operation for their intended purpose. It must conform to the zonification plan of the locality. The building shall: -(a) Provide adequate space for orderly and hygienic lay-out of equipment and materials used in order to minimize any risk of mix-ups of different food and. food products, their component, packaging, or labeling and to control the possibility of cross contamination: of foreign matter or substance, stored or handled on the® same premises. (b) Provide adequate lighting and ventilation when neces- sary for the intended production or control purposes, adequate screening, dust filtration, humidity, and bacteriological contro] to prevent the dissem- ination of micro-organisms from one area to another to facilitate sterilization as may be required, and to provide other conditions favorable to the safety and integrity of the products. (c) Provide adequate washing, cleaning, toilet and locker facilities. ovres0__ SECTION 10—Equrment.—Equipment used for manufacturing, proc- essing, packaging, labeling, holding or controlling of food and food. products shall be maintained in a clean and orderly manner and shall be of suitable design, size, construction and location in relation to surroundings to facili- tate maintenance and operation for its intended purpose. The equipment shall: (a) Be made or constructed that any surface that comes in contact with the food or food products are suitable in that they are not reactive, additive, or absorptive to an extent that significantly affects the whole- someness of the food and its components. (b) Be made or constructed that any substance required for operation of the equipment may be used without hazard of becoming additive of food and food products. (c) Be made or constructed to facilitate adjustments, cleaning and maintenances. (a) Be suitable in size and accuracy for use in intended measuring, mixing or weighing operation. (e) In case the establishment used inflammable materials, a vault for the safe storage of the same in conformity with the Fire. Department specifications and/or fire hazard precautions should. be provided. SECTION 11—Raw mateRtaLs anp. ComponEents.—Raw materials and components used in the manufacture of food and food products shall at all times be free from contamination at the time of its use and are adequately stored, handled, to assure non-contamination. SECTION 12—Propuction anp ContRoL Procepure.—(a) Production and control procedure shall include all reasonable precautions to be under- taken during manufacturing or processing of food and food products to assure purity, quality and wholesomeness, (b) All containers and equip- ment used. in the productions of food and food products shall be well cleaned before use to prevent mix-ups or contamination. (c) Appropriate method or procedure to control the hazard of contaminatin of micro-organisms or foreign matter which is not a normal constituent in the production of food and food products, shall at all time be maintained. (d) Suitable specifica- tions, test method, cleaning procedure or any device to assure that con- tainers, closures, and. other component parts of food packages are suitable for their intended use that they are not reactive, additive or absorptive to an extent that will significantly affect the purity of the food product. CHAPTER IV—Packaging and Labeling SECTION 13—(a) The packaging and labeling of food and food prod- ucts shall be adequately controlled in accordance with law to assure that only those food and food products that have met specifications, definitions, standards of purity and labeling requirements shall be distributed or sold. (b) Adequate control shall be provided to assure correct labeling, prevent mix-ups of different food and food products and to identify finished products with lot and/or control number. (c) Each type of labeling used shall be stored in a manner that avoids mix-ups of labels and labeling and should be carefully checked. CHAPTER V—Personnel SECTION 14—The key personnel employed or involved in the manu- facture, control of food and food products shall have a background of appro- priate education or appropriate experience or combination thereof for as- suming responsibility to assure that the food product has the quality, purity and wholesomeness that it purports to possess. All personnel must be free from contagious or communicable diseases as certified by proper health authorities. 077890CHAPTER VI—Fees SECTION 15—For every permit issued by the Food and Drug Ad- ministration to operate a food and food products manufacturing and proc- essing establishment, a fee shall be charged according to the following schedule of payment: Schedule F, : P100.00 (invested capital of over P1,000,000.00) Schedule F,: P75.00 (invested capital of over P500,000.00 but not more than P1,000,000.00) Schedule Fs : P50.00 (invested capital of over 25,000.00 but not more than P500,000.00) ‘ Schedule F; :. P25.00 (invested capital of P25,000.00: and below) The permit shall be valid only for the year from the date of issue and for the class of food products applied for and shall be subject to renewal within the first three (3) months of each year upon payment of the corresponding scheduled fees. In the event that another class of food products to be manufactured, not falling under any of the eategory previously applied for, and for which a permit has already been issued, a supplemental application shall be made, and the necessary permit shall be required. CHAPTER VUl—Inspection of Food and Food Products Manufacturing and Processing Establishments < SECTION 16—For purposes of .enforcement of these regulation, officers or employees duly appointed by the Secretary to the position of Food Inspector, Supervisor and/or investigator upon presenting appropriate credentials to the owner, operator, or agent in-charge, is empowered to: (a) Enter and. inspect at reasonable hours, any food factory, warehouse, or establishment where food and food products are manufactured, processed, packed. or held, for introduction into’ domestic commerce. — (b) Collect. samples as may be necessary. ‘ CHAPTER VIII—Violations . SECTION 17—(a) Whenever the Food and Drug Administrator finds after inspection that any of the conditions of these rules and, regulations has been violated, the Administrator shall cause the recall or revocation of the permit and the temporary closure of the establishment, until ‘the provi- sions of these regulations has been complied with. (b) Faiulre to comply with the provisions of Section 15'of these regulations is a sufficient ground to Suspend-the permit until compliance thereof, CHAPTER IX—Miscellaneous Provisions SECTION 18—Any rule or regulation or parts thereof not consistent with these regulations are hereby considered null and void, : SECTION 19—These regulations shall take effect thirty (30) days after its publication in the Official Gazette. PAULINO J. GARCIA, M.D. Secretary of Health o77sa0