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Food Safety Laws 01

COMPENDIUM OF RIGHT TO FOOD LAWS IN THE PHILIPPINES

Volume III Food Safety Laws

91 Madasalin Street, Sikatuna Village, Quezon City

National Food Coalition

02 COMPENDIUM OF RTF LAWS

Food Safety Laws 03

Compendium of Right To Food Laws in the Philippines

Volume III Food Safety Laws


Volume II Food Accessibility Laws

04 COMPENDIUM OF RTF LAWS

Published by: National Food Coalition 91 Madasalin Street, Sikatuna Village Diliman, Quezon City Tel. No (02) 351-7553 Fax. No. (02) 436-3593 Lay-out: Ramon T. Ayco, Sr. Set in Janson Text LT Std, pt. 12 Printed in the Philippines

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Table of Contents
Acknowledgement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
A. On Nutritive Quality of Food 1. EO 51, Adopting a National Code of Marketing of Breastmilk Sustitutes, Breastmilk Supplements and Related Products, Penalizing Violations Thereof and for Other Purposes, 20 October 1986 . . . . . . . . . . . 3 2. RA 7600, Rooming-In and Breastfeeding Act of 1992, 2 June 1992 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 3. RA 8172, An Act for Salt Iodization Nationwide, 19 December 1995; Implementing Rules and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 4. RA 8976, Philippine Food Fortification Act of 2000, 7 November 2000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 B. On Safety Standards and Regulation 1. RA 3720, An Act to Ensure the Safety and Purity of Goods, Drugs and Cosmetics Being Made Available to the Public by Creating the Food and Drug Administration which shall Administer and Enforce the Laws Pertaining Thereto, 22 June 1963; . . . . . . . . . . . . . . . . . . .85 2. Executive Order 175, Further Amending RA 3720 22 May 1987; . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134 3. RA 7160, the Local Government Code of 1991, 10 October 1991; see Article 8, Title 5, Book III on powers and duties of Health Officer, including those related to sanitation . . . . . . . . . . . . . . . . . .169 4. EO 292, Revised Administrative Code of 1987, 25 July 1987; see Section 48 (4), Chapter 6, Title IV on specific functions of the National Meat Inspection Service (formerly Commission) . . . . . . . . . . . 173

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4.. EO 137, Providing for the Implementing Rules and Regulations Governing the Devolution of Certain Powers and Functions of the National Meet Inspection Commission to the Local Government Unit Pursuant to RA No. 7160, otherwise known as the Local Government Code of 1991, 28 November 1993 . . . . . . . . . . . . . . . . . . . 175

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Acknowledgment

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ACKNOWLEDGEMENT
This publication is a result of the collaboration of individuals and institutions that support the National Food Coalition. We would like to extend our deepest gratitude to the following organizations: Philippine Human Rights Information Center (PhilRights), Alternate Forum for Research in Mindanao (AFRIM), Peoples Development Institute (PDI) and Food First Information and Action Network (FIAN) Philippines for their contribution in developing this book. For the technical staff, we would like to express our deepest appreciation to Marina Wetzlmaier and Ramon Ayco. This compendium of RTAF Laws can serve as a reference material for the development of policy papers and reform agenda. Aurea G. Miclat Teves Convenor, NFC

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Food Safety Laws 1

Compendium of Right To Food Laws in the Philippines

Volume III Food Safety Laws

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Food Safety Laws 3 EXECUTIVE ORDER NO. 51 October 20, 1986 ADOPTING A NATIONAL CODE OF MARKETING OF BREASTMILK SUBSTITUTES, BREASTMILK SUPPLEMENTS AND RELATED PRODUCTS, PENALIZING VIOLATIONS THEREOF, AND FOR OTHER PURPOSES WHEREAS, in order to ensure that safe and adequate nutrition for infants is provided, there is a need to protect and promote breastfeeding and to inform the public about the proper use of breastmilk substitutes and supplements and related products through adequate, consistent and objective information and appropriate regulation of the marketing and distribution of the said substitutes, supplements and related products; WHEREAS, consistent with Article 11 of the International Code of Marketing of Breast-milk Substitutes, the present government should adopt appropriate legislation to give effect to the principles and aim of the aforesaid International Code; NOW, THEREFORE, I, CORAZON C. AQUINO, President of the Philippines, do hereby order: Section 1. Title - This Code shall be known and cited as the National Code of Marketing of Breastmilk Substitutes, Breastmilk Supplements and Other Related Products. Section 2. Aim of the Code - The aim of the Code is to contribute to the provision of safe and adequate nutrition for infants by the protection and promotion of breastfeeding

4 COMPENDIUM OF RTF LAWS and by ensuring the proper use of breastmilk substitutes and breastmilk supplements when these are necessary, on the basis of adequate information and through appropriate marketing and distribution. Section 3. Scope of the Code - The Code applies to the marketing, and practices related thereto, of the following products: breastmilk substitutes, including infant formula; other milk products, foods and beverages, including bottle-fed complementary foods, when marketed or otherwise represented to be suitable, with or without modification, for use as a partial or total replacement of breastmilk; feeding bottles and teats. It also applies to their quality and availability, and to information concerning their use. Section 4. Definition of Terms - For the purposes of this Code, the following definition of terms shall govern: (a) Breastmilk Substitute means any food being marketed or otherwise represented as a partial or total replacement for breastmilk, whether or not suitable for that purpose. (b) Complementary Food means any food, whether manufactured or locally prepared, suitable as a complement to breastmilk or to infant formula, when either becomes insufficient to satisfy the nutritional requirements of the infant. Such food is

Food Safety Laws 5 also commonly called weaning food or breastmilk supplement. (c) Container means any form of packaging of products for sale as a normal retail unit, including wrappers. (d) Distributor means a person, corporation or any other entity in the public or private sector engaged in the business (whether directly or indirectly) of marketing at the wholesale or retail level a product within the scope of this Code. A primary distributor is a manufacturers sales agent, representative, national distributor or broker. (e) Infant means a person falling within the age bracket of 0-12 months. (f) Health care system means governmental, non-governmental or private institutions or organizations engaged, directly or indirectly, in health care for mothers, infants and pregnant women; and nurseries or child care institutions. It also includes health workers in private practice. For the purpose of this Code, the health care system does not include pharmacies or other established sales outlets. (g) Health Worker means a person working in a component of such health care system, whether professional or non-professional, including volunteer workers.

6 COMPENDIUM OF RTF LAWS (h) Infant Formula means a breastmilk substitute formulated industrially in accordance with applicable Codex Alimentarius standards to satisfy the normal nutritional requirements of infants up to between four to six months of age, and adapted to their physiological characteristics. Infant formula may also be prepared at home in which case it is described as home-prepared. (i) Label means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed or impressed on, or attached to, a container of any product within the scope of this Code. (j) Manufacturer means a corporation or other entity in the public or private sector engaged in the business or function (whether directly or through an agent or an entity controlled by or under contract with it) of manufacturing a product within the scope of this Code. (k) Marketing means product promotion, distribution, selling, advertising, product public relations, and information services. (l) Marketing personnel means any person whose functions involve the marketing of a product or products coming within the scope of this Code. (m) Sample means single or small quantities of a product provided without costs.

Food Safety Laws 7 (n) Supplies means quantities of a product provided for use over an extended period, free or at a low price, for social purposes, including those provided to families in need. Section 5. Information and Education (a) The government shall ensure that objective and consistent information is provided on infant feeding, for use by families and those involved in the field of infant nutrition. This responsibility shall cover the planning, provision, design and dissemination of information, and the control thereof, on infant nutrition. (b) Information and educational materials, whether written, audio, or visual, dealing with the feeding of infants and intended to teach pregnant women and mothers of infants, shall include clear information on all the following points: (1) the benefits and superiority of breastfeeding; (2) maternal nutrition, and the preparation for and maintenance of breastfeeding; (3) the negative effect on breastfeeding of introducing partial bottle-feeding; (4) the difficulty of reversing the decision not to breastfeed; and (5) where needed, the proper use of infant formula, whether manufactured indus-

8 COMPENDIUM OF RTF LAWS trially or home-prepared. When such materials contain information about the use of infant formula, they shall include the social and financial implications of its use; the health hazards of inappropriate foods or feeding methods; and, in particular, the health hazards of unnecessary or improper use of infant formula and other breastmilk substitutes. Such materials shall not use any picture or text which may idealize the use of breastmilk substitutes. Section 6. The General Public and Mothers (a) No advertising, promotion or other marketing materials, whether written, audio or visual, for products, within the scope of this Code shall be printed, published, distributed, exhibited and broadcast unless such materials are duly authorized and approved by an inter-agency committee created herein pursuant to the applicable standards provided for in this Code. (b) Manufacturers and distributors shall not be permitted to give, directly, or indirectly, samples and supplies of products within the scope of this Code or gifts of any sort to any member of the general public, including members of their families, to hospitals and other health institutions, as well as to personnel within the health care system, save as otherwise provided in this Code.

Food Safety Laws 9 (c) There shall be no point-of-sale advertising, giving of samples or any other promotion devices to induce sales directly to the consumers at the retail level, such as special displays, discount coupons, premiums, special sales, bonus and tie-in sales for the products within the scope of this Code. This provision shall not restrict the establishment of pricing policies and practices intended to provide products at lower prices on a long term basis. (d) Manufacturers and distributors shall not distribute to pregnant women or mothers of infants any gifts or articles or utensils which may promote the use of breastmilk substitutes or bottle feeding, nor shall any other groups, institutions or individuals distribute such gifts, utensils or products provided by this Code. (e) Marketing personnel shall be prohibited from advertising or promoting in any other manner the products covered by this Code, either directly or indirectly, to pregnant women or with mother of infants, except as otherwise provided by this Code. (f) Nothing herein contained shall prevent donations from manufacturers and distributors of products within the scope of this Code upon request by or with the approval of the Ministry of Health.

10 COMPENDIUM OF RTF LAWS Section 7. Health Care System (a) The Ministry of Health shall take appropriate measures to encourage and promote breastfeeding. It shall provide objective and consistent information, training and advice to health workers on infant nutrition, and on their obligations under this Code. (b) No facility of the health care system shall be used for the purpose of promoting infant formula or other products within the scope of this Code. This Code does not, however, preclude the dissemination of information to health professionals as provided in Section 8(b). (c) Facilities of the health care system shall not be used for the display of products within the scope of this Code, or for placards or posters concerning such products. (d) The use by the health care system of professional service representatives, mothercraft nurses or similar personnel, provided or paid for by manufacturers or distributors, shall not be permitted. (e) In health education classes for mothers and the general public, health workers and community workers shall emphasize the hazards and risks of the improper use of breastmilk substitutes particularly infant formula. Feeding with infant formula

Food Safety Laws 11 shall be demonstrated only to mothers who may not be able to breastfeed for medical or other legitimate reasons. Section 8. Health Workers (a) Health workers shall encourage and promote breastfeeding and shall make themselves familiar with objectives and consistent information on maternal and infant nutrition, and with their responsibilities under this Code. (b) Information provided by manufacturers and distributors to health professionals regarding products within the scope of this Code shall be restricted to scientific and factual matters and such information shall not imply or create a belief that bottlefeeding is equivalent or superior to breastfeeding. It shall also include the information specified in Section 5(b). (c) No financial or material inducements to promote products within the scope of this Code shall be offered by manufacturers or distributors to health workers or members of their families, nor shall these be accepted by the health workers or members of their families, except as otherwise provided in Section 8(e). (d) Samples of infant formulas or other products within the scope of this Code, or of equipment or utensils for their preparation or use, shall not be provided

12 COMPENDIUM OF RTF LAWS to health workers except when necessary for the purpose of professional evaluation or research in accordance with the rules and regulations promulgated by the Ministry of Health. No health workers shall give samples of infant formula to pregnant women and mothers of infants or members of their families. (e) Manufacturers and distributors of products within the scope of this Code may assist in the research, scholarships and continuing education, of health professionals, in accordance with the rules and regulations promulgated by the Ministry of Health. Section 9. Persons Employed by Manufacturers and Distributors - Personnel employed in marketing products within the scope of this Code shall not, as part of their job responsibilities, perform educational functions in relation to pregnant women or mothers of infants. Section 10. Containers/Label (a) Containers and/or labels shall be designed to provide the necessary information about the appropriate use of the products, and in such a way as not to discourage breastfeeding. (b) Each container shall have a clear, conspicuous and easily readable and understandable message in Pilipino

Food Safety Laws 13 or English printed on it, or on a label, which message can not readily become separated from it, and which shall include the following points: (i) the words Important Notice or their equivalent; (ii) a statement of the superiority of breastfeeding; (iii) a statement that the product shall be used only on the advice of a health worker as to the need for its use and the proper methods of use; and (iv) in stru ctio ns f or a ppropria t e p rep aratio n , a nd a w a rning again st th e hea lt h ha z a rds of inappropriate preparation. (c) Neither the container nor the label shall have pictures or texts which may idealize the use of infant formula. They may, however, have graphics for easy identification of the product and for illustrating methods of preparation. (d) The term humanized, maternalized or similar terms shall not be used. (e) Food products within the scope of this Code marketed for infant feeding, which do not meet all the requirements of an infant formula but which can be modified to do so, shall carry on the label a warning that the unmodified product should not be the sole source of nourishment of an infant.

14 COMPENDIUM OF RTF LAWS (f) The labels of food products within the scope of this Code shall, in addition to the requirements in the preceding paragraphs, conform with the rules and regulations of the Bureau of Food and Drugs. Section 11. Quality (a) The quality of products is an essential element for the protection of the health of infants, and therefore shall be of high recognized standard. (b) Food products within the scope of this Code shall, when sold or otherwise distributed, meet applicable standards recommended by the Codex Alimentarius Commission and also the Codex Code of Hygienic Practice for Foods for Infants and Children. (c) To prevent quality deterioration, adulteration or contamination of food products within the scope of this Code, distribution outlets, including the smallest sari-sari store, shall not be allowed to open cans and boxes for the purpose of retailing them by the cup, bag or in any other form. Section 12. Implementation and Monitoring (a) For purposes of Section 6(a) of this Code, an inter-agency committee composed of the following members is hereby created: > Minister of Health - Chairman > Minister of Trade and Industry Member

Food Safety Laws 15 > Minister of Justice - Member > Minister of Social Services and Development - Member The members may designate their duly authorized representative to every meeting of the Committee. The Committee shall have the following powers and functions: (1) T o review and examine all advertising, promotion or other marketing materials, whether written, audio or visual, on products within the scope of this Code; (2) To approve or disapprove, delete objectionable portions from and prohibit the printing, publication, distribution, exhibition and broadcast of, all advertising promotion or other marketing materials, whether written, audio or visual, on products within the scope of this Code; (3) To prescribe the internal and operational procedure for the exercise of its powers and functions as well as the performance of its duties and responsibilities; and (4) To promulgate such rules and regulations as are necessary or proper for the implementation of Section 6(a) of this Code. (b) The Ministry of Health shall be principally responsible for the implementation and

16 COMPENDIUM OF RTF LAWS enforcement of the provisions of this Code. For this purpose, the Ministry of Health shall have the following powers and functions: (1) To promulgate such rules and regulations as are necessary or proper for the implementation of this Code and the accomplishment of its purposes and objectives. (2) To call the assistance of government agencies and the private sector to ensure the implementation and enforcement of, and strict compliance with, the provisions of this Code and the rules and regulations promulgated in accordance herewith. (3) T o cause the prosecution of the violators of this Code and other pertinent laws on products covered by this Code. (4) To exercise such other powers and functions as may be necessary for or incidental to the attainment of the purposes and objectives of this Code. Section 13. Sanctions (a) Any person who violates the provisions of this Code or the rules and regulations issued pursuant to this Code shall, upon conviction, be punished by a penalty of two (2) months to one (1) year imprisonment or a fine of not less than One Thousand Pesos (P1,000.00) nor more than Thirty Thousand Pesos (P30,000.00) or both.

Food Safety Laws 17 Should the offense be committed by a juridical person, the chairman of the Board of Directors, the president, general manager, or the partners and/or the persons directly responsible therefor, shall be penalized. (b) Any license, permit or authority issued by any government agency to any health worker, distributor, manufacturer, or marketing firm or personnel for the practice of their profession or occupation, or for the pursuit of their business, may, upon recommendation of the Ministry of Health, be suspended or revoked in the event of repeated violations of this Code, or of the rules and regulations issued pursuant to this Code. Section 14. Repealing Clause - All laws, orders, issuances, and rules and regulations or parts thereof inconsistent with this Executive Order are hereby repealed or modified accordingly. Section 15. Separability Clause - The provisions of this Executive Order are hereby deemed separable. If any provision thereof be declared invalid or unconstitutional, such invalidity or unconstitutionality shall not affect the other provisions which shall remain in full force and effect. Section 16. Effectivity - This Executive Order shall take effect thirty (30) days following its publication in the Official Gazette. Done in the City of Manila, this 20th day of October, in the year of Our Lord, nineteen hundred and eighty-six.

18 COMPENDIUM OF RTF LAWS Republic of the Philippines Congress of the Philippines Metro Manila Fifth Regular Session Begun and held in Metro Manila, on Monday, the twenty second day of July, nineteen hundred and ninety-one. REPUBLIC ACT NO. 7600 AN ACT PROVIDING INCENTIVES TO ALL GOVERNMENT AND PRIVATE HEALTH INSTITUTIONS WITH ROOMING-IN AND BREASTFEEDING PRACTICES AND FOR OTHER PURPOSES Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled: Section 1. Title.- This Act shall be known as The Rooming-In and Breastfeeding Act of 1992. Section 2. Declaration of Policy.- The Senate adopts rooming-in as a national policy to encourage, protect and support the practice of breastfeeding. It shall create an environment where basic physical, emotional, and psychological needs of mothers and infants are fulfilled through the practice of roomingin and breastfeeding. Breastfeeding has district advantages which benefit the infant and the mother, including the

Food Safety Laws 19 hospital and the country that adopts its practice. It is the first preventive health measure that can be given to the child at birth. It also enhances mother-infant relationship. Furthermore, the practice of breastfeeding could save the country valuable foreign exchange that may otherwise be used for milk importation. Breastmilk is the best food since it contains essential nutrients completely suitable for the infants needs. It is also natures first immunization enabling the infant to fight potential serious infection. It contains growth factors that enhance the maturation of an infants organ system. Section 3. Definition of Terms.- For purposes of this Act, the following definitions are adopted: a) Age of gestation - the length of time the fetus is inside the mothers womb. b) Bottlefeeding - the method of feeding an infant using a bottle with artificial nipples, the contents of which can be any type of fluid. c) Breastfeeding - the method of feeding an infant directly from the human breast. d) Breastmilk - the human milk from a mother. e) Expressed breastmilk - the human milk which has been extracted from the breast by hand or by breast pump. It can be fed to an infant using a dropper, a nasogastric tube, a cup and spoon, or a bottle.

20 COMPENDIUM OF RTF LAWS f) Formula feeding - the feeding of a new born with infant formula usually by bottlefeeding. It is also called artificial feeding. g) Health institutions - are hospitals, health infirmaries, health centers, lyingin centers or puericulture centers with obstetrical and pediatric services. h) Health personnel - are professionals and workers who manage and/or administer the entire operations of health institutions and/ or who are involved in providing maternal and child health services. i) Infant - a child within zero (0) to twelve (12) months of age. j) Infant formula - the breastmilk substitute formulated industrially in accordance with applicable Codex Alimentarius standards, to satisfy the normal nutritional requirements of infants up to six (6) months of age, and adopted to their physiological characteristics. k) Lactation management - the general care of a mother-infant nursing couple during the mothers prenatal, immediate postpartum and postnatal periods. It deals with educating and providing knowledge and information to pregnant and lactating mothers on the advantages of breastfeeding, the physiology of lactation,the establishment and maintenance of lactation, the proper

Food Safety Laws 21 care of the breast and nipples, and such other matters that would contribute to successful breastfeeding. l) Low birth weight infant - a newborn weighing less than two thousand five hundred (2,500 ) grams at birth. m) Mothers milk - the breastmilk from the newborns own mother. n) Rooming-in - the practice of placing the newborn in the same room as the mother right after delivery up to discharge to facilitate mother-infant bonding and to initiate breastfeeding. The infant may either share the mothers bed or be placed in a crib beside the mother. o) Seriously ill mothers - are those who are with severe infections, in shock, in severe cardiac or respiratory distress or dying or those with other conditions that may be determined by the attending physicians as serious. p) Wet-nursing - the feeding of a newborn from another mothers breast when his/ her own mother cannot breastfeed. CHAPTER 1 Rooming-In and Breastfeeding of Infants Section 4. Applicability.- The provisions in this chapter shall apply to all private and government health institutions adopting rooming-in and breastfeeding as defined in this Act.

22 COMPENDIUM OF RTF LAWS Section 5. Normal Spontaneous Deliveries.- the following newborn infants shall be put to the breast of the mother immediately after birth and forthwith roomed-in within thirty (30) minutes. a) well infants regardless of age gestation; and b) infants with low birth weights but who can suck. Section 6. Deliveries by Caesarian.- Infants delivered by caesarian section shall be roomed-in and breastfed within three (3) to four (4) hours after birth. Section 7. Deliveries Outside Health Institutions.- Newborns delivered outside health institutions whose mothers have been admitted to the obstetrics department/unit and who both meet the general conditions stated in Section 5 of this Act, shall be roomed-in and breastfed immediately. Section 8. Exemptions.- Infants whose conditions do not permit rooming-in and breastfeeding as determined by the attending physician, and infants whose mothers are either a) seriously ill; b) taking medications contraindicated to breastfeeding; c) violent psychotics; or d) whose conditions do not permit breastfeeding and rooming-in as determined by the attending physician shall be exempted from the provisions of Section 5, 6 and 7: Provided, That these infants shall be fed expressed breastmilk or wet-nursed as may be determined by the attending physician.

Food Safety Laws 23 Section 9. Right of the Mother to Breastfeed.- It shall be the mothers right to breastfeed her child who equally has the right to her breastmilk. Bottlefeeding shall be allowed only after the mother has been informed by the attending health personnel of the advantages of breastfeeding and the proper techniques of infant formula feeding and the mother has opted in writing to adopt infant formula feeding for her infant. CHAPTER II Human Milk Bank Section 10. Provision of Facilities for Breastfeeding Collection and Storage.- The health institution adopting rooming-in and breastfeeding shall provide equipment, facilities, and supplies for breastmilk collection, storage and utilization, the standards of which shall be defined by the Department of Health. CHAPTER III Information, Education and Re-education Drive Section 11. Continuing Education, Re-education and Training of Health Personnel.- The Department of Health with the assistance of other government agencies, professional and non-governmental organizations shall conduct continuing information, education, re-education,

24 COMPENDIUM OF RTF LAWS and training programs for physicians, nurses, midwives, nutritionist-dietitians, community health workers and traditional birth attendants (TBAs) and other health personnel on current and updated lactation management. Information materials shall be given to all health personnel involved in maternal and infant care in health institutions. Section 12. Information Dissemination to Pregnant Women.During the prenatal, perinatal and postnatal consultations and/or confinements of the mothers or pregnant women in a health institution, it shall be the obligation of the health institution and the health personnel to immediately and continuously teach, train, and support the women on current and updated lactation management and infant care, through participatory strategies such as organization of mothers clubs and breastfeeding support groups and to distribute written information materials on such matters free of charge. CHAPTER IV Miscellaneous Provisions Section 13. Incentives.- The expenses incurred by a private health institution in complying with the provisions of this Act, shall be deductible expenses for income tax purposes up to twice the actual amount incurred: Provided, That the deduction shall apply for the taxable period when the

Food Safety Laws 25 expenses were incurred: Provided, further, That the hospitals shall comply with the provisions of this Act within six (6) months after its approval. Government health institutions shall receive an additional appropriation equivalent to the savings they may derive as a result of adopting roomingin and breastfeeding. The additional appropriation shall be included in their budget for the fiscal year. 14. Sanctions.- The Secretary of Health is hereby empowered to impose sanctions for the violation of this Act and the rules issued thereunder. Such sanctions may be in the form of reprimand or censure and in cases of repeated wilful violations, suspension of the permit to operate of the erring health institutions. 15. Rules and Regulations.- The Secretary of Health, in consultation with other government agencies, professional and non-government organizations concerned shall promulgate the rules and regulations necessary to carry out the provisions of this Act. 16. Repealing Clause.- All acts, laws, decrees executive orders, rules and regulations or parts thereof, which are contrary to or inconsistent with this Act are hereby repealed, amended or modified accordingly. 17. Separability Clause.- If any clause, sentence, paragraph or part of this Act shall be declared

Section

Section

Section

Section

26 COMPENDIUM OF RTF LAWS to be invalid, the remainder of this Act or any provision not affected thereby shall remain in force and effect. Section 18. Effectivity.- This Act shall take effect one hundred twenty (120) days after publication in at least two (2) newspapers of general circulation. Approved, (Sgd.) Ramon V. Mitra Speaker of the House of Representatives (Sgd.) Neptali A. Gonzales President of the Senate This Act which is a consolidation of Senate Bill No. 1466 and House Bill No. 34369 was finally passed by the Senate and the House of Representatives on February 5, 1992 and February 4, 1992, respectively. (Sgd.) Camilo L. Sabio Secretary General House of Representatives (Sgd.) Anacleto D. Badoy, Jr. Secretary of the Senate Approved: June 2, 1992 (Sgd.) Corazon C. Aquino President of the Philippines

Food Safety Laws 27 REPUBLIC OF THE PHILIPPINES CONGRESS OF THE PHILIPPINES METRO MANILA FIRST REGULAR SESSION Begun and held in Metro Manila on Monday the twenty-fourth day of July, nineteen hundred and ninety-five. [ REPUBLIC ACT NO. 8172 ] AN ACT PROMOTING SALT IODIZATION NATIONWIDE AND FOR RELATED PURPOSES Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled. Section 1. Title - This Act shall be known as An Act for Salt Iodization Nationwide (ASIN). Section 2. Declaration of Policy - It is hereby declared the policy of the state to protect and promote the health of the people, to maintain an effective food regulatory system and to provide the entire population especially women and children with proper nutrition. For this purpose, the State shall promote the nutritional fortification of food and combat micronutrient malnutrition as a priority health program for the nation. Section 3. Purposes - The purposes of this Act are to: a) contribute to the elimination of the micronutrient malnutrition in the country,

28 COMPENDIUM OF RTF LAWS particularly iodine deficiency disorders, through the cost-effective preventive measure of salt iodization; b) require all producers/manufacturers of food-grade salt to iodize the salt that they produce, manufacture, import, trade or distribute; c) require the Department of Health (DOH) to undertake the salt iodization program and for its Bureau of Food and Drugs (BFAD) to set and enforce standards for food-grade iodized salt and to monitor compliance thereof by the food-grade salt manufacturers; d) require the local government units (LGU), through their health officers and nutritionist/dietitians, or in their absence through their sanitary inspectors, to check and monitor the quality of foodgrade salt being sold in their market in order to ascertain that such salt is properly iodized; e) require the Department of Trade and Industry (DTI) to regulate and monitor trading of iodized salt; f) direct the Department of Science and Technology (DOST) in collaboration with the Technology and Livelihood Resource Center (TLRC) to initiate, promote, and cause the transfer of technology for salt iodization

Food Safety Laws 29 g) authorize the National Nutrition Council (NNC) the policy-making and coordinating body in nutrition, to serve as the advisory board on salt iodization; h) provide mechanisms and incentives for the salt industry in the production, marketing and distribution of iodized salt; and i) ensure the sustainability of the salt iodization program. Section 4. Definition of Terms - For purposes of this Act, the following terms shall mean: a) Micronutrient malnutrition - a disorder resulting from deficiencies in Vitamin A, iron, iodine and other micronutrients which the body needs in minute quantities everyday. b) Iodine deficiency disorders - a broad spectrum of deficiencies resulting from lack of iodine in the diet which leads to the reduction of intellectual and physical capacity affecting everyone who is iodine deficient and may manifest as goiter, mental retardation, physical and mental defects, and cretinism. c) Food fortification - the addition of nutrients to processed foods at levels above the natural state. d) S alt io d izatio n - t he a ddit ion o f iodine to salt intended for human or animal consumption in accordance

30 COMPENDIUM OF RTF LAWS with specifications as to form, fortificant, methods, manner and composition as may be prescribed by the BFAD. e) Food-grade salt - salt for human and animal consumption as distinguished from industrial salt. f) Regu lato ry req uire m ent s - t he provision of all applicable laws, regulations, executive orders, and other enactments related to food quality and safety, purity, nutritional composition and other aspects of food regulation or control. g) Industrial salt - salt used in the treatment, processing and/or manufacture of nonfood commercial products. h) Manufacturer - one who produces , imports trades and distributes salt. i) Subsistence producer/manufacturer - one who produces, trades in or distributes salt not exceeding two metric tons (2m.t.) of salt per year. j) Small producer/manufacturer - one who produces, imports trades in or distributes salt ranging from more than two metric tons (2m.t.) to three hundred metric tons (300m.t.) per year. k) Medium producer/manufacturer - one who produces, imports trades in, or distributes salt ranging from more than

Food Safety Laws 31 three hundred metric tons (300m.t.) to two thousand metric tons (2,000m.t.) per year. l) Large p ro d u cer/m a nuf a c t urer one who produces, imports trades in, or distributes salt exceeding two thousand metric tons (2,000m.t.)per year Section 5. Applicability. a) This act shall apply to the entire salt industry, including salt producers/ manufacturers, importers, traders and distributors, as well as government and non-government agencies involved in salt iodization activities. b) Iodized salt that conforms to the standards set by the BFAD to meet national nutritional needs shall be made available to consumers, Provided, That the implementation of this act shall be enforced over a staggered period of one (1) year for large and medium producers/manufacturers, two (2) years for small salt producers/manufacturers and five (5) years for subsistence producers/ manufacturers. c) All food outlets, restaurants, and stores are hereby required to make available to customers only iodized salt in their establishment upon effectivity of this Act.. These establishments shall be monitored with the help of the LGUs through its health officers and nutritionists/ dietitians or in their absence, the sanitary

32 COMPENDIUM OF RTF LAWS inspectors to check and monitor the quality of food-grade salt being sold or served in such establishments. d) In areas endemic to iodine deficiency disorders, iodized salt shall be made available. Local government officials at the provincial and municipal levels shall provide mechanisms to ensure enforcement of this provision through ordinances and public information campaigns. e) All food manufacturer/processors using food-grade salt are also required to use iodized salt in the processing of their products and must comply with the provisions of the Act not later than one (1) year from its effectivity: Provided, That the use of iodized salt shall not prejudice the quality and safety of their food products. Provided, however, That the burden of proof and testing for any prejudicial effects due to iodized salt fortification lies on the said food manufacturer/processor. f) Salt producers/manufacturers shall register with the BFAD which shall maintain updated registry of salt producers/manufacturers and shall monitor compliance with the salt iodization program. g) All food-grade salt shall be labeled in a manner that is true and accurate,

Food Safety Laws 33 not likely to mislead purchasers and in accordance with the requirements prescribed by the BFAD. h) For a period of three (3) years from the effectivity of the Act, the DOH shall provide free iodized salt to indigents residing in sixth class municipalities as may be allowed by their annual appropriations. Section 6. Support to the Salt Industry. - The following agencies and institutions shall support the salt iodization program through their respective internal programs: a) The DTI is hereby required to assist and support local salt producers/manufacturers in upgrading their production technologies to include iodization by helping them obtain soft loans and financial assistance for the procurement of salt iodization machines, packaging equipment and technology and fortificant; and by ensuring systematic distribution of the iodized salt in the market b) The Cooperative Development Authority (CDA) shall assist the formation of cooperatives of local salt producers/ manufacturers in order that they can economically engage in salt iodization and distribution of iodized salt; c) The DOST, in collaboration with the TLRC, shall develop and implement comprehensive programs for the acquisition of design and manufacture

34 COMPENDIUM OF RTF LAWS of salt iodization machines and transfer of salt iodization technology to small and subsistence local salt producers/ manufacturers; and d) The Department of Environment and Natural Resources (DENR) and other appropriate government agencies shall identify areas that are suitable for use as salt farms with the purpose of protecting such areas from environmental risks to ensure sustainability of iodized salt production. Section 7. Public Information - The benefits and rationale of the use of iodized salt shall be adequately disseminated and promoted through organized systematic and nationwide information campaign which shall involve major sectors of society to be spearheaded by the DOH in cooperation and coordination with the LGUs and other government agencies concerned, particularly the Department of Education, Culture and Sports (DECS), the Philippine Information Agency (PIA), provincial science centers, private sectors and students. The implementing agency, in coordination with PIA, shall seek the cooperation of the media sector in public information dissemination. Salt iodization and its benefits shall also be included and given emphasis in all levels of health subjects in both private and public schools.

Food Safety Laws 35 Section 8. The Salt Iodization Advisory Board - The National Nutrition Council (NNC), as presently composed, including representatives of the DENR, the medical profession and the salt manufacturers shall serve as the salt iodization advisory board and shall function as the policy and coordinating body on salt iodization programs and activities. It shall coordinate the efforts of all agencies concerned and monitor the implementation of the provisions of this Act. It shall also submit an annual report to the Congress of the Philippines on the progress of the salt iodization program and offer recommendations for its improvement. Section 9. Sanctions - The procedures for imposing sanctions under this Act and investigating the premises where any salt is received, held, manufactured, labeled, stored, displayed, delivered, distributed, sold, or located, or where it is reasonably believed these activities are being carried out or where salt is located, shall be in accordance with the provisions of Republic Act No. 7320, otherwise known as the Food, Drugs and Cosmetics Act As Amended. Provided, That any person, whether natural or juridical, who violates any of the provisions of this Act or any of the rules and regulations promulgated for its effective implementation shall be punished by a fine of not less than One thousand pesos (P1,000.00) nor more than One hundred thousand pesos

36 COMPENDIUM OF RTF LAWS (P100,000.00); Provided, however, That if the violation is committed by any officer, director or member of a business and a juridical entity acting beyond the scope of his authority, such officer, director or member responsible therefor shall be personally liable for the fine: Provided, further, That such violation shall suffer a revocation of its business permit and/or ban of its product from the market: Provided, finally, That the BFAD, in coordination with the LGUs concerned, shall be authorized to impose and collect the fines from the violators, and such collections shall accrue to the BFAD for its use in the implementation of this Act. Section 10. Appropriations - The amount necessary for the implementation of this Act shall initially be charged to the appropriations of its agencies concerned as may be appropriated under the current General Appropriations Act. Thereafter, such as amount may be necessary for its implementation shall be included in the annual General Appropriations Act. Section 11. Implementing Rules and Regulations - The DOH in cooperation with the agencies concerned shall formulate the necessary rules and regulations for the effective implementation of this Act within sixty (60) days from its approval. Section 12. Separability Clause - If any portion of this Act is declared invalid, the remainder of this Act shall not be affected by such declaration and shall remain valid and enforceable.

Food Safety Laws 37 Section 13. Effectivity Clause - This Act shall take effect fifteen (15) days after its publication in the Official Gazette or in two (2) national newspapers of general circulation, whichever is earlier. Approved. (Sgd) JOSE DE VENECIA Speaker of the House of Representatives (Sgd) NEPTALI A. GONZALES President of the Senate This Act which is a consolidation of Senate Bill No. 1132 and House Bill No. 45 was finally passed by the Senate and the House of Representatives on November 16, 1995 and November 15, 1995, respectively. (Sgd) CAMILO L. SABIO Secretary General House of Representatives (Sgd) HEZEL P. GACUTAN Secretary of the Senate Approved: December 20, 1995 (Sgd) FIDEL V. RAMOS President of the Philippines

38 COMPENDIUM OF RTF LAWS IMPLEMENTING RULES AND REGULATIONS OF REPUBLIC ACT No. 8172 AN ACT PROMOTING SALT IODIZATION NATIONWIDE AND FOR RELATED PURPOSES BACKGROUND Pursuant to Section 2 of the Republic Act No. 8172, entitled An Act Promoting Salt Nationwide (ASIN), approved by the President on 20 December 1995 and which took effect on 20 January 1996, mandating the Department of Health (DOH) as the lead agency in the implementation of said Act and, in accordance with Section 11 of said Act mandating the DOH to formulate the Implementing Rules And Regulations (IRR) in cooperation with the other government agencies involved in the implementation of the law, the following Rules and Regulations are hereby adopted to implement effectively the provisions of R.A. No. 8172. RULE I COVERAGE Section 1. These Rules and Regulations shall apply to: a) All producers/manufacturers/importers/ traders of salt for human or animal consumption, b) All restaurants and other food establishments where food is being served hot or cold, c) All food manufacturers/processors using

Food Safety Laws 39 salt in their manufacturing processes, d) All local government units (LGUs) e) All other government agencies, f) All non governmental agencies and related professional organizations; and g) All government and private hospitals and other institutions. RULE II INTERPRETATIONS Section 2. These Rules and Regulations shall be construed in a manner that can achieve the objectives of R.A. 8172 namely: a) to contribute to the elimination of micronutrient malnutrition, particularly iodine deficiency disorders; b) to require salt producers/manufacturers to iodize the salt they manufacture, produce, distribute, trade and/or import; c) for the government agencies to undertake their roles and responsibilities in carrying out the provisions of this Act; d) for the food processing and the food service industries to use only iodized salt; e) to provide mechanisms and incentives for the salt industry; and f) to ensure the sustainability of the salt iodization program.

40 COMPENDIUM OF RTF LAWS Any question or doubt as to the intent and meaning of the provisions shall be construed or resolved in accordance with the Policy and Purposes as provided in R.A. 8172. RULE III DEFINITION OF TERMS In the implementation of the Act, terms that have specific meaning shall be construed in accordance with the general definitions provided in Section 4 of the Act, to wit: a) Distribution - means the exchange, transmittal, conveyance, consignment, supply, delivery, trade, sale, or disposal of food-grade salt, whether for remuneration or other considerations. b) Distributor - refers to an establishment which distributes, sells or imports salt for distribution to retailers. c) Fortificant - in relation to the process of salt iodization, the term shall refer to potassium iodate or other suitable fortificant as recommended by DOH, taking into consideration the circumstances of quality, effectiveness, stability, availability and new discoveries that can bring salt iodization in the most effective and economic manner. d) Food fortification - the addition of nutrients to processed foods at levels above the natural state. e) Food-grade salt - refers to salt for human and animal consumption as distinguished from industrial salt.

Food Safety Laws 41 f) Food manufacturers/processors - refer to the business/enterprise of manufacturing or processing food using salt in their products. g) Food service establishments - refers to hotels, restaurants, carinderias, catering firms, hospitals and other related outlets which serve or sell food to consumer. h) Industrial salt - refers to salt used in the treatment, processing, and/or manufacture of non-food commercial products. i) Iodine deficiency disorders - a broad spectrum of manifestations resulting from lack of iodine in the diet which leads to the reduction of intellectual and physical capacity affecting everyone who is iodine deficient and may manifest as goiter, mental retardation, physical and mental defects, and cretinism. j) Manufacturer - one who produces, imports, trades in and distributes salt and is categorized as follows: Large producer/manufacturer - one who produces, imports, trades and/or distributes salt exceeding two thousand metric tons (2,000 MT) per year. Medium producer/manufacturer - one who produces, imports, trades and/or distributes salt ranging from more than three hundred metric tons (300 MT) to two thousand metric tons (2,000 MT) per year Small salt producer/manufacturer - one who produces, imports, trades and/or distributes salt ranging from more than two metric tons (2 MT) to three hundred metric tons (300 MT) per year Subsistence producer/manufacturer - one who produces, imports, trades and/or distributes salt not exceeding two metric tons (2 MT) of salt per year

42 COMPENDIUM OF RTF LAWS k) Method - refers to the scientifically accepted technique that is perceived to bring about the best and most effective way of salt iodization. l) Micronutrient malnutrition - refers to a disorder resulting from deficiencies in vitamin A, iron, iodine and other micronutrients which the body needs in minute quantities every day. m) Registration - the process of acquiring a business/ enterprise license/permit to manufacture, produce, trade or import iodized salt with the Bureau of Food and Drugs (BFAD) or appropriate LGU. n) Regulatory Requirements - the provisions of all applicable laws, regulations, executive orders, and other enactments related to food quality and safety, purity, nutritional composition, and other aspects of food regulations and control. In applying or interpreting the regulatory requirements, reference may also be made to scientifically accepted standards or regulations. o) Salt industry - refers to the business sector engaged in the production, distribution, trading, retailing and importation of salt. p) Salt iodization - the addition of iodine to salt intended for human or animal consumption in accordance with specifications as to form, fortificant, method, manner and composition as may be prescribed by the BFAD of the DOH. q) Salt Iodization Advisory Board (SIAB) - composed of the National Nutrition Council (NNC) Governing Board, including a representative each from the Department of Environment and Natural Resources

Food Safety Laws 43 (DENR), the medical profession, and the salt manufacturers. r) Stores - refer to department stores, shops, groceries, mini-marts, and other outlets which wholesale or retail iodized salt for the consumers and users. s) Trading - refers to the buying and selling of foodgrade salt by wholesale or retail. RULE IV STANDARDS and REQUIREMENTS Section 1. Iodized salt to be sold/distributed in the Philippines, whether locally produced or imported, shall conform with the standards formulated by the BFAD of DOH which is in Annex 1 of these implementing rules and regulations. Such standards shall be periodically reviewed and updated by the BFAD in consultation with the SIAB and other concerned parties. Section 2. Failure to comply with the quality specifications and labeling requirements prescribed in the standards shall mean a violation of the provisions on adulteration and misbranding under Sections 14 and 15 of R.A. 3720, otherwise known as the Food, Drugs and Cosmetics Act, as amended and the relevant provisions of RA 7394 otherwise known as the Consumer Act of the Philippines.

44 COMPENDIUM OF RTF LAWS Section 3. To ensure the quality of iodized salt prior to distribution, all manufacturers of iodized salt shall conduct routine quality assurance activities. Such activities shall include, but shall not be limited to the following: a. Iodine levels testing: at regular intervals on a daily basis, samples of iodized salt shall be collected from the production line and tested for iodine content. b. Equipment inspection: at least twice daily to ensure its proper operation. c. Mixing process: shall be monitored regularly to ensure consistent mixing and homogeneity of iodine content in the batch being processed. d. Monitoring of salt ready for distribution: each lot shall be sampled to ensure conformity to prescribed iodine level. e. Packaging and labelling inspection shall be routinely conducted to ensure the integrity of the package and conformity to prescribed labelling requirements. f. Record keeping: daily control charts and weekly summaries of activities and corrective actions taken shall be maintained for a period of at least 12 months from date of manufacture. Manufacturers of iodized salt shall

Food Safety Laws 45 provide traders with a Certificate of Iodization of the specified batch or lot sold to the traders. Section 4. Iodized salt shall be distributed and sold according to the principle of first in, first out. Iodized salt may be sold at retail or final distribution points within a period of not more than 12 months from the date of manufacture, after which it shall be considered expired. Expired salt shall be replaced by or returned to the last seller or distributor in the manufacturingdistribution chain. Section 5. The DOH shall put in place a system to monitor the quality of iodized salt in collaboration with the LGUs and the Department of Interior and Local Government (DILG). It shall also seek the assistance of the Department of Finance (DOF) and LGUs to determine the volume of production and sale of the locally manufactured and imported iodized salt. Section 6. Until such time when all food-grade salt shall be iodized in accordance with RA 8172, salt manufacturers/ producers, traders and retailers shall maintain the proper identification and segregation of iodized salt from non-iodized salt in storage and during display at retail. They shall make sure that salt buyers or

46 COMPENDIUM OF RTF LAWS consumers get the appropriate kind of salt they purchase. Section 7. Within one (1) year from the effectivity of the Act, all food manufacturers, and processors shall utilize iodized salt in their products except when the use of iodized salt will have an adverse effect on a specified product. In such cases, the food manufacturers/ processors shall present appropriate evidence to the BFAD which shall serve as basis for exemption from compliance with Section 5(e) of this Act. The BFAD shall submit to the SIAB a list of food manufacturers utilizing iodized salt and those with definite exemption, and shall update this list annually. RULE V REGISTRATION OF IODIZED SALT MANUFACTURERS AND SALT IMPORTERS/DISTRIBUTORS Section 1. All iodized salt manufacturers and salt importers/distributors shall register with the BFAD according to the following schedule: The large and medium manufacturers shall register within one (1) year from the effectivity of this Act; small manufacturers within two (2) years, and subsistence manufacturers within five (5) years. After the effectivity of the IRR, new salt producers/manufacturers shall register before operation.

Food Safety Laws 47 Section 2. The BFAD shall issue a License to Operate (LTO) to iodized salt manufacturers and salt importers/distributors upon their compliance with prescribed documentary and technical requirements in Annexes 2 and 3. Those engaged in manual salt iodization shall secure a Certificate of Training from DOH before they can be provided with a LTO. If an importer is already holding a valid LTO as importer, he/she need not apply for another license; however, the importer must comply with the technical requirements and their products shall be subject to monitoring. Section 3. The BFAD may delegate to the LGUs its authority to issue LTOs in cities and municipalities other than those in the National Capital Region (NCR) and in areas where the seat or office of the DOHRegional Field Offices (RFOs) is located, through a memorandum of agreement between the BFAD and the LGU, or the BFAD and the RFO, with the suggested terms and conditions contained in Annex 4 hereof. Such agreements shall be considered part of these IRR. Section 4. All distributors/traders of locally produced iodized salt, whether or not engaged in repacking iodized salt from bulk to retail containers, shall register with the LGUs.

48 COMPENDIUM OF RTF LAWS RULE VI ROLE OF AGENCIES CONCERNED IN THE SALT IODIZATION PROGRAM Section 1. The DOH shall lead in the implementation of this Act. Specifically, it shall: a) Spearhead a public information drive in cooperation and coordination with the LGUs and other agencies particularly the Department of Education, Culture and Sports (DECS), Philippine Information Agency (PIA), Provincial Science Centers-Department of Science and Technology (DOST), private sector and students. All sectors in the salt industry shall also assist in such information campaign through tri-media and all other social marketing activities for a systematic and sustained public information campaign; b) Provide training on salt iodization technology and quality assurance and control through its Nutrition Service (NS) in coordination with the DOST and the Technology and Livelihood Resource Center (TLRC); and c) Set and enforce standards for foodgrade iodized salt and monitor compliance thereof by the foodgrade salt manufacturers through its BFAD.

Food Safety Laws 49 Section 2. The LGUs shall support the development and sustainability of the salt industry through: a) The formulation of ordinances and information campaigns promoting the availability and use of iodized salt. b) Provision of budget for health and nutrition programs; c) Assistance to other government agencies in the implementation of the salt iodization program; d) Monitoring the quality of salt as provided by law through its respective health officers and nutritionist-dietitians or, in their absence, through the sanitary inspectors; and e) Establishment and maintenance of a list of salt producers in their respective territorial jurisdiction. A list of registered salt producers in every province shall be submitted to the BFAD within 6 months from the effectivity of these IRR and shall be updated annually. The list shall reflect the following information per salt producer/manufacturer: 1) Name and address of company and/ or owner 2) Location of salt production site (sitio/ barangay)

50 COMPENDIUM OF RTF LAWS 3) Annual production capacity (in metric tons) 4) Types of salt produced: i) food-grade (coarse or fine) - iodized salt - non-iodized salt ii) industrial salt 5) Distribution channels, such as: - direct sale to consumers within the province - traders within the province - traders from other provinces/ regions - food manufacturers within the province - food manufacturers outside the province/region Section 3. The Department of Trade and Industry (DTI) shall assist and support local salt producers/manufacturers in upgrading their production technologies to include iodization by helping them obtain soft loans and financial assistance for the procurement of salt iodization machines, packaging equipment and technology, and fortificants; and by ensuring the systematic distribution of the iodized salt in the market. Specifically, it shall: a) Regulate and monitor the trading of iodized salt in accordance with R.A. 7581 otherwise known as the Price Act;

Food Safety Laws 51 b) Provide incentives to the salt industry by including salt iodization as a priority investment program of the government through its Board of Investment; c) Assist salt producers/manufacturers to obtain soft loans for machines, equipment and other materials such as fortificant and other chemicals needed to upgrade the salt industry, through its Bureau of Small and Medium Business Development (BSMBD) and Small Business Guarantee and Finance Corporation (SBGFC); and d) Provide assistance to salt producers/ manufacturers on matters of package design and packaging technology through its Product Development and Design Center of the Philippines (PDDCP). Section 4. The Department of Science and Technology (DOST) shall develop and implement a comprehensive program for the acquisition of, design, and manufacture of salt iodization equipment, and transfer of the salt iodization technology to salt producers/manufacturers. Section 5. The Technology and Livelihood Resource Center (TLRC) shall: a) Assist the DOST in the development and implementation of a comprehensive program for the acquisition of design and

52 COMPENDIUM OF RTF LAWS manufacture of salt iodization machines and transfer of salt iodization technology to small and subsistence local salt producers/manufacturers; b) Provide funding assistance to qualified small producers, especially if located in one of the priority provinces in support of the governments poverty alleviation and industry decentralization drive; c) Develop a program of training entrepreneurs in setting up micro/ cottage/small business enterprises to be located in its Technology and Livelihood Resource Center (TLRC) in the provinces; d) Undertake an all-out information campaign to promote the use of iodized salt nationwide through its tri-media information program and in its business technology courses. Section 6. The Cooperative Development Authority (CDA) shall provide assistance to the small and subsistence salt producers/ manufacturers so that they may organize themselves into cooperatives and undertake salt iodization and marketing of iodized salt in the spirit of cooperativism. The organized cooperatives shall be registered in accordance with the CDA guidelines, rules, regulations and applicable laws.

Food Safety Laws 53 Section 7. The Department of Environment and Natural Resources (DENR) shall provide assistance to the prospective salt producers/manufacturers in identifying suitable land areas appropriate for use as salt works/farms. The conversion of such lands into salt farms shall require the concurrence of the landowner and the concerned agency/entity. The DENR shall ensure, through the Environmental Impact Statement (EIS) System, that proposed activities near the salt farms do not adversely affect the latter. The DENR shall also monitor the adoption of antipollution control measures by iodized salt producers/manufacturers. Section 8. The Bureau of Customs of the Department of Finance (DOF) shall assist the DOH in monitoring salt importation by providing quarterly reports of entries, including names and addresses of importers/consignees and quantity of shipment. It shall likewise inform the DOH on the quality and quantity of importation of the iodized salt. Section 9. Any assistance to salt producers/ manufacturers/traders/importers shall take into favorable consideration the size and capability of such salt producers as well as their faithful compliance with laws on health, labor and employment, environment, environment and ecology.

54 COMPENDIUM OF RTF LAWS RULE VII ADVISORY BOARD Section 1. Creation of the Salt Iodization Advisory Board - The Salt Iodization Advisory Board (SIAB) shall be composed of all members of the NNC Governing Body namely the Departments of Agriculture; Health; Social Welfare and Development; Education, Culture and Sports; Science and Technology; the Interior and Local Government; Labor and Employment; Trade and Industry; and Budget and Management; the National Economic and Development Authority; its three (3) private sector representatives and a representative from the DENR, the medical profession and the salt manufacturers, as mandated by Section 8 of this Act. The chairman of the NNC Governing Board shall chair the SIAB. The chairman shall convene the SIAB within one (1) month upon the approval of these IRR. Section 2. Role - The SIAB shall function as the policy and coordinating body on the national salt iodization program and activities. It shall coordinate and monitor all activities concerning the salt iodization program from production and marketing, to public information campaign. It shall analyze the effectiveness of the salt iodization activities and then evaluate the progress of

Food Safety Laws 55 the program annually based on the reports submitted by DOH and other concerned agencies in the implementation of this Act. The SIAB shall submit an annual report every end of December to the Congress of the Philippines on the status of the salt iodization program and offer recommendations for its improvement. RULE VIII SANCTIONS Section 1. The BFAD Director is hereby authorized to impose an administrative fine to existing salt producers/manufacturers/importers/ traders based on the applicability of this Act. The provisions of this Act shall be immediately applicable to salt producers/ manufacturers/importers/traders newly established or organized after the effectivity of the Act. The LGUs are authorized to impose an administrative fine to food service establishments and outlets one year after the effectivity of the Act. The administrative fine shall be in the amount of not less than One Thousand Pesos (P1,000.00) but not more than One Hundred Thousand Pesos (P100,000.00), after notice and hearing for violation of any of the provisions of R.A. 8172 or its implementing rules and regulations.

56 COMPENDIUM OF RTF LAWS In the imposition of the said administrative penalty, the imposable fine of One Thousand Pesos (P1,000.00) to Thirty Thousand Pesos (P30,000.00) shall be considered minimum penalty, Thirty One Thousand Pesos (P31,000.00) to Sixty Thousand Pesos (P60,000.00) as medium penalty, and Sixty One Thousand Pesos (61,000.00) to One Hundred Thousand Pesos (P100,000.00) as maximum penalty: provided that the maximum fine shall be in addition to the revocation of the offenders License to Operate, and provided further that in all cases where the subject matter of the offense is a prohibited product, the Director shall order the recall and/or withdrawal of the product from the market. Section 2. When the offense is committed with the following circumstances, the minimum penalty shall be imposed: a) a history or record of satisfactory compliance with the rules and regulations prior to the commission of the offense, or absence of previous violation of R.A. 8172 or its IRR; and b) lack of information on the part of the offender about the rules and regulations or requirements of the subject matter of the violation/offense.

Food Safety Laws 57 Section 3. When the act or omission in violation of R.A. 8172 and its implementing rules and regulations is attended by a manifest intention to mislead, defraud or deceive the consuming public, the maximum fine and revocation of License to Operate shall be imposed. Section 4. The medium penalty shall be imposed when the offense committed is not attended by any of the circumstances described in Section 2 and 3 hereof. Section 5. The BFAD Director may delegate the conduct of administrative investigation of any violation of R.A. 8172 or its IRR to the head of the LGU: provided that the recommendation shall be subject to review and confirmation by the BFAD Director before the same shall be deemed final and executory. In such case, the LGU may be authorized by the BFAD Director to collect the fine that may be imposed provided that such fine collected shall be held in trust for the exclusive use by the investigating LGU in the implementation of this Act. RULE IX SEPARABILITY CLAUSE If any provision of these Implementing Rules and Regulations is declared null and void, for any reason, the

58 COMPENDIUM OF RTF LAWS remaining provisions shall not be affected thereby and shall remain valid. RULE X EFFECTIVITY These Implementing Rules and Regulations shall take effect thirty days after its publication in a newspaper of general circulation. APPROVED HON CARMENCITA NORIEGA-REODICA, M.D., MPH Secretary Department of Health Member, NNC Governing Board HON. SALVADOR H. ESCUDERO III Secretary Department of Agriculture Chairman, National Nutrition Council HON. WILLIAM G. PADOLINA Secretary Department of Science and Technology Member, NNC Governing Board HON. ROBERTO Z. BARBERS Secretary Department of Interior and Local Government Member, NNC Governing Board

Food Safety Laws 59 HON. CESAR B. BAUTISTA Secretary Department of Trade and Industry Member, NNC Governing Board HON. RICARDO T. GLORIA Secretary Department of Education, Culture and Sports Member, NNC Governing Board

HON. HONESTO M. ISLETA Press Undersecretary and Officer-In-Charge Philippine Information Agency HON. VICTOR O. RAMOS Secretary Department of Environment and Natural Resources HON. ROBERTO F. DE OCAMPO Secretary Department of Finance HON. LINA B. LAIGO Secretary Department of Social Welfare and Development Member, NNC Governing Board

60 COMPENDIUM OF RTF LAWS HON. LEONARDO A. QUISUMBING Secretary Department of Labor and Employment Member, NNC Governing Board HON. SALVADOR M. ENRIQUEZ, JR. Secretary Department of Budget and Management Member, NNC Governing Board HON. CIELITO F. HABITO Secretary Department of Socio-Economic Planning Member, NNC Governing Board HON. FLORENTINO S. SOLON Executive Director Nutrition Center of the Philippines Member, NNC Governing Board HON. SUSAN O. PAGDANGANAN National President Rural Improvement Clubs of the Philippines Member, NNC Governing Board HON. ROBERTO M. ADOR Executive Director Philippine Legislators Committee on Population and Development Foundation Inc.

Food Safety Laws 61 HON. QUINTIN L. KINTANAR, M.D.,Ph.D., CESO I Director, Bureau of Food and Drug Department of Health Member, NNC Governing Board HON. ANDRES V. SANCHEZ, JR. Director General Technology and Livelihood Resource Center Office of the President HON. JOSE C. MEDINA JR. Chairman, Cooperative Development Authority HON. MINERVA P. FRANCO Executive Director Product Development and Design Center Of the Philippines Department of Trade and Industry WITNESSES: ASUNCION L. MACALALAG, M.S., Acting Executive Director, National Nutrition Council ADELISA C. RAMOS, MPA, MPH, CESO IV Director III, Nutrition Service Department of Health

62 COMPENDIUM OF RTF LAWS Annex 1 STANDARD FOR IODIZED SALT 1. SCOPE This standard applies to iodized salt used as a condiment or an ingredient in the preparation of food in households, food service and food manufacturing establishments. 2. DESCRIPTION Iodized salt is food-grade salt that contains the prescribed level of iodine. It shall be produced from refined or unrefined (crude) salt obtained from underground rock salt deposits or by evaporation of seawater or natural brine. The finished product shall be in the form of solid crystals or powder, white in color, without visible spots of clay, sand, gravel or other foreign matter. 3. IODIZATION PROCESS 3.1. Salt may be iodized with potassium iodate (KIO3) or potassium iodide (KI) by means of any of the following methods: a. dry mixing if salt is in powdered form b. drip feeding or spray mixing if salt is in crsytal form c. submersion of salt crystals in iodated brine

Food Safety Laws 63 4. ESSENTIAL COMPOSITION AND QUALITY FACTORS 4.1. Purity Requirements To ensure the stability of iodine, salt to be iodized must conform with the following purity requirements: Moisture, max - 4% for refined salt, 7% for unrefined salt NaCl, min - 97% (dry basis) Calcium and Magnesium, max - 2% Water insolubles, max - 0.2% Heavy metal contaminants, max Arsenic as As, 0.5 mg/kg Cadmium as Cd, 0.5 mg/kg Lead as Pb, 2.1 mg/kg Mercury as Hg, 0.1 mg/kg 4.2. Naturally Present Secondary Products and Contaminants in Raw Salt Notwithstanding the purity requirements in section 4.1, the raw salt may contain natural secondary products, which are present in varying amounts depending on the origin and method of production of the salt, and which are composed mainly of calcium, potassium, magnesium and sodium sulphates, carbonates, bromides, and of calcium, potassium, magnesium chlorides as well. Natural contaminants may also be present in amounts varying with the origin and the method of production of the salt.

64 COMPENDIUM OF RTF LAWS 4.3. Iodine Levels In order to meet national nutritional needs, the prescribed levels of iodine (I2) in iodized salt shall be as indicated below: Type of Container/Package
Sampling Point Production Site Port of Entry* Retail Site Bulk (>2 kg) 70 - 150 mg/kg 70 - 150 mg/kg >50 mg/kg Retail (< 2 kg) 60 - 100 mg/kg 60 - 100 mg/kg >40mg/kg

*For imported iodized salt; also at importers/distributors warehouse.

5. FOOD ADDITIVES 5.1 All additives used, including KIO3 and KI, shall be of food-grade quality and shall conform to specifications prescribed by JECFA or the Food Chemicals Codex. Permitted additives for iodized salt are listed below: 5.1.1 Anticaking Agents Maximum Level in the Final Product 5.1.2 Coating agents; Carbonates, calcium/magnesium Magnesium oxide; Tricalcium phosphate; 20 g/kg singly or in Silicon dioxide, amorphous; combination (for Silicates of calcium, sodium or magnesium; 5.2.1 and 5.2.2) Alumino of sodium or calcium 5.1.3 Coating hydrophobic agents; aluminum, calcium, Magnesium, potassium or sodium salts of myristic, Palmitic or stearic acids

Food Safety Laws 65 5.1.4 Crystal modifiers; 10 mg/kg singly or in Ferrocyanides, calcium, combination expressed Potassium or sodium as [Fe(CN6)]3 5.2 Emulsifiers Polysorbate 90 - 10 mg/kg 5.3 Processing Aid Dimethylpolysiloxane - 10 mg of residue/kg 6. PACKAGING All iodized salt shall be packed in woven polypropylene bags, clean and unused jute bags, or other non-porous material with a lining of high density polyethylene to ensure the retention of appropriate iodine level at the time of consumption. 7. LABELLING 7.1 Iodized salt for commercial distribution shall carry appropriate labelling in accordance with BFAD rules and regulations on labelling of prepackaged foods. Specifically, the following information shall be declared in every container of iodized salt whether in bulk or retail package: 7.1.1. For locally produced iodized salt a) The name of the product, IODIZED SALT, printed in bold capital letters b) Name and address of manufacturer c) Net weight (in metric units) d) Iodine compound used

66 COMPENDIUM OF RTF LAWS e) Chemical additives e.g. anticaking agents, emulsifiers f) Open date marking e.g. Best Before or Consume Before Date g) Lot identification Code (Repackers must use manufacturers lot i.d. code) h) Storage instruction: STORE IN COOL DRY PLACE 7.1.2. For imported iodized salt a) same as in 7.1.1(a), (c) to (h) b) Name and address of importer/local distributor c) Country of origin 7.2 Labelling of Non-Retail Containers In the case of non-retail containers of at least 25 kg of iodized salt, the labelling information required in section 7.1.1 (b), (d), (e) or in 7.1.2 (b) may not be declared if such bulk packages are intended for delivery to distributors/repackers or food manufacturers/ institutional users, provided every shipment or delivery is accompanied by a document containing all the information in 7.1.1 or 7.1.2. 8. STORAGE, TRANSPORT AND DISPLAY AT RETAIL In order to minimize avoidable losses of iodine, iodized salt shall not be exposed to any of the following conditions during storage, transport and display at retail outlets: a) direct sunlight or near source of strong light b) high temperature and humidity

Food Safety Laws 67 c) contamination with moisture e.g. rain, flood, etc. d) contamination with dust or filth from the environment CHECKLIST OF REQUIREMENTS FOR LICENSING OF IODIZED SALT MANUFACTURERS (With Iodizing Machines) I. DOCUMENTARY REQUIREMENTS 1. Accomplished Petition Form (duly notarized) 2. ID picture of owner/general manager 3. If corporation, copy of SEC Registration and Articles of Incorporation 4. If single proprietor, copy of Bureau of Domestic Trade Registration 5. Address of manufacturing plant (with location map) 6. Contract of Lease of Building (if not owned by applicant) 7. Floor plan of manufacturing plant with dimension in meters II. TECHNICAL REQUIREMENTS 1. Qualification of key personnel in production and quality control 2. Flow chart of manufacturing process with emphasis on identification of critical control points 3. Quality Assurance System (QAS) including in-plant quality control 4. Certificate of analysis of finished product in accordance with prescribed standard for iodized salt

68 COMPENDIUM OF RTF LAWS III. FEES TO BE PAID 1. Filing fee of P50.00 upon submission of complete documentary and technical requirements 2. Fee for LTO (valid for 1 year): P1,000.00 for large and medium manufacturer P500.00 for small manufacturer P200.00 for subsistence manufacturer NOTE: 1. Technical requirements are subject to verification during inspection. 2. Inspection shall be scheduled only after compliance with documentary and technical requirements. 3. Original copy of SEC/BDT Registration shall be presented for verification 4. Only owner and/or authorized technical staff will be entertained. CHECKLIST OF REQUIREMENTS FOR LICENSING OF SALT IMPORTERS/ DISTRIBUTORS I. DOCUMENTARY REQUIREMENTS 1. Accomplished Petition Form (duly notarized) 2. ID picture of owner/general manager 3. If corporation, copy of SEC Registration and Articles of Incorporation 4. If single proprietor, copy of Bureau of Domestic Trade Registration 5. Copy of warehouse address (with location map) 6. Contract of Lease of Office and Warehouse (if not owned by applicant)

Food Safety Laws 69 7. Document indicating terms of agreement between manufacturers/suppliers and importer (duly notarized) 8. Document including terms of agreement between importer and local distributor, if importer is not the local distributor (duly notarized) 9. Product specifications from manufacturer 10. Certificate of analysis from government or accredited laboratory from the country of origin II. TECHNICAL REQUIREMENTS Importer/distributors must have the capability to assure the quality of the iodized salt during storage and prior to distribution which at a minimum shall cover the following: 1. Proper storage conditions 2. Random testing of stocks of iodized salt prior to distribution (products may be tested in designated government or private analytical laboratories) 3. Maintenance of records of quality assurance activities and distribution practices 4. Compliance with packaging and labelling requirements III. FEES TO BE PAID 1. Filing fee of P50.00 upon submission of complete documentary and technical requirements 2. Fee for LTO (valid for one year) - P1,000.00 NOTE: 1. Technical requirements are subject to verification during inspection. 2. Inspection shall be scheduled only after compliance with documentary and technical requirements. 3. Original copy of SEC/BDT Registration shall be presented for verification

70 COMPENDIUM OF RTF LAWS MEMORANDUM OF AGREEMENT KNOW ALL MEN BY THESE PRESENTS: The BUREAU OF FOOD AND DRUGS of Alabang, Muntinlupa City, represented herein by DR. QUINTIN L. KINTANAR, its Director hereafter referred to as the Bureau, AND The Municipality of _____________ represented by the Municipal Mayor __________ hereafter referred to as the LGU. hereby STIPULATE that 1. The Bureau has been authorized by the Department of Health through Administrative Order _____ to enter into a Memorandum of Agreement with Local Government Units to implement Republic Act No. 8172. 2. The Municipal Mayor _________ has been duly authorized by the Sangguniang Bayan through Resolution No. ________ to enter likewise into a Memorandum of Agreement with the Bureau for the implementation of the same Act. 3. This Agreement is necessary and indispensable for the effective implementation and enforcement of the said Act. Wherefore, the Bureau and the LGU hereby AGREE TO UNDERTAKE THE FOLLOWING FUNCTIONS, DUTIES AND RESPONSIBILITIES under the terms and conditions hereunder set forth. 4. The Bureau delegates the authority to register and issue license to operate to producers manufacturers

Food Safety Laws 71 and importers of food-grade iodized salt to the LGU after determining the latters compliance with the standards and requirements provided by the IRR (Adm. Order ) 4.a All salt producers/manufacturers and importers shall register with the LGU before a Mayors (Business) Permit shall be issued. 4.b If such salt producer or importer intends to produce and distribute food-grade iodized salt, he shall be required to apply for a license to operate an Iodized Salt Establishment/Plant 4.c F ollo wing su ch ap p lic a t ion, t he LG U shall inspect the facilities and equipment of the producer/importer-applicant and determine its compliance with the standard and requirements, after which the LGU may require the applicant to pay the license fee in the amount not more than what is provided for in Section of Admin. Order No. and issue a License to Operate. 4.d The license to operate shall be issued in four copies, the original of which shall be given to the licensee, a duplicate copy shall be forwarded to the Bureau and the last two copies shall be retained by the LGU for its file. 5. The LGU by its municipal health officers and nutritional-dietitians or in their absence, the sanitary inspectors shall monitor the operation of all the registered salt producers to ensure their compliance with the conditions, standards and requirements provided for by the IRR ( )

72 COMPENDIUM OF RTF LAWS provided that subsistence salt producers who are manually producing iodized salt shall not be allowed to distribute pre-packaged iodized salt in the market. 6. In cases where the LGU finds a probable violation of the RA 8172 or its implementing rules and regulations, the LGU shall conduct an investigation to determine if sanctions are imposable. After notice and hearing, the LGU shall issue a recommendatory resolution to the Bureau. If such resolution is confirmed, the LGU shall execute and impose the appropriate administrative sanctions in accordance with the law, or its implementing rules and regulations (Admin. Order ___). 7. The license fees and fines collected under this Agreement may be retained and used by the LGU exclusively for the effective implementation of this Act. 8. The LGU shall submit an annual progress report of its implementation of RA 8172 to the Bureau in the format which the latter shall prescribe (after consultation with the DOH Nutrition Services) 9. The LGU shall support the development and sustainability of salt industry through ordinances, and information campaign promoting the use of the iodized salt. 10. The Bureau in coordination with the DOST, DOH-Nutrition Service, DTI, LTRC, CDA and NNC shall provide regular technical assistance to the LGU (in the form of salt- iodization technology transfer, training of inspectors and enforcers/ investigators, facilitate financial assistance to small/subsistence producers).

Food Safety Laws 73 REPUBLIC ACT NO. 8976 November 7, 2000 AN ACT ESTABLISHING THE PHILIPPINE FOOD FORTIFICATION PROGRAM AND FOR OTHER PURPOSES. Be it enacted by the Senate and House of Representatives of the Philippines Congress assembled: Section 1. Title.- This Act shall be known as the Philippine Food Fortification Act of 2000. Section 2. Declaration of Policies.- Section 15 of Article II of the Constitution provides that the State shall protect and promote the right of health of the people and instill health consciousness among them. State recognizes that nutritional deficiency problems in the Philippines, based on nutrition surveys, include deficiency in energy, iron, vitamin A, iodine, thiamin and riboflavin. T oa minor extent, the Filipino diet is also deficient in ascorbic acid, calcium and folate. The State recognizes that food fortification is vital where there is a demonstrated need to increase the intake of an essential nutrient by one or more population groups, as manifested in dietary, biochemical or clinical evidences of deficiency. Food fortification is considered important in the promotion of optimal health and to compensate for the loss of nutrients due to processing and/or storage of food.

74 COMPENDIUM OF RTF LAWS Food fortification, therefore, shall carried out to compensate for the inadequacies in Filipino diet, based on present-day needs as measured using the most recent Recommended Dietary Allowances (RDA) Section 3. Definition of Terms.- For purposes of this Act, the following terms shall mean: (a) BFAD - the Bureau of Food and Drugs of the Department of Health. (b) DOH - the Department of Health. (c) Fortification - the addition of nutrients to processed foods or food products at levels above the natural state. As an approach to control micronutrient deficiency, food fortification is addition of a micronutrient, deficiency in the diet, to a food which is widely consumed by a specific at-risk groups. (d) Fortificant - a substance, in chemical or natural form, added to food to increase its nutrient value. (e) Micronutrient - an essential nutrient required by the body in very small quantities; recommended intakes are in milligrams or micrograms. (f) Manufacturer - the refinery in case of refined sugar or cooking oil, the miller in case of flour or rice, or the importer in case of imported processed foods or food products, or the processor in case of other processed foods or foods products.

Food Safety Laws 75 (g) NCC - the Governing Board of the National Nutrition Council. (h) Nutrient - any chemical substance needed by the body for one or more of these functions: to provide heat or energy, to build and repair tissues, and to regulate life processes. Although nutrients are found chiefly in foods, some can be synthesized in the laboratory like vitamin and mineral supplements or in the body through biosynthesis. (i) Nutrition Facts - a statement or information on food labels indicating the nutrient(s) and the quantity of said nutrient found or added in the processed foods or food products. (j) Nutrition labeling - a system of describing processed foods or food products on the basis of their selected nutrient content. It aims to provide accurate nutrition information about each food. This is printed in food labels as Nutrition Facts. (k) Processed food or food products - food that has been subjected to some degree of processing like milling, drying, concentrating, canning, or addition of some ingredients which changes partially or completely the physico-chemical and/ or sensory characteristics of the foods raw material.

76 COMPENDIUM OF RTF LAWS (l) Recommended Dietary Allowances (RDA) - levels of nutrient intakes which are considered adequate to maintain health and provide reasonable levels or reserves in body tissues of nearly all health persons in the population. (m) Sangkap Pinoy Seal Program (SPSP). - a strategy to encourage food manufacturers to fortify processed foods or food products with essential nutrients at levels approved by the DOH. The fundamental concept of the program is to authorize food manufacturers to use the DOH seal of acceptance for processed foods or food products, after these products passed a set of defined criteria. The seal is a guide used by consumers in selecting nutritions foods. (n) Unprocessed food - food that has not undergone any treatment that results in substantial change in the original state even if it may have been divided boned, skinned, peeled, ground, cut cleaned, trimmed, fresh-frozen or chilled. Section 4. The Philippine Food fortification Program. - The Philippine Food fortification Program, hereinafter referred to as the Program, shall cover all imported or locally processed foods or food products for sale or distribution in the Philippines; Provided, That, dietary supplements for

Food Safety Laws 77 which established standards have already been prescribed by the DOH through the BFAD and which standards include specifications for nutrient composition or levels of fortification shall not be covered by this Act. The program shall consist of (1) Voluntary Food Fortification and (2) Mandatory Food Fortification. Section 5. Voluntary Food Fortification. - Under the Sangkap Pinoy Seal Program (SPSP), the Department shall encourage the fortification of all processed foods or food products based on rules and regulations which the DOH through the BFAD shall issue after the effectivity of this act. Manufacturers who opt to fortify their processed foods of food products but do not apply for Sangkap Pinoy Seal shall fortify their processed food or food products based on acceptable standards on food fortification set by the DOH through the BFAD. Section 6. Mandatory Food Fortification. (a) the fortification fo staple foods based on standards sets by the DOH through the BFAD is hereby made mandatory for the following: (1) Rice - with Iron; (2) Wheat flour 0 with vitamins A and Iron;

78 COMPENDIUM OF RTF LAWS (3) Refined sugar - with vitamin A; (4) Cooking oil - with vitamin A; and (5) Other staple foods with nutrients as may later required by The NCC. The National Nutrition Council (NCC) shall require other processed foods or food products to be fortified based on the findings of nutrition surveys. Such requirement shall be promulgated through regulations to be issued by the Department of Health (DOH) through the Bureau of Food and Drugs (BFAD) and other concerned agencies. (b) The fortification of processed foods or food products under this Section shall be undertaken by the manufacturers: Provided, That in the case of imported processed foods or food products, the required fortification shall be done by the producers/manufacturers of such imported processed foods or food products. Otherwise, the importer shall have responsibility of fortifying the imported processed foods or food products before said products are allowed to be distributed or sold to the public: Provided, further, That the implementation of the mandatory fortification for wheat flour, refined sugar, cooking oil and rice, including those milled and/or distributed by

Food Safety Laws 79 the National Food Authority, shall commence after four (4) years from the effectivity of this Act. (c) The DOH guidelines on micronutrient fortification of processed food or food products included in Administrative Order No. 4-A series of 1995 and such other necessary guidelines that may be issued by the DOH, shall serve as a basis for the addition of micronutrient(s) to processed foods or food products to avoid over or under fortification that may create imbalance in the diet as well as avoid misleading label claims to gain competitive marketing advantage. (d) Manufacturers of processed foods or food products shall include on the label a statement of nutrition facts indicating the nutrient(s) and the quantities of said nutrients added in the food. (e) Imported rice, wheat flour, refined sugar, cooking oil and other processed foods or food products that may identified later by the NCC, shall comply with the requirements of this Act on entry in country, at the end of manufacturing process and/or at all points of sale or distribution. Section 7. Quality Assurance.- The agencies charged with the implementation of this Act shall establish a quality assurance

80 COMPENDIUM OF RTF LAWS system. Likewise, the manufacturers and importers of processed foods or food products shall also establish their own quality assurance system in accordance with the quality assurance system of the implementing agencies. Section 8. Implementation, Monitoring and Review.- The DOH through the BFAD shall be the lead agency responsible for the implementation and monitoring of this Act while the NNC, the policy-making and coordinating body of nutrition, shall serve as the advisory board on food fortification. The DOH shall also be responsible in the conduct of promotional and advocacy activities on the use of fortified processed foods or food products through its Sangkap Pinoy Seal Program (SPSP) and/or other programs designed to promote nutrition. Products approved by the SPSP shall be allowed to use the Sangkap Pinoy Seal. Futher, the DOH is hereby authorized to charge reasonable fees for applications in the SPSP and use of such fees in the promotion and advocacy activities of nutrition. The NCC shall conduct a periodic review of the micronutrients added to food. This review will provide the basis for determining if the mandatory fortification is still required or not. The review shall be done at least every

Food Safety Laws 81 five (5) years to coincide with the conduct of the Food and Nutrition Research Institutes (FNRI) national nutrition survey and/or the assessment of the Philippine Plan of Action for Nutrition (PPAN). The local government units, through their health officers or agricultural officers or nutritionist-dieticians or the sanitary inspectors shall assist in monitoring/checking that foods to be mandated to be fortified like rice, refined sugar, wheat flour and cooking oil are properly fortified and labeled with nutrition facts indicating the specific micronutrient it was fortified with. The local food industries shall report on the production, marketing and distribution of fortified foods. They shall send annual reports to the DOH, also indicating their industrial concerns and recommendations. Section 9. Support to Affected Manufacturers.- The following government agencies shall support the implementation of this Act through their respective programs: (a) The Department of Trade and Industry (DTI) is hereby required to assist and support affected manufacturers in upgrading their technologies by helping them obtain soft loans and financial assistance for the procurement of technologies and machines to comply with the provision of this Act;

82 COMPENDIUM OF RTF LAWS (b) The Department of Science and Technology (DOST) shall develop and implement comprehensive programs for the acquisition, design and manufacture of machines and technologies and transfer said machines and technologies to manufacturers; (c) The Land Bank of the Philippines (LBP) and the Livelihood Corporation (LIVERCOR) are hereby required to assist and support the implementation of this Act by granting loans, to affected manufacturers, at preferential rates; and (d) The various agencies/institutions with accredited analytical laboratories for nutrient analysis and other technology development generators shall provide the necessary services that may be required by the food industry in compliance with this Act. Section 10. Noncompliance with Fortification Process.- The following shall be considered non compliance with the fortification process: (a) if the food fortification levels do not comply with the DOH requirements, except when the deviation from the fortification levels are justified and are properly declared in the labeling; (b) If the fortificant used is different from that approved by the DOH; and

Food Safety Laws 83 (c) If the process of fortification does not conform to the DOH standard. Section 11. Administrative Sanctions.- The DOH through the BFAD, after notice and hearing, shall impose any or all of the following administrative sanctions in cases of noncompliance with the food fortification guidelines it has set: (a) Denial of registration of the processed foods or food products by the DOH through the BFAD if the processed foods or food products do not comply with the food fortification requirements. Said processed foods or food products shall not be allowed to be put in the market; (b) Order the recall of the processed foods or food product(s); and (c) Impose a fine or not less than Three Hundred Thousand Pesos (P300,000.00) and suspension of registration for the first violation; not more than Six hundred thousand pesos (P600,000.00) and suspension of registration for the second violation; and not more than one million pesos (P1,000,000.00) and cancellation of the registration of the product for the third violation of the provisions of this Act or its Implementing Rules and Regulations (IRR).

84 COMPENDIUM OF RTF LAWS Section 12. Implementing Rules and Regulations.The DOH through the BFAD and in consultation with other concerned government agencies, nongovernment organizations, private sectors and consumer groups involved in nutrition, shall formulate the implementing rules and regulations (IRR) necessary to implement the provisions of this Act within ninety (90) days from the approval of this Act. The IRR issued pursuant to this Section shall take effect thirty (30) days after publication in a national newspaper of general application. Section 13. International Commitments.- Nothing in this Act is intended to violate provisions of Treaties and International Agreements to which the Philippines is a party. Section 14. Repealing Clause.- All laws, decrees, rules and regulations, executive orders inconsistent with the provisions of this Act are hereby repealed or modified accordingly. Section 15. Separability Clause.- If any provision of this Act is declared unconstitutional or unlawful, the remaining provisions shall remain legal and in full effect. Section 16. Effectivity.- This Act shall take effect upon its approval. Approved: November 7, 2000

Food Safety Laws 85 FIFTH CONGRESS OF THE REPUBLIC OF THE PHILIPPINES Second Session H. No. 3052 REPUBLIC ACT No. 3720 AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO. Be it enacted by the Senate and House of Representative of the Philippines in Congress assembled: CHAPTER I Title Section 1. This Act shall be known as the Food, Drug, and Cosmetic Act. CHAPTER II Declaration of Policy Section 2. It is hereby declared the policy of the State to insure safe and good quality of food, drug and cosmetic, and to regulate the

86 COMPENDIUM OF RTF LAWS production, sale and traffic of the same to protect the health of the people. Section 3. In the implementation of the foregoing policy, the Government shall in accordance with the provisions of this Act: a. Establish standards and quality measures for food, drug, and cosmetic. b. Adopt measures to insure pure and safe supply of food, drug, and cosmetic in the country. CHAPTER III Creation of the Food and Drug Administration Section 4. T o carry out the provisions of this Act, there is hereby created an office to be called the Food and Drug Administration in the Department of Health. Said Administration shall be under the Office of the Secretary and shall have the following functions, powers and duties; a. T o administer and supervise the implementation of this Act and of rules and regulation issued pursuant to the same. b. To provide for the collection of samples of food, drug and cosmetic. c. To analyze and inspect food, drug and cosmetic in connection with the implementation of this Act. d. To establish analytical data to serve as basis for the preparation of food, drug and cosmetic standards, and to recommend

Food Safety Laws 87 standards of identity, purity, quality and fill of container. e. To issue certificate of compliance with technical requirements to serve as basis for the issuance of license and spot-check for compliance with regulations regarding operation of food, drug and cosmetic manufacturers and establishments. f. T o levy, assess and collect fees for inspection, analysis and testing of products and materials submitted in compliance with the provisions of this Act. g. To certify batches of antibiotic and antibiotic preparations in compliance with the provisions of this Act. Section 5. The Food and Drug Administration shall have the following Divisions: a. Inspection and Licensing Division, which shall have charge of the inspection of food, drug and cosmetic establishments engaged in their manufacture and sale. b. Laboratory Division, which shall conduct all the tests analysis and trials of products covered by this Act. Section 6. The Food and Drug Administration shall have a Food and Drug Administrator who shall be appointed by the Secretary of Health subject to the Civil Service rules and regulations. The compensation of said official shall be determined by the Secretary of Health.

88 COMPENDIUM OF RTF LAWS Section 7. The Secretary of Health shall provide for the additional personnel needed to carry out the functions and duties of the Food and Drug Administration. Section 8. The powers, functions and duties of the Division of Food and Drug T esting of the Bureau of Research and Laboratories and the Board of Food Inspection, all personnel in the Bureau of Health Services who are engaged in food and drug control work, together with all their equipment, supplies, records, files, personnel and balance of appropriations are transferred to the Food and Drug Administration. CHAPTER IV Board of Food and Drug Inspection Section 9. The Board of Food Inspection is hereby converted into the Board of Food and Drug Inspection which shall consist of: a. A representative of the Department of Health to be designated by the Secretary of Health , as Chairman; b. A representative of the Department of Agriculture and Natural Resources; c. A representative of the Department of Commerce and Industry; d. An authorized designate of the Commission of Customs; e. An authorized representative of the Office of the Solicitor-General;

Food Safety Laws 89 f. A technical member to be designated by the Food and Drug Administrator with the approval of the Secretary of Health; g. The President of the Philippine Medical Association or his authorized representative; h. The President of the Philippine Dental Association or his authorized representative; i. The President of the Philippine Pharmaceutical Association or his authorized representative. Each member of the Board as well as the Board Secretary shall receive a per diem of twenty pesos per meeting, hearing or investigation actually attended, but in no case shall the total per diem exceed two hundred pesos each month. It shall be the duty of the Board, conformably with the rules and regulations, to hold hearing and conduct investigations relative to matters touching the administration of this Act, to investigate processes of food, drug and cosmetic manufacture and to submit reports to the Food and Drug Administrator, recommending food and drug standards for adoption. Said Board shall also perform such additional functions, properly within the scope of the administration hereof, as may be assigned to it by the Food and Drug Administrator. The decisions of the board shall be advisory to the Food and Drug Administrator.

90 COMPENDIUM OF RTF LAWS ANNOTATION: The Food and Drug Administration was abolished by Section 4 of Executive Order No. 851 dated December 2, 1982, which provides: Section 4. There is hereby created a Bureau of Food and Drugs which shall assume the functions of the Food and Drug Administration which is hereby abolished. The functions to be assumed by the Bureau shall not include those previous functions of the Narcotic Drug Division of the Food and Drug Administration which have already have assumed by the Dangerous Drugs Board pursuant to Batas Pambansa Bilang 179. In addition to those functions transferred from the Food and Drug Administration, the Bureau shall have the authority to prescribe general standards and guidelines with respect to the veracity of nutritional and medicinal claims in the advertisement of food, drugs and cosmetics in the various media, to monitor such advertisements, and to call upon any manufacturer, distributor, or advertiser to desist from such inaccurate or misleading nutritional or medicinal claims in their advertising. Should such manufacturer, distributor or advertiser refuse or fail to obey the desistance order issued by the Bureau, he shall be subject to the applicable penalties as may be prescribed by law and regulations. The functions of the Bureau of Food and Drugs have been further defined and/or modified by the Executive Order 119 dated January 30, 1987. Section 13(b) of this Order states:

Food Safety Laws 91 The Office for Standards and Regulations (of the Department of Health) shall include (the) Bureau of Food and Drugs which shall act as the policy formulation and sector monitoring arm of the Minister on matters pertaining to foods, drugs, traditional medicines, cosmetics and household products containing hazardous substances, and the formulation of rules, regulations and standards in accordance with Republic Act 3720 and other pertinent laws for their proper enforcement; prescribe general standards and guidelines with respect to the veracity of nutritional and medicinal claims in the advertisement of food, drugs and cosmetics in the various media, to monitor such advertisements; advise the Ministrys field offices to call upon any erring manufacturer, distributor, or advertiser to desist from such inaccurate or misleading nutritional or medicinal claims in their advertising; should such manufacturer, distributor, or advertising refuse or fail to obey the desistance order issued by the Bureau, he shall be subject to the applicable penalties as may be prescribed by law and regulations; the Bureau shall provide consultative, training and advisory services to all agencies and organizations involved in food and drug manufacturing and distribution with respect to assuring safety and efficacy of food and drugs; conduct studies and research related to food and drug safety; maintain a corps of specially trained food and drug inspectors for assignment to the various field offices of the Ministry (of Health); while these inspectors shall

92 COMPENDIUM OF RTF LAWS be under the technical supervision and guidance of the Bureau, they shall be under the administrative supervision of the head of the field office to which they shall be assigned, the latter being responsible for regulatory program implementation within the geographic area of the jurisdiction. In line with this Executive Order No. 119 and the approved staffing pattern of the Department of Health under Administrative Order No. 30 s. 1987, Office Order No. 1 s. 1988 was promulgated reorganizing the Bureau of Food and Drugs. This Office Order No. 1 s. 1988 and the Administrative Order No. 30 s. 1987 are made part of this chapter. CHAPTER V Definitions Section 10. For the purposes of this Act, the term: a. Board means the Board of Food and Drug Inspection. b. Secretary means the Secretary of Health c. Department means Department of Health d. Person includes individual, partnership, corporation, and association e. Food means (1) articles used for food or drink for man, (2) chewing gum, and (3) articles used for components of any such article.

Food Safety Laws 93 f. Drug means (1) articles recognized in the official United States Pharmacopoeia, official Momeopathic Pharmacopoeia of the United States, of official National Formulary or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or animals; and (4) articles intended for use as component of any articles specified in clauses (1), (2), or (3), but does not include devices or their components, parts, or accessories. g. Devise means instrument, apparatus, or contrivances, including their components, parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or (2) to affect the structure or any function of the body of man or animals. h. Cosmetic means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof

94 COMPENDIUM OF RTF LAWS for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles. i. Label means a display of written, printed, or graphic matter upon the immediate container of any article and a requirement made by or under authority of this Act that any word, statement, or other information appearing on the label shall not be considered to be complied with unless such word, statement, or wrapper, if any there be, of the retail package of such article, or easily legible through the outside container or wrapper. j. Immediate container does not include package liners. k. Labelling means all labels and other written, printed or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. l. New drugs mean: (1) any drug which is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labelling thereof. (2) any drug the composition of which is such that said drug, as a result of

Food Safety Laws 95 investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions. a. If an article is alleged to be misbranded because the labeling is misleading then in determining whether the labeling is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such result from the use of the article to which the labeling relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual. b. Food additive means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, 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

96 COMPENDIUM OF RTF LAWS food; and including any source of radiation intended for any such use), if such substance is not 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. CHAPTER VI Prohibited Acts and Penalties PROHIBITED ACTS Section 11. The following acts and the causing thereof are hereby prohibited: a. The manufacture, sale, offering for sale or transfer of any food, drug, of any food, drugs, of cosmetic that is adulterated or misbranded. b. The adulteration or misbranding of any food, drug, device or cosmetic. c. The refusal to permit entry or inspection as authorized by Section twenty- seven hereof or to follow samples to be collected. d. The giving of a guaranty or undertaking referred to in Section twelve (a) hereof which guaranty or undertaking to the same effect signed by, and containing the name and address of, the person

Food Safety Laws 97 residing in the Philippines from whom he received in good faith the food, drug, device, or cosmetic or the giving of a guaranty or undertaking referred to in Section twelve (b) which guaranty or undertaking is false. e. Forging, counterfeiting, simulating, or falsely representing or without proper authority using any mark, stamp, tag label, or other identification device authorized or required by regulations promulgated under the provisions of this Act. f. The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department or to the courts when relevant in any judicial proceeding under this Act, any information acquired under authority of Section nine, or concerning any method or process which as a trade secret is entitled to protection. g. The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) and results in such article being adulterated or misbranded.

98 COMPENDIUM OF RTF LAWS h. The use, on the labeling of any drug or in any advertising relating to such drug, of any representation or suggestion that an application with respect to such drug is effective under Section twenty-one hereof, or that such drug complies with the provisions of such section i. The use, in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance with Section twenty-six hereof. PENALTIES Section 12. (a) Any person who violates any of the provisions of Section eleven hereof shall upon conviction, be subject to imprisonment of not less than six months and one day, but not more than five years, or a fine of not less than one thousand pesos, or both such imprisonment and fine, in the discretion of the Court. (b) Person shall be subject to the penalties of subsection (a) of this Section (1) for having sold, offered for sale or transferred any article and delivered it, if such delivery was made in good faith, unless he refuses to furnish the request of the Board of Food and Drug Inspection or an officer

Food Safety Laws 99 or employee duly designated by the Secretary, the name and address of the person from who he purchased or received such article and copies of all documents, if any there be, pertaining to the delivery of the article to him; (2) for having violated Section eleven (a) if he established a guaranty or undertaking signed by, and containing the name and address of, the person residing in the Philippines from whom he received in good faith the article, or (3) for having violated Section eleven (a), where the violation exists because the article is adulterated by reason of containing a coal-tar color not permissible under regulations promulgated by the Secretary under this Act, if such person establishes a guaranty or undertaking signed by, and containing the name and address, of the manufacturer of the coal-tar color, to the effect that such color is permissible, under applicable regulations promulgated by the Secretary under this Act. (c) Any article of food, drug, device or cosmetic that is adulterated or misbranded when introduced into the

100 COMPENDIUM OF RTF LAWS domestic commerce may be seized and held in custody pending proceedings pursuant to section twenty-six (d) hereof, without hearing or court order, when the Secretary has probable cause to believe from facts found by him or any officer or employee of the Food and Drug Administration that the misbranded article is fraudulent, or would be in a material respect misleading to the injury or damage of the purchaser or consumer. CHAPTER VII Definitions and Standards for Food Section 13. Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall, upon recommendation of the Food and Drug Administrator, promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, and/or reasonable standards of fill of container: provided, that no definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh or dried vegetables.

Food Safety Laws 101 ADULTERATED FOOD Section 14. A food shall be deemed to be adulterated: (a) (1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; (2) if it bears or contains any added poisonous or added deleterious substance other than one which is a pesticide chemical in or on a raw agricultural commodity for which tolerances have been established and it conforms to such tolerances; (3) if it consists in whole or in part of any filthy, putrid, or in part decomposed substance, or if it is otherwise unfit for food. (4) if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby, it may have been rendered injurious to health; (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter;

102 COMPENDIUM OF RTF LAWS (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. (b) (1) If any valuable constituent has been, in whole in part, omitted or abstracted therefrom and same has not been substituted by any healthful equivalent of such constituents; (2) if any substance injurious to health has been added or substituted; (3) if damage or inferiority has been concealed in any manner; and (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is. (c) If it bears or contains a coal-tar color other than on which is permissible under existing regulations; (d) If it is a confectionary, and it bears or contains any alcohol or non-nutritive article or substance except harmless coloring, harmless flavoring, harmless resinous glass not in excess of four-tenths of one per centum, natural gum and pectin: Provided, that this paragraph shall not apply to any confectionary by reason of its containing less than one half of one per centum by volume of alcohol derived solely from the

Food Safety Laws 103 use of flavoring extracts, or to any chewing gum by reason of its containing harmless non-nutritive masticatory substances; (e) If it is oleomargarine or margarine or butter and any of the raw material used therein consists in whole or in part of any filthy, putrid or decomposed substance, or such oleomargarine, margarine or butter is otherwise unfit for food. MISBRANDED FOOD Section 15. A food shall be deemed to be misbranded: a. if its labeling is false or misleading in any particular; b. if it is offered for sale under the name of another food; c. if it is an imitation of another food, unless its label bears in type of uniform size and prominence, the word imitation and immediately thereafter, the name of the food imitated; d. if its container is so made, formed, or filled as to be misleading; e. if in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, numerical count: Provided,

104 COMPENDIUM OF RTF LAWS that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary. If any word, statement, or other information required by or under authority of the act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other word, statements, designs, or devices, in the labeling), and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard, and insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food. If it purports to be or is represented as If it is not subject to the provisions of paragraph (g) of this section unless its label bears

f.

g.

h. i.

Food Safety Laws 105 (1) the common or usual name of the food, if there be any, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except the spices, flavorings and colorings without naming each: Provided, that to the extent that compliance with the requirements of clause (2) of this paragraph is impracticable or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary. j. If it purports to be or is presented for special dietary uses, unless its label bears such information concerning its vitamin, mineral and other dietary properties as the Secretary determines to be, and by regulations prescribes as necessary in order to fully inform purchasers as to its value for such uses. k. If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact: Provided, that to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary. The provisions of this paragraph or paragraphs (g) and (j) with

106 COMPENDIUM OF RTF LAWS respect to artificial coloring shall not apply in the case of butter, cheese or ice cream. Section 16. (a) Whenever the Secretary finds after investigation in domestic commerce of any class of food may be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered domestic commerce, he shall promulgate regulations also in accordance with the recommendations of the Food and Drug Administrator providing for the issuance, to manufacturers processors, or packers of such class of food in such locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary period of the effective date of such regulations, and during such temporary period, no person shall manufacture, sell or offer for sale or transfer any such food manufactured, processed or packed by any such manufacturer, processor, or packer unless such manufacturer, processor or packer holds a permit issued by the Secretary as provided by such regulations. (b) The Secretary is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated.

Food Safety Laws 107 (c) Any officer or employee duly designated by the Secretary shall have access to any factory or establishment, the operator of which holds a permit from the Secretary for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator. Tolerance for Poisonous Ingredients in Food COAL-TAR COLOR FOR FOOD Section 17. (a) Any poisonous or deleterious substance added to any food, shall be deemed to be unsafe except when such substance is required or cannot be avoided in its production or manufacture. In such case the Secretary shall promulgate, upon recommendation of the Food and Drug Administrator, regulations limiting the quantity therein to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe. In determining the quantity of such added substance to be tolerated in different articles of food, the Secretary shall take into account the extent to

108 COMPENDIUM OF RTF LAWS which the use of such article is required or cannot be avoided in the production or manufacture of such article and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances. (b) The Secretary, shall, upon recommendation of the Food and Drug Administrator, promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in food. CHAPTER VIII Drugs and Devices ADULTERATED DRUGS AND DEVICES Section 18. A drug or device shall be deemed to be adulterated: (a) (1) If it consists in whole or in part of any filthy, putrid, decomposed substance; or (2) if it had been prepared, packed, or held under unsanitary conditions contaminated with filth or whereby it may have been rendered injurious to health; or (3) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

Food Safety Laws 109 (4) if it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than a permissible one. (b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below the standard set forth in such compendium, except that whenever tests or methods of assay as are prescribed are, in the judgement of the Secretary, insufficient for the making of such determination, the Secretary shall promulgate, upon recommendation of the Food and Drug Administrator, regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength quality, or purity therefor set forth in such compendium, if its difference in strength, quality of purity from such standards is plainly stated on its label. (c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

110 COMPENDIUM OF RTF LAWS (d) If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefor. MISBRANDED DRUGS AND DEVICES Section 19. A drug or device shall be deemed to be misbranded: (a) If its labeling is false or misleading in any particular. (b) If in a package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer or distributor; (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, that reasonable variations shall be established by regulations prescribed by the Secretary. (c) If any work, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Food Safety Laws 111 (d) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alphaeucaine, barbituric acid, beta-eucaine, bromal, cannabis, cabromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote or sulfonmethane; or any chemical derivative of such substance, which derivative has been recommended by the Secretary, after investigation, and by regulations, designated as, habit forming; unless its label bears the name, and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement Warning May be habit forming. (e) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug, if such there be; and (2) in case it is fabricated from two or more ingredients, the common or usual name of each active ingredient, including the quantity, kind, and proportion of any alcohol, and also including the quantity, kind, and proportion of any alcohol, and also including whether active or not, the name and quality of proportion of any bromides, either, chloroform, acetanilid, acetaphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyocyanamine, arsenic,

112 COMPENDIUM OF RTF LAWS digitalis, digitalis glycosides, mercury, ouabain, strophantin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein: Provided, that where compliance with this paragraph is impracticable, exemptions shall, upon recommendation of the Food and Drug Administrator, be established by regulations promulgated by the Secretary. (f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users: Provided, that where any requirements of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the publicc health, the Secretary shall, upon recommendation of the Food and Drug Administrator, promulgate regulations exempting such drug or device from such requirement (g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and

Food Safety Laws 113 labeled as prescribed therein: Provided, that the method of packing may be modified with the consent of the Secretary. (h) If it has been found by the Secretary to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the Secretary shall by regulations require as necessary for the protection of the public health. (i) (1) it if is a drug and its container is so made, formed, or filed as to be misleading; or (2) if it is imitation of another drug; or (3) if it is offered for sale under the name of another drug. (j) if it is dangerous to health when used in the dosage, or with the frequency of duration prescribed, recommended or suggested in the labeling thereof. (k) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate of release has been issued pursuant to Section twenty-two (a), and (2) such certificate of release is in effect with respect to such drug: Provided, that

114 COMPENDIUM OF RTF LAWS this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated under Section twenty-two (a), (b), and (c). EXEMPTION IN CASE OF DRUGS AND DEVICES Section 20. (a) The Secretary is hereby directed to promulgate regulations exempting from any labeling or packaging requirement of this act drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded, under the provisions of this Act upon removal from such processing, labeling, or repacking establishment. (b) (1) Drugs intended for use by man which: A. are habit-forming B. Because of its toxicity or other potentiality for harmful effect, or the method of its use is not safe foruse except under the supervision of a practitioner licensed by law to administer such drug:

Food Safety Laws 115 C. Are new drugs whose applications are limited to investigational use shall be dispensed only (1) upon a written prescription of a practitioner licensed by law to administer such drug, or (2) an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (3) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale. (2) Any drug dispensed by filling or refilling a written prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of Section nineteen, except paragraphs (a), (1), (2) and (3), and the packaging

116 COMPENDIUM OF RTF LAWS requirements of paragraph (g) and (h), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of prescriber, and, if stated in the prescription the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. (3) The Secretary may by regulation remove drugs subject to Section nineteen (d) and Section twenty-one from the requirements of Subsection 9b) 91) of this Section, when such requirements are not necessary for the protection of the public health. (4) A drug which is subject to subsection (b) (1) of this section shall be deemed to be misbranded if at any time prior to dispensing, its label fails to bear the statement Caution: Food, Drug and Cosmetics Law prohibits dispensing without prescription. A drug to which subsection (b) (1) of this Section does not apply shall be deemed to be misbranded if at any time prior to dispensing, its label bears the caution statement quoted in the preceding sentence.

Food Safety Laws 117 NEW DRUGS Section 21. (a) No person shall manufacture, sell, offer for sale or transfer any new drug, unless an application filed pursuant to subsection (b) is effective with respect to such drug. (b) A n y p erso n m a y f ile w it h t he Secretary, through the Food and Drug Administration, an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary through the Food and Drug Administration as a part of the application (1) full reports of investigations which have been made to show whether or not such drug is safe for use; (2) a full list of the articles used as components of such drug; (3) a full statement of the composition of such drug; (4) a full description of the methods used in and the facilities and controls used for the manufacture, processing, and packing of such drug; (5) such samples of such drug and of the article used as components thereof as the Secretary may require; and

118 COMPENDIUM OF RTF LAWS (6) specimens of the labeling proposed to be used for such drug. (c) Within one hundred and eighty days after the filing of an application under this subsection, or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either (1) approve the application if he then finds that none of the grounds for denying approval specified in subsection (d) applies, or (2) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question whether such application is approvable. (d) If the Secretary finds, after due notice to the applicant and giving him an opportunity for a hearing, that (1) investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labelling thereof;

Food Safety Laws 119 (2) the results of such test show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; (3) the metho d s use d in, a nd t he facilities and controls used for the manufacture, processing and packing of such drug are inadequate to preserve its identity, strength, quality, and purity; or (4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug he has insufficient information to determine whether such drug is unsafe for use under such conditions; or (5) evaluated on the basis of the information submitted to him as part of the application, and any other information before him with respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or

120 COMPENDIUM OF RTF LAWS (6) based on a fair evaluation of all materials facts, such labeling is false or misleading in any particular; he shall issue an order refusing to approve the application. (e) The effectiveness of an application with respect to any drug shall, after due notice and opportunity for hearing to the applicant, by order of the Secretary be suspended if the Secretary finds (1) that clinical experience, tests by new methods, or tests by methods not deemed reasonably applicable when such application became effective show that such drug is unsafe for use under the conditions of use upon the basis of which the application became effective, or (2) that the application contains any untrue statement of a material fact. The order shall state the findings upon which it is based. (f) An order refusing to permit an application with respect to any drug to become effective shall be evoked whenever the Secretary finds that the facts so require. (g) The Secretary shall promulgated regulations for exempting from the operation of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.

Food Safety Laws 121 CHAPTER IX Certification of Drugs containing Penicillin, Streptomycin, Chlortetracycline, Chloramphenicol or Bacitracin Section 22. (a) The Secretary, pursuant to regulations promulgated by him shall provide for the certification of batches of drugs composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof. A batch of such drug shall be certified if such drug has such characteristics for identity, strength, quality and purity, as the Secretary prescribes in such regulations as necessary to adequately insure safety and efficacy of use, but shall not otherwise be certified. Prior to the effective date of such regulations, the Secretary, in lieu of certification, shall issue a release for any batch which, in his judgement, may be released without risk as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof. For purposes of this section and of Section nineteen (k), the term antibiotic drug means any drug intended for use by man containing any quantity of any chemical substance

122 COMPENDIUM OF RTF LAWS which is produced by microorganism and which has the capacity to inhibit or destroy microorganism in dilute solution (including the chemically synthesized equivalent of any such substance). (b) Whenever in the judgement of the Secretary, the requirements of this section and of Section nineteen (k) with respect to any drug or class of drugs are not necessary to insure safety and efficacy of use, the Secretary shall promulgate regulations exempting such drug or class of drugs from such requirements. (c) The Secretary shall promulgate regulations exempting from any requirement of this Section and Section nineteen (k), (1) drugs which are to be stored, processed, labeled, or repacked at establishments other than those where manufactured, on condition that such drugs comply with all such requirements upon removal from such establishments; (2) drugs which conform to applicable standards of identity, strength, quality, and purity prescribed by these regulations and are intended for use in manufacturing other drugs; and (3) drugs which are intended for investigational use by experts qualified by scientific training and experience to investigate the safety and efficacy of drugs.

Food Safety Laws 123 CHAPTER X Cosmetics ADULTERATED COSMETICS Section 23. A cosmetic shall be deemed to be adulterated: (a) if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under the conditions of use as are customary as usual: Provided, that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: Caution: This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness, and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph (e) the term hair dye shall not include eyelash dyes or eyebrow dyes. (b) If it contains in whole or in part of any filthy, putrid, or decomposed substance. (c) If it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with

124 COMPENDIUM OF RTF LAWS the filth, or whereby it may have been rendered injurious to health. (d) If its container is composed, in whole or in parts of any poisonous or deleterious substance which may render the contents injurious to health. (e) If it is not a hair dye and it bears or contains a coal-tar color other than one which is permissible. MISBRANDED COSMETIC Section 24. A cosmetic shall be deemed to be misbranded: (a) If its labeling is false or misleading in any particular. (b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical counts: Provided, that reasonable variations shall be permitted and exemptions as to small package shall be established, by regulations prescribed by the Secretary. (c) If any word, statement, or other information required by or under authority of this Act, to appear on label or labeling is not prominently placed thereon with such conspicuousness (as compared with other word, statements, designs, or devices, in

Food Safety Laws 125 the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d) If its container is so made, formed, or filled as to be misleading. REGULATIONS MAKING EXEMPTIONS Section 25. The Secretary shall promulgate regulations exempting from any labeling requirements of this Act cosmetics which are, in accordance with the practice of this trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed on condition that such cosmetics are not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling, repacking establishment. CHAPTER XI General Administration Provisions, Regulations, Hearing and Institution of Criminal Action Section 26. (a) Except as otherwise provided in this section, the Secretary of Health shall, upon recommendation of the Food and Drug Administrator, issue rules and regulations as may be necessary to enforce effectively the provisions of this Act.

126 COMPENDIUM OF RTF LAWS (b) The Commissioner of Customs, the Commissioner of Internal Bureau and the Secretary of Health shall jointly prescribe regulations for the efficient enforcement of the provisions of Section thirty, except as otherwise provided therein. Such regulations shall be promulgated upon the recommendation of the Food and Drug Administrator and shall take effect at such time, after due notice, as the Secretary of Health shall determine. (c) Hearings authorized or required by this Act shall be conducted by the Board of Food and Drug Inspection which shall submit its recommendation to the Food and Drug Administrator. (d) When it appears to the Food and Drug Administrator from the report of the Food and Drug Laboratory that any article of food or any drug, or cosmetic secured pursuant to Section twenty-eight of this Act is adulterated or misbranded, he shall cause notice thereof to be given to the person or persons concerned and such person or persons shall be given an opportunity to be heard before the Board of Food and Drug Inspection and to submit evidence impeaching the correctness of the finding or charge in question.

Food Safety Laws 127 (e) When a violation of any provisions of this Act comes to the knowledge of the Food and Drug Administrator of such character that a criminal prosecution ought to be instituted against the offender, he shall certify the facts to the Secretary of Justice through the Secretary of Health, together with the chemists report, the findings of the Board of Food and Drug Inspection, or other documentary evidence on which the charge is based. (f) Nothing in this Act shall be construed as requiring the Food and Drug Administrator to certify for prosecution pursuant to sub-paragraph (e) hereof, minor violation of this Act whenever he believes that public interest will be adequately served by a suitable written notice or warning. FACTORY INSPECTION Section 27. (a) For purposes of enforcement of this Act, officers or employees duly designated by the Secretary, upon presenting appropriate credentials to the owner, operator, or agent in charge, are authorized (1) to enter, at reasonable hours, any factory, warehouse, or establishment

128 COMPENDIUM OF RTF LAWS in which food, drugs, devices or cosmetics are manufactured, processed, packed, or held, for introduction into domestic commerce; and (2) to inspect, in a reasonable manner , such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished or unfinished materials, containers, and labeling therein. Section 28. (a) If the officer or employee making any such inspection of a factory, warehouse or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to leaving the premises, he shall give to the owner, operator, or agent in charge a receipt describing the samples obtained. (b) Wh enever in the c ourse of a ny such inspection of a factory or other establishment where food is manufactured, processed, or packed, the officer or employee making the inspection obtains a sample of any such food, and an analysis is made of such sample for the purpose of ascertaining whether such food consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge.

Food Safety Laws 129 PUBLICITY Section 29. (a) The Secretary may cause to be disseminated information regarding food, drugs, devices, or cosmetics in situations involving in the opinion of the Secretary, imminent danger to health, or gross deception of the consumer. Nothing in this Section shall be construed to prohibit the Secretary from collecting, reporting and illustrating the results of the investigations of the Department. CHAPTER XII Imports and Exports Section 30. (a) The Commissioner of Customs shall cause to be delivered to the Food and Drug Administration samples taken at random from every incoming shipment of food, drugs devices, and cosmetics which are being imported or offered for import into the Philippines giving notice thereof to the owner or consignee. The quantity of such samples shall be fixed by regulation issued by the Secretary. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under unsanitary conditions, or

130 COMPENDIUM OF RTF LAWS (2) such article is forbidden or restricted from sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of Section twenty-one, then the Food and Drug Administrator shall so inform the Commissioner of Customs and such article shall be refused admission, except as provided in subsection (b) of this section. The Commissioner of Customs shall then cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Commissioner of Customs, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulation. If the food, drugs, devices and cosmetics being imported or offered for import into the Philippines arrive at a port of entry other than Manila, the collection of such samples shall be the responsibility of the Regional Health Director having jurisdiction over the port of entry and such samples shall be forwarded to the Food and Drug Administration.

Food Safety Laws 131 (b) Pending decision as to the admission of an article being imported or offered for import, the Commissioner of Customs may authorize delivery of such article to the owner or consignee upon execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Commissioner of Customs. If it appears to the Secretary that an article included within the provisions of clause (3) of subsection (a) of this section can, by relabeling or other action, be brought into compliance with the Act or rendered other than a food, drug, device or cosmetic, final determination as to admission of such article may be deferred, and upon filing of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions of this subsection, the Secretary may, in accordance with regulations, authorize the applicant to perform such relabeling or other actions specified in such authorization with regulations (including destruction or export of rejected articles or portions thereof as may be specified in the Secretarys authorization). All such relabeling or other action pursuant to such authorization shall be in accordance with regulations and

132 COMPENDIUM OF RTF LAWS be under the supervision of an official or employee of the Commissioner of Customs and a duly authorized representative of the Food and Drug Administrator. (c) All expenses (including travel per diem or subsistence, and salaries) of officers or employees of the Philippines in connection with the destruction provided for in subsection (a) of this section and the supervision of the relabeling or other action authorized under the provisions of subsection (b) of this section, the amount of such expenses to be determined in accordance with regulations, and all expenses in connection with the storage, cargo, or labor with respect to any article refused admission under subsection (a) of this section, shall be paid by the owner or consignee, and in default of such payment, shall constitute a lien against any future importations made by such owner or consignee. (d) A food, drug device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act if it (1) conforms with the specifications of the foreign purchaser, (2) is not in conflict with laws of the country to which it is intended for export. But if such article is sold or offered for sale in domestic commerce, this subsection shall not exempt it from any of the provisions of this Act.

Food Safety Laws 133 CHAPTER XIII Financing Section 31. The amount of one million pesos is hereby appropriated from any funds in the National Treasury not otherwise appropriated to augment the funds transferred to this Office under Section eight for the implementation of this Act. All income derived from fees authorized in Section four of this Act shall accrue to the General Fund. CHAPTER XIV Repealing Clause Effectivity Section 32. If any provision of this Act or the application of such provision to any person or circumstance is held invalid, the remainder of this Act or the application of such provision to other persons or circumstances should not be affected thereby Section 33. Section eleven hundred and nine to Section eleven hundred twenty-nine of the Administrative Code, and such other laws, executive orders, rules and regulations inconsistent with the provisions of this Act are repealed. Section 34. This Act shall take effect upon its approval. Approved, June 22, 1963

134 COMPENDIUM OF RTF LAWS MALACAANG MANILA EXECUTIVE ORDER NO. 175 FURTHER AMENDING REPUBLIC ACT NO. 3720, ENTITLED AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO, AS AMENDED, AND FOR OTHER PURPOSES. WHEREAS, it is State policy, under Article II, Section 15, of the 1987 Constitution to protect and promote the right to health of the people and instill health consciousness among them; WHEREAS, the 1987 Constitution also provides, in its Article XIII, Section 12, that: The State shall establish and maintain an effective food and drug regulatory system and undertake appropriate health manpower development and research, responsive to the countrys health needs and problems; NOW, THEREFORE, I, CORAZON C. AQUINO, President of the Philippines, do hereby order: Section 1. The title of Republic Act No. 3720 is hereby amended to read as follows: An Act To Ensure The Safety and Purity of Foods and Cosmetics, And The Purity,

Food Safety Laws 135 Safety, Efficacy and Quality of Drugs and Devices Being Made Available To The Public, Vesting The Bureau of Food and Drugs with Authority T o Administer and Enforce the Laws Pertaining Thereto, and For Other Purposes Section 2. Section 1 of Republic Act No. 3729 is hereby amended to read as follows: SECTION 1. This Act shall be known as the Foods, Drugs and Devices, and Cosmetics Act. Section 3. The headnote of Chapter II of Republic Act No. 3720 is hereby amended to read as follows: Declaration of Policies and Section 2 thereof is likewise amended as follows: Section 2. The State policies as embodied in Article II, Section 15 of the 1987 Constitution, that: The State shall protect and promote the right to health of the people and instill health consciousness among them: and in Section 12, Article XIII of the 1987 Constitution, that: The State shall establish and maintain an effective food and drug regulatory system and undertake appropriate health manpower development and research, responsive to the countrys health needs and problems are iterated. Section 4. Section 3 of Republic Act No. 3720 is hereby amended to read as follows: Section 3. In the implementation of the foregoing policies, the Government, through the Department of Health, shall, in accordance with the provisions of this Act:

136 COMPENDIUM OF RTF LAWS a. Establish standards and quality measures for foods, drugs and devices and cosmetics b. Adopt measures to ensure pure and safety supply of foods and cosmetics, and pure, safe, efficacious and good quality drugs and devices in the country. c. Adopt measures to ensure the rational use of drugs and devices, such as, but not limited to, banning, recalling or withdrawing from the market drugs and devices which are not registered, unsafe, inefficacious or of doubtful therapeutic value, the adoption of an official National Drug Formulary, and the use of generic names in the labeling of drugs. d. Strengthen the Bureau of Food and Drugs. Section 5. Section 10 of Republic Act No. 3720 is hereby amended to read as follows: Section 10. For the purpose of this Act, the term: a) Bureau means the Bureau of Food and Drugs. f) Drugs means (1) articles recognized in the current official United States Pharmacopoeia-National Formulary (USP-NF), official Homeopathic Pharmacopoeia of the United States, official National Drug Formulary, or any supplement to any of them: and

Food Safety Laws 137 (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or animals and (4) articles intended for use as a component of any articles specified in clauses (1), (2), or (3) but do not include devices or their components, parts or accessories. l) New drugs mean: (1) any drug the composition of which is such that said drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety, efficacy, and quality of drugs as safe, efficacious and of good quality for use under the conditions prescribed, recommended, or suggested in the labelling thereof. (2) Any drug the composition of which is such that said drug, as a result of previous investigations to determine its safety, efficacy and good quality for use under certain conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under new conditions.

138 COMPENDIUM OF RTF LAWS (3) New drugs shall include drugs (a) containing a newly discovered active ingredient; (b) containing a new fixed combination of drugs, either by molecular or physical combination; (c) intended for new indications; (d) in an additional new mode of administration; or (e) in an additional dosage or strength of the dosage form, which meets the conditions as defined under the new drug. The definition of new drugs covers, to the extent applicable, new devices. Section 6. Section 10 of Republic Act No. 3720 is hereby amended by adding thereto the following subsections: o) Batch means a quantity of any drug or device produced during a given cycle of manufacture. p) Batch number means a designation printed on the label of a drug or device that identifies the batch, and permits the production history of the batch, including all stages of manufacture and control, to be traced and reviewed. q) Director means Director of Bureau of Food and Drugs. r) Distribute means the delivery or sale of any drug or device for purposes of

Food Safety Laws 139 distribution in commerce, except that such term does not include a manufacturer or retailer of such product. s) Expiry or expiration date means the date stated in the label of a drug or device after which the drug is not expected to retain its claimed safety, efficacy and quality or potency or after which it is not permissible to sell the drug or device. t) Export means to bring out of the Philippines by sea, land, or air. u) Import means to bring into the Philippines by sea, land, or air. v) Manufacture, in relation to a drug, or device where applicable, means any and all operations involved in the production of a drug or device including propagation, processing, compounding, formulation, filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view of its storage, sale or distribution; Provided, that the term shall not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies. w) New veterinary drugs means drugs intended for use of animals including any drug intended for use in animal feeds but not including animal feeds within the contemplation of the implementing rules and regulations.

140 COMPENDIUM OF RTF LAWS Section 7. Section 11 Republic Act No. 3720 is hereby amended to read as follows: Section 11. The following acts and the causing thereof are hereby prohibited: (a) The manufacture, importation, exportation, sale, offering for sale, distribution or transfer of any food, drug, device or cosmetic that is adulterated or misbranded. (b) The adulteration or misbranding of any food, drug, device, or cosmetic. (c) The refusal to permit entry of inspection as authorized by Section twenty-seven hereof or to allow samples to be collected. (d) The giving of a guaranty or undertaking referred to in Section twelve (b) hereby which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the Philippines from whom he received in good faith the food, drug, device, or cosmetic or the giving of a guaranty or undertaking referred to in Section twelve (b) which guaranty or undertaking is false. (e) Forging, counterfeiting, simulating, or falsely representing or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by regulations promulgated under the provisions of this Act.

Food Safety Laws 141 (f) The using by any person to his own advantage, or revealing, other than to the Secretary or officers and employees of the Department or to the courts when relevant in any judicial proceeding under this Act, any information concerning any method or process which as a trade secret is entitled to protection. (g) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) and results in such article being adulterated or misbranded. (h) The use, on the labeling of any drug or in any advertising relating to such drug, of any representation or suggestion that an application with respect to such drug is effective under Section twentyone and twenty-one-B hereof, or that such drug complies with the provisions of such sections. (i) The use, in labeling, advertising or other sales promotions of any reference to any report of analysis furnished in compliance with Section twenty-six hereof. Section 8. Section 11 of Republic Act No. 3720 is hereby amended by adding thereto the following subsections:

142 COMPENDIUM OF RTF LAWS (j) The manufacture, importation, exportation, sale, offering for sale, distribution, or transfer of any drug or device which is not registered with the Bureau pursuant to this Act. k) The manufacture, importation, exportation, sale, offering for sale, distribution, or transfer of any drug or device by any person without the license from the Bureau required under this Act. l) The sale or offering for sale of any drug or device beyond its expiration or expiry date. m) The release for sale or distribution of a batch of drugs without batch certification when required under Section twenty-two hereof. Section 9. Section 12 of Republic Act No. 3720 is hereby amended to read as follows: Section 12. (a) Any person who violates any of the provisions of Section eleven hereof shall, upon conviction, be subject to imprisonment of not less than one year but not more than five years, or a fine of not less than five thousand pesos but not more than ten thousand pesos, or both such imprisonment and fine, in the discretion of the Court. Should the offense be committed by a juridical person, the Chairman of the Board of Directors, the president,

Food Safety Laws 143 general manager, or the partners and/or the persons directly responsible therefor shall be penalized. (b) No person shall be subject to the penalties of subsection (a) of this section (1) for having sold, offered for sale or transferred any article and delivered it, if such delivery was made in good faith, unless he refuses to furnish on request of the Bureau or an officer or employee duly designated by the Secretary, the name and address of the person from whom he purchased or received such article and copies of all documents, if any there be, pertaining to the delivery of the article to him; (2) for having violated Section 11 (a) if he established a guaranty or undertaking signed by, and containing the name and address of, the person residing in the Philippines from whom he received in good faith the article, or (3) for having violated Section eleven (a), where the violation exists because the article is adulterated by reason of containing a color other than the permissible one under regulations promulgated by the Secretary under this Act, if such person established a guaranty or undertaking signed by, and containing the name and address, of the

144 COMPENDIUM OF RTF LAWS manufacturer of the color, to the effect that such color is permissible, under applicable regulations promulgated by the Secretary under this Act. Section 10. Section 18 of Republic Act No. 3720 is hereby amended to read as follows: Section 18. A drug or device shall be deemed to be adulterated: (a) (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance which may affect its safety, efficacy or good quality; or (2) if it has been manufactured, prepared or held under unsanitary conditions whereby it may have been contaminated with dirt or filth or whereby it may have been rendered injurious to health; or (3) if it is a drug or device and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if it is a drug and it bears or contains, for purposes of coloring only, any color other than a permissible one as determined by the Secretary, taking into consideration standards of safety, efficacy or good quality. b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs

Food Safety Laws 145 from, or its safety, efficacy, quality or purity falls below the standards set forth in such compendium, except that whenever tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination the Secretary shall promulgate, upon recommendation of the Director, regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, safety, efficacy, quality or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standards of strength, safety, efficacy, quality, or purity therefor set forth in such compendium, if its difference in strength, safety, efficacy, quality or purity from such standards is plainly stated in its label and approved for registration as such. c) If it not subject to the provisions of paragraph (b) and its strength differs from, or its efficacy, quality or purity falls below, that which it purports or is represented to possess. d) If it is a drug or device and any substance has been mixed or packed therewith, or any substance that has been substituted wholly or in part thereof, so as to reduce its safety, efficacy, quality, strength or purity.

146 COMPENDIUM OF RTF LAWS e) If the methods used in, or the facilities or controls used for its manufacture or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety, quality and efficacy, and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. Section 11. Section 19 of Republic Act No. 3720 is hereby amended to read as follows: Section 19. A drug or device shall be deemed to be misbranded: a) If its labeling is false or misleading in any particular. b) If it is in package form unless it bears a label containing (1) The name and place of business of the manufacturer, importer, packer, or distributor; (2) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, that reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the Secretary.

Food Safety Laws 147 c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. d) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, or sulfonmethane; or any chemical derivative of such substance, which derivative has been recommended by the Secretary, after investigation, and by regulations, designated as, habit forming; unless its label bears the name, and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement Warning - May be habit forming. e) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears

148 COMPENDIUM OF RTF LAWS (1) the common or usual name of the drug, if such there be; and (2) in case it is fabricated from two or more ingredients, the common or usual name of active ingredient, including the quantity, kind, and proportion of any alcohol, and also including whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glycosides, mercury, ouabain, strophantin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein: Provided, that where compliance with this paragraph is impracticable, exemptions shall, upon recommendation of the Director, be established by regulations promulgated by the Secretary. f) Unless its labelling bears (1) adequate directions for use; and (2) such adequate warning against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary

Food Safety Laws 149 for the protection of users: Provided, that where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall, upon recommendation of the Director, promulgate regulations exempting such drug or device from such requirement g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein: Provided, that the method of packing may be modified with the consent of the Secretary. h) If it has been found by the Secretary to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the Secretary shall by regulations require as necessary for the protection of the public health. i) (1) If it is a drug and its container is so made, formed, or filled as to be misleading: or (2) It if is an imitation of another drug; or (3) It if is offered for sale under the name of another drug.

150 COMPENDIUM OF RTF LAWS j) If it is dangerous to health when used in the dosage, or with the frequency of duration prescribed, recommended or suggested in the labelling thereof. k) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, cephalosporins, aminoglycosides, tetracycline, chloramphenicol, erythromycin, or any other antibiotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate of release has been issued pursuant to Section twenty-two (a) and (2) such certificate of release is in effect with respect to such drug: Provided, that this paragraph shall not apply to any drug or class or drugs exempted by regulations promulgated under section twenty-two (a), (b) and (c). Section 12. Section 20 of Republic Act No. 3720 is hereby amended to read as follows: Section 20. (a) The Secretary is hereby directed to promulgate regulations exempting from any labelling or packaging requirement of this Act drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed on condition that such drugs and

Food Safety Laws 151 devices are not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling or repacking establishment. (b) (1) Drugs intended for use by man which: A. are habit-forming; B. because of their toxicity or other potentiality for harmful effect, or the method of their use is not safe for use except under the supervision of practitioner licensed by law to administer such drug; C. are new drugs whose applications are limited to investigational use; shall be dispensed only (1) upon a written prescription of a practitioner licensed by law to administer such drug, or (2) upon an oral prescription of such practitioner which is reduced promptly to writing and filled by the pharmacist, or (3) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filled by the pharmacist. The act of

152 COMPENDIUM OF RTF LAWS dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale. (2) Any drug dispensed by filling or refilling a written prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirement of Section nineteen, except paragraphs (a), (i)(2) and (3) and the packaging requirements of paragraphs (g) and (h), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or its filling, the name of the prescriber, and if stated in the prescription the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. (3) The Secretary may by regulation remove drugs subject to Section nineteen (d) and Sections twentyone and twenty-one-B from the requirements of subsection (b) (d) of this Section, when such requirements are not necessary for the protection of the public health.

Food Safety Laws 153 (4) A drug which is subject to subsection (b) (1) of this Section shall be deemed to be misbranded if at any time prior to dispensing, its label fails to bear the statement Caution: Foods, Drugs and Devices, and Cosmetics law prohibits dispensing without prescription. A drug to which subsection (b) (1) of this Section does not apply shall be deemed to be misbranded if at any time prior to dispensing, its label bears the caution statement quoted in the preceding sentence. Section 13. The headnote NEW DRUGS before Section 21 hereof is hereby amended to read as follows: LICENSING AND REGISTRATION. Section 14. Section 21 of Republic Act No. 3720 is hereby amended to read as follows: Section 21. (a) No person shall manufacture, sell, offer for sale, import, export, distribute or transfer any drug or device, unless an application filed pursuant to subsection (b) hereof is effective with respect to such drug or device. (b) Any person may file with the Secretary, through the Bureau, an application under oath with respect to any drug or device subject to the provisions of subsection (a) hereof. Such persons shall submit to the Secretary through the Bureau:

154 COMPENDIUM OF RTF LAWS (1) full reports of investigations which have been made to show whether or not such drug or device is safe, efficacious and of good quality for use based on clinical studies conducted in the Philippines; (2) a full list of the articles used as components of such drug or device: (3) a full statement of the composition of such drug or device; (4) a full description of the methods used in and the facilities and controls used for the manufacture of such drug or device; (5) such samples of such drug or device and of the articles used as components thereof as the Secretary may require; (6) specimens of the labeling proposed to be used for such drug or device; and (7) such other requirements as may be prescribed by regulations to ensure the safety, efficacy and good quality of such drug or device. (c) Within one hundred and eighty days after the filling of an application under this subsection, or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either (1) approve the application if he then finds that none of the grounds for denying approval specified in subsection (d) applies, or

Food Safety Laws 155 (2) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question whether such application is approvable. (d) If the Secretary finds, after due notice to the applicant and giving him the opportunity for a hearing, that (1) the reports of the investigations which are required to be submitted to the Secretary pursuant to subsection (b) hereof, do not include adequate tests by all methods reasonably applicable to show whether or not such drug or device is safe, efficacious and of good quality for use under the conditions prescribed, recommended, or suggested in the proposed labelling thereof; (2) the results of such test show that such drug or device is unsafe, inefficacious or of doubtful therapeutic value for use under such conditions or do not show that such drug or device is safe, efficacious or of good quality for use under such conditions; (3) the methods used in, and the facilities and controls used for the manufacture of such drug or device are inadequate to preserve its identity, strength, quality and purity; or

156 COMPENDIUM OF RTF LAWS (4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug or device, he has insufficient information to determine whether such drug or device is safe, efficacious or of good quality for use under such conditions; or (5) on evaluation on the basis of the information submitted to him as part of the application, and any other information before him with respect to such drug or device, there is a lack of substantial evidence that the drug or device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labelling thereof; or (6) based on a fair evaluation of all material facts, such labelling is false or misleading facts, such labelling is false or misleading in any particular; he shall issue an order disapproving the application. (e) The effectiveness of an application with respect to any drug or device shall, after due notice and opportunity for hearing to the applicant, by order of the Secretary be suspended if the Secretary finds

Food Safety Laws 157 (1) that clinical experience, tests by new methods, or tests by methods not deemed reasonably applicable when such application became effective show that such drug or device is unsafe or ineffective for use under the conditions of use upon the basis of which the application became effective. (2) that the application contains any untrue statement of a material fact. The order shall state the findings upon which it is based. (f) The Secretary shall promulgate regulations for exempting from the operation of this section drugs and devices intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs and devices. (g) The procedure herein prescribed applies likewise to new veterinary drugs. Section 15. New sections to be known as Sections 21-A, 21-B and 21-C are hereby added to Republic Act No. 3720 to read as follows: Section 21-A. No person shall manufacture, sell, offer for sale, import, export, distribute or transfer any drug or device without first securing a license to operate from the Bureau after due compliance with technical requirements in accordance with

158 COMPENDIUM OF RTF LAWS the rules and regulations promulgated by the Secretary pursuant to this Act. Section 21-B.. No drugs or device shall be manufactured, sold, offered for sale, imported, exported, distributed or transferred, unless registered by the manufacturer, importer or distributor thereof in accordance with rules and regulations promulgated by the Secretary pursuant to this Act. The provisions of Section 21 (b), (d) and (e), to the extent applicable, shall govern the registration of such drugs and devices. Section 21-C. The Secretary shall promulgate a schedule of fees for the issuance of the certificate of product registration and the license to operate provided for under Section 21, 21-A and 21-B. Section 16. The title of Chapter IX Republic Act No. 3720 is hereby amended to read as follows: Certification of Drugs Containing Antibiotics Section 17. Section 22 of Republic Act No. 3720 is hereby amended to read as follows Section 22. (a) The Secretary, pursuant to regulations promulgated by him, shall provide for the certification of batches of drugs composed wholly or partially of any kind of antibiotic. A batch of such drug shall be certified if such drug has such

Food Safety Laws 159 characteristics of identity, strength, quality and purity, as the Secretary prescribes in such regulations as necessary to insure adequately safety and efficacy of use and good quality, but shall not otherwise be certified. Prior to the effective date of such regulations the Secretary, in lieu of certification, shall issue a release for any batch which, in his judgment, may be released without risk as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as portions thereof. For purposes of this section and of Section nineteen (k), the term antibiotic drug means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has the capacity to inhibit or destroy microorganisms in dilute solution (including the chemically synthesized equivalent of any such substance). (b) Whenever in the judgment of the Secretary, the requirements of this section and the Section nineteen (k) with respect to any drug or class of drugs are not necessary to insure safety and efficacy of use and good quality, the Secretary shall promulgate regulations exempting

160 COMPENDIUM OF RTF LAWS such drug or class of drugs from such requirements. (c) The Secretary shall promulgate regulations exempting from any requirement of this section and Section nineteen (k), (1) drugs which are to be stored, processed, labelled, or repacked at establishments other than those where manufactured, on condition that such drugs comply with all such requirements upon removal from such establishments; (2) drugs which conform to applicable standards of identity, strength, quality, and purity prescribed by these regulations and are intended for use in manufacturing other drugs; and (3) drugs which are intended for investigational use by experts qualified by scientific training and experience to investigate the safety and efficacy of drugs. Section 18. The headnote of Chapter XI of Republic Act No. 3720 is hereby amended to read as follows: Gener al Adminis tra t ion Provisions, Administrative Sanctions, Regulations, Hearing and Institution of Criminal Action. Section 19. Section 26 of Republic Act No. 3720 is hereby amended to read as follows: Section 26.

Food Safety Laws 161 (a) Except as otherwise provided in this section, the Secretary of Health shall, upon recommendation of the Director, issue rules and regulations as may be necessary to enforce effectively the provisions of this Act. The rules and regulations shall provide for, among others, the banning, recalling or withdrawing from the market drugs and devices which are not registered, unsafe, inefficacious or of doubtful therapeutic value, the adoption of an official National Drug Formulary, and the use of generic names in the labeling of drugs. b) The Commissioner of Customs and the Secretary of Health shall jointly prescribe regulations for the efficient enforcement of the provisions of Section thirty, except as otherwise provided therein. Such regulations shall be promulgated upon the recommendation of the Director and shall take effect at such time, after due notice, as the Secretary of Health shall determine. c) Hearing authorized or required by this Act shall be conducted by the Bureau which shall submit its recommendation to the Secretary. d) When it appears to the Director that the report of the bureau that any

162 COMPENDIUM OF RTF LAWS article of food or any drug, device, or cosmetic secured pursuant to Section twenty-eight of this Act is adulterated, misbranded, or not registered, he shall cause notice thereof to be given to the person or persons concerned and such person or persons shall be given an opportunity to be heard before the Bureau and to submit evidence impeaching the correctness of the finding or charge in question. e) When any violation of any provisions of this Act comes to the knowledge of the Director of such character that a criminal prosecution ought to be instituted against the offender, he shall certify the facts to the Secretary of Justice through the Secretary of Health, together with the laboratory report, the findings of the Bureau or other documentary evidence on which the charge is based. f) The Secretary is hereby authorized to call on the assistance of any Department Office or Agency for the effective implementation of the provisions of this Act. Section 20. The headnote before Section 29 Republic Act No. 3720 is hereby amended to read as follows: PUBLICITY AND PUBLICATION

Food Safety Laws 163 Section 21. Section 29 of Republic Act No. 3720 is hereby amended to read as follows: Section 29. (a) Th e S ecretary ma y c a use t o be disseminated information regarding foods, drugs, devices, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health, or gross deception to the consumer. Nothing in this Section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department. b) Th e Bu reau shall publish a D rug Reference Manual and Drug Bulletin to serve as reference by manufacturers, distributors, physicians, consumers and such other groups as may be deemed necessary. The Bureau is hereby authorized to sell the Drug Reference Manual at cost. Section 22. A new headnote, ADMINISTRATIVE SANCTIONS and a new section, Section 29-A are hereby added to Republic Act No. 3720 to read as follows: Section 29-A. In addition to the administrative sanctions provided for under Letter of Instructions No. 1223, the Secretary is hereby authorized to impose, after notice and hearing, administrative

164 COMPENDIUM OF RTF LAWS fines of not less than one thousand pesos nor more than five thousand pesos for any violation of this Act. Section 23. Section 30 of Republic Act No. 3720 is hereby amended to read as follows: Section 30. (a) The Commissioner of Customs shall cause to be delivered to the Bureau samples taken at random from every incoming shipment of food, drugs, devices, and cosmetics which are being imported or offered for import into the Philippines giving notice thereof to the owner or consignee. The quantity of such samples shall be fixed by regulation issued by the Secretary. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured under unsanitary conditions, or (2) su ch article is f orbidde n or restricted from sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of Sections twenty-one and twentyone-B, then the Director shall so inform the Commissioner and such article shall be refused admission, except as provided in

Food Safety Laws 165 subsection (b) of this section. The Commissioner of Customs shall then cause the destruction of any such article refused admission unless such articles is exported, under regulations prescribed by the Commissioner of Customs, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. If the foods, drugs, devices, and cosmetics being imported or offered for import into the Philippines arrives at a port of entry other than Manila, the collection of such samples shall be the responsibility of the Regional Food and Drug Supervisor having jurisdiction over the port of entry and such samples shall be forwarded to the Bureau. b) Pending decision as to the admission of an article being imported or offered for import, the Commissioner of Customs may authorize delivery of such article to the owner or consignee upon execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of

166 COMPENDIUM OF RTF LAWS the Commissioner of Customs. If it appears to the Secretary that an article included within the provisions of clause (3) of subsection (a) of this section can, by relabeling or other action, be brought into compliance with the Act or rendered other than a food, drug, device, or cosmetic, final determination as to admission of such article may be deferred, and upon filing of timely written application by the owner or consignee, and the execution by him of a bond as provided in the preceding provisions of this subsection, the Secretary may, in accordance with regulations, authorize the applicant to perform such relabeling or other actions specified in such authorization with regulations (including destruction or export of rejected articles or portions thereof, as may be specified in the Secretarys authorization). All such relabeling or other action pursuant to such authorization shall be in accordance with regulations and be under the provision of an officer or employee of the Bureau of Customs designated by the Commissioner of Customs and a duly authorized representative of the Bureau.

Food Safety Laws 167 c) All expenses (including travel, per diem or subsistence, and salaries) of officers or employees of the Philippines in connection with the destruction provided for in subsection (a) of this section and the supervision of the relabeling or other action authorized under the provisions of subsection (b) of this section, the amount of such expenses to be determined in accordance with regulations, and all expenses in connection with the storage, cargo, or labor with respect to any article refused admission under subsection (a) of this section, shall be paid by the owner or consignee, and in default of such payment, shall constitute a lien against any future importations made by such owner or consignee. d) A food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act if it (1) conforms with the specification of the foreign purchaser, (2) is not in conflict with laws of the country to which it is intended for export, and (3) is labelled on the outside of the shipping package to show that it is intended for export.

168 COMPENDIUM OF RTF LAWS But if such article is sold or offered for sale in domestic commerce, this subsection shall not exempt it from any of the provisions of this Act. Section 24. All laws, orders, issuances, rules and regulations or parts thereof inconsistent with this Executive Order are hereby repealed or modified accordingly. Section 25. This Executive Order shall take effect fifteen days after publication in the Official Gazette. Done in the City of Manila, this 22nd day of May in the year of Our Lord, nineteen hundred and eightyseven. (Sgd) CORAZON C. AQUINO President of the Philippines By the President: (Sgd) JOKER P. ARROYO Executive Secretary CERTIFIED COPY: (Sgd) MELQUIADES T. DELA CRUZ President Staff Director Malacaang Records Office

Food Safety Laws 169 Republic of the Philippines Congress of the Philippines Metro Manila Eighth Congress Republic Act No. 7160 October 10, 1991 Section 41(b) Amended byRA 8553 Section 43 Amended byRA 8553 AN ACT PROVIDING FOR A LOCAL GOVERNMENT CODE OF 1991 BOOK III LOCAL GOVERNMENT UNITS TITLE V APPOINTED LOCAL OFFICIALS COMMON TO ALL MUNICIPALITIES, CITIES AND PROVINCES ARTICLE VIII The Health Officer Section 478. Qualifications, Powers and Duties. (a) No person shall be appointed health officer unless he is a citizen of the Philippines, a resident of the local government unit concerned, of good moral character, and a licensed

170 COMPENDIUM OF RTF LAWS medical practitioner. He must have acquired experience in the practice of his profession for at least five (5) years in the case of the provincial or city health officer, and three (3) years in the case of the municipal health officer. The appointment of a health officer shall be mandatory for provincial, city and municipal governments. (b) The health officer shall take charge of the office on health and shall: (1) Take charge of the office on health services, supervise the personnel and staff of said office, formulate program implementation guidelines and rules and regulations for the operation of the said office for the approval of the governor or mayor, as the case may be, in order to assist him in the efficient, effective and economical implementation of a health services program geared to implementation of health-related projects and activities; (2) Formulate measures for the consideration of the sanggunian and provide technical assistance and support to the governor or mayor, as the case may be, in carrying out activities to ensure the delivery of basic services and provisions of

Food Safety Laws 171 adequate facilities relative to health services provided under Section 17 of this Code; (3) Develop plans and strategies and upon approval thereof by the governor or mayor as the case may be, implement the same, particularly those which have to do with health programs and projects which the governor or mayor, is empowered to implement and which the sanggunian is empowered to provide for under this Code; (4) In addition to the foregoing duties and functions, the health officer shall: (i) Formulate and implement policies, plans, programs and projects to promote the health of the people in the local government unit concerned; (ii) Advise the governor or mayor, as the case may be, and the sanggunian on matters pertaining to health; (iii) Execute and enforce laws, ordinances and regulations relating to public health; (iv) Recommend to the sanggunian, through the local health board, the passage of such ordinances as he

172 COMPENDIUM OF RTF LAWS may deem necessary for the preservation of public health; (v) Recommend the prosecution of any violation of sanitary laws, ordinances or regulations; (vi) Direct the sanitary inspection of all business establishments selling food items or providing accommodations such as hotels, motels, lodging houses, pension houses, and the like, in accordance with the Sanitation Code; (vii) Conduct health information campaigns and render health intelligence services; (viii) Coordinate with other government agencies and nongovernmental organizations involved in the promotion and delivery of health services; and (ix) In the case of the provincial health officer, exercise general supervision over health officers of component cities and municipalities; and (5) Be in the frontline of health services, delivery, particularly during and in the aftermath of man-made and natural disasters and calamities; and

Food Safety Laws 173 (c) Exercise such other powers and perform such other duties and functions as may be prescribed by law or ordinance. EXECUTIVE ORDER NO. 292 INSTITUTING THE ADMINISTRATIVE CODE OF 1987 Title IV AGRICULTURE CHAPTER 6 ATTACHED AGENCIES Section 48. Specific Functions.(1) The National Agricultural and Fishery Council shall act as an advisory and coordinative body of the Department. As such, it shall conduct and encourage consultative discussions among all agricultural sectors at the municipal, provincial, regional and national levels; (2) Th e Philip p in e Te c hnic a l a nd A d ministrative Com m it t ee f or Southeast Asia Fisheries Development Center (SEA F D E C) sha ll be responsible for the administration and management of the SEAFDEC Aquaculture Department and shall monitor and assess the performance

174 COMPENDIUM OF RTF LAWS of research projects on fisheries and aquaculture in accordance with the policies or standards established by the SEAFDEC International Council and the Department; (3) The Livestock Development Council shall be responsible for the formulation and establishment of comprehensive policy guidelines for the livestock industry, preparation of plans and programs and evaluation of livestock programs/projects; (4) The National Meat Inspection Commission shall conduct actual ante mortem inspection on all animals presented for slaughter and post mortem inspection on all carcasses intended for human consumption in all abattoirs in the country; render technical assistance in the construction of meat establishments (abattoirs, dressing plants, processing plants and meat markets) particularly on the selection of sites, and plant design preparation, equipment design and test runs; exercise overall supervision and control of management and operations of all abattoirs, dressing plants, meat processing plants and meat markets.

Food Safety Laws 175 EXECUTIVE ORDER NO. 137 November 28, 1993 PROVIDING FOR THE IMPLEMENTING RULES AND REGULATIONS GOVERNING THE DEVOLUTION OF CERTAIN POWERS AND FUNCTIONS OF THE NATIONAL MEAT INSPECTION COMMISSION TO THE LOCAL GOVERNMENT UNITS PURSUANT TO REPUBLIC ACT NO. 7160, OTHERWISE GOVERNMENT CODE OF 1991 WHEREAS, Section 17 of Republic Act No. 7160 provides for the establishment and operation of public slaughterhouses as one of the basic services and facilities to be undertaken by cities and municipalities; WHEREAS, Section 447(a) (3) (vii) and (5) (ii), (iv) and similar paragraphs of Section 58 of Republic Act No. 7160 provided that the sangguniang bayan and sangguniang panlungsod shall enact ordinances that shall regulate the sale of meat, fish, vegetables, fruits, fresh dairy products, and other foodstuff for human consumption; establish or regulate the construction and operation of public markets, slaughterhouses or animal corrals; or grant a franchise to any person to establish and operate the same as may be allowed by existing laws; and to levy, assess, collect taxes, fees, and charges as may be necessary for these purposes;

176 COMPENDIUM OF RTF LAWS WHEREAS, Section 489 (a) (2) (3) (i) (iii) of Republic Act No. 7160 provides that there shall be a local veterinarian in every province and city, and if a municipal government deems it necessary to appoint a municipal veterinarian, who shall advise the governor or the mayor, as the case may be, on all matters pertaining to the slaughter of animals and the regulation of slaughterhouses and other veterinary related services in the preparation and preservation of meat, milk and dairy products; WHEREAS, Republic Act No. 7394, otherwise known as the Consumers Act of the Philippines, provides that the Department of Agriculture shall inspect and analyze consumer products related to agriculture to determine conformity to established quality and safety standards; and to levy, assess, collect, and retain fees as are necessary to cover the cost of inspection, certification, analysis, and test of samples of consumer products; WHEREAS, the National Meat Inspection Commission (NMIC) of the Department of Agriculture, created under Presidential Decree No. 7 and Letter of Instruction No. 16, is responsible for promulgating specific policies and procedures governing the flow of livestock and livestock products through various stages of marketing and the proper preservation and inspection of such products; WHEREAS, there is a need to harmonize the various provisions of the Local Government Code of 1991 and the Consumer Act of the Philippines, including

Food Safety Laws 177 the role of the National Meat Inspection Commission in the establishment, operation, and regulation of slaughterhouses, livestock, and meat inspection, and the imposition and collection of fees and other charges rendered thereon; NOW, THEREFORE, I, FIDEL V. RAMOS, President of the Philippines, by virtue of the powers vested in me by law, and upon recommendation of the Oversight Committee created under Section 533 of Republic Act No. 7160, do hereby order: Section 1. Construction, Improvement, Expansion, and Operation of Slaughterhouses. - To prevent wastage in terms of time and valuable logistics and to maintain a uniform, high standard of sanitation in the operation and maintenance of slaughterhouses, the NWIC and the LGUs concerned shall perform the following: (a) The city or municipality: (1) shall, by ordinance, establish and operate a public slaughterhouse. In the construction, improvement, and expansion of such establishment, the city or municipality shall conform to applicable local and national policies, standards, and guidelines. For this purpose, the concerned local government unit may seek the assistance of the NMIC and other government agencies;

178 COMPENDIUM OF RTF LAWS (2) shall, upon approval by a majority vote of all the members of the sangguniang panlungsod or sangguniang bayan, grant a franchise to any person, partnership, corporation, or cooperative to establish, construct, operate, and maintain slaughterhouses as may be allowed by applicable laws, provided that cooperatives shall be given preference in the grant of such a franchise; (3) sh all, b y o rd ina nc e, sell, le a se encumber, or otherwise dispose of its slaughterhouse to ensure active participation of the private sector in local governance; and (4) shall authorize the establishment and operations of private slaughterhouses, whether for public use or exclusively as part of a meat processing complex; (b) The province shall: (1) ensure that the establishment and operation of the slaughterhouses of its component cities and municipalities are in accordance with the policies, standards, and guidelines set by the national and provincial governments;

Food Safety Laws 179 (2) provide technical supervision and may give financial assistance in the establishment and operation of slaughterhouses owned by its component cities and municipalities; and (3) review the ordinances of component cities and municipalities on matters relating to the establishment and operation of slaughterhouses and the granting of franchise thereof, including the imposition of taxes, fees and charges; (c) The NMIC shall: (1) fo rmu late na t iona l polic ies, guidelines, rules and regulations governing the establishment and operations of slaughterhouses; and (2) exercise technical supervision over the establishment and operations of slaughterhouses with authority to recommend sanctions and closure to local chief executives for those that do not comply or meet the requirements and standards set thereof; Section 2. C las s if ication and Ac c redit a t ion of Slaughterhouses - The NMIC shall, based on established standards for production, plans, designs, and specifications, classify and accredit slaughterhouses in accordance with the following:

180 COMPENDIUM OF RTF LAWS AAA - Those with facilities and operational procedures appropriate to slaughter livestock and fowls for sale in any market, domestic or international. AA - Those with facilities and operational procedures sufficiently adequate that the livestock and fowls slaughtered therein are suitable for sale in any market, domestic or international. A - Those with facilities and procedures of minimum adequacy that the livestock and fowls slaughtered therein are suitable for distribution and sale only within the city or municipality where the slaughterhouse is located. Section 3. Meat Inspection - All livestock and fowls slaughtered for food and their meat products shall be subject to veterinary inspection and examination before distribution and sale. To effectively implement meat inspection, the NMIC and the LGU concerned shall perform the following: (a) The NMIC shall: (1) formulate national policies, guidelines, rules and regulations, quality and safety standards governing marketing, marketing preservation, and inspection of meat and meat products; (2) formulate and implement rules and regulations governing the import and export of meat and meat products;

Food Safety Laws 181 (3) exercise technical supervision over local meat inspectors in class AAA slaughterhouses and, in AA when there is regular distribution of meat outside of the province or of the independent city; (4) in coordination with the LGU, provide direct technical supervision over operation of class AAA slaughterhouse and in class AA in case of preceding paragraph; (5) c ertify the f it ne ss f or hum a n co nsu mp tio n of m e a t a nd m e a t products intended for export and for distribution outside of the province or of the independent city; and (6) provide laboratory support to the meat industry . (b) The Provincial Government, thru its provincial veterinarian, shall: (1) regulate the flow of meat and meat products within the provincial jurisdiction in accordance with national policies, guidelines and standards; (2) exercise technical supervision over meat inspection work and operation in class AA slaughterhouses in the component city or municipality when there is regular meat distribution outside the local area but within the

182 COMPENDIUM OF RTF LAWS province. However, the function may be vested to the NMIC alone in case meat distribution extends beyond the province; and (3) certify th e fit ne ss f or hum a n consumption of meat and meat products in case of the preceding paragraph. (c) The City or Municipality shall: (1) regulate the preparation and sale of meat for human consumption based on national policies, guidelines, and standards within their territorial jurisdiction; (2) directly supervise the operation in Class A slaughterhouses and, in class AA, when meat distribution is limited within the locality only; (3) conduct meat inspection in all classes of slaughterhouses; and (4) certify th e fit ness f or hum a n consumption of meat and meat products intended for distribution within the locality only. Section 4. Meat Transport and Post Abattoir Control (a) Only transport vehicles accredited by the city veterinarian shall be used to deliver meat/meat products within the city; by the municipal veterinarian, and if none, by the provincial veterinarian, when transporting the same

Food Safety Laws 183 within the municipality; by the provincial veterinarian when transporting from one city or municipality to other localities within a province; and, by the NMIC when the destination is outside the province. (b) The meat to be suitable for transport must be from livestock or fowl dressed in an accredited slaughterhouse and have been subjected to ante and post mortem inspection, and certified and marked INSPECTED and PASSED for food by the controlling authority prescribed in the preceding section. (c) Post-abattoir control operation shall be exercised by the concerned LGU/NGA. A task force, composed of one or more concerned local government units may be organized and headed by a higher local government unit to strengthen the capability of checking illegal slaughtering and meat distribution. (d) Any additional post-mortem inspection and examination, when deemed necessary, shall be conducted either by the city, provincial or NMIC veterinarian, as the case may be. (e) Licensing and registration of butchers, meat vendors, meat dealers, and meat stalls/shops is to be exercised by the city or municipality.

184 COMPENDIUM OF RTF LAWS (f) The NMIC, together with the LGU concerned, shall control movement of meat and meat products from priority reportable diseases endemic areas to free zones in the country. Meat and meat products from such areas shall not be allowed to enter free zones in support of the Livestock Priority Diseases Eradication Program of the Philippines and its commitment to the international animal health program. Section 5. Monitoring and Evaluation. - The NMIC, in coordination with the LGU concerned, shall monitor, conduct field inspection, and require those involved in slaughterhouse operation to submit periodic and special reports to the NMIC. Section 6. Training and information. (a) The NMIC shall design a training program on slaughterhouse operation and shall be responsible for training local personnel involved in slaughterhouse regulations and operations. It shall also provide the means whereby the local government units, slaughterhouse operators and workers, and those engaged in livestock propagation and meat preparation have access to information about slaughterhouse management, facilities, LGUs regulations and impositions, and including the supply and demand of meat products here and abroad.

Food Safety Laws 185 (b) No p erso n may be e m ploye d in livestock and meat inspection without undergoing training and accreditation of the NMIC. (c) No person shall be allowed to work inside the slaughterhouse without proper training and license. Section 7. Fees and Charges. (a) The LGU concerned, thru an appropriate ordinance, may impose fees and charges related to meat inspection in accordance with the rules and regulations of the LG Code. (b) The twenty five (25) per cent of the veterinary inspection fees (ante and post mortem) collected by the city and municipalities in Class AAA shall be shared and remitted by the city or municipal treasurer to the NMIC on a quarterly basis but not beyond five (5) days after the end of each quarter. As in the case of Class AA, the same shall accrue to whoever is directly supervising the inspection service as mentioned in Section 3 of this Order. Section 8. Effectivity. - This Order shall take effect fifteen (15) days after publication in a national newspaper of general circulation.

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