Compendium III - Food Safety Laws

Food Safety Laws 01
COMPENDIUM OF
RIGHT TO FOOD LAWS
IN THE PHILIPPINES
Volume III
Food Safety Laws
National Food Coalition

91 Madasalin Street, Sikatuna Village,
Quezon City
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
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

Food Safety Laws i
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
ii COMPENDIUM OF RTF LAWS
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
Food Safety Laws iii
Acknowledgment
iv COMPENDIUM OF RTF LAWS
Food Safety Laws v
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
vi COMPENDIUM OF RTF LAWS
Food Safety Laws 1
Compendium of
Right To Food Laws
in the Philippines
Volume III
Food Safety Laws
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
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
manufacturer’s 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.
(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-
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 inappro-
priate foods or feeding methods; and,
in particular, the health hazards of un-
necessary or improper use of infant for-
mula 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.
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
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.
(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) To 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
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) To 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.
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 rooming-
in 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 infant’s needs. It is also nature’s first
immunization enabling the infant to fight
potential serious infection. It contains
growth factors that enhance the maturation
of an infant’s 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 mother’s 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.
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, lying-
in 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 mother’s 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) Mother’s milk - the breastmilk from the
newborn’s 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 mother’s 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 mother’s 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.
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 mother’s 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,
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 rooming-
in and breastfeeding. The additional
appropriation shall be included in their
budget for the fiscal year.
Section 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.
Section 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.
Section 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.
Section 17. Separability Clause.- If any clause, sentence,
paragraph or part of this Act shall be declared
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
(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

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,
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 food-
grade 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
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 non-
food 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
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
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 LGU’s
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
(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 LGU’s 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
(Sgd) HEZEL P. GACUTAN
Secretary of the Senate
Approved: December 20, 1995
(Sgd) FIDEL V. RAMOS

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.
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
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 food-
grade 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.
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 manufacturing-
distribution 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
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 DOH-
Regional 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.
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 food-
grade iodized salt and monitor
compliance thereof by the food-
grade 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)
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
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 government’s 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 anti-
pollution 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.
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.
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
offender’s 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
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
HON. ROBERTO Z. BARBERS

Secretary
Department of Interior and Local Government
Food Safety Laws 59
HON. CESAR B. BAUTISTA

Secretary
Department of Trade and Industry
HON. RICARDO T. GLORIA

Secretary
Department of Education,
Culture and Sports
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
HON. LEONARDO A. QUISUMBING

Secretary
Department of Labor and Employment
HON. SALVADOR M. ENRIQUEZ, JR.

Secretary
Department of Budget and Management
HON. CIELITO F. HABITO

Secretary
Department of Socio-Economic Planning
HON. FLORENTINO S. SOLON

Executive Director
Nutrition Center of the Philippines
HON. SUSAN O. PAGDANGANAN

National President
Rural Improvement Clubs
of the Philippines
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
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
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.
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 Bulk (>2 kg) Retail (< 2 kg)
Production Site 70 - 150 mg/kg 60 - 100 mg/kg
Port of Entry* 70 - 150 mg/kg 60 - 100 mg/kg
Retail Site >50 mg/kg >40mg/kg
*For imported iodized salt; also at importer’s/distributor’s 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
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 manufacturer’s 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
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
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 latter’s 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 Mayor’s
(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 ( )
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.

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. To a
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.
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 food’s
raw material.
(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;
(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
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 Institute’s
(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;
(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).
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
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. To 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. To 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. To 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.
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 Testing 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.
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 Ministry’s 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
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
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
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.
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
(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
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;
(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
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,
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.
f. 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.
g. 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.
h. If it purports to be or is represented as –
i. If it is not subject to the provisions of
paragraph (g) of this section unless its
label bears
(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
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.
(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
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
(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.
(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
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
(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, 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,
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
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
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:
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
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.
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
(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;
(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,
proposed labeling thereof; or
(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.
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
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.
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
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:
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
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
(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,
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
Administrator, issue rules and regulations as
may be necessary to enforce effectively
(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
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.
(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 chemist’s 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
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.
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
(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.
(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 Secretary’s
authorization). All such relabeling or other
action pursuant to such authorization shall
be in accordance with regulations and
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.
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

MALACAÑANG 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 country’s
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,
Safety, Efficacy and Quality of Drugs and

Devices Being Made Available To The Public,
Vesting The Bureau of Food and Drugs with
Authority To 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 country’s health needs and problems” are
iterated.”
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:
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.”
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
(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.
(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.”
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
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.
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
(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 twenty-
one 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.
amended by adding thereto the following
subsections:
(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.”
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,
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
(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
manufacturer of the color, to the effect

that such color is permissible, under
applicable regulations promulgated by
the Secretary under this Act.”
“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
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.
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 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:
shall be permitted and exemptions as
to small packages 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 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
(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
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.
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 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
devices are not adulterated or misbranded

under the provisions of this Act upon
removal from such processing, labeling or
(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
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 twenty-
one 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.
(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 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:
(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
(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
(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,
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
(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
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”
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
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
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 26.
(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
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”

“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
fines of not less than one thousand pesos

nor more than five thousand pesos for any
violation of this Act.
“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 twenty-
one-B, then the Director shall
so inform the Commissioner
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 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
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 Secretary’s
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.
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.
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 eighty-
seven.
(Sgd) CORAZON C. AQUINO

By the President:
(Sgd) JOKER P. ARROYO

Executive Secretary
CERTIFIED COPY:
(Sgd) MELQUIADES T. DELA CRUZ

President Staff Director
Malacañang Records Office
Republic of the Philippines

Congress of the Philippines
Metro Manila
Eighth Congress
Republic Act No. 7160

October 10, 1991
Section 41(b) Amended by RA 8553

Section 43 Amended by RA 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
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
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
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 non-
governmental 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
(c) Exercise such other powers and perform

such other duties and functions as may be
prescribed by law or ordinance.

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
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.

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;
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
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;
(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;
(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:
“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;

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;
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
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
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.
(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, LGU’s
regulations and impositions, and
including the supply and demand of
meat products here and abroad.
(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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Food Safety Laws 01

National Food Coalition

Published by: National Food Coalition

Lay-out: Ramon T. Ayco, Sr.

Printed in the Philippines

4.. EO 137, Providing for the Implementing Rules

This publication is a result of the collaboration of

Aurea G. Miclat – Teves

EXECUTIVE ORDER NO. 51 October 20, 1986

WHEREAS, in order to ensure that safe and adequate

and by ensuring the proper use of breastmilk

also commonly called “weaning food” or

(h) “Infant Formula” means a breastmilk

(n) “Supplies” means quantities of a product

trially or home-prepared. When such

(c) There shall be no point-of-sale advertising,

Section 7. Health Care System

shall be demonstrated only to mothers

to health workers except when necessary

or English printed on it, or on a label,

(f) The labels of food products within the

> Minister of Justice - Member

enforcement of the provisions of this Code.

Should the offense be committed by a

Done in the City of Manila, this 20th day of October, in

Republic of the Philippines

Fifth Regular Session

Begun and held in Metro Manila, on Monday, the twenty

REPUBLIC ACT NO. 7600

AN ACT PROVIDING INCENTIVES TO ALL

Be it enacted by the Senate and House of Representatives

hospital and the country that adopts its practice.

f) Formula feeding - the feeding of a new

care of the breast and nipples, and such

Section 4. Applicability.- The provisions in this chapter

Section 5. Normal Spontaneous Deliveries.- the following

Section 9. Right of the Mother to Breastfeed.- It shall be

Section 10. Provision of Facilities for Breastfeeding Collection

Section 11. Continuing Education, Re-education and Training

and training programs for physicians, nurses,

Section 13. Incentives.- The expenses incurred by a private

expenses were incurred: Provided, further,

to be invalid, the remainder of this Act or any

This Act which is a consolidation of Senate Bill No.

(Sgd.) Camilo L. Sabio

Approved: June 2, 1992

(Sgd.) Corazon C. Aquino

REPUBLIC OF THE PHILIPPINES

FIRST REGULAR SESSION

Begun and held in Metro Manila on Monday the

[ REPUBLIC ACT NO. 8172 ]

AN ACT PROMOTING SALT IODIZATION

Be it enacted by the Senate and House of Representatives

particularly iodine deficiency disorders,

g) authorize the National Nutrition

with specifications as to form,

three hundred metric tons (300m.t.) to two

inspectors to check and monitor the quality

not likely to mislead purchasers and

of salt iodization machines and transfer

Section 8. The Salt Iodization Advisory Board - The National

(P100,000.00); Provided, however, That if the

Section 13. Effectivity Clause - This Act shall take effect

(Sgd) JOSE DE VENECIA