MALACANANG

Manila

PRESIDENTIAL DECREE NO. 881

EMPOWERING THE SECRETARY OF HEALTH

TO REGULATE THE LABELING, SALE AND
DISTRIBUTION OF HAZARDOUS SUBSTANCES

WHEREAS, the Food, Drug and Cosmetics Act (Republic Act No. 3720)
establishes standards and quality measures for food, drugs and cosmetics;

WHEREAS, there are substances other than food, drugs and cosmetics that
are hazardous to health and safety of the public;

WHEREAS, there is no law at present that regulates the labeling, sale and
distribution of hazardous substances;

WHEREAS, there is an urgent need to adopt appropriate measures designed

to protect the people against other hazards to their health and safety;

NOW THEREFORE, I, FERDINAND E. MARCOS, President of the Philippines,

by virtue of the powers vested in me by the Constitution, do hereby order and
decree, as part of the law of the land, the following:

SECTION 1. Definitions. -

For purposes of this Decree, the following terms are defined as follows:

(a) “Secretary” means the Secretary of Health.

(b) “Administrator” means the Food and Drug Administrator

(c) “Person” means any individual, partnership, corporation or association,

trust, government or governmental subdivision or any other legal entity other than
the consumer.

(d) “Hazardous substance” means:

(1) (A) Any substance or mixture or substances which (i) is toxic, (ii)
is corrosive, (iii) is an irritant, (iv) is a strong sensitizer, (v) is flammable or
combustible, or (vi) generates pressure through decomposition, heat or other means,
if such substance or mixture of substances may cause substantial injury or
substantial illness during or as a proximate result of any customary or reasonably
foreseeable ingestion by children.

(B) Any substance which the Secretary by regulation finds, pursuant

to the provisions of this Decree, to be under the categories enumerated in
sub-paragraph (1) (A) of this paragraph.

(C) Any radioactive substance, if with respect to such substance as

used in a particular class of article or as packaged, the Secretary determines
by regulation that the substance is sufficiently hazardous to require labeling
in accordance with the Section in order to protect the public health.

(2) This term shall not apply to foods, drugs, and cosmetics nor to
substances intended for use as fuels when stored in containers and used in
 the heating, cooking or refrigeration system of a house, but such term shall
apply to any article which is not in itself a pesticide but which is a hazardous
substance, as construed in paragraph (1) of this sub-section, by reason of
bearing or containing such harmful substances described therein.

(e) “Toxic” means any substance (other than radioactive substance) which
can cause injury or illness or death to man through ingestion, inhalation, or
absorption through any body surface.

(f) “Highly Toxic” means any substance which has any of the following
effects:
(1) produces death within fourteen days to one half or more than one half of a group
of ten or more laboratory white rats each weighing between two hundred and three
hundred grams, at a single dose of fifty milligrams or less per kilogram of body
weight, when orally administered: or (2) produces death within fourteen days to
one half or more of a group of ten or more laboratory white rats each weighing
between two hundred and three hundred grams, when inhaled continuously for a
period of one hour or less at an atmospheric concentration of two hundred parts per
million by volume or less of gas or vapor or two milligrams per liter by volume or less
of mist or dust, provided such concentration is likely to be encountered by man
when the substance is used in any reasonably foreseeable manner; or (3) produces
death within fourteen days to one half or more of a group of ten or more rabbits,
when tested in a dosage of two hundred milligrams or less per kilogram of body
weight, or when administered through continuous contact with the bare skin for
twenty four hours or less.

(g) “Corrosive” means any substance which on contact with living tissue will
cause destruction of tissue by chemical action, but shall not refer to action on
inanimate surfaces.

(h) “Irritant” means any substance not corrosive within the meaning of
subparagraph (g) of this section which, on immediate, prolonged or repeated contact
with normal living tissue will induce a local inflammatory reaction.

(i) “Strong sensitizer” means any substance which will cause on normal
living tissue, allergy or photodynamic quality on hypersensitivity which becomes
evident on reapplication of the same substance, to be designated as such by the
Secretary. Before designating any substance as a strong sensitizer the Secretary
upon consideration of the frequency of occurrence and severity of the reaction shall
find that the substance has a significant capacity to cause hypersensitivity.

(j) “Extremely flammable” means any substance which has a flash point at or
below twenty degrees Fahrenheit as determined by the Tagliabue Open Cup Tester;
the term “flammable” shall apply to any substance which has a flash point of above
twenty degrees to an including eighty degrees Fahrenheit as determined by the
Tagliabue Open Cut Tester; and the term “combustible” shall apply to any substance
which as a flash point above eighty degrees Fahrenheit to an including one hundred
and fifty degrees Fahrenheit to and including one hundred and fifty degrees as
determined by the Tagliabue Open Cut Tester: Provided, That the flammability or
combustibility of solids and of the contents of self-pressurized containers shall be
determined through methods found by the Secretary to be generally applicable to
such materials or containers, respectively, and established by regulations issued by
him. Such regulations shall also define the terms “Flammable”, “Combustible” and
“Extremely Flammable” in accordance with acceptable methods.

(k) “Radioactive substance” means any substance which emits ionizing

radiation.
 (l) “Label” means a display of written, printed or graphic matter upon the
immediate container of any substance, or in the case of an article which is not
packaged in an immediate container but suitable for delivery to the consumer in
such condition, a display of such matter directly upon the article involved or upon a
tag or other suitable material affixed thereto. A requirement made by or under
authority of this Section that certain words, statements, or other information also
appear (1) on the outside container or wrapper, if any there be, unless they are
readable through the outside container or wrapper, and (2) on all accompanying
literature where there are directions for use, written or otherwise.

(m) “Immediate container” refers to the container or package which is

immediately after or near the substance excluding package liners.

(n) “Misbranded hazardous substance” means any hazardous substance

intended, or packaged in a form suitable, for use in households, especially by
children, the packaging or labeling of which is in violation of the special packaging
regulation issued by the Secretary or if such substance fails to bear a label -

(1) which states conspicuously (A) the name and place of business of
the manufacturer, packer, distributor or seller; (B) the common or usual
name, or the chemical name (if there be no common or usual name) of the
hazardous substance or of each component which contributes substantially
to the harmfulness of the substance, unless the Secretary by regulation
permits or requires the use of the recognized generic name; (C) the signal
word “DANGER” on substances which are extremely flammable, corrosive, or
highly toxic; (D) the signal word “WARNING” or “CAUTION” on all other
hazardous substances; (E) a frank statement of the principal hazard or
hazards involved, as “Flammable”, “Vapor Harmful,” “Causes Burns”,
“Absorbed Through Skin”, or similar wording descriptive of the hazard; (F)
precautionary measures describing the action to be followed or avoided,
except when modified by regulation by the Secretary pursuant to Section 2
of this decree; (G) instructions, when necessary or appropriate, for first-aid
treatment; (H) the word “poison” for any hazardous substance which is
defined as highly toxic; (I) instructions for handling and storage of
packages which require special care in handling or storage; and (J)
the statement “Keep out of the reach of children”, or its practical equivalent,
if the article is intended use by children and is not a banned hazardous
substance, with for use by children and is not a banned hazardous
substance, with adequate directions for the protection of children from the
hazard involved. The aforementioned signal words, affirmative statements,
description of precautionary measures necessary instructions or other words
or statements may be in the English language or its equivalent in Pilipino;
and

(2) on which any statement required under subparagraph (1) of this

paragraph are located prominently and in conspicuous and legible type in
contrast by typography, layout, or color with other printed matters on the
label.

(o) “Banned hazardous substance” means (1) any toy or other articles
intended for use by children, which are hazardous per se, or which bear or contain
substances harmful to human beings; or (2) any hazardous substance intended, or
packaged in a form suitable, for use in the household, which the Secretary of
regulation classifies as a “banned hazardous substance” notwithstanding the
existence of cautionary labels, to safeguard public health and safety: Provided, That
the Secretary, by regulation, shall exempt from the Section articles, which by reason
of their functional purpose require the inclusion of the hazardous substance
involved and which bear appropriate labels giving adequate directions and warnings
for their safe use.
 Procedures for the issuance, amendment or repeal of regulations pursuant to
paragraph (2) of this subsection shall be governed by the rules and regulation
promulgated by the Secretary: Provided, That if the Secretary finds that the
distribution for household use of the hazardous substance involved presents an
imminent hazard to the public health, he may publish in a newspaper of general
circulation a notice of such finding, and such substance shall be deemed to be a
“banned hazardous substance” pending the issuance of regulation formally banning
such substance.

SECTION 2. Regulations Declaring Hazardous Substances And Establishing

Variations And Exemptions

The administrator, upon approval by the Secretary, shall promulgate the

rules and regulations governing the implementation of this decree.

To resolve uncertainty as to the coverage of this decree, the Secretary may by

regulation declare as hazardous any substance or mixture of substances which he
finds meets the requirements of paragraph (1) (A) of Section 1 (d).

If the Secretary finds that for good and sufficient reasons, full compliance
with the labeling requirements otherwise applicable under this Decree is
impracticable or is not necessary for the adequate protection of the public health
and safety, he shall promulgate regulations exempting such substances from these
requirements to the extent he deems consistent with the objective of adequately
safeguarding public health and safety, and any hazardous substance which does not
bear a label in accordance with such regulations shall be deemed to be a
misbranded hazardous substance.

SECTION 3. Grounds For Seizure And Condemnation Of Misbranded

Hazardous Substances -

(a) Any misbranded hazardous substance or banned hazardous substance

when introduced into commerce or while held for sale shall be liable to be proceeded
against while in commerce or at any time thereafter and condemned upon order of
the Administrator in accordance with existing procedure for seizure and
condemnation of articles in commerce: Provided, That this Section shall not apply to
a hazardous substance intended for export to any foreign country if it (1) is in a
package branded in accordance with the specifications of the foreign purchaser, (2)
is labeled in accordance with the laws of the foreign country, (3) is labeled on the
outside of the shipping package to show that it is intended for export, and (4) is so
exported.

(b) Any hazardous substance condemned under this Section shall, after entry
of the order be disposed of by destruction or sale as the Administrator may direct
and the proceeds thereof, if sold, less the legal costs and charges shall be paid into
the Treasury of the Philippines; but such hazardous substance shall not be sold
under any order which is contrary to the provisions of this Decree: Provided, That,
after entry of the order and upon the payment of the costs of such proceedings and
the execution of a good and sufficient bond conditioned that such hazardous
substance shall not be sold or disposed of contrary to the provisions of this Decree,
the Administrator may direct that such hazardous substance be delivered to the
owner thereof for destruction or for alteration to comply with the provisions of this
Decree under the supervision of an officer or employee duly designated by the
Administrator. The expenses for such supervision shall be paid by the person
obtaining release of the hazardous substance under bond.

(c) All expenses in connection with the destruction provided for in subsection
(a) of this Section and all expenses in connection with the storage and labor with
respect to such hazardous substance shall be paid by the owner or consignee, and
default in such payment, shall constitute a lien against any importation by such
owner or consignee.

SECTION 4. Imports: Regulations On Imported Hazardous Substances.-

(a) The Commissioner of Customs shall deliver to the Administrator, upon his
request, samples of hazardous substances being imported or offered for export to the
Philippines, giving notice thereof to the owner or consignee who may appear before
the Administrator and exercise the right to make testimony. If it appears from the
examination of such samples that such hazardous substance or banned hazardous
substance, then such hazardous substance shall be refused admission except as
may be provided in an order issued by the Administrator authorizing delivery of the
refused articles under the requirements imposed therein. The Commissioner of
Customs shall cause the destruction of any hazardous substance refused admission
unless such hazardous substance is exported, under regulations issued by the
Commissioner within ninety days from the date of notice of such refusal or within
such additional time as may be fixed by him.

(b) Pending decision on the admissibility of a hazardous substance being

imported or offered for import, the Commissioner of Customs may authorize delivery
of

(c) such hazardous substance 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. If it appears to the Administrator that the
hazardous substance, can by relabeling or other action, be made to comply with the
requirements of this Decree, final determination as to the admission of such
hazardous substance may be deferred, and upon filing of a timely written application
by the owner or consignee and the execution by him of a bond as provided in the
provisions of this subsection. The Administrator, may in accordance with
regulations, authorize the applicant to perform such relabeling or other action
specified in such authorization (including destruction or export of such rejected
hazardous substance). All such relabeling or other action pursuant to such
authorization shall be in accordance with regulations and shall be under the
supervision of an officer or employee of the Bureau of Customs and the Food and
Drug Administration.

SECTION 5. Examination And Investigation For Purposes Of Enforcement Of

This Decree. -

Officers or employees duly designated by the Administrator upon presenting

appropriate credentials to the owner, operator, or agent in charge are authorized (1)
to enter at reasonable hours, any establishment or warehouse in which hazardous
substances are manufactured, labeled, packed or held for introduction into domestic
commerce or are held after such introduction, or to enter any vehicle being used to
transport or hold such hazardous substance in domestic commerce; (2) To inspect,
in a reasonable manner, such establishment or vehicle, warehouse and all pertinent
equipment, finished or unfinished, materials and labeling therein; and (3) to obtain
samples of such materials or packages therein or of such labeling, issuing proper
receipts for them.

SEC. 6. Prohibited Acts And Penalties.-

(a) Prohibited acts. - The following acts and the causing thereof are
prohibited:

(1) The introduction or delivery of introduction into commerce of any

misbranded hazardous substance or banned hazardous substance.
 (2) The alteration, mutilation, destruction, obliteration, or removal of the
whole or any part of the label of a misbranded hazardous
substance or banned hazardous substance, if such act is done
while the substance is in commerce or while the substance is held
for sale (whether or not it is the first sale).

(3) The receipt in commerce of any misbranded hazardous substance or

banned hazardous substance and the delivery or offered delivery
thereof at cost or otherwise.

(4) The giving of a guarantee or undertaking referred to in Section 3(b)

and Section 4(b) if such guarantee or undertaking is false, except
by a person who relied upon a guarantee or undertaking which
received in good faith.

(5) The introduction or delivery for introduction into commerce, or the

receipt in commerce and subsequent delivery or proffered delivery
at cost or otherwise, of a hazardous substance in a reused food,
drug, or cosmetic container or in a container which, though not a
reused container, is identifiable as a food, drug, or cosmetic
container, by its labeling or by other identification. The use of a
used food, drug, or cosmetic container as a container for a
hazardous substance involved, therefore such substance shall be
deemed a misbranded hazardous substance. As used in this
paragraph, the terms “food,” “drug,” and “cosmetic” shall have the
same meanings as in the Food, Drug, and Cosmetic Act (Republic
Act No. 3720).

(b) Penalties, exception. - (1) any person who violates any of the provisions of
subsection (a) shall, upon conviction, be subject to imprisonment of nor 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 fine and imprisonment to be at the discretion of the
court;
(2) no person shall be subject to the penalties of paragraph (1) of this subsection, (i)
for having violated subsection (a) (3) of this Section unless he refuses to furnish
upon request by the Administrator or his representative the name and address of the
person from whom he purchased or received such hazardous substance, (ii) for
having violated subsection (a) (1) of this Section, if he establishes a guarantee or
undertaking signed by, and containing the name and address of, the person from
whom he received in good faith, the hazardous substance to the affect that the
hazardous substance is not a misbranded hazardous substance or banned
hazardous substance with in the meaning of that term in this Decree.

SECTION 7. Effectivity. - This Decree shall take effect immediately.

Done in the City of Manila, this 30th day of January in the year of Our Lord
nineteen hundred and seventy-six.

(Sgd) FERDINAND E. MARCOS

President of the Philippines

By the President:

(Sgd) J.C. TUVERA

Presidential Assistant