Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

Fifteenth Congress
First Regular Session
1924

HOUSE BILL NO.
Tntroduced by: Hon. Mary Mitzi “Mitch” L. Cajayon
EXPLANATORY NOTE

Health Care Without Harm, an international coalition of hospitals and health care
systems, medical professionals, community groups, health-affected constituencies, and other
organizations warned that PVC, or vinyl, plastic — the most widely used plastic in medical
devices — can be harmful to patients, the environment and public health as dioxin, a known
human carcinogen, can be formed during the manufacture of PVC, and during the incineration or
burning of PVC products.

Moreover, di-ethylhexyl-phthalate (DEHP), a phthalate used to soften PVC plastic that
can leach from PVC medical devices, is linked to reproductive birth defects and other illnesses,
according to animal studies. Accordingly, patients may be harmed when exposed to DEHP leaks
from PVC medical devices.

According to Ruth Stringer, international science and policy coordinator for Health Care
Without Harm, doctors and health care experts in the Philippi yet to become aware of
the hazards of DEHP to human health. While visiting various hospi Stringer
identified San Lazaro Hospital, Philippine Children’s Medical Center and Philippine Heart

Center as among those hospitals where PVC products abound.

In 2005, the National Toxicology Program (NTP) of the United States reaffirmed that
DEHP poses a risk to human development and fertility. The NTP’s conclusion, which is an
authoritative statement of the severity of concems regarding exposure to DEHP in medical
devices, affirms the urgent need for medical device manufacturers to stop using DEHP in their
products as DEHP leaching out of PVC medical devices is among the highest routes of exposure
to the chemical.

Some countries in Asia, Europe and the US have started to require the labeling of PVC
products particularly medical devices made with DEHP in a move to adopt PVC- and DEHP-free
products because the lack of labelling allows confusion and misleading statements about PVC
products.

Hence, this bill aims to address the need to protect the general public from the harmful
effects of PVC products especially those made with DEHP by requiring all manufacturers to
consistently label all PVC products with the end view of protecting the general public from the
harmful effects of dioxin and phthalates to human health and environment.

In view of the foregoing, the passage of this bill is earnestly sought.

Sprapey-

MARY MITZI “Mitch” L. CAJAYON


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City
Fifteenth Congress
First Regular Session

HOUSE BILLNO._ 1924

Introduced by ajayon

AN ACT
PROVIDING FOR A MANDATORY LABELING OF POLYVINYL CHLORIDE (PVC)
PRODUCTS AND FOR OTHER PURPOSES

Be it enacted by the Senate and House of Representatives of the Philippines in Congress
assembled:

SECTION 1. Short Title. - This Act shall be known as the “PVC Labeling Act of 2008”.

SECTION 2. Declaration of Policy. - It shall be the policy of the State to protect the
interest of the public and to promote their general welfare. Toward this end, the State shall
implement measures to achieve the provision of safety standards for consumer products by
requiring that polyvinyl chloride (PVC) made products be consistently marked with or
accompanied by clear safety warnings that these products pose a risk to human health and
development.

SECTION 3. Objectives. - This Act shall have the following objectives:

(@ To protect public health, patients and environment from the harmful effects
of PVC;

(b) To wam the public about the risk of potentially harmful exposures for
vulnerable populations from DEH!

© To minimize exposures to DEHP;

@ To provide alternatives to PVC products including those made with DEHP

SECTION 4. Definition of Terms. - For purposes of this Act, the following terms are
hereby defined:

(@) “Di-ethylhexyl-phthalate or DEHP” means a phthalate used to soften PVC plastic that
can leach from PVC medical devices which is linked to reproductive birth defects and
other illnesses.

(b) "Label, labelling” means a display of written, printed or graphic matter upon the
surface of the product, immediate container or article and a requirement made by ot
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 is easily legible
through the outside container or wrapper.

(©) "Manufacturer" means any natural person or juridical entity, whether domestic or
foreign who manufactures, assembles or processes consumer products except that if
the goods are manufactured, assembled or processed for another person who attaches
his own brand name to the consumer products, the latter shall be deemed the
manufacturer. In case of imported products, the manufacture’s representative or, in
his absence, the importer, shall be deemed the manufacturer.

(@) “Medical device” means an apparatus or contrivances, including their components,
parts and accessories intended (1) for use in the diagnosis, cure,


mitigation/alleviation, treatment, monitoring, or prevention of disease,
injuries/handicap in man or animals; or (2) to affect the structure or any function of
the body of man or animals.

SECTION 5. PVC Products Labeling Requirements. - All manufacturers are hereby
required to consistently label all PVC products including medical devices that may cause patient
exposure to DEHP. PVC products that contain DEHP shall include a cautionary statement in a
prominent, clearly-worded warning label on the product stating the following:

WARNING:
PVC CONTAINS DEHP

and/or

BABALA:
PVC MAY DEHP

In the case of PVC products that do not contain DEHP, they shall bear or contain the
following statements:

WARNING:
PVC NO DEHP

and/or

BABALA:
PVC WALANG DEHP

SECTION 6. General Labeling Requirements. — Any warning label or statement shall be
displayed in its entirety on PVC product, on the principal display panel of the PVC product's
package and on any descriptive material which accompany the product, if there is any, in English
or Filipino or both, in conspicuous and legible type in contrast by typography, lay-out, or color
with other printed matter on such package and descriptive materials and in the manner consistent
with the provisions of the RA 7394 on labelling.

SECTION 7. Treatment as Mislabelled or Banned Hazardous Product. - Any PVC
product that is not in compliance with the requirements of this Act shall be considered a
mislabelled or banned hazardous product and shall be withdrawn from the market at the expense
of the manufacturer or shall not be allowed to be distributed, sold or offered for sale unless and
until the requirements of this Act is complied without prejudice to whatever liability and penalty
to be incurred under Section 10.

SECTION 8. Public Awareness Programs. ~ The Department of Trade and Industry, with
the assistance of the Department of Health, shall develop, lead and coordinate a nationwide
program to heighten public awareness and involvement in furtherance of the objectives of this
Act. The program shall utilize existing resources and efforts of the national government, local
government units and concerned non-government organizations.

SECTION 9. Reduction Strategies for PVC Products and Medical Devices. — The
Department of Health is hereby authorized to issue a directive, under such regulations as may be
prescribed in the implementing rules and regulations of this Act, to all heads of government and


private hospitals, clinics and health centers to conduct an audit to determine the presence of PVC
medical devices including those made with DEHP in their respective medical facilities and to
implement a purchasing policy that requires the reduction or elimination of such medical
devices.

The Department of Trade and Industry shall coordinate with concerned government and
private institutions in identifying and evaluating altemative products to PVC and in establishing
a mechanism for the procurement of PVC- and DEHP-free products of equivalent quality and
performance.

SECTION 10. Penalties. - Any person who shall violate any provision of this Act, shall,
upon conviction suffer the penalty of imprisonment ranging from one (1) year but not more than
ten (10) years or a fine of not less than Fifty Thousand Pesos (Php50,000.00) but not more than
Five Hundred Thousand Pesos (Php500,000.00), or both at 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.

Should the offense be committed by a foreign national, he shall, in addition to the
penalties prescribed, be deported without further proceedings after service of sentence.

SECTION 11. Regulations. - The Department of Trade and Industry, with the assistance
of the Department of Health, shall promulgate regulations for the implementation of this Act in
accordance with the provisions of RA 7394 on labeling. In addition, the Department of Trade
and Industry shall regularly publish the list of all manufacturers who failed to comply with the
requirements of this Act.

SECTION 12. - Grace Period. - Manufacturers are given three (3) months grace period to
comply with these requirements from the effectivity of this Act.

SECTION 13. Separability Clause. If any provision or part hereof, is held invalid or
unconstitutional, the remainder of the law or the provision not otherwise affected shall remain
valid and subsisting.

SECTION 14. Appropriations. — The amount necessary to carry out the provisions of this
Act shall be taken from the respective budgets of the DTI and DOH and shall be immediately
included in the following year’s annual General Appropriations Act and thereafter.

SECTION 15. Repealing Clause. - Any law, presidential decree, or issuance, executive
order, letter of instruction, administrative order, rule or regulation contrary to or inconsistent
with the provisions of this Act is hereby repealed, modified or amended accordingly.

SECTION 16. Effectivity Clause. - This Act shall take effect fifteen (15) days after its
publication in at least two (2) newspapers of general circulation.

Approved,