FOURTEENTH CONGRESS OF THE 
) 
REPUBLIC OF THE PHILIPPINES ) 
Second Regular Session 
) 
SENATE 
’ 
S.NO. 320 
Introduced by Senator Antonio “Sonny” F. Trillanes IV 
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EWLlL’YATORY NOTE 
Polyvinyl Chloride (PVC) or simply vinyl plastic is most widely and commonly used plastic in 
medical devices. However, the use of PVC in these devices can prove to be harmful to patients, 
the environment, and the public in general. PVC upon manufacturing and during incineration or 
burning can produce Dioxins, a lm~w 
human carcinogen. 
Moreover, manufacturers often use DEHP or diehylhexyl phthalate to soften PVC plastic and to 
inake them more flexible. However, DEHP is linked to reproductive birth defects and other 
illnesses. DEHP may leach out from PVC devices/ materials and cause harm to the public. 
In addition, soft PVC toys have been made for babies for years, and concerns were raised 
because it is possible that these additives leach out of soft toys into the mouths of the children 
chewing on them. Other vinyl products, including car interiors, shower curtains, and flooring, 
initially release chemical gases into the air. Some studies indicate that this outgassing of 
additives may contribute to health complications, and have resulted in a call for banning the use 
of DEHP on shower curtains, aniong other uses. In 2004, a joint Swedish-Danish research team 
found a statistical association between allergies in children and indoor air levels of DEHP. 
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. 
This bill seeks to address the need to protect the public from the harmful effects of PVC products 
by requiring all manufacturers to provide proper labeling of all PVC products with the end view 
of protecting the general public from the harmful effects of dioxin and phthalates to human 
heaith and the environment. 
In view of the foregoing, immediate passage of this bill is earnestly sought. 
A N T ~ N ~  
“SONNY” F. TRILLANES IV 
Senator 
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FOURTEENTH CONGRESS OF THE 
) 
REPUBLIC OF TEE PHULPPINES 
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Second Regular Session 
SENATE 
S.NO. 310 
Introduced by Senator Antonio “Sonny” F. Trillanes IV 
AN ACT 
PROVIDING FOR A MANDATORY LABELM6 OF PQLYVt’YL CEELOMDE (PVC) 
PRODUCTS AND FOR OTHER PURPOSES 
Be it enacted by the Senate and the House of Representatives of the Philippines in Congress 
assembled. 
SECTION 1. Stwit Titie. ~ 
This Act shall be knoa\~ as the “PVC Labeling Act of 
2009”. 
SEC. 2. Declaratiim of Pdicy. - 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. 
SEC. 3.0bjec$ives. -This Act shall have the follosving objectives: 
(a) To protect public health, patients and environment from the harmful effects of PVC; 
(b) To warn the public about the risk of potentially harmful exposures for vulnerable 
populations &om DEW; 
(c) To minimize exposures to DEW; 
(d) To provide alternatives to PVC products including those made with DEHP. 
SEC. 4. Definition of Term. - For purposes of this Act, the following terms are hereby 
defined as follows: 
(a) Dkthylhexyl-phthalate or DEHP - mans 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, labeling - means a &splay of a*&&, 
printed or graphic matter upon the 
surface of the product, immediate container or article and a requirement made by or 
under authority of this Act that any word, statement, or other information appearing 


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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 
thou& the Quaside COnaiMP OT W F a p F .  
(c) Manufacturer - means any natural person or juridical entity, whether domestic or 
foreign who manufactures, assembles or processes consumer products except that if 
tk gads are manufactwed, assembled OT processed for mother person who attaches 
his own brand name to the consumer products, the latter shall be deemed the 
manufacturer. In case of imported products, the manufacturer's representative or, in 
his absence, the importer, shall be deemed the mmufixturer. 
(d) Medical device - means an apparatus or contrivances, including their components, 
parts and accessories intended (1) for use in the diagnosis, cure, mitigation/ 
alleviation, treatment, mo&&ng, 
0% peventim of disease, injuries/ handicap in man 
or animals; or (2) to affect the structure or any function of the body of man or 
animals. 
SEC. 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 DEW. PVC! products that c~ntain DEW shall include a c a u t i w  statement in a prominent, 
clearly-worded warning label on the product stating the following: 
WARNING 
PVC CQNTAKPINS DEHP 
and or 
In the case of PVC products that do not contain DEW, they shall bear or contain the 
following statements: 
I 
WARNING 
I 
PV€ NO DEHP 
and/ or 
I 
BABALA: 
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PVC WALANG DEHP 
SEC. 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 whch accompany the product, if there is any, in English 
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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 
tiah the ~ Q - V ~ S ~ C X I S  
of RA 7394 on labding. 
SEC. 7. Treatment as Mislabeled or Banned Hazardous Product. - Any PVC product 
that is not in compliance with t k  requiremeats of this Act shall be considered a mislabeled 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 reqwirements ofthis Act is complied w i t h t  pxeju&e to whatever liability and penalty to be 
incurred under Section 10. 
SEC. 8. Public Awareness RO~FQ~S. 
- The Departnrnent of TF& and Industry (DTI), 
with the Assistance of the Department of Health (DOH), 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. 
SEC. 9. Reduction Strategies for PV€ Froducts and Medical Devices. - The 
Department of Health (DOH) 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 hospitmls, clinics itnd health centers to CQnduCt an audit to- determine the 
presence of PVC medical devices including those made with DEW 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 (DTI) shall coordinate with concerned 
government and private institutions in ideatifylaag isnd evaluating aitemtive, products to PVG 
and in establishing a mechanism for the procurement of PVC- and DEHF-free products of 
equivalent quality and performance. 
SEC. 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 Thou~itnd Pesos (PSQ,W.QO) but not more than Five 
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Hundred Thousand Pesos (P500,000.00), or both at the discretion of the court. 
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Should the offense be committed by a juridical person, the Chairman of the Board of 
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Directors, the president, general manager, or the partners and/ or the persons directly responsible 
thc~cftx shall be penalized. 
Should the offense be committed by a foreign national, he shall, in addition to the 
penakies prescribed, be deported without hrtkr proceedings after service of sentence. 
SEC. 11. Regulations. - The Department of Trade and Industry, with the assistance of 
the Depwtment of Health, shall p m d g a t e  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 ofthis Act. 
SEC. 12. Grace Period - Manufacturers are given three (3) months grace period to 
~ ~ m p l y  
with these requirements fk~m 
ahk. effectivity ofths Act. 
SEC. 13. Separability Clause. - If any provision of this Act is held invalid, the other 
pravisions not affected s a l  remain in full force and eEe& 
SEC. 14. Repealing Clause. - Any law, presidential decree, or issuance, executive order, 
letter of in&uc.tion, administrative order, d e  or regulation cantraw t~ or inconsistent with the 
provisions of this Act is hereby repealed, modified or amended accordingly. 
SEC. 15. Efleeclity C€ause. - This Act: shall take effect fifteen (15) days after the 
completion of its publication in the Official Gazette or in at least two (2) newspapers of general 
circulation. 
Approved, 
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