SIXTEENTH CONGRESS )
OF THE REPUBLIC OF THE PHILIPPINES )
First Regular Session )

HOUSE OF REPRESENTATIVES

House Bill No. 1904

Introduced by Representative Susan A. Yap

EXPLANATORY NOTE

In late 2012, the EcoWaste Coalition’s Project Protect came out with a pre-Christmas
analysis of toys indicating that 60 of the 100 samples (60%), contain lead and other toxic
metals that have been linked with reproductive abnormalities, endocrine disorders, behavioral,
developmental, and learning problems and even cancers. Found tainted with heavy metals
above levels of concern were some dolls with PVC materials, play makeup sets, toy animals,
toy boxing gadgets, toy cars, toy guns, toy musical instruments, among other toys.

‘The proposed measure secks “to regulate the importation, manufacture, sale, and
distribution of children’s toys, school supplies, childcare articles and other related products
containing toxic chemicals.” These toxic chemicals include (but are not limited to) antimony,
arsenic, cadmium, chromium, lead, and mercury, as well as bisphenol A (BPA) and phthalates.

‘The bill likewise seeks to delineate the roles played by the different implementing
agencies in ensuring the health safety of consumers relative to the use of products.

To ensure the health safety of consumers relative to the use of products covered in this
Act, the bill mandates the Department of Health (DOH) to publish and update the list of
toxic chemicals and substances used in the manufacture, sale and distribution of covered.
products for the information of the general public.

‘The bill mandates the Department of Environment and Natural Resources (DENR) to
regulate, control, restrict or prohibit the importation, manufacture, processing, sale,
distribution, handling, use, teansport and disposal of chemical substances mixtures under
Republic Act No. 6969, "Loxic Substances and Hazardous and Nuclear Waste Control Act of
1990", among others.

‘The Department of Finance (DOF), on the other hand, shall monitor the entry of
imported products as well as review and conduct examination of documentary requirements of
imported products.

Moreover, the Department of Trade and Industry (DTI) is mandated to enforce
policies and regulate the importation, manufacture, distribution and sale of educational kits or
school supplies, ensure that covered products comply with the Philippine National Standards
on the Safety of Toys set by the Bureau of Product Standards and monitor and conduct
market inspections on covered products.

Finally, the bill creates a Children's Product Safety Council (CPSC), attached to the
DOH to engage in studies and researches on harmful and toxic chemicals and substances;
conducts consultations with stakeholders, information campaigns; undertakes activities to
improve policies and rules and regulations on the subject.



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SIXTEENTH CONGRESS )
OF THE REPUBLIC OF THE PHILIPPINES )
First Regular Session )

HOUSE OF REPRESENTATIVES

1904

House Bill No.
Introduced by Representative Susan A. Yap

AN ACT
TO REGULATE THE IMPORTATION, MANUFACTURE, SALE AND
DISTRIBUTION OF CHILDREN’S TOYS, SCHOOL SUPPLIES, CHILDCARE
ARTICLES AND OTHER RELATED PRODUCTS, CONTAINING TOXIC
CHEMICALS AND FOR OTHER PURPOSES

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

TON 1. Short Title. — This Act shall be known as th
Products Act of 2013”,

afe and Nontoxic Children’s

SECTION 2. Declaration of Policy. — It is hereby declared the poli

of the State to protect and

promote the rights of the people to health, a balanced and healthful ecology and to information.
‘Toward these ends, the State shall regulate the importation, manufacture, sale and distribution of

children’s toys, school supplies and other childcare articles containing toxic chemicals.

SECTION 3. Definition of Terms. ~ For purposes of this Act, the following terms are hereby
defined:

(@) Bioanailability refers to the availability and possibility of the chemical from a product or
children’s toys to be released and absorbed into a child’s body via the gastro intestinal tract, the

Jungs or the skin and mucus membranes.

(b) Chemical substance refers to any organic or inorganic substance of a particular

molecular identity, including:

(1) Any combination of such substances occurring, in whole or in part, as a result of

chemical reaction or occurring in nature; and
(2) Any element or uncombined chemical

(©) Childcare article refers to any product intended to facilitate sleep, relaxation, hygiene,
the feeding of children or sucking on the part of children such as nipples, feeding bottles,

baby dresses, pacifiers, etc.


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(d) Children refer to persons below eighteen (18) years of age or those over but are
unable to fully take care of themselves or protect themselves from abuse, neglect, cruelty,

exploitation or discrimination because of a physical or mental disability or condition.

(©) Distributor refers to any entity to which the toy product is delivered or sold for
purposes of distribution in commerce, or in such case repackages toys under different trade
name or trademark with permission from the original legal distributor, except that such term

does not include a manufacturer or retailer of such product.

(0) Educational kit refers to a collection of materials and associated scientific apparatus

that are not likely to be licked or put in the mouth by children and which are typically used to
perform experiments or demonstrations in the different fields of science. These materials
include, among others, notebooks, pad papers, envelopes, plastic covers, folders, mugs, school

uniforms and school bags.

(g) Hazardous wastes refer to substances that are without any safe commercial, industrial,
agricultural, or economic usage to byproducts, side-products, process residues, spent reaction,
media, contaminated plant or equipment or other substances from manufacturing operations,
and as consumer discards from manufactured products. It can also refer to waste which,
because of its quantity, concentration, or physical, chemical, or infectious characteristics, may
pose a substantial present or potential hazard to human health or the environment when

improperly treated, stored or disposed of, otherwise mismanaged; or cause or contribute to an

increase in mortality, or an increase in irreversible or incapacitating illness.
(h) Hazardous substance/ chemical refers to:

(1) A substance which presents short-term acute hazards, such as acute toxicity by

ingestion, inhalation ot skin absorption, corrosivity or other skin or eye contact hazard or the

tisk of fire ot explosion;

(2) A substance which presents long-term environmental hazards, including chronic

toxicity upon repeated exposure, carcinogenicity (which may in some cases result from acute
exposure but with a long latent period), resistance to detoxification process such as
biodegradation, the potential to pollute underground or surface waters, or aesthetically

objectionable properties such as offensive odors;

(3) A chemical for which there is statistically significant evidence (based on at least one
study conducted according to established scientific principles) that acute or chronic health

effects may occur;


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(4) Any radioactive substance, if, with respect to such substance as used in a particular
class of article or as packaged, the Department of Health (DOH) determines by regulation that
it is sufficiently hazardous to require labeling in accordance with this Act in order to protect

the public health;

() Any toy or other articles intended for use by children that may, by regulation, be

determined to contain an electrical, mechanical or thermal hazard; or
(6) Any substance which the DOH finds to be under the categories enumerated above.

(i) Importation refers to the entry of a product or substance into the Philippines (through
the seaports or airports of entry) whether already properly cleared through or still remaining
under customs control, which is intended for direct consumption, merchandising, warchousing

and for further processing.

i) Label refers to the display of printed or graphic matter on any consumer product, its
immediate container, tag, literature ot other suitable material affixed thereto for the purpose

of giving information as to the identity, components, ingredients, attributes, directions for use,

specifications and such other information as may be necessary to protect health and safety of

the consumers.

(k) License to operate (LTO) refers to the license

sued by the Food and Drug
Administration (FDA) to manufacturers, importers and distributors whose toy products,
children articles and school implements, under this Act, conform to the health and safety
requirements of the DOH and the relevant Philippine National Standards (PNS) and their

future amendments.

() Manufacturer refers to any establishment that assembles or processes products under
this Act: Provided, ‘That if such products are manufactured, assembled or processed for another
establishment that attaches its own brand name to the products, the latter shall be deemed the
manufacturer. In case of imported products under this Act, the manufacturer's representative

or, in his absence, the importer shall be deemed the manufacturer.

(m) Philippine National Standards (PNS) refer to the national standards approved by the
technical committee under the Bureau of Product Standards (BPS) of the Department of

Trade and Industry (DTI)

(n) Sale or distribution refers to an act made by a manufacturer or seller, or the respective
representative or agent to make available consumer products, services or credit to the end

consumers under a consumer sale transaction. It shall not include sampling or any other


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distribution not for sale.

(0) Schoo! implement refers to a tool used for writing, drawing, coloring, marking, gluing or

erasing by children that are likely to be licked or put in the mouth.

(p) Schoo! supplies refer to items/atticles used for educational purposes which are not
likely to be licked or put inside the mouth by children. These include, among others,
notebooks, crayons, pad papers, envelopes, plastic covers, folders, mugs, school uniforms and

school bags.

(q) Testing laboratory refers to an accredited facility for measuring, examining and

determining the level of chemical elements in products under this Act.

(2) Toy refers to an object or a number of objects clearly intended as a plaything for

children as defined in Section 3 of this Act.

(8) Toxie substance refers to any substance other than a radioactive substance which can
cause injury, illness or death through ingestion, inhalation or absorption through any body

surface.

“TION 4. Scope. — This Act shall apply to the importation, manufacture, sale and

distribution of children’s toys, school supplies, childcare articles and other related products,

whether or not designed or intended for use or play solely by children under eighteen (18)

years old, and other childcare articles and related products that are sold or given free of charge

in the Philippines.

SECTION 5. Chemicals and Substances Covered. ~ Within three (3) months from the
effectivity of this Act, the FDA shall prepare a list of chemicals and substances used in

children’s products which ca th to children. The FDA

¢ or may cause harm, injury or d

shall specifically identify absolutely banned or prohibited substances and chemicals used in the
manufacture, production and preparation of children’s products. Maximum levels and limits
and reference values for certain chemicals used for this purpose shall also be specifically and

clearly identified.

Chemicals and substances deemed most harmful and toxic to children and commonly
used in the manufacture and production of children’s products shall include, but shall not be

limited to, the following:
(a) Toxic metals:

(1) Antimony;


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(2) Arsenic;
(@) Cadmium;
(4) Chromium;
(5) Lead; and
(© Mercury.

(b) Phthalates — when applied in the manufacture and production of products covered

under this Act, include:
(1) Di 2 Ethlyhexyl) Phthalate (Dehp);
(2) Dibutyl Phthalate (bp);

(3) Ber

Butyl Phthalate (Bbp);
(4) Diisononyl Phthalate (Dinp);

(5) Diisodecyl Phthalate (Didp); and
(6) Di-N-Octyl Phthalate (Dnop).
(©) Bisphenol-A (Bpa)

SECTION 6. Compliance With Philippine National Standards (PNS). ~ Importers,
manufacturers, distributors and sellers of products under this Act shall comply with the
standards, rules and processes of the BPS of the DTI. ‘The same shall collaborate with other

relevant government agencies to harmonize/upgrade existing standards, where applicable.

SECTION 7. Powers and Functions of the Department of Health (DOH). ~ To effectively carry
out its mandate of ensuring the quality of products under this Act, the DOH shall have the

following powers and functions:

(a) Formulate guidelines in the filing of application for the issuance of LTO to

importers, distributors and local manufacturers of products under this Act;

(b) Formulate specific guidelines on the issuance of the Certificate of Conformity (COC)
to manufacturers, distributors and importers for every shipment, freight, batch/lot of their

products covered in this Act;

(© Issue quality control orders (QCOs) to enforce the provisions of this Act and to


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ensure strict compliance with existing standards and regulations set by government authorities;

(d) Issue compliance orders (COs) if it finds noncompliance and/or nonconformity with

this Act, its rules and regulations, and guidelines issued to enforce and implement the same;

(©) Undertake researches, develop and establish quality and safety standards for products

covered by this Act in coordination with other implementing government agencies;

(f) Set the maximum allowable level of toxicity of chemical elements in products

covered by this Act;

(g) Inspect and analyze products covered by this Act for purposes of determining

conformity to established quality and safety standards;

(h) Conduct constant and regular inspection, product testing, and onsight and random

product testing and sampling of various children’s products in the market;

(i) Levy, assess, collect and retain fees as are necessary to cover the cost of inspection,

cettification, analysis and tests of samples of products under this Act;

i) Investigate the causes of and maintain a record of product-related deaths, illnesses

and injuries for use in researches or studies on the prevention of such deaths, illnesses and

injuries;

(k) Aceredit independent, competent nongovernment bodies to assist in monitoring the
market for the presence of toxic chemicals in products under this Act and to look for
appropriate means to expand the monitoring and enforcement outreach of the Department in

relation to its manpower, testing and certification resources at a given time;
(l) Accredit independent competent testing laboratories; and

(m) Perform such other functions as needed and necessary in the enforcement of this

Act.

SECTION 8. Role Delineation of Implementing Agencies. —Vhe provisions of this Act and its

implementing rules and regulations (IRR) shall be enforced by the following agencies:

(a) DOH. ~ The Department of Health shall formulate policies, rules and regulations on

food, drugs, cosmetics, devices and substances.

The FDA shall conduct regular testing, evaluation, monitoring and  post-market

surveillance of covered products to include all school implements as defined in Section 3 of


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this Act to ensure compliance with the PNS on the Safety of Toy

(b) DENR. — The Department of Environment and Natural Resources shall regulate,
control, restrict or prohibit the importation, manufacture, processing, sale, distribution,
handling, use, transport and disposal of chemical substances mixtures under Republic Act No.
6969, “Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990”. It shall
monitor toxic substances/chemicals used as industrial raw material to produce the covered
products under this Act in terms of their compliance to environmental laws, It shall

administer the industrial toxic chemicals through a system of review, evaluation and

monitoring of these toxic chemicals under DENR Administrative Order No. 2007-23 and
formulate policies and guidelines for the gradual phase-out of lead in paints pursuant to
Section 20(1) of DENR Administrative Order No. 20, Series of 1992 and DENR
Administrative Order No. 05, Series of 2005 (Toxic Chemical Substances for Issuance of

Chemical Control Orders);

() DOF. ~ The Department of Finance, through the Bureau of Customs (BoC), shall
monitor the entry of imported products covered under this Act at the different ports of entry

in the Philippines. It shall review and conduct exami

ion of documentary requirements of

imported products pursuant to the guidelines of the Department; and

(d) DTI. = The Department of Trade and Industry shall enforce policies and regulate the
importation, manufacture, distribution and sale of educational kits or school supplies as
defined in Section 3 of this Act and other consumer products not covered by the mandates of
the other implementing agencies. It shall ensure that covered products comply with the PNS

on the Safety of Ti

ys set by the BPS and shall monitor and conduct market inspections on

covered produets.

SECTION 9. Creation of the Children’s Product Safety Council (CPSC). — There is hereby
created a Children’s Product Safety Council (CPSC) to be attached to the DOH and composed

of the following:
(a) The Secretary of the DOH, Chairperson;
(b) The Secretary of the DTI, Vice Chairperson;
(©) The Secretary of the DENR, member;

(@) The Secretary of the Department of the Interior and Local Government DILG,

member;

(©) The Secretary of the Department of Education (DepED), member;


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(© The Secretary of the DOF, member;
(@ The Director of the FDA, member;
(h) The National Consumer Affairs Council (NCAC), member;

(@ One (1) representative from a nongovernment organization (NGO) engaged in

consumer rights protection, member; and

() One (1) representative from an NGO engaged in environmental protection and

advocacy, member.

The departments and government agencies shall be represented by their respective heads

or their duly designated representatives who shall be of a rank not lower than Director level.

‘The Chairperson of the CPSC shall recommend the nominees for the NGO sector

representatives to the President of the Philippines.
‘The EDA shall serve as the secretariat and operational arm of the CPSC.

Other gov and private sector representatives may be invited to

ernment agencie:

participate in the CPSC as the exigencies and circumstances may require.

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STION 10. Powers and Functions of the CPSC. - ‘The CPSC shall have the following

powers and functions:

(a) To provide coordination and linkage mechanisms between and among its members,
other government agencies concerned, local government units (I.GUs), the private sector and

other stakeholders;

(b) To engage in studies and researches on harmful and toxic chemicals and substances,

and provide the necessary information materials on the same;

(©) To conduct and facilitate consultation and dialogues within and among all concerned

stakeholders in the industry;
(@) To conduct information and education campaigns, especially for children;

(©) To propose amendments to laws, rules and regulations pursuant to its mandate and

the objectives of this Act;

(8 To provide periodic and regular reports to the Secretary of Health;


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(g) To create a technical advisory committee composed of experts from both
government and private sectors that would assist the council in providing technical and

scientific recommendations necessary to effectively carry out its mandate;

(h) To provide coordination and linkage mechanisms between and among its members,
other government agencies concerned, the Business Processing and Licensing Office (BPI.O)

of LGUs, the private sector and other stakeholders; and
(i) To perform such other functions as may be directed by the DOH.

SECTION 11. Application to Trade. ~ The following procedures shall be observed at the

first port of entry of imported products:

(a) The FDA or its commissioned /designated agent, in coordination with the BoC, shall
conduct product inspection, sample testing and clearance of imported products covered under

this Act for compliance with the national standards for the safety of toys prior to their

assessment and charging of tariffs and other charges by the BoC;

(b) Samples of products covered by this Act being imported into the Philippines shall be
obtained for purposes of determining the toxicity level of chemical elements and substances
content without charge from the owner or consignee thereof. The owner or consignee of the
imported product under examination shall be afforded an opportunity to a hearing with
respect to the importation of such product into the Philippines. If it is proven that such
product does not conform to the allowable level of chemical elements and substances content

as provided for under the IRR of this Act, said product shall be refused admission;

(6) Any product covered by this Act, the sale or use of which has been banned or

withdrawn in the country of manufacture, shall not be imported into the country; and

(@ All expenses in connection with the storage, destruction and disposition of any
product under this Act which was refused admission shall be paid by the owner or consignee

and, in default of such payment, shall constitute a lien against any future importation made by

such owner or consignee.

SECTION 12. Clearance for Customs Release, — All importers of products under this Act

shall secure a clearance for customs release from the DOH prior to importation.

‘A clearance for conditional release shall be issued by the appropriate center of the FDA

to facilitate the release of goods from BoC custody pending the issuance of the COC. The

importer, however, shall not sell, distribute or transfer, in whole or in part, the products to

any place other than the address specified in the conditional release. To ensure that no


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distribution, sale, transfer to or use of products covered by this Act in any place other than
the address specified in the conditional release is made, the importers shall allow authorized
personnel of the FDA to conduct an inspection/inventory of the import shipment within
three (3) days from the date of issuance of the clearance for conditional release at any time

within official working hours.

SECTION 13. Certification. - The DOH, after the conduct of a thorough examination,

shall issue the necessary certificate to show whether or not the imported products are safe for

distribution in the market,

SECTION 14. Disposal of Noncompliant Products. ~ All products covered by this Act that

are recalled by the manufacturer or the Department for whatever reason, shall be disposed of

in accordance with the submitted disposal plan subject to the FDA approval. The plan shall
comply with the existing rules and regulations set by all concerned agencies of the government

and other related laws of the country. The concerned manufacturer, importer or distributor

shall shoulder the expenses to be incurred in the disposal of the recalled products.

All import-shipments denied the requ

ite COC shall not be disposed of in the domestic
market in any manner. They must be properly disposed in accordance with the provisions of

ions.

the Tariff and Customs Code of the Philippines and other pertinent rules and regu:

SEC

PION 15. Labeling and Packaging Requirement. — The labeling and packaging

requirement of products under this Act shall comply with the relevant PN’

ION 16. Monitoring and Factory Inspection. ~The FDA shall observe the following
procedures in the inspection and monitoring of establishments to determine compliance with

safety regulations:

(a) Officers or employees duly designated by the FDA, 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
products under this Act are manufactured or held for introduction into domestic commerce or
are held after such introduction, of to enter any vehicle being used to transport or hold such

products; and

(2) To inspect, in a reasonable manner, such factory, warehouse, establishment or vehicle

and all pertinent equipment, finished and unfinished materials, containers and labeling therein.

(b) Upon completion of the inspection of a factory, warehouse or other establishment

and prior to leaving the premises, the officer or employee who conducted such inspection and

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has obtained any sample in the course of the inspection, shall give the owner, operator or

agent in charge a receipt describing the samples obtained; and

(©) Whenever in the course of any such inspection of a factory or other establishment
where products covered by this Act are manufactured or held, the officer or employee making
the inspection obtains a sample of any such product, and an analysis made of such sample for
the purpose of ascertaining whether such product contains, in whole or in part, disallowed

level of toxicity of chemical elements and hazardous substances, a copy of the result of such

hall be furnished the owner, operator or officer-in-charge.

SECTION 17. Market Inspection. — The DOH shall conduct routine inspection in the

market and take samples of suspected products for examination.

SECTION 18. Injuriows, Dangerous and Unsafe Products. ~ Whenever the DOH finds, by its
own initiative or by petition of a consumer, that a product covered by this Act is injurious,
dangerous or unsafe, it shall, after due notice and hearing, make the appropriate order for its
recall, prohibition or seizure from public sale or distribution. It may declare a product to be
imminently injurious, dangerous or unsafe, and order its immediate recall, ban or seize from
public sale ot distribution, in which case, the seller, distributor or producer thercof shall be

afforded a hearing within forty-eight (48) hours from such order.

There shall be immediate information dissemination, through the mass media, of

products which are found to be injurious, dangerous and unsafe.

SEC

TION 19. Product Confiscation. — Imported products shall be allowed entry into the

country as provided under Section 11 of this Act when accompanied by certificate of testing
or analysis of its composition. The BoC shall require pertinent clearance or certification from

the FDA prior to entry. The entire shipment or batch of the product found to be in violation

of the provisions of this Act shall be seized. The confiscated products shall be properly
disposed of in accordance with the prescribed procedure to be issued by the DOH in

coordination with the DENR.

SECTION 20. Publication and Information. — The DOH is mandated to conduct
information campaigns utilizing any form of mass media and other electronic means deemed
effective to ensure the proper guidance of consumers, industries, businesses and other

concerned sectors.

The DOH shall likewise publish a consumer chemical substance advisory notice which
shall include a list of toxic chemicals and substances used in the manufacture, distribution and

sale of covered products for the information of the general public. Such advisory notice shall

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be made available to government agencies, consumers, industries, businesses and the general
public,

‘The advisories to be issued under this Act shall explain in an casily understandable
manner, the dangers of hazardous substances exposure. It shall be printed in English and
Filipino or in any dialect determined by the DOH to be culturally and linguistically

appropriate utilizing any form of mass media and electronic means of communication.

SE!

ION 21. Public Access to Records, Reports or Notification. - The public shall have

access to records, reports, test results, or information concerning chemicals, substances and

mixtures, including safety data submitted, and methods of production and preparation.

Such documents shall be available for inspection or reproduction during normal busine

hours: Provided, That the DTI m:

consider a record, report ot information or particular

portions thereof confidential and which may not be made public when such would divulge
trade secrets, production or sales figures or methods, production or processes unique to such
manufacturer, processor or distributor, or would otherwise tend to affect adversely the
competitive position of such manufacturer, processor or distributor. The DTI, however, may
release information subject to claim of confidentiality to a medical research or scientific

institution where the information is needed for the purpose of medical diagnosis or treatment

of a person exposed to the chemical substance or mixture.

‘The DOH shall establish a website to be maintained by the CPSC which shall provide

the following information:

(a) Basic data on manufacturer, producer, assembler, importer, distributor and seller of

covered products;

() Kinds and amount of chemicals and substances used in the production of products;

and
(©) The potential risks and dangers to consumers.

‘The website shall also make available reports, records and inventories submitted by the

companies and businesses covered by this Act.

SECTION 22. Disclosure of Toxicological Information on Labels. ~ It shall be mandatory for
manufacturers, distributors and importers of products covered by this Act to disclose and
identify, through accurate and truthful labeling, the substances and chemical contents and
bioavailability of said substances/chemicals. Graphic symbols shall also be used in product

packaging showing product safety and regulatory compliance.

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SECTION 23. Probibited Acts. — The following acts are hereby prohibited:

(a) The importation, distribution, manufacture and sale of products under Section 4
hereof containing more than the allowable level of chemical elements and hazardous
substances such as, but not limited to, antimony, arsenic, bisphenol, cadmium, chromium,

lead, mercury and phthalate;
(b) Mislabeling of the level of chemical elements in products under this Act;

() Material misrepresentation or concealment of significant data or information about

the product sought for certification;

(@) Importation, manufacture, sale, distribution, labeling and operation without

registration;

(c) Noncompliance with the standards and requirements of the DOH on the

importation, manufacture, distribution and sale of covered products;

(8) Refusal to allow required inspections as determined by the Department; and

(g) Other prohibited acts stipulated in Republic Act No. 9711, otherwise known as the
“Food and Drug Administration (FDA) Act of 2009”.

SE

CTION 24. Administrative Sanctions. — Where there is a finding of a violation against
the provisions of this Act and a determination of the persons liable thereto, after notice and
hearing, the FDA director-general may impose one or more of the following administrative

penalties:
(a) Suspension of License to Operate (LTO);
(b) Revocation of LTO; and

(©) Seizure of the unregistered, noncompliant or falsely represented products covered by

this Act.

SECTION 25. Penalties. — Pursuant to Section 11 of Republic Act No. 9711, as amended,
any person who violates any of the provisions of Section 24 hereof and other prohibited acts
stipulated in the same 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 (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00), or both, at
the discretion of the court: Provided, That if the offender is a manufacturer, importer or
distributor of any product covered under this Act, the penalty of at least five (5) years

imprisonment but not more than ten (10) years and a fine of at least Five hundred thousand

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pesos (P500,000.00) but not more than Five million pesos (P5,000,000.00) shall be imposed:
Provided, further, That an additional fine of one percent (1%) of the economic value/cost of the
violative product or violation, or One thousand pesos (P1,000.00), whichever is higher, shall
be imposed for each day of continuing violation: Provided, finally, That products found in
violation of the provisions of this Act and other relevant laws, rules and regulations may be
seized and held in custody pending proceedings, without hearing or court order, when the
FDA director-general has reasonable cause to believe from facts found by him/her or an
authorized officer or employee of the FDA that such products may cause injury or prejudice

to the consuming public.

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/she shall, in addition to the

penalties prescribed, be deported without further proceedings after service of sentence.

SE

ION 26. Citizens Suit. - For purposes of enforcing the provisions of this Act ot
its IRR, any citizen may file an appropriate civil, criminal or administrative action in the

proper courts/bodies against:

‘a) Any person who violates or fails to comply with the provisions of this Act and its
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IRR; or

(b) The officials or employees of the DOH and other implementing agencies with

respect to orders, rules and regulations issued inconsistent with this Act; and/or

(©) Any public officer who willfully or grossly neglects the performance of an act
specifically enjoined as a duty by this Act or its IRR; or abuses authority in the performance of
duty; or, in any manner improperly performs his duties under this Act or its IRR: Provided,
however, That no suit can be filed until after a thirty (30)-day notice has been given to the
public officer and the alleged violator concerned and no appropriate action has been taken

thereon.

‘The court shall exempt such action from the payment of filing fees and shall likewise,
upon prima facie showing of the nonenforcement or violation complained of, exempt the

plaintiff from the filing of an injunction bond for the issuance of preliminary injunction.

In the event that the citizen suit should prosper, the court may award reasonable

attorney’s fees, moral damages and litigation costs.

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SECTION 27. Suits and Strategic Legal Action Against Public Participation (SLAPP) and the
Enforcement of this Act. ~ Where a suit is brought against a person who filed an action as
provided in Section 26 of this Act, or against any person, institution or government agency
that implements this Act or any other consumer related laws, rules and regulations, it shall be
the duty of the investigating prosecutor or the court, as the case may be, to immediately make
a determination within a period not exceeding thirty (30) days whether said legal action has
been filed to harass, vex, exert undue pressure or stifle such legal recourses of the person
complaining or enforcing the provisions of this Act. Upon determination of the evidences,

the court may dismiss the case and award attorney’s fees and damages.

‘This provision shall also apply and benefit public officers who are sued for acts
committed in their official capacity, there being no grave abuse of authority, and done in the

course of enforcing this Act, its rules, regulations and guidelines.

SECTION 28. Burden of Proof of Product Safety. ~ The burden of proof to prove the

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© of due diligence, compliance with this Act and other laws, rules and regulations

relating to consumer products, precaution and to prove the absence of fault and/or negligence

shall lie with the manufacturer, producer, assembler, importer and/or seller of the children’s

product involved or concerned.

“TION 29. Appropriations. — Such amount as may be necessary to implement the
provisions of this Act shall be included in the annual appropriations of the DOH under the

General Appropriations Act.

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TION 30. Congressional Oversight Committee. ~ Vhe Joint Congressional Oversight
Committee created under Republic Act No. 9711 or the “Food and Drug Administration
(FDA) Act of 2009” shall function as the oversight committee to monitor and evaluate the

implementation of this Act

SECTION 31. Suppletory Provision. — Pertinent provisions of Republic Act No. 7394,
otherwise known as the “Consumer Act of the Philippines” shall have suppletory effect in the

implementation of this Act.

SECTION 32. Implementing Rules and Regulations. — Within sixty (60) days after the
effectivity of this Act, the DOH, in coordination with the DTI, the DENR and the DOF

through the BoC, shall issue the rules and regulations to implement the provisions of this Act.

SECTION 33. Separability Clause. — If, for any reason, any provision or part hereof is

declared invalid, the other provisions not affected thereby shall remain in full force and effect.

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SECTION 34. Repealing Clause. — All laws, decrees, executive orders, rules and
regulations or parts thereof inconsistent with the provisions of this Act are hereby repealed,

amended or modified accordingly.

ION 35. Effectivity Clause. — This Act shall take effect fifteen (15) days after its

publication in any newspaper of general circulation,

Approved,

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