REPUBLIC OF THE PHILIPPINES
HOUSE OF REPRESENTATIVES
QUEZON CITY

Seventeenth Congress
First Regular Session

2
House Bill No, 3942

Introduced by AGRI PARTYLIST Representative Orestes T. Salon

EXPLANATORY NOTE

This bill seeks to regulate the importation, manufacture, distribution and
sale of children’s toys, school supplies, childcare articles and other related products
containing hazardous chemicals and providing for violation thereof.

The Constitution provides in Section 15 Article II that “The State shall
protect and promote the right to health of the people and instill health
consciousness among them”. Likewise, in Section 12 Article XIII, it declares that
“The State shall establish and maintain an effective food and drug regulatory
system and undertake appropriate manpower development and research, responsive
to the country’s health needs and problems”.

Playtime is one of the most fundamental parts of childhood development
and toys are considered vital tools that help foster mental, physical, emotional and
social development of children.

However, the inadequate labeling of these products or materials and the
inability of the consumers to tell whether a particular toy or child article contains
toxic and hazardous substances poses danger to the consumers, more particularly
the children. Such exposure can cause adverse health effects ranging from asthma
and allergy symptoms, acute poisoning, neurological disorders, hyperactivity,
deficits in fine motor function, lowered intelligence performance, kidney and skin
problems and even cancers among others.


It is also the purpose of this bill to make mandatory for toy designers,
makers, manufacturers, importers, distributors and suppliers, as part of their social
responsibility, to fully disclose the chemical contents of their products for proper
information of the buying public. Labeling standards and enforcement are an
effective approach to toy safety.

This bill was originally filed as House Bill 220 in the 16" Congress
introduced by former Rep. Cinchona Cruz-Gonzales which was considered the
same and recommended as House Bill 5087 as an approved substitution of the
previous bill. The bill was referred in the Committee on Health. 7

REP. ORESTES T. SALON
AGRI Partylist


REPUBLIC OF THE PHILIPPINES
HOUSE OF REPRESENTATIVES
QUEZON CITY

Seventeenth Congress
First Regular Session

House Bill No. 3942

Introduced by AGRI PARTYLIST Representative Orestes T. Salon

AN ACT REGULATING THE IMPORTATION, MANUFACTURE,
DISTRIBUTION AND SALE OF CHILDREN’S TOYS, SCHOOL
SUPPLIES, CHILDCARE ARTICLES AND OTHER RELATED
PRODUCTS CONTAINING HAZARDOUS CHEMICALS AND
PROVIDING PENALTIES FOR VIOLATION THEREOF

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 “Safe and Non-
Hazardous Children’s Products Act”.

SEC, 2. Declaration of Policy. — It is hereby declared the policy of the State
to protect and promote the right to health of the people and of access to
information on matters of public concern. Towards this end, the State shall regulate
the importation, manufacture, distribution and sale of children’s toys, school

supplies and other childcare articles containing hazardous chemicals.

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SEC. 3. Definition of Terms. — As used in this Act:

(a) Bioavailability refers to the amount or proportion of a chemical
substance actually available to interact with human biological systems through
ingestion by mouth, skin exposure or by inhalation of a product under
consideration, taking into account solubility under conditions present in the body,
biological deactivation mechanisms, accessibility to physiological activity sites,
and other relevant factors;

(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.

(c) Childcare article refers to any product intended to facilitate sleep,
relaxation, hygiene, the feeding of children or sucking on the part of children;

(d) Children refer to persons under fourteen (14) years of age;

(e) Distributor refers to any entity to which the toy product is delivered or
sold for purposes of distribution in commerce or, in such case, any entity which
repackages toys under a different trade name or trademark with permission from
the original legal distributor: Provided, That such term does not include a
manufacturer or retailer of such product;

(f) Educational kit refers to a collection of materials or associated scientific
apparatus that is intended for children but is not likely to be chewed or put in the
mouth by children and which are typically used to perform experiments or

demonstrations in the different fields of science or associated with educational
purposes;


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(g) Hazardous wastes refer to substances that are without any safe
commercial, industrial, agricultural, or economic usage to by-products, side-
products, process residues, spent reaction, media, contaminated plant or equipment
or other substances from manufacturing operations, and as consumer discards from
manufactured products. These can also refer to waste which, because of their
quantity, concentration, or physical, chemical, or infectious characteristics, may
pose 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 increase in irreversible or incapacitating
illness;

(h) Hazardous substance or hazardous chemical refers to a substance which
has been determined to be in one (1) or more of the following categories of the
United Nations Globally Harmonized System (GHS) for classification and labeling
of chemicals:

(1) Flammable liquids and solids: Category 1

(2) Explosives: Category 1.1

(3) Acute toxicity (oral, dermal, inhalation): Category 1

(4) Bye irritation/corrosivity: Category 1

(5) Dermal irritation/corosivity: Category 1

(6) Mutagenicity: Category 1A.

(7) Carcinogenicity: Category 1A

(8) Reproductive toxicity: Category 1A

(9) Acute/Chronic aquatic toxicity: Category 1A

(i) Importation refers to the entry of a product or substance into the

Philippines (through seaports or airports of entry), whether already properly


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cleared through or still remaining under customs control, which is intended for
direct consumption, merchandising, warehousing or for further processing;

(j) Label refers to the display of printed or graphic matter on any consumer
product, its immediate container, tag, literature or 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 the health and safety of the consumers;

(k) License to Operate (LTO) refers to the license issued by the Food and
Drug Administration (FDA) to importers, manufacturers and distributors whose
toy products, childcare articles and school implements, under this Act, conform to
the health and safety requirements of the Department of Health (DOH) and the
relevant Philippine National Standards (PNS) and their future amendments;

(1) 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, manufacturer's designated
representative or, in the absence of one of these parties, the importer shall be
deemed the manufacturer;

(m) Philippine National Standards (PNS) refer to the national standards
promulgated by the Bureau of Product Standards of the Department of Trade and
Industry (DT);

(n) Distribution or Sale 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 distribution not for sale;


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(0) School implement refers to a tool used by children for writing, drawing,
coloring, marking, gluing, or erasing that is likely to be licked or put in the mouth;

(p) School supplies refer to items/articles used for educational purposes
which are not likely to be put inside the mouth by children;

(q) Testing laboratory refers to a facility which is accredited by the
Philippine Accreditation Office with International Organization for Standardization
(ISO) 17025 or by an International Laboratory Accreditation Committee Mutual
Recognition Agreement (ILAC MRA) signatory; and

(8) Toy refers to any product or material designed and clearly intended for
use in play by children under fourteen (14) years of age.

SEC. 4. Scope. — This Act shall apply to the importation, manufacture,
distribution and sale of children’s toys, school supplies, and childcare articles as

defined in Section 3 hereof that are manufactured, distributed, or sold in the

Philippines.

SEC. 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 cause or may cause harm, injury, or death to
children. The FDA 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 hazardous to children

and commonly used in the manufacture and production of children’s products shall
include the following:

(a) Toxic Metals:


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(1) Antimony;
(2) Arsenic;
(3) Cadmium;
(4) Chromium;
(5) Lead; and
(6) Mercury

(b) Phthalates — When used in the manufacture and production of products
covered under this Act, include:
(1) Di (2-Ethlyhexy!) Phthalate (DEHP);
(2) Dibutyl Phthalate (DBP);
(3) Benzyl Butyl Phthalate (BBP);
(4) Diisonony! Phthalate (DINP);
(5) Diisodecyl Phthalate (DIDP); and
(6) Di-N-Octy] Phthalate (DNOP).

(c) Bisphenol-A (BPA).

SEC. 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 Bureau of Product Standards
of the DTI who shall collaborate with other relevant government agencies to
harmonize and upgrade existing standards, where applicable.

SEC. 7. Powers and Functions of the DOH. - To effectively carry out its
mandate of ensuring the quality of products under this Act, the DOH shall be
vested with the following powers and functions:

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(a) Formulate guidelines in the filing of application for the issuance of a
License to Operate (LTO) to importers, distributors and local manufacturers of
products covered by this Act;

(b) Formulate specific guidelines on the issuance of the Certificate of
Conformity to manufacturers, distributors, and importers for every shipment,
freight, batch or lot of their products covered in this Act;

(c) Issue Quality Control Orders (QCOs) to enforce the provisions of this
Act and to 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;

(e) 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 on-sight
and random product testing and sampling of various children’s products in the
market;

(i) Assess and collect fees as necessary to cover the cost of inspection,
certification, analysis and tests of samples of products under this Act;

(j) 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;


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(k) Accredit independent, competent nongovernment bodies, to assist in
monitoring the market for the presence of hazardous chemicals in products under
this Act and to look for appropriate means to expand the monitoring and
enforcement outreach of the DOH in relation to its manpower, testing and
certification resources at a given time;

(1) Accredit independent competent testing laboratories; and

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

SEC. 8. Role Delineation of Implementing Agencies. — The provisions of
this Act and its implementing rules and regulations shall be enforced by the
following agencies:

(a) The DOH, through the FDA, shall formulate policies, rules and
regulations on food, drugs, cosmetics, devices and substances; the FDA shall
conduct regular testing of toxicity levels of chemical elements and substances
content of products covered by this Act and accreditation of product importers;

(b) The Department of Environment and Natural Resources (DENR) shall
regulate, control, restrict or prohibit the importation, manufacture, processing,
distribution, sale, handling, use, transport and disposal of chemical substances or
mixtures listed under Republic Act No. 6969, otherwise known as the “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 admi

ster the industrial toxic chemicals through a system of review,
evaluation and monitoring of these toxic chemicals under DENR Administrative
Order (DAO) No. 2013-24 and formulate policies and guidelines for the gradual
phase-out of lead in paints pursuant to Section 20(1) of DAO 20, series of 1992

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and DAO 05, series of 2005 (Toxic Chemical Substances for Issuance of Chemical
Control Orders);

c) The Department of Finance (DOF), 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 examination
of documentary requirements of imported products pursuant to the guidelines of
the Department; and

d) The DTI shall ensure that the products covered by this Act comply with
the Philippine National Standards on the Safety of Toys set by the Bureau of

Product Standards and shall monitor prices of school supplies and conduct market

inspections on these products.

SEC. 9. Creation of the Children’s Product Safety Council. — There is
hereby created a Children’s Product Safety Council (CPSC) which shall be
attached to the DOH. It shall be composed of the following:

a) Secretary of the DOH — Chairperson;

(b) Secretary of the DTI — Vice Chairperson;

(c) Secretary of the DENR — member;

(d) Secretary of the Department of the Interior and Local Government
(DILG) - member;

(e) Secretary of the Department of Education (DepED) — member;

(f) Secretary of the DOF — member;

(g) Director-General of the FDA — member;

(h) National Consumer Affairs Council (NCAC) — member;

(i) One (1) representative from a nongovernment organization (NGO)
engaged in consumer safety and environment protection — member; and

(j) One (1) representative from the health groups — member.

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‘The heads of departments may be represented by their duly designated
representatives who shall be of a rank not lower than Director level

The Chairperson of the CPSC shall nominate to the President of the
Philippines the representative of the NGO sector.

The FDA shall serve as the Secretariat of the CPSC.

Other government agencies and private sector representatives may be

invited to participate in the meetings of the CPSC as exigencies and circumstances
may require.

SEC. 10. Powers and Functions of the CPSC. — The CPSC shall have the
following powers and functions:

(a) To serve as primary link and coordinator for its member institutions such
as the Business Processing and Licensing Office (BPLO) of the local government
units (LGUs), the private sector and other stakeholders;

(b) To engage in studies and researches on hazardous chemicals and
substances, and provide the necessary information materials on the same;

(c) To conduct and facilitate consultation and dialogues within and among
all concerned stakeholders in the industry;

(d) To conduct information and education campaigns on the adverse health
effects of hazardous chemicals on children;

(c) To propose amendments to laws, rules and regulations pursuant to its
mandate and the objectives of this Act;

(f) To provide periodic and regular reports to the Secretary of Health on the
compliance of importers and manufacturers on the provisions of this Act;

(g) To create a Technical Advisory Committee composed of experts from
both government and private sectors that would assist the Council in providing

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technical and scientific recommendations necessary to effectively carry out its

mandate; and

(h) To perform such other functions as may be directed by the DOH.

SEC. 11. Disclosure of Toxicological Information on Labels. — It shall be
mandatory for importers, manufacturers and distributors of products covered by
this Act to provide documentation showing compliance with international
standards when the products left the port of origin through test reports from testing,
laboratories accredited with ISO 17025 or by an ILAC MRA signatory.

SEC. 12. Application to Trade. — Importers shall provide the FDA with test
reports from laboratories accredited with ISO 17025 or by an ILAC MRA
signatory, which confirms compliance of a representative sample of the products
which left the port of origin with the following international standards:

(a) For heavy metals identified in PNS/ISO 8124-3, compliance with ISO
8124-3, EN-71-3, or ASTM F963-standards; and

(b) For phthalates listed in Secion 5(b), compliance with US CPSIA (Section
108 of CPSIA 2008) or EU REACH (Entity 52 of Annex XVII to REACH
Regulation 1907/2006).

The following procedures shall be observed at the first port of entry in the
inspection of imported products covered by this Act:

(1) The FDA, or its commissioned/designated agent, in coordination with the
BOC, shall conduct inspection, testing and clearance of representative samples 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;

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(2) 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 the product into the Philippines. If it is proven that the product does
not conform with the allowable level of chemical elements and substance content
as provided for under the implementing rules and regulations of this Act, the
product shall be refused admission;

3) Imported products that are supported by test reports from laboratories
accredited with ISO 17025 or by an ILAC MRA signatory which confirms
compliance of a representative sample with international standards when the
products left the port of origin, shall be exempt from the requirements of
subparagraphs (1) and (2) of this section;

(4) 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

(5) 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 the payment, shall constitute a lien against

any future importation to be made by the owner or consignee.

SEC. 13. 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
office of the FDA to facilitate the release of goods from BOC custody, pending the

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issuance of the Certificate of Conformity. The importer, however, shall not
distribute, transfer, or sell in whole or in part, the products to any place other than
the address specified in the conditional release. To ensure that no distribution,
transfer, sale 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 anytime within official working hours.

SEC. 14. Certification. - The DOH, after the conduct of a thorough

examination, shall certify whether or not the imported products are safe for

distribution in the market.

SEC. 15. Disposal of Noncompliant Products. — All products covered by
this Act that are recalled by the manufacturer or the DOH for whatever reason,
shall be disposed of in accordance with the submitted disposal plan of the
manufacturer subject to 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 importer, manufacturer, or distributor
shall shoulder the expenses to be incurred in the disposal of the recalled products.

All import-shipments denied the requisite Certificate of Conformity shall not
be disposed of in the domestic market in any manner. They must be properly
disposed in accordance with the provisions of the Tariff and Customs Code and
other pertinent rules and regulations.


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SEC. 16. Labeling and Packaging Requirement. — The labeling and

packaging requirement of products under this Act shall comply with relevant PNS

and existing laws.

SEC. 17. 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, shall be
authorized 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, and any vehicle being used
by such officers or employees to transport or hold the products shall likewise be
allowed entry. They shall inspect, in a reasonable manner, the 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 has obtained a sample or samples in the course of
the inspection, shall give the owner, operator, or agent in charge a receipt
describing the samples obtained; and

(c) Whenever in the course of any inspection of a factory, warehouse, 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 product, and
an analysis made of the sample for the purpose of ascertaining whether the product

contains, in whole or in part, disallowed levels of toxicity of chemical elements

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and hazardous substances, a copy of the result of the analysis shal] be furnished the

owner, operator, or agent in charge.

SEC. 18. Market Inspection. - The DOH shall conduct routine inspection in

the market and take samples of suspected products for examination.

SEC. 19. Injurious, 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, and unsafe, it shall, after due notice and hearing,
make the appropriate order for its recall, prohibition, or seizure from public
distribution or sale. It may declare a product to be imminently injurious,
dangerous, and unsafe, and order its immediate recall, ban or seize from public
distribution or sale, in which case, the distributor, producer, or seller thereof 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. 20. Product Confiscation. — Imported products shall be allowed entry
into the country as provided under Section 12 of this Act when accompanied by
Certificates 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

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SEC. 21. 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, for the information of consumers, a list of
products that may be in the market that have been determined to be noncompliant.

The advisories to be issued under this Act shall explain in an easily
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.

SEC. 22. Public Access to Records, Reports or Notification. — The public
shall be allowed easy access to publicly disclosed records, reports, test results, or
information concerning chemicals, substances and mixtures, including safety data
submitted, and methods of production and preparation.

The DOH shall establish a website to be maintained by the CPSC which
shall publish all publicly disclosed information.

SEC. 23. Prohibited Acts. — The following acts are hereby prohibited:

(a) The importation, manufacture, distribution and sale of products under
Section 4 hereof containing more than the allowable level of substances listed in
Section 5 of this Act;

(b) Intentional misrepresentation or concealment of significant data or
information about the product sought for certification;

(c) Importation, manufacture, distribution, sale, labeling, and operation

without registration;

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(4) Noncompliance with the standards and requirements of the DOH on the
importation, manufacture, distribution, and sale of covered products;

(c) Refusal to allow required inspections as determined by the DOH;
And

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

SEC. 24. Administrative Sanctions. — Where there is a finding of a violation
against the provisions of Section 23 of this Act and a determination of the persons
liable thereto, after notice and hearing, the following administrative penalties shall
be imposed:

(a) Suspension of LTO;

(b) Revocation of LTO; and

(c) Seizure of the unregistered, noncompliant or falsely represented products
covered by this Act.

SEC. 25. Penalties. — Any person who shall commit any of the prohibited
acts under Section 23 hereof 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 and in
accordance with Section 11 of the “Food and Drug Administration (FDA) Act of
2009”: 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 of
imprisonment but not more than ten (10) years and a fine of at least five hundred
thousand 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

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ana
44s
446
4a7
448
449
450
451
452
453
454
455
456
457
458
459
460
461
462
463
464
465
466
467
468
469

470

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 after reasonable notice of such 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 an authorized officer or employee
of the FDA that the products may cause injury or prejudice to the consuming
public.

Should the offense be committed by a juridical person, the Chairperson 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, the person shall, in

addition to the penalties prescribed, be deported without further proceedings after

service of sentence.

SEC. 26. Citizen Suit. — For purposes of enforcing the provisions of this Act
or its implementing rules and regulations, 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 implementing rules and regulations;

(b) Any official or employee of the DOH and other implementing agencies
with respect to orders, rules and regulations issued inconsistent with this Act; and

(c) Any public officer who willfully or grossly neglects the performance of
an act specifically enjoined as a duty by this Act or its implementing rules and
regulations; or abuses authority in the performance of duty; or, in any manner
improperly performs the duties under this Act or its implementing rules and

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471

472

473

474

475,

476

477

478

479

480

481

482

483

484

485

486

487

488

489

495
496

497

regulations: 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.

SEC. 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 the 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 evidence, 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,

SEC. 28. Burden of Proof of Product Safety. - The burden of proof to prove
the exercise of due diligence, compliance with this Act and other laws, rules and

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502
503
504
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506
507
508
509
510

511

513
514
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523

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.

SEC. 29. Appropriations. — The 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.

SEC. 30. Congressional Oversight Committee. — The 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,

SEC. 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.

SEC. 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,

SEC. 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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524 SEC. 34. Repealing Clause. — All laws, decrees, executive orders, rules and
525 regulations or parts thereof inconsistent with the provisions of this Act are hereby

526 repealed, amended or modified accordingly.

527
528 SEC. 35. Effectivity. — This Act shall take effect fifteen (15) days after its
529 publication in the Official Gazette or ina newspaper of general circulation.

530

531 Approved,

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