" 
SIXTEENTH CONGRESS OF THE REPUBLIC) 
OF THE PHILIPPINES 
) 
Second Regular Session 
) 
SENATE 
Senate Bill No. 
2302 
INTRODUCED BY SEN. JINGGOY EJERCITO ESTRADA 
AN ACT 
'scrmtr 
(~Ih;. 01 Ih.,j'<TfIOf~ 
"14 JUl -7 A10 :08 
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 
EXPLANATORY NOTE 
Toys are effective instruments to give joy, entertainment and education to our 
children. Toys and school supplies such as marbles, spin tops, toy make-up and 
jewelries, crayola, and water color might seem harmless but not visible to the 
naked eye is the possible grave threat they pose to our children's health if their 
chemical composition is left unchecked. 
In the recent efforts of some privat.e organizations to check the chemical 
composition of toys, it was revealed that toxic toys that contain high levels of 
arsenic, antimony, cadmium, chromium, lead, and mercury, are being sold near 
the area of at least thirty eight (38) public elementary schools in Metro Manila. 
These chemicals could cause serious health problems, including neurological 
and behavioural disorders. 
The "Safe and Non-Toxic Children's Products Act of 2014" intends to regulate 
the importation, manufacture, sale and distribution of children's toys, school 
supplies and other child care articles containing toxic chemicals. 
A Children's Product Safety Council (CPSC) is created under this proposed 
measure which shall be attached to the Department of Health (DOH). It shall, 
among others, provide coordination and linkage mechanisms between and 
among government and private stakeholders, and engage in studies and 
researches on harmful and toxic chemicals and substances, and provide the 
necessary information materials on the same. 
This measure was previously filed by Sen. Manny Villar in the 15th Congress. 
For the protection and safety of our children, the immediate passage of this bill is 
earnestly sought. 
Senator 


" 
SIXTEENTH CONGRESS OF THE REPUBLIC) 
OF THE PHILIPPINES 
) 
Second Regular Session 
) 
'14 
JUL -7 AID :08 
SENATE 
Senate Bill No. 
2302 
INTRODUCED BY SEN. JINGGOY EJERCITO ESTRADA 
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 the House of Representatives of the Philippines 
in Congress assembled: 
1 
SECTION 1. Short Title. - This Act shall be known as the "Safe and Non-Toxic 
2 
Children's Products Act of 2014". 
3 . 
4 
5 
SEC. 2. Declaration of Policy. - It is hereby declared the policy of the State to 
6 
protect and promote the rights of the people to health, a balanced and healthful 
7 
ecology and to information. 
Towards this end, the State shall regulate the 
8 
importation, manufacture, sale and distribution of children's toys, school supplies 
9 
and other child care articles containing toxic chemicals. 
10 
11 
12 
SEC. 3. Definition of Terms. - For purposes of this Act, the following terms are 
13 
hereby defined: 
14 
15 
(a) Bioavailability refers to the availability and possibility of the chemical from 
16 
a product or children's toys to be released and absorbed into a child's 
17 
body via the gastro intestinal tract, the lungs, or the skin and mucus 
18 
membranes; 
19 
20 
(b) Chemical substance refers to any organic or inorganic substance of a 
21 
particular molecular identity, including: 
22 
23 
1. any combination of such substances occurring, in whole or in part, 
24 
as a result of chemical reaction or occurring in nature; and, 
25 
26 
2. any element or uncombined chemical 
27 
28 
(c) Childcare article refers to any product intended to facilitate sleep, 
29 
relaxation, hygiene, the feeding of children or sucking on the part of 
30 
children such as nipples, feeding bottles, baby dresses, pacifiers etc.; 
31 
1 


1 
(d) Children refer to persons below eighteen (1S) years of age or those over 
2 
but are unable to fully take care of themselves or protect themselves from 
3 
abuse, neglect, cruelty, exploitation or discrimination because of a 
4 
physical or mental disability or condition; 
5 
6 
(e) Distributor refers to any entity to which the toy product is delivered or sold 
7 
for purposes of distribution in commerce, or in such case repackages toys 
8 
under different trade name or trademark with permission from the original 
9 
legal distributor, except that such term does not include a manufacturer or 
10 
retailer of such product; 
11 
12 
(f) Educational Kit refers to a collection of materials and associated scientific 
13 
apparatus that are not likely to be licked or put in the mouth by children 
14 
and which are typically used to perform experiments or demonstrations in 
15 
the different fields of science. These materials include, among others, 
16 
notebooks, pad papers, envelopes, plastic covers, foldl9rs, mugs, school 
17 
uniforms and school bags; 
18 
19 
(g) Hazardous Wastes refer to substances that are without any safe 
20 
commercial, industrial, agricultural, or economic usage to by-products, 
21 
side-products, process residues, spent reaction, media, contaminated 
22 
plant or equiprnent or other substances from manufacturing operations, 
23 
and as consumer discards frorn manufactured products. It can also refer 
24 
to waste which, because of its quantity, concentration, or physical, 
25 
chemical, or infectious characteristics, may pose a substantial present or 
26 
potential hazard to hurnan health or the environment when improperly 
27 
treated, stored or disposed of, otherwise misrnanaged; or cause or 
28 
contribute to an increase in rnortality, or an increase in irreversible or 
29 
incapacitating illness; 
30 
31 
(h) Hazardous Substance/Chemical refers to: 
32 
33 
1. a substance which presents short-term acute hazards, such as 
34 
acute toxicity by ingestion, inhalation or skin absorption, corrosivity 
35 
or other skin or eye contact hazard or the risk of fire or explosion; 
36 
37 
2. a substance which presents long-term environmental hazards, 
38 
including chronic toxicity upon repeated exposure, carcinogenicity 
39 
(which may in some cases result frorn acute exposure but with a 
40 
long latent period), resistance to detoxification process such as 
41 
biodegradation, the potential to pollute underground or surface 
42 
waters, or aesthetically objectionable properties Such as offensive 
43 
odors; 
44 
45 
3. a chernical for which there is statistically significant evidence 
46 
(based on at least one study conducted according to established 
47 
scientific principles) that acute or chronic health effects may occur; 
48 
49 
4. any radioactive substance, if, with respect to such substance as 
50 
used in a particular class of article or as packaged, the DOH 
51 
determines by regulation that it is sufficiently hazardous to require 
52 
labeling in accordance with this Act in order to protect the public 
53 
health; 
54 
55 
5. any toy or other intended for use by children that rnay, by 
56 
regulation, be determined to contain an electrical, mechanical or 
57 
thermal hazard; or, 
2 


1 
6. any substance which the DOH finds to be under the categories 
2 
enumerated above. 
3 
4 
(i) Importation reters to the entry of a product or substance into the 
5 
Philippines (through the seaports or airports of entry) whether already 
6 
properly cleared through or still remaining under customs control, which is 
7 
intended for direct consumption, merchandising, warehousing and for 
8 
further processing; 
9 
10 
U) Label refers to the display of printed or graphic matter on any consumer 
11 
product, its immediate container, tag, literature or other suitable material 
12 
affixed thereto for the purpose of giving information as to the identity, 
13 
components, ingredients, attributes, directions for use, specifications and 
14 
such other information as may be necessary to protect health and safety 
15 
of the consumers; 
16 
17 
(k) License to Operate (L TO) refers to the license issued by the FDA to 
18 
manufacturers, importers and distributors whose toy products, children 
19 
articles and school implements, under this Act, conform to the health and 
20 
safety requirements of the DOH and the relevant Philippine National 
21 
Standards and their future amendments; 
22 
23 
(I) Manufacturer refers to any establishment that assembles or processes 
24 
products under this Act, provided that If such products are manufactured, 
25 
assembled or processed for another establishment that attaches its own 
26 
brand name to the products, the latter shall be deemed the manufacturer. 
27 
In case of imported products under this Act, the manufacturer's 
28 
representative or, in his absence, the importer shall be deemed the 
29 
manufacturer; 
30 
31 
(m)Philippine National Standards (PNS) refer to the national standards 
32 
approved by the Technical Committee under the Bureau of Products 
33 
Standard of the Department of Trade and Industry; 
34 
35 
(n) Sale or distribution refers to an act made by a manufacturer or seiler, or 
36 
the respective representative or agent to make available consumer 
37 
products, services or credit to the end consumers under a consumer sale 
38 
transaction. It shall not include sampling or any other distribution not for 
39 
sale; 
40 
41 
(0) School Implement refers to a tool used for writing, drawing, coloring, 
42 
marking, gluing, or erasing by children that are likely to be licked or put in 
43 
the mouth; 
44 
45 
(p) School Supplies refer to items/articles used for educational purposes 
46 
which are not likely to be licked or put inside the mouth by children. These 
47 
include, among others, notebooks, crayons, pad papers, envelopes, 
48 
plastic covers, folders, mugs, school uniforms and school bags; 
49 
50 
(q) Testing Laboratory refers to an accredited facility for measuring, 
51 
examining, and determining the level of chemical elements in products 
52 
under this Act; 
53 
54 
(r) Toy refers to an object or a number of objects clearly intended as a 
55 
plaything for children as defined in Section 3 of this Act; 
56 
3 


1 
(s) Toxic substance refers to any substance other than a radioactive 
2 
sUbstance which can cause injury, illness or death through ingestion, 
3 
inhalation, or absorption through any body surface. 
4 
5 
6 
SEC. 4. Scope. - This Act shall apply to the importation, manufacture, sale and 
7 
distribution of children's toys, school supplies, childcare articles and other related 
8 
products, whether or not designed or intended for use or play solely by children 
9 
under the age of eighteen (18), and other childcare articles and related products 
10 
that are sold or given free of charge in the Philippines. 
11 
12 
13 
SEC. 5. Chemicals and Substances Covered. - Within three (3) months from the 
14 
effectivity of this Act, the Food and Drug Administration (FDA) shall prepare a list 
15 
of chemicals and substances used in children's products which cause or may 
16 
cause harm, injury, or death to children. 
The FDA shall specifically identify 
17 
absolutely banned or prohibited sUbstances and chemicals used in the 
18 
manufacture, production, and preparation of children's products. 
Maximum 
19 
levels and limits and reference values for certain chemicals used for this purpose 
20 
shall also be specifically and clearly identified. 
21 
22 
Chemicals and substances deemed most harmful and toxic to children and 
23 
commonly used in the manufacture and production of children's products shall 
24 
include, but shall not be limited, to the following: 
25 
26 
(a) Toxic Metals: 
27 
28 
1. Antimony 
29 
2. Arsenic 
30 
3. Cadmium 
31 
4. Chromium 
32 
5. Lead 
33 
6. Mercury 
34 
35 
(b) Phthalates - when applied in the manufacture and production of products 
36 
covered under this Act, include: 
37 
38 
1. Oi (2-Ethlyhexyl) Phthalate (Oehp) 
39 
2. Dibutyl Phthalate (Dbp) 
40 
3. Benzyl Butyl Phthalate (Sbp) 
41 
4. Oiisononyl Phthalate (Oinp) 
42 
5. Oiisodecyl Phthalate (Oidp) 
43 
6. Oi-N-Octyl Phthalate (Onop) 
44 
45 
(c) Bisphenol-A (Spa) 
46 
47 
48 
SEC. 6. 
Compliance with Philippine National Standards (PNS). -
Importers, 
49 
manufacturers, distributors and sellers of products under this Act shall comply 
50 
with the standards, rules and processes of the Bureau of Product Standards of 
51 
the Department of Trade and Industry. The same shall collaborate with other 
52 
relevant government agencies to harmonizelupgrade existing standards, where 
53 
applicable. 
54 
55 
4 


SEC. 7. 
Powers and Functions of the DOH. -
To effectively carry out its 
2 
mandate of ensuring the quality of products under this Act, the DOH shall have 
3 
the following powers and functions: 
4 
5 
(a) Formulate guidelines in the filing of application for the issuance of License 
6 
to Operate (L TO) to importers, distributors and local manufacturers of 
7 
products under this Act; 
8 
9 
(b) Formulate specific guidelines on the issuance of the Certificate of 
10 
Conformity to manufacturers, distributors, and importers for every 
11 
shipment, freight, batch/lot of their products covered in this Act; 
12 
13 
(c) Issue quality control orders (OCOs) to enforce the provisions of this Act 
14 
and to ensure strict compliance with existing standards and regulations set 
15 
by government authorities; 
16 
17 
(d) Issue compliance orders (COs) if it finds non-compliance and/or 
18 
nonconformity with this Act, its rules and regulations, and guidelines 
19 
issued to enforce and implement the same; 
20 
21 
(e) Undertake researches, develop and establish quality and safety standards 
22 
for products covered by this Act in coordination with other implementing 
23 
government agencies; 
24 
25 
(f) Set the maximum allowable level of toxicity of chemical elements in 
26 
products covered by this Act; 
27 
28 
(g) Inspect and analyze products covered by this Act for purposes of 
29 
determining conformity to established quality and safety standards; 
30 
31 
(h) Conduct constant and regular inspection, product testing, and on-sight 
32 
and random product testing and sampling of various children'S products in 
33 
the market; 
34 
35 
(i) Levy, asses, collect and retain fees as are necessary to cover the cost of 
36 
inspection, certification, analysis and tests of samples of products under 
37 
this Act; 
38 
39 
U) Investigate the causes of and maintain a record of product-related deaths, 
40 
illnesses and injuries for use in researches or studies on the prevention of 
41 
such deaths, illnesses and injuries; 
42 
43 
(k) Accredit independent, competent non-government bodies, to assist in 
44 
monitoring the market for the presence of toxic chemicals in products 
45 
under this Act and to look for appropriate means to expand the monitoring 
46 
and enforcement outreach of the Department in relation to its manpower, 
47 
testing and certification resources at a given time; 
48 
49 
(I) Accredit independent competent testing laboratories; and, 
50 
51 
(m)Perform such other functions as needed and necessary in the 
52 
enforcement of this Act. 
53 
54 
55 
SEC. 8. Role Delineation of Implementing Agencies. - The provisions of this Act 
56' and its implementing rules and regulations shall be enforced by the following 
57 
agencies: 
5 


1 
(a) DOH -
The Department of Health shall formulate policies, rules and 
2 
regulations on food, drugs, cosmetics, devices and substances. The FDA 
3 
shall conduct regular testing, evaluation, monitoring and post-market 
4 
surveillance of covered products to include all school implements as 
5 
defined in Section 3 of this Act to ensure compliance with the Philippine 
6 
National Standards on the Safety of Toys; 
7 
8 
(b) DENR -
The Department of Environment and Natural Resources shall 
9 
regulate, control, restrict or prohibit the importation, manufacture, 
10 
processing, sale, distribution, handling, use, transport and disposal of 
11 
chemical substances mixtures under Republic Act No. 6969, "Toxic 
12 
Substances and Hazardous and Nuclear Waste Control Act of 1990". It 
13 
shall monitor toxic substances/chemicals used as industrial raw material to 
14 
produce the covered products under this Act in terms of their compliance 
15 
to environmental laws. It shall administer the industrial toxic chemicals 
16 
through a system of review, evaluation and monitoring of these toxic 
17 
chemicals under the DENR Administrative Order No. 2007-23 and 
18 
formulate policies and guidelines for the gradual phase-out of lead in 
19 
paints pursuant to Sec. 20 (1) of DAO 20, Series of 1992 and DAO 05, 
20 
Series of 2005 (Toxic Chemical Substances for Issuance of Chemical 
21 
Control Orders); 
22 
23 
(c) DOF - The Department of Finance, through the Bureau of Customs, shall 
24 
monitor the entry of imported products covered under this Act at the 
25 
different ports of entry in the Philippines. 
It shall review and conduct 
26 
examination of documentary requirements of imported products pursuant 
27 
to the guidelines of the Department; 
28 
29 
(d) DTI - The Department of Trade and Industry shall enforce policies and 
30 
regulate the importation, manufacture, distribution and sale of educational 
31 
kits or school supplies as defined in Section 3 of this Act and other 
32 
consumer products not covered 
by the mandates of the other 
33 
implementing agencies. It shall ensure that covered products comply with 
34 . 
the Philippine National Standards on the Safety of Toys set by the Bureau 
35 
of Product Standards and shall monitor and conduct market inspections 
36 
on covered products. 
37 
38 
39 
SEC. 9. Creation of the Children's Product Safety Council (CPSC). - There is 
40 
hereby created a Children's Product Safety Council (CPSC) to be attached to the 
41 
Department of Health (DOH) and composed of the following: 
42 
43 
(a) The Secretary of the DOH - Chairperson; 
44 
(b) The Secretary of the DTI - Vice Chairperson; 
45 
(c) The Secretary of the DENR - Member; 
46 
(d) The Secretary of the Department of Interior and Local Government 
47 
(DILG) - Member; 
48 
(e) The Secretary of the Department of Education (DepEd) - Member; 
49 
(f) The Secretary of DOF - Member; 
50 
(g) The Director of the FDA - Member; 
51 
(h) The National Consumer Affairs Council (NCAC) - Member; 
52 
(i) One (1) Representative from a Non-Government Organization (NGO) 
53 
engaged in consumer rights protection - Member; and, 
54 
U) One (1) Representative from a Non-Government Organization (NGO) 
55 
engaged in environmental protection and advocacy - Member; 
56 
6 


1 
The departments and govemment agencies shall be represented by their 
2 
respective heads or their duly designated representatives who shall be of a rank 
3 
not lower than Director level. 
4 
5 
The Chairperson of the CPSC shall recommend the nominees for the NGO 
6 
Sector Representatives to the President of the Philippines. 
7 
8 
The FDA shall serve as the secretariat and operational arm of the CPSC. 
9 
10 
Other govemment agencies and private sector representatives may be invited to 
11 
participate in the CPSC as the exigencies and circumstances may require. 
12 
13 
14 
SEC. 10. 
Powers and Functions of the CPSC. - The CPSC shall have the 
15 
following powers and functions: 
16 
17 
(a) To provide coordination and linkage mechanisms between and among its 
18 
members, other government agencies concerned, local government units 
19 
(LGUs), the private sector, and other stakeholders; 
20 
21 
(b) To engage in studies and researches on harmful and toxic chemicals and 
22 
substances, and provide the necessary information materials on the same; 
23 
24 
(c) To conduct and facilitate consultation and dialogues within and among all 
25 
concerned stakeholders in the industry; 
26 
27 
(d) To conduct information and education campaigns, especially for children; 
28 
29 
(e) To propose amendments to laws, rules, and regulations pursuant to its 
30 
mandate and the objectives of this Act; 
31 
32 
(f) To provide periodic and regular reports to the Secretary of Health; 
33 
34 
(g) To create a Technical Advisory Committee composed of experts from both 
35 
government and private sectors that would assist the council in providing 
36 
technical and scientific recommendations necessary to effectively carry 
37 
out its mandate; 
38 
39 
(h) To provide coordination and linkage mechanisms between and among its 
40 
members, 
other 
government 
agencies 
concerned, 
the 
Business 
41 
Processing and Licensing Office (BPLO) of Local Government Units 
42 
(LGUs), the private sector, and other stakeholders; and, 
43 
44 
(i) To perform such other functions as may be directed by the DOH. 
45 
46 
47 
SEC. 11. Application to Trade. - The following procedures shall be observed at 
48 
the first port of entry of imported products: 
49 
50 
(a) The FDA, or its commissioned/designated agent, in coordination with the 
51 
Bureau of Customs (BOC), shall conduct product inspection, sample 
52 
testing and clearance of imported products covered under this Act for 
53 
compliance with the national standards for the safety of toys prior to their 
54 
assessment and charging of tariffs and other charges by the BOC; 
55 
56 
(b) Samples of products covered by this Act being imported into the 
57 
Philippines shall be obtained for purposes of determining the toxicity level 
7 


1 
of chemical elements and substances content without charge from the 
2 
owner or consignee thereof. The owner or consignee of the imported 
3 
product under examination shall be afforded an opportunity to a hearing 
4 
with respect to the importation of such product into the Philippines. If it is 
5 
proven that such product does not conform to the allowable level of 
6 
chemical elements and substances content as provided for under the 
7 
implementing rules and regulation of this Act, said product shall be 
8 
refused admission; 
9 
10 
(c) Any product covered by this Act, the sale or use of which has been 
11 
banned or withdrawn in the country of manufacture, shall not be imported 
12 
into the country; and, 
13 
14 
(d) All expenses in connection with the storage, destruction and disposition of 
15 
any product under this Act which was refused admission shall be paid by 
16 
the owner or consignee and, in default of such payment, shall constitute a 
17 
lien against any future importation made by such owner or consignee. 
18 
19 
20 
SEC. 12. Clearance for Customs Release. - All importers of products under this 
21 
Act shall secure a Clearance for Customs Release from the DOH prior to 
22 
importation. 
23 
24 
A Clearance for Conditional Release shall be issued by the appropriate Center of 
25 
the FDA to facilitate the release of goods from the BOC custody pending the 
26 
issuance of the Certificate of Conformity. The importer, however shall not sell, 
27 
distribute or transfer in whole or in part, the products to any place other than the 
28 
address specified in the conditional release. To ensure that no distribution, sale, 
29 
transfer to or use of products covered by this Act in any place other than the 
30 
address specified in the conditional release is made, the importers shall allow 
31 
authorized personnel of the FDA to conduct an inspectionlinventory of the import 
32 
shipment within three days from the date of issuance of the clearance for 
33 
conditional release at anytime within official working hours. 
34 
35 
36 
SEC. 13. Certification. - The DOH, after the conduct of a thorough examination, 
37 
shall issue the necessary certificate to show whether or not the imported 
38 
products are safe for distribution in the market. 
39 
40 
41 
SEC. 14. Disposal of Non-Compliant Products. - All products covered by this 
42 
Act that are recalled by the manufacturer or the Department for whatever reason, 
43 
shall be disposed of in accordance with the submitted disposal plan subject to 
44 
FDA approval. The plan shall comply with the existing rules and regulations set 
45 
by all concerned agencies of the government and other related laws of the 
46 
country. The concerned manufacturer, importer or distributor shall shoulder the 
47 
expenses to be incurred in the disposal.of the recalled products. 
48 
49 
All import-shipments denied the requisite Certificate of Conformity shall not be 
50 
disposed of in the domestic market in any manner. 
They must be properly 
51 
disposed in accordance with the provisions of the Tariff and Customs Code and 
52 
other pertinent rules and regulations. 
53 
54 
55 
SEC. 15. Labeling and Packaging Requirement. - The packaging and labeling 
56 
requirement of products under this Act shall comply with the relevant Philippine 
57 
National Standards. 
8 


1 
SEC. 16. 
Monitoring and Factory Inspection. -
The FDA shall observe the 
2 
following procedures in the inspection and monitoring of establishments to 
3 
determine compliance with safety regulations: 
4 
5 
(a) Officers or employees duly designated by the FDA, upon presenting 
6 
appropriate credentials to the owner, operator, or agent in charge, are 
7 
authorized (1) to enter, at reasonable hours, any factory, warehouse or 
8 
establishment in which products under this Act are manufactured or held 
9 
for introduction into domestic commerce or are held after such 
10 
introduction, or to enter any vehicle being used to transport or hold such 
11 
products; and (2) to inspect, in a reasonable manner, such factory, 
12 
warehouse, establishment or vehicle and all pertinent equipment, finished 
13 
and unfinished materials, containers and labeling therein; 
14 
15 
(b) Upon completion of the inspection of a factory, warehouse or other 
16 
establishment and prior to leaving the premises, the officer or employee 
17 
who conducted such inspection and has obtained any sample in the 
18 
course of the inspection, shall give the owner, operator, or agent in charge 
19 
a receipt describing the samples obtained; 
20 
21 
(c) Whenever in the course of any such inspection of a factory or other 
22 
establishment where products covered by this Act are manufactured or 
23 
held, the officer or employee making the inspection obtains a sample of 
24 
any such product, and an analYSis made of such sample for the purpose 
25 
of ascertaining whether such product contains, in whole or in part, 
26 
disallowed level of toxicity of chemical elements and hazardous 
27 
substances, a copy of the result of such analysis shall be furnished the 
28 
owner, operator, or officer- in- charge. 
29 
30 
31 
SEC. 17. Market Inspection. - The DOH shall conduct routine inspection in the 
32 
market and take samples of suspected products for examination. 
33 
34 
35 
SEC. 18. 
Injurious, Dangerous and Unsafe Products. - Whenever the DOH 
36 
finds, by its own initiative or by petition of a consumer, that a product covered by 
37 
this Act is injurious, unsafe or dangerous, it shall, after due notice and hearing, 
38 
make the appropriate order for its recall, prohibition, or seizure from public sale 
39 
or distribution. It may declare a product to be imminently injurious, unsafe or 
40 
dangerous, and order its immediate recall, ban or seize from public sale or 
41 
distribution, in which case, the seller, distributor or producer thereof shall be 
42 
afforded a hearing within forty-eight (48) hours from such order. 
43 
44 
There shall be immediate information dissemination, through the mass media, of 
45' products which are found to be injurious, dangerous and unsafe. 
46 
47 
48 
SEC. 19. Product Confiscation. - Imported products shall be allowed entry into 
49 
the country as provided under Section 11 of this Act when accompanied by 
50 
Certificate of Testing or Analysis of its composition. 
The BOC shall require 
51 
pertinent clearance or certification from the FDA prior to entry. 
The entire 
52 
shipment or batch of the product found to be in violation of the provisions of this 
53 
Act shall be seized. The confiscated products shall be properly disposed of in 
54 
accordance with the prescribed procedure to be issued by the DOH in 
55 
coordination with the DENR. 
56 
57 
9 


, 
' 
1 
SEC. 20. 
Publication and Information. - The Department of Health (DOH) is 
2 
mandated to conduct information campaigns utilizing any form of mass media 
3 
and other electronic means deemed effective to ensure the proper guidance of 
4 
consumers, industries, businesses and other concerned sectors. 
5 
6 
The DOH shall likewise publish a consumer chemical substance advisory notice 
7 
which shall include a list of toxic chemicals and substances used in the 
8 
manufacture, distribution and sale of covered products for the information of the 
9 
general public. 
Such advisory notice shall be made available to government 
10 
agencies, consumers, industries, businesses and general public. 
11 
12 
The advisories to be issued under this Act shall explain in an easily 
13 
understandable manner, the dangers of hazardous substances exposure. It shall 
14 
be printed in English and Filipino or in any dialect determined by the DOH to be 
15 
culturally and linguistically appropriate utilizing any form of mass media and 
16 
electronic means of communication. 
17 
18 
19 
SEC. 21. Public Access to Records, Reports or Notification. - The public shall 
20 
have access to records, reports, test results, or information concerning 
21 
chemicals, substances and mixtures, including safety data submitted, and 
22 
methods of production and preparation. 
23 
24 
Such documents shall be available for inspection or reproduction during normal 
25 
business hours; 
Provided, That the DTI may consider a record, report or 
26 
information or particular portions thereof confidential and which may not be made 
27 
public when such would divulge trade secrets, production or sales figures or 
28 
methods, production or processes unique to such manufacturer, processor or 
29 
distributor, or would otherwise tend to affect adversely the competitive position of 
30 
such manufacturer, processor or distributor. 
The DTI, however, may release 
31 
information subject to claim of confidentiality to a medical research or scientific 
32 
institution where the information is needed for the purpose of medical diagnosis 
33 
or treatment of a person exposed to the chemical substance or mixture. 
34 
35 
The DOH shall establish a website to be maintained by the CPSC which shall 
36 
provide the following information: basic data on manufacturer, producer, 
37 
assembled, importer, distributor and seller of covered products; kinds and 
38 
amount of chemicals and substances used in the production of products; and the 
39 
potential risks and dangers to consumers. The website shall also make available 
40 
reports, records, and inventories submitted by the companies and businesses 
41 
covered by this Act. 
42 
43 
44 
SEC. 22. 
Disclosure of Toxicological Information on Labels. -
It shall be 
45 
mandatory for manufacturers, distributors and importers of products covered by 
46 
this Act to disclose and identify, through accurate and truthful labeling, the 
47 
substances and chemical contents and bioavailability of said substances I 
48 
chemicals. Graphic symbols shall also be used in product packaging showing 
49 
product safety and regulatory compliance. 
50 
51 
52 
SEC. 23. Prohibited Acts. - The following acts are hereby prohibited: 
53 
54 
(a) The importation, distribution, manufacture and sale of products under 
55 
Section 4 hereof containing more than the allowable level of chemical 
56 
elements and hazardous substances such as, but not limited to, antimony, 
57 
arsenic, bisphenol, cadmium, chromium, lead, mercury and phthalate; 
10 


, ' 
(b) Mislabeling of the level of chemical elements in products under this Act; 
2 
3 
(c) Material 
misrepresentation or concealment of significant data or 
4 
information about the product sought for certification; 
5 
6 
(d) Importation, manufacture, sale, distribution, labeling, operation without 
7 
registration; 
8 
9 
(e) Non-compliance with the standards and requirements of the DOH on the 
10 
importation, manufacture, distribution, sale of covered products; 
11 
12 
(f) Refusal to allow required inspections as determined by the Department; 
13 
and, 
14 
15 
(g) Other prohibited acts stipulated in Republic Act 9711, otherwise known as 
16 
the "Food and Drug Administration Act of 2009". 
17 
18 
19 
SEC. 24. 
Administrative Sanction. - Where there is a finding of a violation 
20 
against the provisions of this Act and a determination of the persons liable 
21 
thereto, after notice and hearing, the FDA director-general may impose one or 
22 
more of the following administrative penalties: 
23 
24 
(a) Suspension of License to Operate (L TO); 
25 
26 
(b) Revocation of LTO; and, 
27 
28 
(c) Seizure of the unregistered, non-compliant or falsely represented products 
29 
covered by this Act. 
30 
31 
32 
SEC. 25. Penalties. -- Pursuant to Section 11 of Republic Act 9711, any person 
33 
who violates any of the provisions of Section 24 hereof and other prohibited acts 
34 
stipulated in the same Act shall, upon conviction, suffer the penalty of 
35 
imprisonment ranging from one (1) year but not more than ten (10) years or a 
36 
fine of not less than Fifty Thousand Pesos (P50,000.00) but not more than Five 
37 
Hundred Thousand Pesos (P500,000.00) or both, at the discretion of the court; 
38 
Provided, That if the offender is a manufacturer, importer or distributor of any 
39 
product covered under this Act, the penalty of at least five (5) years imprisonment 
40 
but not more than ten (10) years and a fine of at least Five Hundred Thousand 
41 
Pesos (P500,000.00) but not more than Five Million Pesos (P5,000,000.00) shall 
42 
be imposed; Provided, further, That an additional fine of one percent (1 %) of the 
43 
economic value / cost of the violative product or violation, or One Thousand 
44 
Pesos (Pi ,000.00), whichever is higher, shall be imposed for each day of 
45 
continuing violation; 
Provided, finally, That products found in violation of the 
46 
provisions of this Act and other relevant laws, rules and regUlations may be 
47 
seized and held in custody pending proceedings, without hearing or court order, 
48 
when the FDA director-general has reasonable cause to believe from facts found 
49 
by him/her or an authorized officer or employee of the FDA that such products 
50 
may cause injury or prejudice to the consuming public. 
51 
52 
Should the offense be committed by a juridical person, the Chairman of the 
53 
Board of Directors, the president, general manager, or the partners and/or the 
54 
persons directly responsible therefore shall be penalized. 
55 
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1 
Should the offense be committed by a foreign national, he/she shall, in addition 
2 
to the penalties prescribed, be deported without further proceedings after service 
3 
of sentence. 
4 
5 
6 
SEC. 26. Citizens'Suit. - For purposes of enforcing the provisions of this Act or 
7 
its implementing rules and regulations, any citizen may file an appropriate civil, 
8 
criminal or administrative action in the proper courts/bodies against: 
9 
10 
(a) any person who violates or fails to comply with the provisions of this Act 
11 
and its implementing rules and regulations; or, 
12 
13 
(b) the officials or employees of the DOH and other implementing agencies 
14 
with respect to orders, rules and regulations issued inconsistent with this 
15 
Act; and/or, 
16 
17 
(c) any public officer who willfully or grossly neglects the performance of an 
18 
act specifically enjoined as a duty by this Act or its implementing rules and 
19 
regulations; or abuses authority in the performance of duty; or, in any 
20 
manner improperly performs his duties under this Act or its implementing 
21 
rules and regulations; Provided, however, That no suit can be filed until 
22 
after a thirty-day (30) notice has been given to the public officer and the 
23 
alleged violator concerned and no appropriate action has been taken 
24 
thereon. 
25 
26 
The court shall exempt such action from the payment of filing fees and shall 
27 
likewise, upon prima facie showing of the non-enforcement or violation 
28 
complained of, exempt the plaintiff from the filing of an injunction bond for the 
29 
issuance of preliminary injunction. 
30 
31 
In the event that the citizen suit should prosper, the court may award reasonable 
32 
attorney's fees, moral damages and litigation costs. 
33 
34 
35 
SEC. 27. Suits and Strategic Legal Action Against Public Participation (SLAPP) 
36 
and the Enforcement of this Act. - Where a suit is brought against a person who 
37 
filed an action as provided in Section 26 of this Act, or against any person, 
38 
institution or government agency that implements this Act or any other consumer 
39 
related laws, rules, and regulations, it shall be the duty of the investigating 
40 
prosecutor or the court, as the case may be, to immediately make a 
41 
determination within a period not exceeding thirty (30) days whether said legal 
42 
action has been filed to harass, vex, exert undue pressure or stifle such legal 
43 
recourses of the person complaining or enforcing the provisions of this Act. 
44 
Upon determination of the evidences, the court may dismiss the case and award 
45 
attorney's fees and damages. 
46 
47 
This provision shall also apply and benefit public officers who are sued for acts 
48 
committed in their official capacity, there being no grave abuse of authority, and 
49 
done in the course of enforCing this Act, its rules, regulations, and guidelines. 
50 
51 
52 
SEC. 28. Burden of Proof of Product Safety. - The burden of proof to prove the 
53 
exercise of due diligence, compliance with this Act and other laws, rules, and 
54 
regulations relating to consumer products, precaution, and to prove the absence 
55 
of fault and/or negligence shall lie with the manufacturer, producer, assembler, 
56 
importer, and/or seller of the children's product involved or concerned. 
57 . 
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1 
SEC. 29. Appropriations. - Such amount as may be necessary to implement the 
2 
provisions of this Act shall be included in the annual appropriations of the 
3 
Department of Health under the General Appropriations Act. 
4 
5 
6 
SEC. 30. 
Congressional Oversight Committee. -
The joint Congressional 
7 
Oversight Committee created under RA No. 9711 or the Food and Drug 
8 
Administration (FDA) Act of 2009 shall function as the oversight committee to 
9 
monitor and evaluate the implementation of this Act 
10 
11 
12 
SEC. 31. Suppletory Provision. - Pertinent provisions of Republic Act No. 7394 
13 
otherwise known as the "Consumer Act of the Philippines" shall have suppletory 
14 
effect in the implementation of this Act. 
15 
16 
17 
SEC. 32. Implementing Rules. - Within sixty (60) days after the effectivity of this 
18 
Act, the DOH, in coordination with the DTI, DENR and the DOF through the 
19 
BOC, shall issue the rules and regulations to implement the provisions of this Act 
20 
21 
22 
SEC. 33. Separability Clause. - If, for any reason, a provision or part hereof is 
23 
declared invalid, the other provisions not affected thereby shall remain in full 
24 
force and effect. 
25 
26 
27 
SEC. 34. Repealing Clause. - All laws, decrees, executive orders, rules and 
28 
regulations or parts thereof inconsistent with the provisions of this Act are hereby 
29 
repealed, amended or modified accordingly. 
30 
31 
32 
SEC. 35. Effectivity Clause. - This Act shall take effect after fifteen (15) days 
33 
after its complete publication in two (2) newspapers of general circulation. 
34 
35 . 
36 
37 
38 
39 
Approved, 
13