';"["1;, ',d 
FIFTEENTH CONGRESS OF THE 
) 
REPUBLIC OF THE PHILIPPINES 
) 
Third Regular Session 
) 
'1" 
' .,: ~ \/ " , r'.! 1 :r 2-
,.,\ 
SENATE 
S.B. No. 3337 
INTRODUCED BY SEN. MANNY VILLAR 
EXPLANATORY NOTE 
The 1987 Constitution states that "[t]he State shall protect and promote the 
right to health of the people and instill health consciousness among them (Article II, 
S 9ction 15)." Further, our Constitution also provides that "[t]he State shall protect 
cunsumers from trade malpractices and from substandard or hazardous products 
(Article XVI, Section 9)." 
Recently, the United States of America enacted their Consumer Product 
Safety Improvement Act of 2008, which banned products with toxic lead that 
exceeded federal guidelines. Considering the dangers posed by lead in toys, other 
countries followed suit in the banning of use of lead in manufacture of toys, these 
countries include members of the European Union, Canada and Samoa. 
Unfortunately, there is currently no strict policy being implemented by the 
Philippine government as regards the banning or restriction of manufacture or 
importation of toys laden with either lead or Cadmium or any other toxic materials. 
These pieces of legislations are timely to curb the growing number of toys 
laced with toxic materials. For example in the USA, in the Associated Press (AP) 
investigation, wherein a lab technician tested 103 children's metal charm bracelets 
a 1d pendant trinkets from around the country and sold at US Stores i.e. Wal-Mart, 
Claire's, and dollar stores, it was found that "twelve percent of those tested contained 
at least 10 percent cadmium, a carcinogenic metal that has been shown to cause 
developmental problems in small children. Some items tested contained more than 
90 percent cadmium by weight, and many shed the toxic metal easily, making it 
particularly dangerous to children, who often put toys in their mouth.,,1 
Locally, in a pre-Christmas screening made by an independent group of toys 
bought from the metropolis last September 2012 revealed that 74 of the 150 samples 
(49 percent) were laced with heavy metals above levels of concern, including lead 
that exceeded the US lead in paint limit of 90 parts per million (ppm) in 54 samples 
(36 percent)2 
I hllp://www.rodale.com/toxic-toys-china 
2 http://www.pchrd.dost.gov.ph/index.php/20 12-05-23-07 -46-36/20 \ 2-05-24-00-03-06/5484-you-d-better-
watch-ou t -I'or -to xi c-toy s-for -chri strn as 
,,', 


Considering the health risks posed to the public especially to children, it is 
necessary that this legislation be passed to ensure that the toys bought and sold in 
the market are free from excessively high levels of toxic metals such as, but not 
limited to, that of cadmium or lead. 
This bill is earnestly sought. 


FIFTEENTH CONGRESS OF THE 
Republic of the Philippines 
Third Regular Session 
) 
) 
) 
SENATE 
NO. 
3337 
Introduced by SEN. MANNY VILLAR 
AN ACT 
" 
,1 ['I 
~ 
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 Tilt/e. - This Act shall be known as the" Safe and NOll-toxic 
2 
Children's Products Act of 2012" 
3 
4 
SEC. 2. Declaration of Policy. - It is hereby declared the policy of the State to 
5 
protect and promote the rights of the people to health, a balanced and 
6 
healthful ecology and to information. Towards this end, the State shall 
7 
regulate the importation, manufacture, sale and distribution of children's toys, 
8 
school supplies and other child care articles containing toxic chemicals. 
9 
10 
SEC. 3. Definitioll of Terms. - For purposes of this Act, the following terms 
II 
are hereby defined: 
12 
13 
a. Bioavailability refers to the availability and possibility of the 
14 
chemical from a product or children's toys to be released and 
15 
absorbed into a child's body via the gastro intestinal tract, the lungs, 
16 
or the skin and mucus membranes; 
17 
18 
b. 
Chemical substance refers to any organic or inorganic substance 
19 
of a particular molecular identity, including: 
20 
21 
1) any combination of such substances occurring, in whole or in 
22 
part, as a result of chemical reaction or occurring in nature; and 
23 
2) any element or uncombined chemical 
24 
25 
c. Childcare article refers to any product intended to faCilitate sleep, 
26 
relaxation, hygiene, the feeding of children or sucking on the part of 
27 
children such as nipples, feeding bottles, baby dresses, pacifiers 
28 
etc. 
29 
30 
d. Children refer to persons below eighteen (18) years of age or those 
31 
over but are unable to fully take care of themselves or protect 
32 
themselves 
from 
abuse, 
neglect, 
cruelty, 
exploitation 
or 
Page 1 of 13 


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


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


I 
r. 
Toy refers to an object or a number of objects clearly intended as a 
2 
plaything for children as defined in Section 3 of this Act; 
3 
4 
s. Toxic sUbstance refers to any substance other than a radioactive 
5 
substance which can cause injury, illness or death through 
6 
ingestion, inhalation, or absorption through any body surface. 
7 
8 
SEC. 4. Scope. - This Act shall apply to the importation, manufacture, sale 
9 
and distribution of children's toys, school supplies, childcare articles and other 
10 
related products, whether or not designed or intended for use or play solely by 
II 
children under the age of eighteen (18), and other childcare articles and 
12 
related products that are sold or given free of charge in the Philippines. 
13 
14 
SEC. 5. Chemicals and Substances Covered. - Within three (3) months from 
15 
the effectivity of this Act, the Food and Drug Administration (FDA) shall 
16 
prepare a list of chemicals and substances used in children's products which 
17 
cause or may cause harm, injury, or death to children. The FDA shall 
18 
specifically identify absolutely banned or prohibited substances and chemicals 
19 
used in the manufacture, production, and preparation of children's products. 
20 
Maximum levels and limits and reference values for certain chemicals used 
21 
for this purpose shall also be specifically and clearly identified. 
22 
23 
Chemicals and substances deemed most harmful and toxic to children 
24 
and commonly used in the manufacture and production of children's products 
25 
shall include, but shall not be limited, to the following: 
26 
27 
a. Toxic Metals: 
28 
1. Antimony 
29 
2. Arsenic 
30 
3. Cadmium 
31 
4. Chromium 
32 
5. Lead 
33 
6. Mercury 
34 
' b. Phthalates - when applied in the manufacture and production of 
35 
products covered under this Act, include: 
36 
1 Di (2-Ethlyhexyl) Phthalate (Dehp) 
37 
2. Dibutyl Phthalate (Dbp) 
38 
3. Benzyl Butyl Phthalate (Sbp) 
39 
4. Diisononyl Phthalate (Dinp) 
40 
5. Diisodecyl Phthalate (Didp) 
41 
6. Di-N-Octyl Phthalate (Dnop) 
42 
c. Bisphenol-A (Spa) 
43 
44 
SEC. 6. Compliance with Philippine National Standards (PNS). - Importers, 
45 
manufacturers, distributors and sellers of products under this Act shall comply 
46 
with the standards, rules and processes of the Bureau of Product Standards 
47 
of the Department of Trade and Industry. The same shall collaborate with 
48 
other relevant government agencies to harmonize/upgrade existing standards, 
49 
where applicable. 
50 
51 
SEC. 7. Powers and Functions of the DOH. - To effectively carry out its 
52 
mandate of ensuring the quality of products under this Act, the DOH shall 
53 
have the following powers and functions: 
54 
Page 4 of13 


a. 
Formulate guidelines in the filing of application for the issuance of 
2 
License to Operate (L TO) to importers, distributors and local 
3 
manufacturers of products under this Act; 
4 
5 
b. Formulate specific guidelines on the issuance of the Certificate of 
6 
Conformity to manufacturers, distributors, and importers for every 
7 
shipment, freight, batch/lot of their products covered in this Act; 
8 
9 
c. Issue quality control orders (QCOs) to enforce the provisions of this Act 
10 
and to ensure strict compliance with existing standards and regulations 
II 
set by government authorities; 
12 
13 
d. Issue compliance orders (COs) if it finds non-compliance and/or non-
14 
conformity with this Act, its rules and regulations, and guidelines issued 
15 
to enforce and implement the same; 
16 
17 
e. Undertake researches, develop and establish quality and safety 
18 
standards for products covered by this Act in coordination with other 
19 
implementing government agencies; 
20 
21 
f. 
Set the maximum allowable level of toxicity of chemical elements in 
22 
products covered by this Act; 
23 
24 
g. Inspect and analyze products covered by this Act for purposes of 
25 
determining conformity to established quality and safety standards; 
26 
27 
h. Conduct constant and regular inspection, product testing, and on-sight 
28 
and random product testing and sampling of various children's 
29 
products in the market; 
30 
31 
i. 
Levy, asses, collect and retain fees as are necessary to cover the cost 
32 
of inspection, certification, analysis and tests of samples of products 
33 
under this Act; 
34 
35 
j. 
Investigate the causes of and maintain a record of product-related 
36 
deaths, illnesses and injuries for use in researches or studies on the 
37 
prevention of such deaths, illnesses and injuries; 
38 
39 
k. Accredit independent, competent non-government bodies, to assist in 
40 
monitoring the market for the presence of toxic chemicals in products 
41 
under this Act and to look for appropriate means to expand the 
42 
monitoring and enforcement outreach of the Department in relation to 
43 
its manpower, testing and certification resources at a given time; 
44 
4S 
I. 
Accredit independent competent testing laboratories; and 
46 
47 
m. Perform such other functions as needed and necessary in the 
48 
enforcement of this Act. 
49 
50 
SEC. 8. Role Delineation of Implementing Agencies. - The provisions of this 
51 
Act and its implementing rules and regulations shall be enforced by the 
52 
following agencies: 
53 
S4 
a. DOH - The Department of Health shall formulate policies, rules and 
55 
regulations on food, drugs, cosmetics, devices and sUbstances; 
Page 5 of 13 


1 
The FDA shall conduct regular testing, evaluation, monitoring and 
2 
post-market surveillance of covered products to include all school 
3 
implements as defined in Section 3 of this Act to ensure compliance 
4 
with the Philippine National Standards on the Safety of Toys; 
5 
6 
b. DENR - The Department of Environment and Natural Resources 
7 
shall 
regulate, 
control, 
restrict or 
prohibit the 
importation, 
8 
manufacture, processing, sale, distribution, handling, use, transport 
9 
and disposal of chemical substances mixtures under Republic Act 
10 
No. 6969, "Toxic Substances and Hazardous and Nuclear Waste 
11 
Control Act of 1990". It shall monitor toxic substances/chemicals 
12 
used as industrial raw material to produce the covered products 
13 
under this Act in terms of their compliance to environmental laws. It 
14 
shall 
administer the industrial toxic chemicals through a system of 
15 
review, evaluation and monitoring of these toxic chemicals under 
16 
the DENR Administrative Order No. 2007-23 and formulate policies 
17 
and guidelines for the gradual phase-out of lead in paints pursuant 
18 
to Sec. 20 (1) of DAO 20, Series of 1992 and DAO 05,Series of 
19 
2005 (TOXIC Chemical Substances for Issuance of Chemical Control 
20 
Orders); 
21 
22 
c. OOF -
The Department of Finance, through the Bureau of 
23 
Customs, shall monitor the entry of imported products covered 
24 
under this Act at the different ports of entry in the Philippines. It 
25 
shall review and conduct examination of documentary requirements 
26 
of imported products pursuant to the guidelines of the Department; 
27 
28 
d. DTI - The Department of Trade and Industry shall enforce policies 
29 
and regulate the importation, manufacture, distribution and sale of 
30 
educational kits or school supplies as defined in Section 3 of this 
31 
Act and other consumer products not covered by the mandates of 
32 
the other implementing agencies. It shall ensure that covered 
33 
products comply with the Philippine National Standards on the 
34 
Safety of Toys set by the Bureau of Product Standards and shall 
35 
monitor and conduct market inspections on covered products. 
36 
37 
SEC. 9. Creation of the Children'S Product Safety Council. 
There is hereby 
38 
created a Children's Product Safety Council (CPSC) to be attached to the 
39 
Department of Health (DOH) and composed of the following: 
40 
a. The Secretary of the DOH - Chairperson 
41 
b. The Secretary of the DTI - Vice Chairperson 
42 
c. The Secretary of the DENR - Member 
43 
d. The Secretary of the Department of Interior and Local Government 
44 
(DILG) - Member 
45 
e. The Secretary of the Department of Education (DEPEd) - Member 
46 
f. 
The Secretary of DOF - Member 
47 
g. The Director of the FDA -Member 
48 
h. The National Consumer Affairs Council (NCAC) - Member 
49 
i. 
One (1) Representative from a Non-Government Organization (NGO) 
50 
engaged in consumer rights protection - Member 
51 
j. 
One (1) Representative from a Non-Government Organization (NGO) 
52 
engaged in environmental protection and advocacy - Member 
53 
Page 6 of13 


The departments and government agencies shall be represented by 
2 
their respective heads or their duly designated representatives who shall be of a 
3 
rank not lower than Director level. 
4 
5 
The Chairperson of the CPSC shall recommend the nominees for the 
6 
NGO Sector Representatives to the President of the Philippines. 
7 
8 
The FDA shall serve as the secretariat and operational arm of the 
9 
CPSC. 
10 
11 
Other government agencies and private sector representatives may 
12 
be invited to participate in the CPSC as the exigencies and circumstances 
13 
may require. 
14 
15 
SEC 10. Powers and Functions of the CPSC. The CPSC shall have the 
16 
following powers and functions: 
17 
18 
a. To provide coordination and linkage mechanisms between and 
19 
among its members, other government agencies concerned, local 
20 
government 
units 
(lGUs), 
the 
private 
sector, 
and 
oth'9r 
21 
stakeholders; 
22 
b. To engage in studies and researches on harmful and toxic 
23 
chemicals and substances, and provide the necessary information 
24 
materials on the same; 
25 
c. To conduct and facilitate consultation and dialogues within and 
26 
among all concerned stakeholders in the industry; 
27 
d. To conduct information and education campaigns, especially for 
28 
children; 
29 
e. To propose amendments to laws, rules, and regulations pursuant 
30 
to its mandate and the objectives of this Act; 
31 
f. 
To provide periodic and regular reports to the Secretary of Health; 
32 
g. To create a Technical Advisory Committee composed of experts 
33 
from both government and private sectors that would assist the 
34 
council in providing technical and scientific recommendations 
35 
necessary to effectively carry out its mandate; 
36 
h. To provide coordination and linkage mechanisms between and 
37 
among its members, other government agencies concerned, the 
38 
Business Processing and Licensing Office (BPlO) of Local 
39 
Government Units (LGUs) 
, the private sector, 
and 
other 
40 
stakeholders; and 
41 
i. 
To perform such other functions as may be directed by the DOH. 
42 
43 
SEC. 11. Application to Trade. -
The following procedures shall be observed 
44 
at the first port of entry of imported products: 
45 
a. 
The FDA, or its commissioned/designated agent, in coordination 
46 
with the Bureau of Customs (BOC), shall conduct product inspection, sample 
47 
testing and clearance of imported products covered under this Act for 
48 
compliance with the national standards for the safety of toys prior to their 
49 
assessment and charging of tariffs and other charges by the BOC; 
50 
51 
b. Samples of prodUcts covered by this Act being imported into the 
52 
Philippines shall be obtained for purposes of determining the toxicity level of 
53 
Chemical elements and substances content without charge from the owner or 
54 
consignee thereof. The owner or consignee of the imported product und':lr 
55 
examination shall be afforded an opportunity to a hearing with respect to the 
Page 70f13 


I 
importation of such product into the Philippines. If it is proven that such 
2 
product does not conform to the allowable level of chemical elements and 
3 
substances content as provided for under the implementing rules and 
4 
regulation of this Act, said product shall be refused admission; 
5 
6 
c. Any product covered by this Act, the sale or use of which has been 
7 
banned or withdrawn in the country of manufacture, shall not be imported into 
8 
the country; and 
9 
10 
d. All expenses in connection with the storage, destruction and 
II 
disposition of any product under this Act which was refused admission shall 
12 
be paid by the owner or consignee and, in default of such payment, shall 
13 
constitute a lien against any future importation made by such owner 0r 
14 
consignee. 
15 
16 
SEC. 12. Clearance for Customs Release. - All importers of products under 
17 
this Act shall secure a Clearance for Customs Release from the DOH prior to 
18 
importation. 
19 
20 
A Clearance for Conditional Release shall be issued by the appropriate 
21 
Center of the FDA to facilitate the release of goods from the BOC custody 
22 
pending the issuance of the Certificate of Conformity. The importer, however 
23 
shall not sell. distribute or transfer in whole or in part, the products to any 
24 
place other than the address specified in the conditional release. To ensure 
25 
that no distribution, sale, transfer to or use of products covered by this Act in 
26 
any place other than the address specified in the conditional release is made, 
27 
the importers shall allow authorized personnel of the FDA to conduct an 
28 
inspection/inventory of the import shipment within three days from the date of 
29 
issuance of the clearance for conditional release at anytime within official 
30 
working hours. 
31 
32 
SEC.13. Certification. 
The DOH, after the conduct of a thorough 
33 
examination, shall issue the necessary certificate to show whether or not the 
34 
imported products are safe for distribution in the market 
35 
36 
SEC. 14. Disposal of Non-compliant Products. - All products covered by this 
37 
Act that are recalled by the manufacturer or the Department for whatever 
38 
reason, shall be disposed of in accordance with the submitted disposal plan 
39 
subject to FDA approval. The plan shall comply with the existing rules and 
40 
regulations set by all concerned agencies of the government and other related 
41 
laws of the country. The concerned manufacturer, importer or distributor shall 
42 
shoulder the expenses to be incurred in the disposal of the recalled products. 
43 
All import-shipments denied the requisite Certificate of Conformity shall 
44 
not be disposed of in the domestic market in any manner. They must be 
45 
properly disposed in accordance with the provisions of the Tariff and Customs 
46 
Code and other pertinent rules and regulations. 
47 
48 
SEC.15. Labeling and Packaging Requirement. - The packaging and labeling 
49 
requirement of products under this Act shall comply with the relevant 
50 
Philippine National Standards. 
51 
52 
SEC. 16. Monitoring and Factory Inspection. - The FDA shall observe the 
53 
following procedures in the inspection and monitoring of establishments to 
54 
determine compliance with safety regulations: 
55 
Page 8 01'13 


a. Officers or employees duly designated by the FDA, upon presenting 
2 
appropriate credentials to the owner, operator, or agent in charge, are 
3 
authorized (1) to enter, at reasonable hours, any factory, warehouse or 
4 
establishment in which products under this Act are manufactured or held for 
5 
introduction into domestic commerce or are held after such introduction, or to 
6 
enter any vehicle being used to transport or hold such products; and (2) to 
7 
inspe,ct, in a reasonable manner, such factory, warehouse, establishment or 
8 
vehicle and all pertinent eqUipment, finished and unfinished materials, 
9 
containers and labeling therein, 
10 
11 
b. Upon completion of the inspection of a factory, warehouse or other 
12 
establishment and prior to leaving the premises, the officer or employee who 
13 
conducted such inspection and has obtained any sample in the course of the 
14 
inspection, shall give the owner, operator, or agent in charge a receipt 
15 
describing the samples obtained; 
16 
17 
c. Whenever in the course of any such inspection of a factory or other 
18 
establishment where products covered by this Act are manufactured or held, 
19 
the officer or employee making the inspection obtains a sample of any such 
20 
product, and an analysis made of such sample for the purpose of ascertaining 
21 
whether such product contains, in whole or in part, disallowed level of toxicity 
22 
of chemical elements and hazardous substances, a copy of the result of such 
23 
analysis shall be furnished the owner, operator, or officer- in- charge. 
24 
25 
SEC. 17. Market Inspection. - The DOH shall conduct routine inspection in 
26 
the market and take samples of suspected products for examination. 
27 
28 
SEC. 18. Injurious, Oangerous and Unsafe Products. - Whenever the DOH 
29 
finds,' by its own initiative or by petition of a consumer, that a product covered 
30 
by this Act is injurious, unsafe or dangerous, it shall, after due notice and 
31 
hearing, make the appropriate order for its recal" prohibition, or seizure from 
32 
public sale or distribution. It may declare a product to be imminently injurious, 
33 
unsafe or dangerous, and order its immediate recall, ban or seize from public 
34 
sale or distribution, in Which case, the seller, distributor or producer thereof 
35 
shall be afforded a hearing within forty-eight (48) hours from such order. 
36 
37 
There shall be immediate information dissemination, through the mass 
38 
media, of products which are found to be injurious, dangerous and unsafe. 
39 
40 
SEC. 19. Product Confiscation. - Imported products shall be allowed entry 
41 
into the country as provided under Section 11 of this Act when accompanied 
42 
by Certificate of Testing or Analysis of its composition. The BOC shall require 
43 
pertinent clearance or certification from the FDA prior to entry. The entire 
44 
shipment or batch of the product found to be in violation of the provisions of 
45 
this Act shall be seized. The confiscated products shall be properly disposed 
46 
of in accordance with the prescribed procedure to be issued by the DOH in 
47 
coordination with the DENR. 
48 
49 
SEC. 20. Publication and Information. - The Department of Health (DOH) is 
50 
mandated to conduct information campaigns utilizing any form of mass media 
51 
and other electronic means deemed effective to ensure the proper guidance 
52 
of consumers, industries, businesses and other concerned sectors. 
53 
54 
The DOH shall likewise publish a consumer chemical substance 
55 
advisory notice which shall include a list of toxic chemicals and substances 
Page 9 of13 


I 
2 
3 
4 
5 
6 
7 
8 
9 
10 
I 1 
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used in the manufacture, distribution and sale of covered products for the 
information of the general public. Such advisory notice shall be made 
available to government agencies, consumers, industries, businesses and 
general public. 
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., 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 business hours: Provided, That the DTI may consider a record, 
report or 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: basic data on manufacturer, producer, 
assembled, 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. 
SEC. 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 
Ichemicals. 
Graphic symbols shall also be used in product packaging 
showing product safety and regulatory compliance. 
SEC. 23. Prohibited 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; 
Page 10 of13 


c. Material misrepresentation or concealment of significant data or 
2 
information about the product sought for certification; 
3 
4 
d. Importation, manufacture, sale, distribution, labeling, operation without 
5 
registration; 
6 
7 
e. Non-compliance with the standards and requirements of the DOH on 
8 
the importation, manufacture, distribution, sale of covered products, 
9 
10 
f. 
Refusal 
to 
allow required 
inspections 
as 
determined 
by 
the 
11 
Department; and 
12 
13 
g. Other prohibited acts stipulated in Republic Act 9711, otherwise known 
14 
as the "Food and Drug Administration Act of 2009." 
15 
16 
SEC. 24. Administrative Sanctions - lIVhere there is a finding of a violation 
17 
against the provisions of this Act and a determination of the persons liable 
18 
thereto, after notice and hearing, the FDA director-general may impose one or 
19 
more of the following administrative penalties: 
20 
a. Suspension of License to Operate (L TO); 
21 
b. Revocation of L TO; and 
22 
c. Seizure of the unregistered, non-compliant or falsely represented 
23 
products covered by this Act. 
24 
25 
SEC. 25. Penalties -
Pursuant to Section 11 of Republic Act 9711, any 
26 
person who violates any of the provisions of Section 24 hereof and other 
27 
prohibited acts stipulated in the same Act shall, upon conviction, suffer the 
28 
penalty of imprisonment ranging from one (1) year but not more than ten (10) 
29 
years or a fine of not less than Fifty Thousand Pesos (P50,OOO.00) but not 
30 
more than' Five Hundred Thousand Pesos (P500,000 00) or both, at the 
31 
discretion of the court: Provided, That if the offender is a manufacturer, 
32 
importer or distributor of any product covered under this Act, the penalty of at 
33 
least five (5) years imprisonment but not more than ten (10) years and a fine 
34 
of at,least Five Hundred Thousand Pesos (P500,000.00) but not more than 
35 
Five Million Pesos (P5,000,000.00) shall be imposed. Provided, further, That 
36 
an additional fine of one percent (1 %) of the economic value/cost of the 
37 
violative product or violation, or One Thousand Pesos (P1 ,000.00), whichever 
38 
is higher, shall be imposed for each day of continuing violation: Provided, 
39 
finally, That products found in violation of the provisions of this Act and other 
40 
relevant laws, rules and regulations may be seized and held in custody 
41 
pending proceedings, without hearing or court order, when the FDA director-
42 
general has reasonable cause to believe from facts found by him/her or an 
43 
authorized officer or employee of the FDA that such products may cause 
44 
injury or prejudice to the consuming public. 
45 
46 
Should the offense be committed by a juridical person, the Chairman of 
47 
the Board of Directors, the president, general manager, or the partners and/or 
48 
the persons directly responsible therefore shall be penalized. 
49 
50 
Should the offense be committed by a foreign national, he/she shall, in 
51 
addition to the penalties prescribed, be deported without further proceedings 
52 
after service of sentence. 
53 
Page 11 of 13 


I 
SEC 26. Citizens Suit. - For purposes of enforcing the provisions of this Act or 
2 
its implementing rules and regulations, any citizen may file an appropriate 
3 
civil, criminal or administrative action in the proper courts/bodies against: 
4 
5 
a. any person who violates or fails to comply with the provisions 
6 
of this Act and its implementing rules and regulations; or 
7 
b. the officials or employees of the DOH and other implementing 
8 
agencies with respect to orders, rules and regulations issued 
9 
inconsistent with this Act, and/or 
10 
c. any public officer who willfully or grossly neglects the 
II 
performance of an act specifically enjoined as a duty by this 
12 
Act or its implementing rules and regulations; or abuses 
13 
authority in the performance of duty; or, in any manner 
14 
improperly performs his duties under this Act or its 
15 
implementing rules and regulations: Provided, however, That 
16 
no suit can be filed until after a thirty-day (30) notice has 
17 
been given to the public officer and the alleged 
violator 
18 
concerned and no appropriate action has been taken thereon. 
19 
20 
The court shall exempt such action from the payment of filing fees and 
21 
shall likewise, upon prima facie showing of the non-enforcement or violation 
22 
complained of, exempt the plaintiff from the filing of an injunction bond for the 
23 
issuance of preliminary injunction. 
24 
25 
In the event that the citizen suit should prosper, the court may award 
26 
reasonable attorney's fees, moral damages and litigation costs. 
27 
28 
SEC 27. Suits and Strategic Legal Action Against Public Participation 
29 
(SLAPP) and the Enforcement of this Act.- Where a suit is brought against a 
30 
person who filed an action as provided in Section 26 of this Act, or against 
31 
any person, institution or government agency that implements this Act or any 
32 
other consumer related laws, rules, and regulations, it shall be the duty of the 
33 
investigating prosecutor or the court, as the case may be, to immediately 
34 
make a determination within a period not exceeding thirty (30) days whether 
35 
said legal action has been filed to harass, vex, exert undue pressure or stifle 
36 
such legal recourses of the person complaining or enforcing the provisions of 
37 
this Act. Upon determination of the evidences, the court may dismiss the case 
38 
and award attorney's fees and damages. 
39 
40 
This provision shall also apply and benefit public officers who are sued 
41 
for acts committed in their official capacity, there being no grave abuse of 
42 
authority, and done in the course of enforcing this Act, its rules, regulations, 
43 
and guidelines. 
44 
45 
SEC. 28. Burden of Proof of Product Safety.- The burden of proof to prove the 
46 
exercise of due diligence, compliance with this Act and other laws, rules, and 
47 
regulations relating to consumer products, precaution, and to prove the 
48 
absence of fault and/or negligence shall lie with the manufacturer, producer, 
49 
assembler, importer, and/or seller of the children'S product involved or 
50 
concerned. 
51 
52 
SEC. 29. Appropriations - Such amount as may be necessary to implement 
53 
the provisions of this Act shall be included in the annual appropriations of the 
54 
Department of Health under the General Appropriations Act. 
55 
Page 12 of 13 


1 
SEC. 30. Congressional Oversight Committee. - The joint Congressional 
2 
Oversight Committee created under RA No. 9711 or the Food and Drug 
3 
Administration (FDA) Act of 2009 shall function as the oversight committee to 
4 
. monitor and evaluate the implementation of this Act. 
5 6 
SEC.31. Suppletory Provision - Pertinent provisions of Republic Act No. 7394 
7 
otherwise known as the "Consumer Act of the Philippines" shall have 
8 
suppletory effect in the implementation of this Act 
9 
10 
SEC. 32. Implementing Rules. - Within sixty (60) days after the effectivity of 
11 
this Act, the DOH, in coordination with the DTI, DENR and the DOF throu!;'h 
12 
the BOC, shall issue the rules and regulations to implement the provisions of 
13 
this Act 
14 
15 
SEC. 33. Separability Clause. - If, for any reason, a provision or part hereof is 
16 
declared invalid, the other provisions not affected thereby shall remain in full 
17 
force and effect 
18 
19 
SEC. 34. Repealing Clause. - All laws, decrees, executive orders, rules and 
20 
regulations or parts thereof inconsistent with the provisions of this Act are 
21 
hereby repealed, amended or modified accordingly. 
22 
SEC. 35. Effectivity Clause. - This Act shall take effect fifteen (15) days after 
23 
its publication in any newspaper of general CIrculation. 
24 
25 
Approved, 
Page 13 of13