FOURTEENTH CONGRESS OF THE REPUBLIC) 
OF THE PHILIPPINES 
First Regular Session 
Introduced by Senator Miriam Defensor Santiago 
EXPLANATORY NOTE 
Government scientists recently identified a group of toxic chemicals 
known as phthalates in urine of adults, with highest levels in premenopausal 
women, resulting from inhalation and skin exposure to volatile parent ingredients 
used extensively as solvents and plasticizers in personal care and cosmetic (PCC) 
products. These include perfumes, shampoos, hair sprays and nail polishes. 
These findings raise major concerns in view of documented evidence, dating back 
to 1985, that these phthalates induce birth defects, low sperm counts, and other 
reproductive toxicity in experimental animals.* 
For some time now, it has been observed that a number of cosmetics are made with 
cancer-causing chemicals. However, the public has remained unaware of its dangers and that the 
substances that are used could be human carcinogens that are toxic. Examples of these cosmetics 
and their carcinogenic components are the following: 
Black and dark brown permanent hair dyes contain numerous 
ingredients, such as diaminoanisole and FD&C Red 33, recognized as carcinogens 
in experimental animals. This evidence is supported by studies establishing that 
regular use of these dyes poses major risks of relatively rare cancers--non- 
Hodgkin's lymphoma, Hodgkin's disease and multiple myeloma. 
Cosmetic grade talc is carcinogenic in experimental animals. Also, 
frequent genital dusting with talc, routinely practiced by some 17% of women, 
increases risks of ovarian cancer. 
A group of widely used preservatives, such as quaterniuml5 and 
bronopol, widely used in baby products, though not carcinogenic themselves, 
break down to release formaldehyde, a potent irritant and carcinogen. 
Lanolin, widely used on babies' skin and nipples of nursing mothers, is 
commonly contaminated with DDT and other carcinogenic pesticides. 
Commonly used PCC detergents and foaming agents, such as 
polysorbates and PEG, are usually contaminated with the volatile carcinogen 
dioxane, although this could be easily removed by vacuum stripping during 
manufacture. 
DEA, another widely used chemical detergent, has been known since 
1975 to combine with nitrite preservatives or contaminants in PCC products to 
form a highly carcinogenic nitrosamine. Furthermore, recent government studies 
showed that DEA itself is also carcinogenic following application to mouse skin.+ 
* Undisclosed Carcinogens In Cosmetics And Personal Care Products Pose Avoidable Risks Of Cancer Warns 
Samuel Epstein, M.D. 
http://www. safe2use.com/health/cosmetics.htm 
' Ibid, 


Hence, this bill seeks to ensure the safety of cosmetic products sold in the Philippines by 
requiring that such products be free of any ingredients which have been identified as chemicals 
causing cancer or reproductive toxicity. Because the compliance of resident manufacturers and 
sellers - in the case of foreign manufacturers - is key, this bill also provides a penalty in case of 
their non-compliance. 


FOURTEENTH CONGRESS OF THE REPUBLIC) 
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OF THE PHILIPPINES 
First Regular Session 
Introduced by Senator Miriam Defensor Santiago 
AN ACT 
ESTABLISHING THE SAFE COSMETICS ACT OF 2008 
Be it enacted by the Senate and the House of Representatives of the Philippines in 
Congress assembled: 
SECTION 1. Short Title. - This Act shall be known as “Safe Cosmetics Act of 2008.” 
SECTION 2. Declurution of Policy. - It is the policy of the State to promote the general 
welfare of the people. Pursuant to this policy, this Act seeks to ensure that cosmetic products are 
free of any ingredients which have been identified as chemicals causing cancer or reproductive 
toxicity. 
SECTION 3. Dejnition of Terms. -For the purposes of this Act, the term: 
(A) “Authoritative body” means any agency, division, body or formally organized 
program or group recognized by the Department of Health as being authoritative for the purpose 
of identifying chemicals that may cause cancer or reproductive toxicity; 
(B)“Center” means the Occupational Safety and Health Center of the Department of 
Labor and Employment; 
(C) “Chemical identified as causing cancer or reproductive toxicity” means a chemical 
identified by an authoritative body as any of the following: 
(1) A substance listed as known or reasonably anticipated to be a human 
carcinogen in a national toxicology report on carcinogens; 
(2) A substance given on overall carcinogencity evaluation of Group 1, Group 2A 
or Group 2B by the International Agency for Research on Cancer; 
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(3) A substance identified as a Group A, Group B1 or Group B2 carcinogen, or as 
a known or likely carcinogen by the United States Environmental Protection Agency; 
(4) A substance identified as having some clear evidence of adverse 
developmental, male reproductive or female reproductive toxicity effects in a report by 
an expert panel of the National Toxicology Program’s Center for the Evaluation of Risks 
to Human Reproduction of the United States; 
(D) “Department” means the Department of Health; 
(E) “Ingredient” means anything that forms part of a cosmetic product’s formulation; 
(F) “Manufacturer” means any person whose name appears on the label of a cosmetic 
product; and 
(G)“Seller” means any person who offers for sale any cosmetic product. 
SECTION 4. Listing of Products. - (A) Commencing January 1 of the year following the 
passage of this Act, the manufacturer of any cosmetic product that is subject to regulation by the 
Food and Drug Administration and is manufactured and sold in the Philippines, shall, on a 
schedule and in electronic or other format, provide the Department of Health with a complete 
and accurate list of its cosmetic products that contain any ingredient that is a chemical identified 
as causing cancer or reproductive toxicity, including: 
(1) A chemical contained in the product for purposes of fragrance or flavoring; 
or 
(2) A chemical identified by the phrase “and other ingredients” and determined to 
be a trade secret. 
(B) Any ingredient identified pursuant to this paragraph shall be considered to be a trade 
secret and shall be treated by the Department in a manner consistent with the Intellectual 
Property Law. 
(C) If the cosmetic product is sold in the Philippines but is manufactured outside the 
Philippines by a foreign entity, the resident seller thereof shall have the same obligation to 
provide the Department the product listing described in the preceding paragraph. 
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(D) Any information submitted pursuant to paragraph (A) of this Section shall identify 
each chemical both by name and chemical abstract service number and shall specify the product 
or products in which the chemical is contained. 
(E) If any ingredient identified pursuant to this Section subsequently is removed from 
the product in which it was contained, or is removed from the list of chemicals known to cause 
cancer or reproductive toxicity, or is no longer a chemical identified as causing cancer or 
reproductive toxicity by an authoritative body, the manufacturer of the product containing the 
ingredient shall submit the new information to the Department. Upon receipt of new information, 
the Department, after verifying the accuracy of that information, shall revise the manufacturer’s 
information on record with the Department to reflect the new information. The manufacturer 
shall not be under obligation to submit subsequent information on the presence of the ingredient 
in the product unless subsequent changes require submittal of the information. 
(F) This section shall not apply to any manufacturer of cosmetic products with 
annual aggregate sales of cosmetic products, both within and outside of the Philippines, of less 
than One Hundred Thousand Pesos (PlOO,OOO.OO), based on the manufacturer’s most recent tax 
year. 
SECTION 5. Investigation. - (A) In order to determine potential health effects of 
exposure to ingredients in cosmetics in the Philippines, the Department may conduct an 
investigation of one or more cosmetic products that contain chemicals identified as causing 
cancer or reproductive toxicity or other ingredients of concern to the Department. 
(B) An investigation conducted pursuant to paragraph (A) of this Section may include, 
but not be limited to, a review of available health effects, data and studies, worksite health 
hazard evaluations, epidemiological studies to determine the health effects of exposures to 
chemicals in various subpopulations, and exposure assessments to determine total exposures to 
individuals in various settings. 
(C) If an investigation is conducted pursuant to paragraph (A) of this section, the 
manufacturer of my product subject to the investigation may submit relevant health effects 
data and studies to the Department. 
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(D) In order to further the purposes of an investigation, the Department may require 
manufacturers of products subject to the investigation to submit to the Department relevant 
health effects data and studies available to the manufacturer and other available information as 
requested by the Department, including, but not limited to, the concentration of the chemical in 
the product, the amount by volume or weight of the product that comprises the average daily 
application or use, and sales and use data necessary to determine where the product is used in 
the occupational setting. 
(E) The department shall establish reasonable deadlines for the submission of information 
required pursuant to paragraph (D) of this Section. Failure by a manufacturer to submit the 
information in compliance with the requirements of the Department shall constitute a violation 
punishable under Section 7 of this Act. 
SECTION 6. Referral of Results. - (A) If the Department determines pursuant to an 
investigation that an ingredient in a cosmetic product is potentially toxic at the concentration 
present in the product or under the conditions used, the Department shall immediately refer the 
results of its investigation to the Occupational Safety and Health Center. 
(B) Within one hundred eighty (180) days after it receives the results of an 
investigation pursuant to paragraph (A) of this Section, the Center shall develop and present 
one or more proposed occupational health standards to the Department of Labor and 
Employment, unless the Center affirmatively determines, in a written finding within ninety (90) 
days, that a standard is not necessary to protect the health of an employee or has regular exposure 
to the hazard for the period of his or her working life. The written finding shall identify the 
reasons for determining the standard is not necessary and the factual basis for the finding. 
SECTION 7. Penalty for Non-Compliance. - Failure by a manufacturer to submit the 
information in compliance with the requirements of the Department under Section 5 of this Act 
shall constitute a violation punishable by a penalty of Ten Thousand Pesos (Pl0,OOO.OO) to not 
more that One Hundred Thousand Pesos (PlOO,OOO.OO) at the discretion of the court, taking into 
consideration the circumstances of the case. 
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SECTION 8. Separability Cluuse. - If any provision or part hereof, is held invalid or 
unconstitutional, the remainder of the law or the provision not otherwise affected shall remain 
valid and subsisting. 
SECTION 9. Repealing Clause. - Any law, presidential decree or issuance, executive 
order, letter of instruction, administrative order, rule or regulation contrary to, or inconsistent 
with, the provisions of this Act is hereby repealed, modified or amended accordingly. 
SECTION 10. Effectivity Clause. - This Act shall take effect fifteen (15) days after its 
publication in at least two (2) newspapers of general circulation. 
Approved, 
/rgs 
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