FIFTEENTH CONGRESS OF THE REPUBLIC)
OF THE PHILIPPINES )
)

First Regular Session
SEN.
sno 1886 A

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.

* Undisclosed Carcinogens In Cosmetics And Personal Care Proxtucts Pose Avoidable Risks Of Cancer Warns
Samuel Epstein, M.D.
http://www. safe2use.com/health/cosmetics htm


Cosmetic grade tale 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 quaterniumlS 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.

DBA, 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.?

Hence, this bill secks 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.®

Gee, of sate
oo ipsa

? Ibid.

? This bill was originally filed during the Fourteenth Congress, First Regular Session.

2


10

cu

12

13

14

15

v7

18

19

20

aa

FIFTEENTH CONGRESS OF THE REPUBLIC) a
OF THE PHILIPPINES )
First Regular Session )

SENATE

s.No.__1886

Introduced by Senator Miriam Defensor Santiago

AN ACT
ESTABLISHING THE SAFE COSMETICS ACT

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.”

SECTION 2. Declaration 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. Definition 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;

(©) “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;

(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;


1

10

1

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

(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) “Repartment” means the Department of Health;

(© “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
produet; and

(G)*Seller” means any person who offers for sale any cosmetic product.

SECTION 4. Listing of Products. - (A) Commencing January | 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.

() ‘Any information submitted pursuant to paragraph (A) of this Section shall identify
cach chemical both by name and chemical abstract service number and shall specify the product

or products in which the chemical is contained.



10

ou

12

13

14

15

16

7

18

19

20

21

22

23

24

25

26

27

28

(B) 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 (P 100,000.00), 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.

(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


10

i

12

13

14

15

16

17

18

19

20

24

22

23

24

25

26

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 (P10,000.00) to not
more than One Hundred Thousand Pesos (P100,000.00) at the discretion of the court, taking into

consideration the circumstances of the case.

SECTION 8. Separability Clause. — If any provision or part hereof, is held invalid or
unconstitutional, the remainder of the law or the provision not otherwise dffected shall remain

valid and subsisting.


1

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,

ings