BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Deborah V. Ortiz, Chair
BILL NO: SB 484
S
AUTHOR: Migden
B
AMENDED: March 29, 2005
HEARING DATE: April 20, 2005
4
FISCAL: Appropriations
8
4
CONSULTANT:
Machi / ak
SUBJECT
Cosmetics: chronic health effects
SUMMARY
This bill establishes the California Safe Cosmetics Act of
2005; requires the cosmetic manufacturers to disclose to
the Department of Health Services (DHS) a list of
ingredients in their products that are chemicals that have
been identified to cause cancer (carcinogenic) or
reproductive harm; authorizes DHS to investigate the health
impacts of chemicals in cosmetics that are linked to cancer
or birth defects; requires DHS, if it finds exposure to the
chemical may be toxic, to submit its findings to the
Division of Occupational Safety and Health within the
Department of Industrial Relations (DIR); requires DHS to
investigate, when resources are available, the presence of
chemicals in cosmetics that have been declared unsafe by
the Cosmetics Ingredient Review panel.
ABSTRACT
Existing state law:
1.Regulates, under the Sherman Food, Drug, and Cosmetic
Law, the packaging, labeling, and advertising of food,
drugs, and cosmetics. A violation of any of the
Continued---
STAFF ANALYSIS OF SENATE BILL 484 (Migden) Page
2
provisions of this Act is punishable as a misdemeanor.
2.Prohibits a person from manufacturing, selling,
delivering, holding, offering for sale, or receiving in
commerce any cosmetic that is adulterated and prohibits a
person from adulterating any cosmetic.
3.Prohibits, under the Safe Drinking Water and Toxic
Enforcement Act of 1986 (Proposition 65), any person, in
the course of doing business, from knowingly and
intentionally exposing any individual to a chemical known
to the state to cause cancer or reproductive toxicity
without first giving clear and reasonable warning
("Proposition 65 warning"). It also provides that no
person shall knowingly discharge
or release those same chemicals into any source of
drinking water ("Proposition 65 discharge prohibition").
Certain exemptions apply, including where the exposure or
discharge would pose no significant risk of cancer, or,
for chemicals that cause reproductive toxicity, would
have no observable effect at 1,000 times the level in
question.
4.Requires the Governor to revise and republish the list of
Proposition 65 chemicals once a year.
Existing federal law:
The Fair Packaging and Labeling Act of 1973 regulates
cosmetic labeling. The Act requires that a cosmetic label:
"bear a declaration of each ingredient in descending order
of prominence, excepting that fragrance, flavoring, and
coloring may be declared as such."
This bill:
1.Authorizes DHS to conduct an investigation of cosmetic
products that contain chemicals identified as causing
cancer or reproductive toxicity or other ingredients of
concern to DHS.
2.Authorizes DHS to require manufacturers of products
subject to investigation to submit relevant health
Continued---
STAFF ANALYSIS OF SENATE BILL 484 (Migden) Page
3
effects data and studies and other information as
requested by DHS.
3.Requires DHS to establish reasonable deadlines for the
submittal of that information and would make failure by a
manufacturer to submit the information a crime.
4.Requires DHS to submit the results of any investigation
conducted to appropriate entities within the Division of
Environmental and Occupational Disease Control within
DIR.
5.Requires DHS, if it is determined that an ingredient in a
cosmetic product is potentially toxic, to immediately
refer the results of its investigation to the Division of
Occupational Safety and Health and requires the division,
within 180 days of receiving the results, to develop and
present one or more proposed occupational health
standards to the Occupational Safety and Health Standards
Board within DIR, unless the division affirmatively
determines in writing, within 90 days, that a standard is
not necessary to protect the health of an employee who
has regular exposure to the hazard for the period of his
or her working life.
6.Requires DHS, as early as feasible within existing
resources, to determine whether certain cosmetics have
been adequately substantiated for safety, and if the
cosmetic has, to determine if the designated use is safe.
If DHS finds that a product has been adequately
substantiated for safety despite containing an unsafe
ingredient, DHS is required to refer its findings to the
Attorney General and the federal Food and Drug
Administration (FDA) for possible enforcement.
FISCAL IMPACT
Unknown.
BACKGROUND AND DISCUSSION
Purpose of the bill
According to the author, the purpose of SB 484 is simple:
Continued---
STAFF ANALYSIS OF SENATE BILL 484 (Migden) Page
4
to require the manufacturers of cosmetics and other personal
care products to disclose of hazardous ingredients and give
the state authority to regulate such hazards where
appropriate. A variety of chemicals in cosmetics have been
linked to cancer and birth defects. As far back as 1978 the
General Accounting Office told Congress that cosmetics
"contain ingredients that may cause cancer, birth defects
and other chronic toxic effects." Over a third of products
on the market contain chemicals with potential links to
cancer.
The author believes that Proposition 65's most important
contribution to public health is that it requires the state
to identify chemicals that it determines cause cancer and
reproductive toxicity. But Proposition 65 does not trigger
any regulatory activity by the state. In fact the only
means of chemicals enforcing Proposition 65's warning
requirements, as well as its prohibition on discharges to
water, is by filing a lawsuit. Proposition 65 does not
provide regulatory authority over cosmetics and other
personal care products.
FDA regulation
According to the FDA's website on cosmetic safety issues,
although federal law does not require that cosmetic
manufacturers or marketers test their products for safety,
the FDA strongly urges cosmetic manufacturers to conduct
whatever toxicological or other tests are appropriate to
substantiate the safety of their cosmetics. If the safety
of a cosmetic is not adequately substantiated, the product
may be considered misbranded and may be subject to
regulatory action unless the label bears a warning
statement declaring that the safety of this product has not
been determined.
The FDA policy also states, "With the exception of color
additives and a few prohibited ingredients, a cosmetic
manufacturer may, of its own responsibility, use
essentially any raw material as a cosmetic ingredient and
market the product without approval. Although the
[federal] Act does not require cosmetic firms to register
manufacturing establishments or formulations with the FDA
or make available safety data or other information before a
product is marketed in the United States, manufacturers or
Continued---
STAFF ANALYSIS OF SENATE BILL 484 (Migden) Page
5
distributors of cosmetics may submit this information to
the agency voluntarily. Voluntary registration and
assignment of a registration number by the agency does not
denote approval of a firm or product by the FDA."
The European Union
In January 2003, the European Union prohibited the use of
certain chemicals that cause cancer, reproductive harm or
mutagenicity in cosmetics. The ban is absolute for
chemicals that fall into categories 1 and 2 of these
substances. For category 3 conditional use is allowed if
the proposed use is determined to be safe.
The categories denote the level of certainty that the
chemical harms human health. Category 1 substances are
those that are known to cause the specified health problems
in humans. Category 2 substances are known to cause the
effects in animals and the scientific literature is strong
enough that the European Union has determined to treat the
chemicals as though they cause the effects in humans.
Category 3 substances have also shown health effects in
animals, but the scientific literature is less strong than
for category 2.
In some cases the European Union ban has resulted in
cosmetic companies changing their formulas to completely
discontinue the use of banned chemicals, regardless of
where the product is sold: in Europe or the United States.
In other cases, the result has been to create one product
for the European market, without the chemical, and another
product for the US market that contains the chemical that
the European Union has determined to be harmful to human
health.
Authoritative bodies
By regulation, the Office of Environmental Health Hazard
Assessment (OEHHA) created two committees, the Carcinogen
Identification Committee and the Developmental and
Reproductive Toxicant Committee, which identify certain
agencies as "authoritative" for the purposes of identifying
chemicals that cause cancer or reproductive toxicity.
OEHHA reviews the chemicals identified by these agencies
and may add them to those chemicals OEHHA has already
identified under Proposition 65 as causing cancer or
Continued---
STAFF ANALYSIS OF SENATE BILL 484 (Migden) Page
6
reproductive harm. To date, the following agencies have
been recognized as "authoritative bodies": U.S.
Environmental Protection Agency; the US Food and Drug
Administration; the National Toxicology Program; the
International Agency for Research on Cancer (within the
World Health Organization) and the National Institute for
Occupational Safety and Health.
Cosmetic Ingredient Review (CIR) panel
The CIR is a panel of scientists established by the
cosmetics industry about 30 years ago to review cosmetics
ingredients for safety. The CIR is funded by the cosmetics
industry and most of the panel members are appointed by the
cosmetics industry. The CIR is the only entity within the
United States that does any review of long-term health
effects of cosmetic ingredients.
Environmental Working Group (EWG) study
A recent study by the EWG found that one-third of all
products tested contain one or more ingredients, such as
coal tar, formaldehyde and lead acetate with a potential
link to cancer. Other ingredients that were commonly found
in the cosmetics tested have been linked to birth defects
and reproductive harm, including dibutyl phthatlate and the
solvent, toluene.
Arguments in support
According to the sponsors, this bill would address decades
of inattention to the safety of chemicals in cosmetics in a
manner that is expedient and attentive to worker and
consumer health.
The sponsors argue that a variety of chemicals in cosmetics
have been linked to cancer and birth defects; over a third
of products on the market contain chemicals with potential
links to cancer; workers in nail and beauty salons are on
the front lines of exposure to these hazardous chemicals;
that the vast majority of these workers and their customers
are female; and that these women suffer a range of short-
and long-term illnesses as a result of their work. They
argue that chemicals linked to birth defects can present a
variety of health hazards for pregnant women. With
cost-effective alternative chemicals and formulations
already widely available, in utero exposure to chemical
Continued---
STAFF ANALYSIS OF SENATE BILL 484 (Migden) Page
7
hazards in cosmetics could be entirely avoided.
The sponsors argue that self-regulation by the industry has
not worked in the interest of public health. The FDA does
not review cosmetic ingredients for their health and safety
before they come to market nor have authority to recall
hazardous products. FDA relies on the cosmetics industry's
self-policing committee, the Cosmetic Ingredient Review
(CIR) panel, for information on product safety. They argue
that because testing is voluntary and controlled by the
manufacturers, 89 percent of the ingredients used in
cosmetic products have not been evaluated for safety by the
CIR, the FDA or any other publicly accountable institution.
The FDA has banned or restricted the use of only nine
cosmetic in gradients in 67 years and the CIR has found
only nine additional chemicals unsafe for use. The
sponsors argue that even when the CIR has designated
chemicals of concern, they have continued to appear in
products.
Arguments in opposition
The opposition argues that SB 484 would impose sweeping and
unnecessary new California-specific requirements on the
cosmetic industry.
According to the opposition, the FDA is already working to
address the concerns that SB 484 is intended to address.
In fact, the agency lists as a priority for 2005 responding
to a citizen petition from the Environmental Working Group
alleging that some cosmetics contain ingredients that have
been found to be unsafe by the Cosmetic Ingredient Review.
FDA recently warned the cosmetic industry that it intends
to take appropriate compliance action against any products
that might contain such ingredients.
The opposition argues that SB 484 is based on bad science
and it is unnecessary. Every cosmetic manufacturer who
sells products in California is already subject to a wide
range of state and federal laws and rules that govern
everything from how cosmetic products are formulated and
manufactured to how they are packaged. These requirements
include California's Sherman Food, Drug and Cosmetic Act,
Proposition 65 (the Safe Drinking Water Act of 1986), the
Federal Food Drug and Cosmetic Act, the Fiar Labeling and
Continued---
STAFF ANALYSIS OF SENATE BILL 484 (Migden) Page
8
Packaging Act, and both federal and state clean air laws.
They ensure that products are safe for consumers to use.
The opposition states that both DHS and the FDA have ample
authority to ensure that cosmetics are safe. For example,
they can ban or restrict ingredients safety reasons,
mandate warning labels, seize illegal products, enjoin
unlawful activities, prosecute violators of the law's
adulteration and misbranding provisions and publicize
health issues.
The opposition argues that there is no credible research
that has ever shown that any cosmetic or personal care
products cause cancer or reproductive activity.
Related legislation
AB 980 (Chu, 2005) provides that any cosmetic is
misbranded if sold by Internet Web site where the list of
ingredients in the cosmetic is not easily and readily
available to be viewed by the prospective purchaser
before the purchase is completed. Prohibits, on and
after January 1, 2007, a person or entity from
manufacturing, selling, or distributing in commerce any
cosmetic that contains dibutyl phthalate (DBP) or
di-(2-ethylhexyl) phthalate (DEHP). Set to heard in the
Assembly Health Committee on April 19, 2005.
SB 600 (Ortiz, 2005) establishes the Healthy Californians
Biomonitoring Program, to be administered jointly by the
Division of Environmental and Occupational Disease
Control at DHS and the OEHHA within the California
Environmental Protection Agency (CalEPA). Provides under
the Program to monitor the presence and concentration of
designated chemicals in Californians. Requires DHS and
CalEPA to establish an advisory panel to assist the
department and the agency and establishes the Healthy
Californians Biomonitoring Fund for deposit of funds for
the purposes of the Program. Passed the Senate Health
Committee on a 6-2 vote on March 29, 2005. Will be heard
in the Senate Committee on Environmental Quality on April
18.
AB 2012 (Chu, 2004) would have required, by January 1,
2006, the manufacturer of any cosmetic or personal care
Continued---
STAFF ANALYSIS OF SENATE BILL 484 (Migden) Page
9
product subject to regulation by the U.S. FDA and
manufactured, processed, or distributed in commerce in
the state to notify the OEHHA of any ingredient in its
product that is a chemical identified as causing cancer
or reproductive toxicity, as specified. Non-concurrence
on the Assembly Floor.
Comment
Because this bill requires the cosmetic manufacturers to
disclose to DHS a list of ingredients in their products
that contain chemicals that have been identified to be
carcinogenic or to cause cancer or reproductive harm, the
author may wish to define "ingredient" for the purpose of
this bill.
POSITIONS
SupportBreast Cancer Action (co-sponsor)
Breast Cancer Fund (co-sponsor)
National Environmental Trust (co-sponsor)
Asian Americans for Civil Rights and Equality
Asian Communities for Reproductive Justice
Asian Health Services
Asian Pacific Environmental Network
Association of Asian Pacific Community Health
Organizations
California Church IMPACT
California Interfaith Partnership for Children's
Health and
the Environment
California Nurses Association
California Women Lawyers
Center for Environmental Health
Center for Ethics and Toxics
Chinese for Affirmative Action/Center for Asian
American Advocacy
East Bay Asian Consortium
Ecology Action of Santa Cruz
Environmental Justice Coalition for Water
Filipinos for Affirmative Action
Learning Disabilities Association of California
Physicians for Social Responsibility, San
Francisco Bay Area Chapter
Presbyterians for Restoring Creation
Continued---
STAFF ANALYSIS OF SENATE BILL 484 (Migden) Page
10
Sierra Club California
United Food and Commercial Workers
Women's Foundation of California
OpposeAlticor, Inc.
American Chemistry Council
Bay Cities, Pico Rivera
Berje
Bertaut Beauty
BioOrganic Concepts
Body Bistro
California Grocers Association
California Retailers Association
Cosmedx Science
Cosmetic Laboratories of America
Cosmetic, Toiletry, and Fragrance Association
D. D. Chemco, Inc
Dial Corporation
Elmans Marketing
Estee Lauder Companies, Inc.
Gar Labs
Grocery Manufacturers of America
Hampton Papers
Innovative Beauty Science
International Cosmetics
Johnson & Johnson
Kalloch & Associates
LifeTech Resources
Levlad, Inc.
Continued---
Maleface Skin Care
MDPar International Corporation
Montage Cosmetic Laboratories, Inc.
Presperse
Procter & Gamble
Raffaello Research Laboratories
Rose Organic Specialty Sales, Inc.
Shaklee Corporation
Solution Marketing
TCR Industries
Thibian International, Inc.
TopCo
Tovi/SMB Enterprises
Tri-K Industries
U. G. Laboratories
Unilever
West Coast Cosmetics
Western Flavors
One individual
-- END --
Continued---