I 
111TH CONGRESS 
2D SESSION 
H. R. 5786 
To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure 
the safe use of cosmetics, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 20, 2010 
Ms. SCHAKOWSKY (for herself, Mr. MARKEY of Massachusetts, and Ms. BALD-
WIN) introduced the following bill; which was referred to the Committee 
on Energy and Commerce, and in addition to the Committee on Edu-
cation and Labor, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To amend title VI of the Federal Food, Drug, and Cosmetic 
Act to ensure the safe use of cosmetics, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safe Cosmetics Act 
of 2010’’. 
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SEC. 2. COSMETIC REGULATION. 
(a) IN GENERAL.—Chapter VI of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amend-
ed— 
(1) by inserting before section 601 the fol-
lowing: 
‘‘Subchapter A—Adulterated and Misbranded 
Cosmetics’’; 
and 
(2) by adding at the end the following: 
‘‘Subchapter B—Regulation of Cosmetics 
‘‘SEC. 611. DEFINITIONS. 
‘‘In this subchapter: 
‘‘(1) 
INGREDIENT.—The 
term 
‘ingredient’ 
means a chemical in a cosmetic, including— 
‘‘(A) chemicals that provide a technical or 
functional effect; 
‘‘(B) chemicals that have no technical or 
functional effect in the cosmetic but are present 
by reason of having been incorporated into the 
cosmetic as an ingredient of another cosmetic 
ingredient; 
‘‘(C) processing aids that are present by 
reason of having been added to a cosmetic dur-
ing the processing of such cosmetic; 
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‘‘(D) substances that are present by reason 
of having been added to a cosmetic during proc-
essing for their technical or functional effect; 
‘‘(E) contaminants present at levels above 
technically feasible detection limits; 
‘‘(F) contaminants that may leach from 
container materials or form via reactions over 
the shelf life of a cosmetic and that may be 
present at levels above technically feasible de-
tection limits; 
‘‘(G) the components of a fragrance, fla-
vor, or preservative declared individually by 
their appropriate label names; and 
‘‘(H) any individual component of a botan-
ical, petroleum-derived, animal-derived, or other 
ingredient that the Secretary determines be 
considered an ingredient. 
‘‘(2) PROFESSIONAL
USE.—The term ‘profes-
sional use’ means the use of any cosmetic— 
‘‘(A) by an employee (within the scope of 
the employment of such employee) of; or 
‘‘(B) purchased by a consumer in, 
a hair salon, nail salon, beauty salon, spa, or other 
establishment that provides cosmetic treatment serv-
ices for humans. 
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‘‘(3) REASONABLE CERTAINTY.—The term ‘rea-
sonable certainty’, when used in establishing a safety 
standard (as defined in paragraph (5)) for an ingre-
dient or cosmetic— 
‘‘(A) means that no harm will be caused by 
aggregate exposure for a member of a vulner-
able population to that ingredient or cosmetic; 
and 
‘‘(B) corresponds to the lower dose derived 
from— 
‘‘(i) data demonstrating that exposure 
to all sources of the ingredient or cosmetic 
present not more than a 1 in a million risk 
for any adverse effect in the population of 
concern, at the lower 95th percentile con-
fidence bound; or 
‘‘(ii) the amount of an ingredient or 
cosmetic shown to produce no adverse ef-
fects, incorporating an uncertainty factor 
of at least 1,000 and considering all 
sources of exposure. 
‘‘(4) REPRODUCTIVE
AND
DEVELOPMENTAL 
TOXICITY.—With respect to an ingredient or cos-
metic, the term ‘reproductive and developmental tox-
icity’ means that the ingredient or cosmetic causes 
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biologically adverse effects on the reproductive sys-
tems of female or male humans or animals, includ-
ing alterations to the female or male reproductive 
system development, the related endocrine system, 
fertility, pregnancy, pregnancy outcomes, or modi-
fications in other functions that are dependent on 
the integrity of the reproductive system. 
‘‘(5) SAFETY STANDARD.— 
‘‘(A) IN
GENERAL.—The term ‘safety 
standard’ means— 
‘‘(i) with respect to an ingredient, 
when the route of exposure is directly rel-
evant to a particular cosmetic use, a stand-
ard that— 
‘‘(I) provides a reasonable cer-
tainty that no harm will result from 
aggregate exposure to the cosmetic or 
ingredient, including impacts on vul-
nerable populations, taking into ac-
count possible harmful effects from 
low dose exposures to the cosmetic or 
ingredient or from additive effects, 
where such evidence exists; and 
‘‘(II) is requisite to protect the 
public welfare from any known or an-
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ticipated adverse effects associated 
with the cosmetic or ingredient; and 
‘‘(ii) with respect to a cosmetic, when 
the route of exposure is directly relevant to 
the use of the cosmetic, a standard that a 
cosmetic fails to meet if— 
‘‘(I) the cosmetic would fail to 
meet the standard under clause (i) if 
the cosmetic was treated in the same 
manner as an ingredient under such 
clause; or 
‘‘(II) one or more ingredients in 
the cosmetic fail to meet such stand-
ard. 
‘‘(B) DETERMINATION
OF
SAFETY.—A 
cosmetic or ingredient shall fail to meet the 
safety standard under subparagraph (A)— 
‘‘(i) unless the Secretary determines 
that there is a reasonable certainty that no 
harm will result from aggregate exposure 
to the ingredient or cosmetic, including im-
pacts on highly exposed or vulnerable pop-
ulations, taking into account, where evi-
dence exists, possible harmful effects 
from— 
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‘‘(I) low dose exposures to the 
cosmetic or ingredient; or 
‘‘(II) additive effects; or 
‘‘(ii) if the Secretary determines nec-
essary to protect the public welfare from 
any known or anticipated adverse effects 
associated with the cosmetic or ingredient. 
‘‘(6) VULNERABLE
POPULATIONS.—The term 
‘vulnerable populations’ includes pregnant women, 
infants, children, the elderly, people with com-
promised immune systems, and highly exposed popu-
lations, including workers employed by establish-
ments listed under paragraph (2) and cosmetic man-
ufacturing plants. 
‘‘SEC. 612. REGISTRATION OF ESTABLISHMENTS AND REG-
ISTRATION FEES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) DOMESTIC
ESTABLISHMENT.—The term 
‘domestic establishment’ means an establishment lo-
cated in any State that manufactures, packages, or 
distributes cosmetics. 
‘‘(2) FOREIGN ESTABLISHMENT.— 
‘‘(A) IN GENERAL.—The term ‘foreign es-
tablishment’ means an establishment that man-
ufactures, packages, or distributes cosmetics 
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that are exported to the United States without 
further processing or packaging outside the 
United States. 
‘‘(B) NOT CONSIDERED TO HAVE UNDER-
GONE FURTHER PROCESSING OR PACKAGING.— 
A cosmetic may not be considered to have un-
dergone further processing or packaging for 
purposes of subparagraph (A) solely on the 
basis that labeling was added or that any simi-
lar activity of a de minimis nature was carried 
out with respect to the cosmetic. 
‘‘(b) REGISTRATION.—The Secretary shall require 
that any establishment engaged in manufacturing, pack-
aging, or distributing cosmetics for use in the United 
States register annually with the Secretary. To be reg-
istered— 
‘‘(1) as a domestic establishment, the owner, 
operator, or agent in charge of the domestic estab-
lishment shall submit a registration to the Secretary; 
or 
‘‘(2) as a foreign establishment, the owner, op-
erator, or agent in charge of the foreign establish-
ment— 
‘‘(A) shall submit a registration to the Sec-
retary; and 
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‘‘(B) shall include with the registration the 
name of the United States agent for the foreign 
establishment. 
‘‘(c) SUBMISSION OF REGISTRATION.— 
‘‘(1) IN GENERAL.—An establishment (referred 
to in this section as the ‘registrant’) shall submit a 
registration under subsection (b) to the Secretary 
containing, with respect to any cosmetics that the 
establishment manufactures, packages, or distrib-
utes— 
‘‘(A) any information necessary to notify 
the Secretary of the name and address of each 
establishment at which, and all trade names 
under which, the registrant manufactures, 
packages, or distributes cosmetics; 
‘‘(B) a description of the establishment’s 
activities with respect to cosmetics; 
‘‘(C) the number of workers employed at 
the establishment; 
‘‘(D) the gross receipts of sales; and 
‘‘(E) the name and address of any com-
pany that supplies the establishment, if the es-
tablishment manufactures cosmetics, with any 
ingredient (including preservatives, fragrances, 
or any other chemical component of a finished 
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cosmetic product) and the name of the ingre-
dient supplied to such establishment by such 
supplier. 
‘‘(2) NOTIFICATION OF CHANGES.— 
‘‘(A) IN GENERAL.—The registrant shall 
notify the Secretary in a timely manner of 
changes to the information described in para-
graph (1). 
‘‘(B) 
DEADLINE
FOR
CERTAIN 
CHANGES.—The registrant shall notify the Sec-
retary of any change in the products, function, 
or legal status of each establishment at which 
the registrant manufactures, packages, or dis-
tributes cosmetics (including cessation of busi-
ness activities) not later than 60 days after the 
date of such change. 
‘‘(d) PROCEDURE.—Upon receipt of a completed reg-
istration submitted under subsection (b), the Secretary 
shall notify the registrant of the receipt of such registra-
tion and assign a registration number to each registered 
establishment. 
‘‘(e) LIST OF REGISTERED ESTABLISHMENTS.— 
‘‘(1) MAINTENANCE OF LIST.—The Secretary 
shall compile and maintain an up-to-date list of es-
tablishments that are registered under this section. 
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‘‘(2) REMOVAL
AND
SUSPENSION.—The Sec-
retary shall remove from the list under paragraph 
(1) the name of any establishment that fails to re-
register in accordance with this section and shall 
treat such removal as a suspension of the establish-
ment’s registration. 
‘‘(3) APPLICATION OF FOIA.— 
‘‘(A) LIST.—The list under paragraph (1) 
shall be subject to disclosure under section 552 
of title 5, United States Code. 
‘‘(B) REGISTRATION
DOCUMENTS.—Any 
registration documents submitted pursuant to 
this section shall not be subject to disclosure 
under section 552 of title 5, United States 
Code. 
‘‘(C) OTHER
INFORMATION.—Information 
derived from— 
‘‘(i) the list under paragraph (1); or 
‘‘(ii) registration documents submitted 
pursuant to this section, 
shall not be subject to disclosure under section 
552 of title 5, United States Code, except to the 
extent that such information discloses the iden-
tity or location of a specific registrant. 
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‘‘(f) FEE SCHEDULE.—A schedule of fees shall be de-
veloped by the Secretary to provide for oversight and en-
forcement of this subchapter. The fee structure shall— 
‘‘(1) be prorated based on the establishment’s 
gross receipts or sales; and 
‘‘(2) only be assessed on companies with annual 
gross receipts or sales of more than $1,000,000. 
‘‘(g) REGISTRATION CANCELLATION.—The Secretary 
may cancel the registration of any establishment under 
this section— 
‘‘(1) if the information submitted by the estab-
lishment for such registration is incomplete, inac-
curate, or out-of-date; or 
‘‘(2) if a registered establishment fails to up-
date such information promptly when there is a 
change in such information. 
‘‘SEC. 613. INGREDIENTS LABELS ON COSMETICS. 
‘‘(a) IN GENERAL.—The Secretary shall require the 
label on each package of cosmetics, including cosmetics 
distributed for retail sale and professional use, to bear a 
declaration of the name of each ingredient in such cos-
metic in descending order of predominance. The Secretary 
may allow that the declaration of an ingredient present 
as a contaminant is not required if the contaminant is 
present at levels below technically feasible detection limits. 
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‘‘(b) LABELING
OF INGREDIENTS
IN COSMETICS 
SOLD THROUGH INTERNET COMMERCE.—Subject to sub-
section (d), the Secretary shall require— 
‘‘(1) in the case of a cosmetic sold on the Web 
site of an Internet vendor, that the manufacturers 
and distributors of such cosmetic provide to such 
Internet vendor a list of the ingredients of the cos-
metic; and 
‘‘(2) each Internet vendor to display the list of 
ingredients of each cosmetic sold by such vendor on 
the Web site of the vendor. 
‘‘(c) TRADE SECRETS.—Notwithstanding any other 
provision of law, an ingredient required to be listed or la-
beled under this section shall not have protection as a 
trade secret. 
‘‘(d) DEADLINE.—Not later than one year after the 
date of the enactment of the Safe Cosmetics Act of 
2010— 
‘‘(1) all cosmetics that are available for retail 
sale shall be labeled in a manner that complies with 
the requirements under subsection (a); and 
‘‘(2) manufacturers, distributors, and Internet 
venders shall comply with the applicable require-
ments of subsection (b). 
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‘‘SEC. 614. COSMETIC AND INGREDIENT TESTING AND SAFE-
TY. 
‘‘(a) PUBLICLY AVAILABLE COSMETIC AND INGRE-
DIENT TEST DATA.— 
‘‘(1) SUBMISSION OF INFORMATION.— 
‘‘(A) INITIAL SUBMISSION.—Not later than 
1 year after the date of the enactment of the 
Safe Cosmetics Act of 2010, manufacturers and 
distributors of cosmetics and ingredients shall 
submit to the Secretary (in an electronic format 
that the Secretary shall determine) all reason-
ably available information in the possession or 
control of the manufacturer or distributor that 
has not previously been submitted to the Sec-
retary regarding the physical, chemical, and 
toxicological properties of single or multiple 
chemicals listed on the cosmetic labels under 
section 613, including— 
‘‘(i) functions and uses; 
‘‘(ii) exposure and fate information; 
‘‘(iii) tests of finished cosmetics; and 
‘‘(iv) any other information used to 
substantiate the safety of such cosmetics 
or ingredients. 
‘‘(B) NEW OR UPDATED INFORMATION.— 
Not later than 60 days after the date on which 
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new or updated information that is required 
under subparagraph (A) becomes available to a 
manufacturer or distributer, such manufacturer 
or distributor shall submit such information to 
the Secretary in the same form and manner as 
information submitted under subparagraph (A). 
‘‘(2) AVAILABILITY
OF
INFORMATION.—The 
Secretary shall require that any manufacturer, dis-
tributor, or marketer of a cosmetic or ingredient (in-
cluding a fragrance or preservative) make available 
to any entity purchasing the cosmetic or ingredient 
(excluding an individual who is a consumer and who 
is purchasing the cosmetic or ingredient for personal 
use) all available information in the possession or 
control of the manufacturer, distributor, or marketer 
described in paragraph (1), within 90 days of receipt 
of the request from such entity. 
‘‘(3) DATABASE.— 
‘‘(A) INITIAL
PUBLICATION.—Not later 
than 12 months after the date of the enactment 
of the Safe Cosmetics Act of 2010, the Sec-
retary shall publish a comprehensive, publicly 
accessible database containing all non-confiden-
tial information submitted under paragraph (1). 
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‘‘(B) UPDATES.—Not later than 90 days 
after the Secretary receives new or updated in-
formation under paragraph (1)(B), the Sec-
retary shall update the database described in 
subparagraph (A) with such information. 
‘‘(b) LISTS OF INGREDIENTS.— 
‘‘(1) PROHIBITED AND RESTRICTED INGREDI-
ENTS.— 
‘‘(A) LIST
OF
INGREDIENTS
THAT
ARE 
PROHIBITED OR RESTRICTED.—Not later than 
2 years after the date of the enactment of the 
Safe Cosmetics Act of 2010, the Secretary shall 
issue, by regulation, a list of ingredients that 
are identified by the Secretary as— 
‘‘(i) prohibited ingredients; or 
‘‘(ii) restricted ingredients. 
‘‘(B) UPDATES.—The Secretary shall con-
tinually update the list under subparagraph 
(A), including when— 
‘‘(i) determinations under paragraph 
(3)(D) are made; or 
‘‘(ii) new information becomes avail-
able demonstrating that an ingredient fails 
to meet the safety standard. 
‘‘(C) INFORMATION SOURCES.— 
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‘‘(i) USE OF AUTHORITATIVE INFOR-
MATION.—The list under subparagraph 
(A) shall contain ingredients that are 
known to be carcinogenic, mutagenic, or 
have reproductive and developmental tox-
icity, based on information from the Envi-
ronmental Protection Agency, the Inter-
national Agency for Research on Cancer, 
the National Toxicity Program through the 
National Institutes of Health, the Cali-
fornia Environmental Protection Agency, 
and other authoritative international, Fed-
eral, and State entities (as determined by 
the Secretary). 
‘‘(ii) USE
OF
OTHER
INFORMATION 
SOURCES.—In identifying ingredients for 
purposes of the list under subparagraph 
(A), the Secretary shall use all reasonably 
available information, including new sci-
entific information and submissions from 
manufacturers and distributors of cos-
metics. 
‘‘(D) PROHIBITED
INGREDIENTS.—Ingre-
dients that are listed as prohibited under sub-
paragraph (A) shall include all ingredients that 
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the Secretary determines are unsafe for use in 
cosmetics in any amount because such ingredi-
ents fail to meet the safety standard defined in 
section 611(5). 
‘‘(E) RESTRICTED
INGREDIENTS.—Ingre-
dients that are listed as restricted under sub-
paragraph (A) shall include all ingredients for 
which the Secretary determines that limits on 
use or concentration are necessary to satisfy the 
safety standard defined in section 611(5). 
‘‘(F) 
INGREDIENTS
AND
COSMETICS 
FOUND TO INDUCE CANCER OR BIRTH DEFECTS 
OR HAVE REPRODUCTIVE OR DEVELOPMENTAL 
TOXICITY.— 
‘‘(i) PRESUMPTION.—The Secretary 
shall presume that any ingredient or cos-
metic that induces cancer or birth defects 
or has reproductive or developmental tox-
icity when ingested by, inhaled by, or 
dermally applied to a human or an animal 
has failed to meet the safety standard (as 
defined in section 611(5)). 
‘‘(ii) REBUTTAL.—The presumption 
under clause (i) may be rebutted only if 
the Secretary determines that the ingre-
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dient or cosmetic meets such safety stand-
ard. 
‘‘(iii) PUBLIC
COMMENT.—The Sec-
retary shall solicit public comment before 
making a determination under clause (ii). 
‘‘(2) SAFE WITHOUT LIMITS.— 
‘‘(A) IN GENERAL.—Not later than 2 years 
after the date of the enactment of the Safe Cos-
metics Act of 2010, the Secretary shall issue, 
by regulation, a list of ingredients that the Sec-
retary has determined are safe without limits 
for use in cosmetics. 
‘‘(B) 
STANDARD
FOR
INCLUSION
IN 
LIST.—The Secretary may only include an in-
gredient on the list under subparagraph (A) if 
the Secretary determines that such ingredient 
meets the safety standard (as defined in section 
611(5)) regardless of— 
‘‘(i) the type and form of cosmetic the 
ingredient is used in; or 
‘‘(ii) the concentration of the ingre-
dient that is used in a cosmetic. 
‘‘(C) UPDATE.—The Secretary shall up-
date the list under subparagraph (A) when new 
information becomes available. 
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‘‘(D) CONSULTATIONS.—In determining 
whether a cosmetic or ingredient is safe, the 
Secretary shall consult hazard listings and as-
sessments 
from 
authoritative 
international, 
Federal, and State entities, including the enti-
ties listed in paragraph (1)(C)(i). 
‘‘(E) REDETERMINATIONS.—The Secretary 
may redetermine whether a cosmetic or ingre-
dient distributed in commerce meets the safety 
standard if, in the judgment of the Secretary, 
new information raises a credible question as to 
whether the cosmetic or ingredient continues to 
meet the safety standard. 
‘‘(3) PRIORITY ASSESSMENT LIST.— 
‘‘(A) IN
GENERAL.—Not later than 18 
months after the date of the enactment of the 
Safe Cosmetics Act of 2010, the Secretary shall 
develop a priority assessment list of not less 
than 300 ingredients— 
‘‘(i) which cannot be included on the 
restricted and prohibited list under para-
graph (1) or the safe without limits list 
under paragraph (2) because of a lack of 
authoritative information on the safety of 
the ingredient; and 
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‘‘(ii) for which safety determinations 
under subparagraph (D) shall be made. 
‘‘(B) 
ADDITIONAL
INGREDIENTS.—The 
Secretary shall add not less than 100 ingredi-
ents to the priority assessment list under sub-
paragraph (A) annually until all ingredients 
that are used in the formulation or manufac-
ture of cosmetics have been added to the pri-
ority assessment list, the safe without limits 
list, or the prohibited and restricted list. 
‘‘(C) CONSIDERATIONS.—In developing or 
updating the priority assessment list under this 
paragraph, the Secretary shall take into ac-
count all relevant data with respect to ingredi-
ents including whether the ingredients— 
‘‘(i) react to form harmful byproducts; 
‘‘(ii) are found to be present in the 
body through biomonitoring; 
‘‘(iii) are found in drinking water or 
indoor or outdoor air; 
‘‘(iv) are a known or suspected neuro-
logical or immunological toxicant, res-
piratory 
asthmagens, 
or 
endocrine 
disruptor, or have other toxicological con-
cerns; or 
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‘‘(v) persist in the environment or bio-
accumulate. 
‘‘(D) DETERMINATION
OF
WHETHER
IN-
GREDIENT MEETS SAFETY STANDARD.— 
‘‘(i) IN GENERAL.—Not later than 24 
months after the date on which an ingre-
dient is placed on the priority assessment 
list under subparagraph (A), the Secretary 
shall issue, by rule, a determination of— 
‘‘(I) whether the ingredient meets 
the safety standard (as defined in sec-
tion 611(5)) and can be placed on the 
safe without limits list under para-
graph (2); or 
‘‘(II) whether to include the in-
gredient in the prohibited and re-
stricted ingredients list under para-
graph (1), to ensure that the safety 
standard is not violated. 
‘‘(ii) RULEMAKING.—Before issuing 
final regulations under clause (ii), the Sec-
retary shall issue a notice of proposed rule-
making and provide a period of not less 
than 60 days for public comment on the 
proposed regulation, except that a shorter 
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period for comment may be provided if the 
Secretary— 
‘‘(I) finds that it would be in the 
public interest to have a shorter pe-
riod; and 
‘‘(II) states the reasons for such 
finding in the notice of proposed rule-
making. 
‘‘(c) MANUFACTURER INFORMATION
AND SAFETY 
TESTING.— 
‘‘(1) PROVISION OF INFORMATION.—A manu-
facturer of an ingredient or cosmetic shall provide to 
the Secretary, through a statement under paragraph 
(3), all information required to determine if an in-
gredient or cosmetic meets the safety standard. 
‘‘(2) MINIMUM DATA REQUIREMENTS AND TEST 
PROTOCOLS.—Not later than 1 year after the date 
of the enactment of the Safe Cosmetics Act of 2010, 
the Secretary shall establish minimum data require-
ments and test protocols to be used by manufactur-
ers to assess the safety of cosmetic ingredients that 
would ensure that statements under paragraph 
(3)(A) regarding compliance with the safety stand-
ard are based on sufficient and reliable data. 
‘‘(3) STATEMENTS.— 
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‘‘(1) monitor developments in the scientific un-
derstanding of any adverse health effects related to 
the use of nanotechnology in the formulation of cos-
metics; and 
‘‘(2) consider scale specific hazard properties of 
ingredients when conducting or reviewing safety sub-
stantiation of cosmetic ingredients. 
‘‘(e) PRODUCT TESTING AND REVIEW AUDIT.—The 
Secretary shall conduct annual audits of random samples 
of cosmetic products to assess or test for acute negative 
reactions, pathogen hazards, contaminants, or leaching of 
packaging additives, mislabeling, or other relevant issues 
of concern (as determined by the Secretary). 
‘‘SEC. 615. MARKET RESTRICTIONS. 
‘‘(a) FAILURE TO PROVIDE DATA OR MEET SAFETY 
STANDARD.—No person shall manufacture, import, dis-
tribute, or market in commerce a cosmetic or an ingre-
dient for use in a cosmetic if the Secretary determines 
that— 
‘‘(1) the person failed to provide information to 
the Secretary as required under this subchapter; or 
‘‘(2) beginning 180 days after the date on 
which the Secretary places an ingredient on a list 
under section 614(b)(1)— 
‘‘(A) the ingredient— 
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‘‘(i) is on the list under section 
614(b)(1)(A)(i); or 
‘‘(ii) is a cosmetic containing an in-
gredient on such list; 
‘‘(B) the ingredient is on the list under 
section 614(b)(1)(A)(ii) and is being used in a 
cosmetic in a manner that violates the limit on 
use or concentration of such ingredient under 
section 614(b)(1)(E). 
‘‘(b) FAILURE OF SECRETARY TO ACT.— 
‘‘(1) ISSUANCE OF PENDING NOTIFICATION.—If 
the Secretary fails to act by an applicable deadline 
under section 614, a manufacturer or marketer of 
an ingredient affected by the failure to act shall 
issue to the Secretary, the public, and each known 
customer of the ingredient a written notice that a 
determination by the Secretary of the safety of the 
ingredient for use in cosmetics is pending. 
‘‘(2) PROHIBITED USE.—If, by the last day of 
the 5 year period beginning on the date on which an 
ingredient is placed on the priority assessment list 
under section 614(b)(3), the Secretary has not made 
a determination under such section concerning 
whether such ingredient meets the safety standard, 
the ingredient may not be— 
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‘‘(A) used in cosmetics; or 
‘‘(B) manufactured, imported, distributed, 
or marketed for use in cosmetics. 
‘‘SEC. 616. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED COS-
METICS. 
‘‘(a) NOTIFICATION, NONDISTRIBUTION, AND RE-
CALL OF ADULTERATED OR MISBRANDED COSMETICS.— 
‘‘(1) IN GENERAL.—A responsible party that 
has reason to believe that a cosmetic, when intro-
duced into or while in interstate commerce, or while 
held for sale (regardless of whether such sale is the 
first sale of such cosmetic) after shipment in inter-
state commerce, is adulterated or misbranded in a 
manner that presents a reasonable probability that 
the use or exposure to the cosmetic (or an ingredient 
or component used in any such cosmetic) will cause 
a threat of serious adverse health consequences or 
death to humans shall, as soon as practicable, notify 
the Secretary of the identity and location of the cos-
metic. 
‘‘(2) MANNER OF NOTIFICATION.—Notification 
under paragraph (1) shall be made in such manner 
and by such means as the Secretary may require by 
regulation or guidance. 
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‘‘(3) RESPONSIBLE PARTY DEFINED.—For pur-
poses of this subsection, the term ‘responsible party’ 
means a manufacturer, packager, retailer, or dis-
tributor of the cosmetic. 
‘‘(b) VOLUNTARY RECALL.—The Secretary may re-
quest that any person who distributes a cosmetic that the 
Secretary has reason to believe is adulterated, misbranded, 
or otherwise in violation of this Act voluntarily— 
‘‘(1) recall such cosmetic; and 
‘‘(2) provide for notice, including to individuals 
as appropriate, to persons who may be affected by 
the recall. 
‘‘(c) ORDER TO CEASE DISTRIBUTION.— 
‘‘(1) IN GENERAL.—If the Secretary has reason 
to believe that— 
‘‘(A) the use of, or exposure to, a cosmetic 
may cause serious adverse health consequences 
or death to humans; 
‘‘(B) the cosmetic is misbranded; or 
‘‘(C) the cosmetic is manufactured, pack-
aged, or distributed by an unregistered facility; 
the Secretary shall have the authority to issue an 
order requiring any person who distributes such cos-
metic to immediately cease distribution of such cos-
metic. 
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‘‘(2) ACTION FOLLOWING ORDER.—Any person 
who is subject to an order under paragraph (1) shall 
immediately cease distribution of such cosmetic and 
provide notification as required by such order, and 
may appeal such order to the Secretary within 24 
hours of the issuance of such order. Such appeal 
may include a request for an informal hearing and 
a description of any efforts to recall such cosmetic 
undertaken voluntarily by the person, including after 
a request under subsection (b). Except as provided 
in subsection (e), an informal hearing shall be held 
as soon as practicable, but not later than 5 calendar 
days, or less as determined by the Secretary, after 
such an appeal is filed, unless the parties jointly 
agree to an extension. After affording an oppor-
tunity for an informal hearing, the Secretary shall 
determine whether the order should be amended to 
require a recall of such cosmetic. If, after providing 
an opportunity for such a hearing, the Secretary de-
termines that inadequate grounds exist to support 
the actions required by the order, the Secretary shall 
vacate the order. 
‘‘(d) ORDER TO RECALL.— 
‘‘(1) AMENDMENT.—Except as provided under 
subsection (e), if after providing an opportunity for 
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an informal hearing under subsection (c)(2), the 
Secretary determines that the order should be 
amended to include a recall of the cosmetic with re-
spect to which the order was issued, the Secretary 
shall amend the order to require a recall. 
‘‘(2) CONTENTS.—An amended order under 
paragraph (1) shall— 
‘‘(A) specify a timetable in which the recall 
will occur; 
‘‘(B) require periodic reports to the Sec-
retary describing the progress of the recall; and 
‘‘(C) provide for notice, including to indi-
viduals as appropriate, to persons who may be 
affected by the recall. 
In providing for such notice, the Secretary may 
allow for the assistance of health professionals, State 
or local officials, or other individuals designated by 
the Secretary. 
‘‘(3) NONDELEGATION.—An amended order 
under this subsection shall be ordered by the Sec-
retary or an official designated by the Secretary. An 
official may not be so designated unless the official 
is the director of the district under this Act in which 
the cosmetic involved is located, or is an official sen-
ior to such director. 
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‘‘(e) EMERGENCY RECALL ORDER.— 
‘‘(1) IN GENERAL.—If the Secretary has cred-
ible evidence or information that a cosmetic subject 
to an order under subsection (c) presents an immi-
nent threat of serious adverse health consequences 
or death to humans, the Secretary may issue an 
order requiring any person who distributes such cos-
metic— 
‘‘(A) to immediately recall such cosmetic; 
and 
‘‘(B) to provide for notice, including to in-
dividuals as appropriate, to persons who may be 
affected by the recall. 
‘‘(2) ACTION FOLLOWING ORDER.—Any person 
who is subject to an emergency recall order under 
this subsection shall immediately recall such cos-
metic and provide notification as required by such 
order, and may appeal within 24 hours after 
issuance such order to the Secretary. An informal 
hearing shall be held as soon as practicable but not 
later than 5 calendar days, or less as determined by 
the Secretary, after such an appeal is filed, unless 
the parties jointly agree to an extension. After af-
fording an opportunity for an informal hearing, the 
Secretary shall determine whether the order should 
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be amended pursuant to subsection (d)(1). If, after 
providing an opportunity for such a hearing, the 
Secretary determines that inadequate grounds exist 
to support the actions required by the order, the 
Secretary shall vacate the order. 
‘‘(3) NONDELEGATION.—An order under this 
subsection shall be issued by the Commissioner of 
Food and Drugs, the Principal Deputy Commis-
sioner, or the Associate Commissioner for Regu-
latory Affairs of the Food and Drug Administration. 
‘‘(f) NOTICE TO CONSUMERS AND HEALTH OFFI-
CIALS.—The Secretary shall, as the Secretary determines 
to be necessary, provide notice of a recall order under this 
section to consumers to whom the cosmetic was, or may 
have been, distributed and to appropriate State and local 
health officials. 
‘‘(g) SAVINGS CLAUSE.—Nothing contained in this 
section shall be construed as limiting the authority of the 
Secretary to issue an order to cease distribution of, or to 
recall, a cosmetic under any other provision of this Act. 
‘‘SEC. 617. PETITIONS. 
‘‘(a) IN GENERAL.—The Secretary shall complete 
and publish a review, and, if appropriate, immediately re-
vise related, relevant information, including ingredient 
lists, ingredient restrictions or prohibitions, or ingredient 
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or cosmetic safety determinations, not later than 180 days 
after the date on which the Secretary receives from any 
individual or entity a reasonable petition— 
‘‘(1) to prohibit or restrict an ingredient for use 
in cosmetics and list such ingredient on the list 
under section 614(b)(1); 
‘‘(2) to remove an ingredient from the list of in-
gredients that are safe without limits under section 
614(b)(2); or 
‘‘(3) to add an ingredient to the priority assess-
ment list under section 614(b)(3). 
‘‘(b) REASONABLE PETITION.—Not later than one 
year after the date of the enactment of this Act, the Sec-
retary shall issue rules specifying the criteria which the 
Secretary will use to determine if a petition submitted 
under this section is a reasonable petition. 
‘‘SEC. 618. COSMETIC AND INGREDIENT STATEMENTS. 
‘‘(a) IN GENERAL.—Each establishment engaged in 
the manufacture of a cosmetic intended to be marketed 
in the United States shall submit electronically to the Sec-
retary for each cosmetic manufactured in the establish-
ment that is intended to be marketed in the United States 
a statement containing— 
‘‘(1) the registration number of the manufac-
turing establishment where the cosmetic is manufac-
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tured or, if the same cosmetic is manufactured in 
more than 1 establishment, the registration number 
of each establishment where it is manufactured; 
‘‘(2) the registration number of the establish-
ment responsible for distributing the cosmetic; 
‘‘(3) the brand name and the product name for 
the cosmetic; 
‘‘(4) the applicable use for the cosmetic; 
‘‘(5) the ingredient list as it appears on the cos-
metic label or insert, including the particle size of 
any nanoscale cosmetic ingredients; 
‘‘(6) any warnings and directions for use from 
the cosmetic label or insert; and 
‘‘(7) the title and full contact information for 
the individual responsible for submitting and main-
taining such statement. 
‘‘(b) NOTIFICATION OF CHANGES.—The establish-
ment shall notify the Secretary in a timely manner of any 
change to the information required under subsection (a). 
‘‘(c) PROCEDURE.—Upon receipt of a completed 
statement described under subsection (a), the Secretary 
shall notify the establishment of the receipt of such state-
ment and assign a cosmetic statement number. 
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‘‘(d) LIST.—The Secretary shall compile and main-
tain an up-to-date list of cosmetics for which statements 
are submitted under this section. 
‘‘(e) LABELING
OF
NANOMATERIALS
IN
COS-
METICS.—The Secretary may require that— 
‘‘(1) minerals and other particulate ingredients 
be labeled as ‘nano-scale’ on a cosmetic ingredient 
label or list if not less than 1 dimension is 100 
nanometers or smaller for not less than 1 percent of 
the ingredient particles in the cosmetic; and 
‘‘(2) other ingredients in a cosmetic be des-
ignated with scale-specific information on a cosmetic 
ingredient label or list if such ingredients possess 
scale-specific hazard properties. 
‘‘(f) ACCESS TO SAFETY INFORMATION.—The cos-
metic and ingredient statements collected under this sec-
tion shall be added to the publicly accessible database cre-
ated by the Secretary under section 614(a)(3). 
‘‘(g) EFFECTIVE DATES.— 
‘‘(1) IN GENERAL.—The provisions of this sec-
tion shall take effect 1 year after the date of the en-
actment of the Safe Cosmetics Act of 2010. 
‘‘(2) APPLICATION
TO
NEW
COSMETICS.—An 
establishment that begins to manufacture a cosmetic 
after the date of the enactment of the Safe Cos-
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metics Act of 2010 shall comply with the require-
ments of subsections (a) and (b) not later than 6 
months after beginning to manufacture such cos-
metic. 
‘‘SEC. 619. MANDATORY REPORTING OF ADVERSE HEALTH 
EFFECTS. 
‘‘(a) SUBMISSION OF REPORT ON ADVERSE HEALTH 
EFFECTS.—The Secretary shall require that the manufac-
turer, packager, or distributer of a cosmetic whose name 
appears on the label of a cosmetic marketed in the United 
States submit to the Secretary a report containing infor-
mation received concerning any serious adverse event asso-
ciated with the use of the cosmetic. 
‘‘(b) TIMING OF REPORT.—A report under subsection 
(a) shall be submitted to the Secretary not later than 15 
business days after information concerning the adverse 
event is received at the place of business of the manufac-
turer, packager, or distributer. 
‘‘(c) CONTENT OF REPORT.—A report under sub-
section (a) shall include the following information to the 
extent to which the manufacturer, packager, or distributer 
submitting the report has been able to verify the informa-
tion: 
‘‘(1) An identifiable patient. 
‘‘(2) An identifiable report. 
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‘‘(3) A suspect cosmetic. 
‘‘(4) A serious and unexpected adverse event. 
‘‘(d) PUBLIC AVAILABILITY AND PRIVACY.— 
‘‘(1) PUBLIC AVAILABILITY.—Subject to para-
graph (2), the adverse health effects reports col-
lected by the Secretary under this section shall be 
submitted electronically and shall be made accessible 
to the public. 
‘‘(2) PRIVACY.— 
‘‘(A) PERSONALLY IDENTIFIABLE INFOR-
MATION.—Notwithstanding any other provision 
of law, personally identifiable information in ad-
verse event reports provided to the Secretary 
under this section, shall not— 
‘‘(i) be made publicly available pursu-
ant to any State or other law requiring dis-
closure of information or records; or 
‘‘(ii) otherwise be disclosed or distrib-
uted to any party without the written con-
sent of the Secretary and the person sub-
mitting such information to the Secretary. 
‘‘(B) 
TREATMENT
OF
INFORMATION 
UNDER PRIVACY ACT AND FOIA.—An adverse 
event report submitted to the Secretary under 
this section, shall be considered to be a record 
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about an individual under section 552a of title 
5, United States Code (commonly referred to as 
the ‘‘Privacy Act of 1974’’) and a medical or 
similar file the disclosure of which would con-
stitute a violation of section 552 of such title 5 
(commonly referred to as the ‘‘Freedom of In-
formation Act’’), and shall not be publicly dis-
closed unless all personally identifiable informa-
tion is redacted. 
‘‘SEC. 620. NONCONFIDENTIAL INFORMATION. 
‘‘(a) IN GENERAL.—Subject to subsection (b) and 
section 619(d)(2), all nonconfidential information sub-
mitted pursuant to this subchapter shall be made available 
to the public. The name, identity, and structure of a chem-
ical substance, contaminant, or impurity that is an ingre-
dient and all information concerning function, exposure, 
health hazards, and environmental hazards, and the func-
tions of ingredients in cosmetics shall not be considered 
to be confidential business information under this sub-
chapter. Fragrance, flavor, and colorants shall not be con-
sidered confidential business information under this sub-
chapter. The concentration of cosmetic ingredients used 
in a finished cosmetic shall be considered confidential busi-
ness information except as otherwise required in section 
613. 
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‘‘(b) PETITION FOR INFORMATION TO REMAIN CON-
FIDENTIAL.— 
‘‘(1) IN GENERAL.—The Secretary shall create 
a process for an entity to petition for nonconfidential 
information described in subsection (a) to remain 
confidential if the entity shows that there would be 
serious commercial harm to such entity if such infor-
mation were disclosed publicly. 
‘‘(2) LIMITATION.—The Secretary may not ap-
prove a petition under paragraph (1) to the extent 
that such petition would prevent the public disclo-
sure of— 
‘‘(A) the name, identity, and structure of 
any substance referred to in subsection (a); 
‘‘(B) all health and safety data related to 
that substance; or 
‘‘(C) any data used to substantiate the 
safety of that substance. 
‘‘SEC. 621. SAVINGS CLAUSE. 
‘‘Nothing in this subchapter shall affect the right of 
a State, political subdivision of a State, or tribe to adopt 
or enforce any regulation, requirement, liability, or stand-
ard of performance that is more stringent than a regula-
tion, requirement, liability, or standard of performance es-
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tablished by this subchapter, including requiring the provi-
sion of a warning of risk, illness, or injury. 
‘‘SEC. 622. ANIMAL TESTING ALTERNATIVES. 
‘‘(a) IN GENERAL.—To minimize the use of animal 
testing of ingredients, the Secretary shall— 
‘‘(1) require, where practicable, alternative test-
ing methods that— 
‘‘(A) do not involve the use of an animal 
to test the chemical substance; 
‘‘(B) provide information that is equivalent 
or superior in scientific quality to the animal 
testing method; and 
‘‘(C) use fewer animals than conventional 
animal-based tests when non-animal methods 
are impracticable, including the use of tests 
that combine multiple endpoints; and 
‘‘(2) encourage, where practicable— 
‘‘(A) estimation of toxicological properties 
of a chemical through the use of testing infor-
mation for 1 or more structurally similar chemi-
cals where such estimates provide information 
of sufficient scientific quality; 
‘‘(B) the formation of industry consortia to 
conduct testing to avoid duplication of tests; 
and 
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‘‘(C) funding for research and validation of 
alternative test methods, in accordance with 
this subsection. 
‘‘(b) LIST OF ALTERNATIVE TESTING METHODS.— 
Not later than 1 year after the date of the enactment of 
the Safe Cosmetics Act of 2010, and triennially thereafter, 
the Secretary shall publish a list of the alternative testing 
methods described in subsection (a). 
‘‘SEC. 623. INTERAGENCY COOPERATION AND FUNDING. 
‘‘There is established an Interagency Council on Cos-
metic Safety for the purpose of sharing data and pro-
moting collaboration on cosmetic safety among and be-
tween the Food and Drug Administration, the National 
Institute of Environmental Health Sciences, the Centers 
for Disease Control and Prevention, the Occupational 
Safety and Health Administration, and the Environmental 
Protection Agency. 
‘‘SEC. 624. AUTHORIZATION OF APPROPRIATIONS. 
‘‘There are authorized to be appropriated such sums 
as may be necessary to carry out this subchapter for each 
of the fiscal years 2011 through 2015.’’. 
(b) ADULTERATED AND MISBRANDED COSMETICS.— 
(1) ADULTERATED COSMETICS.—Section 601 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 361) is amended— 
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‘‘(7) is manufactured in a manner that fails to 
comply with good manufacturing practices for cos-
metics, as determined (and periodically updated), by 
the Secretary; or 
‘‘(8) is manufactured by a manufacturer who 
fails to submit the statement required under section 
618 or notify the Secretary of changes to informa-
tion contained in such statement as required by such 
section.’’. 
(2) MISBRANDED COSMETICS.—Section 602 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 362) is amended in subsection (a), by insert-
ing ‘‘, fails to meet the requirements of section 
613(a), or fails to meet any requirements under sec-
tion 618(e)’’ before the period. 
SEC. 3. WORKER ISSUES. 
(a) IN GENERAL.—The Secretary of Labor shall pro-
mulgate an occupational safety and health standard under 
section 6 of the Occupational Safety and Health Act of 
1970 (29 U.S.C. 655) that requires the following: 
(1) MANUFACTURERS AND IMPORTERS.— 
(A) IN GENERAL.—Each manufacturer or 
importer selling any cosmetic for professional 
use shall— 
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(i) obtain or develop an expanded ma-
terial safety data sheet described in sub-
section (b) for each such cosmetic or per-
sonal care product that— 
(I) the manufacturer or importer 
produces or imports; and 
(II) includes a hazardous chem-
ical, or product ingredient associated 
with any chemical hazard, that has 
been indicated by authoritative bodies 
or scientific studies to be linked to 
health hazards including mutation, re-
productive or developmental toxicity, 
neurotoxicity, endocrine disruption, 
asthma, or other immunological tox-
icity; and 
(ii) make the expanded material safety 
data sheet available to distributors and 
employers, including salon owners, in 
English and, upon request, in other lan-
guages, including Spanish and Vietnamese. 
(B) PROFESSIONAL
USE
DEFINED.—In 
this paragraph, the term ‘‘professional use’’ has 
the meaning given such term in section 611 of 
the Federal Food, Drug, and Cosmetic Act. 
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(2) DISTRIBUTORS.—Each distributor of a cos-
metic or personal care product for professional use 
shall distribute and provide expanded material safety 
data sheets described in subsection (b) in the same 
manner as a distributor of a chemical hazard is re-
quired to distribute and provide material safety data 
sheets under section 1910.1200(g) of title 29, Code 
of Federal Regulations, or any successor regulations. 
(3) EMPLOYERS.—Each employer, including 
any operator of a salon, shall— 
(A) have an expanded material safety data 
sheet in the workplace for each cosmetic or per-
sonal care product for professional use that is 
used in the course of the employer’s business; 
(B) make such expanded material safety 
data sheet available to all employees of the em-
ployer who are exposed or use the product to 
the same extent and in the same manner as 
material safety data sheets are required to be 
made available under section 1910.1200(g) of 
title 29, Code of Federal Regulations, or any 
successor regulations; and 
(C) upon request, provide employees with 
translations of such expanded material safety 
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data sheet in other languages, including Span-
ish and Vietnamese. 
(b) CONTENTS OF EXPANDED MATERIAL SAFETY 
DATA SHEET.—An expanded material safety data sheet 
for a cosmetic or personal care product for professional 
use described in this section shall— 
(1) contain the information required in a mate-
rial safety data sheet under section 1910.1200(g) of 
title 29, Code of Federal Regulations, or any suc-
cessor regulations, for each hazardous chemical, or 
product ingredient associated with any chemical haz-
ard, described in subsection (a)(1)(A)(i)(II); and 
(2) include the following statement: ‘‘This ex-
panded material safety data sheet is also available in 
multiple languages by contacting the manufacturer, 
using the contact information provided on this 
sheet.’’. 
SEC. 4. FDA SAFETY STANDARD AS IT RELATES TO OTHER 
ADMINISTRATIVE AGENCIES. 
(a) USE OF DATA FROM FEDERAL SOURCES.—The 
Secretary shall request and utilize ingredient toxicity, use, 
and exposure data from other Federal agencies as appro-
priate, to assist with developing the priority assessment 
list under section 614(b)(3) of the Federal Food, Drug, 
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and Cosmetic Act, and for reaching safety determinations 
under section 614(b)(3)(E) of such Act. 
(b) USE OF OTHER FEDERAL STANDARDS.—If any 
Federal agency has promulgated a standard for an ingre-
dient that satisfies the safety standard under section 611 
of the Federal Food, Drug, and Cosmetic Act, the Sec-
retary may adopt it for purposes of this Act or an amend-
ment made by this Act. 
Æ 
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