I 
112TH CONGRESS 
1ST SESSION H. R. 2359 
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 
JUNE 24, 2011 
Ms. SCHAKOWSKY (for herself, Mr. MARKEY, Ms. BALDWIN, Mr. MORAN, Ms. 
WOOLSEY, Mr. BLUMENAUER, Ms. CHU, Mr. GUTIERREZ, Ms. LEE of 
California, Mr. FRANK
of Massachusetts, and Ms. WASSERMAN 
SCHULTZ) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
Education and the Workforce, 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; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Safe Cosmetics Act of 2011’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
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Sec. 1. Short title; table of contents. 
Sec. 2. Cosmetic regulation. 
‘‘SUBCHAPTER A—ADULTERATED AND MISBRANDED COSMETICS 
‘‘SUBCHAPTER B—REGULATION OF COSMETICS 
‘‘Sec. 611. Definitions. 
‘‘Sec. 612. Registration of establishments and registration fees. 
‘‘Sec. 613. Ingredients labels on cosmetics. 
‘‘Sec. 614. Safety standard and good manufacturing practices. 
‘‘Sec. 615. Cosmetic and ingredient safety information. 
‘‘Sec. 616. Lists of ingredients and required responses. 
‘‘Sec. 617. Treatment of cosmetics based on ingredient lists. 
‘‘Sec. 618. Treatment of contaminants. 
‘‘Sec. 619. Cosmetic and ingredient statements. 
‘‘Sec. 620. Notification, nondistribution, and recall of adulterated or mis-
branded cosmetics. 
‘‘Sec. 621. Petitions. 
‘‘Sec. 622. Mandatory reporting of adverse health effects. 
‘‘Sec. 623. Nonconfidential information. 
‘‘Sec. 624. Animal testing alternatives. 
‘‘Sec. 625. Product Testing and Review Audit. 
‘‘Sec. 626. Resources for small businesses. 
‘‘Sec. 627. Interagency cooperation. 
‘‘Sec. 628. Savings clause. 
‘‘Sec. 629. Authorization of appropriations. 
Sec. 3. Worker issues. 
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: 
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‘‘Subchapter B—Regulation of Cosmetics 
‘‘SEC. 611. DEFINITIONS. 
‘‘In this subchapter: 
‘‘(1) DOMESTIC
ESTABLISHMENT.—The term 
‘domestic establishment’ means an establishment lo-
cated in any State that manufactures or packages 
cosmetics. 
‘‘(2) FOREIGN
ESTABLISHMENT.—The term 
‘foreign establishment’ means an establishment that 
manufactures or packages cosmetics that are ex-
ported to the United States. 
‘‘(3) MANUFACTURER.—The term ‘manufac-
turer’ only includes manufacturers that determine 
the final formulation of a cosmetic. 
‘‘(4) INGREDIENT.— 
‘‘(A) IN GENERAL.—The term ‘ingredient’ 
means a chemical in a cosmetic, including— 
‘‘(i) chemicals that provide a technical 
or functional effect; 
‘‘(ii) chemicals that have no technical 
or functional effect in the cosmetic but are 
present by reason of having been incor-
porated into the cosmetic as an ingredient 
of another cosmetic ingredient; 
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‘‘(iii) processing aids that are present 
by reason of having been added to a cos-
metic during the processing of such cos-
metic; 
‘‘(iv) substances that are present by 
reason of having been added to a cosmetic 
during processing for their technical or 
functional effect; 
‘‘(v) the components of a fragrance, 
flavor, or preservative; and 
‘‘(vi) any individual component of a 
petroleum-derived, animal-derived, or other 
ingredient that the Secretary deems an in-
gredient for purposes of this chapter. 
‘‘(B) TREATMENT
OF
CONTAMINANTS.— 
For purposes of sections 614 through 617, the 
term ‘ingredient’ also includes— 
‘‘(i) contaminants present at levels 
above technically feasible detection limits; 
and 
‘‘(ii) contaminants that may leach 
from container materials or form via reac-
tions over the shelf life of a cosmetic and 
that may be present at levels above tech-
nically feasible detection limits. 
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‘‘(5) MICROBUSINESS.—The term ‘microbusi-
ness’ means a business— 
‘‘(A) that is engaged in the manufacturing 
or packaging of cosmetics; and 
‘‘(B) that has annual sales receipts for cos-
metic products that do not exceed $2,000,000. 
‘‘(6) 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. 
‘‘(7) REASONABLE CERTAINTY OF NO HARM.— 
With respect to an ingredient or cosmetic, the term 
‘reasonable certainty of no harm’ means that no 
harm will be caused to members of the general popu-
lation or any vulnerable population by aggregate ex-
posure to the cosmetic or ingredient, taking into ac-
count possible harmful effects from— 
‘‘(A) low-dose exposures to the cosmetic or 
ingredient; or 
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‘‘(B) additive effects resulting from re-
peated exposure to the cosmetic or ingredient 
over time; or 
‘‘(C) cumulative exposure resulting from 
all sources, including both the cosmetic or in-
gredient and environmental sources. 
‘‘(8) REPRODUCTIVE OR DEVELOPMENTAL TOX-
ICITY.—With respect to an ingredient or cosmetic, 
the term ‘reproductive or developmental toxicity’ 
means that the ingredient or cosmetic can contribute 
to biologically adverse effects on the development of 
humans or animals, including effects on the female 
or male reproductive system, the endocrine system, 
fertility, pregnancy, pregnancy outcomes, or modi-
fications in other functions of the body that are de-
pendent on the integrity of the reproductive system 
as well normal fetal development. 
‘‘(9) 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 hair salons, 
nail salons, beauty salons, spas, other establishments 
that provide cosmetic treatment services for humans, 
and cosmetic manufacturing plants. 
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‘‘SEC. 612. REGISTRATION OF ESTABLISHMENTS AND REG-
ISTRATION FEES. 
‘‘(a) REGISTRATION.— 
‘‘(1) IN GENERAL.—Beginning 1 year after the 
date of the enactment of this subchapter, and annu-
ally thereafter, any establishment (except for micro-
businesses) engaged in manufacturing or packaging 
cosmetics for use in the United States shall register 
with the Secretary and pay to the Secretary the ap-
plicable fee, as established under the fee schedule in 
subsection (e). 
‘‘(2) RULES FOR DOMESTIC AND FOREIGN ES-
TABLISHMENTS.—To be registered under paragraph 
(1)— 
‘‘(A) as a domestic establishment, the 
owner, operator, or agent in charge of the do-
mestic establishment shall submit a registration 
to the Secretary; or 
‘‘(B) as a foreign establishment, the owner, 
operator, or agent in charge of the foreign es-
tablishment shall— 
‘‘(i) submit a registration to the Sec-
retary; and 
‘‘(ii) include with the registration the 
name of the United States agent for the 
foreign establishment. 
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‘‘(C) The gross receipts or sales for the es-
tablishment from cosmetics. 
‘‘(D) The name and address of any com-
pany that supplies the establishment, if the es-
tablishment manufactures cosmetics, with any 
ingredient and the name of the ingredient sup-
plied to such establishment by such supplier. 
‘‘(2) NOTIFICATION OF CHANGES.—When sub-
mitting the annual registration, the registrant shall 
notify the Secretary of changes to the information 
described in paragraph (1). 
‘‘(c) PROCEDURE.—Upon receipt of a completed reg-
istration submitted under subsection (a), the Secretary 
shall notify the registrant of the receipt of such registra-
tion and assign a registration number to each registered 
establishment. 
‘‘(d) LIST OF REGISTERED ESTABLISHMENTS.— 
‘‘(1) MAINTENANCE OF LIST.—The Secretary 
shall— 
‘‘(A) compile, maintain, and update as ap-
propriate, a list of establishments that are reg-
istered under this section; 
‘‘(B) make such list publically available; 
and 
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‘‘(C) remove from such list the name of 
any establishment that fails to register in ac-
cordance with this section. 
‘‘(2) APPLICATION OF FOIA.— 
‘‘(A) 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. 
‘‘(B) 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. 
‘‘(e) 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 
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‘‘(2) only be assessed on companies with annual 
gross receipts or sales of cosmetics that exceed 
$10,000,000. 
‘‘(f) SUSPENSION AND CANCELLATION OF REGISTRA-
TION.— 
‘‘(1) CRITERIA FOR SUSPENSION.—Registration 
under this section is subject to suspension if the 
Secretary finds— 
‘‘(A) the information submitted by the es-
tablishment for registration under subsection 
(a) is incomplete, inaccurate, or out of date; 
‘‘(B) the establishment fails to notify the 
Secretary of changes required under subsection 
(b)(2); 
‘‘(C) the establishment fails to pay reg-
istration fees, as required under subsection (a), 
in a timely manner; or 
‘‘(D) the establishment violates any portion 
of this chapter. 
‘‘(2) SUSPENSION
OF
REGISTRATION.—If the 
Secretary determines that an establishment is sub-
ject to suspension under subsection (f) and that it 
is appropriate to suspend the registration of such es-
tablishment, the Secretary shall— 
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‘‘(A) suspend the registration of such es-
tablishment; and 
‘‘(B) provide a notice of suspension to such 
establishment. 
‘‘(3) CANCELLATION.—If the establishment 
fails to correct the issue that resulted in the suspen-
sion under paragraph (2) before the last day of the 
30-day period beginning on the date that the estab-
lishment receives notice under such paragraph, the 
Secretary may cancel the registration of such estab-
lishment. 
‘‘SEC. 613. INGREDIENTS LABELS ON COSMETICS. 
‘‘(a) IN GENERAL.—Subject to subsections (b) and 
(c), the Secretary shall require that the label on each pack-
age of cosmetics (including cosmetics distributed for retail 
sale and professional use) bears a declaration of the name 
of each ingredient in such cosmetic in descending order 
of predominance. 
‘‘(b) ADJUSTMENTS FOR LABEL SIZE.— 
‘‘(1) RULES FOR SMALL PRODUCTS.—Not later 
than 6 months after the date of the enactment of 
this subchapter, the Secretary shall issue regulations 
that apply to any cosmetic for which the product 
packaging is not of sufficient size to bear or contain 
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a label that meets the requirements of subsection 
(a). 
‘‘(2) REQUIREMENTS
FOR
PUBLIC
DISCLO-
SURE.—Such regulations shall establish require-
ments for listing ingredients on the label of such 
cosmetics and additional requirements for public dis-
closure of the ingredients in such cosmetics. 
‘‘(c) SPECIAL RULE FOR CONTAMINANTS.—The Sec-
retary shall require, in the case of a contaminant, that 
a contaminant be declared on the label of a cosmetic, in 
the same manner as an ingredient under subsection (a), 
if the contaminant is present at the lower of the following 
levels: 
‘‘(1) A level that is greater than one part-per- 
billion by weight of product formation. 
‘‘(2) A level that is greater than one percent of 
the restriction on the concentration for such con-
taminant for such use, as determined by the Sec-
retary under section 616(a)(2). 
‘‘(d) 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 percent of the ingre-
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dient particles in the cosmetic are 100 nanometers 
or smaller in not less than 1 dimension; 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. 
‘‘(e) LABELING
OF INGREDIENTS
IN COSMETICS 
SOLD THROUGH INTERNET COMMERCE.—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) that each Internet vendor display the list 
of ingredients of a cosmetic sold by such vendor on 
the Web page that is the primary Web page pro-
viding information relating to the sale of such cos-
metic on the Web site of the vendor. 
‘‘(f) TRADE SECRETS.—Notwithstanding any other 
provision of law, an ingredient required to be listed on a 
label under this section shall not be treated as a trade 
secret. 
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‘‘(g) APPLICATION.—Beginning 18 months after the 
date of the enactment of this subchapter, the requirements 
of this section shall apply to— 
‘‘(1) all cosmetics that are available for retail 
sale; and 
‘‘(2) manufacturers, distributors, and Internet 
vendors of such cosmetics. 
‘‘SEC. 614. SAFETY STANDARD AND GOOD MANUFACTURING 
PRACTICES. 
‘‘(a) SAFETY STANDARD.— 
‘‘(1) IN GENERAL.—Taking into account the ex-
pected use of a cosmetic, the Secretary shall estab-
lish a safety standard that, with respect to a cos-
metic or an ingredient in a cosmetic provides a rea-
sonable certainty of no harm (as such term is de-
fined in section 611(7)) from exposure to the cos-
metic or ingredient and protects the public from any 
known or anticipated adverse health effects associ-
ated with the cosmetic or ingredient. 
‘‘(2) STANDARDS FOR ESTABLISHING SAFETY 
STANDARD.—In establishing the safety standard 
under paragraph (1), the Secretary shall ensure 
that— 
‘‘(A) the likely level of exposure to all 
sources of the ingredient or cosmetic (including 
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environmental sources) that will result under 
the safety standard presents not more than a 1 
in a million risk for any adverse health effect 
in any vulnerable population at the lower 95th 
percentile confidence interval; or 
‘‘(B) the safety standard results in expo-
sure to the amount or concentration of an in-
gredient or cosmetic that is shown to produce 
no adverse health effects, incorporating an mar-
gin of safety of at least 1,000 and considering 
the impact of cumulative exposure from all 
sources (including environmental sources). 
‘‘(3) USE OF OTHER FEDERAL STANDARDS.—If 
any Federal agency has promulgated a standard for 
an ingredient that satisfies the requirements under 
paragraph (1), the Secretary may treat such stand-
ard as the safety standard under paragraph (1) for 
purposes of such ingredient. 
‘‘(4) APPLICATION
OF
SAFETY
STANDARD.— 
The Secretary may only determine that an ingre-
dient or a cosmetic meets the safety standard under 
paragraph (1) if there is a reasonable certainty of no 
harm from exposure to the ingredient or cosmetic. 
‘‘(b) GOOD MANUFACTURING PRACTICES.— 
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‘‘(1) IN GENERAL.—The Secretary shall issue 
guidance prescribing good manufacturing practices 
for cosmetics and ingredients, including quality con-
trol procedures that the Secretary determines are 
necessary, and shall update such regulations as nec-
essary. 
‘‘(2) CONSIDERATION OF SMALL BUSINESS.—In 
developing the guidance under paragraph (1), the 
Secretary shall consider how such practices will im-
pact small businesses. 
‘‘SEC. 615. COSMETIC AND INGREDIENT SAFETY INFORMA-
TION. 
‘‘(a) REQUIRED SUBMISSION OF ALL SAFETY INFOR-
MATION.— 
‘‘(1) IN GENERAL.—Manufacturers of cosmetics 
and ingredients shall submit to the Secretary (in an 
electronic format that the Secretary shall determine) 
all data and information that the manufacturer can 
access regarding the safety of the— 
‘‘(A) ingredients listed on the cosmetic 
label under section 613 for a cosmetic; and 
‘‘(B) cosmetic itself. 
‘‘(2) REQUIRED INFORMATION.—The required 
data and information under paragraph (1) shall in-
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clude, for each ingredient in a cosmetic and for the 
cosmetic, the following: 
‘‘(A) Functions and uses. 
‘‘(B) Data and information on the phys-
ical, chemical, and toxicological properties of 
each such ingredient or cosmetic. 
‘‘(C) Exposure and fate information. 
‘‘(D) Results of all safety tests that the 
manufacturer can access or has conducted. 
‘‘(E) Any other information used to sub-
stantiate the safety of such ingredient and cos-
metic. 
‘‘(3) DEADLINES.— 
‘‘(A) INITIAL
SUBMISSION.—A manufac-
turer shall submit the data and information re-
quired under paragraph (1)— 
‘‘(i) in the case of an ingredient or 
cosmetic which is marketed for sale in 
interstate commerce on or before the date 
of the enactment of this subchapter, not 
later than 1 year after such date; and 
‘‘(ii) in the case of an ingredient or 
cosmetic which is not marketed for sale on 
or before such date— 
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‘‘(I) not later than the end of the 
14-month period beginning on the 
date of the enactment of this sub-
chapter; or 
‘‘(II) if the ingredient or cosmetic 
is first marketed for sale in interstate 
commerce after the end of the period 
described in subclause (I), not later 
than 60 days after the date on which 
such ingredient or cosmetic is first 
marketed for sale. 
‘‘(B) UPDATES.— 
‘‘(i) IN GENERAL.—Subject to clause 
(ii), a manufacturer shall update the data 
and information submitted under subpara-
graph (A) annually. 
‘‘(ii) ADVERSE HEALTH EFFECTS.—In 
the case of information related to an ad-
verse health effect that is suspected to be 
caused by an ingredient or a cosmetic, a 
manufacturer shall update the information 
not later than 60 days after receiving such 
information. 
‘‘(4) SUPPLIER INFORMATION.— 
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‘‘(A) USE OF SUPPLIER INFORMATION.— 
In order to meet the requirements of paragraph 
(1) with respect to an ingredient, a manufac-
turer may submit safety data and information 
provided by the supplier of the ingredient. 
‘‘(B) SUPPLIER PROVISION OF INFORMA-
TION.—If a manufacturer requests that a sup-
plier of an ingredient provide to such manufac-
turer any of the data and information described 
under paragraph (2), such supplier shall pro-
vide such data and information to such manu-
facturer not later than 90 days after receiving 
such request. 
‘‘(b) DATABASE.— 
‘‘(1) INITIAL PUBLICATION.—Not later than 1 
year after the date of the enactment of this sub-
chapter, the Secretary shall publish a comprehensive, 
publicly accessible database containing all noncon-
fidential information (as such term is used under 
section 623) submitted under subsection (a)(1). 
‘‘(2) UPDATES.—Not later than 90 days after 
the Secretary receives new or updated information 
under subsection (a)(3)(B), the Secretary shall up-
date the database under paragraph (1) with such in-
formation. 
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‘‘(c) REVIEW AND EVALUATION OF INFORMATION.— 
‘‘(1) IN GENERAL.—Based on the data and in-
formation submitted under subsection (a)(1), avail-
able from an authoritative source (as such term is 
defined in paragraph (3), including data described 
under section 627(b)), and such other information 
as the Secretary may have available, the Secretary 
shall review and evaluate the safety of cosmetics and 
ingredients of cosmetics that are marketed in inter-
state commerce. 
‘‘(2) CONSIDERATION
OF
NANOMATERIALS.— 
The Secretary shall— 
‘‘(A) monitor developments in the scientific 
understanding from any adverse health effects 
related to the use of nanotechnology in the for-
mulation of cosmetic (including progress in the 
standardization of testing methods and specific 
size definitions for nanomaterials); and 
‘‘(B) consider scale specific hazard prop-
erties of ingredients when reviewing and evalu-
ating the safety of cosmetics and ingredients 
under paragraph (1). 
‘‘(3) AUTHORITATIVE SOURCE DEFINED.—For 
purposes of this paragraph, the term ‘authoritative 
source’ means— 
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‘‘(A) the Environmental Protection Agen-
cy; 
‘‘(B) the International Agency for Re-
search on Cancer; 
‘‘(C) 
the 
National 
Toxicity 
Program 
through the National Institutes of Health; 
‘‘(D) the California Environmental Protec-
tion Agency; and 
‘‘(E) any other authoritative international, 
Federal, and State entity, as determined by the 
Secretary. 
‘‘SEC. 616. LISTS OF INGREDIENTS AND REQUIRED RE-
SPONSES. 
‘‘(a) PLACEMENT ON LIST.— 
‘‘(1) IN GENERAL.—Based on an initial review 
and evaluation of an ingredient under subsection (c), 
the Secretary shall place the ingredient on one of the 
following lists: 
‘‘(A) The prohibited and restricted list 
under subsection (b). 
‘‘(B) The safe without limits list under 
subsection (c). 
‘‘(C) The priority assessment list under 
subsection (d). 
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‘‘(2) CONSIDERATIONS.—In determining the 
placement of an ingredient on a list under sub-
section (a), the Secretary shall consider whether the 
ingredient— 
‘‘(A) reacts with other substances to form 
harmful contaminants; 
‘‘(B) is found to be present in the body 
through biomonitoring; 
‘‘(C) is found in drinking water or air; 
‘‘(D) is a known or suspected neurological 
or 
immunological 
toxicant, 
respiratory 
asthmagen, carcinogen, teratogen, or endocrine 
disruptor, or have other toxicological concerns 
(including reproductive or developmental tox-
icity); or 
‘‘(E) is known to persist in the environ-
ment or bioaccumulate. 
‘‘(3) PRIORITIZIATION OF INGREDIENTS THAT 
ARE
FOOD.—In placing ingredients on the lists 
under paragraph (1), the Secretary shall prioritize 
the placement of ingredients that are food (as such 
term is defined under section 201(f)) on such lists. 
‘‘(b) PROHIBITED AND RESTRICTED LIST.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of the enactment of this subchapter, 
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the Secretary shall issue, by regulation, a list of in-
gredients that are identified by the Secretary— 
‘‘(A) as prohibited for use because the Sec-
retary determines that such ingredients are un-
safe for use in cosmetics in any amount because 
such ingredients fail to meet the safety stand-
ard under section 614(a); or 
‘‘(B) as being subject to necessary restric-
tions in use or concentration to allow the use of 
the ingredient in a cosmetic to satisfy the safety 
standard. 
‘‘(2) SPECIFICATION OF RESTRICTIONS.—In the 
case of any ingredient listed under paragraph 
(1)(B), the Secretary shall specify the restrictions on 
use or concentration that are necessary to satisfy the 
safety standard for such ingredient. 
‘‘(3) UPDATES.—The Secretary shall, at a min-
imum, annually update the list under paragraph (1), 
including any— 
‘‘(A) 
determinations 
under 
subsection 
(d)(3); or 
‘‘(B) new information that demonstrates 
that an ingredient fails to meet the safety 
standard, or requires restrictions on use to 
meet such standard. 
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‘‘(4) MANUFACTURER
REQUIREMENTS.—Not 
later than 1 year after the date that an ingredient 
is placed on a list under subsection (b), any manu-
facturer using such ingredient in a cosmetic shall re-
formulate such cosmetic to— 
‘‘(A) eliminate the use of the ingredient, if 
it is listed under paragraph (1)(A); or 
‘‘(B) modify the use of the ingredient if it 
is listed under paragraph (1)(B), to meet the 
restrictions specified under paragraph (2). 
‘‘(c) SAFE WITHOUT LIMITS LIST.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of the enactment of this subchapter, 
the Secretary shall issue, by regulation, a list of in-
gredients that the Secretary has determined are safe 
for use in cosmetics, without limits or restrictions. 
‘‘(2) STANDARD FOR INCLUSION IN LIST.—The 
Secretary may only include an ingredient on the list 
under paragraph (1) if the Secretary determines 
that the ingredient meets the safety standard under 
section 614(a), regardless of— 
‘‘(A) the type and form of cosmetic the in-
gredient is used in; and 
‘‘(B) the concentration of the ingredient 
that is used in a cosmetic. 
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‘‘(3) UPDATES AND REDETERMINATIONS.—The 
Secretary shall annually update the list under para-
graph (1) and may redetermine whether an 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 ingredient continues to meet the safety standard. 
‘‘(d) PRIORITY ASSESSMENT LIST
AND RELATED 
SAFETY DETERMINATIONS.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of the enactment of this subchapter, 
the Secretary shall develop and publish a priority as-
sessment list of not less than 300 ingredients— 
‘‘(A) which, because of a lack of authori-
tative information on the safety of the ingre-
dient, cannot be included on— 
‘‘(i) the list under subsection (b) (re-
lating to prohibited and restricted ingredi-
ents); or 
‘‘(ii) the list under subsection (c) (re-
lating to ingredients that are safe without 
limits); and 
‘‘(B) for which the Secretary has deter-
mined it is a priority to conduct a safety deter-
mination under paragraph (3). 
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‘‘(i) the ingredient meets the require-
ments for inclusion on a list under sub-
section (b) (relating to prohibited and re-
stricted ingredients) or subsection (c) (re-
lating to ingredients that are safe without 
limits); or 
‘‘(ii) insufficient information exists to 
place the ingredient on either such list. 
‘‘(C) GUIDANCE IN THE CASE OF INSUFFI-
CIENT INFORMATION.—If the Secretary deter-
mines under subparagraph (B) that, with re-
spect to an ingredient, insufficient information 
exists to place such ingredient on either of the 
lists under subsection (b) or subsection (c), the 
Secretary shall provide guidance to manufactur-
ers on the data and information (including min-
imum data requirements and safety testing pro-
tocols) that the Secretary requires to evaluate 
whether the ingredient meets the safety stand-
ard under section 614(a) for purposes of plac-
ing such ingredient on such a list. 
‘‘(D) COMMENT
PERIOD.—Upon issuing 
the determination under subparagraph (B), 
and, if applicable, the guidance under subpara-
graph (C), the Secretary shall provide a period 
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of not less than 60 days for public comment on 
the determination before applying such deter-
mination to an ingredient, except that a shorter 
period for comment may be provided if the Sec-
retary— 
‘‘(i) finds that it would be in the pub-
lic interest to have a shorter period; and 
‘‘(ii) publically declares the reasons 
for such finding. 
‘‘(4) MANUFACTURER
RESPONSE
TO
INAD-
EQUATE INFORMATION.—Not later than 18 months 
after the date that the Secretary issues guidance 
under paragraph (3)(C) with respect to an ingre-
dient subject to a determination under paragraph 
(3)(B), a manufacturer using such ingredient in a 
cosmetic shall— 
‘‘(A) reformulate such cosmetic to elimi-
nate the use of the ingredient; or 
‘‘(B) provide the Secretary with the data 
and information specified in such guidance. 
‘‘(5) EVALUATION OF ADDITIONAL DATA AND 
INFORMATION.—With respect to an ingredient, not 
later than 6 months after a manufacturer provides 
the Secretary with the data and information under 
paragraph (4)(B) the Secretary shall review such 
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data and information and shall make a redetermina-
tion under paragraph (3)(B) for such ingredient, 
subject to the comment period under paragraph 
(3)(D). 
‘‘(6) LIMITATION.—If the Secretary has not 
placed an ingredient on either of the lists under sub-
section (b) and subsection (c) by the end of the 5- 
year period beginning on the date that such ingre-
dient is first placed on the list under subsection (d), 
beginning on the first day after such period such in-
gredient may not be— 
‘‘(A) used in a cosmetic; and 
‘‘(B) manufactured, imported, distributed, 
or marketed for use in cosmetics. 
‘‘SEC. 617. TREATMENT OF COSMETICS BASED ON INGRE-
DIENT LISTS. 
‘‘(a) IN GENERAL.—Subject to subsections (b)(4) 
and (d)(4) of section 616, a manufacturer may only manu-
facture a cosmetic for distribution in interstate commerce 
if such cosmetic meets the safety standard under section 
614(a). 
‘‘(b) PRESUMPTION RELATED TO THE SAFETY OF 
COSMETICS.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
for purposes of subsection (a), the Secretary shall 
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presume that the following cosmetics meet the safety 
standard under section 614(a): 
‘‘(A) A cosmetic that is made solely of in-
gredients on the list under section 616(c)(1) 
(relating to ingredients that are safe without 
limits). 
‘‘(B) A cosmetic that is made solely of in-
gredients on the list under section 616(b)(1)(B) 
(relating to ingredients subject to restrictions) 
and the use of each of such ingredients in such 
cosmetic is in compliance with the restrictions 
on the use of such ingredients specified under 
section 616(b)(2). 
‘‘(C) A cosmetic that is made solely of in-
gredients described under subparagraph (A) 
and subparagraph (B). 
‘‘(2) EXCEPTIONS.—The Secretary may require 
that a manufacturer demonstrate that a cosmetic 
meets the safety standard under section 614(a) (in-
cluding by requiring that the manufacturer conduct 
safety testing of a cosmetic described under para-
graph (1)) if the cosmetic— 
‘‘(A) contains penetration enhancers, sensi-
tizers, estrogenic chemicals, or other similar in-
gredients; 
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‘‘(B) contains ingredients that react with 
each other or with other substances to form 
harmful byproducts; or 
‘‘(C) the Secretary has any additional rea-
son to believe that such cosmetic does not meet 
the safety standard under section 614(a). 
‘‘(3) GUIDANCE.—If, under paragraph (2), the 
Secretary requires that a manufacturer demonstrate 
that a cosmetic meets the safety standard under sec-
tion 614(a), the Secretary shall provide the manu-
facturer with guidance on the data and information 
that the Secretary requires to evaluate whether the 
cosmetic meets the safety standard under such sec-
tion. 
‘‘(c) NOTIFICATION OF FAILURE OF SECRETARY TO 
ACT.—If the Secretary fails to act by an applicable dead-
line under section 616 or this section, a manufacturer of 
an ingredient or a cosmetic affected by such failure of the 
Secretary to act shall issue to the Secretary, the public, 
and each known customer of the ingredient or cosmetic, 
a written notice that a determination by the Secretary of 
the safety of the ingredient for use in cosmetics is pending. 
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‘‘SEC. 618. TREATMENT OF CONTAMINANTS. 
‘‘(a) PUBLICATION OF LIST.—Not later than 1 year 
after the date of the enactment of this subchapter, and 
annually thereafter, the Secretary shall publish a list of— 
‘‘(1) ingredients used in cosmetics that may 
contain contaminants; 
‘‘(2) combinations of ingredients that may cre-
ate contaminants when such ingredients interact; 
‘‘(3) contaminants that may leech from product 
packaging into a cosmetic; and 
‘‘(4) any other contaminant of cosmetics identi-
fied by the Secretary. 
‘‘(b) REQUIREMENTS FOR TESTING.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this subchapter, the Sec-
retary shall establish, by rule, requirements for test-
ing ingredients and cosmetics for contaminants list-
ed under subsection (a). 
‘‘(2) 
CONTENTS.—The 
requirements 
under 
paragraph (1) shall include— 
‘‘(A) testing methods and applicable proto-
cols; and 
‘‘(B) maximum allowable detection limits 
for each contaminant in an ingredient. 
‘‘(3) UPDATE.—The Secretary shall annually 
update the requirements under paragraph (1). 
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‘‘(c) SUPPLIER REQUIREMENTS.—Not later than 1 
year after the promulgation of the rule under subsection 
(b)(1), a supplier of an ingredient that is used in a cos-
metic shall, with respect to such ingredient— 
‘‘(1) comply with the requirements under sub-
section (b)(1) for any ingredient listed under sub-
section (a); 
‘‘(2) conduct similar testing on any ingredient 
that— 
‘‘(A) the supplier expects may be used in 
a cosmetic; 
‘‘(B) the supplier suspects may contain a 
contaminant; and 
‘‘(C) is not listed under subsection (a); and 
‘‘(3) upon the sale of an ingredient to the man-
ufacturer, provide to the manufacturer specifications 
for the ingredient that— 
‘‘(A) include the levels of contaminants 
present in such ingredient; and 
‘‘(B) are based on the results of the tests 
under paragraph (1) and paragraph (2). 
‘‘(d) MANUFACTURER REQUIREMENTS.—Not later 
than 1 year after the promulgation of the rule under sub-
section (b)(1), a manufacturer of a cosmetic shall, with 
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respect to each ingredient that the manufacturer uses in 
a cosmetic— 
‘‘(1) obtain, from each supplier of the ingre-
dient, specifications for the ingredient that include— 
‘‘(A) the level of each contaminant present 
in the ingredient; and 
‘‘(B) the detection limits of the analytical 
test used to detect the contaminant; or 
‘‘(2) comply with the requirements under para-
graphs (1) and (2) of subsection (c) for the ingre-
dient, in the same manner as if the manufacturer 
were a supplier. 
‘‘SEC. 619. COSMETIC AND INGREDIENT STATEMENTS. 
‘‘(a) IN GENERAL.—Beginning 1 year after the date 
of the enactment of this subchapter, each establishment 
engaged in the manufacture of a cosmetic intended to be 
marketed in the United States shall submit electronically 
to the Secretary, for each cosmetic manufactured in the 
establishment 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-
tured or, if the same cosmetic is manufactured in 
more than 1 establishment, the registration number 
of each establishment where it is manufactured; 
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‘‘(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 
range 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) NEW COSMETICS.—Any establishment that be-
gins to manufacture a cosmetic after the date of the enact-
ment of this subchapter shall comply with the require-
ments of subsection (a) beginning on the later of the fol-
lowing: 
‘‘(1) The end of the 18-month period beginning 
on the date of the enactment of this subchapter. 
‘‘(2) The 6-month period after the date on 
which the establishment begins to manufacture such 
cosmetic. 
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‘‘(c) NOTIFICATION
OF CHANGES.—The establish-
ment shall notify the Secretary annually of any change 
to the information required under subsection (a). 
‘‘(d) 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. 
‘‘(e) LIST.—The Secretary shall compile, maintain, 
and update as appropriate, a list of cosmetics for which 
statements are submitted under this section. 
‘‘(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 615(b). 
‘‘SEC. 620. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED COS-
METICS. 
‘‘(a) NOTIFICATION
OF ADULTERATED
OR MIS-
BRANDED 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 
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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 effects or death to 
humans shall notify the Secretary of the identity and 
location of the cosmetic. 
‘‘(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. 
‘‘(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— 
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‘‘(A) the use of, or exposure to, a cosmetic 
may cause serious adverse health effects 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. 
‘‘(2) CEASE DISTRIBUTION AND NOTICE.—Any 
person who is subject to an order under paragraph 
(1) shall immediately cease distribution of such cos-
metic and provide notification as required by such 
order. 
‘‘(3) APPEAL.— 
‘‘(A) 24 HOURS.—A person subject to an 
order under paragraph (1) may appeal such 
order to the Secretary within 24 hours of the 
issuance of such order. 
‘‘(B) CONTENTS OF APPEAL.—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). 
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‘‘(C) INFORMAL HEARING.—Except as pro-
vided in subsection (e), an informal hearing 
shall be held as soon as practicable, but not 
later than 5 calendar days (or less as deter-
mined by the Secretary) after such an appeal is 
filed, unless the parties jointly agree to an ex-
tension. 
‘‘(D) IMPACT ON RECALL.—If an appeal is 
filed under subparagraph (A), the Secretary 
may not amend the order to require a recall 
under subsection (d) until after the conclusion 
of the hearing under subparagraph (C). 
‘‘(4) VACATION OF ORDER.—If the Secretary 
determines that inadequate grounds exist to support 
the actions required by the order under paragraph 
(1), the Secretary shall vacate the order. 
‘‘(d) ORDER TO RECALL.— 
‘‘(1) AMENDMENT.—Except as provided under 
subsection (e) and subject to subsection (c)(3)(D), if 
the Secretary determines that a recall of a cosmetic 
subject to an order under subsection (c) is appro-
priate, the Secretary shall amend the order to re-
quire a recall. 
‘‘(2) CONTENTS.—An amended order under 
paragraph (1) shall— 
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‘‘(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 may only be issued by the Sec-
retary or an official designated by the Secretary, and 
may not be delegated to another official or employee. 
‘‘(4) DETERMINATION.—If the Secretary deter-
mines that inadequate grounds exist to support the 
amendment made to the order under paragraph (1), 
the Secretary shall remove such amendment from 
such order. 
‘‘(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 effects or death 
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to humans, the Secretary may issue an order requir-
ing any person who distributes such cosmetic— 
‘‘(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) RECALL AND NOTICE.—Any person who is 
subject to an emergency recall order under this sub-
section shall immediately recall such cosmetic and 
provide notification as required by such order. 
‘‘(3) APPEAL.— 
‘‘(A) 24 HOURS.—Any person subject to 
such an order may appeal such order to the 
Secretary within 24 hours of the issuance of 
such order. 
‘‘(B) CONTENTS OF APPEAL.—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). 
‘‘(C) INFORMAL
HEARING.—An informal 
hearing shall be held as soon as practicable 
after the appeal is filed under subparagraph 
(A), but not later than 5 calendar days after 
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such an appeal is filed, or fewer days (as deter-
mined by the Secretary), unless the parties 
jointly agree to an extension. 
‘‘(4) VACATION OF ORDER.—If the Secretary 
determines that inadequate grounds exist to support 
the actions required by the order under paragraph 
(1), the Secretary shall vacate the order. 
‘‘(5) NONDELEGATION.—An order under this 
subsection may only be issued by the Secretary or an 
official designated by the Secretary, and may not be 
delegated to another official or employee. 
‘‘(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) SUPPLY CHAIN INFORMATION.— 
‘‘(1) IN GENERAL.—In the case of a cosmetic 
that the Secretary has reason to believe is adulter-
ated, misbranded, or otherwise in violation of this 
Act, the Secretary shall request that the entity 
named on the label of such cosmetic (as required 
under section 602(b)(1)) submit all of the following 
information: 
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‘‘(A) The name and place of business of 
the manufacturer, packer, or distributor from 
which such entity received the cosmetic or in-
gredients for manufacturing such cosmetic. 
‘‘(B) The name and place of business of 
any entity (including any retailer) that was pro-
vided with such cosmetic by the entity named 
on the label. 
‘‘(2) COLLECTION
OF
ADDITIONAL
SUPPLY 
CHAIN
INFORMATION.—In the case of a cosmetic 
that the Secretary has reason to believe is adulter-
ated, misbranded, or otherwise in violation of this 
Act, to the extent necessary to protect the safety of 
the public, the Secretary may request that any entity 
(including a supplier of an ingredient, manufacturer, 
packer, distributor, or retailer) in the supply chain 
of such cosmetic submit to the Secretary information 
that is similar to the information described under 
subparagraphs (A) and (B) of paragraph (1). 
‘‘(3) MAINTENANCE OF RECORDS.—Any entity 
in supply chain of a cosmetic (including the entity 
named on the label of a cosmetic) shall— 
‘‘(A) maintain records sufficient to provide 
the information described in subparagraphs (A) 
and (B) of paragraph (1); and 
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‘‘(B) provide such information to the Sec-
retary upon the request of the Secretary. 
‘‘(h) 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. 621. 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 
or cosmetic safety determinations, not later than 6 months 
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 616(b); 
‘‘(2) to remove an ingredient from the list of in-
gredients that are safe without limits under section 
616(c); 
‘‘(3) to add an ingredient to the priority assess-
ment list under section 616(d); or 
‘‘(4) to add an ingredient to the list of contami-
nants under section 618. 
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‘‘(b) REASONABLE PETITION.—Not later than 1 year 
after the date of the enactment of this Act, the Secretary 
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. 622. MANDATORY REPORTING OF ADVERSE HEALTH 
EFFECTS. 
‘‘(a) SUBMISSION OF REPORT ON ADVERSE HEALTH 
EFFECTS.—The Secretary shall require that the manufac-
turer, packager, or distributor 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 adverse health effect 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 
health effect is received at the place of business of the 
manufacturer, packager, or distributor. 
‘‘(c) CONTENT OF REPORT.—A report under sub-
section (a) shall include the following information, to the 
extent to which the manufacturer, packager, or distributor 
submitting the report has been able to verify the informa-
tion: 
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‘‘(1) The identity of the individual experiencing 
the adverse health effect. 
‘‘(2) An identifiable report of such effect. 
‘‘(3) The name of the cosmetic suspected of 
causing such effect. 
‘‘(4) A description of the adverse health effect. 
‘‘(d) PUBLIC AVAILABILITY AND PRIVACY.— 
‘‘(1) PUBLIC AVAILABILITY.—Subject to para-
graph (2), the adverse health effect reports collected 
by the Secretary under this section shall be sub-
mitted 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 health effect reports provided to the Sec-
retary 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. 
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‘‘(B) 
TREATMENT
OF
INFORMATION 
UNDER PRIVACY ACT AND FOIA.—An adverse 
health effect report submitted to the Secretary 
under this section, shall be considered to be a 
record about an individual under section 552a 
of title 5, United States Code (commonly re-
ferred to as the ‘‘Privacy Act of 1974’’) and a 
medical or similar file the disclosure of which 
would constitute a violation of section 552 of 
such title 5 (commonly referred to as the 
‘‘Freedom of Information Act’’), and shall not 
be publicly disclosed unless all personally identi-
fiable information is redacted. 
‘‘SEC. 623. NONCONFIDENTIAL INFORMATION. 
‘‘(a) INFORMATION AVAILABLE TO PUBLIC.—Subject 
to subsection (c) and section 622(d)(2), all nonconfidential 
information submitted pursuant to this subchapter shall 
be made available to the public, including the following 
types of information: 
‘‘(1) The name, identity, and structure of a 
chemical substance, contaminant, or impurity that is 
an ingredient. 
‘‘(2) All information concerning function, expo-
sure, health hazards, and environmental hazards for 
a cosmetic., and 
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‘‘(3) The functions of ingredients in cosmetics. 
‘‘(4) Fragrance, flavor, and colorants in a cos-
metic 
‘‘(b) CONFIDENTIAL INFORMATION.—The concentra-
tion of cosmetic ingredients used in a finished cosmetic 
shall be considered confidential business information and 
may not be made available to the public under subsection 
(a). 
‘‘(c) 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 
a serious negative impact to the entity’s commercial 
interests if such information were disclosed to the 
public. 
‘‘(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 chemical substance, contaminant, or impu-
rity that is an ingredient; 
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‘‘(B) all health and safety data related to 
that substance, contaminant, or impurity; or 
‘‘(C) any data used to substantiate the 
safety of that substance, contaminant, or impu-
rity. 
‘‘SEC. 624. ANIMAL TESTING ALTERNATIVES. 
‘‘(a) IN GENERAL.—To minimize the use of animal 
testing of ingredients and cosmetics, 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 nonanimal 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; 
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‘‘(B) the formation of industry consortia to 
conduct testing to avoid duplication of tests; 
and 
‘‘(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 
this subchapter, and triennially thereafter, the Secretary 
shall publish a list of the alternative testing methods de-
scribed in subsection (a). 
‘‘SEC. 625. PRODUCT TESTING AND REVIEW AUDIT. 
‘‘The Secretary shall conduct annual audits of ran-
dom samples of cosmetics to assess or test for acute nega-
tive reactions, pathogen hazards, contaminants, leaching 
of packaging additives, mislabeling, or other relevant 
issues of concern (as determined by the Secretary). 
‘‘SEC. 626. RESOURCES FOR SMALL BUSINESSES. 
‘‘The Secretary shall provide technical support to as-
sist small businesses in carrying out the requirements of 
this subchapter. 
‘‘SEC. 627. INTERAGENCY COOPERATION. 
‘‘(a) INTERAGENCY COUNCIL ON COSMETIC SAFE-
TY.—There is established an Interagency Council on Cos-
metic Safety for the purpose of sharing data and pro-
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moting collaboration on cosmetic safety between the Food 
and Drug Administration, the National Institute of Envi-
ronmental Health Sciences, the Centers for Disease Con-
trol and Prevention, the Occupational Safety and Health 
Administration, and the Environmental Protection Agen-
cy. 
‘‘(b) USE OF DATA FROM FEDERAL SOURCES.—For 
purposes of this subchapter, the Secretary, as appropriate, 
shall request and utilize ingredient and cosmetic toxicity, 
use, and exposure data from other Federal agencies. 
‘‘SEC. 628. 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-
tablished by this subchapter, including requiring the provi-
sion of a warning of risk, illness, or injury. 
‘‘SEC. 629. 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 2012 through 2016.’’. 
(b) ADULTERATED AND MISBRANDED COSMETICS.— 
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(1) ADULTERATED COSMETICS.—Section 601 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 361) is amended in paragraph (a)— 
(A) by striking ‘‘, except that this provi-
sion shall not apply to coal-tar hair dye’’ and all 
that follows through ‘‘or eyebrow dyes’’; and 
(B) by adding at the end the following: 
‘‘(f) If it is manufactured in a manner that fails 
to comply with section 617(a). 
‘‘(g) If it is imported, distributed, or marketed 
and— 
‘‘(1) it contains an ingredient on the list 
under section 616(b)(1)(A), and the manufac-
turer has not complied with section 616(b)(4) 
with respect to such ingredient and such cos-
metic; or 
‘‘(2) it contains an ingredient on the list 
under section 616(b)(1)(B), such ingredient is 
being used in a manner that violates the limit 
on use or concentration of such ingredient 
under section 616(b)(2), and the manufacturer 
has not complied with section 616(b)(4) with 
respect to such ingredient and such cosmetic. 
‘‘(h) If it is manufactured by a manufacturer 
that, with respect to such cosmetic, is required to 
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demonstrate, under section 617(b)(2), that the cos-
metic meets the safety standard and the manufac-
turer has not yet submitted the required data under 
section 617(b)(3).’’. 
(2) MISBRANDED COSMETICS.—Section 602 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 362) is amended— 
(A) in paragraph (a), by inserting ‘‘ or 
fails to meet the requirements of section 613’’ 
before the period; and 
(B) by adding at the end the following: 
‘‘(g) If it— 
‘‘(1) was manufactured, packaged, or dis-
tributed by an entity that failed to register and 
pay the applicable fee as required under section 
612; 
‘‘(2) is manufactured, packaged, distrib-
uted, or sold in retail by a manufacturer, pack-
ager, distributor, or retailer, respectively, who 
fails to notify the Secretary as required under 
section 620(a)(1); 
‘‘(3) is distributed in violation of an order 
under section 620(c); 
‘‘(4) is not recalled as required by an order 
under subsection (d) or (e) of section 620; 
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‘‘(5) is manufactured in a manner that 
fails to comply with good manufacturing prac-
tices prescribed by the Secretary under section 
614(b); or 
‘‘(6) is manufactured by a manufacturer 
who fails— 
‘‘(A) to submit the statement required 
under section 619; or 
‘‘(B) notify the Secretary of changes 
to information contained in such report, as 
required by such section.’’. 
(3) ADDITIONAL PROHIBITIONS.—Section 301 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 331) is amended by adding at the end the 
following: 
‘‘(aaa) The failure of a manufacturer of a cos-
metic or an ingredient for use in a cosmetic to sub-
mit and update data and information as required 
under section 615(a). 
‘‘(bbb) The manufacture, importation, distribu-
tion, or marketing of an ingredient for use in a cos-
metic that is on the list under section 616(b)(1)(A). 
‘‘(ccc) The failure of a supplier of an ingredient 
for use in a cosmetic— 
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‘‘(1) to provide data and information as re-
quired by section 615(a)(4)(B); or 
‘‘(2) comply with the testing requirements 
under section 618(c). 
‘‘(ddd) The failure of a manufacturer to comply 
with the requirements of section 618(d). 
‘‘(eee) The failure of a manufacturer, packager, 
or distributor of a cosmetic to comply with the re-
quirement of reporting adverse health effects under 
section 622.’’. 
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.—Each 
manufacturer or importer selling any cosmetic for 
professional use shall— 
(A) obtain or develop a material safety 
data sheet described in subsection (b) for each 
such cosmetic or personal care product that— 
(i) the manufacturer or importer pro-
duces or imports; and 
(ii) includes a hazardous chemical, or 
a product ingredient associated with any 
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chemical hazard, that is classified as a 
health hazard in accordance with the cri-
teria found in section 1910.1200(d) of title 
29 of the Code of Federal Regulations, and 
any successor regulations; and 
(B) make the material safety data sheet 
available to distributors and employers, includ-
ing salon owners, in English and, upon request, 
in other languages, including Spanish and Viet-
namese. 
(2) DISTRIBUTORS.—Each distributor of a cos-
metic or personal care product for professional use 
shall distribute and provide material safety data 
sheets described in subsection (b) in the same man-
ner as a distributor of a chemical hazard is required 
to distribute and provide material safety data sheets 
under section 1910.1200(g) of title 29, Code of Fed-
eral Regulations, or any successor regulations. 
(3) EMPLOYERS.—Each employer, including 
any operator of a salon, shall— 
(A) have a material safety data sheet in 
the workplace for each cosmetic or personal 
care product for professional use that is used in 
the course of the employer’s business; 
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(B) make such material safety data sheet 
available to all employees of the employer who 
are exposed or use the product to the same ex-
tent 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 regula-
tions; and 
(C) upon request, provide employees with 
translations of such material safety data sheet 
in other languages, including Spanish and Viet-
namese. 
(b) CONTENTS
OF
MATERIAL
SAFETY
DATA 
SHEET.—A 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)(ii); and 
(2) include the following statement: ‘‘This ma-
terial safety data sheet is also available in multiple 
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languages by contacting the manufacturer, using the 
contact information provided on this sheet.’’. 
(c) PROFESSIONAL USE DEFINED.—In this section, 
the term ‘‘professional use’’ has the meaning given such 
term in section 611(6) of the Federal Food, Drug, and 
Cosmetic Act, except to the extent that such term applies 
to a product that is sold as a retail product in any of the 
establishments listed under such definition. 
Æ 
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