I 
113TH CONGRESS 
1ST SESSION H. R. 1385 
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 
MARCH 21, 2013 
Ms. SCHAKOWSKY (for herself, Mr. MARKEY, Mr. BLUMENAUER, Ms. CHU, 
Mr. CONYERS, Mr. ELLISON, Mr. GRIJALVA, Mr. HASTINGS of Florida, 
Mr. HUFFMAN, Mr. LOWENTHAL, Mr. MICHAUD, Mr. MORAN, Ms. NOR-
TON, Ms. PINGREE of Maine, Ms. WASSERMAN SCHULTZ, and Ms. 
SPEIER) 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 and Personal Care Products Act of 
2013’’. 
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(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
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 serious adverse events. 
‘‘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) BRAND OWNER.—The term ‘brand owner’ 
means the entity responsible for bringing a cosmetic 
to market. 
‘‘(2) CONTAMINANT.—The term ‘contaminant’ 
means unintended substances, such as those that 
can originate from sources outside the chemical 
pathway, chemical processes, storage of primary sub-
stances, instability of the packaging or harmful by-
products of the manufacturing process. 
‘‘(3) DOMESTIC
ESTABLISHMENT.—The term 
‘domestic establishment’ means an establishment lo-
cated in any State that brings a cosmetic to market. 
‘‘(4) FOREIGN
ESTABLISHMENT.—The term 
‘foreign establishment’ means an establishment that 
brings a cosmetic to market and exports those cos-
metics to the United States. 
‘‘(5) 
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 
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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; 
‘‘(D) substances that are present by reason 
of having been added to a cosmetic during proc-
essing for their technical or functional effect; 
‘‘(E) the components of a fragrance, fla-
vor, or preservative; and 
‘‘(F) any individual component that the 
Secretary deems an ingredient for purposes of 
this chapter. 
‘‘(6) MANUFACTURER.—The term ‘manufac-
turer’ means the entity that produces ingredients or 
combines one or more ingredients to produce a cos-
metic product. 
‘‘(7) MICROBUSINESS.—The term ‘microbusi-
ness’ means a business— 
‘‘(A) that is a brand owner as defined in 
this subchapter; and 
‘‘(B) that has annual sales receipts for cos-
metic products that do not exceed $2,000,000. 
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‘‘(8) 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. 
‘‘(9) 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; 
‘‘(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. 
‘‘(10) REPRODUCTIVE
OR
DEVELOPMENTAL 
TOXICITY.—With respect to an ingredient or cos-
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metic, the term ‘reproductive or developmental tox-
icity’ means that the ingredient or cosmetic can con-
tribute to biologically adverse effects on the develop-
ment of humans or animals, including effects on the 
female or male reproductive system, the endocrine 
system, fertility, pregnancy, pregnancy outcomes, or 
modifications in other functions of the body that are 
dependent on the integrity of the reproductive sys-
tem as well normal fetal development. 
‘‘(11) SERIOUS
ADVERSE
EVENT.—The term 
‘serious adverse event’ means— 
‘‘(A) an acute or chronic response that re-
sults in death, a life-threatening experience, 
short- or long-term hospitalization, a persistent 
or significant disability or incapacity, or a con-
genital anomaly or birth defect; or 
‘‘(B) requires, based on a reasonable med-
ical judgment, a medical or surgical interven-
tion to prevent an outcome described above. 
‘‘(12) SUPPLIER.—The term ‘supplier’ means 
the entity that supplies ingredients, raw materials, 
or specific components of a cosmetic product, includ-
ing packaging. 
‘‘(13) VULNERABLE POPULATIONS.—The term 
‘vulnerable populations’ includes pregnant women, 
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infants, children, the elderly, and highly exposed 
populations, including workers employed by hair sa-
lons, nail salons, beauty salons, spas, other estab-
lishments that provide cosmetic treatment services 
for humans, and cosmetic manufacturing plants. 
‘‘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 brand owner (except for micro-
businesses) engaged in bringing a cosmetic to mar-
ket for use in the United States shall register with 
the Secretary and pay to the Secretary the applica-
ble fee, as established under the fee schedule in sub-
section (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 
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trade names under which, the registrant brings 
cosmetics to market. 
‘‘(B) A description of the establishment’s 
activities with respect to cosmetics, including a 
list of all cosmetic products brought to market 
by the establishment and the functions of such 
cosmetics. 
‘‘(C) The gross receipts or sales for the es-
tablishment from cosmetics. 
‘‘(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 publicly available; 
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‘‘(C) remove from such list the name of 
any establishment that fails to register in ac-
cordance with this section; and 
‘‘(D) indicate on such list any establish-
ment which has had its registration suspended 
or cancelled by the Secretary under 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— 
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‘‘(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 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 this subsection and that it 
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is appropriate to suspend the registration of such es-
tablishment, the Secretary shall— 
‘‘(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. 
‘‘(g) RECORDKEEPING.—All establishments that are 
required to register under this section shall maintain 
records that include a current list of suppliers and manu-
facturers, if the registrant does not manufacture or pack-
age its own product. Those records shall be accessible by 
the Secretary upon request for review or audit. 
‘‘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 
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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 
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-
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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-
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 brand owner of 
such cosmetic provide to such Internet vendor a list 
of the ingredients of the cosmetic; 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. 
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‘‘(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. 
‘‘(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) brand owners 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 
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under paragraph (1), the Secretary shall ensure 
that— 
‘‘(A) the likely level of exposure to all 
sources of the ingredient or cosmetic (including 
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 
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paragraph (1) if there is a reasonable certainty of no 
harm from exposure to the ingredient or cosmetic. 
‘‘(b) GOOD MANUFACTURING PRACTICES.— 
‘‘(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.—Brand owners of cosmetics 
shall submit to the Secretary (in an electronic for-
mat that the Secretary shall determine) all data and 
information that the brand owner can access regard-
ing the safety of the— 
‘‘(A) ingredients listed on the cosmetic 
label under section 613 for a cosmetic; and 
‘‘(B) cosmetic itself. 
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‘‘(2) REQUIRED INFORMATION.—The required 
data and information under paragraph (1) shall in-
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 toxicity of each such ingre-
dient or cosmetic. 
‘‘(C) Exposure and fate information. 
‘‘(D) Results of all safety tests that the 
brand owner 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 
brand 
owner 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 
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‘‘(ii) in the case of an ingredient or 
cosmetic which is not marketed for sale on 
or before such date— 
‘‘(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 brand owner 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 
brand owner shall update the information 
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not later than 60 days after receiving such 
information. 
‘‘(4) SUPPLIER AND MANUFACTURER INFORMA-
TION.— 
‘‘(A) USE
OF
SUPPLIER
OR
MANUFAC-
TURER INFORMATION.—In order to meet the re-
quirements of paragraph (1) with respect to an 
ingredient, a brand owner may submit safety 
data and information provided by the supplier 
or manufacturer of the ingredient or cosmetic. 
‘‘(B) SUPPLIER OR MANUFACTURER PRO-
VISION OF INFORMATION.—If a brand owner re-
quests that a supplier or manufacturer of an in-
gredient provide to such brand owner any of the 
data and information described under para-
graph (2) or under section 617, such supplier 
or manufacturer shall provide such data and in-
formation to such brand owner 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-
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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. 
‘‘(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 cosmetics (including progress in the 
standardization of testing methods and specific 
size definitions for nanomaterials); and 
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‘‘(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— 
‘‘(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: 
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‘‘(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). 
‘‘(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 toxicity concerns (in-
cluding reproductive or developmental toxicity); 
or 
‘‘(E) is known to persist in the environ-
ment or bioaccumulate. 
‘‘(3) PRIORITIZATION
OF
INGREDIENTS
THAT 
ARE
FOOD.—In placing ingredients on the lists 
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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, 
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— 
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‘‘(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. 
‘‘(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 
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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. 
‘‘(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 
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‘‘(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). 
‘‘(2) ANNUAL
ADDITION
OF
INGREDIENTS.— 
After the list is developed under paragraph (1), the 
Secretary shall annually add at least 100 additional 
ingredients to such list until all ingredients that are 
used in the formulation or manufacture of cosmetics 
have been added— 
‘‘(A) to such list; 
‘‘(B) to the list under subsection (b); or 
‘‘(C) to the list under subsection (c). 
‘‘(3) DETERMINATION
OF
WHETHER
INGRE-
DIENT MEETS SAFETY STANDARD.— 
‘‘(A) REVIEW
OF
PRIORITY
INGREDI-
ENTS.—During the 2-year period following the 
date on which an ingredient is placed on the list 
under paragraph (1), the Secretary shall— 
‘‘(i) collect data and information on 
such ingredient; and 
‘‘(ii) review and evaluate the safety of 
such ingredient. 
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‘‘(B) DETERMINATION
OF
LIST
PLACE-
MENT.—Not later than the end of the period 
under subparagraph (A), the Secretary shall 
issue a determination, based on the review and 
evaluation under such clause, that— 
‘‘(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 on the data 
and information (including minimum data re-
quirements and safety testing protocols) that 
the Secretary requires to evaluate whether the 
ingredient meets the safety standard under sec-
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tion 614(a) for purposes of placing such ingre-
dient 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 
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) publicly declares the reasons for 
such finding. 
‘‘(4) RESPONSE
TO
INADEQUATE
INFORMA-
TION.—Not later than 18 months after the date that 
the Secretary issues guidance under paragraph 
(3)(C) with respect to an ingredient subject to a de-
termination under paragraph (3)(B), a brand owner 
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. 
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‘‘(5) EVALUATION OF ADDITIONAL DATA AND 
INFORMATION.—With respect to an ingredient, not 
later than 6 months after the Secretary receives the 
data and information under paragraph (4)(B) the 
Secretary shall review such data and information 
and shall make a redetermination 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 brand owner may only dis-
tribute in interstate commerce a cosmetic that meets the 
safety standard under section 614(a). 
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‘‘(b) PRESUMPTION RELATED TO THE SAFETY OF 
COSMETICS.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
for purposes of subsection (a), the Secretary shall 
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 brand owner demonstrate that a cosmetic 
meets the safety standard under section 614(a) (in-
cluding by requiring that the brand owner conduct 
safety testing, or request such safety testing from 
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relevant suppliers and manufacturers, of a cosmetic 
described under paragraph (1)) if the cosmetic— 
‘‘(A) contains penetration enhancers, sensi-
tizers, estrogenic chemicals, or other similar in-
gredients; 
‘‘(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 brand owner demonstrate 
that a cosmetic meets the safety standard under sec-
tion 614(a), the Secretary shall provide the brand 
owner 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, brand owners and 
manufacturers of an ingredient or a cosmetic affected by 
such failure of the Secretary to act shall issue to the Sec-
retary, the public, and each known customer of the ingre-
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dient or cosmetic, a written notice that a determination 
by the Secretary of the safety of the ingredient for use 
in cosmetics is pending. 
‘‘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 
contaminants of concern linked to severe acute reactions 
or long-term adverse health effects, including— 
‘‘(1) ingredients used in cosmetics that may 
contain contaminants of concern; 
‘‘(2) combinations of ingredients that may cre-
ate contaminants of concern when such ingredients 
interact; 
‘‘(3) contaminants of concern that may leech 
from product packaging into a cosmetic; and 
‘‘(4) any other contaminant of concern identi-
fied by the Secretary that are present in cosmetics. 
‘‘(b) EVALUATION; LABELING.—The Secretary shall 
use the process described in sections 615 and 616 to evalu-
ate contaminants of concern for possible elimination or re-
striction in cosmetics. The Secretary shall require that a 
contaminant on the list under subsection (a) be declared 
on the label of a cosmetic, in the same manner as an ingre-
dient under section 613. 
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‘‘(c) 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 or cos-
metic. 
‘‘(3) UPDATE.—The Secretary shall annually 
update the requirements under paragraph (1). 
‘‘(d) 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— 
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‘‘(A) the supplier expects may be used in 
a cosmetic; 
‘‘(B) the supplier suspects may contain a 
contaminant of concern; 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). 
‘‘(e) BRAND OWNER REQUIREMENTS.—Not later 
than 1 year after the promulgation of the rule under sub-
section (b)(1), a brand owner of a cosmetic shall, with re-
spect to each ingredient that the brand owner uses in a 
cosmetic— 
‘‘(1) obtain, from each supplier or manufac-
turer of the ingredient, specifications for the ingre-
dient 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 
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‘‘(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 brand owner 
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 brand owner of 
a cosmetic intended to be marketed in the United States 
shall submit electronically to the Secretary, for each cos-
metic that is intended to be marketed in the United 
States, a statement containing— 
‘‘(1) the registration number of the brand 
owner; 
‘‘(2) the brand name and the product name for 
the cosmetic; 
‘‘(3) the applicable use for the cosmetic; 
‘‘(4) the ingredient list as it appears on the cos-
metic label or insert, including the particle size 
range of any nanoscale cosmetic ingredients; 
‘‘(5) any warnings and directions for use from 
the cosmetic label or insert; and 
‘‘(6) the title and full contact information for 
the individual responsible for submitting and main-
taining such statement. 
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‘‘(b) NEW COSMETICS.—Any brand owner that be-
gins to market a cosmetic after the date of the enactment 
of this subchapter shall comply with the requirements of 
subsection (a) beginning on the later of the following: 
‘‘(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. 
‘‘(c) NOTIFICATION OF CHANGES.—The brand owner 
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 brand owner 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). 
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‘‘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 
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 event shall 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. 
‘‘(3) RESPONSIBLE PARTY DEFINED.—For pur-
poses of this subsection, the term ‘responsible party’ 
means a brand owner, manufacturer, packager, re-
tailer, or distributor of the cosmetic. 
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‘‘(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 event; 
‘‘(B) the cosmetic is misbranded; or 
‘‘(C) the cosmetic is marketed, manufac-
tured, packaged, or distributed by an unregis-
tered brand owner; 
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-
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