I 
115TH CONGRESS 
2D SESSION 
H. R. 6903 
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 
SEPTEMBER 26, 2018 
Ms. SCHAKOWSKY introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committee 
on Education and the Workforce, for a period to be subsequently deter-
mined 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 
2018’’. 
(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 serious adverse events. 
‘‘Sec. 623. Nonconfidential information. 
‘‘Sec. 624. Ban on use of animal testing. 
‘‘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 a technical or 
functional effect in the cosmetic, including the 
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components of intentionally added fragrance in-
gredients and colorants and intentional break-
down products of an added chemical that also 
have a functional or technical effect in the cos-
metic; 
‘‘(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 
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‘‘(B) that has annual sales receipts for cos-
metic products that do not exceed $2,000,000. 
‘‘(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. 
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‘‘(10) REPRODUCTIVE
OR
DEVELOPMENTAL 
TOXICITY.—With respect to an ingredient or cos-
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, a con-
genital anomaly or birth defect, serious and 
persistent rashes or infections, significant hair 
loss, permanent or significant alteration of ap-
pearance, or impacts to maternal health, includ-
ing placentia previa, gestational diabetes, and 
miscarriage; 
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‘‘(B) an event that requires, based on a 
reasonable medical judgment, a medical or sur-
gical intervention; or 
‘‘(C) any other serious adverse health-re-
lated event associated with the use of the prod-
uct. 
‘‘(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, 
infants, children, the elderly, individuals with a com-
promised immune system, and highly exposed popu-
lations, including workers employed by a hair salon, 
nail salon, beauty salon, spa, or cosmetic manufac-
turing plant. 
‘‘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 
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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 
‘‘(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. 
‘‘(3) 
NEW
ESTABLISHMENTS.—Any 
brand 
owner that initially brings a cosmetic to market 
after the date on which the requirements of para-
graph (1) apply shall, not later than 60 days after 
the date on which the establishment brings a cos-
metic to market, register with the Secretary and pay 
the applicable fee, as required under paragraph (1). 
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‘‘(b) SUBMISSION OF REGISTRATION.— 
‘‘(1) IN GENERAL.—In order to register under 
subsection (a), an establishment (referred to in this 
section as the ‘registrant’) shall submit to the Sec-
retary, with respect to any cosmetics that the estab-
lishment brings to market, all of the following: 
‘‘(A) Any information necessary to notify 
the Secretary of the name, address, and legal 
status of each establishment at which, and all 
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-
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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, in-
cluding by posting such list on the public Web 
site of the Food and Drug Administration; 
‘‘(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— 
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‘‘(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 
‘‘(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; 
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‘‘(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 
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. 
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‘‘(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 for retail sale and 
including cosmetics for professional use) bears a declara-
tion 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 
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 
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