(b) REFERENCES TO THE FEDERAL FOOD, DRUG, 
AND COSMETIC ACT.—Except as otherwise specified, 
whenever in this Act an amendment is expressed in terms 
of an amendment to a section or other provision, the ref-
erence shall be considered to be made to a section or other 
provision of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.). 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is as follows: 
Sec. 1. Short title and references. 
Sec. 2. Table of contents. 
Sec. 3. Definitions. 
Sec. 4. Registration of cosmetic manufacturing establishments. 
Sec. 5. Cosmetic and ingredient statement. 
Sec. 6. Serious and unexpected adverse event reporting for cosmetics. 
Sec. 7. Good manufacturing practice. 
Sec. 8. Safety substantiation for cosmetic ingredients and nonfunctional con-
stituents. 
Sec. 9. National Cosmetic Regulatory Databank. 
Sec. 10. Special rules. 
Sec. 11. Prohibited acts. 
Sec. 12. National uniformity for cosmetics. 
Sec. 13. Importation. 
Sec. 14. Effective dates. 
SEC. 3. DEFINITIONS. 
Chapter VI (21 U.S.C. 361 et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 604. DEFINITIONS. 
‘‘In this chapter: 
‘‘(1) 
COSMETIC.—Notwithstanding 
section 
201(i), for purposes of this section and sections 
601(f), 605, 606, 607, 608, and 801(a), the term 
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‘cosmetic’ includes only articles described in section 
201(i)(1). 
‘‘(2) ESTABLISHMENT.— 
‘‘(A) The term ‘establishment’ means a 
place of business where a cosmetic is manufac-
tured, without further processing outside or 
within the United States. 
‘‘(B) A cosmetic shall not be considered to 
have undergone further processing for purposes 
of subparagraph (A) solely on the basis that 
packaging or other labeling was added or 
changed or that any similar activity of a de 
minimis nature was carried out with respect to 
the cosmetic. 
‘‘(C) The term ‘domestic establishment’ 
means an establishment location in any State. 
‘‘(D) The term ‘foreign establishment’ 
means an establishment location outside the 
United States. 
‘‘(3) SAFE; SAFETY.— 
‘‘(A) The terms ‘safe’ and ‘safety’, with re-
spect to a cosmetic, mean the cosmetic does not 
present a significant risk of serious illness or 
injury to humans under the conditions of use 
recommended or suggested in the labeling of 
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the cosmetic, including the limitation of ‘for 
professional use’ only. 
‘‘(B) For purposes of subparagraph (A), 
the term ‘professional’ means an individual 
who— 
‘‘(i) is licensed by an official State au-
thority to practice in the field of cosme-
tology, nail care, barbering, and or esthet-
ics; and 
‘‘(ii) is in compliance with all require-
ments of the State for such licensing.’’. 
SEC. 4. REGISTRATION OF COSMETIC MANUFACTURING ES-
TABLISHMENTS. 
Chapter VI (21 U.S.C. 361 et seq.), as amended by 
section 3, is further amended by adding at the end the 
following: 
‘‘SEC. 605. REGISTRATION OF COSMETIC MANUFACTURING 
ESTABLISHMENTS. 
‘‘(a) IN GENERAL.— 
‘‘(1) REGISTRATION.—The Secretary shall by 
regulation require that every domestic and foreign 
establishment engaged in the manufacture of a cos-
metic intended to be sold in the United States that 
is not exempt under subsection (e) be registered with 
the Secretary within 60 business days after the first 
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commercial sale of a cosmetic in the United States. 
If a cosmetic is processed in more than one estab-
lishment, registration shall be required under this 
section only for the establishment that performs the 
final portion of the manufacturing operation. The 
single registration shall cover all such cosmetics 
manufactured by the establishment. The registration 
shall state only the name of the company or other 
organization name of the establishment, the city, 
street address, State, and country of the establish-
ment, and the title, email address, and telephone 
number for the office within the establishment that 
is responsible for submitting and maintaining the 
registration. For a foreign establishment, the reg-
istration shall include the contact information for 
the initial United States agent of the establishment. 
‘‘(2) UNIQUE
NUMBER.—The Secretary shall 
establish and provide to each registrant under this 
section a unique cosmetic establishment registration 
number within 15 business days after receiving the 
registration. If the Secretary does not provide a 
unique cosmetic establishment registration number 
within such 15 business days, any requirement 
under this Act for such number shall be deemed to 
be inapplicable until 30 business days after such 
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number is received by the person who submitted the 
registration. Where more than one person registers 
the same establishment, the Secretary shall provide 
only one unique establishment registration number 
for the establishment. The unique cosmetic estab-
lishment number shall not be required to be included 
in cosmetic labeling. 
‘‘(b) MAINTENANCE.—The information required in a 
registration under subsection (a) or in an existing reg-
istration under subsection (e)(1)(A) shall be maintained 
as current and accurate by the registrant by withdrawing 
or amending the registration within 60 business days after 
the information becomes no longer current and accurate. 
‘‘(c) ENFORCEMENT.—The Secretary shall enforce 
this section under section 301(ddd) and shall not suspend 
or revoke a registration under this section. 
‘‘(d) LIST.—The Secretary shall compile and main-
tain an up-to-date and publicly available electronic list of 
establishments that are registered under this section. 
‘‘(e) EXEMPTIONS.— 
‘‘(1) IN
GENERAL.—Registration under sub-
section (a) shall not be required for any entity based 
on such entity operating as— 
‘‘(A) an establishment that as of the date 
of enactment of this section is registered as a 
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cosmetic establishment under part 710 of title 
21, Code of Federal Regulations (as in effect on 
such date); 
‘‘(B) a beauty shop or salon or spa; 
‘‘(C) a cosmetic retailer, including any 
such retailer that is— 
‘‘(i) an individual sales representative; 
‘‘(ii) a wholesale or retail distribution 
or sales facility; or 
‘‘(iii) a pharmacy or other person or 
organization that— 
‘‘(I) compounds cosmetics at a 
single location and administers, dis-
penses, or distributes such cosmetics 
at retail from that location; and 
‘‘(II) does not otherwise manu-
facture or package cosmetics from 
that location; 
‘‘(D) a health care provider, including a 
hospital or clinic; 
‘‘(E) a public health agency or other non-
profit entity; 
‘‘(F) a hotel or other entity that provides 
complimentary cosmetics; 
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‘‘(G) a trade show or other venue where 
cosmetic samples are provided; 
‘‘(H) an establishment that manufactures, 
prepares, compounds, or processes cosmetics for 
use in research, teaching, or chemical analysis 
or pilot plant production; 
‘‘(I) a handcrafted soap or cosmetic made 
in a home, a community facility, or a similar es-
tablishment; or 
‘‘(J) a business with less than $1,000,000 
annual net sales of cosmetics. 
‘‘(2) ADDITIONAL
EXEMPTIONS.—The Sec-
retary may supplement the list of exemptions under 
paragraph (1) with additional exemptions for per-
sons and activities where the cost of compliance ex-
ceeds the safety benefit to the public.’’. 
SEC. 5. COSMETIC AND INGREDIENT STATEMENT. 
Chapter VI (21 U.S.C. 361 et seq.), as amended by 
sections 3 and 4, is further amended by adding at the end 
the following: 
‘‘SEC. 606. COSMETIC AND INGREDIENT STATEMENT. 
‘‘(a) IN GENERAL.—The Secretary shall by regula-
tion require that every domestic establishment and foreign 
establishment engaged in the manufacture of a cosmetic 
intended to be sold in the United States submit to the 
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Secretary, for each cosmetic so manufactured in the estab-
lishment, except such cosmetics manufactured by entities 
exempted by section 605(e) from registration under sec-
tion 605, within 60 business days after the first commer-
cial sale of the cosmetic, a cosmetic and ingredient state-
ment. The Secretary shall require the statement to contain 
only— 
‘‘(1) the unique establishment registration num-
ber of the manufacturing establishment where the 
cosmetic is manufactured or, if the same cosmetic is 
manufactured in more than one establishment, the 
unique establishment registration number of each es-
tablishment where it is manufactured; 
‘‘(2) the brand name or names for the cosmetic; 
‘‘(3) the applicable cosmetic category or cat-
egories for the cosmetic; 
‘‘(4) the ingredients in the cosmetic (in accord-
ance with section 701.3 of title 21, Code of Federal 
Regulations (as in effect on the date of enactment 
of the Cosmetic Modernization Amendments of 2015 
and including any successor regulations), and using 
the name of each ingredient established under sub-
section (d), if any), in descending order of predomi-
nance by weight, except that— 
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‘‘(A) flavors and fragrances may be des-
ignated as such; and 
‘‘(B) all variations in color, flavor, or fra-
grance may be included in one statement; and 
‘‘(5) the title, email address, and telephone 
number for the office within the establishment that 
is responsible for submitting and maintaining the 
statement. 
‘‘(b) UNIQUE NUMBER.—The Secretary shall estab-
lish and provide to the office submitting a statement re-
quired by subsection (a) a unique cosmetic and ingredient 
statement number within 15 business days after receiving 
the statement. If the Secretary does not provide a unique 
cosmetic and ingredient statement number within such 15- 
business-day period, any requirement under this Act for 
such number shall be deemed to be inapplicable until the 
date that is 30 business days after such number is received 
by the office that submitted the statement. The unique 
cosmetic and ingredient statement number shall not be re-
quired to be included in cosmetic labeling. 
‘‘(c) CHANGE IN LABELING.—An establishment shall 
not be required to submit a new or revised statement 
under subsection (a) because of a change in labeling ex-
cept to the extent necessary to maintain the accuracy of 
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the information included in a statement under subsection 
(a). 
‘‘(d) NAME OF INGREDIENT.—For purposes of this 
section and cosmetic ingredient labeling under section 
701.3 of title 21, Code of Federal Regulations (as in effect 
on the date of enactment of the Cosmetic Modernization 
Amendments of 2015 and including any successor regula-
tions), the name of a cosmetic ingredient shall be the 
name, if any, in the most recent edition of the Inter-
national Cosmetic Ingredient Dictionary, unless the Sec-
retary by regulation establishes a different name for the 
ingredient. 
‘‘(e) MAINTENANCE.—The information required in a 
statement submitted to the Secretary under subsection (a) 
or in an existing statement under subsection (g)(1) shall 
be maintained as current and accurate by the office that 
filed the statement by withdrawing or amending the state-
ment within 60 business days after the information be-
comes no longer current and accurate, except that no 
amendment shall be required for a change in the order 
of predominance of the ingredients or for any other type 
or category of change for which the costs of amending the 
statement exceed the safety benefit to the public. 
‘‘(f) ENFORCEMENT.—The Secretary shall enforce 
subsections (a) and (e) under section 301(eee) and shall 
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not suspend or revoke a cosmetic and ingredient state-
ment. 
‘‘(g) LIST.—The Secretary shall compile and main-
tain an up-to-date and publicly available electronic list of 
cosmetics and ingredients for which statements are sub-
mitted under this section. A statement submitted pursuant 
to this section shall not be subject to disclosure under sec-
tion 552 of title 5, United States Code. The Secretary may 
make publicly available information derived from such 
statements that discloses the names of ingredients used 
in cosmetics and the number of cosmetics in which a spe-
cific ingredient is used, but may not make publicly avail-
able any information that relates to any ingredient that 
is exempt from public disclosure under section 720.8 of 
title 21, Code of Federal Regulations (as in effect on the 
date of enactment of the Cosmetic Modernization Amend-
ments of 2015 and including any successor regulations), 
or that discloses at what establishment a cosmetic is man-
ufactured. At the written request of the director of a State 
agency responsible for regulating the safety of cosmetics 
stating good cause therefor, the Secretary may disclose to 
such official confidential business and trade secret infor-
mation contained in a statement and such official and 
other State employees who have access to such informa-
tion shall then be subject to the provisions of section 
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301(j) of this Act, section 552(b) of title 5, United States 
Code, and section 1905 of title 18, United States Code, 
with respect to such information. 
‘‘(h) EXEMPTIONS.—Submission of a statement 
under subsection (a) shall not be required— 
‘‘(1) for a cosmetic for which as of the date of 
enactment of this section a cosmetic ingredient 
statement has been submitted to the Secretary 
under part 710 of title 21, Code of Federal Regula-
tions (as in effect on the date of enactment of the 
Cosmetic Modernization Amendments of 2015); 
‘‘(2) for a cosmetic ingredient exempt from 
public disclosure under section 720.8 of title 21, 
Code of Federal Regulations (as in effect on the 
date of enactment of the Cosmetic Modernization 
Amendments of 2015 and including any successor 
regulations); or 
‘‘(3) by an entity to the extent such entity is 
exempted by section 605(e) from registration under 
section 605.’’. 
SEC. 6. SERIOUS AND UNEXPECTED ADVERSE EVENT RE-
PORTING FOR COSMETICS. 
(a) IN GENERAL.—Chapter VI (21 U.S.C. 361 et 
seq.), as amended by sections 3, 4, and 5, is further 
amended by adding at the end the following: 
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‘‘SEC. 607. SERIOUS AND UNEXPECTED ADVERSE EVENT RE-
PORTING FOR COSMETICS. 
‘‘(a) IN GENERAL.—The Secretary shall by regula-
tion require that a domestic or foreign manufacturer, 
packer, or distributor whose name appears on the label 
pursuant to section 602(b)(1) of a cosmetic marketed in 
the United States submit to the Secretary under sub-
section (b) a report containing— 
‘‘(1) information received concerning any seri-
ous and unexpected adverse event in the United 
States allegedly associated with the use of the cos-
metic for which it is reasonably likely that the ad-
verse event was caused by the cosmetic when used 
as recommended or suggested in the labeling; and 
‘‘(2) a copy of the label for the cosmetic. 
‘‘(b) SUBMISSION OF REPORTS.—A report on an ad-
verse event under subsection (a) shall be submitted to the 
Secretary not later than 15 business days after informa-
tion concerning the adverse event is received at the place 
of business labeled on the cosmetic pursuant to section 
602(b)(1). 
‘‘(c) REQUIRED CONTENTS.—A report under sub-
section (a) shall include all of the following information: 
‘‘(1) An identifiable patient. 
‘‘(2) An identifiable reporter. 
‘‘(3) A suspect cosmetic or component thereof. 
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‘‘(4) A serious adverse event. 
‘‘(d) ADDITIONAL CONTENTS; SUPPLEMENTAL RE-
PORTING.—The person submitting a report under sub-
section (a) may— 
‘‘(1) include pertinent information in addition 
to the information listed in subsection (c); and 
‘‘(2) after submitting the initial report, supple-
ment the report with additional information. 
‘‘(e) SPECIAL RULES.— 
‘‘(1) PROTECTED
INFORMATION.—A serious 
and unexpected adverse event report (including all 
information submitted in the initial report or added 
later) submitted under subsection (a)— 
‘‘(A) shall be considered to be a safety re-
port under section 756 that is subject to the 
provisions of that section; and 
‘‘(B) shall be considered to be a record 
about an individual under section 552a of title 
5, United States Code, and a medical or similar 
file the disclosure of which would constitute a 
violation of section 552 of such title 5, and 
shall not be publicly disclosed unless all person-
ally identifiable information is redacted. 
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‘‘(2) NO TREATMENT AS ADMISSION.—The sub-
mission of a serious and unexpected adverse event 
report in compliance with subsection (a)— 
‘‘(A) shall not be construed as an admis-
sion that the cosmetic involved caused or con-
tributed to the adverse event; and 
‘‘(B) may be accompanied by a statement 
that denies that the report constitutes an ad-
mission that the cosmetic involved caused or 
contributed to the adverse event. 
‘‘(3) INCLUSION OF STATEMENT IN PUBLIC DIS-
CLOSURE.—In releasing any report under subsection 
(a) or portion thereof for public disclosure, the Sec-
retary shall include any statement under paragraph 
(2)(B). 
‘‘(f) LABELING.—The label of a cosmetic shall bear 
the domestic telephone number, email address, or mailing 
address through which the person whose name and place 
of business appear on the label may receive a report of 
a serious adverse event. 
‘‘(g) EXEMPTION.—The Secretary may, by regula-
tion, establish an exemption to the requirements under 
subsections (b) and (d) if the Secretary determines that 
such exemption would have no adverse effect on public 
health. 
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‘‘(h) DEFINITIONS.—In this section: 
‘‘(1) The term ‘serious’, with respect to an ad-
verse event, means— 
‘‘(A) resulting in— 
‘‘(i) death; 
‘‘(ii) a life-threatening experience; 
‘‘(iii) inpatient hospitalization; 
‘‘(iv) a persistent and significant dis-
ability or incapacity; 
‘‘(v) a congenital anomaly or birth de-
fect; or 
‘‘(vi) permanent disfiguration; or 
‘‘(B) requiring, based on reasonable med-
ical judgment, a medical or surgical interven-
tion to prevent an outcome described under 
subparagraph (A). 
‘‘(2) The term ‘unexpected’, with respect to an 
adverse event, means not identified on the cosmetic 
label.’’. 
(b) MISBRANDING.—Section 602 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amend-
ed by adding at the end the following: 
‘‘(g) If it is a cosmetic that is marketed in the United 
States, unless the label of such cosmetic includes a domes-
tic address or domestic phone number through which a 
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report of a serious and unexpected adverse event (as such 
term is used in section 607) associated with the use of 
such cosmetic may be submitted to the person described 
in section 607(f).’’. 
SEC. 7. GOOD MANUFACTURING PRACTICE. 
(a) PROHIBITION.—Section 601 (21 U.S.C. 361) is 
amended by adding at the end the following: 
‘‘(f) If it has been manufactured under conditions 
that do not satisfy the principles and standards for good 
manufacturing practice established under section 608 and 
as a result presents a significant risk of serious adverse 
health consequences or death to humans.’’. 
(b) PRINCIPLES AND STANDARDS.—Chapter VI (21 
U.S.C. 361 et seq.), as amended by sections 3, 4, 5, and 
6, is further amended by adding at the end the following: 
‘‘SEC. 608. GOOD MANUFACTURING PRACTICE. 
‘‘(a) IN GENERAL.—The Secretary may by regulation 
establish principles and standards for good manufacturing 
practice for the manufacture of cosmetics in accordance 
with paragraphs (a) and (d) of section 601. 
‘‘(b) NOTICE AND COMMENT.—A regulation under 
subsection (a) shall be promulgated only after providing 
notice and an opportunity for comment in accordance with 
chapter 5 of title 5, United States Code. 
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