I 
115TH CONGRESS 
1ST SESSION 
H. R. 575 
To amend the Federal Food, Drug, and Cosmetic Act to establish new 
procedures and requirements for the registration of cosmetic manufac-
turing establishments, the submission of cosmetic and ingredient state-
ments, and the reporting of serious cosmetic adverse events, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 13, 2017 
Mr. SESSIONS introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
establish new procedures and requirements for the reg-
istration of cosmetic manufacturing establishments, the 
submission of cosmetic and ingredient statements, and 
the reporting of serious cosmetic adverse events, 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 AND REFERENCES. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Cosmetic Modernization Amendments of 2017’’. 
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(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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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(eee) 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 
of annual net revenue from 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 2017 
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 2017 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(fff) and shall 
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