‘‘(c) GOOD MANUFACTURING PRACTICES OF OTHER 
PARTIES.—A manufacturer shall not be responsible under 
section 601(f) or this section for the good manufacturing 
practice of its suppliers. A distributor shall not be respon-
sible under section 601(f) or this section for the good man-
ufacturing practice of its manufacturers.’’. 
SEC. 8. SAFETY SUBSTANTIATION FOR COSMETIC INGREDI-
ENTS AND NONFUNCTIONAL CONSTITUENTS. 
Chapter VI (21 U.S.C. 361 et seq.), as amended by 
sections 3, 4, 5, 6, and 7, is further amended by adding 
at the end the following: 
‘‘SEC. 609. COSMETIC INGREDIENTS AND NONFUNCTIONAL 
CONSTITUENTS THAT ARE SAFE FOR USE IN 
COSMETICS. 
‘‘(a) IN GENERAL.—A manufacturer or distributor of 
a cosmetic may rely on this section to substantiate the 
safety of such cosmetic. 
‘‘(b) SAFE INGREDIENTS.—Unless and until prohib-
ited or limited by the Secretary by regulation, the fol-
lowing ingredients are deemed to be adequately substan-
tiated for safe use in cosmetics subject to the requirements 
of good manufacturing practice: 
‘‘(1) Color additives approved by the Secretary 
for use in cosmetics, within any limits established in 
such approval. 
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‘‘(2) Food additives approved by the Secretary 
for direct addition to food for human consumption, 
within any limits established in such approval. 
‘‘(3) Food ingredients that have been deter-
mined by the Secretary to be generally recognized as 
safe for direct addition to food for human consump-
tion, within any limits established in such deter-
mination. 
‘‘(4) Food ingredients for which monographs 
have been included in the Food Chemicals Codex for 
direct addition to food for human consumption, 
within any limits established in such monographs. 
‘‘(5) Pharmaceutical excipients and inactive in-
gredients approved or permitted by the Secretary, 
listed on a Food and Drug Administration website 
for use in drugs for human consumption or for 
which monographs have been included in the Hand-
book of Pharmaceutical Excipients, within any limits 
established in such lists or monographs. 
‘‘(6) Cosmetic ingredients that have been re-
viewed for safety by a qualified nongovernmental or 
governmental expert scientific body, including the 
Cosmetic Ingredient Review Expert Panel, and that 
are the subject of a monograph published in a peer- 
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reviewed scientific journal, within any limits estab-
lished in such monographs. 
‘‘(7) Fragrance ingredients that have been re-
viewed for safety by a qualified nongovernmental or 
governmental expert scientific body, including the 
Research Institute of Fragrance Materials Expert 
Panel, and that are the subject of a monograph pub-
lished in a peer-reviewed scientific journal, within 
any limits established in such monographs. 
‘‘(8) Cosmetic ingredients approved or per-
mitted for use in cosmetics by any of the countries 
listed in section 802(b)(1)(A) as having an adequate 
regulatory authority, within any limits established by 
such regulatory authority. 
‘‘(c) SAFE NONFUNCTIONAL CONSTITUENTS.— 
‘‘(1) DEFINITION.—A nonfunctional constituent 
in a cosmetic is any substance that— 
‘‘(A) has not been intentionally added as a 
separate substance; and 
‘‘(B) serves no technical or cosmetic func-
tion in the cosmetic. 
‘‘(2) ADEQUATE
SUBSTANTIATION.—The fol-
lowing nonfunctional constituents are deemed to be 
adequately substantiated for safe use in cosmetics, 
subject to the requirements of good manufacturing 
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practice and any limits or bans established by the 
Secretary by regulation: 
‘‘(A) The levels approved or permitted for 
nonfunctional constituents by the Secretary for 
color additives for cosmetic use and for food ad-
ditives and generally recognized as safe food in-
gredients for direct human consumption. 
‘‘(B) The levels approved or permitted for 
nonfunctional constituents by the Secretary for 
cosmetics and for food and food ingredients for 
direct human consumption in compliance policy 
guides, guidance, and website statements. 
‘‘(C) The levels approved or permitted for 
nonfunctional constituents by the Secretary or 
the United States Pharmacopeia for oral non-
prescription drugs. 
‘‘(D) The levels approved or permitted for 
nonfunctional constituents by the Environ-
mental Protection Agency for direct human 
consumption in drinking water. 
‘‘(E) The levels for nonfunctional constitu-
ents approved or permitted in cosmetics and 
human food and food ingredients by any of the 
countries listed in section 802(b)(1)(A) as hav-
ing an adequate regulatory authority. 
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‘‘(d) CENTER.—The Secretary shall establish a pro-
gram within the center of the Food and Drug Administra-
tion with primary responsibility for regulating cosmetics 
to evaluate and make determinations, by regulation, on 
the safe use of cosmetics and ingredients and nonfunc-
tional constituents thereof. 
‘‘(e) APPLICATION; PREEMPTION.—A safety deter-
mination accepted or made by the Secretary or established 
under this section shall apply in every State. No State may 
establish or enforce a safety determination for a cosmetic 
or an ingredient or nonfunctional constituent of a cosmetic 
‘‘(f) EFFECTIVE DATE OF REGULATIONS.—Any reg-
ulation or guidance by the Secretary pursuant to this sec-
tion concerning the safety of a cosmetic or an ingredient 
or nonfunctional constituent of a cosmetic shall apply be-
ginning no earlier than the date that is 2 years after the 
date on which such regulation or guidance is issued as 
final, unless the Secretary determines, after public notice 
and an opportunity for public comment, that an earlier 
date of applicability is required to prevent serious adverse 
health consequences or death to humans.’’. 
SEC. 9. NATIONAL COSMETIC REGULATORY DATABANK. 
Chapter VI (21 U.S.C. 361 et seq.), as amended by 
sections 3, 4, 5, 6, 7, and 8, is further amended by adding 
at the end the following: 
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‘‘SEC. 610. NATIONAL COSMETIC REGULATORY DATABANK. 
‘‘(a) IN GENERAL.—For the purpose of consolidating 
information pertaining to the regulation of cosmetic safe-
ty, the Secretary shall establish and maintain in the center 
of the Food and Drug Administration with primary re-
sponsibility for regulating cosmetics a database, to be 
known as the National Cosmetic Regulatory Databank, 
containing— 
‘‘(1) the information submitted to the Secretary 
under sections 605, 606, 607, and 609; and 
‘‘(2) such other information pertaining to the 
regulation of cosmetics as the Secretary deems ap-
propriate. 
‘‘(b) AVAILABILITY.—In the case of information in 
the National Cosmetic Regulatory Databank that is not 
subject to public disclosure under section 552 of title 5, 
United States Code, the Secretary may nonetheless dis-
close such information to the director of a State agency 
on written request by such director demonstrating good 
cause for the disclosure. A director receiving information 
pursuant to the preceding sentence shall agree to limit to 
the disclosure of such information by State officials and 
employees to the same extent such disclosure is limited 
with respect to Federal officials and employees under sec-
tion 301(j) of this Act, section 552(b) of title 5, United 
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States Code, and section 1905 of title 18, United States 
Code, with respect to such information. 
‘‘(c) PREEMPTION.—No State or political subdivision 
thereof may require submission of information that is 
available in the National Cosmetic Regulatory Databank, 
whether in the same or a different format.’’. 
SEC. 10. SPECIAL RULES. 
(a) CERTAIN RULES.—Chapter VI (21 U.S.C. 361 et 
seq.), as amended by sections 3, 4, 5, 6, 7, 8, and 9, is 
further amended by adding at the end the following: 
‘‘SEC. 611. SPECIAL RULES. 
‘‘(a) CONTRACTORS.—The person described in sec-
tion 607(f) with respect to a cosmetic (referred to in this 
section as the ‘responsible party’) may, by agreement, au-
thorize a manufacturer, distributor, or packer of the cos-
metic or a third-party contractor to submit any required 
report of a serious and unexpected adverse event (as such 
term is used in section 607) so long as the responsible 
party directs to the manufacturer, distributor, packer, or 
third-party contractor all such adverse events associated 
with such cosmetic that are reported to the responsible 
party through the address or telephone number described 
in section 607(f). 
‘‘(b) EXEMPTIONS.—The Secretary, on the Sec-
retary’s own initiative or in response to a petition, may 
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establish exemptions from the requirements of sections 
601(f), 605, 606, 607, and 608— 
‘‘(1) for the efficient and cost-effective imple-
mentation of such requirements; or 
‘‘(2) where the cost of compliance exceeds the 
safety benefit to the public.’’. 
(b) COSMETIC
DEFINITION.—Section 201(i) (21 
U.S.C. 321(i)) is amended by adding at the end the fol-
lowing: ‘‘An article described in subparagraph (1) that is 
intended only for topical external use to alter the appear-
ance by temporarily affecting the structure or any function 
of the human skin, and that is not the subject of an ap-
proved new drug application under section 505, shall, for 
purposes of this Act, be treated only as a cosmetic and 
not a drug.’’. 
(c) COLOR ADDITIVES.—Section 721(f) (21 U.S.C. 
379e(f)) is amended— 
(1) by striking ‘‘(f) The Secretary shall’’ and 
inserting ‘‘(f)(1) The Secretary shall’’; and 
(2) by adding at the end the following: 
‘‘(2) A color additive, including mixtures thereof, in-
tended for use in externally applied cosmetics and not in 
the area of the eye is exempt from the requirements of 
this section if it is generally recognized, among experts 
qualified by scientific training and experience to evaluate 
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its safety, as having been shown through scientific proce-
dures to be safe under the conditions of its intended use. 
Notwithstanding the preceding sentence, the Secretary 
may by regulation require certification of batches under 
subsection (c) for any such color additive.’’. 
SEC. 11. PROHIBITED ACTS. 
(a) IN GENERAL.—Section 301 (21 U.S.C. 331) is 
amended by adding at the end the following: 
‘‘(ddd) The failure to register a cosmetic establish-
ment as required under section 605 or to maintain the 
registration current and accurate. 
‘‘(eee) The failure to submit a cosmetic and ingre-
dient statement as required under section 606 or to main-
tain the statement current and accurate. 
‘‘(fff) The failure to submit a serious and unexpected 
adverse event report, or to include on the label of a cos-
metic the domestic telephone number, email address, or 
mailing address through which a report of a serious ad-
verse event may be received, as required under section 
607.’’. 
(b) INFORMATION SECURITY.—Section 301(j) (21 
U.S.C. 331(j)) is amended by inserting ‘‘605, 606, 609,’’ 
after ‘‘573,’’. 
SEC. 12. NATIONAL UNIFORMITY FOR COSMETICS. 
Section 752 (21 U.S.C. 379s) is amended— 
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(1) by amending the section heading to read as 
follows: ‘‘NATIONAL
UNIFORMITY
FOR
COS-
METICS’’; 
(2) by amending subsection (a) to read as fol-
lows: 
‘‘(a) IN GENERAL.—Except as provided in subsection 
(b) or (d) of this section, no State or political subdivision 
of a State may establish or continue in effect any require-
ment for labeling or packaging of a cosmetic.’’; 
(3) by amending subsection (c) to read as fol-
lows: 
‘‘(c) COSMETIC SAFETY.—No State or political sub-
division of a State may establish or continue in effect any 
law, regulation, order, or other requirement— 
‘‘(1) relating directly or indirectly to, or relying 
upon, a human health or safety evaluation of a non-
functional cosmetic constituent, cosmetic ingredient, 
or cosmetic (as defined in section 201(i)(1)), or re-
lating in any way to the safety standard and the 
human health-based requirements, evaluations, and 
determinations under chapter VI, the Poison Preven-
tion Packaging Act of 1970, or the Fair Packaging 
and Labeling Act; or 
‘‘(2) relating directly or indirectly to registra-
tion or listing of cosmetic facilities, establishments, 
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cosmetics, or cosmetic ingredients, reporting of any 
information relating to cosmetics including adverse 
event reporting, cosmetic manufacturing processes 
or standards including good manufacturing practice, 
cosmetic labels or labeling including any general or 
health related warnings or public statement, or the 
requirement of any fees on cosmetic establishments, 
cosmetics, ingredients, or nonfunctional constitu-
ents.’’; and 
(4) by repealing subsection (e). 
SEC. 13. IMPORTATION. 
Section 801(a) (21 U.S.C. 381(a)) is amended by 
adding at the end the following: ‘‘If a cosmetic is being 
imported or offered for import into the United States and 
the importer does not present both the unique cosmetic 
establishment registration number required under section 
605 for the establishment that performs the final portion 
of the manufacturing operation and the unique cosmetic 
and ingredient statement number required under section 
606 for the cosmetic, or the registration or statement 
number is not correct and accurate, the cosmetic shall be 
denied entry.’’. 
SEC. 14. EFFECTIVE DATES. 
(a)(1) The amendments made by sections 4, 5, 6, and 
13 of this Act apply beginning on the later date of— 
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(A) the date that is one year after the Sec-
retary of Health and Human Services promulgates 
final regulations implementing such amendments; or 
(B) the date that is one year after the Sec-
retary of Health and Human Services publishes a 
notice in the Federal Register determining that an 
effective electronic system has been established and 
is fully operational for— 
(i) the submission of cosmetic manufac-
turing establishment registrations, cosmetic and 
ingredient statements, and reports of serious 
cosmetic adverse events; and 
(ii) the National Cosmetic Regulatory 
Databank. 
(2) Until the date applicable under paragraph (1), 
the voluntary establishment registration and voluntary in-
gredient listing programs established in parts 710 and 720 
of title 21, Code of Federal Regulations (as in effect on 
the date of enactment of this Act), shall remain effective 
and shall be fully implemented by the Secretary of Health 
and Human Services. 
(b) The amendments made by sections 7 and 8 apply 
beginning on the date that is two years after the date of 
enactment of this Act. 
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(c) Notwithstanding subsections (a) and (b), the 
amendments made by sections 5 and 7 shall not apply with 
respect to a cosmetic manufacturer with less than 
$5,000,000 of annual net sales of cosmetics until the later 
of— 
(1)(A) with respect to the amendment made by 
section 5, the date that is 36 months after the date 
otherwise applicable under subsection (a); and 
(B) with respect to the amendments made by 
section 7, the date that is 36 months after the date 
otherwise applicable under subsection (b); and 
(2) such later date as may be determined by the 
Secretary of Health and Human Services. 
(d) Except as provided in subsections (a) through (c), 
this Act takes effect on the date of enactment of this Act. 
Æ 
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