if the Secretary determines that the registration was 
not updated in accordance with this section or other-
wise is not current and accurate. 
‘‘(2) NOTICE OF CANCELLATION.—Cancellation 
shall be preceded by notice to the establishment of 
the intent to cancel the registration and the basis 
for such cancellation. 
‘‘(3) TIMELY UPDATE OR CORRECTION.—If the 
registration for the establishment is updated or cor-
rected no later than 7 days after notice is provided 
under paragraph (2), the Secretary shall not cancel 
the registration.’’. 
SEC. 4. COSMETIC AND INGREDIENT STATEMENT. 
Chapter VI, as amended by section 3, is amended by 
adding at the end the following: 
‘‘SEC. 605. COSMETIC AND INGREDIENT STATEMENT. 
‘‘(a) IN GENERAL.—The Secretary shall by regula-
tion require that every domestic and foreign establishment 
engaged in the manufacture of a cosmetic intended to be 
marketed in the United States submit to the Secretary, 
for each cosmetic manufactured in the establishment, 
within 60 days after beginning manufacture of the prod-
uct, a cosmetic and ingredient statement containing— 
‘‘(1) the unique establishment registration num-
ber of the manufacturing establishment where the 
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cosmetic is manufactured or, if the same cosmetic 
product is manufactured in more than one establish-
ment, the unique establishment registration number 
of each establishment 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, and using the name of each ingredient 
established under subsection (b), if any), in descend-
ing order of predominance by weight, except that— 
‘‘(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 filing and maintaining the state-
ment. 
The Secretary shall establish and provide to the person 
submitting the statement a unique cosmetic and ingre-
dient statement number within 15 business days after re-
ceiving the statement. 
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‘‘(b) NAME OF INGREDIENT.—For purposes of this 
section and cosmetic ingredient labeling under section 
701.3 of title 21, Code of Federal Regulations, the name 
of a cosmetic ingredient shall be the name, if any, in the 
most recent edition of the International Cosmetic Ingre-
dient Dictionary, unless the Secretary, after public notice 
and an opportunity for public comment, by regulation or 
guidance establishes a different name for the ingredient. 
‘‘(c) MAINTENANCE.—The information required in a 
statement submitted to the Secretary under subsection (a) 
or in an existing statement under subsection (e)(1) shall 
be maintained as current and accurate by the person who 
filed the statement by withdrawing or amending the state-
ment within 60 days after the information becomes no 
longer current and accurate, except that no amendment 
shall be required for a change in the order of predomi-
nance of the ingredients or for any other type or category 
of change for which the Secretary determines that the 
costs of amending the statement exceed the benefits. 
‘‘(d) 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 
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make publicly available information derived from such 
statements that discloses the names of ingredients used 
in cosmetic products and the number of cosmetic products 
in which a specific ingredient is used but may not make 
publicly available any information that relates to any in-
gredient that is exempt from public disclosure under sec-
tion 720.8 of title 21, Code of Federal Regulations, or that 
discloses at what establishment a cosmetic is manufac-
tured. At the request of the director of a State agency 
responsible for regulating the safety of cosmetics, the Sec-
retary may disclose to such official confidential business 
and trade secret information contained in a statement and 
such official and other State employees who have access 
to such information shall then be subject to the provisions 
of section 301(j), subsection 552(b) of title 5, United 
States Code, and section 1905 of title 18, United States 
Code, with respect to such information. 
‘‘(e) EXEMPTIONS.—Submission of a statement 
under subsection (a) shall not be required for— 
‘‘(1) a cosmetic for which as of the date of en-
actment of this section a cosmetic ingredient state-
ment has been submitted to the Secretary under 
part 710 of title 21, Code of Federal Regulations; or 
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‘‘(2) a cosmetic ingredient exempt from public 
disclosure under section 720.8 of title 21, Code of 
Federal Regulations.’’. 
SEC. 5. SERIOUS AND UNEXPECTED ADVERSE EVENT RE-
PORTING FOR COSMETICS. 
Chapter VI, as amended by sections 3 and 4, is 
amended by adding at the end the following: 
‘‘SEC. 606. 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 information received con-
cerning a serious and unexpected adverse event in the 
United States allegedly associated with the use of the 
product. 
‘‘(b) SUBMISSION OF REPORTS.—A serious and unex-
pected adverse event report shall be submitted to the Sec-
retary no later than 15 business days after information 
concerning the adverse event is received at the place of 
business labeled on the product under section 602(b)(1). 
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‘‘(c) CONTENTS.—No such report shall be submitted 
unless the person submitting the report has been able to 
verify— 
‘‘(1) an identifiable patient; 
‘‘(2) an identifiable reporter; 
‘‘(3) a suspect cosmetic product; and 
‘‘(4) a serious and unexpected adverse event. 
The person submitting the report may include in the sub-
mission any additional pertinent information and may 
supplement the report with additional information at a 
later time. 
‘‘(d) DEFINITIONS.— 
‘‘(1) A ‘serious’ adverse event is one that— 
‘‘(A) results in— 
‘‘(i) death; 
‘‘(ii) a life-threatening experience; 
‘‘(iii) inpatient hospitalization; 
‘‘(iv) a persistent and significant dis-
ability or incapacity; or 
‘‘(v) congenital anomaly or birth de-
fect; or 
‘‘(B) requires, based on reasonable medical 
judgment, a medical or surgical intervention to 
prevent an outcome described under subpara-
graph (A). 
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‘‘(2) An ‘unexpected’ adverse event is one that 
is not identified in the current labeling for the cos-
metic. 
‘‘(e) RULES OF CONSTRUCTION.— 
‘‘(1) A serious and unexpected adverse event re-
port (including all information submitted in the ini-
tial report or added later) submitted to the Sec-
retary under subsection (a) is— 
‘‘(A) a safety report under section 756 
that is subject to the provisions of that section; 
‘‘(B)(i) a record about an individual under 
section 552a of title 5, United States Code; and 
‘‘(ii) a medical or similar file the disclosure 
of which would constitute a violation of section 
552(b)(6) of such title 5, and shall not be pub-
licly disclosed. 
‘‘(2) The submission of a serious and unex-
pected adverse event report in compliance with sub-
section (a) shall not constitute an admission that the 
cosmetic involved caused or contributed to the ad-
verse event. 
‘‘(f) The label of a cosmetic shall bear the domestic 
telephone number through which the person whose name 
and place of business appear on the label may receive a 
report of a serious and unexpected adverse event.’’. 
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SEC. 6. GOOD MANUFACTURING PRACTICE FOR COS-
METICS. 
Chapter VI, as amended by sections 3, 4, and 5, is 
amended by adding at the end the following: 
‘‘SEC. 607. GOOD MANUFACTURING PRACTICES FOR COS-
METICS. 
‘‘The Secretary shall, after public notice and an op-
portunity for public comment, by regulation establish good 
manufacturing practices for the methods used in, or the 
facilities or controls used for, the manufacture, processing, 
filling, or packaging of cosmetics. In issuing such regula-
tions or guidance, the Secretary shall review international 
standards for cosmetic good manufacturing practices to 
ensure that such regulations or guidance are consistent, 
to the extent the Secretary determines practicable and ap-
propriate, with such standards.’’. 
SEC. 7. TOLERANCES FOR NONFUNCTIONAL CONSTITU-
ENTS IN COSMETICS. 
Chapter VI, as amended by sections 3, 4, 5, and 6, 
is amended by adding at the end the following: 
‘‘SEC. 608. TOLERANCES FOR NONFUNCTIONAL CONSTITU-
ENTS IN COSMETICS. 
‘‘(a) IN GENERAL.—The Secretary may on the Sec-
retary’s own initiative, and shall in response to a petition 
submitted by an interested person, including a State, 
under subsection (b) or in accordance with the provisions 
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under subsection (c), after public notice and an oppor-
tunity for public comment, establish by regulation or guid-
ance a tolerance level for a nonfunctional constituent in 
cosmetics. For purposes of this section, a ‘nonfunctional 
constituent’ in a cosmetic is any substance that is an ancil-
lary part of an ingredient or the manufacturing process, 
has not been added as a separate substance, and serves 
no cosmetic function in the cosmetic. The Secretary shall 
establish such a tolerance at a level that is necessary for 
the protection of the public health using generally recog-
nized principles of scientific risk assessment. In issuing 
such a regulation or guidance, the Secretary shall take 
into consideration the level that is reasonably achievable 
through good manufacturing practices and shall review 
tolerance levels for such nonfunctional constituent estab-
lished by authoritative scientific or regulatory organiza-
tions to ensure that such regulation or guidance is con-
sistent, to the extent the Secretary determines practicable 
and appropriate, with such other tolerance levels. 
‘‘(b) PROCEDURE.— 
‘‘(1)(A)(i) If the review of a nonfunctional con-
stituent is being conducted on the Secretary’s own 
initiative or under subsection (c), the Secretary shall 
initiate the proceeding by publishing in the Federal 
Register a proposed regulation or guidance. The 
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Secretary shall provide 180 days for public com-
ment. 
‘‘(ii) Not later than 180 days after the end of 
the period for public comment, the Secretary shall 
publish in the Federal Register a final regulation or 
guidance. 
‘‘(B)(i) If the review of a nonfunctional con-
stituent is being conducted in response to a petition 
submitted by an interested person, the Secretary 
shall publish the petition in the Federal Register for 
public comment not later than 60 days after receipt 
of the petition. All appendices to the petition shall 
be made available on the Secretary’s website. The 
Secretary shall provide 180 days for public com-
ment. 
‘‘(ii) Any such petition shall specify the non-
functional constituent, the proposed tolerance level, 
and the scientific data and information on which the 
proposed tolerance level is based. 
‘‘(iii) Not later than 180 days after the end of 
the period for public comment, the Secretary shall 
publish in the Federal Register a proposed regula-
tion or guidance for public comment. The Secretary 
shall provide 90 days for public comment. 
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‘‘(iv) Not later than 90 days after the end of 
the period for public comment, the Secretary shall 
publish in the Federal Register a final regulation or 
guidance. 
‘‘(C) The Secretary may on the Secretary’s own 
initiative, and shall in response to a petition sub-
mitted by an interested person, reconsider any toler-
ance level established under subparagraph (A) or 
(B), using the same procedure established in this 
paragraph (1). 
‘‘(D) Any regulation or guidance, including any 
revised regulation or guidance, shall apply to cos-
metics first shipped in interstate commerce begin-
ning two years after the date of issue of the regula-
tion or guidance, unless the Secretary determines, 
after public notice and an opportunity for public 
comment, that an earlier effective date is required to 
prevent serious adverse health consequences or 
death. 
‘‘(2) The failure of the Secretary to comply 
with any applicable time period requirement under 
paragraph (1) shall constitute final agency action for 
purposes of judicial review. If the court conducting 
such review determines that the Secretary has failed 
to comply with the requirement, the court shall 
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order the Secretary to comply within a time period 
determined by the court to be appropriate, but in no 
event later than 90 days following the court’s order. 
‘‘(c) PRIORITY LIST.—Within 180 days after the date 
of enactment, the Secretary shall establish a publicly avail-
able electronic priority list of nonfunctional constituents 
in cosmetics for review under this section. The Secretary 
shall begin and complete a review of at least one such pri-
ority nonfunctional constituent every 365 days. 
‘‘(d) APPLICATION.—A tolerance level established by 
the Secretary under this section shall apply in every 
State.’’. 
SEC. 8. COSMETIC INGREDIENT REVIEW. 
Chapter VI, as amended by sections 3, 4, 5, 6, and 
7, is amended by adding at the end the following: 
‘‘SEC. 609. COSMETIC INGREDIENT REVIEW. 
‘‘(a) PANEL’S RECOMMENDATION.—The Cosmetic 
Ingredient Review Expert Panel determination in an ap-
proved final report that a cosmetic ingredient— 
‘‘(1) is safe for use in cosmetic products with-
out the need for specified conditions of use; 
‘‘(2) is safe for use in cosmetic products under 
specified conditions for use; 
‘‘(3) is not safe for use in a cosmetic product 
under any conditions of use; 
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using the ingredient who has adequate safety substan-
tiation and provides that substantiation to the Secretary 
as confidential business or trade secret information that 
shall not be publicly disclosed under section 301(j) of this 
Act or sections 552(b)(4) of title 5 or 1905 of title 18, 
United States Code. 
‘‘(d) EFFECTIVE DATES.—Subsection (b) shall be ef-
fective— 
‘‘(1) three years after the date of enactment for 
ingredients that are the subject of an approved final 
report as of the date of enactment of this subsection; 
and 
‘‘(2) two years after the date of approval of the 
final report for ingredients that are the subject of an 
approved final report after the date of enactment of 
this subsection. 
‘‘(e) SECRETARY’S
REPRESENTATIVE.—The Sec-
retary shall appoint a representative who shall be a mem-
ber of and shall participate in the deliberations of the Cos-
metic Ingredient Review Expert Panel. 
‘‘(f) APPLICATION.—A safety determination accepted 
or made by the Secretary under this section shall apply 
in every State.’’. 
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SEC. 9. COSMETIC INGREDIENT SAFETY. 
Chapter VI, as amended by sections 3, 4, 5, 6, 7, 
and 8, is amended by adding at the end the following: 
‘‘SEC. 610. COSMETIC INGREDIENT SAFETY. 
‘‘(a) IN GENERAL.— 
‘‘(1) The Secretary may on the Secretary’s own 
initiative, and shall in response to a petition sub-
mitted by an interested person, including a State, 
under subsection (b) or in accordance with the provi-
sions under subsection (c), evaluate the safety of any 
ingredient intended for use as or in a cosmetic prod-
uct and, after public notice and an opportunity for 
public comment, establish by regulation or guidance 
the conditions, if any, under which the ingredient is 
safe for human use. 
‘‘(2) In evaluating the safety of any such ingre-
dient, the Secretary shall apply generally recognized 
principles of scientific risk assessment and shall take 
into account— 
‘‘(A) the conditions of use recommended or 
suggested in the labeling; 
‘‘(B) any relevant safety evaluation con-
ducted by the Cosmetic Ingredient Review Ex-
pert Panel; and 
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‘‘(C) all relevant unpublished and pub-
lished safety data and information, including 
human exposure during marketing. 
The Secretary shall determine the conditions for the 
use of the ingredient that are necessary for safe use, 
or that the ingredient is safe for use without the 
need for specified conditions of use, or that there are 
no conditions under which the ingredient can be 
safely used. 
‘‘(b) PROCEDURE.— 
‘‘(1)(A)(i) If the review of an ingredient is 
being conducted on the Secretary’s own initiative or 
under subsection (c), the Secretary shall initiate the 
proceeding by publishing in the Federal Register a 
proposed regulation or guidance. The Secretary shall 
provide 180 days for public comment. 
‘‘(ii) Not later than 180 days after the end of 
the period for public comment, the Secretary shall 
publish in the Federal Register a final regulation or 
guidance. 
‘‘(B)(i) If the review of an ingredient is being 
conducted in response to a petition submitted by an 
interested person, the Secretary shall publish the pe-
tition in the Federal Register for public comment 
not later than 60 days after receipt of the petition. 
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All appendices to the petition shall be made available 
on the Secretary’s website. The Secretary shall pro-
vide 180 days for public comment. 
‘‘(ii) Any such petition shall specify the ingre-
dient, the uses for which the ingredient is intended, 
any proposed conditions of safe use, and the sci-
entific data and information, including human expo-
sure during marketing, on which the proposed condi-
tions are based. 
‘‘(iii) Not later than 180 days after the end of 
the period for public comment, the Secretary shall 
publish in the Federal Register a proposed regula-
tion or guidance for public comment. The Secretary 
shall provide 90 days for public comment. 
‘‘(iv) Not later than 90 days after the end of 
the period for public comment, the Secretary shall 
publish in the Federal Register a final regulation or 
guidance. 
‘‘(C) The Secretary may on the Secretary’s own 
initiative, and shall in response to a petition sub-
mitted by an interested person, reconsider any con-
ditions for safe use established under subparagraph 
(A) or (B), using the same procedure established in 
this paragraph (1). 
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‘‘(D) Any regulation or guidance, including any 
revised regulation or guidance, shall apply to cos-
metics first shipped in interstate commerce begin-
ning two years after the date of issuance of the reg-
ulation or guidance, unless the Secretary determines, 
after public notice and an opportunity for public 
comment, that an earlier effective date is required to 
prevent serious adverse health consequences or 
death. 
‘‘(2) The failure of the Secretary to comply 
with any applicable time period requirement under 
paragraph (1) shall constitute final agency action for 
purposes of judicial review. If the court conducting 
such review determines that the Secretary has failed 
to comply with the requirement, the court shall 
order the Secretary to comply within a time period 
determined by the court to be appropriate, but in no 
event later than 90 days following the court’s order. 
‘‘(c) PRIORITY LIST.—Within 180 days after the date 
of enactment, the Secretary shall establish a publicly avail-
able electronic priority list of cosmetic ingredients. The 
Secretary shall begin and complete a review of at least 
one such priority cosmetic ingredient every 365 days. 
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‘‘(d) APPLICATION.—A safety determination accepted 
or made by the Secretary under this section shall apply 
in every State.’’. 
SEC. 10. NATIONAL COSMETIC REGULATORY DATABANK. 
Chapter VI, as amended by sections 3, 4, 5, 6, 7, 
8, and 9, is amended by adding at the end the following: 
‘‘SEC. 613. NATIONAL COSMETIC REGULATORY DATABANK. 
‘‘In order to consolidate all information pertaining to 
regulation of the safety of cosmetics in one place for use 
by State officials responsible for the regulation of cos-
metics and by the general public, the Secretary shall es-
tablish and maintain in the Center for Food Safety and 
Applied Nutrition (or any successor organization of such 
Center) of the Food and Drug Administration an elec-
tronic National Cosmetic Regulatory Databank that shall 
contain the information submitted to the Secretary under 
sections 604, 605, and 606, and such other information 
pertaining to the regulation of cosmetics as the Secretary 
shall deem appropriate. Information in the National Cos-
metic Regulatory Databank that is not subject to public 
disclosure under section 552 of title 5, United States 
Code, may be disclosed on request to the director of a 
State agency responsible for regulating the safety of cos-
metics, and such official and other State employees who 
have access to such information shall then be subject to 
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the provisions of section 301(j), subsection 552(b) of title 
5, United States Code, and section 1905 of title 18, 
United States Code, with respect to such information. In-
formation available in the National Cosmetic Regulatory 
Databank shall not be subject to State laws on submission 
of that information, whether in the same or a different 
format.’’. 
SEC. 11. COSMETIC RECORDS INSPECTION. 
Chapter VI, as amended by sections 3, 4, 5, 6, 7, 
8, 9, and 10, is amended by adding at the end the fol-
lowing: 
‘‘SEC. 614. COSMETIC RECORDS INSPECTION. 
‘‘If the Secretary has a reasonable belief that a cos-
metic product, and any other related cosmetic product 
that the Secretary reasonably believes is affected in the 
same manner, is adulterated and presents a threat of seri-
ous adverse health consequences or death to humans, each 
person who manufactures, processes, packs, distributes, 
receives, holds, or imports such article shall, at the request 
of an officer or employee duly designated by the Secretary, 
permit such officer or employee, upon presentation of ap-
propriate credentials and a written notice to such person 
setting forth the basis for the Secretary’s belief, at reason-
able times and within reasonable limits and in a reason-
able manner, to have access to and copy records that are 
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needed to assist the Secretary in determining whether the 
cosmetic product is adulterated and presents a threat of 
serious adverse health consequences or death to humans. 
The Secretary shall prevent the disclosure of trade secret 
or confidential information obtained by the Secretary pur-
suant to this section. This section does not extend to cos-
metic product formulas, financial data, pricing data, per-
sonnel data, research data, or sales data other than ship-
ment data.’’. 
SEC. 12. RULES OF CONSTRUCTION. 
Chapter VI, as amended by sections 3, 4, 5, 6, 7, 
8, 9, 10, and 11, is amended by adding at the end the 
following: 
‘‘SEC. 615. RULES OF CONSTRUCTION. 
‘‘(a) COSMETIC PRODUCTS.—Whenever the term cos-
metic or cosmetics is used in sections 604, 605, 606, or 
607, it shall be deemed to refer only to a cosmetic product 
or cosmetic products. A cosmetic product that is subject 
to the caution legend in section 601(a) shall not be subject 
to the provisions of sections 608, 609, or 610. 
‘‘(b) CONTRACTORS.—A requirement for registration 
of a cosmetic establishment under section 604, submission 
of a cosmetic and ingredient statement under section 605, 
or submission of a serious and unexpected adverse event 
report for a cosmetic under section 606, may be satisfied 
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by a person who contracts to perform that function for 
the person who is required to register or make the submis-
sion. 
‘‘(c) EXEMPTIONS.—The Secretary may, in the Sec-
retary’s discretion, establish exemptions from the require-
ments in this title for the efficient and cost-effective imple-
mentation of these provisions. 
‘‘(d) SAFETY.—For purposes of chapter VI, a cos-
metic shall be deemed to be safe if it does not present 
a risk of significant illness or injury to humans under the 
conditions of use recommended or suggested in the label-
ing.’’. 
SEC. 13. CONFORMING AMENDMENTS. 
(a) Section 301 is amended by adding at the end the 
following: 
‘‘(aaa) The failure to reg-
ister a cosmetic establishment re-
quired to be registered under sec-
tion 604 or to maintain the reg-
istration current and accurate. 
‘‘(bbb) The failure to submit 
a cosmetic and ingredient state-
ment required under section 605 
or to maintain the statement cur-
rent and accurate. 
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‘‘(ccc) The failure to submit 
a serious and unexpected adverse 
event report or to include on a 
label 
the 
domestic 
telephone 
number through which a report 
of a serious and unexpected ad-
verse event may be received, as 
required under section 606. 
‘‘(ddd) The failure to comply 
with cosmetic good manufac-
turing 
practices 
established 
under section 607. 
‘‘(eee) The failure to comply 
with a tolerance for a nonfunc-
tional constituent in cosmetics es-
tablished under section 608. 
‘‘(fff) The failure to comply 
with a determination with respect 
to the safety of a cosmetic ingre-
dient under section 609 or sec-
tion 610. 
‘‘(ggg) For a cosmetic prod-
uct that is being imported or of-
fered for import, the failure of 
the importer to present both the 
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unique 
cosmetic 
establishment 
registration number established 
by the Secretary under section 
604(a) and the unique cosmetic 
and ingredient statement number 
established 
by 
the 
Secretary 
under section 605(a).’’. 
(b) Section 301(j) is amended by inserting ‘‘605, 609, 
613,’’ after ‘‘573,’’. 
SEC. 14. NATIONAL UNIFORMITY FOR COSMETICS. 
Section 752 is amended— 
(1) by amending the section heading to read as 
follows: ‘‘NATIONAL
UNIFORMITY
FOR
COS-
METICS’’; 
(2) in subsection (b), by inserting ‘‘or (f)’’ after 
‘‘subsection (a)’’; and 
(3) by adding at the end the following: 
‘‘(f) COSMETIC SAFETY.— 
‘‘(1) IN GENERAL.—Subject to paragraphs (2) 
and (3), no State or political subdivision of a State 
may establish or continue in effect any law, regula-
tion, order, or other requirement relating to cosmetic 
constituents, cosmetic ingredients, or cosmetic prod-
ucts— 
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smartinez on DSK6TPTVN1PROD with BILLS
‘‘(A) that is different from, in addition to, 
or otherwise not identical to, the provisions of 
chapter VI and the requirements and deter-
minations established or accepted by the Sec-
retary thereunder; or 
‘‘(B) relating to registration, listing, or 
fees for establishments, products, ingredients, 
or constituents, or to submission of reports. 
‘‘(2) STATE PETITIONS.—Not later than 180 
days after the date of the enactment of this sub-
section, a State may petition the Secretary under 
section 609 or 610 to establish as a national stand-
ard a tolerance for a nonfunctional constituent or a 
safety requirement for a cosmetic ingredient that ex-
ists in a State law or a duly promulgated State reg-
ulation that is effective on the date of enactment of 
this subsection. Pending completion of the process 
established under section 608 or 610, the State re-
quirement shall remain in effect for that State. 
Upon completion of the process established under 
section 608 or 610, the final regulation or guidance 
published by the Secretary in the Federal Register 
shall be the national safety standard for the con-
stituent or ingredient. 
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‘‘(3) REQUIREMENTS ADOPTED BY STATE PUB-
LIC INITIATIVE OR REFERENDUM.—This subsection 
shall not apply to a State requirement adopted by a 
State public initiative or referendum enacted prior to 
the enactment of this subsection.’’. 
SEC. 15. IMPORTATION. 
Section 801(a) is amended by adding at the end the 
following: 
‘‘If a cosmetic product is being imported or offered 
for import into the United States and the importer does 
not present both the unique cosmetic establishment reg-
istration number established under section 604 and the 
unique cosmetic and ingredient statement number estab-
lished under section 605, or the registration number or 
statement number is not correct and accurate, the cos-
metic product shall be denied entry.’’. 
SEC. 16. AUTHORIZATION OF APPROPRIATIONS. 
Chapter VI, as amended by sections 3, 4, 5, 6, 7, 
8, 9, 10, 11, and 12, is amended by adding at the end 
the following: 
‘‘SEC. 616. AUTHORIZATION OF APPROPRIATIONS. 
‘‘To carry out this chapter and section 752, there is 
authorized to be appropriated $11,700,000 for each of fis-
cal years 2014 through 2018. The Secretary shall annu-
ally allocate for personnel and functions for the regulation 
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of cosmetics during the period of such fiscal years at least 
$11,700,000 out of the total funds appropriated for the 
Food and Drug Administration, 10 full-time equivalent 
personnel in the Office of Regulatory Affairs, and 1 full- 
time equivalent lawyer in the Office of Chief Counsel.’’. 
SEC. 17. EFFECTIVE DATES. 
(a) Sections 3, 4, 5, 6, and 15 of this Act shall be 
effective on the later date of— 
(1) one year after the Secretary of Health and 
Human Services promulgates final regulations or 
guidance implementing these sections; or 
(2) one year after the Secretary of Health and 
Human Services publishes a notice in the Federal 
Register determining that an effective electronic sys-
tem has been established and is operational for the 
submission of cosmetic manufacturing establishment 
registrations, cosmetic and ingredient filings, reports 
of serious and unexpected cosmetic adverse events, 
good manufacturing practices for cosmetics, and the 
National Cosmetic Regulatory Databank. 
(b) The remaining sections of this Act shall be effec-
tive on the date of the enactment of this Act. 
Æ 
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