I 
117TH CONGRESS 
1ST SESSION H. R. 5539 
To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure 
the supply chain transparency needed for companies to make safe cos-
metics, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 8, 2021 
Ms. SCHAKOWSKY introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend title VI of the Federal Food, Drug, and Cosmetic 
Act to ensure the supply chain transparency needed for 
companies to make safe cosmetics, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Cosmetic Supply Chain 
Transparency Act of 2021’’. 
SEC. 2. COSMETIC REGULATION. 
Chapter VI of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 361 et seq.) is amended— 
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(1) by inserting before section 601 the fol-
lowing: 
‘‘Subchapter A—Adulterated and Misbranded 
Cosmetics’’; 
and 
(2) by adding at the end the following: 
‘‘Subchapter B—Supply Chain Transparency 
‘‘SEC. 611. DEFINITIONS. 
‘‘In this subchapter: 
‘‘(1) BRAND OWNER.—The term ‘brand owner’ 
means the entity responsible for bringing a cosmetic 
to market. 
‘‘(2) FLAVOR OR FRAGRANCE COMPANY.—The 
term ‘flavor or fragrance company’ means an entity 
that makes or supplies fragrance or flavor ingredi-
ents or fragrance or flavor formulations. 
‘‘(3) FORMULATING
LABORATORY.—The term 
‘formulating laboratory’ means an entity that sup-
plies a finished cosmetic product to a retailer or cos-
metic company to sell under the retailer or cosmetic 
company’s brand name. 
‘‘(4) HARMFUL TO HUMAN HEALTH OR THE 
ENVIRONMENT.—The phrase ‘harmful to human 
health or the environment’ means, with respect to a 
nonfunctional constituent— 
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‘‘(A) being— 
‘‘(i) a reproductive or developmental 
toxicant; 
‘‘(ii) persistent, bioaccumulative, and 
toxic; 
‘‘(iii) an allergen; or 
‘‘(iv) an endocrine disruptor, car-
cinogen, or mutagen; and 
‘‘(B) present on the most recent version in 
effect of any of the following lists: 
‘‘(i) Chapter 6.6 of the California 
Safe Drinking Water and Toxic Enforce-
ment Act of 1986 (sections 25249.5 
through 25249.14 of the California Health 
and Safety Code), List of Reproductive 
and Developmental Toxicants and Carcino-
gens. 
‘‘(ii) Chemicals classified as ‘Per-
sistent, Bioaccumulative and Toxic’ by the 
Toxics Release Inventory published by the 
Environmental Protection Agency pursuant 
to section 313 of the Emergency Planning 
and Community Right-to-Know Act of 
1986. 
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‘‘(iii) European Union Regulation 
1223/2009/EC on Cosmetic Products, as 
amended by Regulation (EU) 2020/1683, 
Annex II–Prohibited Substances. 
‘‘(iv) Annex III of European Union 
Cosmetics Regulation No. 1223/2009, as 
required to be disclosed pursuant to Euro-
pean Union Detergents Regulation No. 
21648/2004. 
‘‘(v) Chemicals included in the Euro-
pean Union Candidate List of Substances 
of Very High Concern in accordance with 
Article 59 of the REACH Regulation (EC) 
No. 1907/2006 on the basis of fulfilling 
the criteria defined in Article 57(f) for en-
docrine-disrupting properties. 
‘‘(vi) Substances classified as carcino-
gens, mutagens, or reproductive toxicants 
in Appendices 1–6 of Annex XVII to Regu-
lation (EC) No. 1907/2006 of the Euro-
pean Union’s Registration, Evaluation, 
Authorisation, and Restriction of Chemi-
cals (REACH) law, as revised by the Com-
mission Regulation (EU) 2020/2096 of 
December 15, 2020. 
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‘‘(vii) Group 1, 2A, or 2B carcinogens 
identified by the International Agency for 
Research on Cancer of the World Health 
Organization. 
‘‘(viii) Any other list the Secretary de-
termines appropriate for purposes of this 
subchapter. 
‘‘(5) 
INGREDIENT.—The 
term 
‘ingredient’ 
means an intentionally added chemical in a cosmetic 
that has a technical or functional effect, including— 
‘‘(A) the breakdown products of an inten-
tionally added chemical that also have a func-
tional or technical effect in the cosmetic; 
‘‘(B) a fragrance, flavor, preservative, or 
colorant (and the components thereof); and 
‘‘(C) any individual component that the 
Secretary deems to be an ingredient for pur-
poses of this subchapter. 
‘‘(6) INCIDENTAL COMPONENT.—The term ‘in-
cidental component’ means— 
‘‘(A) a chemical added during the manu-
facturing process at any point in a cosmetic’s, 
or an ingredient’s, supply chain, but which has 
no functional or technical effect in the finished 
cosmetic; or 
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‘‘(A) is used in the manufacture of a cos-
metic for commercial distribution; and 
‘‘(B) is supplied to a cosmetic manufac-
turer, packer, or distributor by a cosmetic raw 
material manufacturer or supplier. 
‘‘(10) SUPPLIER.—The term ‘supplier’— 
‘‘(A) means an entity that supplies a cos-
metic, cosmetic packaging, or an ingredient or 
raw material of a cosmetic or cosmetic pack-
aging; and 
‘‘(B) includes any such entity that is a 
manufacturer, a formulating laboratory, or a 
fragrance or flavor company. 
‘‘SEC. 612. COSMETIC AND INGREDIENT SAFETY INFORMA-
TION. 
‘‘At the request of a brand owner of a cosmetic, a 
supplier of the cosmetic or any ingredient therein shall, 
not later than 90 days after receipt of such request, pro-
vide to the brand owner, with respect to the cosmetic or 
ingredient, any of the following information: 
‘‘(1)(A) Functions and uses. 
‘‘(B) The human health and environmental haz-
ards. 
‘‘(C) The physical and chemical properties. 
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‘‘(D) The Chemical Abstracts Services Registry 
number of any such ingredient. 
‘‘(E) Environmental exposure and fate informa-
tion. 
‘‘(F) Any other information used to substan-
tiate the safety of such ingredient. 
‘‘(2) A full and complete listing of ingredients 
in fragrance or flavor formulations, preservative sys-
tems, or other ingredient formulations, including the 
presence of any allergens. 
‘‘(3) A full and complete listing of ingredients 
in a finished cosmetic presented in descending order 
of predominance by weight, except that ingredients 
present in amounts of 1 percent or less by weight 
can be placed in any order at the end of the ingre-
dient statement. 
‘‘(4) A certificate of analysis for the ingredient. 
‘‘SEC. 613. PROCESS FOR ESTABLISHING AN FDA LIST OF 
NONFUNCTIONAL CONSTITUENTS KNOWN OR 
REASONABLY EXPECTED TO BE PRESENT IN 
COSMETICS AND INGREDIENTS. 
‘‘(a) IN GENERAL.—The Secretary shall create and 
maintain a list of nonfunctional constituents to guide test-
ing under this subchapter conducted by suppliers of cos-
metics and ingredients. 
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‘‘(b) CONTENTS.—The list under subsection (a) shall 
consist of nonfunctional constituents that are— 
‘‘(1) known or reasonably expected to be 
present in cosmetics or ingredients; and 
‘‘(2) subject to subsection (e)(2), harmful to 
human health or the environment. 
‘‘(c) IDENTIFICATION OF INGREDIENTS AND COS-
METICS.—For each nonfunctional constituent on the list 
under subsection (a), the Secretary shall identify the spe-
cific ingredient or cosmetic, or category of ingredients or 
cosmetics, in which the nonfunctional constituent is known 
or reasonably expected to be present. 
‘‘(d) INITIAL LIST.— 
‘‘(1) IN GENERAL.—In creating the initial list 
under subsection (a), the Secretary shall— 
‘‘(A) publish a proposed list and provide 
an opportunity for public comment on such pro-
posed list for a period of 60 days; and 
‘‘(B) not later than 18 months after the 
date of enactment of the Cosmetic Supply 
Chain Transparency Act of 2021, finalize and 
publish the list. 
‘‘(2) ADVISORY COMMITTEE.— 
‘‘(A) IN
GENERAL.—Not later than 9 
months after the date of enactment of the Cos-
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metic Supply Chain Transparency Act of 2021, 
the Secretary shall convene an advisory com-
mittee to advise the Secretary on— 
‘‘(i) creating the initial list under sub-
section (a); and 
‘‘(ii) best practices related to analyt-
ical testing for nonfunctional constituents 
in cosmetics and ingredients. 
‘‘(B) MEMBERSHIP.—The membership of 
the advisory committee convened under sub-
paragraph (A) shall consist of an equal number 
of— 
‘‘(i) representatives from industry; 
‘‘(ii) representatives from the non-
profit community; 
‘‘(iii) representatives from the sci-
entific community; and 
‘‘(iv) representatives from the medical 
and public health community. 
‘‘(C) TERMINATION.—The Secretary shall 
terminate the advisory committee convened 
under this paragraph upon the finalization of 
the initial list pursuant to paragraph (1). 
‘‘(e) UPDATES.—Not less than annually after the fi-
nalization pursuant to subsection (d) of the initial list 
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under subsection (a), and not less than annually there-
after, the Secretary shall— 
‘‘(1) review the list under subsection (a); 
‘‘(2) after providing a period of at least 30 days 
for public comment, update the list by adding non-
functional constituents that are known or reasonably 
expected to be present in a cosmetic or ingredient as 
specified in subsection (b)(1) and— 
‘‘(A) are determined by the Secretary to 
meet 
the 
standard 
specified 
in 
section 
611(4)(A) based on existing and emerging 
science; or 
‘‘(B) have been added to one of the lists in 
section 611(4)(B); and 
‘‘(3) update the list by adding any nonfunc-
tional constituent whose addition was approved pur-
suant to a petition under subsection (f). 
‘‘(f) PETITION PROCESS
FOR ADDING NONFUNC-
TIONAL CONSTITUENTS OR NEW LISTS.— 
‘‘(1) IN GENERAL.—Any person may petition, 
in accordance with paragraph (3), to add— 
‘‘(A) a nonfunctional constituent to the list 
under subsection (a); or 
‘‘(B) a new list to the lists specified in sec-
tion 611(4)(B). 
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‘‘(2) DEVELOPMENT
OF
PROCESS.—The Sec-
retary— 
‘‘(A) not later than 24 months after the 
date of enactment of the Cosmetic Supply 
Chain Transparency Act of 2021, shall develop 
and publish the process for submitting a peti-
tion under this subsection; and 
‘‘(B) may periodically review and update 
such process. 
‘‘(3) REQUIREMENTS FOR PROCESS.—The proc-
ess developed and updated by the Secretary under 
paragraph (2) shall be consistent with the following: 
‘‘(A) Such process shall specify the nec-
essary scientific justification that must be in-
cluded in a petition. 
‘‘(B) The Secretary shall— 
‘‘(i) provide a 30-day period for public 
comment on a petition; and 
‘‘(ii) not later than 90 days after the 
close of such public comment period, ap-
prove or deny the petition. 
‘‘(C) If the Secretary approves a petition, 
the Secretary shall provide notice in the Federal 
Register of each addition made pursuant to 
such approval. 
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‘‘(D) In denying a petition, the Secretary 
shall provide a written justification to the peti-
tioner for the denial. 
‘‘(g) GUIDANCE.—The Secretary— 
‘‘(1) shall, concurrently with the publication of 
the initial list under subsection (a), and upon adding 
any nonfunctional constituent pursuant to subsection 
(e) or (f) to the list under subsection (a), issue guid-
ance for industry on best practices related to— 
‘‘(A) analytical testing for nonfunctional 
constituents in cosmetics and ingredients; and 
‘‘(B) detection limits; and 
‘‘(2) may periodically review and update such 
guidance. 
‘‘SEC. 614. TREATMENT OF NONFUNCTIONAL CONSTITU-
ENTS. 
‘‘A supplier of an ingredient or cosmetic shall— 
‘‘(1) not later than 1 year after a nonfunctional 
constituent is added to the list under section 613(a) 
pursuant to subsection (d), (e), or (f) of section 613, 
conduct testing for such nonfunctional constituent; 
and 
‘‘(2) prior to the sale of the ingredient or cos-
metic to the brand owner, provide the brand owner 
a certificate of analysis that includes— 
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‘‘(A) the levels of each such nonfunctional 
constituent present; 
‘‘(B) any analytical test used; and 
‘‘(C) the detection limits of any analytical 
test used to detect each such nonfunctional con-
stituent. 
‘‘SEC. 615. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED COS-
METICS. 
‘‘(a) SUPPLY CHAIN INFORMATION.—In the case of 
a cosmetic that the Secretary has reason to believe is adul-
terated, misbranded, or otherwise in violation of this Act, 
the Secretary shall request that the brand owner named 
on the label of such cosmetic submit to the Secretary all 
of the following information: 
‘‘(1) The name and place of business of the 
manufacturer of the cosmetic and any supplier of an 
ingredient or raw material used in the manufacture 
of the cosmetic. 
‘‘(2) The name and place of business of any en-
tity (including any retailer) to which the brand 
owner provided the cosmetic. 
‘‘(b) COLLECTION OF ADDITIONAL SUPPLY CHAIN 
INFORMATION.—In the case of a cosmetic that the Sec-
retary has reason to believe is adulterated, misbranded, 
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or otherwise in violation of this Act, to the extent nec-
essary to protect the safety of the public, the Secretary 
may request that any entity in the supply chain of such 
cosmetic submit to the Secretary information that is simi-
lar to the information described in paragraphs (1) and (2) 
of subsection (a). 
‘‘(c) MAINTENANCE OF RECORDS.—Any entity in the 
supply chain of a cosmetic (including the brand owner 
named on the label of a cosmetic) shall— 
‘‘(1) maintain records sufficient to provide the 
information described in paragraphs (1) and (2) of 
subsection (a); and 
‘‘(2) provide such information to the Secretary 
upon the request of the Secretary. 
‘‘SEC. 616. CIVIL PENALTIES. 
‘‘Any person that violates section 612, 614, or 615 
shall be liable to the United States for a civil penalty in 
an amount not to exceed $1,500 for each day on which 
such violation continues.’’. 
Æ 
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