[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4434 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 4434
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 purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 16, 2025
Ms. Schakowsky (for herself, Mrs. Dingell, Mr. Evans of Pennsylvania,
Mr. Khanna, Ms. Norton, Mr. Thanedar, Ms. Tlaib, and Mrs. Watson
Coleman) 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 purposes.
Be it enacted by the Senate and House of Representatives 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 2025''.
SEC. 2. COSMETIC REGULATION.
Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
361 et seq.) is amended--
(1) by inserting before section 601 the following:
``Subchapter A--Adulterated and Misbranded Cosmetics'';
(2) in section 614, by amending subsection (b) to read as
follows:
``(b) Limitations.--
``(1) In general.--Notwithstanding subsection (a), nothing
in this section shall be construed to prevent any State (or a
political subdivision thereof) from--
``(A) prohibiting the use or limiting the amount of
an ingredient in a cosmetic product;
``(B) continuing to implement a requirement of such
State (or a political subdivision thereof) that is in
effect at the time of enactment of the Modernization of
Cosmetics Regulation Act of 2022 for the reporting to
the State (or a political subdivision thereof) of an
ingredient in a cosmetic product; and
``(C) implementing a requirement of such State (or
a political subdivision thereof), or continuing to
implement a requirement that is in effect at the time
of enactment of the Cosmetic Supply Chain Transparency
Act of 2025, that provides greater transparency,
disclosure, or protection than the amendments made by
such Act, with respect to--
``(i) cosmetic ingredients;
``(ii) the practices used in the
manufacture of cosmetics (and the ingredients
thereof); or
``(iii) the disclosure of information with
respect to such ingredients or such practices.
``(2) Modernization of cosmetics regulation act of 2022.--
Nothing in the amendments to this Act made by the Modernization
of Cosmetics Regulation Act of 2022 shall be construed to
preempt any State statute, public initiative, referendum,
regulation, or other State action, except as expressly provided
in subsection (a).''; and
(3) by adding at the end the following:
``Subchapter B--Supply Chain Transparency
``SEC. 621. 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 ingredients or fragrance or flavor
formulations.
``(3) Formulating laboratory.--The term `formulating
laboratory' means an entity that supplies a finished cosmetic
product to a retailer or cosmetic 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--
``(A) being--
``(i) a reproductive or developmental
toxicant;
``(ii) persistent, bioaccumulative, and
toxic;
``(iii) an allergen; or
``(iv) an endocrine disruptor, carcinogen,
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 Enforcement Act of
1986 (sections 25249.5 through 25249.14 of the
California Health and Safety Code), List of
Reproductive and Developmental Toxicants and
Carcinogens.
``(ii) Chemicals classified as `Persistent,
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.
``(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 European Union
Detergents Regulation No. 21648/2004.
``(v) Chemicals included in the European
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 endocrine-disrupting
properties.
``(vi) Substances classified as
carcinogens, mutagens, or reproductive
toxicants in Appendices 1-6 of Annex XVII to
Regulation (EC) No. 1907/2006 of the European
Union's Registration, Evaluation,
Authorisation, and Restriction of Chemicals
(REACH) law, as revised by the Commission
Regulation (EU) 2020/2096 of December 15, 2020.
``(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
determines 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 intentionally
added chemical that also have a functional 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 purposes of this
subchapter.
``(6) Incidental component.--The term `incidental
component' means--
``(A) a chemical added during the manufacturing
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
``(B) a chemical present in the environment which
was introduced into a cosmetic, or into an ingredient,
at any point in the supply chain for the cosmetic or
ingredient.
``(7) Manufacturer.--The term `manufacturer' means any
entity that--
``(A) produces an ingredient; or
``(B) combines one or more ingredients to produce a
cosmetic.
``(8) Nonfunctional constituent.--The term `nonfunctional
constituent' means a chemical that has no functional or
technical effect on the product or ingredient and is present--
``(A) as an incidental component of an
intentionally added ingredient;
``(B) as a breakdown product of an intentionally
added ingredient;
``(C) as a byproduct of the manufacturing process;
``(D) due to storage of primary substances; or
``(E) due to instability of the packaging.
``(9) Raw material.--The term `raw material' means a
substance or mixture of substances that--
``(A) is used in the manufacture of a cosmetic for
commercial distribution; and
``(B) is supplied to a cosmetic manufacturer,
packer, or distributor by a cosmetic raw material
manufacturer or supplier.
``(10) Supplier.--The term `supplier'--
``(A) means an entity that supplies a cosmetic,
cosmetic packaging, or an ingredient or raw material of
a cosmetic or cosmetic packaging; and
``(B) includes any such entity that is a
manufacturer, a formulating laboratory, or a fragrance
or flavor company.
``SEC. 622. COSMETIC AND INGREDIENT SAFETY INFORMATION.
``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, provide 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 hazards.
``(C) The physical and chemical properties.
``(D) The Chemical Abstracts Services Registry number of
any such ingredient.
``(E) Environmental exposure and fate information.
``(F) Heavy metal testing results.
``(G) Safety data sheets.
``(H) Manufacturing flow charts.
``(I) Composition statement.
``(J) Fragrance allergen statement.
``(K) International Fragrance Association (IFRA) standards
conformity certificate.
``(L) Any other information used to substantiate the safety
of such ingredient.
``(2) A full and complete listing of ingredients in
fragrance or flavor formulations, preservative systems, 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 ingredient statement.
``(4) A certificate of analysis for the ingredient.
``SEC. 623. 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 testing under this subchapter
conducted by suppliers of cosmetics and ingredients.
``(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 Cosmetics.--For each
nonfunctional constituent on the list under subsection (a), the
Secretary shall identify the specific 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 proposed 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 2025, finalize and publish the list.
``(2) Advisory committee.--
``(A) In general.--Not later than 9 months after
the date of enactment of the Cosmetic Supply Chain
Transparency Act of 2025, the Secretary shall convene
an advisory committee to advise the Secretary on--
``(i) creating the initial list under
subsection (a); and
``(ii) best practices related to analytical
testing for nonfunctional constituents in
cosmetics and ingredients.
``(B) Membership.--The membership of the advisory
committee convened under subparagraph (A) shall consist
of an equal number of--
``(i) representatives from industry;
``(ii) representatives from the nonprofit
community;
``(iii) representatives from the scientific
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 finalization
pursuant to subsection (d) of the initial list under subsection (a),
and not less than annually thereafter, 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 nonfunctional
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 621(4)(A) based on
existing and emerging science; or
``(B) have been added to one of the lists in
section 621(4)(B); and
``(3) update the list by adding any nonfunctional
constituent whose addition was approved pursuant to a petition
under subsection (f).
``(f) Petition Process for Adding Nonfunctional 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 section
621(4)(B).
``(2) Development of process.--The Secretary--
``(A) not later than 24 months after the date of
enactment of the Cosmetic Supply Chain Transparency Act
of 2025, shall develop and publish the process for
submitting a petition under this subsection; and
``(B) may periodically review and update such
process.
``(3) Requirements for process.--The process developed and
updated by the Secretary under paragraph (2) shall be
consistent with the following:
``(A) Such process shall specify the necessary
scientific justification that must be included 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, approve 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.
``(D) In denying a petition, the Secretary shall
provide a written justification to the petitioner 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 guidance 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. 624. TREATMENT OF NONFUNCTIONAL CONSTITUENTS.
``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 623(a) pursuant
to subsection (d), (e), or (f) of section 623, conduct testing
for such nonfunctional constituent; and
``(2) prior to the sale of the ingredient or cosmetic to
the brand owner, provide the brand owner a certificate of
analysis that includes--
``(A) the levels of each such nonfunctional
constituent present;
``(B) any analytical test used;
``(C) the detection limits of any analytical test
used to detect each such nonfunctional constituent; and
``(D) heavy metal testing results.
``SEC. 625. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR
MISBRANDED COSMETICS.
``(a) Supply Chain Information.--In the case of a cosmetic that the
Secretary has reason to believe is adulterated, 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 entity
(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 Secretary has reason to believe is
adulterated, misbranded, or otherwise in violation of this Act, to the
extent necessary 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 similar 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. 626. CIVIL PENALTIES.
``Any person that violates section 622, 624, or 625 shall be liable
to the United States for a civil penalty in an amount up to $10,000 for
each day on which such violation continues.''.
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