119-hr4434

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4434 Introduced in House

    (IH) ]

<DOC>

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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