[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4435 Introduced in House (IH)]

<DOC>






119th CONGRESS
  1st Session
                                H. R. 4435

     To amend the Federal Food, Drug, and Cosmetic Act to increase 
   transparency with respect to cosmetic ingredients, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 16, 2025

  Ms. Schakowsky (for herself, Ms. Matsui, 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 the Federal Food, Drug, and Cosmetic Act to increase 
   transparency with respect to cosmetic ingredients, 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 Hazardous Ingredient Right 
to Know Act of 2025''.

SEC. 2. COSMETIC REGULATION.

    (a) Definition.--Section 201(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(i)) is amended by adding at the end the 
following: ``Such term includes such an article that is intended for 
consumer sale or professional use (as defined in section 617).''.
    (b) 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 602, by adding at the end the following:
    ``(g) If the fragrance and flavor ingredient information required 
to be disclosed pursuant to sections 615 and 616 is not disclosed in 
accordance with such sections.
    ``(h) If its packaging fails to include any fragrance or flavor 
ingredient present in such cosmetic or the website of the brand owner 
of such cosmetic fails to disclose any such fragrance or flavor 
ingredient.
    ``(i) If the website of the brand owner of the cosmetic fails to 
include a link to the Uniform Resource Locator (referred to in this 
chapter as a `URL') for any list specified in section 616(b) on which 
each ingredient present in such cosmetic appears.'';
            (3) 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; or
                    ``(C) implementing a requirement of such State (or 
                a political subdivision thereof) that provides for 
                greater transparency, disclosure, or protection with 
                respect to a cosmetic ingredient than the requirements 
                established under the amendments made by the Cosmetic 
                Hazardous Ingredient Right to Know Act of 2025 (or 
                continuing to implement any such requirement that is in 
                effect as of the date of the enactment of such Act).
            ``(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).''.
            (4) by adding at the end the following:

                 ``Subchapter B--Fragrances and Flavors

``SEC. 615. WEBSITE DISCLOSURE OF INGREDIENTS.

    ``(a) In General.--Effective beginning on the date that is 1 year 
after the date of the enactment of the Cosmetic Hazardous Ingredient 
Right to Know Act of 2025, a brand owner shall disclose in an 
electronically readable format on the website of the brand owner, and 
make available to any relevant internet vendor, with respect to each 
cosmetic sold or offered for sale in interstate commerce by such brand 
owner, the following information:
            ``(1) A full listing of each ingredient present in such 
        cosmetic, including each fragrance or flavor ingredient present 
        in such cosmetic, in descending order of predominance.
            ``(2) Any ingredient present in such cosmetic, listed in 
        descending order of predominance, followed by a link to the URL 
        of any list under section 616(b) on which such ingredient 
        appears.
            ``(3) The functional purpose served by each such fragrance 
        or flavor ingredient.
            ``(4) A link to the hazard communication safety data sheet 
        for any such cosmetic intended for professional use.
    ``(b) Updates.--In the case of an update to any of the lists 
specified in subsection (b) or (c) of section 616 with respect to a 
cosmetic sold or offered for sale in interstate commerce by a brand 
owner, the brand owner shall revise the disclosure made under 
subsection (a) to reflect such update not later than 7 months after the 
date on which such update is formally noticed by the authoritative body 
who administers the list.

``SEC. 616. COSMETIC INGREDIENT PRODUCT LABEL DISCLOSURE.

    ``(a) In General.--Effective beginning on the date that is 2 years 
after the date of the enactment of the Cosmetic Hazardous Ingredient 
Right to Know Act of 2025, for purposes of section 602(h), the 
packaging or labeling of a cosmetic shall include--
            ``(1) A full listing of each ingredient present in such 
        cosmetic (including each fragrance or flavor ingredient), 
        listed in descending order of predominance.
            ``(2) In the case of a cosmetic in which any ingredient 
        specified in subsection (b) is present, the following 
        statement: `For health impacts related to any ingredients in 
        this product, visit: www.____.', with the uniform resource 
        locator of the website of the brand owner placed in the blank 
        space.
    ``(b) Ingredients Specified.--The ingredients specified in this 
subsection are the following chemicals (including chemicals included in 
any list specified in this subsection after the date of the enactment 
of this subchapter):
            ``(1) Chemicals for which a reference dose or reference 
        concentration has been developed based on neurotoxicity in the 
        Environmental Protection Agency's Integrated Risk Information 
        System.
            ``(2) Chemicals that are identified as carcinogenic to 
        humans, likely to be carcinogenic to humans, or as group A, B1, 
        or B2 carcinogens, in the Environmental Protection Agency's 
        Integrated Risk Information System.
            ``(3) Persistent, bioaccumulative, and toxic Priority 
        Chemicals identified by the Environmental Protection Agency's 
        National Waste Minimization Program as of February 22, 2016.
            ``(4) Chemicals that are identified in volumes 1 through 4 
        of the Reports on Human Exposure to Environmental Chemicals 
        issued by the Centers for Disease Control and Prevention (and 
        any updates to such reports).
            ``(5) Toxic pollutants listed under section 20 307(a)(1) of 
        the Federal Water Pollution Control Act and priority pollutants 
        identified in appendix A to part 423 of title 40, Code of 
        Federal Regulations (or successor regulations).
            ``(6) 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.
            ``(7) Chemicals that are identified in the Agency for Toxic 
        Substances and Disease Registry's Toxic Substances Portal.
            ``(8) Chemicals that are hazardous substances, as such term 
        is defined in section 101(14) of the Comprehensive 
        Environmental Response, Compensation, and Liability Act of 
        1980.
            ``(9) Reproductive and developmental toxicants identified 
        by monographs issued by the National Toxicology Program Center 
        for the Evaluation of Risks to Human Reproduction.
            ``(10) Chemicals that are identified as known to be, or 
        reasonably anticipated to be human carcinogens by the most 
        recent Report on Carcinogens prepared by the National 
        Toxicology Program pursuant to section 301(b)(4) of the Public 
        Health Service Act.
            ``(11) Chemicals identified as persistent, bioaccumulative, 
        and toxic (PBT) chemicals by the Department of Ecology of the 
        State of Washington (WAC 173-333 (2006)).
            ``(12) Chemicals specified in 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.
            ``(13) Chemicals for which primary maximum contaminant 
        levels have been established and adopted under section 64431, 
        64444, or 64444.5 of division 22 of title 26 of the California 
        Code of Regulations and chemicals for which notification 
        levels, as defined in section 116455 of the California Health 
        and Safety Code, have been established by the California State 
        Water Resources Control Board.
            ``(14) Chemicals identified as toxic air contaminants under 
        section 93000 or 93001 of title 17 of the California Code of 
        Regulations.
            ``(15) Substances classified as carcinogens, mutagens or 
        reproductive toxicants in Appendices 1 through 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 15 December 2020.
            ``(16) 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.
            ``(17) Chemicals included in such European Chemicals Agency 
        Candidate List of Substances of Very High Concern on the basis 
        of fulfilling the criteria defined in Article 57(d), Article 
        57(e), or Article 57(f) for persistent, bioaccumulative and 
        toxic, or very persistent and very bioaccumulative, properties.
            ``(18) Chemicals classified by the European Union in Annex 
        VI to Regulation (EC) No. 1272/2008 as respiratory sensitizer 
        category 1.
            ``(19) Chemicals that are identified as persistent, 
        bioaccumulative, and inherently toxic to the environment by the 
        Canadian Environmental Protection Act Environmental Registry 
        Domestic Substances List pursuant to subsection 66(1) of the 
        Canadian Environmental Protection Act, 1999.
            ``(20) Group 1, 2A, or 2B carcinogens identified by the 
        International Agency for Research on Cancer of the World Health 
        Organization.
            ``(21) Chemicals that are identified on Part A of the list 
        of Chemicals for Priority Action prepared by the Oslo and Paris 
        Conventions for the Protection of the Marine Environment of the 
        North-East Atlantic.
            ``(22) Chemicals that are skin sensitizers and irritants 
        classified by Regulation (EC) No 1272/2008 of the European 
        Parliament and of the Council of 16 December 2008 on 
        classification, labelling and packaging of substances and 
        mixtures, amending and repealing Directives 67/548/EEC and 
        1999/45/EC, and amending Regulation (EC) No 1907/2006.
    ``(c) Master List.--
            ``(1) In general.--Not later than 6 months after the date 
        of the enactment of the Cosmetic Hazardous Ingredient Right to 
        Know Act of 2025, the Secretary shall--
                    ``(A) establish a master list of the chemicals that 
                appear on the lists specified in subsections (b) and 
                (c);
                    ``(B) post such master list on a publicly available 
                website of the Food and Drug Administration; and
                    ``(C) establish a voluntary electronic distribution 
                list to which cosmetic manufacturers and other 
                interested parties may subscribe to receive a copy of 
                the master list and any subsequent updates.
            ``(2) Updates.--
                    ``(A) In general.--The Secretary shall maintain the 
                master list established under paragraph (1) and make 
                updates to such list as necessary.
                    ``(B) Notification.--Not later than 30 days after 
                making an update pursuant to subparagraph (A), the 
                Secretary shall notify subscribers to the electronic 
                distribution list referred to in paragraph (1)(C) of 
                that update.
                    ``(C) Semi-annual updates.--Not less frequently 
                than twice per year, the Secretary shall publish on a 
                publicly available website of the Food and Drug 
                Administration a list of updates to the master list 
                made during the preceding 6-month period that includes 
                summaries of any chemicals added to or removed from the 
                lists specified in subsections (b) and (c).

``SEC. 617. DEFINITIONS.

    ``In this subchapter:
            ``(1) Brand owner.--The term `brand owner' means the entity 
        responsible for bringing a cosmetic to market for retail 
        consumer sale or professional use.
            ``(2) Electronically readable format.--The term 
        `electronically readable format' means, with respect to 
        information, that the information provided--
                    ``(A) is machine readable by automated systems, 
                including, web browsers, accessibility software to aid 
                the disabled, automated scripts, and other software 
                programs or applications;
                    ``(B) is not restricted from access by search 
                engines;
                    ``(C) is not restricted from access by a 
                requirement for registration, the provision of 
                personally identifiable information, or the use of 
                CAPTCHA or similar challenge response test 
                technologies, whether visual, auditory, or otherwise; 
                and
                    ``(D) conforms to the most current version of the 
                Web Content Accessibility Guidelines adopted by the Web 
                Content Accessibility Guidelines Working Group of the 
                World Wide Web Consortium.
            ``(3) Flavor ingredient.--The term `flavor ingredient' 
        means, with respect to a cosmetic, any intentionally added 
        substance or complex mixture of aroma chemicals, flavor 
        chemicals, natural essential oils, and other functional 
        ingredient or ingredients, including the constituent 
        ingredients of botanicals, for which the purpose is to impart a 
        flavor or taste, or to counteract a flavor or taste.
            ``(4) Fragrance ingredient.--The term `fragrance 
        ingredient' means, with respect to a cosmetic, any 
        intentionally added substance or complex mixture of aroma 
        chemicals, natural essential oils, and other functional 
        ingredient or ingredients for which the purpose is to impart an 
        odor or scent, or to counteract an odor.
            ``(5) Ingredient.--The term `ingredient' means a chemical 
        in a cosmetic, including--
                    ``(A) a chemical that has a technical or functional 
                effect in the cosmetic, including the breakdown 
                products of an intentionally added chemical that also 
                have a functional or technical effect in the cosmetic;
                    ``(B) a substance that is present by reason of 
                having been added to a cosmetic during processing for 
                the substance's technical or functional effect;
                    ``(C) a fragrance, flavor, preservative, or 
                colorant (and the components thereof); and
                    ``(D) any individual component that the Secretary 
                deems to be an ingredient for purposes of this 
                subchapter.
            ``(6) Professional use.--The term `professional use' 
        means--
                    ``(A) the application of a cosmetic to a human 
                customer or client that is intended only for use by an 
                employee or contractor, in settings such as 
                cosmetology, nail care, barbering, esthetics, spa, and 
                other professions as determined by the Secretary 
                through regulation; or
                    ``(B) the use by, or application to, a human of a 
                cosmetic purchased from a hair salon, nail salon, 
                beauty salon, spa, or other establishment that provides 
                cosmetic treatment services for humans.''.
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