[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5538 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 5538

   To amend title VI of the Federal Food, Drug, and Cosmetic Act to 
 provide for greater transparency with respect to fragrance and flavor 
           ingredients in cosmetics, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 8, 2021

 Ms. Schakowsky (for herself and Ms. Matsui) 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 
 provide for greater transparency with respect to fragrance and flavor 
           ingredients in 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 Fragrance and Flavor 
Ingredient Right to Know 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--
            (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 ingredient information required to be disclosed 
pursuant to section 611 is not disclosed in accordance with such 
section.
    ``(h) If it contains ingredients specified in a list included in 
section 612 and its packaging or labeling fails to include any such 
ingredient.''; and
            (3) by adding at the end the following:

                 ``Subchapter B--Fragrances and Flavors

``SEC. 611. WEBSITE LABELING OF FRAGRANCE AND FLAVOR INGREDIENTS.

    ``(a) In General.--Effective beginning on the date that is one year 
after the date of the enactment of the Cosmetic Fragrance and Flavor 
Ingredient Right to Know Act of 2021, 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) any fragrance or flavor ingredient present in such 
        cosmetic at a concentration that equals or exceeds .01 percent;
            ``(2) any fragrance or flavor ingredient present in such 
        cosmetic included on a list specified in section 612(b);
            ``(3) any fragrance allergen in such cosmetic if the 
        fragrance allergen meets the criteria specified in section 
        612(c);
            ``(4) the functional purpose served by each such fragrance 
        or flavor ingredient;
            ``(5) a link to the URL of the list referred to in 
        paragraph (2) on which the fragrance or flavor ingredient 
        present in such cosmetic appears (including a cosmetic intended 
        for retail consumer sale or professional use); and
            ``(6) 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 612 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 seven months after 
the date on which such update is formally noticed by the authoritative 
body who administers the list.

``SEC. 612. COSMETIC INGREDIENT LABEL DISCLOSURE.

    ``(a) In General.--Effective beginning on the date that is 2 years 
after the date of the enactment of the Cosmetic Fragrance and Flavor 
Ingredient Right to Know Act of 2021, for purposes of section 602(h), 
in the case of a cosmetic in which any of the ingredients specified in 
subsection (b) or fragrance allergens specified in subsection (c) is 
present, the packaging or labeling of such cosmetic shall--
            ``(1) list each such ingredient; and
            ``(2) not later than 18 months after the date on which an 
        update to any of the lists referred to in subsection (b) or (c) 
        with respect to an ingredient or allergen present in such 
        cosmetic are formally noticed by the authoritative body who 
        administers the list, include any necessary revisions with 
        respect to such ingredient or fragrance allergen to reflect 
        such update.
    ``(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 sections 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.
    ``(c) Fragrance Allergens.--A fragrance allergen specified in this 
subsection is an allergen that is--
            ``(1) included in Annex III of European Union Cosmetics 
        Regulation No. 1223/2009, as required to be disclosed pursuant 
        to European Union Detergents Regulation No. 21648/2004 
        (including any subsequent updates to those regulations); and
            ``(2) present in--
                    ``(A) a rinse-off cosmetic at a concentration at or 
                above 0.01 percent; or
                    ``(B) a leave-on cosmetic product at a 
                concentration at or above 0.001 percent.
    ``(d) Master List.--
            ``(1) In general.--Not later than 6 months after the date 
        of the enactment of the Cosmetic Fragrance and Flavor 
        Ingredient Right to Know Act of 2021, 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. 613. GENERAL PROVISIONS.

    ``(a) Treatment of Confidential Commercial Information and Trade 
Secrets.--Notwithstanding any other provision of law, for purposes of 
applying section 552(b)(4) of title 5, United States Code, or section 
1905 of title 18, United States Code--
            ``(1) an ingredient required to be listed on a cosmetic 
        packaging or labeling or on the website of a brand owner (or 
        other entity) under this section shall not be treated as a 
        trade secret; and
            ``(2) the concentration of any such ingredient shall be 
        treated as confidential commercial information.
    ``(b) 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 is--
                    ``(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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