[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5539 Introduced in House (IH)]

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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 
                   cosmetics, 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 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 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'';

         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 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. 612. 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) 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. 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 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 2021, 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 2021, 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 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 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 
                611(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 2021, 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. 614. 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 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 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; and
                    ``(C) the detection limits of any analytical test 
                used to detect each such nonfunctional constituent.

``SEC. 615. 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. 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.''.
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