Cosmetic Supply Chain Transparency Act of 2023

I 118TH CONGRESS 1ST SESSION H. R. 3622 To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the supply chain transparency needed for companies to make safe cos- metics, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MAY 24, 2023 Ms. SCHAKOWSKY (for herself, Ms. NORTON, Ms. TLAIB, Ms. VELA´ZQUEZ, Mr. GRIJALVA, Mr. JOHNSON of Georgia, and Ms. MENG) introduced the following bill; which was referred to the Committee on Energy and Com- merce 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 pur- poses. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Cosmetic Supply Chain 4 Transparency Act of 2023’’. 5 VerDate Sep 11 2014 02:53 Jun 15, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3622.IH H3622 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 3622 IH SEC. 2. COSMETIC REGULATION. 1 Chapter VI of the Federal Food, Drug, and Cosmetic 2 Act (21 U.S.C. 361 et seq.) is amended— 3 (1) by inserting before section 601 the fol- 4 lowing: 5 ‘‘Subchapter A—Adulterated and Misbranded 6 Cosmetics’’; 7 and 8 (2) by adding at the end the following: 9 ‘‘Subchapter B—Supply Chain Transparency 10 ‘‘SEC. 621. DEFINITIONS. 11 ‘‘In this subchapter: 12 ‘‘(1) BRAND OWNER.—The term ‘brand owner’ 13 means the entity responsible for bringing a cosmetic 14 to market. 15 ‘‘(2) FLAVOR OR FRAGRANCE COMPANY.—The 16 term ‘flavor or fragrance company’ means an entity 17 that makes or supplies fragrance or flavor ingredi- 18 ents or fragrance or flavor formulations. 19 ‘‘(3) FORMULATING LABORATORY.—The term 20 ‘formulating laboratory’ means an entity that sup- 21 plies a finished cosmetic product to a retailer or cos- 22 metic company to sell under the retailer or cosmetic 23 company’s brand name. 24 ‘‘(4) HARMFUL TO HUMAN HEALTH OR THE 25 ENVIRONMENT.—The phrase ‘harmful to human 26 VerDate Sep 11 2014 02:53 Jun 15, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3622.IH H3622 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 3622 IH health or the environment’ means, with respect to a 1 nonfunctional constituent— 2 ‘‘(A) being— 3 ‘‘(i) a reproductive or developmental 4 toxicant; 5 ‘‘(ii) persistent, bioaccumulative, and 6 toxic; 7 ‘‘(iii) an allergen; or 8 ‘‘(iv) an endocrine disruptor, car- 9 cinogen, or mutagen; and 10 ‘‘(B) present on the most recent version in 11 effect of any of the following lists: 12 ‘‘(i) Chapter 6.6 of the California 13 Safe Drinking Water and Toxic Enforce- 14 ment Act of 1986 (sections 25249.5 15 through 25249.14 of the California Health 16 and Safety Code), List of Reproductive 17 and Developmental Toxicants and Carcino- 18 gens. 19 ‘‘(ii) Chemicals classified as ‘Per- 20 sistent, Bioaccumulative and Toxic’ by the 21 Toxics Release Inventory published by the 22 Environmental Protection Agency pursuant 23 to section 313 of the Emergency Planning 24 VerDate Sep 11 2014 02:53 Jun 15, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3622.IH H3622 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •HR 3622 IH and Community Right-to-Know Act of 1 1986. 2 ‘‘(iii) European Union Regulation 3 1223/2009/EC on Cosmetic Products, as 4 amended by Regulation (EU) 2020/1683, 5 Annex II–Prohibited Substances. 6 ‘‘(iv) Annex III of European Union 7 Cosmetics Regulation No. 1223/2009, as 8 required to be disclosed pursuant to Euro- 9 pean Union Detergents Regulation No. 10 21648/2004. 11 ‘‘(v) Chemicals included in the Euro- 12 pean Union Candidate List of Substances 13 of Very High Concern in accordance with 14 Article 59 of the REACH Regulation (EC) 15 No. 1907/2006 on the basis of fulfilling 16 the criteria defined in Article 57(f) for en- 17 docrine-disrupting properties. 18 ‘‘(vi) Substances classified as carcino- 19 gens, mutagens, or reproductive toxicants 20 in Appendices 1–6 of Annex XVII to Regu- 21 lation (EC) No. 1907/2006 of the Euro- 22 pean Union’s Registration, Evaluation, 23 Authorisation, and Restriction of Chemi- 24 cals (REACH) law, as revised by the Com- 25 VerDate Sep 11 2014 02:53 Jun 15, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3622.IH H3622 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •HR 3622 IH mission Regulation (EU) 2020/2096 of 1 December 15, 2020. 2 ‘‘(vii) Group 1, 2A, or 2B carcinogens 3 identified by the International Agency for 4 Research on Cancer of the World Health 5 Organization. 6 ‘‘(viii) Any other list the Secretary de- 7 termines appropriate for purposes of this 8 subchapter. 9 ‘‘(5) INGREDIENT.—The term ‘ingredient’ 10 means an intentionally added chemical in a cosmetic 11 that has a technical or functional effect, including— 12 ‘‘(A) the breakdown products of an inten- 13 tionally added chemical that also have a func- 14 tional or technical effect in the cosmetic; 15 ‘‘(B) a fragrance, flavor, preservative, or 16 colorant (and the components thereof); and 17 ‘‘(C) any individual component that the 18 Secretary deems to be an ingredient for pur- 19 poses of this subchapter. 20 ‘‘(6) INCIDENTAL COMPONENT.—The term ‘in- 21 cidental component’ means— 22 ‘‘(A) a chemical added during the manu- 23 facturing process at any point in a cosmetic’s, 24 or an ingredient’s, supply chain, but which has 25 VerDate Sep 11 2014 02:53 Jun 15, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3622.IH H3622 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •HR 3622 IH no functional or technical effect in the finished 1 cosmetic; or 2 ‘‘(B) a chemical present in the environ- 3 ment which was introduced into a cosmetic, or 4 into an ingredient, at any point in the supply 5 chain for the cosmetic or ingredient. 6 ‘‘(7) MANUFACTURER.—The term ‘manufac- 7 turer’ means any entity that— 8 ‘‘(A) produces an ingredient; or 9 ‘‘(B) combines one or more ingredients to 10 produce a cosmetic. 11 ‘‘(8) NONFUNCTIONAL CONSTITUENT.—The 12 term ‘nonfunctional constituent’ means a chemical 13 that has no functional or technical effect on the 14 product or ingredient and is present— 15 ‘‘(A) as an incidental component of an in- 16 tentionally added ingredient; 17 ‘‘(B) as a breakdown product of an inten- 18 tionally added ingredient; 19 ‘‘(C) as a byproduct of the manufacturing 20 process; 21 ‘‘(D) due to storage of primary substances; 22 or 23 ‘‘(E) due to instability of the packaging. 24 VerDate Sep 11 2014 02:53 Jun 15, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3622.IH H3622 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •HR 3622 IH ‘‘(9) RAW MATERIAL.—The term ‘raw material’ 1 means a substance or mixture of substances that— 2 ‘‘(A) is used in the manufacture of a cos- 3 metic for commercial distribution; and 4 ‘‘(B) is supplied to a cosmetic manufac- 5 turer, packer, or distributor by a cosmetic raw 6 material manufacturer or supplier. 7 ‘‘(10) SUPPLIER.—The term ‘supplier’— 8 ‘‘(A) means an entity that supplies a cos- 9 metic, cosmetic packaging, or an ingredient or 10 raw material of a cosmetic or cosmetic pack- 11 aging; and 12 ‘‘(B) includes any such entity that is a 13 manufacturer, a formulating laboratory, or a 14 fragrance or flavor company. 15 ‘‘SEC. 622. COSMETIC AND INGREDIENT SAFETY INFORMA- 16 TION. 17 ‘‘At the request of a brand owner of a cosmetic, a 18 supplier of the cosmetic or any ingredient therein shall, 19 not later than 90 days after receipt of such request, pro- 20 vide to the brand owner, with respect to the cosmetic or 21 ingredient, any of the following information: 22 ‘‘(1)(A) Functions and uses. 23 ‘‘(B) The human health and environmental haz- 24 ards. 25 VerDate Sep 11 2014 02:53 Jun 15, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3622.IH H3622 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •HR 3622 IH ‘‘(C) The physical and chemical properties. 1 ‘‘(D) The Chemical Abstracts Services Registry 2 number of any such ingredient. 3 ‘‘(E) Environmental exposure and fate informa- 4 tion. 5 ‘‘(F) Heavy metal testing results. 6 ‘‘(G) Safety data sheets. 7 ‘‘(H) Manufacturing flow charts. 8 ‘‘(I) Composition statement. 9 ‘‘(J) Fragrance allergen statement. 10 ‘‘(K) International Fragrance Association 11 (IFRA) standards conformity certificate. 12 ‘‘(L) Any other information used to substan- 13 tiate the safety of such ingredient. 14 ‘‘(2) A full and complete listing of ingredients 15 in fragrance or flavor formulations, preservative sys- 16 tems, or other ingredient formulations, including the 17 presence of any allergens. 18 ‘‘(3) A full and complete listing of ingredients 19 in a finished cosmetic presented in descending order 20 of predominance by weight, except that ingredients 21 present in amounts of 1 percent or less by weight 22 can be placed in any order at the end of the ingre- 23 dient statement. 24 ‘‘(4) A certificate of analysis for the ingredient. 25 VerDate Sep 11 2014 02:53 Jun 15, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3622.IH H3622 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •HR 3622 IH ‘‘SEC. 623. PROCESS FOR ESTABLISHING AN FDA LIST OF 1 NONFUNCTIONAL CONSTITUENTS KNOWN OR 2 REASONABLY EXPECTED TO BE PRESENT IN 3 COSMETICS AND INGREDIENTS. 4 ‘‘(a) IN GENERAL.—The Secretary shall create and 5 maintain a list of nonfunctional constituents to guide test- 6 ing under this subchapter conducted by suppliers of cos- 7 metics and ingredients. 8 ‘‘(b) CONTENTS.—The list under subsection (a) shall 9 consist of nonfunctional constituents that are— 10 ‘‘(1) known or reasonably expected to be 11 present in cosmetics or ingredients; and 12 ‘‘(2) subject to subsection (e)(2), harmful to 13 human health or the environment. 14 ‘‘(c) IDENTIFICATION OF INGREDIENTS AND COS- 15 METICS.—For each nonfunctional constituent on the list 16 under subsection (a), the Secretary shall identify the spe- 17 cific ingredient or cosmetic, or category of ingredients or 18 cosmetics, in which the nonfunctional constituent is known 19 or reasonably expected to be present. 20 ‘‘(d) INITIAL LIST.— 21 ‘‘(1) IN GENERAL.—In creating the initial list 22 under subsection (a), the Secretary shall— 23 ‘‘(A) publish a proposed list and provide 24 an opportunity for public comment on such pro- 25 posed list for a period of 60 days; and 26 VerDate Sep 11 2014 02:53 Jun 15, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3622.IH H3622 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •HR 3622 IH ‘‘(B) not later than 18 months after the 1 date of enactment of the Cosmetic Supply 2 Chain Transparency Act of 2023, finalize and 3 publish the list. 4 ‘‘(2) ADVISORY COMMITTEE.— 5 ‘‘(A) IN GENERAL.—Not later than 9 6 months after the date of enactment of the Cos- 7 metic Supply Chain Transparency Act of 2023, 8 the Secretary shall convene an advisory com- 9 mittee to advise the Secretary on— 10 ‘‘(i) creating the initial list under sub- 11 section (a); and 12 ‘‘(ii) best practices related to analyt- 13 ical testing for nonfunctional constituents 14 in cosmetics and ingredients. 15 ‘‘(B) MEMBERSHIP.—The membership of 16 the advisory committee convened under sub- 17 paragraph (A) shall consist of an equal number 18 of— 19 ‘‘(i) representatives from industry; 20 ‘‘(ii) representatives from the non- 21 profit community; 22 ‘‘(iii) representatives from the sci- 23 entific community; and 24 VerDate Sep 11 2014 02:53 Jun 15, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3622.IH H3622 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •HR 3622 IH ‘‘(iv) representatives from the medical 1 and public health community. 2 ‘‘(C) TERMINATION.—The Secretary shall 3 terminate the advisory committee convened 4 under this paragraph upon the finalization of 5 the initial list pursuant to paragraph (1). 6 ‘‘(e) UPDATES.—Not less than annually after the fi- 7 nalization pursuant to subsection (d) of the initial list 8 under subsection (a), and not less than annually there- 9 after, the Secretary shall— 10 ‘‘(1) review the list under subsection (a); 11 ‘‘(2) after providing a period of at least 30 days 12 for public comment, update the list by adding non- 13 functional constituents that are known or reasonably 14 expected to be present in a cosmetic or ingredient as 15 specified in subsection (b)(1) and— 16 ‘‘(A) are determined by the Secretary to 17 meet the standard specified in section 18 621(4)(A) based on existing and emerging 19 science; or 20 ‘‘(B) have been added to one of the lists in 21 section 621(4)(B); and 22 ‘‘(3) update the list by adding any nonfunc- 23 tional constituent whose addition was approved pur- 24 suant to a petition under subsection (f). 25 VerDate Sep 11 2014 02:53 Jun 15, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H3622.IH H3622 pbinns on DSKJLVW7X2PROD with $$_JOB 12 •HR 3622 IH ‘‘(f) PETITION PROCESS FOR ADDING NONFUNC- 1 TIONAL CONSTITUENTS OR NEW LISTS.— 2 ‘‘(1) IN GENERAL.—Any person may petition, 3 in accordance with paragraph (3), to add— 4 ‘‘(A) a nonfunctional constituent to the list 5 under subsection (a); or 6 ‘‘(B) a new list to the lists specified in sec- 7 tion 621(4)(B). 8 ‘‘(2) DEVELOPMENT OF PROCESS.—The Sec- 9 retary— 10 ‘‘(A) not later than 24 months after the 11 date of enactment of the Cosmetic Supply 12 Chain Transparency Act of 2023, shall develop 13 and publish the process for submitting a peti- 14 tion under this subsection; and 15 ‘‘(B) may periodically review and update 16 such process. 17 ‘‘(3) REQUIREMENTS FOR PROCESS.—The proc- 18 ess developed and updated by the Secretary under 19 paragraph (2) shall be consistent with the following: 20 ‘‘(A) Such process shall specify the nec- 21 essary scientific justification that must be in- 22 cluded in a petition. 23 ‘‘(B) The Secretary shall— 24 VerDate Sep 11 2014 02:53 Jun 15, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H3622.IH H3622 pbinns on DSKJLVW7X2PROD with $$_JOB 13 •HR 3622 IH ‘‘(i) provide a 30-day period for public 1 comment on a petition; and 2 ‘‘(ii) not later than 90 days after the 3 close of such public comment period, ap- 4 prove or deny the petition. 5 ‘‘(C) If the Secretary approves a petition, 6 the Secretary shall provide notice in the Federal 7 Register of each addition made pursuant to 8 such approval. 9 ‘‘(D) In denying a petition, the Secretary 10 shall provide a written justification to the peti- 11 tioner for the denial. 12 ‘‘(g) GUIDANCE.—The Secretary— 13 ‘‘(1) shall, concurrently with the publication of 14 the initial list under subsection (a), and upon adding 15 any nonfunctional constituent pursuant to subsection 16 (e) or (f) to the list under subsect [Text truncated for display. Full text available on Congress.gov.]