Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2023

I 118TH CONGRESS 1ST SESSION H. R. 3621 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 MAY 24, 2023 Ms. SCHAKOWSKY (for herself, Ms. MATSUI, 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 En- ergy 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 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 Fragrance 4 and Flavor Ingredient Right to Know Act of 2023’’. 5 VerDate Sep 11 2014 23:40 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3621.IH H3621 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 3621 IH SEC. 2. COSMETIC REGULATION. 1 (a) DEFINITION.—Section 201(i) of the Federal 2 Food, Drug, and Cosmetic Act (21 U.S.C. 321(i)) is 3 amended by adding at the end the following: ‘‘Such term 4 includes such an article that is intended for consumer sale 5 or professional use (as defined in section 617).’’. 6 (b) REGULATION.—Chapter VI of the Federal Food, 7 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amend- 8 ed— 9 (1) by inserting before section 601 the fol- 10 lowing: 11 ‘‘Subchapter A—Adulterated and Misbranded 12 Cosmetics’’; 13 (2) in section 602, by adding at the end the fol- 14 lowing: 15 ‘‘(g) If the fragrance and flavor ingredient informa- 16 tion required to be disclosed pursuant to sections 615 and 17 616 is not disclosed in accordance with such sections. 18 ‘‘(h) If its packaging fails to include any fragrance 19 or flavor ingredient present in such cosmetic or the 20 website of the brand owner of such cosmetic fails to dis- 21 close any such fragrance or flavor ingredient.’’; and 22 (3) by adding at the end the following: 23 VerDate Sep 11 2014 23:40 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3621.IH H3621 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 3621 IH ‘‘Subchapter B—Fragrances and Flavors 1 ‘‘SEC. 615. WEBSITE DISCLOSURE OF INGREDIENTS. 2 ‘‘(a) IN GENERAL.—Effective beginning on the date 3 that is 1 year after the date of the enactment of the Cos- 4 metic Fragrance and Flavor Ingredient Right to Know Act 5 of 2023, a brand owner shall disclose in an electronically 6 readable format on the website of the brand owner, and 7 make available to any relevant internet vendor, with re- 8 spect to each cosmetic sold or offered for sale in interstate 9 commerce by such brand owner, the following information: 10 ‘‘(1) A full listing of each ingredient present in 11 such cosmetic, including each fragrance or flavor in- 12 gredient present in such cosmetic, in descending 13 order of predominance. 14 ‘‘(2) Any fragrance or flavor ingredient present 15 in such cosmetic that is specified in section 616(b), 16 listed in descending order of predominance, followed 17 by a link to the URL of any list on which such in- 18 gredient appears. 19 ‘‘(3) In the case of a fragrance allergen in such 20 cosmetic that meets the criteria specified in section 21 616(c), the following statement: ‘This product con- 22 tains the following fragrance allergens.’. 23 ‘‘(4) The functional purpose served by each 24 such fragrance or flavor ingredient. 25 VerDate Sep 11 2014 23:40 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3621.IH H3621 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •HR 3621 IH ‘‘(5) A link to the hazard communication safety 1 data sheet for any such cosmetic intended for profes- 2 sional use. 3 ‘‘(b) UPDATES.—In the case of an update to any of 4 the lists specified in subsection (b) or (c) of section 616 5 with respect to a cosmetic sold or offered for sale in inter- 6 state commerce by a brand owner, the brand owner shall 7 revise the disclosure made under subsection (a) to reflect 8 such update not later than 7 months after the date on 9 which such update is formally noticed by the authoritative 10 body who administers the list. 11 ‘‘SEC. 616. COSMETIC INGREDIENT PRODUCT LABEL DIS- 12 CLOSURE. 13 ‘‘(a) IN GENERAL.—Effective beginning on the date 14 that is 2 years after the date of the enactment of the Cos- 15 metic Fragrance and Flavor Ingredient Right to Know Act 16 of 2023, for purposes of section 602(h), the packaging or 17 labeling of a cosmetic shall include— 18 ‘‘(1) A full listing of each ingredient present in 19 such cosmetic (including each fragrance or flavor in- 20 gredient), listed in descending order of predomi- 21 nance. 22 ‘‘(2) In the case of a cosmetic in which any in- 23 gredient specified in subsection (b) is present, the 24 following statement: ‘For health impacts related to 25 VerDate Sep 11 2014 23:40 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3621.IH H3621 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •HR 3621 IH the fragrance or flavor ingredients in this product, 1 visit: www.llll.’. The uniform resource locator 2 of the website of the brand owner shall be placed in 3 the space identifying the website.’. 4 ‘‘(3) In the case of a fragrance allergen in such 5 cosmetic that meets the criteria specified in section 6 616(c), the following statement: ‘This product con- 7 tains the following fragrance allergens.’. 8 ‘‘(4) Not later than 18 months after the date 9 on which an update to any of the lists referred to 10 in subsection (b) or (c) with respect to an ingredient 11 or allergen present in such cosmetic are formally no- 12 ticed by the authoritative body who administers the 13 list, any necessary revisions with respect to such in- 14 gredient or fragrance allergen to reflect such update. 15 ‘‘(b) INGREDIENTS SPECIFIED.—The ingredients 16 specified in this subsection are the following chemicals (in- 17 cluding chemicals included in any list specified in this sub- 18 section after the date of the enactment of this subchapter): 19 ‘‘(1) Chemicals for which a reference dose or 20 reference concentration has been developed based on 21 neurotoxicity in the Environmental Protection Agen- 22 cy’s Integrated Risk Information System. 23 ‘‘(2) Chemicals that are identified as carcino- 24 genic to humans, likely to be carcinogenic to hu- 25 VerDate Sep 11 2014 23:40 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3621.IH H3621 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •HR 3621 IH mans, or as group A, B1, or B2 carcinogens, in the 1 Environmental Protection Agency’s Integrated Risk 2 Information System. 3 ‘‘(3) Persistent, bioaccumulative, and toxic Pri- 4 ority Chemicals identified by the Environmental Pro- 5 tection Agency’s National Waste Minimization Pro- 6 gram as of February 22, 2016. 7 ‘‘(4) Chemicals that are identified in volumes 1 8 through 4 of the Reports on Human Exposure to 9 Environmental Chemicals issued by the Centers for 10 Disease Control and Prevention (and any updates to 11 such reports). 12 ‘‘(5) Toxic pollutants listed under section 20 13 307(a)(1) of the Federal Water Pollution Control 14 Act and priority pollutants identified in appendix A 15 to part 423 of title 40, Code of Federal Regulations 16 (or successor regulations). 17 ‘‘(6) Chemicals classified as ‘Persistent, Bio- 18 accumulative and Toxic’ by the Toxics Release In- 19 ventory published by the Environmental Protection 20 Agency pursuant to section 313 of the Emergency 21 Planning and Community Right-to-Know Act of 22 1986. 23 VerDate Sep 11 2014 23:40 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3621.IH H3621 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •HR 3621 IH ‘‘(7) Chemicals that are identified in the Agen- 1 cy for Toxic Substances and Disease Registry’s 2 Toxic Substances Portal. 3 ‘‘(8) Chemicals that are hazardous substances, 4 as such term is defined in section 101(14) of the 5 Comprehensive Environmental Response, Compensa- 6 tion, and Liability Act of 1980. 7 ‘‘(9) Reproductive and developmental toxicants 8 identified by monographs issued by the National 9 Toxicology Program Center for the Evaluation of 10 Risks to Human Reproduction. 11 ‘‘(10) Chemicals that are identified as known to 12 be, or reasonably anticipated to be human carcino- 13 gens by the most recent Report on Carcinogens pre- 14 pared by the National Toxicology Program pursuant 15 to section 301(b)(4) of the Public Health Service 16 Act. 17 ‘‘(11) Chemicals identified as persistent, bio- 18 accumulative, and toxic (PBT) chemicals by the De- 19 partment of Ecology of the State of Washington 20 (WAC 173–333 (2006)). 21 ‘‘(12) Chemicals specified in Chapter 6.6 of the 22 California Safe Drinking Water and Toxic Enforce- 23 ment Act of 1986 (sections 25249.5 through 24 25249.14 of the California Health and Safety Code), 25 VerDate Sep 11 2014 23:40 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3621.IH H3621 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •HR 3621 IH List of Reproductive and Developmental Toxicants 1 and Carcinogens. 2 ‘‘(13) Chemicals for which primary maximum 3 contaminant levels have been established and adopt- 4 ed under section 64431, 64444, or 64444.5 of divi- 5 sion 22 of title 26 of the California Code of Regula- 6 tions and chemicals for which notification levels, as 7 defined in section 116455 of the California Health 8 and Safety Code, have been established by the Cali- 9 fornia State Water Resources Control Board. 10 ‘‘(14) Chemicals identified as toxic air contami- 11 nants under section 93000 or 93001 of title 17 of 12 the California Code of Regulations. 13 ‘‘(15) Substances classified as carcinogens, 14 mutagens or reproductive toxicants in Appendices 1 15 through 6 of Annex XVII to Regulation (EC) No. 16 1907/2006 of the European Union’s Registration, 17 Evaluation, Authorisation and Restriction of Chemi- 18 cals (REACH) law, as revised by the Commission 19 Regulation (EU) 2020/2096 of 15 December 2020. 20 ‘‘(16) Chemicals included in the European 21 Union Candidate List of Substances of Very High 22 Concern in accordance with Article 59 of the 23 REACH Regulation (EC) No. 1907/2006 on the 24 VerDate Sep 11 2014 23:40 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3621.IH H3621 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •HR 3621 IH basis of fulfilling the criteria defined in Article 57(f) 1 for endocrine disrupting properties. 2 ‘‘(17) Chemicals included in such European 3 Chemicals Agency Candidate List of Substances of 4 Very High Concern on the basis of fulfilling the cri- 5 teria defined in Article 57(d), Article 57(e), or Arti- 6 cle 57(f) for persistent, bioaccumulative and toxic, or 7 very persistent and very bioaccumulative, properties. 8 ‘‘(18) Chemicals classified by the European 9 Union in Annex VI to Regulation (EC) No. 1272/ 10 2008 as respiratory sensitizer category 1. 11 ‘‘(19) Chemicals that are identified as per- 12 sistent, bioaccumulative, and inherently toxic to the 13 environment by the Canadian Environmental Protec- 14 tion Act Environmental Registry Domestic Sub- 15 stances List pursuant to subsection 66(1) of the Ca- 16 nadian Environmental Protection Act, 1999. 17 ‘‘(20) Group 1, 2A, or 2B carcinogens identi- 18 fied by the International Agency for Research on 19 Cancer of the World Health Organization. 20 ‘‘(21) Chemicals that are identified on Part A 21 of the list of Chemicals for Priority Action prepared 22 by the Oslo and Paris Conventions for the Protec- 23 tion of the Marine Environment of the North-East 24 Atlantic. 25 VerDate Sep 11 2014 23:40 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3621.IH H3621 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •HR 3621 IH ‘‘(22) Chemicals that are skin sensitizers and 1 irritants classified by Regulation (EC) No 1272/ 2 2008 of the European Parliament and of the Council 3 of 16 December 2008 on classification, labelling and 4 packaging of substances and mixtures, amending 5 and repealing Directives 67/548/EEC and 1999/45/ 6 EC, and amending Regulation (EC) No 1907/2006. 7 ‘‘(c) FRAGRANCE ALLERGENS.—A fragrance allergen 8 specified in this subsection is an allergen that is— 9 ‘‘(1) included in Annex III of European Union 10 Cosmetics Regulation No. 1223/2009, as required to 11 be disclosed pursuant to European Union Deter- 12 gents Regulation No. 21648/2004 (including any 13 subsequent updates to those regulations); and 14 ‘‘(2) present in— 15 ‘‘(A) a rinse-off cosmetic at a concentra- 16 tion at or above 0.01 percent; or 17 ‘‘(B) a leave-on cosmetic product at a con- 18 centration at or above 0.001 percent. 19 ‘‘(d) MASTER LIST.— 20 ‘‘(1) IN GENERAL.—Not later than 6 months 21 after the date of the enactment of the Cosmetic Fra- 22 grance and Flavor Ingredient Right to Know Act of 23 2023, the Secretary shall— 24 VerDate Sep 11 2014 23:40 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3621.IH H3621 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •HR 3621 IH ‘‘(A) establish a master list of the chemi- 1 cals that appear on the lists specified in sub- 2 sections (b) and (c); 3 ‘‘(B) post such master list on a publicly 4 available website of the Food and Drug Admin- 5 istration; and 6 ‘‘(C) establish a voluntary electronic dis- 7 tribution list to which cosmetic manufacturers 8 and other interested parties may subscribe to 9 receive a copy of the master list and any subse- 10 quent updates. 11 ‘‘(2) UPDATES.— 12 ‘‘(A) IN GENERAL.—The Secretary shall 13 maintain the master list established under para- 14 graph (1) and make updates to such list as nec- 15 essary. 16 ‘‘(B) NOTIFICATION.—Not later than 30 17 days after making an update pursuant to sub- 18 paragraph (A), the Secretary shall notify sub- 19 scribers to the electronic distribution list re- 20 ferred to in paragraph (1)(C) of that update. 21 ‘‘(C) SEMI-ANNUAL UPDATES.—Not less 22 frequently than twice per year, the Secretary 23 shall publish on a publicly available website of 24 the Food and Drug Administration a list of up- 25 VerDate Sep 11 2014 23:40 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H3621.IH H3621 pbinns on DSKJLVW7X2PROD with $$_JOB 12 •HR 3621 IH dates to the master list made during the pre- 1 ceding 6-month period that includes summaries 2 of any chemicals added to or removed from the 3 lists specified in subsections (b) and (c). 4 ‘‘SEC. 617. DEFINITIONS. 5 ‘‘In this subchapter: 6 ‘‘(1) BRAND OWNER.—The term ‘brand owner’ 7 means the entity responsible for [Text truncated for display. Full text available on Congress.gov.]