I 

116TH CONGRESS 

1ST SESSION H. R. 4296 

To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure 

the safe use of cosmetics, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 12, 2019 

Ms. SCHAKOWSKY (for herself, Mr. SEAN PATRICK MALONEY of New York, 

Ms. LEE of California, Mr. TED LIEU of California, Mr. GRIJALVA, Ms. 

DELAURO, Mr. HUFFMAN, Ms. PRESSLEY, Mr. HASTINGS, Mr. 

LOWENTHAL, Ms. JUDY CHU of California, Ms. SPEIER, Ms. JAYAPAL, 

Ms. DEGETTE, Ms. PINGREE, Ms. MATSUI, and Ms. WASSERMAN

SCHULTZ) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on 

Education and Labor, for a period to be subsequently determined by the 

Speaker, in each case for consideration of such provisions as fall within 

the jurisdiction of the committee concerned 

A BILL 

To amend title VI of the Federal Food, Drug, and Cosmetic 

Act to ensure the safe use of cosmetics, and for other 

purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Safe Cosmetics and Personal Care Products Act of 

6 2019’’. 


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1 (b) TABLE OF CONTENTS.—The table of contents of 

2 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Cosmetic regulation. 

‘‘SUBCHAPTER A—ADULTERATED AND MISBRANDED COSMETICS

‘‘SUBCHAPTER B—REGULATION OF COSMETICS

‘‘Sec. 611. Definitions. 

‘‘Sec. 612. Registration of establishments and registration fees. 

‘‘Sec. 613. Ingredients labels and website disclosure for cosmetics. 

‘‘Sec. 614. Safety standard and good manufacturing practices. 

‘‘Sec. 615. Cosmetic and ingredient safety information. 

‘‘Sec. 616. Lists of ingredients and required responses. 

‘‘Sec. 617. Treatment of cosmetics based on ingredient lists. 

‘‘Sec. 618. Treatment of contaminants. 

‘‘Sec. 619. Cosmetic and ingredient statements. 

‘‘Sec. 620. Notification, nondistribution, and recall of adulterated or misbranded cosmetics. 

‘‘Sec. 621. Petitions. 

‘‘Sec. 622. Mandatory reporting of serious adverse events. 

‘‘Sec. 623. Nonconfidential information. 

‘‘Sec. 624. Ban on use of animal testing. 

‘‘Sec. 625. Product testing and review audit. 

‘‘Sec. 626. Resources for small businesses. 

‘‘Sec. 627. Interagency cooperation. 

‘‘Sec. 628. Savings clause. 

‘‘Sec. 629. Authorization of appropriations. 

Sec. 3. Adulterated and misbranded cosmetics. 

Sec. 4. Support for creating safer alternatives. 

Sec. 5. Support by National Institute of Environmental Health Sciences for research on health disparities impacting communities of color. 

‘‘Sec. 463C. Research on health disparities related to cosmetics impacting 

communities of color. 

Sec. 6. Worker issues. 

3 SEC. 2. COSMETIC REGULATION. 

4 Chapter VI of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 361 et seq.) is amended— 

6 (1) by inserting before section 601 the fol7 lowing: 

8 ‘‘Subchapter A—Adulterated and Misbranded 

9 Cosmetics’’; 

10 and 


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1 (2) by adding at the end the following: 

2 ‘‘Subchapter B—Regulation of Cosmetics 

3 ‘‘SEC. 611. DEFINITIONS. 

4 ‘‘In this subchapter: 

5 ‘‘(1) BRAND OWNER.—The term ‘brand owner’ 

6 means the entity responsible for bringing a cosmetic 

7 to market. 

8 ‘‘(2) CONTAMINANT.—The term ‘contaminant’ 

9 means unintended substances, such as those that 

10 can originate from sources outside the chemical 

11 pathway, chemical processes, storage of primary sub12 stances, instability of the packaging or harmful by13 products of the manufacturing process. 

14 ‘‘(3) DOMESTIC ESTABLISHMENT.—The term 

15 ‘domestic establishment’ means an establishment lo16 cated in any State that brings a cosmetic to market. 

17 ‘‘(4) FOREIGN ESTABLISHMENT.—The term 

18 ‘foreign establishment’ means an establishment that 

19 brings a cosmetic to market and exports those cos20 metics to the United States. 

21 ‘‘(5) INGREDIENT.—The term ‘ingredient’ 

22 means a chemical in a cosmetic, including— 

23 ‘‘(A) chemicals that have a technical or 

24 functional effect in the cosmetic, including the 

25 breakdown products of an intentionally added 


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1 chemical that also have a functional or technical 

2 effect in the cosmetic; 

3 ‘‘(B) substances that are present by reason 

4 of having been added to a cosmetic during proc5 essing for their technical or functional effect; 

6 ‘‘(C) the components of a fragrance, flavor, 

7 preservative, or colorant; and 

8 ‘‘(D) any individual component that the 

9 Secretary deems an ingredient for purposes of 

10 this chapter. 

11 ‘‘(6) MANUFACTURER.—The term ‘manufac12 turer’ means the entity that produces ingredients or 

13 combines one or more ingredients to produce a cos14 metic product. 

15 ‘‘(7) MICROBUSINESS.—The term ‘microbusi16 ness’ means a business— 

17 ‘‘(A) that is a brand owner as defined in 

18 this subchapter; and 

19 ‘‘(B) that has annual sales receipts for cos20 metic products that do not exceed $1,000,000. 

21 ‘‘(8) PROFESSIONAL USE.—The term ‘profes22 sional use’ means— 

23 ‘‘(A) the application of a cosmetic to a 

24 human customer or client by an employee or 

25 contractor of a hair salon, nail salon, beauty 


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1 salon, spa, or other establishment within the 

2 scope of the work conducted by such employee 

3 or contractor; or 

4 ‘‘(B) the use by or application to a human 

5 of a cosmetic purchased from a hair salon, nail 

6 salon, beauty salon, spa, or other establishment 

7 that provides cosmetic treatment services for 

8 humans. 

9 ‘‘(9) REASONABLE CERTAINTY OF NO HARM.— 

10 With respect to an ingredient or cosmetic, the term 

11 ‘reasonable certainty of no harm’ means that no 

12 harm will be caused to members of the general popu13 lation or any vulnerable population by aggregate ex14 posure to the cosmetic or ingredient, taking into ac15 count possible harmful effects from— 

16 ‘‘(A) low-dose exposures to the cosmetic or 

17 ingredient; 

18 ‘‘(B) additive effects resulting from re19 peated exposure to the cosmetic or ingredient 

20 over time; or 

21 ‘‘(C) cumulative exposure resulting from 

22 all sources, including both the cosmetic or in23 gredient and environmental sources. 

24 ‘‘(10) REPRODUCTIVE OR DEVELOPMENTAL

25 TOXICITY.—With respect to an ingredient or cosVerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296

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1 metic, the term ‘reproductive or developmental tox2 icity’ means that the ingredient or cosmetic can con3 tribute to biologically adverse effects on the develop4 ment of humans or animals, including effects on the 

5 female or male reproductive system, the endocrine 

6 system, fertility, pregnancy, pregnancy outcomes, or 

7 modifications in other functions of the body that are 

8 dependent on the integrity of the reproductive sys9 tem as well as normal fetal development. 

10 ‘‘(11) SERIOUS ADVERSE EVENT.—The term 

11 ‘serious adverse event’ means— 

12 ‘‘(A) an acute or chronic response that re13 sults in death, a life-threatening experience, 

14 short- or long-term hospitalization, a persistent 

15 or significant disability or incapacity, a con16 genital anomaly or birth defect, serious and 

17 persistent rashes or infections, significant hair 

18 loss, permanent or significant alteration of ap19 pearance, or impacts to maternal health, includ20 ing placentia previa, gestational diabetes, and 

21 miscarriage; 

22 ‘‘(B) an event that requires, based on a 

23 reasonable medical judgment, a medical or sur24 gical intervention; or 


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1 ‘‘(C) any other serious adverse health-re2 lated event associated with the use of the prod3 uct. 

4 ‘‘(12) SUPPLIER.—The term ‘supplier’ means 

5 the entity that supplies ingredients, raw materials, 

6 or specific components of a cosmetic or cosmetic 

7 packaging. 

8 ‘‘(13) VULNERABLE POPULATIONS.—The term 

9 ‘vulnerable populations’ includes pregnant women, 

10 infants, children, the elderly, individuals with a com11 promised immune system, and highly exposed popu12 lations including workers in a hair salon, nail salon, 

13 beauty salon, spa, or cosmetic manufacturing plant. 

14 ‘‘SEC. 612. REGISTRATION OF ESTABLISHMENTS AND REG15 ISTRATION FEES. 

16 ‘‘(a) REGISTRATION.— 

17 ‘‘(1) IN GENERAL.—Beginning 1 year after the 

18 date of the enactment of this subchapter, and annu19 ally thereafter, any brand owner engaged in bringing 

20 a cosmetic to market for use in the United States 

21 shall register with the Secretary and pay to the Sec22 retary the applicable fee, as established under the 

23 fee schedule in subsection (e). 


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1 ‘‘(2) EXCEPTION FOR MICROBUSINESSES.—The 

2 requirements of this section do not apply with re3 spect to microbusinesses. 

4 ‘‘(3) RULES FOR DOMESTIC AND FOREIGN ES5 TABLISHMENTS.—To be registered under paragraph 

6 (1)— 

7 ‘‘(A) as a domestic establishment, the 

8 owner, operator, or agent in charge of the do9 mestic establishment shall submit a registration 

10 to the Secretary; or 

11 ‘‘(B) as a foreign establishment, the owner, 

12 operator, or agent in charge of the foreign es13 tablishment shall— 

14 ‘‘(i) submit a registration to the Sec15 retary; and 

16 ‘‘(ii) include with the registration the 

17 name of the United States agent for the 

18 foreign establishment. 

19 ‘‘(4) NEW ESTABLISHMENTS.—Any brand 

20 owner that initially brings a cosmetic to market 

21 after the date on which the requirements of para22 graph (1) apply shall, not later than 60 days after 

23 the date on which the establishment brings a cos24 metic to market, register with the Secretary and pay 

25 the applicable fee, as required under paragraph (1). 


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1 ‘‘(b) SUBMISSION OF REGISTRATION.— 

2 ‘‘(1) IN GENERAL.—In order to register under 

3 subsection (a), an establishment (referred to in this 

4 section as the ‘registrant’) shall submit to the Sec5 retary, with respect to any cosmetics that the estab6 lishment brings to market, all of the following: 

7 ‘‘(A) Any information necessary to notify 

8 the Secretary of the name, address, and legal 

9 status of each establishment at which, and all 

10 trade names under which, the registrant brings 

11 cosmetics to market. 

12 ‘‘(B) A description of the establishment’s 

13 activities with respect to cosmetics, including a 

14 list of all cosmetic products brought to market 

15 by the establishment and the functions of such 

16 cosmetics. 

17 ‘‘(C) The gross receipts or sales for the es18 tablishment from cosmetics. 

19 ‘‘(2) NOTIFICATION OF CHANGES.—When sub20 mitting the annual registration, the registrant shall 

21 notify the Secretary of changes to the information 

22 described in paragraph (1). 

23 ‘‘(c) PROCEDURE.—Upon receipt of a completed reg24 istration submitted under subsection (a), the Secretary 

25 shall notify the registrant of the receipt of such registraVerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296

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1 tion and assign a registration number to each registered 

2 establishment. 

3 ‘‘(d) LIST OF REGISTERED ESTABLISHMENTS.— 

4 ‘‘(1) MAINTENANCE OF LIST.—The Secretary 

5 shall— 

6 ‘‘(A) compile, maintain, and update as ap7 propriate, a list of establishments that are reg8 istered under this section; 

9 ‘‘(B) make such list publicly available, in10 cluding by posting such list on the public 

11 website of the Food and Drug Administration; 

12 ‘‘(C) remove from such list the name of 

13 any establishment that fails to register in ac14 cordance with this section; and 

15 ‘‘(D) indicate on such list any establish16 ment which has had its registration suspended 

17 or cancelled by the Secretary under this section. 

18 ‘‘(2) APPLICATION OF FOIA.— 

19 ‘‘(A) REGISTRATION DOCUMENTS.—Any 

20 registration documents submitted pursuant to 

21 this section shall not be subject to disclosure 

22 under section 552 of title 5, United States 

23 Code. 

24 ‘‘(B) OTHER INFORMATION.—Information 

25 derived from— 


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1 ‘‘(i) the list under paragraph (1); or 

2 ‘‘(ii) registration documents submitted 

3 pursuant to this section, 

4 shall not be subject to disclosure under section 

5 552 of title 5, United States Code, except to the 

6 extent that such information discloses the iden7 tity or location of a specific registrant. 

8 ‘‘(e) FEE SCHEDULE.—A schedule of fees shall be de9 veloped by the Secretary to provide for oversight and en10 forcement of this subchapter. The fee structure shall— 

11 ‘‘(1) be prorated based on the establishment’s 

12 gross receipts or sales; and 

13 ‘‘(2) only be assessed on companies with annual 

14 gross receipts or sales of cosmetics that exceed 

15 $5,000,000. 

16 ‘‘(f) SUSPENSION AND CANCELLATION OF REGISTRA17 TION.— 

18 ‘‘(1) CRITERIA FOR SUSPENSION.—Registration 

19 under this section is subject to suspension if the 

20 Secretary finds— 

21 ‘‘(A) the information submitted by the es22 tablishment for registration under subsection 

23 (a) is incomplete, inaccurate, or out of date; 


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1 ‘‘(B) the establishment fails to notify the 

2 Secretary of changes required under subsection 

3 (b)(2); 

4 ‘‘(C) the establishment fails to pay reg5 istration fees, as required under subsection (a), 

6 in a timely manner; or 

7 ‘‘(D) the establishment violates any portion 

8 of this chapter. 

9 ‘‘(2) SUSPENSION OF REGISTRATION.—If the 

10 Secretary determines that an establishment is sub11 ject to suspension under this subsection and that it 

12 is appropriate to suspend the registration of such es13 tablishment the Secretary shall— 

14 ‘‘(A) suspend the registration of such es15 tablishment; and 

16 ‘‘(B) provide a notice of suspension to such 

17 establishment. 

18 ‘‘(3) CANCELLATION.—If the establishment 

19 fails to correct the issue that resulted in the suspen20 sion under paragraph (2) before the last day of the 

21 30-day period beginning on the date that the estab22 lishment receives notice under such paragraph, the 

23 Secretary may cancel the registration of such estab24 lishment. 


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1 ‘‘(g) RECORDKEEPING.—All establishments that are 

2 required to register under this section shall maintain 

3 records that include a current list of suppliers and manu4 facturers if the registrant does not manufacture or pack5 age its own product. Those records shall be accessible by 

6 the Secretary upon request for review or audit. 

7 ‘‘SEC. 613. INGREDIENTS LABELS AND WEBSITE DISCLO8 SURE FOR COSMETICS. 

9 ‘‘(a) IN GENERAL.—Subject to subsections (b) and 

10 (c), the Secretary shall require that the label on each pack11 age of cosmetics (including cosmetics for retail sale and 

12 professional use) bears a declaration of the name of each 

13 ingredient in such cosmetic in descending order of pre14 dominance. 

15 ‘‘(b) ADJUSTMENTS FOR LABEL SIZE.— 

16 ‘‘(1) RULES FOR SMALL PRODUCTS.—Not later 

17 than 6 months after the date of the enactment of 

18 this subchapter, the Secretary shall issue regulations 

19 that apply to any cosmetic for which the product 

20 packaging is not of sufficient size to bear or contain 

21 a label that meets the requirements of subsection 

22 (a). 

23 ‘‘(2) REQUIREMENTS FOR PUBLIC DISCLO24 SURE.—Such regulations shall establish require25 ments for listing ingredients on the label of such 


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1 cosmetics and additional requirements, as appro2 priate, for public disclosure of the ingredients in 

3 such cosmetics. 

4 ‘‘(c) SPECIAL RULE FOR CONTAMINANTS.—The Sec5 retary shall require, in the case of a contaminant (as de6 fined by section 618), that a contaminant be declared on 

7 the label of a cosmetic, in the same manner as an ingre8 dient under subsection (a), if the contaminant is present 

9 in a personal care product in any quantity exceeding one 

10 half of one percent of the content of the product by weight. 

11 ‘‘(d) LABELING OF NANOMATERIALS IN COS12 METICS.—The Secretary may require that— 

13 ‘‘(1) minerals and other particulate ingredients 

14 be labeled as ‘nano-scale’ on a cosmetic ingredient 

15 label or list if not less than 1 percent of the ingre16 dient particles in the cosmetic are 100 nanometers 

17 or smaller in not less than 1 dimension; and 

18 ‘‘(2) other ingredients in a cosmetic be des19 ignated with scale-specific information on a cosmetic 

20 ingredient label or list if such ingredients possess 

21 scale-specific hazard properties. 

22 ‘‘(e) WEBSITE DISCLOSURE OF COSMETIC INGREDI23 ENTS.—The Secretary shall require that the website of a 

24 brand owner of a cosmetic include a declaration of the inVerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296

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1 gredients in the cosmetic in descending order of predomi2 nance, including the function of each ingredient. 

3 ‘‘(f) LABELING OF INGREDIENTS IN COSMETICS

4 SOLD THROUGH INTERNET COMMERCE.—The Secretary 

5 shall require— 

6 ‘‘(1) in the case of a cosmetic sold on the 

7 website of an internet vendor, that the brand owner 

8 of such cosmetic provide to such internet vendor a 

9 list of the ingredients in the cosmetic; and 

10 ‘‘(2) that each internet vendor display the list 

11 of ingredients in a cosmetic sold by such vendor on 

12 the web page that is the primary web page providing 

13 information relating to the sale of such cosmetic on 

14 the website of the vendor. 

15 ‘‘(g) PRODUCT LABELING OF FRAGRANCE AND FLA16 VOR INGREDIENTS.— 

17 ‘‘(1) REQUIREMENTS.—The Secretary shall re18 quire that all fragrance and flavor ingredients in a 

19 cosmetic that are deemed hazardous to human 

20 health or the environment by paragraph (2) appear 

21 on the label of the cosmetic. 

22 ‘‘(2) LIST OF INGREDIENTS DEEMED HAZ23 ARDOUS.—The following ingredients (including 

24 chemicals added by the relevant government agency 

25 or authoritative body subsequent to the date of enVerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296

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1 actment of this subchapter) are deemed hazardous 

2 to human health or the environment for purposes of 

3 paragraph (1)(A): 

4 ‘‘(A) Chemicals known to cause cancer or 

5 reproductive toxicity that are listed pursuant to 

6 California Health & Safety Code Section 

7 25249.5 et seq. 

8 ‘‘(B) Chemicals classified by the European 

9 Union as carcinogens, mutagens, or reproduc10 tive toxicants pursuant to Category 1A or 1B 

11 in Annex VI to Regulation (EC) No. 1272/ 

12 2008. 

13 ‘‘(C) Chemicals included in the European 

14 Union Candidate List of Substances of Very 

15 High Concern in accordance with Article 59 of 

16 Regulation (EC) No. 1907/2006 on the basis of 

17 Article 57(f) for endocrine disrupting prop18 erties. 

19 ‘‘(D) Chemicals for which a reference dose 

20 or reference concentration has been developed 

21 based on neurotoxicity in the Environmental 

22 Protection Agency’s Integrated Risk Informa23 tion System. 

24 ‘‘(E) Chemicals that are identified as car25 cinogenic to humans, likely to be carcinogenic 


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1 to humans, or as Group A, B1, or B2 carcino2 gens, in the Environmental Protection Agency’s 

3 Integrated Risk Information System. 

4 ‘‘(F) Chemicals included in the European 

5 Chemicals Agency Candidate List of Substances 

6 of Very High Concern in accordance with Arti7 cle 59 of Regulation (EC) No. 1907/2006 on 

8 the basis of Article 57(d), Article 57(e), or Arti9 cle 57(f) of Regulation (EC) No. 1907/2006 for 

10 persistent, bioaccumulative and toxic, or very 

11 persistent and very bioaccumulative, properties. 

12 ‘‘(G) Chemicals that are identified as per13 sistent, bioaccumulative, and inherently toxic to 

14 the environment by the Canadian Environ15 mental Protection Act Environmental Registry 

16 Domestic Substances List pursuant to sub17 section 66(1) of the Canadian Environmental 

18 Protection Act, 1999. 

19 ‘‘(H) Chemicals classified by the European 

20 Union in Annex VI to Regulation (EC) No. 

21 1272/2008 as respiratory sensitizer category 1. 

22 ‘‘(I) Group 1, 2A, or 2B carcinogens iden23 tified by the International Agency for Research 

24 on Cancer. 


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1 ‘‘(J) Neurotoxicants that are identified in 

2 the Agency for Toxic Substances and Disease 

3 Registry’s Toxic Substances Portal. 

4 ‘‘(K) Persistent bioaccumulative and toxic 

5 priority chemicals that are identified by the En6 vironmental Protection Agency’s National 

7 Waste Minimization Program as of February 

8 22, 2016. 

9 ‘‘(L) Reproductive and developmental toxi10 cants identified by National Toxicology Pro11 gram Center for the Evaluation of Risks mono12 graphs. 

13 ‘‘(M) Chemicals identified as ‘Persistent 

14 Bioaccumulative Toxic’ by the Environmental 

15 Protection Agency on the Toxics Release Inven16 tory under section 313 of the Emergency Plan17 ning and Community Right-to-Know Act of 

18 1986 (42 U.S.C. 11023). 

19 ‘‘(N) The State of Washington Depart20 ment of Ecology’s Persistent, Bioaccumulative, 

21 Toxic (PBT) Chemicals identified in Chapter 

22 173–333 of Title 173 of the Washington Ad23 ministrative Code. 

24 ‘‘(O) Chemicals that are identified as 

25 known to be, or reasonably anticipated to be, 


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1 human carcinogens by the most recent Report 

2 on Carcinogens prepared by the Federal Na3 tional Toxicology Program. 

4 ‘‘(P) Chemicals for which primary max5 imum contaminant levels have been established 

6 for drinking water by the Environmental Pro7 tection Agency. 

8 ‘‘(Q) Chemicals identified as hazardous air 

9 pollutants by the Environmental Protection 

10 Agency pursuant to section 112 of the Clean 

11 Air Act (42 U.S.C. 7412). 

12 ‘‘(R) Toxic pollutants listed under section 

13 307(a)(1) of the Federal Water Pollution Con14 trol Act (33 U.S.C. 1317) and priority pollut15 ants identified in appendix A to part 423 of 

16 title 40, Code of Federal Regulations. 

17 ‘‘(S) Chemicals that are identified on the 

18 Centers for Disease Control and Prevention’s 

19 most recent Report on Human Exposure to En20 vironmental Chemicals and Updated Tables 

21 Volume 1 and Volume 2. 

22 ‘‘(T) Chemicals that are identified on Part 

23 A of the list of Chemicals for Priority Action 

24 prepared by the Oslo and Paris Conventions for 


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1 the Protection of the Marine Environment of 

2 the North-East Atlantic. 

3 ‘‘(U) Chemicals identified as hazardous 

4 under section 101(14) or 102 of the Com5 prehensive Environmental Response, Compensa6 tion, and Liability Act of 1980 (42 U.S.C. 

7 9601(14), 9602). 

8 ‘‘(h) FRAGRANCE ALLERGENS.—The Secretary shall 

9 require that any fragrance allergen in a cosmetic be in10 cluded on the label of the cosmetic and identified as a fra11 grance allergen if the fragrance allergen is— 

12 ‘‘(1) included in Annex III of European Union 

13 Cosmetics Regulation No. 1223/2009, as required to 

14 be disclosed pursuant to European Union Deter15 gents Regulation No. 21648/2004, and subsequent 

16 updates to those regulations; and 

17 ‘‘(2) is present in— 

18 ‘‘(A) a rinse-off cosmetic at a concentra19 tion at or above 0.01 percent; or 

20 ‘‘(B) a leave-on cosmetic product at a con21 centration at or above 0.001 percent. 

22 ‘‘(i) TRADE SECRETS.—Notwithstanding any other 

23 provision of law, an ingredient required to be listed on a 

24 product label or on a brand owner or internet commerce 


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1 website under this section shall not be treated as a trade 

2 secret. 

3 ‘‘(j) APPLICATION.—Beginning 18 months after the 

4 date of the enactment of this subchapter, the requirements 

5 of this section shall apply to— 

6 ‘‘(1) all cosmetics that are available for retail 

7 sale (including such cosmetics for professional use); 

8 and 

9 ‘‘(2) brand owners and internet vendors of such 

10 cosmetics. 

11 ‘‘SEC. 614. SAFETY STANDARD AND GOOD MANUFACTURING 

12 PRACTICES. 

13 ‘‘(a) SAFETY STANDARD.— 

14 ‘‘(1) IN GENERAL.—Taking into account the ex15 pected or reasonably foreseeable use of a cosmetic, 

16 the Secretary shall establish a safety standard that, 

17 with respect to a cosmetic or an ingredient in a cos18 metic, provides a reasonable certainty of no harm 

19 (as such term is defined in section 611(9)) from ex20 posure to the cosmetic or ingredient and protects the 

21 public from any known or anticipated adverse health 

22 effects associated with the cosmetic or ingredient. 

23 ‘‘(2) STANDARDS FOR ESTABLISHING SAFETY

24 STANDARD.—In establishing the safety standard 


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1 under paragraph (1), the Secretary shall ensure 

2 that— 

3 ‘‘(A) the likely level of exposure to all 

4 sources of the ingredient or cosmetic (including 

5 environmental sources) that will result under 

6 the safety standard presents not more than a 

7 one in a million risk for any adverse health ef8 fect in any vulnerable population at the lower 

9 95th percentile confidence interval; or 

10 ‘‘(B) the safety standard results in expo11 sure to the amount or concentration of an in12 gredient or cosmetic that is shown to produce 

13 no adverse health effects, incorporating a mar14 gin of safety of at least 1,000 and considering 

15 the impact of cumulative exposure from all 

16 sources (including environmental sources). 

17 ‘‘(3) USE OF OTHER FEDERAL STANDARDS.—If 

18 any Federal agency has promulgated a standard for 

19 an ingredient that satisfies the requirements of 

20 paragraph (1), the Secretary may treat such stand21 ard as the safety standard under paragraph (1) for 

22 purposes of such ingredient. 

23 ‘‘(b) GOOD MANUFACTURING PRACTICES.— 

24 ‘‘(1) IN GENERAL.—The Secretary shall issue 

25 guidance prescribing good manufacturing practices 


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1 for cosmetics and ingredients, including quality con2 trol procedures that the Secretary determines are 

3 necessary, and shall update such guidance as nec4 essary. 

5 ‘‘(2) CONSIDERATION OF SMALL BUSINESS.—In 

6 developing the guidance under paragraph (1), the 

7 Secretary shall consider how such practices will im8 pact small businesses. 

9 ‘‘SEC. 615. COSMETIC AND INGREDIENT SAFETY INFORMA10 TION. 

11 ‘‘(a) REQUIRED SUBMISSION OF ALL SAFETY INFOR12 MATION.— 

13 ‘‘(1) IN GENERAL.—Brand owners of cosmetics 

14 shall submit electronically to the Secretary all data 

15 and information that the brand owner can access re16 garding the safety of— 

17 ‘‘(A) the ingredients listed on the cosmetic 

18 label and the brand owner’s website under sec19 tion 613 for a cosmetic; and 

20 ‘‘(B) the cosmetic itself. 

21 ‘‘(2) REQUIRED INFORMATION.—The required 

22 data and information under paragraph (1) shall in23 clude, for each ingredient in a cosmetic and for the 

24 cosmetic, the following: 

25 ‘‘(A) Functions and uses. 


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1 ‘‘(B) Data and information on the phys2 ical, chemical, and toxicity properties of each 

3 such ingredient or cosmetic. 

4 ‘‘(C) Exposure and fate information. 

5 ‘‘(D) Results of all safety tests that the 

6 brand owner can access or has conducted. 

7 ‘‘(E) Any other information used to sub8 stantiate the safety of such ingredient and cos9 metic. 

10 ‘‘(3) DEADLINES.— 

11 ‘‘(A) INITIAL SUBMISSION.—A brand 

12 owner shall submit the data and information re13 quired under paragraph (1)— 

14 ‘‘(i) in the case of an ingredient or 

15 cosmetic which is marketed for sale in 

16 interstate commerce on or before the date 

17 of the enactment of this subchapter, not 

18 later than 1 year after such date; and 

19 ‘‘(ii) in the case of an ingredient or 

20 cosmetic which is not marketed for sale on 

21 or before such date— 

22 ‘‘(I) not later than the end of the 

23 14-month period beginning on the 

24 date of the enactment of this sub25 chapter; or 


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1 ‘‘(II) if the ingredient or cosmetic 

2 is first marketed for sale in interstate 

3 commerce after the end of the period 

4 described in subclause (I), not later 

5 than 60 days after the date on which 

6 such ingredient or cosmetic is first 

7 marketed for sale. 

8 ‘‘(B) UPDATES.— 

9 ‘‘(i) IN GENERAL.—Subject to clause 

10 (ii), a brand owner shall update the data 

11 and information submitted under subpara12 graph (A) annually. 

13 ‘‘(ii) ADVERSE HEALTH EFFECTS.—In 

14 the case of information related to an ad15 verse health effect that is suspected to be 

16 caused by an ingredient or a cosmetic, a 

17 brand owner shall update the information 

18 not later than 60 days after receiving such 

19 information. 

20 ‘‘(4) SUPPLIER AND MANUFACTURER INFORMA21 TION.— 

22 ‘‘(A) USE OF SUPPLIER OR MANUFAC23 TURER INFORMATION.—In order to meet the re24 quirements of paragraph (1) with respect to an 

25 ingredient, a brand owner may submit safety 


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1 data and information provided by the supplier 

2 or manufacturer of the ingredient or cosmetic. 

3 ‘‘(B) SUPPLIER OR MANUFACTURER PRO4 VISION OF INFORMATION.—If a brand owner re5 quests that a supplier or manufacturer of an in6 gredient provide to such brand owner any of the 

7 data and information described under para8 graph (2) or under section 617, such supplier 

9 or manufacturer shall provide such data and in10 formation to such brand owner not later than 

11 90 days after receiving such request. 

12 ‘‘(b) DATABASE.— 

13 ‘‘(1) INITIAL PUBLICATION.—Not later than 1 

14 year after the date of the enactment of this sub15 chapter, the Secretary shall publish a comprehensive 

16 database that— 

17 ‘‘(A) is publicly accessible, including on the 

18 public website of the Food and Drug Adminis19 tration; and 

20 ‘‘(B) contains all nonconfidential informa21 tion (as such term is used in section 623) sub22 mitted under subsection (a)(1). 

23 ‘‘(2) UPDATES.—Not later than 90 days after 

24 the Secretary receives new or updated information 

25 under subsection (a)(3)(B), the Secretary shall upVerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296

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1 date the database under paragraph (1) with such in2 formation. 

3 ‘‘(c) REVIEW AND EVALUATION OF INFORMATION.— 

4 ‘‘(1) IN GENERAL.—Based on the data and in5 formation submitted under subsection (a)(1), avail6 able from an authoritative source (as such term is 

7 defined in paragraph (3), including data described in 

8 section 627(b)), and such other information as the 

9 Secretary may have available, the Secretary shall re10 view and evaluate the safety of cosmetics and ingre11 dients of cosmetics that are marketed in interstate 

12 commerce. 

13 ‘‘(2) CONSIDERATION OF NANOMATERIALS.— 

14 The Secretary shall— 

15 ‘‘(A) monitor developments in the scientific 

16 understanding from any adverse health effects 

17 related to the use of nanotechnology in the for18 mulation of cosmetics (including progress in the 

19 standardization of testing methods and specific 

20 size definitions for nanomaterials); and 

21 ‘‘(B) consider scale-specific hazard prop22 erties of ingredients when reviewing and evalu23 ating the safety of cosmetics and ingredients 

24 under paragraph (1). 


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1 ‘‘(3) AUTHORITATIVE SOURCE DEFINED.—For 

2 purposes of this subsection, the term ‘authoritative 

3 source’ means— 

4 ‘‘(A) the Environmental Protection Agen5 cy; 

6 ‘‘(B) the International Agency for Re7 search on Cancer; 

8 ‘‘(C) the National Institutes of Health; 

9 ‘‘(D) the California Environmental Protec10 tion Agency; and 

11 ‘‘(E) any other authoritative international, 

12 Federal, or State entity, as determined by the 

13 Secretary. 

14 ‘‘SEC. 616. LISTS OF INGREDIENTS AND REQUIRED RE15 SPONSES. 

16 ‘‘(a) PLACEMENT ON LIST.— 

17 ‘‘(1) IN GENERAL.—Based on an initial review 

18 and evaluation of the chronic health impacts associ19 ated with an ingredient that is used in one or more 

20 cosmetics, the Secretary shall create and periodically 

21 update a list of ingredients for safety review. From 

22 such list, the Secretary shall place ingredients on a 

23 priority assessment list and, after comprehensive 

24 safety review, place each ingredient on the priority 

25 assessment list on one of the following lists: 


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1 ‘‘(A) The prohibited and restricted lists 

2 under subsection (b). 

3 ‘‘(B) The safe without limits list under 

4 subsection (c). 

5 ‘‘(C) The insufficient data list under sub6 section (d). 

7 ‘‘(2) INITIAL LIST.—The Secretary shall add 20 

8 ingredients to the initial priority assessment list cre9 ated under paragraph (1) immediately after the en10 actment of this subchapter. 

11 ‘‘(3) CONSIDERATIONS.—In determining the 

12 placement of an ingredient on the priority assess13 ment list under paragraph (1), the Secretary shall 

14 consider the scientific evidence linking that ingre15 dient to harm and conduct further prioritization 

16 based on whether the ingredient— 

17 ‘‘(A) is found to be present in the body 

18 through biomonitoring; 

19 ‘‘(B) is found in drinking water or air; 

20 ‘‘(C) is a known or suspected neurological 

21 or immunological toxicant, respiratory 

22 asthmagen, carcinogen, teratogen, or endocrine 

23 disruptor, or have other toxicity concerns (in24 cluding reproductive or developmental toxicity); 


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1 ‘‘(D) is known to persist in the environ2 ment or bioaccumulate; or 

3 ‘‘(E) is of particular concern to a commu4 nity disproportionately impacted by cosmetic 

5 chemicals in products marketed to them be6 cause of their particular race, ethnicity, or oc7 cupation. 

8 ‘‘(4) PRIORITIZATION OF INGREDIENTS THAT

9 ARE FOOD.—In placing ingredients on the lists 

10 under paragraph (1), the Secretary shall prioritize 

11 the placement of ingredients that are food (as such 

12 term is defined under section 201(f)) on such lists. 

13 ‘‘(b) PROHIBITED AND RESTRICTED LISTS.— 

14 ‘‘(1) IN GENERAL.—The Secretary shall issue, 

15 by regulation, two lists of ingredients that are iden16 tified by the Secretary— 

17 ‘‘(A) in the first list, as prohibited for use 

18 in cosmetics because the Secretary determines 

19 that such ingredients are unsafe for use in cos20 metics in any amount because such ingredients 

21 fail to meet the safety standard under section 

22 614(a); or 

23 ‘‘(B) in the second list, as being subject to 

24 necessary restrictions in use or concentration to 


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1 allow the use of the ingredient in a cosmetic to 

2 satisfy the safety standard. 

3 ‘‘(2) INITIAL PROHIBITED LIST.— 

4 ‘‘(A) IMMEDIATELY PROHIBITED INGREDI5 ENTS.—Effective as of the date of enactment of 

6 this subchapter, the following ingredients are 

7 deemed to be listed pursuant to paragraph 

8 (1)(A) as prohibited for use: 

9 ‘‘(i) Benzophenones, including benzo10 phenone-1, benzophenone-3 (also known as 

11 ozybenzone), benzophenone-4, and benzo12 phenone-5. 

13 ‘‘(ii) Octinoxate. 

14 ‘‘(iii) Butylated Hydroxyanisole and 

15 Butylated Hydroxyoluen. 

16 ‘‘(iv) Coal tar dyes (P-phenylenedia17 mine). 

18 ‘‘(v) Cocamide Diethanolamine. 

19 ‘‘(vi) Dibutyalated Phthalate (Phtha20 lates DBP), Bis(2-ethylhexyl) Phthalate 

21 (DEHP). 

22 ‘‘(vii) Toluene. 

23 ‘‘(viii) Styrene or Styrene acrylates. 

24 ‘‘(ix) Formaldehydes (Methylene gly25 col/methanediol/formaldehyde) and FormVerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296

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1 aldehyde-releasing preservatives (DMDM 

2 hydantoin, diazolidinyl urea, imidazolidinyl 

3 urea, methenamine, quaternium-15, and 

4 sodium hydroxymethylglycinate). 

5 ‘‘(x) Triclosan. 

6 ‘‘(xi) Lead acetate or other lead com7 pounds. 

8 ‘‘(xii) Parabens (isoproylparaben, iso9 butylparaben, pheylparaben, benzylpara10 ben, pentylparaben, propylparaben, and 

11 butylparaben). 

12 ‘‘(B) FIRST INGREDIENTS LISTED BY REG13 ULATION.—Not later than 2 years after the 

14 date of enactment of this subchapter, the Sec15 retary shall promulgate by final regulation the 

16 lists required by subparagraphs (A) and (B) of 

17 paragraph (1), to supplement the ingredients 

18 deemed by subparagraph (A) of this paragraph 

19 to be listed pursuant to paragraph (1)(A). 

20 ‘‘(3) SPECIFICATION OF RESTRICTIONS.—In the 

21 case of any ingredient listed under paragraph 

22 (1)(B), the Secretary shall specify the restrictions on 

23 use or concentration that are necessary to satisfy the 

24 safety standard for such ingredient. 

25 ‘‘(4) UPDATES.— 


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1 ‘‘(A) IN GENERAL.—After promulgating 

2 the initial list pursuant to paragraph (2)(B), 

3 the Secretary shall update the lists under para4 graph (1) at a minimum annually, including— 

5 ‘‘(i) updates to determinations under 

6 subsection (d)(3); or 

7 ‘‘(ii) any updates prompted by new in8 formation that demonstrates that an ingre9 dient fails to meet the safety standard, or 

10 requires restrictions on use to meet such 

11 standard. 

12 ‘‘(B) CHEMICALS IDENTIFIED PURSUANT

13 TO NIH-FUNDED RESEARCH.—The Secretary 

14 shall— 

15 ‘‘(i) consult with the Director of the 

16 National Institute of Environmental 

17 Health Sciences to identify any chemicals 

18 that are determined to be of concern pur19 suant to investigations funded under sec20 tion 463C of the Public Health Service 

21 Act; and 

22 ‘‘(ii) review any such chemicals in ac23 cordance with this section to determine 

24 whether such chemicals should be prohibVerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296

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1 ited or subject to restrictions under this 

2 section. 

3 ‘‘(5) MANUFACTURER REQUIREMENTS.—Not 

4 later than 1 year after the date on which an ingre5 dient is placed on a list under this subsection, any 

6 manufacturer using such ingredient in a cosmetic 

7 shall reformulate such cosmetic to— 

8 ‘‘(A) eliminate the use of the ingredient, if 

9 it is listed under paragraph (1)(A); or 

10 ‘‘(B) modify the use of the ingredient if it 

11 is listed under paragraph (1)(B), to meet the 

12 restrictions specified under paragraph (3). 

13 ‘‘(c) SAFE WITHOUT LIMITS LIST.— 

14 ‘‘(1) IN GENERAL.—Not later than 2 years 

15 after the date of the enactment of this subchapter, 

16 the Secretary shall issue, by regulation, a list of in17 gredients that the Secretary has determined are safe 

18 for use in cosmetics, without limits or restrictions. 

19 ‘‘(2) STANDARD FOR INCLUSION IN LIST.—The 

20 Secretary may only include an ingredient on the list 

21 under paragraph (1) if the Secretary determines 

22 that the ingredient meets the safety standard under 

23 section 614(a), regardless of— 

24 ‘‘(A) the type and form of cosmetic the in25 gredient is used in; and 


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1 ‘‘(B) the concentration of the ingredient 

2 that is used in a cosmetic. 

3 ‘‘(3) UPDATES AND REDETERMINATIONS.— 

4 After promulgating the initial list pursuant to para5 graph (1), the Secretary— 

6 ‘‘(A) shall annually update the list under 

7 paragraph (1); and 

8 ‘‘(B) may redetermine whether an ingre9 dient distributed in commerce meets the safety 

10 standard under section 614(a) if, in the judg11 ment of the Secretary, new information raises a 

12 credible question as to whether the ingredient 

13 continues to meet the safety standard. 

14 ‘‘(d) PRIORITY ASSESSMENT LIST AND RELATED

15 SAFETY DETERMINATIONS.— 

16 ‘‘(1) IN GENERAL.—Not later than 1 year after 

17 the creation of the initial priority assessment list of 

18 ingredients for review under subsection (a)(1), the 

19 Secretary shall evaluate the safety of not less than 

20 10 ingredients for which the Secretary has deter21 mined it is a priority to conduct a safety determina22 tion under paragraph (3). 

23 ‘‘(2) ANNUAL ADDITION OF INGREDIENTS.— 

24 After the initial evaluation of 10 ingredients pursu25 ant to paragraph (1), the Secretary shall annually 


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1 add at least 10 additional ingredients to such list 

2 until all ingredients that are used in the formulation 

3 or manufacture of cosmetics have been evaluated for 

4 safety and added to— 

5 ‘‘(A) the prohibited and restricted lists 

6 under subsection (b); 

7 ‘‘(B) the safe without limits list under sub8 section (c); or 

9 ‘‘(C) the insufficient data list under this 

10 subsection. 

11 ‘‘(3) DETERMINATION OF WHETHER INGRE12 DIENT MEETS SAFETY STANDARD.— 

13 ‘‘(A) REVIEW OF PRIORITY INGREDI14 ENTS.—During the 2-year period following the 

15 date on which an ingredient is listed pursuant 

16 to paragraph (1) or (2), the Secretary shall— 

17 ‘‘(i) collect data and information on 

18 such ingredient; and 

19 ‘‘(ii) review and evaluate the safety of 

20 such ingredient. 

21 ‘‘(B) DETERMINATION OF LIST PLACE22 MENT.—Not later than the end of the period 

23 under subparagraph (A), the Secretary shall 

24 issue a determination, based on the review and 

25 evaluation under such subparagraph, that the 


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1 ingredient meets the requirements for inclusion 

2 on a list specified in subparagraph (A), (B), or 

3 (C) of paragraph (2). 

4 ‘‘(C) GUIDANCE IN THE CASE OF INSUFFI5 CIENT OR NO DATA.—If the Secretary deter6 mines under subparagraph (B) that, with re7 spect to an ingredient, insufficient or no data 

8 exists to place such ingredient on either the 

9 prohibited and restricted list under subsection 

10 (b) or the safe without limits list under sub11 section (c), the Secretary shall provide guidance 

12 on the data and information (including min13 imum data requirements and safety testing pro14 tocols) that the Secretary requires to evaluate 

15 whether the ingredient meets the safety stand16 ard under section 614(a) for purposes of plac17 ing such ingredient on either such list. 

18 ‘‘(D) COMMENT PERIOD.—Upon issuing 

19 the determination under subparagraph (B), 

20 and, if applicable, the guidance under subpara21 graph (C), the Secretary shall provide a period 

22 of not less than 60 days for public comment on 

23 the determination before applying such deter24 mination to an ingredient, except that a shorter 


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1 period for comment may be provided if the Sec2 retary— 

3 ‘‘(i) finds that it would be in the pub4 lic interest to have a shorter period; and 

5 ‘‘(ii) publicly declares the reasons for 

6 such finding. 

7 ‘‘(4) RESPONSE TO INADEQUATE INFORMA8 TION.—Not later than 18 months after the date that 

9 the Secretary issues guidance under paragraph 

10 (3)(C) with respect to an ingredient subject to a de11 termination under paragraph (3)(B), a brand owner 

12 using such ingredient in a cosmetic shall— 

13 ‘‘(A) reformulate such cosmetic to elimi14 nate the use of the ingredient; or 

15 ‘‘(B) provide the Secretary with the data 

16 and information specified in such guidance. 

17 ‘‘(5) EVALUATION OF ADDITIONAL DATA AND

18 INFORMATION.—With respect to an ingredient, not 

19 later than 6 months after the Secretary receives the 

20 data and information under paragraph (4)(B), the 

21 Secretary shall— 

22 ‘‘(A) review such data and information; 

23 and 


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1 ‘‘(B) make a redetermination under para2 graph (3)(B) for such ingredient, subject to the 

3 comment period under paragraph (3)(D). 

4 ‘‘SEC. 617. TREATMENT OF COSMETICS BASED ON INGRE5 DIENT LISTS. 

6 ‘‘(a) IN GENERAL.—Subject to subsections (b)(5) 

7 and (d)(4) of section 616, a brand owner may only dis8 tribute in interstate commerce a cosmetic that meets the 

9 safety standard under section 614(a). 

10 ‘‘(b) PRESUMPTION RELATED TO THE SAFETY OF

11 COSMETICS.— 

12 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

13 for purposes of subsection (a), the Secretary shall 

14 presume that the following cosmetics meet the safety 

15 standard under section 614(a): 

16 ‘‘(A) A cosmetic that is made solely of in17 gredients on the list under section 616(c)(1) 

18 (relating to ingredients that are safe without 

19 limits). 

20 ‘‘(B) A cosmetic that is made solely of in21 gredients on the list under section 616(b)(1)(B) 

22 (relating to ingredients subject to restrictions) 

23 and the use of each of such ingredients in such 

24 cosmetic is in compliance with the restrictions 


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1 on the use of such ingredients specified under 

2 section 616(b)(3). 

3 ‘‘(C) A cosmetic that is made solely of in4 gredients described in subparagraph (A) and 

5 subparagraph (B). 

6 ‘‘(2) EXCEPTIONS.—The Secretary may require 

7 that a brand owner demonstrate that a cosmetic 

8 meets the safety standard under section 614(a) (in9 cluding by requiring that the brand owner conduct 

10 safety testing, or request such safety testing from 

11 relevant suppliers and manufacturers, of a cosmetic 

12 described under paragraph (1)) if— 

13 ‘‘(A) the cosmetic contains— 

14 ‘‘(i) penetration enhancers, sensi15 tizers, endocrine-disrupting compounds, or 

16 other similar ingredients; or 

17 ‘‘(ii) ingredients that react with each 

18 other or with other substances to form 

19 harmful byproducts; or 

20 ‘‘(B) the Secretary has any additional rea21 son to believe that such cosmetic does not meet 

22 the safety standard under section 614(a). 

23 ‘‘(3) GUIDANCE.—If, under paragraph (2), the 

24 Secretary requires that a brand owner demonstrate 

25 that a cosmetic meets the safety standard under secVerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00040 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296

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1 tion 614(a), the Secretary shall provide the brand 

2 owner with guidance on the data and information 

3 that the Secretary requires to evaluate whether the 

4 cosmetic meets the safety standard under such sec5 tion. 

6 ‘‘(c) NOTIFICATION OF FAILURE OF SECRETARY TO

7 ACT.—If the Secretary fails to act by an applicable dead8 line under section 616 or this section, brand owners and 

9 manufacturers of an ingredient or a cosmetic affected by 

10 such failure of the Secretary to act shall issue to the Sec11 retary, the public, and each known customer of the ingre12 dient or cosmetic, a written and electronic notice that a 

13 determination by the Secretary of the safety of the ingre14 dient or cosmetic is pending. 

15 ‘‘SEC. 618. TREATMENT OF CONTAMINANTS. 

16 ‘‘(a) PUBLICATION OF LIST.—Not later than 1 year 

17 after the date of the enactment of this subchapter, and 

18 annually thereafter, the Secretary shall publish a list of 

19 contaminants of concern linked to severe acute reactions 

20 or chronic adverse health effects, including— 

21 ‘‘(1) ingredients used in cosmetics that may 

22 contain contaminants of concern; 

23 ‘‘(2) combinations of ingredients that may cre24 ate contaminants of concern when such ingredients 

25 interact; 


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1 ‘‘(3) contaminants of concern that may leech 

2 from product packaging into a cosmetic; and 

3 ‘‘(4) any other contaminant of concern identi4 fied by the Secretary that are present in cosmetics. 

5 ‘‘(b) EVALUATION; LABELING.—The Secretary shall 

6 use the process described in sections 615 and 616 to evalu7 ate contaminants of concern for possible elimination or re8 striction in cosmetics. The Secretary shall require that a 

9 contaminant on the list under subsection (a) be declared 

10 on the label of a cosmetic, in the same manner as an ingre11 dient under section 613. 

12 ‘‘(c) REQUIREMENTS FOR TESTING.— 

13 ‘‘(1) IN GENERAL.—Not later than 1 year after 

14 the date of enactment of this subchapter, the Sec15 retary shall establish, by rule, requirements for test16 ing ingredients and cosmetics for contaminants list17 ed under subsection (a). 

18 ‘‘(2) CONTENTS.—The requirements under 

19 paragraph (1) shall include— 

20 ‘‘(A) testing methods and applicable proto21 cols; and 

22 ‘‘(B) maximum allowable detection limits 

23 for each contaminant in an ingredient or cos24 metic. 


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1 ‘‘(3) UPDATE.—The Secretary shall annually 

2 update the requirements under paragraph (1). 

3 ‘‘(d) SUPPLIER REQUIREMENTS.—Beginning not 

4 later than 1 year after the promulgation of the rule under 

5 subsection (c)(1) with respect to an ingredient that is used 

6 in a cosmetic, a supplier of the ingredient shall, with re7 spect to such ingredient— 

8 ‘‘(1) comply with the requirements under sub9 section (c)(1) for any ingredient listed under sub10 section (a); 

11 ‘‘(2) conduct similar testing on any ingredient 

12 that— 

13 ‘‘(A) the supplier expects may be used in 

14 a cosmetic; 

15 ‘‘(B) the supplier suspects may contain a 

16 contaminant of concern; and 

17 ‘‘(C) is not listed under subsection (a); and 

18 ‘‘(3) upon the sale of an ingredient to the man19 ufacturer of a cosmetic, provide to the manufacturer 

20 specifications for the ingredient that— 

21 ‘‘(A) include the levels of contaminants 

22 present in such ingredient; and 

23 ‘‘(B) are based on the results of the tests 

24 under paragraph (1) and paragraph (2). 


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1 ‘‘(e) BRAND OWNER REQUIREMENTS.—Not later 

2 than 1 year after the promulgation of the rule under sub3 section (c)(1), a brand owner of a cosmetic shall, with re4 spect to each ingredient that the brand owner uses in a 

5 cosmetic— 

6 ‘‘(1) obtain, from each supplier or manufac7 turer of the ingredient, specifications for the ingre8 dient that include— 

9 ‘‘(A) the level of each contaminant present 

10 in the ingredient; and 

11 ‘‘(B) the detection limits of the analytical 

12 test used to detect the contaminant; or 

13 ‘‘(2) comply with the requirements under para14 graphs (1) and (2) of subsection (d) for the ingre15 dient, in the same manner as if the brand owner 

16 were a supplier. 

17 ‘‘SEC. 619. COSMETIC AND INGREDIENT STATEMENTS. 

18 ‘‘(a) IN GENERAL.—Beginning 1 year after the date 

19 of the enactment of this subchapter, each brand owner of 

20 a cosmetic intended to be marketed in the United States 

21 shall submit electronically to the Secretary, for each cos22 metic that is intended to be marketed in the United 

23 States, a statement containing— 

24 ‘‘(1) the registration number of the brand 

25 owner; 


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1 ‘‘(2) the brand name and the product name for 

2 the cosmetic; 

3 ‘‘(3) the applicable use for the cosmetic; 

4 ‘‘(4) a list of the ingredients in the product, in5 cluding fragrance, flavorants, and the particle size 

6 range of any nanoscale cosmetic ingredients; 

7 ‘‘(5) any warnings and directions for use from 

8 the cosmetic label or insert; and 

9 ‘‘(6) the name, title, and full contact informa10 tion for the individual responsible for submitting and 

11 maintaining such statement. 

12 ‘‘(b) NEW COSMETICS.—Any brand owner that be13 gins to market a cosmetic after the date of the enactment 

14 of this subchapter shall comply with the requirements of 

15 subsection (a) beginning on the later of the following: 

16 ‘‘(1) The end of the 18-month period beginning 

17 on the date of the enactment of this subchapter. 

18 ‘‘(2) The end of the 6-month period after the 

19 date on which the establishment begins to manufac20 ture such cosmetic. 

21 ‘‘(c) NOTIFICATION OF CHANGES.—The brand owner 

22 shall notify the Secretary annually of any change to the 

23 information required under subsection (a). 

24 ‘‘(d) PROCEDURE.—Upon receipt of a completed 

25 statement described under subsection (a), the Secretary 


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1 shall notify the brand owner of the receipt of such state2 ment and assign a cosmetic statement number. 

3 ‘‘(e) LIST.—The Secretary shall compile, maintain, 

4 and update as appropriate, a list of cosmetics for which 

5 statements are submitted under this section. 

6 ‘‘(f) ACCESS TO SAFETY INFORMATION.—The cos7 metic and ingredient statements collected under this sec8 tion shall be added to the publicly accessible database cre9 ated by the Secretary under section 615(b). 

10 ‘‘SEC. 620. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

11 OF ADULTERATED OR MISBRANDED COS12 METICS. 

13 ‘‘(a) NOTIFICATION OF ADULTERATED OR MIS14 BRANDED COSMETICS.— 

15 ‘‘(1) IN GENERAL.—A responsible party that 

16 has reason to believe that a cosmetic, when intro17 duced into or while in interstate commerce, or while 

18 held for sale (regardless of whether such sale is the 

19 first sale of such cosmetic) after shipment in inter20 state commerce, is adulterated or misbranded in a 

21 manner that presents a reasonable probability that 

22 the use or exposure to the cosmetic (or an ingredient 

23 or component used in any such cosmetic) will cause 

24 a threat of a serious adverse event shall notify the 


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1 Secretary of the identity and location of the cos2 metic. 

3 ‘‘(2) MANNER OF NOTIFICATION.—Notification 

4 under paragraph (1) shall be made in such manner 

5 and by such means as the Secretary may require by 

6 regulation or guidance. 

7 ‘‘(3) RESPONSIBLE PARTY DEFINED.—For pur8 poses of this subsection, the term ‘responsible party’ 

9 means a brand owner, manufacturer, packager, re10 tailer, or distributor of the cosmetic. 

11 ‘‘(b) VOLUNTARY RECALL.—The Secretary may re12 quest that any person who distributes a cosmetic that the 

13 Secretary has reason to believe is adulterated, misbranded, 

14 or otherwise in violation of this Act voluntarily— 

15 ‘‘(1) recall such cosmetic; and 

16 ‘‘(2) provide for notice, including to individuals 

17 as appropriate, to persons who may be affected by 

18 the recall. 

19 ‘‘(c) ORDER TO CEASE DISTRIBUTION.— 

20 ‘‘(1) IN GENERAL.—If the Secretary has reason 

21 to believe that— 

22 ‘‘(A) the use of, or exposure to, a cosmetic 

23 may cause a serious adverse event; 

24 ‘‘(B) the cosmetic is misbranded; or 


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1 ‘‘(C) the cosmetic is marketed, manufac2 tured, packaged, or distributed by an unregis3 tered brand owner, 

4 the Secretary may issue an order requiring any per5 son who distributes such cosmetic to immediately 

6 cease distribution of such cosmetic. 

7 ‘‘(2) CEASE DISTRIBUTION AND NOTICE.—Any 

8 person who is subject to an order under paragraph 

9 (1) shall immediately cease distribution of such cos10 metic and provide notification as required by such 

11 order. 

12 ‘‘(3) APPEAL.— 

13 ‘‘(A) 24 HOURS.—A person subject to an 

14 order under paragraph (1) may appeal such 

15 order to the Secretary within 24 hours of the 

16 issuance of such order. 

17 ‘‘(B) CONTENTS OF APPEAL.—Such appeal 

18 may include a request for an informal hearing 

19 and a description of any efforts to recall such 

20 cosmetic undertaken voluntarily by the person, 

21 including after a request under subsection (b). 

22 ‘‘(C) INFORMAL HEARING.—Except as pro23 vided in subsection (d)(2), an informal hearing 

24 shall be held as soon as practicable, but not 

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1 mined by the Secretary) after such an appeal is 

2 filed, unless the parties jointly agree to an ex3 tension. 

4 ‘‘(D) IMPACT ON RECALL.—If an appeal is 

5 filed under subparagraph (A), the Secretary 

6 may not amend the order to require a recall 

7 under subsection (d) until after the conclusion 

8 of the hearing under subparagraph (C). 

9 ‘‘(4) VACATION OF ORDER.—If the Secretary 

10 determines that inadequate grounds exist to support 

11 the actions required by the order under paragraph 

12 (1), the Secretary shall vacate the order. 

13 ‘‘(d) MANDATORY RECALL ORDERS.— 

14 ‘‘(1) IN CONJUNCTION WITH ORDER TO CEASE

15 DISTRIBUTION.— 

16 ‘‘(A) AMENDMENT.—Except as provided 

17 under paragraph (2) and subject to subsection 

18 (c)(3)(D), if the Secretary determines that a re19 call of a cosmetic subject to an order under 

20 subsection (c) is appropriate, the Secretary 

21 shall amend the order to require a recall. 

22 ‘‘(B) CONTENTS.—An amended order 

23 under subparagraph (A) shall— 

24 ‘‘(i) specify a timetable in which the 

25 recall will occur; 


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1 ‘‘(ii) require periodic reports to the 

2 Secretary describing the progress of the re3 call; and 

4 ‘‘(iii) provide for notice, including to 

5 individuals as appropriate, to persons who 

6 may be affected by the recall. 

7 ‘‘(C) ASSISTANCE IN PROVIDING NO8 TICE.—In providing for notice under subpara9 graph (B), the Secretary may allow for the as10 sistance of health professionals, State or local 

11 officials, or other individuals designated by the 

12 Secretary. 

13 ‘‘(D) DETERMINATION.—If the Secretary 

14 determines that inadequate grounds exist to 

15 support the amendment made to the order 

16 under subparagraph (A), the Secretary shall re17 move such amendment from such order. 

18 ‘‘(2) FOR IMMINENT THREAT OF A SERIOUS AD19 VERSE EVENT.— 

20 ‘‘(A) IN GENERAL.—If the Secretary has 

21 credible evidence or information that a cosmetic 

22 subject to an order under subsection (c) pre23 sents an imminent threat of a serious adverse 

24 event, the Secretary shall issue an order requir25 ing any person who distributes such cosmetic— 


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1 ‘‘(i) to immediately recall such cos2 metic; and 

3 ‘‘(ii) to provide for notice, including to 

4 individuals as appropriate, to persons who 

5 may be affected by the recall. 

6 ‘‘(B) RECALL AND NOTICE.—Any person 

7 who is subject to an emergency recall order 

8 under this subsection shall immediately recall 

9 such cosmetic and provide notification as re10 quired by such order. 

11 ‘‘(3) APPEAL.— 

12 ‘‘(A) 24 HOURS.—Any person subject to 

13 such an order (including an amended order) 

14 under paragraph (1) or (2) may appeal such 

15 order to the Secretary within 24 hours of the 

16 issuance of such order. 

17 ‘‘(B) CONTENTS OF APPEAL.—Such appeal 

18 may include a request for an informal hearing 

19 and a description of any efforts to recall such 

20 cosmetic undertaken voluntarily by the person, 

21 including after a request under subsection (b). 

22 ‘‘(C) INFORMAL HEARING.—An informal 

23 hearing shall be held as soon as practicable 

24 after the appeal is filed under subparagraph 

25 (A), but not later than 5 calendar days after 


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1 such an appeal is filed, or fewer days (as deter2 mined by the Secretary), unless the parties 

3 jointly agree to an extension. 

4 ‘‘(D) VACATION OF ORDER.—If the Sec5 retary determines that inadequate grounds exist 

6 to support the actions required by the order 

7 under paragraph (1) or (2), the Secretary shall 

8 vacate the order. 

9 ‘‘(4) NONDELEGATION.—An order (including 

10 an amended order) under paragraph (1) or (2) may 

11 only be issued by the Secretary or an official des12 ignated by the Secretary, and may not be delegated 

13 to another official or employee. 

14 ‘‘(e) NOTICE TO CONSUMERS AND HEALTH OFFI15 CIALS.—The Secretary shall post on the Food and Drug 

16 Administration’s website and provide notice of a recall 

17 order under this section to consumers to whom the cos18 metic was, or may have been, distributed and to appro19 priate State and local health officials. 

20 ‘‘(f) SUPPLY CHAIN INFORMATION.— 

21 ‘‘(1) IN GENERAL.—In the case of a cosmetic 

22 that the Secretary has reason to believe is adulter23 ated, misbranded, or otherwise in violation of this 

24 Act, the Secretary shall request that the brand 

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1 quired under section 602(b)(1)) submit all of the fol2 lowing information: 

3 ‘‘(A) The name and place of business of 

4 the manufacturer, packager, supplier, or dis5 tributor from which such entity received the 

6 cosmetic or ingredients for manufacturing such 

7 cosmetic. 

8 ‘‘(B) The name and place of business of 

9 any entity (including any retailer) that was pro10 vided with such cosmetic by the entity named 

11 on the label. 

12 ‘‘(2) COLLECTION OF ADDITIONAL SUPPLY

13 CHAIN INFORMATION.—In the case of a cosmetic 

14 that the Secretary has reason to believe is adulter15 ated, misbranded, or otherwise in violation of this 

16 Act, to the extent necessary to protect the safety of 

17 the public, the Secretary may request that any entity 

18 (including a supplier of an ingredient, manufacturer, 

19 packer, distributor, or retailer) in the supply chain 

20 of such cosmetic submit to the Secretary information 

21 that is similar to the information described in sub22 paragraphs (A) and (B) of paragraph (1). 

23 ‘‘(3) MAINTENANCE OF RECORDS.—Any entity 

24 in the supply chain of a cosmetic (including the 


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1 brand owner named on the label of a cosmetic) 

2 shall— 

3 ‘‘(A) maintain records sufficient to provide 

4 the information described in subparagraphs (A) 

5 and (B) of paragraph (1); and 

6 ‘‘(B) provide such information to the Sec7 retary upon the request of the Secretary. 

8 ‘‘(g) SAVINGS CLAUSE.—Nothing contained in this 

9 section shall be construed as limiting the authority of the 

10 Secretary to issue an order to cease distribution of, or to 

11 recall, a cosmetic under any other provision of this Act. 

12 ‘‘SEC. 621. PETITIONS. 

13 ‘‘(a) IN GENERAL.—The Secretary shall complete 

14 and publish a review, and, if appropriate, immediately re15 vise related, relevant information, including ingredient 

16 lists, ingredient restrictions or prohibitions, or ingredient 

17 or cosmetic safety determinations, not later than 6 months 

18 after the date on which the Secretary receives from any 

19 individual or entity a reasonable petition— 

20 ‘‘(1) to prohibit or restrict an ingredient for use 

21 in cosmetics and list such ingredient on the list 

22 under section 616(b); 

23 ‘‘(2) to remove an ingredient from the list of in24 gredients that are safe without limits under section 

25 616(c); 


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1 ‘‘(3) to add an ingredient to the priority assess2 ment list under section 616(d); 

3 ‘‘(4) to add an ingredient to the list of ingredi4 ents with insufficient data under section 616(d); or 

5 ‘‘(5) to add an ingredient to the list of contami6 nants under section 618. 

7 ‘‘(b) REASONABLE PETITION.—Not later than 1 year 

8 after the date of enactment of this subchapter, the Sec9 retary shall issue rules specifying the criteria which the 

10 Secretary will use to determine if a petition submitted 

11 under this section is a reasonable petition. 

12 ‘‘SEC. 622. MANDATORY REPORTING OF SERIOUS ADVERSE 

13 EVENTS. 

14 ‘‘(a) SUBMISSION OF REPORT ON SERIOUS ADVERSE

15 EVENTS.—The Secretary shall require that the brand 

16 owner of a cosmetic whose name appears on the label of 

17 a cosmetic marketed in the United States submit to the 

18 Secretary a report containing information received con19 cerning any serious adverse event associated with the use 

20 of the cosmetic. 

21 ‘‘(b) TIMING OF REPORT.—A report under subsection 

22 (a) shall be submitted to the Secretary not later than 15 

23 business days after information concerning the serious ad24 verse event is received at the place of business of the brand 

25 owner. 


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1 ‘‘(c) CONTENT OF REPORT.—A report under sub2 section (a) shall include the following information, to the 

3 extent to which the brand owner submitting the report has 

4 been able to verify the information: 

5 ‘‘(1) The identity of the individual experiencing 

6 the adverse health event. 

7 ‘‘(2) An identifiable report of such effect. 

8 ‘‘(3) The name of the cosmetic suspected of 

9 causing such effect. 

10 ‘‘(4) A description of the adverse health event. 

11 ‘‘(d) PUBLIC AVAILABILITY AND PRIVACY.— 

12 ‘‘(1) PUBLIC AVAILABILITY.—Subject to para13 graph (2), the serious adverse event reports collected 

14 by the Secretary under this section shall be sub15 mitted electronically and shall be made accessible to 

16 the public in a summary fashion on the Food and 

17 Drug Administration’s website. 

18 ‘‘(2) PRIVACY.— 

19 ‘‘(A) PERSONALLY IDENTIFIABLE INFOR20 MATION.—Notwithstanding any other provision 

21 of law, personally identifiable information in se22 rious adverse event reports provided to the Sec23 retary under this section, shall not— 


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1 ‘‘(i) be made publicly available pursu2 ant to any State or other law requiring dis3 closure of information or records; or 

4 ‘‘(ii) otherwise be disclosed or distrib5 uted to any party without the written con6 sent of the Secretary and the person sub7 mitting such information to the Secretary. 

8 ‘‘(B) TREATMENT OF INFORMATION

9 UNDER PRIVACY ACT AND FOIA.—A report sub10 mitted to the Secretary under this section, shall 

11 be considered to be a record about an individual 

12 under section 552a of title 5, United States 

13 Code (commonly referred to as the ‘Privacy Act 

14 of 1974’) and a medical or similar file the dis15 closure of which would constitute a violation of 

16 section 552 of such title 5 (commonly referred 

17 to as the ‘Freedom of Information Act’), and 

18 shall not be publicly disclosed unless all person19 ally identifiable information is redacted. 

20 ‘‘SEC. 623. NONCONFIDENTIAL INFORMATION. 

21 ‘‘(a) INFORMATION AVAILABLE TO PUBLIC.—Subject 

22 to subsection (c) and section 622(d)(2), all nonconfidential 

23 information submitted pursuant to this subchapter shall 

24 be made available to the public, including the following 

25 types of information: 


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1 ‘‘(1) The name, identity, and structure of a 

2 chemical substance, contaminant, or impurity that is 

3 an ingredient. 

4 ‘‘(2) All information concerning function, expo5 sure, toxicity data, health hazards, and environ6 mental hazards for a cosmetic. 

7 ‘‘(3) The functions of ingredients in cosmetics. 

8 ‘‘(4) Fragrance, flavor, and colorants in a cos9 metic. 

10 ‘‘(b) CONFIDENTIAL INFORMATION.—The concentra11 tion of cosmetic ingredients used in a finished cosmetic 

12 shall be considered confidential business information and 

13 may not be made available to the public under subsection 

14 (a). 

15 ‘‘(c) PETITION FOR INFORMATION TO REMAIN CON16 FIDENTIAL.— 

17 ‘‘(1) IN GENERAL.—The Secretary shall create 

18 a process for an entity to petition for nonconfidential 

19 information described in subsection (a) to remain 

20 confidential if the entity shows that there would be 

21 a serious negative impact to the entity’s commercial 

22 interests if such information were disclosed to the 

23 public. 

24 ‘‘(2) LIMITATION.—The Secretary may not ap25 prove a petition under paragraph (1) to the extent 


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1 that such petition would prevent the public disclo2 sure of— 

3 ‘‘(A) the name, identity, and structure of 

4 any chemical substance, contaminant, or impu5 rity that is an ingredient; 

6 ‘‘(B) all health and safety data related to 

7 that substance, contaminant, or impurity; or 

8 ‘‘(C) any data used to substantiate the 

9 safety of that substance, contaminant, or impu10 rity. 

11 ‘‘SEC. 624. BAN ON USE OF ANIMAL TESTING. 

12 ‘‘(a) BAN.—Beginning on the date of enactment of 

13 this subchapter, it shall be unlawful for any entity to con14 duct, directly or pursuant to contract, animal testing for 

15 the purpose of developing a cosmetic for sale in or affect16 ing interstate commerce. 

17 ‘‘(b) LIMITATION ON CONSIDERATION OF DATA.— 

18 The Secretary shall not take into consideration any animal 

19 testing on a finished cosmetic product or an ingredient 

20 that occurs on or after the date of enactment of this sub21 chapter with respect to any determination as to whether 

22 a cosmetic or ingredient meets the safety standard under 

23 section 614(a). 

24 ‘‘(c) EXCEPTION.—Subsections (a) and (b) shall not 

25 apply with respect to animal testing if— 


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1 ‘‘(1) the animal testing is for the purpose of de2 termining whether an ingredient, or the relevant cat3 egory of ingredients, meets the safety standard 

4 under section 614(a); and 

5 ‘‘(2) the Secretary determines that the safety of 

6 the ingredient, or the relevant category of ingredi7 ents, cannot be established using a non-animal test8 ing method that is validated by the Interagency Co9 ordinating Committee on the Validation of Alter10 native Methods authorized by section 3 of the 

11 ICCVAM Authorization Act of 2000 (42 U.S.C. 

12 285l–3) . 

13 ‘‘(d) VALIDATED, ELIGIBLE NON-ANIMAL TESTING

14 METHODS.— 

15 ‘‘(1) LIST.—The Secretary shall develop, main16 tain, and make publicly available a list of non-animal 

17 testing methods that— 

18 ‘‘(A) are validated by the Interagency Co19 ordinating Committee on the Validation of Al20 ternative Methods; and 

21 ‘‘(B) are eligible for use pursuant to the 

22 exception described in subsection (c). 

23 ‘‘(2) INITIAL LIST; UPDATES.—The Secretary 

24 shall— 


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1 ‘‘(A) not later than 1 year after the date 

2 of enactment of this subchapter, publish the ini3 tial list under paragraph (1); and 

4 ‘‘(B) annually thereafter, update such list. 

5 ‘‘(e) GRANTS.—The Secretary shall award grants for 

6 the development of testing methods that may be used to 

7 replace animal testing pursuant to the exception described 

8 in subsection (c). 

9 ‘‘SEC. 625. PRODUCT TESTING AND REVIEW AUDIT. 

10 ‘‘The Secretary shall conduct annual audits of ran11 dom samples of cosmetics to assess or test for acute nega12 tive reactions, pathogen hazards, contaminants, leaching 

13 of packaging additives, mislabeling, or other relevant 

14 issues of concern (as determined by the Secretary). 

15 ‘‘SEC. 626. RESOURCES FOR SMALL BUSINESSES. 

16 ‘‘The Secretary shall provide technical support to as17 sist small businesses in carrying out the requirements of 

18 this subchapter. 

19 ‘‘SEC. 627. INTERAGENCY COOPERATION. 

20 ‘‘(a) INTERAGENCY COUNCIL ON COSMETIC SAFE21 TY.—There is established an Interagency Council on Cos22 metic Safety for the purpose of sharing data and pro23 moting collaboration on cosmetic safety between the Food 

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1 trol and Prevention, the Occupational Safety and Health 

2 Administration, and the Environmental Protection Agen3 cy. 

4 ‘‘(b) USE OF DATA FROM FEDERAL SOURCES.—For 

5 purposes of this subchapter, the Secretary, as appropriate, 

6 shall request and utilize ingredient and cosmetic toxicity, 

7 use, and exposure data from other Federal agencies. 

8 ‘‘SEC. 628. SAVINGS CLAUSE. 

9 ‘‘Nothing in this Act affects the right of a State or 

10 a political subdivision of a State to adopt or enforce any 

11 regulation, requirement, or standard of performance that 

12 is different from, or in addition to, a regulation, require13 ment, liability, or standard for performance established 

14 pursuant to this Act unless compliance with both this Act 

15 and the State or political subdivision of a State’s regula16 tion, requirement, liability, or standard of performance is 

17 impossible, in which case the applicable provisions of this 

18 Act shall control. 

19 ‘‘SEC. 629. AUTHORIZATION OF APPROPRIATIONS. 

20 ‘‘There are authorized to be appropriated such sums 

21 as may be necessary to carry out this subchapter for each 

22 of the fiscal years 2020 through 2024.’’. 


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1 SEC. 3. ADULTERATED AND MISBRANDED COSMETICS. 

2 (a) ADULTERATED COSMETICS.—Section 601 of the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361) 

4 is amended— 

5 (1) in paragraph (a), by striking ‘‘, except that 

6 this provision shall not apply to coal-tar hair dye’’ 

7 and all that follows through ‘‘or eyebrow dyes’’; and 

8 (2) by adding at the end the following: 

9 ‘‘(f) If it is manufactured in a manner that fails to 

10 comply with section 617(a). 

11 ‘‘(g) If it is imported, distributed, or marketed and— 

12 ‘‘(1) it contains an ingredient on the list under 

13 section 616(b)(1)(A), and the manufacturer has not 

14 complied with section 616(b)(5) with respect to such 

15 ingredient and such cosmetic; or 

16 ‘‘(2) it contains an ingredient on the list under 

17 section 616(b)(1)(B), such ingredient is being used 

18 in a manner that violates the limit on use or con19 centration of such ingredient under section 

20 616(b)(3), and the manufacturer has not complied 

21 with section 616(b)(5) with respect to such ingre22 dient and such cosmetic. 

23 ‘‘(h) If it is marketed by a brand owner that, with 

24 respect to such cosmetic, is required to demonstrate, 

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1 ty standard and the brand owner has not yet submitted 

2 the required data under section 617(b)(3).’’. 

3 (b) MISBRANDED COSMETICS.—Section 602 of the 

4 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 362) 

5 is amended— 

6 (1) in paragraph (a), by inserting ‘‘or fails to 

7 meet the requirements of section 613 or 618(b)’’ be8 fore the period; and 

9 (2) by adding at the end the following: 

10 ‘‘(g) If it— 

11 ‘‘(1) was brought to market by a brand owner 

12 that failed to register and pay the applicable fee as 

13 required under section 612; 

14 ‘‘(2) is brought to market, manufactured, pack15 aged, distributed, or sold in retail by a brand owner, 

16 manufacturer, packager, distributor, or retailer, re17 spectively, who fails to notify the Secretary as re18 quired under section 620(a)(1); 

19 ‘‘(3) is distributed in violation of an order 

20 under section 620(c); 

21 ‘‘(4) is not recalled as required by an order 

22 under section 620(d); 

23 ‘‘(5) is manufactured in a manner that fails to 

24 comply with good manufacturing practices pre25 scribed by the Secretary under section 614(b); or 


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1 ‘‘(6) is brought to market by a brand owner 

2 who fails— 

3 ‘‘(A) to submit the statement required 

4 under section 619; or 

5 ‘‘(B) notify the Secretary of changes to in6 formation contained in such report, as required 

7 by such section.’’. 

8 (c) ADDITIONAL PROHIBITIONS.—Section 301 of the 

9 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) 

10 is amended— 

11 (1) in paragraph (e), by inserting ‘‘612,’’ after 

12 ‘‘564,’’ each place it appears; and 

13 (2) by adding at the end the following: 

14 ‘‘(fff) The failure of a brand owner, manufacturer, 

15 or supplier of a cosmetic or an ingredient for use in a 

16 cosmetic to submit and update data and information as 

17 required under section 615(a). 

18 ‘‘(ggg) The manufacture, importation, distribution, 

19 or marketing of an ingredient for use in a cosmetic that 

20 is on the list under section 616(b)(1)(A). 

21 ‘‘(hhh) The failure of a supplier of an ingredient for 

22 use in a cosmetic— 

23 ‘‘(1) to provide data and information as re24 quired by section 615(a)(4)(B); or 


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1 ‘‘(2) to comply with the testing requirements 

2 under section 618(d). 

3 ‘‘(iii) The failure of a manufacturer to comply with 

4 the requirements of section 618(e). 

5 ‘‘(jjj) The failure of a brand owner of a cosmetic to 

6 comply with the requirement of reporting serious adverse 

7 events under section 622. 

8 ‘‘(kkk) The conduct of animal testing in violation of 

9 section 624.’’. 

10 SEC. 4. SUPPORT FOR CREATING SAFER ALTERNATIVES. 

11 (a) IN GENERAL.—The Secretary of Health and 

12 Human Services (in this section referred to as the ‘‘Sec13 retary’’), acting through the Commissioner of Food and 

14 Drugs, in consultation with the Administrator of the Envi15 ronmental Protection Agency, shall award grants to eligi16 ble entities to support research focused on the design of 

17 safer alternatives to chemicals in cosmetics with inherent 

18 toxicity or associated with chronic adverse health effects. 

19 (b) ELIGIBLE ENTITIES.—To be eligible to receive a 

20 grant under subsection (a), an entity shall— 

21 (1) be a public institution such as a university, 

22 a not-for-profit research institution, or a small busi23 ness; and 


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1 (2) not benefit from a financial relationship 

2 with a cosmetics manufacturer, supplier, or trade as3 sociation. 

4 (c) PRIORITY.—In awarding grants under subsection 

5 (a), the Secretary shall give priority to applicants pro6 posing to focus on— 

7 (1) replacing chemicals in professional cosmetic 

8 products used by nail and hair and beauty salon 

9 workers with safer alternatives; or 

10 (2) replacing chemicals in cosmetic products 

11 marketed to women and girls of color, including any 

12 such beauty, personal hygiene, and intimate care 

13 products, with safer alternatives. 

14 (d) AUTHORIZATION OF APPROPRIATIONS.—To carry 

15 out this section, there are authorized to be appropriated 

16 such sums as may be necessary for fiscal years 2020 

17 through 2025. 

18 SEC. 5. SUPPORT BY NATIONAL INSTITUTE OF ENVIRON19 MENTAL HEALTH SCIENCES FOR RESEARCH 

20 ON HEALTH DISPARITIES IMPACTING COM21 MUNITIES OF COLOR. 

22 Subpart 12 of part C of title IV of the Public Health 

23 Service Act (42 U.S.C. 285l et seq.) is amended by adding 

24 at the end the following new section: 


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1 ‘‘SEC. 463C. RESEARCH ON HEALTH DISPARITIES RELATED 

2 TO COSMETICS IMPACTING COMMUNITIES OF 

3 COLOR. 

4 ‘‘(a) IN GENERAL.—The Director of the Institute 

5 shall award grants to eligible entities— 

6 ‘‘(1) to expand support for basic, epidemiolog7 ical, and social scientific investigations into— 

8 ‘‘(A) the chemicals linked to adverse health 

9 effects most commonly found in cosmetics mar10 keted to women and girls of color, including 

11 beauty, personal hygiene, and intimate care 

12 products; 

13 ‘‘(B) the marketing and sale of such cos14 metics containing chemicals linked to adverse 

15 health effects to women and girls of color across 

16 their lifespans; or 

17 ‘‘(C) the use of such cosmetics by women 

18 and girls of color across their lifespans; and 

19 ‘‘(2) to disseminate the results of any such re20 search described in subparagraph (A) or (B) of 

21 paragraph (1) (conducted by the grantee pursuant 

22 to this section or otherwise) to help communities 

23 identify and address potentially unsafe chemical ex24 posures in the use of cosmetics. 

25 ‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive 

26 a grant under subsection (a), an entity shall— 


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1 ‘‘(1) be a public institution such as a university, 

2 a not-for-profit research institution, or a small busi3 ness; and 

4 ‘‘(2) not benefit from a financial relationship 

5 with a cosmetics manufacturer, supplier, or trade as6 sociation. 

7 ‘‘(c) REPORT.—Not later than the end 1 year after 

8 awarding grants under this section, the Director of the 

9 Institute shall issue for the public and submit to the Com10 mittee on Energy and Commerce of the House of Rep11 resentatives and the Committee on Health, Education, 

12 Labor, and Pensions of the Senate a report on the results 

13 of the investigations funded under subsection (a), includ14 ing— 

15 ‘‘(1) summary findings on— 

16 ‘‘(A) marketing strategies, product cat17 egories, and specific cosmetics containing ingre18 dients linked to adverse health effects; and 

19 ‘‘(B) the demographics of the populations 

20 marketed to and using these cosmetics; and 

21 ‘‘(2) recommended public health information 

22 strategies to reduce potentially unsafe exposures to 

23 cosmetics. 

24 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—To 

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1 priated such sums as may be necessary for fiscal years 

2 2020 through 2025.’’. 

3 SEC. 6. WORKER ISSUES. 

4 (a) IN GENERAL.—The Secretary of Labor shall pro5 mulgate an occupational safety and health standard under 

6 section 6 of the Occupational Safety and Health Act of 

7 1970 (29 U.S.C. 655) that requires the following: 

8 (1) MANUFACTURERS AND IMPORTERS.—Each 

9 manufacturer or importer selling any cosmetic for 

10 professional use shall— 

11 (A) obtain or develop a material safety 

12 data sheet described in subsection (b) for each 

13 such cosmetic or personal care product that— 

14 (i) the manufacturer or importer pro15 duces or imports; and 

16 (ii) includes a hazardous chemical, or 

17 a product ingredient associated with any 

18 chemical hazard, that is classified as a 

19 health hazard in accordance with the cri20 teria found in section 1910.1200(d) of title 

21 29 of the Code of Federal Regulations, and 

22 any successor regulations; and 

23 (B) make the material safety data sheet 

24 available on the manufacturer or importer’s 

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1 ner of making such sheet available) to distribu2 tors and employers, including owners of hair, 

3 nail, and beauty salons or spas or other estab4 lishments that provide cosmetic services for hu5 mans, in English, Spanish, Vietnamese, Chi6 nese, Korean, and upon request other lan7 guages. 

8 (2) DISTRIBUTORS.—Each distributor of a cos9 metic or personal care product for professional use 

10 shall distribute and provide material safety data 

11 sheets described in subsection (b) in the same man12 ner as a distributor of a chemical hazard is required 

13 to distribute and provide material safety data sheets 

14 under section 1910.1200(g) of title 29, Code of Fed15 eral Regulations, or any successor regulations. 

16 (3) EMPLOYERS.—Each employer, including 

17 any operator of a salon or other establishment de18 scribed in paragraph (1)(B), shall— 

19 (A) have a material safety data sheet in 

20 the workplace for each cosmetic or personal 

21 care product for professional use that is used in 

22 the course of the employer’s business; 

23 (B) make such material safety data sheet 

24 available to all employees of the employer who 

25 are exposed or use the product to the same exVerDate Sep 11 2014 04:13 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00071 Fmt 6652 Sfmt 6201 E:\BILLS\H4296.IH H4296

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1 tent and in the same manner as material safety 

2 data sheets are required to be made available 

3 under section 1910.1200(g) of title 29, Code of 

4 Federal Regulations, or any successor regula5 tions; and 

6 (C) upon request, provide employees with 

7 translations of such material safety data sheet 

8 in other languages, including Spanish, Viet9 namese, Chinese, Korean, and upon request 

10 other languages. 

11 (b) CONTENTS OF MATERIAL SAFETY DATA

12 SHEET.—A material safety data sheet for a cosmetic or 

13 personal care product for professional use described in this 

14 section shall— 

15 (1) contain the information required in a mate16 rial safety data sheet under section 1910.1200(g) of 

17 title 29, Code of Federal Regulations, or any suc18 cessor regulations, for each hazardous chemical, or 

19 product ingredient associated with any chemical haz20 ard, described in subsection (a)(1)(A)(ii); and 

21 (2) include the following statement: ‘‘This ma22 terial safety data sheet is also available in multiple 

23 languages by contacting the manufacturer, using the 

24 contact information provided on this sheet.’’. 


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1 (c) PROFESSIONAL USE DEFINED.—In this section, 

2 the term ‘‘professional use’’ has the meaning given such 

3 term in section 611 of the Federal Food, Drug, and Cos4 metic Act, as added by this Act, except to the extent that 

5 such term applies to a product that is sold as a retail prod6 uct in any of the establishments listed under such defini7 tion. 

Æ 


kjohnson on DSK79L0C42 with BILLS