I 

112TH CONGRESS 

1ST SESSION H. R. 2359 

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 

JUNE 24, 2011 

Ms. SCHAKOWSKY (for herself, Mr. MARKEY, Ms. BALDWIN, Mr. MORAN, Ms. 

WOOLSEY, Mr. BLUMENAUER, Ms. CHU, Mr. GUTIERREZ, Ms. LEE of 

California, Mr. FRANK of Massachusetts, 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 the Workforce, 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 Act of 2011’’. 

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

7 this Act is as follows: 


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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 on 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 adverse health effects. 

‘‘Sec. 623. Nonconfidential information. 

‘‘Sec. 624. Animal testing alternatives. 

‘‘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. Worker issues. 

1 SEC. 2. COSMETIC REGULATION. 

2 (a) IN GENERAL.—Chapter VI of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amend4 ed— 

5 (1) by inserting before section 601 the fol6 lowing: 

7 ‘‘Subchapter A—Adulterated and Misbranded 

8 Cosmetics’’; 

9 and 

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


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1 ‘‘Subchapter B—Regulation of Cosmetics 

2 ‘‘SEC. 611. DEFINITIONS. 

3 ‘‘In this subchapter: 

4 ‘‘(1) DOMESTIC ESTABLISHMENT.—The term 

5 ‘domestic establishment’ means an establishment lo6 cated in any State that manufactures or packages 

7 cosmetics. 

8 ‘‘(2) FOREIGN ESTABLISHMENT.—The term 

9 ‘foreign establishment’ means an establishment that 

10 manufactures or packages cosmetics that are ex11 ported to the United States. 

12 ‘‘(3) MANUFACTURER.—The term ‘manufac13 turer’ only includes manufacturers that determine 

14 the final formulation of a cosmetic. 

15 ‘‘(4) INGREDIENT.— 

16 ‘‘(A) IN GENERAL.—The term ‘ingredient’ 

17 means a chemical in a cosmetic, including— 

18 ‘‘(i) chemicals that provide a technical 

19 or functional effect; 

20 ‘‘(ii) chemicals that have no technical 

21 or functional effect in the cosmetic but are 

22 present by reason of having been incor23 porated into the cosmetic as an ingredient 

24 of another cosmetic ingredient; 


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1 ‘‘(iii) processing aids that are present 

2 by reason of having been added to a cos3 metic during the processing of such cos4 metic; 

5 ‘‘(iv) substances that are present by 

6 reason of having been added to a cosmetic 

7 during processing for their technical or 

8 functional effect; 

9 ‘‘(v) the components of a fragrance, 

10 flavor, or preservative; and 

11 ‘‘(vi) any individual component of a 

12 petroleum-derived, animal-derived, or other 

13 ingredient that the Secretary deems an in14 gredient for purposes of this chapter. 

15 ‘‘(B) TREATMENT OF CONTAMINANTS.— 

16 For purposes of sections 614 through 617, the 

17 term ‘ingredient’ also includes— 

18 ‘‘(i) contaminants present at levels 

19 above technically feasible detection limits; 

20 and 

21 ‘‘(ii) contaminants that may leach 

22 from container materials or form via reac23 tions over the shelf life of a cosmetic and 

24 that may be present at levels above tech25 nically feasible detection limits. 


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1 ‘‘(5) MICROBUSINESS.—The term ‘microbusi2 ness’ means a business— 

3 ‘‘(A) that is engaged in the manufacturing 

4 or packaging of cosmetics; and 

5 ‘‘(B) that has annual sales receipts for cos6 metic products that do not exceed $2,000,000. 

7 ‘‘(6) PROFESSIONAL USE.—The term ‘profes8 sional use’ means the use of any cosmetic— 

9 ‘‘(A) by an employee (within the scope of 

10 the employment of such employee) of; or 

11 ‘‘(B) purchased by a consumer in, 

12 a hair salon, nail salon, beauty salon, spa, or other 

13 establishment that provides cosmetic treatment serv14 ices for humans. 

15 ‘‘(7) REASONABLE CERTAINTY OF NO HARM.— 

16 With respect to an ingredient or cosmetic, the term 

17 ‘reasonable certainty of no harm’ means that no 

18 harm will be caused to members of the general popu19 lation or any vulnerable population by aggregate ex20 posure to the cosmetic or ingredient, taking into ac21 count possible harmful effects from— 

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

23 ingredient; or 


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1 ‘‘(B) additive effects resulting from re2 peated exposure to the cosmetic or ingredient 

3 over time; or 

4 ‘‘(C) cumulative exposure resulting from 

5 all sources, including both the cosmetic or in6 gredient and environmental sources. 

7 ‘‘(8) REPRODUCTIVE OR DEVELOPMENTAL TOX8 ICITY.—With respect to an ingredient or cosmetic, 

9 the term ‘reproductive or developmental toxicity’ 

10 means that the ingredient or cosmetic can contribute 

11 to biologically adverse effects on the development of 

12 humans or animals, including effects on the female 

13 or male reproductive system, the endocrine system, 

14 fertility, pregnancy, pregnancy outcomes, or modi15 fications in other functions of the body that are de16 pendent on the integrity of the reproductive system 

17 as well normal fetal development. 

18 ‘‘(9) VULNERABLE POPULATIONS.—The term 

19 ‘vulnerable populations’ includes pregnant women, 

20 infants, children, the elderly, people with com21 promised immune systems, and highly exposed popu22 lations, including workers employed by hair salons, 

23 nail salons, beauty salons, spas, other establishments 

24 that provide cosmetic treatment services for humans, 

25 and cosmetic manufacturing plants. 


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1 ‘‘SEC. 612. REGISTRATION OF ESTABLISHMENTS AND REG2 ISTRATION FEES. 

3 ‘‘(a) REGISTRATION.— 

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

5 date of the enactment of this subchapter, and annu6 ally thereafter, any establishment (except for micro7 businesses) engaged in manufacturing or packaging 

8 cosmetics for use in the United States shall register 

9 with the Secretary and pay to the Secretary the ap10 plicable fee, as established under the fee schedule in 

11 subsection (e). 

12 ‘‘(2) RULES FOR DOMESTIC AND FOREIGN ES13 TABLISHMENTS.—To be registered under paragraph 

14 (1)— 

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

16 owner, operator, or agent in charge of the do17 mestic establishment shall submit a registration 

18 to the Secretary; or 

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

20 operator, or agent in charge of the foreign es21 tablishment shall— 

22 ‘‘(i) submit a registration to the Sec23 retary; and 

24 ‘‘(ii) include with the registration the 

25 name of the United States agent for the 

26 foreign establishment. 


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1 ‘‘(3) NEW ESTABLISHMENTS.—Any establish2 ment that begins to manufacture or package a cos3 metic after the date on which the requirements of 

4 paragraph (1) apply shall, not later than 60 days 

5 after the date on which the establishment began to 

6 manufacture or package such cosmetic, register with 

7 the Secretary and pay the applicable fee, as required 

8 under paragraph (1). 

9 ‘‘(b) SUBMISSION OF REGISTRATION.— 

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

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

12 section as the ‘registrant’) shall submit to the Sec13 retary, with respect to any cosmetics that the estab14 lishment manufactures or package, all of the fol15 lowing: 

16 ‘‘(A) Any information necessary to notify 

17 the Secretary of the name, address, and legal 

18 status of each establishment at which, and all 

19 trade names under which, the registrant manu20 factures or package cosmetics. 

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

22 activities with respect to cosmetics, including a 

23 list of all cosmetic products manufactured or 

24 packaged by the establishment and the func25 tions of such cosmetics. 


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1 ‘‘(C) The gross receipts or sales for the es2 tablishment from cosmetics. 

3 ‘‘(D) The name and address of any com4 pany that supplies the establishment, if the es5 tablishment manufactures cosmetics, with any 

6 ingredient and the name of the ingredient sup7 plied to such establishment by such supplier. 

8 ‘‘(2) NOTIFICATION OF CHANGES.—When sub9 mitting the annual registration, the registrant shall 

10 notify the Secretary of changes to the information 

11 described in paragraph (1). 

12 ‘‘(c) PROCEDURE.—Upon receipt of a completed reg13 istration submitted under subsection (a), the Secretary 

14 shall notify the registrant of the receipt of such registra15 tion and assign a registration number to each registered 

16 establishment. 

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

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

19 shall— 

20 ‘‘(A) compile, maintain, and update as ap21 propriate, a list of establishments that are reg22 istered under this section; 

23 ‘‘(B) make such list publically available; 

24 and 


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

2 any establishment that fails to register in ac3 cordance with this section. 

4 ‘‘(2) APPLICATION OF FOIA.— 

5 ‘‘(A) REGISTRATION DOCUMENTS.—Any 

6 registration documents submitted pursuant to 

7 this section shall not be subject to disclosure 

8 under section 552 of title 5, United States 

9 Code. 

10 ‘‘(B) OTHER INFORMATION.—Information 

11 derived from— 

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

13 ‘‘(ii) registration documents submitted 

14 pursuant to this section, 

15 shall not be subject to disclosure under section 

16 552 of title 5, United States Code, except to the 

17 extent that such information discloses the iden18 tity or location of a specific registrant. 

19 ‘‘(e) FEE SCHEDULE.—A schedule of fees shall be de20 veloped by the Secretary to provide for oversight and en21 forcement of this subchapter. The fee structure shall— 

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

23 gross receipts or sales; and 


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

2 gross receipts or sales of cosmetics that exceed 

3 $10,000,000. 

4 ‘‘(f) SUSPENSION AND CANCELLATION OF REGISTRA5 TION.— 

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

7 under this section is subject to suspension if the 

8 Secretary finds— 

9 ‘‘(A) the information submitted by the es10 tablishment for registration under subsection 

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

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

13 Secretary of changes required under subsection 

14 (b)(2); 

15 ‘‘(C) the establishment fails to pay reg16 istration fees, as required under subsection (a), 

17 in a timely manner; or 

18 ‘‘(D) the establishment violates any portion 

19 of this chapter. 

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

21 Secretary determines that an establishment is sub22 ject to suspension under subsection (f) and that it 

23 is appropriate to suspend the registration of such es24 tablishment, the Secretary shall— 


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1 ‘‘(A) suspend the registration of such es2 tablishment; and 

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

4 establishment. 

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

6 fails to correct the issue that resulted in the suspen7 sion under paragraph (2) before the last day of the 

8 30-day period beginning on the date that the estab9 lishment receives notice under such paragraph, the 

10 Secretary may cancel the registration of such estab11 lishment. 

12 ‘‘SEC. 613. INGREDIENTS LABELS ON COSMETICS. 

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

14 (c), the Secretary shall require that the label on each pack15 age of cosmetics (including cosmetics distributed for retail 

16 sale and professional use) bears a declaration of the name 

17 of each ingredient in such cosmetic in descending order 

18 of predominance. 

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

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

21 than 6 months after the date of the enactment of 

22 this subchapter, the Secretary shall issue regulations 

23 that apply to any cosmetic for which the product 

24 packaging is not of sufficient size to bear or contain 


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1 a label that meets the requirements of subsection 

2 (a). 

3 ‘‘(2) REQUIREMENTS FOR PUBLIC DISCLO4 SURE.—Such regulations shall establish require5 ments for listing ingredients on the label of such 

6 cosmetics and additional requirements for public dis7 closure of the ingredients in such cosmetics. 

8 ‘‘(c) SPECIAL RULE FOR CONTAMINANTS.—The Sec9 retary shall require, in the case of a contaminant, that 

10 a contaminant be declared on the label of a cosmetic, in 

11 the same manner as an ingredient under subsection (a), 

12 if the contaminant is present at the lower of the following 

13 levels: 

14 ‘‘(1) A level that is greater than one part-per15 billion by weight of product formation. 

16 ‘‘(2) A level that is greater than one percent of 

17 the restriction on the concentration for such con18 taminant for such use, as determined by the Sec19 retary under section 616(a)(2). 

20 ‘‘(d) LABELING OF NANOMATERIALS IN COS21 METICS.—The Secretary may require that— 

22 ‘‘(1) minerals and other particulate ingredients 

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

24 label or list if not less than 1 percent of the ingreVerDate Mar 15 2010 02:35 Jul 01, 2011 Jkt 099200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H2359.IH H2359

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1 dient particles in the cosmetic are 100 nanometers 

2 or smaller in not less than 1 dimension; and 

3 ‘‘(2) other ingredients in a cosmetic be des4 ignated with scale-specific information on a cosmetic 

5 ingredient label or list if such ingredients possess 

6 scale-specific hazard properties. 

7 ‘‘(e) LABELING OF INGREDIENTS IN COSMETICS

8 SOLD THROUGH INTERNET COMMERCE.—The Secretary 

9 shall require— 

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

11 site of an Internet vendor, that the manufacturers 

12 and distributors of such cosmetic provide to such 

13 Internet vendor a list of the ingredients of the cos14 metic; and 

15 ‘‘(2) that each Internet vendor display the list 

16 of ingredients of a cosmetic sold by such vendor on 

17 the Web page that is the primary Web page pro18 viding information relating to the sale of such cos19 metic on the Web site of the vendor. 

20 ‘‘(f) TRADE SECRETS.—Notwithstanding any other 

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

22 label under this section shall not be treated as a trade 

23 secret. 


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1 ‘‘(g) APPLICATION.—Beginning 18 months after the 

2 date of the enactment of this subchapter, the requirements 

3 of this section shall apply to— 

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

5 sale; and 

6 ‘‘(2) manufacturers, distributors, and Internet 

7 vendors of such cosmetics. 

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

9 PRACTICES. 

10 ‘‘(a) SAFETY STANDARD.— 

11 ‘‘(1) IN GENERAL.—Taking into account the ex12 pected use of a cosmetic, the Secretary shall estab13 lish a safety standard that, with respect to a cos14 metic or an ingredient in a cosmetic provides a rea15 sonable certainty of no harm (as such term is de16 fined in section 611(7)) from exposure to the cos17 metic or ingredient and protects the public from any 

18 known or anticipated adverse health effects associ19 ated with the cosmetic or ingredient. 

20 ‘‘(2) STANDARDS FOR ESTABLISHING SAFETY

21 STANDARD.—In establishing the safety standard 

22 under paragraph (1), the Secretary shall ensure 

23 that— 

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

25 sources of the ingredient or cosmetic (including 


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1 environmental sources) that will result under 

2 the safety standard presents not more than a 1 

3 in a million risk for any adverse health effect 

4 in any vulnerable population at the lower 95th 

5 percentile confidence interval; or 

6 ‘‘(B) the safety standard results in expo7 sure to the amount or concentration of an in8 gredient or cosmetic that is shown to produce 

9 no adverse health effects, incorporating an mar10 gin of safety of at least 1,000 and considering 

11 the impact of cumulative exposure from all 

12 sources (including environmental sources). 

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

14 any Federal agency has promulgated a standard for 

15 an ingredient that satisfies the requirements under 

16 paragraph (1), the Secretary may treat such stand17 ard as the safety standard under paragraph (1) for 

18 purposes of such ingredient. 

19 ‘‘(4) APPLICATION OF SAFETY STANDARD.— 

20 The Secretary may only determine that an ingre21 dient or a cosmetic meets the safety standard under 

22 paragraph (1) if there is a reasonable certainty of no 

23 harm from exposure to the ingredient or cosmetic. 

24 ‘‘(b) GOOD MANUFACTURING PRACTICES.— 


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

2 guidance prescribing good manufacturing practices 

3 for cosmetics and ingredients, including quality con4 trol procedures that the Secretary determines are 

5 necessary, and shall update such regulations as nec6 essary. 

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

8 developing the guidance under paragraph (1), the 

9 Secretary shall consider how such practices will im10 pact small businesses. 

11 ‘‘SEC. 615. COSMETIC AND INGREDIENT SAFETY INFORMA12 TION. 

13 ‘‘(a) REQUIRED SUBMISSION OF ALL SAFETY INFOR14 MATION.— 

15 ‘‘(1) IN GENERAL.—Manufacturers of cosmetics 

16 and ingredients shall submit to the Secretary (in an 

17 electronic format that the Secretary shall determine) 

18 all data and information that the manufacturer can 

19 access regarding the safety of the— 

20 ‘‘(A) ingredients listed on the cosmetic 

21 label under section 613 for a cosmetic; and 

22 ‘‘(B) cosmetic itself. 

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

24 data and information under paragraph (1) shall inVerDate Mar 15 2010 02:35 Jul 01, 2011 Jkt 099200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H2359.IH H2359

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1 clude, for each ingredient in a cosmetic and for the 

2 cosmetic, the following: 

3 ‘‘(A) Functions and uses. 

4 ‘‘(B) Data and information on the phys5 ical, chemical, and toxicological properties of 

6 each such ingredient or cosmetic. 

7 ‘‘(C) Exposure and fate information. 

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

9 manufacturer can access or has conducted. 

10 ‘‘(E) Any other information used to sub11 stantiate the safety of such ingredient and cos12 metic. 

13 ‘‘(3) DEADLINES.— 

14 ‘‘(A) INITIAL SUBMISSION.—A manufac15 turer shall submit the data and information re16 quired under paragraph (1)— 

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

18 cosmetic which is marketed for sale in 

19 interstate commerce on or before the date 

20 of the enactment of this subchapter, not 

21 later than 1 year after such date; and 

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

23 cosmetic which is not marketed for sale on 

24 or before such date— 


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

2 14-month period beginning on the 

3 date of the enactment of this sub4 chapter; or 

5 ‘‘(II) if the ingredient or cosmetic 

6 is first marketed for sale in interstate 

7 commerce after the end of the period 

8 described in subclause (I), not later 

9 than 60 days after the date on which 

10 such ingredient or cosmetic is first 

11 marketed for sale. 

12 ‘‘(B) UPDATES.— 

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

14 (ii), a manufacturer shall update the data 

15 and information submitted under subpara16 graph (A) annually. 

17 ‘‘(ii) ADVERSE HEALTH EFFECTS.—In 

18 the case of information related to an ad19 verse health effect that is suspected to be 

20 caused by an ingredient or a cosmetic, a 

21 manufacturer shall update the information 

22 not later than 60 days after receiving such 

23 information. 

24 ‘‘(4) SUPPLIER INFORMATION.— 


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1 ‘‘(A) USE OF SUPPLIER INFORMATION.— 

2 In order to meet the requirements of paragraph 

3 (1) with respect to an ingredient, a manufac4 turer may submit safety data and information 

5 provided by the supplier of the ingredient. 

6 ‘‘(B) SUPPLIER PROVISION OF INFORMA7 TION.—If a manufacturer requests that a sup8 plier of an ingredient provide to such manufac9 turer any of the data and information described 

10 under paragraph (2), such supplier shall pro11 vide such data and information to such manu12 facturer not later than 90 days after receiving 

13 such request. 

14 ‘‘(b) DATABASE.— 

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

16 year after the date of the enactment of this sub17 chapter, the Secretary shall publish a comprehensive, 

18 publicly accessible database containing all noncon19 fidential information (as such term is used under 

20 section 623) submitted under subsection (a)(1). 

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

22 the Secretary receives new or updated information 

23 under subsection (a)(3)(B), the Secretary shall up24 date the database under paragraph (1) with such in25 formation. 


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

2 ‘‘(1) IN GENERAL.—Based on the data and in3 formation submitted under subsection (a)(1), avail4 able from an authoritative source (as such term is 

5 defined in paragraph (3), including data described 

6 under section 627(b)), and such other information 

7 as the Secretary may have available, the Secretary 

8 shall review and evaluate the safety of cosmetics and 

9 ingredients of cosmetics that are marketed in inter10 state commerce. 

11 ‘‘(2) CONSIDERATION OF NANOMATERIALS.— 

12 The Secretary shall— 

13 ‘‘(A) monitor developments in the scientific 

14 understanding from any adverse health effects 

15 related to the use of nanotechnology in the for16 mulation of cosmetic (including progress in the 

17 standardization of testing methods and specific 

18 size definitions for nanomaterials); and 

19 ‘‘(B) consider scale specific hazard prop20 erties of ingredients when reviewing and evalu21 ating the safety of cosmetics and ingredients 

22 under paragraph (1). 

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

24 purposes of this paragraph, the term ‘authoritative 

25 source’ means— 


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1 ‘‘(A) the Environmental Protection Agen2 cy; 

3 ‘‘(B) the International Agency for Re4 search on Cancer; 

5 ‘‘(C) the National Toxicity Program 

6 through the National Institutes of Health; 

7 ‘‘(D) the California Environmental Protec8 tion Agency; and 

9 ‘‘(E) any other authoritative international, 

10 Federal, and State entity, as determined by the 

11 Secretary. 

12 ‘‘SEC. 616. LISTS OF INGREDIENTS AND REQUIRED RE13 SPONSES. 

14 ‘‘(a) PLACEMENT ON LIST.— 

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

16 and evaluation of an ingredient under subsection (c), 

17 the Secretary shall place the ingredient on one of the 

18 following lists: 

19 ‘‘(A) The prohibited and restricted list 

20 under subsection (b). 

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

22 subsection (c). 

23 ‘‘(C) The priority assessment list under 

24 subsection (d). 


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1 ‘‘(2) CONSIDERATIONS.—In determining the 

2 placement of an ingredient on a list under sub3 section (a), the Secretary shall consider whether the 

4 ingredient— 

5 ‘‘(A) reacts with other substances to form 

6 harmful contaminants; 

7 ‘‘(B) is found to be present in the body 

8 through biomonitoring; 

9 ‘‘(C) is found in drinking water or air; 

10 ‘‘(D) is a known or suspected neurological 

11 or immunological toxicant, respiratory 

12 asthmagen, carcinogen, teratogen, or endocrine 

13 disruptor, or have other toxicological concerns 

14 (including reproductive or developmental tox15 icity); or 

16 ‘‘(E) is known to persist in the environ17 ment or bioaccumulate. 

18 ‘‘(3) PRIORITIZIATION OF INGREDIENTS THAT

19 ARE FOOD.—In placing ingredients on the lists 

20 under paragraph (1), the Secretary shall prioritize 

21 the placement of ingredients that are food (as such 

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

23 ‘‘(b) PROHIBITED AND RESTRICTED LIST.— 

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

25 after the date of the enactment of this subchapter, 


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1 the Secretary shall issue, by regulation, a list of in2 gredients that are identified by the Secretary— 

3 ‘‘(A) as prohibited for use because the Sec4 retary determines that such ingredients are un5 safe for use in cosmetics in any amount because 

6 such ingredients fail to meet the safety stand7 ard under section 614(a); or 

8 ‘‘(B) as being subject to necessary restric9 tions in use or concentration to allow the use of 

10 the ingredient in a cosmetic to satisfy the safety 

11 standard. 

12 ‘‘(2) SPECIFICATION OF RESTRICTIONS.—In the 

13 case of any ingredient listed under paragraph 

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

15 use or concentration that are necessary to satisfy the 

16 safety standard for such ingredient. 

17 ‘‘(3) UPDATES.—The Secretary shall, at a min18 imum, annually update the list under paragraph (1), 

19 including any— 

20 ‘‘(A) determinations under subsection 

21 (d)(3); or 

22 ‘‘(B) new information that demonstrates 

23 that an ingredient fails to meet the safety 

24 standard, or requires restrictions on use to 

25 meet such standard. 


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1 ‘‘(4) MANUFACTURER REQUIREMENTS.—Not 

2 later than 1 year after the date that an ingredient 

3 is placed on a list under subsection (b), any manu4 facturer using such ingredient in a cosmetic shall re5 formulate such cosmetic to— 

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

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

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

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

10 restrictions specified under paragraph (2). 

11 ‘‘(c) SAFE WITHOUT LIMITS LIST.— 

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

13 after the date of the enactment of this subchapter, 

14 the Secretary shall issue, by regulation, a list of in15 gredients that the Secretary has determined are safe 

16 for use in cosmetics, without limits or restrictions. 

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

18 Secretary may only include an ingredient on the list 

19 under paragraph (1) if the Secretary determines 

20 that the ingredient meets the safety standard under 

21 section 614(a), regardless of— 

22 ‘‘(A) the type and form of cosmetic the in23 gredient is used in; and 

24 ‘‘(B) the concentration of the ingredient 

25 that is used in a cosmetic. 


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1 ‘‘(3) UPDATES AND REDETERMINATIONS.—The 

2 Secretary shall annually update the list under para3 graph (1) and may redetermine whether an ingre4 dient distributed in commerce meets the safety 

5 standard if, in the judgment of the Secretary, new 

6 information raises a credible question as to whether 

7 the ingredient continues to meet the safety standard. 

8 ‘‘(d) PRIORITY ASSESSMENT LIST AND RELATED

9 SAFETY DETERMINATIONS.— 

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

11 after the date of the enactment of this subchapter, 

12 the Secretary shall develop and publish a priority as13 sessment list of not less than 300 ingredients— 

14 ‘‘(A) which, because of a lack of authori15 tative information on the safety of the ingre16 dient, cannot be included on— 

17 ‘‘(i) the list under subsection (b) (re18 lating to prohibited and restricted ingredi19 ents); or 

20 ‘‘(ii) the list under subsection (c) (re21 lating to ingredients that are safe without 

22 limits); and 

23 ‘‘(B) for which the Secretary has deter24 mined it is a priority to conduct a safety deter25 mination under paragraph (3). 


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

2 After the list is developed under paragraph (1), the 

3 Secretary shall annually add at least 100 additional 

4 ingredients to such list until all ingredients that are 

5 used in the formulation or manufacture of cosmetics 

6 have been added— 

7 ‘‘(A) to such list; 

8 ‘‘(B) to the list under subsection (b); or 

9 ‘‘(C) to the list under subsection (c). 

10 ‘‘(3) DETERMINATION OF WHETHER INGRE11 DIENT MEETS SAFETY STANDARD.— 

12 ‘‘(A) REVIEW OF PRIORITY INGREDI13 ENTS.—During the 2-year period following the 

14 date on which an ingredient is placed on the list 

15 under paragraph (1), the Secretary shall— 

16 ‘‘(i) collect data and information on 

17 such ingredient; and 

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

19 such ingredient. 

20 ‘‘(B) DETERMINATION OF LIST PLACE21 MENT.—Not later than the end of the period 

22 under subparagraph (A), the Secretary shall 

23 issue a determination, based on the review and 

24 evaluation under such clause, that— 


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1 ‘‘(i) the ingredient meets the require2 ments for inclusion on a list under sub3 section (b) (relating to prohibited and re4 stricted ingredients) or subsection (c) (re5 lating to ingredients that are safe without 

6 limits); or 

7 ‘‘(ii) insufficient information exists to 

8 place the ingredient on either such list. 

9 ‘‘(C) GUIDANCE IN THE CASE OF INSUFFI10 CIENT INFORMATION.—If the Secretary deter11 mines under subparagraph (B) that, with re12 spect to an ingredient, insufficient information 

13 exists to place such ingredient on either of the 

14 lists under subsection (b) or subsection (c), the 

15 Secretary shall provide guidance to manufactur16 ers on the data and information (including min17 imum data requirements and safety testing pro18 tocols) that the Secretary requires to evaluate 

19 whether the ingredient meets the safety stand20 ard under section 614(a) for purposes of plac21 ing such ingredient on such a list. 

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

23 the determination under subparagraph (B), 

24 and, if applicable, the guidance under subpara25 graph (C), the Secretary shall provide a period 


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1 of not less than 60 days for public comment on 

2 the determination before applying such deter3 mination to an ingredient, except that a shorter 

4 period for comment may be provided if the Sec5 retary— 

6 ‘‘(i) finds that it would be in the pub7 lic interest to have a shorter period; and 

8 ‘‘(ii) publically declares the reasons 

9 for such finding. 

10 ‘‘(4) MANUFACTURER RESPONSE TO INAD11 EQUATE INFORMATION.—Not later than 18 months 

12 after the date that the Secretary issues guidance 

13 under paragraph (3)(C) with respect to an ingre14 dient subject to a determination under paragraph 

15 (3)(B), a manufacturer using such ingredient in a 

16 cosmetic shall— 

17 ‘‘(A) reformulate such cosmetic to elimi18 nate the use of the ingredient; or 

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

20 and information specified in such guidance. 

21 ‘‘(5) EVALUATION OF ADDITIONAL DATA AND

22 INFORMATION.—With respect to an ingredient, not 

23 later than 6 months after a manufacturer provides 

24 the Secretary with the data and information under 

25 paragraph (4)(B) the Secretary shall review such 


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1 data and information and shall make a redetermina2 tion under paragraph (3)(B) for such ingredient, 

3 subject to the comment period under paragraph 

4 (3)(D). 

5 ‘‘(6) LIMITATION.—If the Secretary has not 

6 placed an ingredient on either of the lists under sub7 section (b) and subsection (c) by the end of the 5- 

8 year period beginning on the date that such ingre9 dient is first placed on the list under subsection (d), 

10 beginning on the first day after such period such in11 gredient may not be— 

12 ‘‘(A) used in a cosmetic; and 

13 ‘‘(B) manufactured, imported, distributed, 

14 or marketed for use in cosmetics. 

15 ‘‘SEC. 617. TREATMENT OF COSMETICS BASED ON INGRE16 DIENT LISTS. 

17 ‘‘(a) IN GENERAL.—Subject to subsections (b)(4) 

18 and (d)(4) of section 616, a manufacturer may only manu19 facture a cosmetic for distribution in interstate commerce 

20 if such cosmetic meets the safety standard under section 

21 614(a). 

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

23 COSMETICS.— 

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

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


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1 presume that the following cosmetics meet the safety 

2 standard under section 614(a): 

3 ‘‘(A) A cosmetic that is made solely of in4 gredients on the list under section 616(c)(1) 

5 (relating to ingredients that are safe without 

6 limits). 

7 ‘‘(B) A cosmetic that is made solely of in8 gredients on the list under section 616(b)(1)(B) 

9 (relating to ingredients subject to restrictions) 

10 and the use of each of such ingredients in such 

11 cosmetic is in compliance with the restrictions 

12 on the use of such ingredients specified under 

13 section 616(b)(2). 

14 ‘‘(C) A cosmetic that is made solely of in15 gredients described under subparagraph (A) 

16 and subparagraph (B). 

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

18 that a manufacturer demonstrate that a cosmetic 

19 meets the safety standard under section 614(a) (in20 cluding by requiring that the manufacturer conduct 

21 safety testing of a cosmetic described under para22 graph (1)) if the cosmetic— 

23 ‘‘(A) contains penetration enhancers, sensi24 tizers, estrogenic chemicals, or other similar in25 gredients; 


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1 ‘‘(B) contains ingredients that react with 

2 each other or with other substances to form 

3 harmful byproducts; or 

4 ‘‘(C) the Secretary has any additional rea5 son to believe that such cosmetic does not meet 

6 the safety standard under section 614(a). 

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

8 Secretary requires that a manufacturer demonstrate 

9 that a cosmetic meets the safety standard under sec10 tion 614(a), the Secretary shall provide the manu11 facturer with guidance on the data and information 

12 that the Secretary requires to evaluate whether the 

13 cosmetic meets the safety standard under such sec14 tion. 

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

16 ACT.—If the Secretary fails to act by an applicable dead17 line under section 616 or this section, a manufacturer of 

18 an ingredient or a cosmetic affected by such failure of the 

19 Secretary to act shall issue to the Secretary, the public, 

20 and each known customer of the ingredient or cosmetic, 

21 a written notice that a determination by the Secretary of 

22 the safety of the ingredient for use in cosmetics is pending. 


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1 ‘‘SEC. 618. TREATMENT OF CONTAMINANTS. 

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

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

4 annually thereafter, the Secretary shall publish a list of— 

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

6 contain contaminants; 

7 ‘‘(2) combinations of ingredients that may cre8 ate contaminants when such ingredients interact; 

9 ‘‘(3) contaminants that may leech from product 

10 packaging into a cosmetic; and 

11 ‘‘(4) any other contaminant of cosmetics identi12 fied by the Secretary. 

13 ‘‘(b) REQUIREMENTS FOR TESTING.— 

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

15 the date of enactment of this subchapter, the Sec16 retary shall establish, by rule, requirements for test17 ing ingredients and cosmetics for contaminants list18 ed under subsection (a). 

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

20 paragraph (1) shall include— 

21 ‘‘(A) testing methods and applicable proto22 cols; and 

23 ‘‘(B) maximum allowable detection limits 

24 for each contaminant in an ingredient. 

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

26 update the requirements under paragraph (1). 


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1 ‘‘(c) SUPPLIER REQUIREMENTS.—Not later than 1 

2 year after the promulgation of the rule under subsection 

3 (b)(1), a supplier of an ingredient that is used in a cos4 metic shall, with respect to such ingredient— 

5 ‘‘(1) comply with the requirements under sub6 section (b)(1) for any ingredient listed under sub7 section (a); 

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

9 that— 

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

11 a cosmetic; 

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

13 contaminant; and 

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

15 ‘‘(3) upon the sale of an ingredient to the man16 ufacturer, provide to the manufacturer specifications 

17 for the ingredient that— 

18 ‘‘(A) include the levels of contaminants 

19 present in such ingredient; and 

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

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

22 ‘‘(d) MANUFACTURER REQUIREMENTS.—Not later 

23 than 1 year after the promulgation of the rule under sub24 section (b)(1), a manufacturer of a cosmetic shall, with 


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1 respect to each ingredient that the manufacturer uses in 

2 a cosmetic— 

3 ‘‘(1) obtain, from each supplier of the ingre4 dient, specifications for the ingredient that include— 

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

6 in the ingredient; and 

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

8 test used to detect the contaminant; or 

9 ‘‘(2) comply with the requirements under para10 graphs (1) and (2) of subsection (c) for the ingre11 dient, in the same manner as if the manufacturer 

12 were a supplier. 

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

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

15 of the enactment of this subchapter, each establishment 

16 engaged in the manufacture of a cosmetic intended to be 

17 marketed in the United States shall submit electronically 

18 to the Secretary, for each cosmetic manufactured in the 

19 establishment that is intended to be marketed in the 

20 United States, a statement containing— 

21 ‘‘(1) the registration number of the manufac22 turing establishment where the cosmetic is manufac23 tured or, if the same cosmetic is manufactured in 

24 more than 1 establishment, the registration number 

25 of each establishment where it is manufactured; 


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1 ‘‘(2) the registration number of the establish2 ment responsible for distributing the cosmetic; 

3 ‘‘(3) the brand name and the product name for 

4 the cosmetic; 

5 ‘‘(4) the applicable use for the cosmetic; 

6 ‘‘(5) the ingredient list as it appears on the cos7 metic label or insert, including the particle size 

8 range of any nanoscale cosmetic ingredients; 

9 ‘‘(6) any warnings and directions for use from 

10 the cosmetic label or insert; and 

11 ‘‘(7) the title and full contact information for 

12 the individual responsible for submitting and main13 taining such statement. 

14 ‘‘(b) NEW COSMETICS.—Any establishment that be15 gins to manufacture a cosmetic after the date of the enact16 ment of this subchapter shall comply with the require17 ments of subsection (a) beginning on the later of the fol18 lowing: 

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

20 on the date of the enactment of this subchapter. 

21 ‘‘(2) The 6-month period after the date on 

22 which the establishment begins to manufacture such 

23 cosmetic. 


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1 ‘‘(c) NOTIFICATION OF CHANGES.—The establish2 ment shall notify the Secretary annually of any change 

3 to the information required under subsection (a). 

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

5 statement described under subsection (a), the Secretary 

6 shall notify the establishment of the receipt of such state7 ment and assign a cosmetic statement number. 

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

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

10 statements are submitted under this section. 

11 ‘‘(f) ACCESS TO SAFETY INFORMATION.—The cos12 metic and ingredient statements collected under this sec13 tion shall be added to the publicly accessible database cre14 ated by the Secretary under section 615(b). 

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

16 OF ADULTERATED OR MISBRANDED COS17 METICS. 

18 ‘‘(a) NOTIFICATION OF ADULTERATED OR MIS19 BRANDED COSMETICS.— 

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

21 has reason to believe that a cosmetic, when intro22 duced into or while in interstate commerce, or while 

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

24 first sale of such cosmetic) after shipment in inter25 state commerce, is adulterated or misbranded in a 


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1 manner that presents a reasonable probability that 

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

3 or component used in any such cosmetic) will cause 

4 a threat of serious adverse health effects or death to 

5 humans shall notify the Secretary of the identity and 

6 location of the cosmetic. 

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

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

9 and by such means as the Secretary may require by 

10 regulation or guidance. 

11 ‘‘(3) RESPONSIBLE PARTY DEFINED.—For pur12 poses of this subsection, the term ‘responsible party’ 

13 means a manufacturer, packager, retailer, or dis14 tributor of the cosmetic. 

15 ‘‘(b) VOLUNTARY RECALL.—The Secretary may re16 quest that any person who distributes a cosmetic that the 

17 Secretary has reason to believe is adulterated, misbranded, 

18 or otherwise in violation of this Act voluntarily— 

19 ‘‘(1) recall such cosmetic; and 

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

21 as appropriate, to persons who may be affected by 

22 the recall. 

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

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

25 to believe that— 


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

2 may cause serious adverse health effects or 

3 death to humans; 

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

5 ‘‘(C) the cosmetic is manufactured, pack6 aged, or distributed by an unregistered facility; 

7 the Secretary shall have the authority to issue an 

8 order requiring any person who distributes such cos9 metic to immediately cease distribution of such cos10 metic. 

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

12 person who is subject to an order under paragraph 

13 (1) shall immediately cease distribution of such cos14 metic and provide notification as required by such 

15 order. 

16 ‘‘(3) APPEAL.— 

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

18 order under paragraph (1) may appeal such 

19 order to the Secretary within 24 hours of the 

20 issuance of such order. 

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

22 may include a request for an informal hearing 

23 and a description of any efforts to recall such 

24 cosmetic undertaken voluntarily by the person, 

25 including after a request under subsection (b). 


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1 ‘‘(C) INFORMAL HEARING.—Except as pro2 vided in subsection (e), an informal hearing 

3 shall be held as soon as practicable, but not 

4 later than 5 calendar days (or less as deter5 mined by the Secretary) after such an appeal is 

6 filed, unless the parties jointly agree to an ex7 tension. 

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

9 filed under subparagraph (A), the Secretary 

10 may not amend the order to require a recall 

11 under subsection (d) until after the conclusion 

12 of the hearing under subparagraph (C). 

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

14 determines that inadequate grounds exist to support 

15 the actions required by the order under paragraph 

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

17 ‘‘(d) ORDER TO RECALL.— 

18 ‘‘(1) AMENDMENT.—Except as provided under 

19 subsection (e) and subject to subsection (c)(3)(D), if 

20 the Secretary determines that a recall of a cosmetic 

21 subject to an order under subsection (c) is appro22 priate, the Secretary shall amend the order to re23 quire a recall. 

24 ‘‘(2) CONTENTS.—An amended order under 

25 paragraph (1) shall— 


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1 ‘‘(A) specify a timetable in which the recall 

2 will occur; 

3 ‘‘(B) require periodic reports to the Sec4 retary describing the progress of the recall; and 

5 ‘‘(C) provide for notice, including to indi6 viduals as appropriate, to persons who may be 

7 affected by the recall. 

8 In providing for such notice, the Secretary may 

9 allow for the assistance of health professionals, State 

10 or local officials, or other individuals designated by 

11 the Secretary. 

12 ‘‘(3) NONDELEGATION.—An amended order 

13 under this subsection may only be issued by the Sec14 retary or an official designated by the Secretary, and 

15 may not be delegated to another official or employee. 

16 ‘‘(4) DETERMINATION.—If the Secretary deter17 mines that inadequate grounds exist to support the 

18 amendment made to the order under paragraph (1), 

19 the Secretary shall remove such amendment from 

20 such order. 

21 ‘‘(e) EMERGENCY RECALL ORDER.— 

22 ‘‘(1) IN GENERAL.—If the Secretary has cred23 ible evidence or information that a cosmetic subject 

24 to an order under subsection (c) presents an immi25 nent threat of serious adverse health effects or death 


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1 to humans, the Secretary may issue an order requir2 ing any person who distributes such cosmetic— 

3 ‘‘(A) to immediately recall such cosmetic; 

4 and 

5 ‘‘(B) to provide for notice, including to in6 dividuals as appropriate, to persons who may be 

7 affected by the recall. 

8 ‘‘(2) RECALL AND NOTICE.—Any person who is 

9 subject to an emergency recall order under this sub10 section shall immediately recall such cosmetic and 

11 provide notification as required by such order. 

12 ‘‘(3) APPEAL.— 

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

14 such an order may appeal such order to the 

15 Secretary within 24 hours of the issuance of 

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

5 determines that inadequate grounds exist to support 

6 the actions required by the order under paragraph 

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

8 ‘‘(5) NONDELEGATION.—An order under this 

9 subsection may only be issued by the Secretary or an 

10 official designated by the Secretary, and may not be 

11 delegated to another official or employee. 

12 ‘‘(f) NOTICE TO CONSUMERS AND HEALTH OFFI13 CIALS.—The Secretary shall, as the Secretary determines 

14 to be necessary, provide notice of a recall order under this 

15 section to consumers to whom the cosmetic was, or may 

16 have been, distributed and to appropriate State and local 

17 health officials. 

18 ‘‘(g) SUPPLY CHAIN INFORMATION.— 

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

20 that the Secretary has reason to believe is adulter21 ated, misbranded, or otherwise in violation of this 

22 Act, the Secretary shall request that the entity 

23 named on the label of such cosmetic (as required 

24 under section 602(b)(1)) submit all of the following 

25 information: 


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

2 the manufacturer, packer, or distributor from 

3 which such entity received the cosmetic or in4 gredients for manufacturing such cosmetic. 

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

6 any entity (including any retailer) that was pro7 vided with such cosmetic by the entity named 

8 on the label. 

9 ‘‘(2) COLLECTION OF ADDITIONAL SUPPLY

10 CHAIN INFORMATION.—In the case of a cosmetic 

11 that the Secretary has reason to believe is adulter12 ated, misbranded, or otherwise in violation of this 

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

14 the public, the Secretary may request that any entity 

15 (including a supplier of an ingredient, manufacturer, 

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

17 of such cosmetic submit to the Secretary information 

18 that is similar to the information described under 

19 subparagraphs (A) and (B) of paragraph (1). 

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

21 in supply chain of a cosmetic (including the entity 

22 named on the label of a cosmetic) shall— 

23 ‘‘(A) maintain records sufficient to provide 

24 the information described in subparagraphs (A) 

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


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1 ‘‘(B) provide such information to the Sec2 retary upon the request of the Secretary. 

3 ‘‘(h) SAVINGS CLAUSE.—Nothing contained in this 

4 section shall be construed as limiting the authority of the 

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

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

7 ‘‘SEC. 621. PETITIONS. 

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

9 and publish a review, and, if appropriate, immediately re10 vise related, relevant information, including ingredient 

11 lists, ingredient restrictions or prohibitions, or ingredient 

12 or cosmetic safety determinations, not later than 6 months 

13 after the date on which the Secretary receives from any 

14 individual or entity a reasonable petition— 

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

16 in cosmetics and list such ingredient on the list 

17 under section 616(b); 

18 ‘‘(2) to remove an ingredient from the list of in19 gredients that are safe without limits under section 

20 616(c); 

21 ‘‘(3) to add an ingredient to the priority assess22 ment list under section 616(d); or 

23 ‘‘(4) to add an ingredient to the list of contami24 nants under section 618. 


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

2 after the date of the enactment of this Act, the Secretary 

3 shall issue rules specifying the criteria which the Secretary 

4 will use to determine if a petition submitted under this 

5 section is a reasonable petition. 

6 ‘‘SEC. 622. MANDATORY REPORTING OF ADVERSE HEALTH 

7 EFFECTS. 

8 ‘‘(a) SUBMISSION OF REPORT ON ADVERSE HEALTH

9 EFFECTS.—The Secretary shall require that the manufac10 turer, packager, or distributor of a cosmetic whose name 

11 appears on the label of a cosmetic marketed in the United 

12 States submit to the Secretary a report containing infor13 mation received concerning any adverse health effect asso14 ciated with the use of the cosmetic. 

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

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

17 business days after information concerning the adverse 

18 health effect is received at the place of business of the 

19 manufacturer, packager, or distributor. 

20 ‘‘(c) CONTENT OF REPORT.—A report under sub21 section (a) shall include the following information, to the 

22 extent to which the manufacturer, packager, or distributor 

23 submitting the report has been able to verify the informa24 tion: 


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

2 the adverse health effect. 

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

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

5 causing such effect. 

6 ‘‘(4) A description of the adverse health effect. 

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

8 ‘‘(1) PUBLIC AVAILABILITY.—Subject to para9 graph (2), the adverse health effect reports collected 

10 by the Secretary under this section shall be sub11 mitted electronically and shall be made accessible to 

12 the public. 

13 ‘‘(2) PRIVACY.— 

14 ‘‘(A) PERSONALLY IDENTIFIABLE INFOR15 MATION.—Notwithstanding any other provision 

16 of law, personally identifiable information in ad17 verse health effect reports provided to the Sec18 retary under this section, shall not— 

19 ‘‘(i) be made publicly available pursu20 ant to any State or other law requiring dis21 closure of information or records; or 

22 ‘‘(ii) otherwise be disclosed or distrib23 uted to any party without the written con24 sent of the Secretary and the person sub25 mitting such information to the Secretary. 


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1 ‘‘(B) TREATMENT OF INFORMATION

2 UNDER PRIVACY ACT AND FOIA.—An adverse 

3 health effect report submitted to the Secretary 

4 under this section, shall be considered to be a 

5 record about an individual under section 552a 

6 of title 5, United States Code (commonly re7 ferred to as the ‘‘Privacy Act of 1974’’) and a 

8 medical or similar file the disclosure of which 

9 would constitute a violation of section 552 of 

10 such title 5 (commonly referred to as the 

11 ‘‘Freedom of Information Act’’), and shall not 

12 be publicly disclosed unless all personally identi13 fiable information is redacted. 

14 ‘‘SEC. 623. NONCONFIDENTIAL INFORMATION. 

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

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

17 information submitted pursuant to this subchapter shall 

18 be made available to the public, including the following 

19 types of information: 

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

21 chemical substance, contaminant, or impurity that is 

22 an ingredient. 

23 ‘‘(2) All information concerning function, expo24 sure, health hazards, and environmental hazards for 

25 a cosmetic., and 


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

2 ‘‘(4) Fragrance, flavor, and colorants in a cos3 metic 

4 ‘‘(b) CONFIDENTIAL INFORMATION.—The concentra5 tion of cosmetic ingredients used in a finished cosmetic 

6 shall be considered confidential business information and 

7 may not be made available to the public under subsection 

8 (a). 

9 ‘‘(c) PETITION FOR INFORMATION TO REMAIN CON10 FIDENTIAL.— 

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

12 a process for an entity to petition for nonconfidential 

13 information described in subsection (a) to remain 

14 confidential if the entity shows that there would be 

15 a serious negative impact to the entity’s commercial 

16 interests if such information were disclosed to the 

17 public. 

18 ‘‘(2) LIMITATION.—The Secretary may not ap19 prove a petition under paragraph (1) to the extent 

20 that such petition would prevent the public disclo21 sure of— 

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

23 any chemical substance, contaminant, or impu24 rity that is an ingredient; 


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

2 that substance, contaminant, or impurity; or 

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

4 safety of that substance, contaminant, or impu5 rity. 

6 ‘‘SEC. 624. ANIMAL TESTING ALTERNATIVES. 

7 ‘‘(a) IN GENERAL.—To minimize the use of animal 

8 testing of ingredients and cosmetics, the Secretary shall— 

9 ‘‘(1) require, where practicable, alternative test10 ing methods that— 

11 ‘‘(A) do not involve the use of an animal 

12 to test the chemical substance; 

13 ‘‘(B) provide information that is equivalent 

14 or superior in scientific quality to the animal 

15 testing method; and 

16 ‘‘(C) use fewer animals than conventional 

17 animal-based tests when nonanimal methods 

18 are impracticable, including the use of tests 

19 that combine multiple endpoints; and 

20 ‘‘(2) encourage, where practicable— 

21 ‘‘(A) estimation of toxicological properties 

22 of a chemical through the use of testing infor23 mation for 1 or more structurally similar chemi24 cals where such estimates provide information 

25 of sufficient scientific quality; 


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1 ‘‘(B) the formation of industry consortia to 

2 conduct testing to avoid duplication of tests; 

3 and 

4 ‘‘(C) funding for research and validation of 

5 alternative test methods, in accordance with 

6 this subsection. 

7 ‘‘(b) LIST OF ALTERNATIVE TESTING METHODS.— 

8 Not later than 1 year after the date of the enactment of 

9 this subchapter, and triennially thereafter, the Secretary 

10 shall publish a list of the alternative testing methods de11 scribed in subsection (a). 

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

13 ‘‘The Secretary shall conduct annual audits of ran14 dom samples of cosmetics to assess or test for acute nega15 tive reactions, pathogen hazards, contaminants, leaching 

16 of packaging additives, mislabeling, or other relevant 

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

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

19 ‘‘The Secretary shall provide technical support to as20 sist small businesses in carrying out the requirements of 

21 this subchapter. 

22 ‘‘SEC. 627. INTERAGENCY COOPERATION. 

23 ‘‘(a) INTERAGENCY COUNCIL ON COSMETIC SAFE24 TY.—There is established an Interagency Council on Cos25 metic Safety for the purpose of sharing data and proVerDate Mar 15 2010 02:35 Jul 01, 2011 Jkt 099200 PO 00000 Frm 00051 Fmt 6652 Sfmt 6201 E:\BILLS\H2359.IH H2359

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1 moting collaboration on cosmetic safety between the Food 

2 and Drug Administration, the National Institute of Envi3 ronmental Health Sciences, the Centers for Disease Con4 trol and Prevention, the Occupational Safety and Health 

5 Administration, and the Environmental Protection Agen6 cy. 

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

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

9 shall request and utilize ingredient and cosmetic toxicity, 

10 use, and exposure data from other Federal agencies. 

11 ‘‘SEC. 628. SAVINGS CLAUSE. 

12 ‘‘Nothing in this subchapter shall affect the right of 

13 a State, political subdivision of a State, or tribe to adopt 

14 or enforce any regulation, requirement, liability, or stand15 ard of performance that is more stringent than a regula16 tion, requirement, liability, or standard of performance es17 tablished by this subchapter, including requiring the provi18 sion of a warning of risk, illness, or injury. 

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 2012 through 2016.’’. 

23 (b) ADULTERATED AND MISBRANDED COSMETICS.— 


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1 (1) ADULTERATED COSMETICS.—Section 601 of 

2 the Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 361) is amended in paragraph (a)— 

4 (A) by striking ‘‘, except that this provi5 sion shall not apply to coal-tar hair dye’’ and all 

6 that follows through ‘‘or eyebrow dyes’’; and 

7 (B) by adding at the end the following: 

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

9 to comply with section 617(a). 

10 ‘‘(g) If it is imported, distributed, or marketed 

11 and— 

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

13 under section 616(b)(1)(A), and the manufac14 turer has not complied with section 616(b)(4) 

15 with respect to such ingredient and such cos16 metic; or 

17 ‘‘(2) it contains an ingredient on the list 

18 under section 616(b)(1)(B), such ingredient is 

19 being used in a manner that violates the limit 

20 on use or concentration of such ingredient 

21 under section 616(b)(2), and the manufacturer 

22 has not complied with section 616(b)(4) with 

23 respect to such ingredient and such cosmetic. 

24 ‘‘(h) If it is manufactured by a manufacturer 

25 that, with respect to such cosmetic, is required to 


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1 demonstrate, under section 617(b)(2), that the cos2 metic meets the safety standard and the manufac3 turer has not yet submitted the required data under 

4 section 617(b)(3).’’. 

5 (2) MISBRANDED COSMETICS.—Section 602 of 

6 the Federal Food, Drug, and Cosmetic Act (21 

7 U.S.C. 362) is amended— 

8 (A) in paragraph (a), by inserting ‘‘ or 

9 fails to meet the requirements of section 613’’ 

10 before the period; and 

11 (B) by adding at the end the following: 

12 ‘‘(g) If it— 

13 ‘‘(1) was manufactured, packaged, or dis14 tributed by an entity that failed to register and 

15 pay the applicable fee as required under section 

16 612; 

17 ‘‘(2) is manufactured, packaged, distrib18 uted, or sold in retail by a manufacturer, pack19 ager, distributor, or retailer, respectively, who 

20 fails to notify the Secretary as required under 

21 section 620(a)(1); 

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

23 under section 620(c); 

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

25 under subsection (d) or (e) of section 620; 


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1 ‘‘(5) is manufactured in a manner that 

2 fails to comply with good manufacturing prac3 tices prescribed by the Secretary under section 

4 614(b); or 

5 ‘‘(6) is manufactured by a manufacturer 

6 who fails— 

7 ‘‘(A) to submit the statement required 

8 under section 619; or 

9 ‘‘(B) notify the Secretary of changes 

10 to information contained in such report, as 

11 required by such section.’’. 

12 (3) ADDITIONAL PROHIBITIONS.—Section 301 

13 of the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 331) is amended by adding at the end the 

15 following: 

16 ‘‘(aaa) The failure of a manufacturer of a cos17 metic or an ingredient for use in a cosmetic to sub18 mit and update data and information as required 

19 under section 615(a). 

20 ‘‘(bbb) The manufacture, importation, distribu21 tion, or marketing of an ingredient for use in a cos22 metic that is on the list under section 616(b)(1)(A). 

23 ‘‘(ccc) The failure of a supplier of an ingredient 

24 for use in a cosmetic— 


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1 ‘‘(1) to provide data and information as re2 quired by section 615(a)(4)(B); or 

3 ‘‘(2) comply with the testing requirements 

4 under section 618(c). 

5 ‘‘(ddd) The failure of a manufacturer to comply 

6 with the requirements of section 618(d). 

7 ‘‘(eee) The failure of a manufacturer, packager, 

8 or distributor of a cosmetic to comply with the re9 quirement of reporting adverse health effects under 

10 section 622.’’. 

11 SEC. 3. WORKER ISSUES. 

12 (a) IN GENERAL.—The Secretary of Labor shall pro13 mulgate an occupational safety and health standard under 

14 section 6 of the Occupational Safety and Health Act of 

15 1970 (29 U.S.C. 655) that requires the following: 

16 (1) MANUFACTURERS AND IMPORTERS.—Each 

17 manufacturer or importer selling any cosmetic for 

18 professional use shall— 

19 (A) obtain or develop a material safety 

20 data sheet described in subsection (b) for each 

21 such cosmetic or personal care product that— 

22 (i) the manufacturer or importer pro23 duces or imports; and 

24 (ii) includes a hazardous chemical, or 

25 a product ingredient associated with any 


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1 chemical hazard, that is classified as a 

2 health hazard in accordance with the cri3 teria found in section 1910.1200(d) of title 

4 29 of the Code of Federal Regulations, and 

5 any successor regulations; and 

6 (B) make the material safety data sheet 

7 available to distributors and employers, includ8 ing salon owners, in English and, upon request, 

9 in other languages, including Spanish and Viet10 namese. 

11 (2) DISTRIBUTORS.—Each distributor of a cos12 metic or personal care product for professional use 

13 shall distribute and provide material safety data 

14 sheets described in subsection (b) in the same man15 ner as a distributor of a chemical hazard is required 

16 to distribute and provide material safety data sheets 

17 under section 1910.1200(g) of title 29, Code of Fed18 eral Regulations, or any successor regulations. 

19 (3) EMPLOYERS.—Each employer, including 

20 any operator of a salon, shall— 

21 (A) have a material safety data sheet in 

22 the workplace for each cosmetic or personal 

23 care product for professional use that is used in 

24 the course of the employer’s business; 


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1 (B) make such material safety data sheet 

2 available to all employees of the employer who 

3 are exposed or use the product to the same ex4 tent and in the same manner as material safety 

5 data sheets are required to be made available 

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

7 Federal Regulations, or any successor regula8 tions; and 

9 (C) upon request, provide employees with 

10 translations of such material safety data sheet 

11 in other languages, including Spanish and Viet12 namese. 

13 (b) CONTENTS OF MATERIAL SAFETY DATA

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

15 personal care product for professional use described in this 

16 section shall— 

17 (1) contain the information required in a mate18 rial safety data sheet under section 1910.1200(g) of 

19 title 29, Code of Federal Regulations, or any suc20 cessor regulations, for each hazardous chemical, or 

21 product ingredient associated with any chemical haz22 ard, described in subsection (a)(1)(A)(ii); and 

23 (2) include the following statement: ‘‘This ma24 terial safety data sheet is also available in multiple 


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1 languages by contacting the manufacturer, using the 

2 contact information provided on this sheet.’’. 

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

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

5 term in section 611(6) of the Federal Food, Drug, and 

6 Cosmetic Act, except to the extent that such term applies 

7 to a product that is sold as a retail product in any of the 

8 establishments listed under such definition. 

Æ 


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