I 

113TH CONGRESS 

1ST SESSION H. R. 1385 

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 

MARCH 21, 2013 

Ms. SCHAKOWSKY (for herself, Mr. MARKEY, Mr. BLUMENAUER, Ms. CHU, 

Mr. CONYERS, Mr. ELLISON, Mr. GRIJALVA, Mr. HASTINGS of Florida, 

Mr. HUFFMAN, Mr. LOWENTHAL, Mr. MICHAUD, Mr. MORAN, Ms. NORTON, Ms. PINGREE of Maine, Ms. WASSERMAN SCHULTZ, and Ms. 

SPEIER) 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 and Personal Care Products Act of 

6 2013’’. 


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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 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 serious adverse events. 

‘‘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. 

3 SEC. 2. COSMETIC REGULATION. 

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

5 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amend6 ed— 

7 (1) by inserting before section 601 the fol8 lowing: 

9 ‘‘Subchapter A—Adulterated and Misbranded 

10 Cosmetics’’; 

11 and 

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

5 means the entity responsible for bringing a cosmetic 

6 to market. 

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

8 means unintended substances, such as those that 

9 can originate from sources outside the chemical 

10 pathway, chemical processes, storage of primary sub11 stances, instability of the packaging or harmful by12 products of the manufacturing process. 

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

14 ‘domestic establishment’ means an establishment lo15 cated in any State that brings a cosmetic to market. 

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

17 ‘foreign establishment’ means an establishment that 

18 brings a cosmetic to market and exports those cos19 metics to the United States. 

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

21 means a chemical in a cosmetic, including— 

22 ‘‘(A) chemicals that provide a technical or 

23 functional effect; 

24 ‘‘(B) chemicals that have no technical or 

25 functional effect in the cosmetic but are present 


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1 by reason of having been incorporated into the 

2 cosmetic as an ingredient of another cosmetic 

3 ingredient; 

4 ‘‘(C) processing aids that are present by 

5 reason of having been added to a cosmetic dur6 ing the processing of such cosmetic; 

7 ‘‘(D) substances that are present by reason 

8 of having been added to a cosmetic during proc9 essing for their technical or functional effect; 

10 ‘‘(E) the components of a fragrance, fla11 vor, or preservative; and 

12 ‘‘(F) any individual component that the 

13 Secretary deems an ingredient for purposes of 

14 this chapter. 

15 ‘‘(6) MANUFACTURER.—The term ‘manufac16 turer’ means the entity that produces ingredients or 

17 combines one or more ingredients to produce a cos18 metic product. 

19 ‘‘(7) MICROBUSINESS.—The term ‘microbusi20 ness’ means a business— 

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

22 this subchapter; and 

23 ‘‘(B) that has annual sales receipts for cos24 metic products that do not exceed $2,000,000. 


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1 ‘‘(8) PROFESSIONAL USE.—The term ‘profes2 sional use’ means the use of any cosmetic— 

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

4 the employment of such employee) of; or 

5 ‘‘(B) purchased by a consumer in, 

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

7 establishment that provides cosmetic treatment serv8 ices for 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

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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 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, or a con16 genital anomaly or birth defect; or 

17 ‘‘(B) requires, based on a reasonable med18 ical judgment, a medical or surgical interven19 tion to prevent an outcome described above. 

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

21 the entity that supplies ingredients, raw materials, 

22 or specific components of a cosmetic product, includ23 ing packaging. 

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

25 ‘vulnerable populations’ includes pregnant women, 


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1 infants, children, the elderly, and highly exposed 

2 populations, including workers employed by hair sa3 lons, nail salons, beauty salons, spas, other estab4 lishments that provide cosmetic treatment services 

5 for humans, and cosmetic manufacturing plants. 

6 ‘‘SEC. 612. REGISTRATION OF ESTABLISHMENTS AND REG7 ISTRATION FEES. 

8 ‘‘(a) REGISTRATION.— 

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

10 date of the enactment of this subchapter, and annu11 ally thereafter, any brand owner (except for micro12 businesses) engaged in bringing a cosmetic to mar13 ket for use in the United States shall register with 

14 the Secretary and pay to the Secretary the applica15 ble fee, as established under the fee schedule in sub16 section (e). 

17 ‘‘(2) RULES FOR DOMESTIC AND FOREIGN ES18 TABLISHMENTS.—To be registered under paragraph 

19 (1)— 

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

21 owner, operator, or agent in charge of the do22 mestic establishment shall submit a registration 

23 to the Secretary; or 


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

2 operator, or agent in charge of the foreign es3 tablishment shall— 

4 ‘‘(i) submit a registration to the Sec5 retary; and 

6 ‘‘(ii) include with the registration the 

7 name of the United States agent for the 

8 foreign establishment. 

9 ‘‘(3) NEW ESTABLISHMENTS.—Any brand 

10 owner that initially brings a cosmetic to market 

11 after the date on which the requirements of para12 graph (1) apply shall, not later than 60 days after 

13 the date on which the establishment brings a cos14 metic to market, register with the Secretary and pay 

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

16 ‘‘(b) SUBMISSION OF REGISTRATION.— 

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

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

19 section as the ‘registrant’) shall submit to the Sec20 retary, with respect to any cosmetics that the estab21 lishment brings to market, all of the following: 

22 ‘‘(A) Any information necessary to notify 

23 the Secretary of the name, address, and legal 

24 status of each establishment at which, and all 


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1 trade names under which, the registrant brings 

2 cosmetics to market. 

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

4 activities with respect to cosmetics, including a 

5 list of all cosmetic products brought to market 

6 by the establishment and the functions of such 

7 cosmetics. 

8 ‘‘(C) The gross receipts or sales for the es9 tablishment from cosmetics. 

10 ‘‘(2) NOTIFICATION OF CHANGES.—When sub11 mitting the annual registration, the registrant shall 

12 notify the Secretary of changes to the information 

13 described in paragraph (1). 

14 ‘‘(c) PROCEDURE.—Upon receipt of a completed reg15 istration submitted under subsection (a), the Secretary 

16 shall notify the registrant of the receipt of such registra17 tion and assign a registration number to each registered 

18 establishment. 

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

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

21 shall— 

22 ‘‘(A) compile, maintain, and update as ap23 propriate, a list of establishments that are reg24 istered under this section; 

25 ‘‘(B) make such list publicly available; 


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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; and 

4 ‘‘(D) indicate on such list any establish5 ment which has had its registration suspended 

6 or cancelled by the Secretary under this section. 

7 ‘‘(2) APPLICATION OF FOIA.— 

8 ‘‘(A) REGISTRATION DOCUMENTS.—Any 

9 registration documents submitted pursuant to 

10 this section shall not be subject to disclosure 

11 under section 552 of title 5, United States 

12 Code. 

13 ‘‘(B) OTHER INFORMATION.—Information 

14 derived from— 

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

16 ‘‘(ii) registration documents submitted 

17 pursuant to this section, 

18 shall not be subject to disclosure under section 

19 552 of title 5, United States Code, except to the 

20 extent that such information discloses the iden21 tity or location of a specific registrant. 

22 ‘‘(e) FEE SCHEDULE.—A schedule of fees shall be de23 veloped by the Secretary to provide for oversight and en24 forcement of this subchapter. The fee structure shall— 


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

2 gross receipts or sales; and 

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

4 gross receipts or sales of cosmetics that exceed 

5 $10,000,000. 

6 ‘‘(f) SUSPENSION AND CANCELLATION OF REGISTRA7 TION.— 

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

9 under this section is subject to suspension if the 

10 Secretary finds— 

11 ‘‘(A) the information submitted by the es12 tablishment for registration under subsection 

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

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

15 Secretary of changes required under subsection 

16 (b)(2); 

17 ‘‘(C) the establishment fails to pay reg18 istration fees, as required under subsection (a), 

19 in a timely manner; or 

20 ‘‘(D) the establishment violates any portion 

21 of this chapter. 

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

23 Secretary determines that an establishment is sub24 ject to suspension under this subsection and that it 


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1 is appropriate to suspend the registration of such es2 tablishment, the Secretary shall— 

3 ‘‘(A) suspend the registration of such es4 tablishment; and 

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

6 establishment. 

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

8 fails to correct the issue that resulted in the suspen9 sion under paragraph (2) before the last day of the 

10 30-day period beginning on the date that the estab11 lishment receives notice under such paragraph, the 

12 Secretary may cancel the registration of such estab13 lishment. 

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

15 required to register under this section shall maintain 

16 records that include a current list of suppliers and manu17 facturers, if the registrant does not manufacture or pack18 age its own product. Those records shall be accessible by 

19 the Secretary upon request for review or audit. 

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

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

22 (c), the Secretary shall require that the label on each pack23 age of cosmetics (including cosmetics distributed for retail 

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


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1 of each ingredient in such cosmetic in descending order 

2 of predominance. 

3 ‘‘(b) ADJUSTMENTS FOR LABEL SIZE.— 

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

5 than 6 months after the date of the enactment of 

6 this subchapter, the Secretary shall issue regulations 

7 that apply to any cosmetic for which the product 

8 packaging is not of sufficient size to bear or contain 

9 a label that meets the requirements of subsection 

10 (a). 

11 ‘‘(2) REQUIREMENTS FOR PUBLIC DISCLO12 SURE.—Such regulations shall establish require13 ments for listing ingredients on the label of such 

14 cosmetics and additional requirements for public dis15 closure of the ingredients in such cosmetics. 

16 ‘‘(c) SPECIAL RULE FOR CONTAMINANTS.—The Sec17 retary shall require, in the case of a contaminant, that 

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

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

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

21 levels: 

22 ‘‘(1) A level that is greater than one part-per23 billion by weight of product formation. 

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

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1 taminant for such use, as determined by the Sec2 retary under section 616(a)(2). 

3 ‘‘(d) LABELING OF NANOMATERIALS IN COS4 METICS.—The Secretary may require that— 

5 ‘‘(1) minerals and other particulate ingredients 

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

7 label or list if not less than 1 percent of the ingre8 dient particles in the cosmetic are 100 nanometers 

9 or smaller in not less than 1 dimension; and 

10 ‘‘(2) other ingredients in a cosmetic be des11 ignated with scale-specific information on a cosmetic 

12 ingredient label or list if such ingredients possess 

13 scale-specific hazard properties. 

14 ‘‘(e) LABELING OF INGREDIENTS IN COSMETICS

15 SOLD THROUGH INTERNET COMMERCE.—The Secretary 

16 shall require— 

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

18 site of an Internet vendor, that the brand owner of 

19 such cosmetic provide to such Internet vendor a list 

20 of the ingredients of the cosmetic; and 

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

22 of ingredients of a cosmetic sold by such vendor on 

23 the Web page that is the primary Web page pro24 viding information relating to the sale of such cos25 metic on the Web site of the vendor. 


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

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

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

4 secret. 

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

6 date of the enactment of this subchapter, the requirements 

7 of this section shall apply to— 

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

9 sale; and 

10 ‘‘(2) brand owners and Internet vendors of such 

11 cosmetics. 

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

13 PRACTICES. 

14 ‘‘(a) SAFETY STANDARD.— 

15 ‘‘(1) IN GENERAL.—Taking into account the ex16 pected use of a cosmetic, the Secretary shall estab17 lish a safety standard that, with respect to a cos18 metic or an ingredient in a cosmetic provides a rea19 sonable certainty of no harm (as such term is de20 fined in section 611(7)) from exposure to the cos21 metic or ingredient and protects the public from any 

22 known or anticipated adverse health effects associ23 ated with the cosmetic or ingredient. 

24 ‘‘(2) STANDARDS FOR ESTABLISHING SAFETY

25 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 1 

7 in a million risk for any adverse health effect 

8 in any vulnerable population at the lower 95th 

9 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 an 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 under 

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

22 purposes of such ingredient. 

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

24 The Secretary may only determine that an ingre25 dient or a cosmetic meets the safety standard under 


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

2 harm from exposure to the ingredient or cosmetic. 

3 ‘‘(b) GOOD MANUFACTURING PRACTICES.— 

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

5 guidance prescribing good manufacturing practices 

6 for cosmetics and ingredients, including quality con7 trol procedures that the Secretary determines are 

8 necessary, and shall update such regulations as nec9 essary. 

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

11 developing the guidance under paragraph (1), the 

12 Secretary shall consider how such practices will im13 pact small businesses. 

14 ‘‘SEC. 615. COSMETIC AND INGREDIENT SAFETY INFORMA15 TION. 

16 ‘‘(a) REQUIRED SUBMISSION OF ALL SAFETY INFOR17 MATION.— 

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

19 shall submit to the Secretary (in an electronic for20 mat that the Secretary shall determine) all data and 

21 information that the brand owner can access regard22 ing the safety of the— 

23 ‘‘(A) ingredients listed on the cosmetic 

24 label under section 613 for a cosmetic; and 

25 ‘‘(B) cosmetic itself. 


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

2 data and information under paragraph (1) shall in3 clude, for each ingredient in a cosmetic and for the 

4 cosmetic, the following: 

5 ‘‘(A) Functions and uses. 

6 ‘‘(B) Data and information on the phys7 ical, chemical, and toxicity of each such ingre8 dient or cosmetic. 

9 ‘‘(C) Exposure and fate information. 

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

11 brand owner can access or has conducted. 

12 ‘‘(E) Any other information used to sub13 stantiate the safety of such ingredient and cos14 metic. 

15 ‘‘(3) DEADLINES.— 

16 ‘‘(A) INITIAL SUBMISSION.—A brand 

17 owner shall submit the data and information re18 quired under paragraph (1)— 

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

20 cosmetic which is marketed for sale in 

21 interstate commerce on or before the date 

22 of the enactment of this subchapter, not 

23 later than 1 year after such date; and 


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

2 cosmetic which is not marketed for sale on 

3 or before such date— 

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

5 14-month period beginning on the 

6 date of the enactment of this sub7 chapter; or 

8 ‘‘(II) if the ingredient or cosmetic 

9 is first marketed for sale in interstate 

10 commerce after the end of the period 

11 described in subclause (I), not later 

12 than 60 days after the date on which 

13 such ingredient or cosmetic is first 

14 marketed for sale. 

15 ‘‘(B) UPDATES.— 

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

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

18 and information submitted under subpara19 graph (A) annually. 

20 ‘‘(ii) ADVERSE HEALTH EFFECTS.—In 

21 the case of information related to an ad22 verse health effect that is suspected to be 

23 caused by an ingredient or a cosmetic, a 

24 brand owner shall update the information 


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1 not later than 60 days after receiving such 

2 information. 

3 ‘‘(4) SUPPLIER AND MANUFACTURER INFORMA4 TION.— 

5 ‘‘(A) USE OF SUPPLIER OR MANUFAC6 TURER INFORMATION.—In order to meet the re7 quirements of paragraph (1) with respect to an 

8 ingredient, a brand owner may submit safety 

9 data and information provided by the supplier 

10 or manufacturer of the ingredient or cosmetic. 

11 ‘‘(B) SUPPLIER OR MANUFACTURER PRO12 VISION OF INFORMATION.—If a brand owner re13 quests that a supplier or manufacturer of an in14 gredient provide to such brand owner any of the 

15 data and information described under para16 graph (2) or under section 617, such supplier 

17 or manufacturer shall provide such data and in18 formation to such brand owner not later than 

19 90 days after receiving such request. 

20 ‘‘(b) DATABASE.— 

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

22 year after the date of the enactment of this sub23 chapter, the Secretary shall publish a comprehensive, 

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1 fidential information (as such term is used under 

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

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

4 the Secretary receives new or updated information 

5 under subsection (a)(3)(B), the Secretary shall up6 date the database under paragraph (1) with such in7 formation. 

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

9 ‘‘(1) IN GENERAL.—Based on the data and in10 formation submitted under subsection (a)(1), avail11 able from an authoritative source (as such term is 

12 defined in paragraph (3), including data described 

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

14 as the Secretary may have available, the Secretary 

15 shall review and evaluate the safety of cosmetics and 

16 ingredients of cosmetics that are marketed in inter17 state commerce. 

18 ‘‘(2) CONSIDERATION OF NANOMATERIALS.— 

19 The Secretary shall— 

20 ‘‘(A) monitor developments in the scientific 

21 understanding from any adverse health effects 

22 related to the use of nanotechnology in the for23 mulation of cosmetics (including progress in the 

24 standardization of testing methods and specific 

25 size definitions for nanomaterials); and 


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1 ‘‘(B) consider scale specific hazard prop2 erties of ingredients when reviewing and evalu3 ating the safety of cosmetics and ingredients 

4 under paragraph (1). 

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

6 purposes of this paragraph, the term ‘authoritative 

7 source’ means— 

8 ‘‘(A) the Environmental Protection Agen9 cy; 

10 ‘‘(B) the International Agency for Re11 search on Cancer; 

12 ‘‘(C) the National Toxicity Program 

13 through the National Institutes of Health; 

14 ‘‘(D) the California Environmental Protec15 tion Agency; and 

16 ‘‘(E) any other authoritative international, 

17 Federal, and State entity, as determined by the 

18 Secretary. 

19 ‘‘SEC. 616. LISTS OF INGREDIENTS AND REQUIRED RE20 SPONSES. 

21 ‘‘(a) PLACEMENT ON LIST.— 

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

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

24 the Secretary shall place the ingredient on one of the 

25 following lists: 


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1 ‘‘(A) The prohibited and restricted list 

2 under subsection (b). 

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

4 subsection (c). 

5 ‘‘(C) The priority assessment list under 

6 subsection (d). 

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

8 placement of an ingredient on a list under sub9 section (a), the Secretary shall consider whether the 

10 ingredient— 

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

12 harmful contaminants; 

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

14 through biomonitoring; 

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

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

17 or immunological toxicant, respiratory 

18 asthmagen, carcinogen, teratogen, or endocrine 

19 disruptor, or have other toxicity concerns (in20 cluding reproductive or developmental toxicity); 

21 or 

22 ‘‘(E) is known to persist in the environ23 ment or bioaccumulate. 

24 ‘‘(3) PRIORITIZATION OF INGREDIENTS THAT

25 ARE FOOD.—In placing ingredients on the lists 


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1 under paragraph (1), the Secretary shall prioritize 

2 the placement of ingredients that are food (as such 

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

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

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

6 after the date of the enactment of this subchapter, 

7 the Secretary shall issue, by regulation, a list of in8 gredients that are identified by the Secretary— 

9 ‘‘(A) as prohibited for use because the Sec10 retary determines that such ingredients are un11 safe for use in cosmetics in any amount because 

12 such ingredients fail to meet the safety stand13 ard under section 614(a); or 

14 ‘‘(B) as being subject to necessary restric15 tions in use or concentration to allow the use of 

16 the ingredient in a cosmetic to satisfy the safety 

17 standard. 

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

19 case of any ingredient listed under paragraph 

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

21 use or concentration that are necessary to satisfy the 

22 safety standard for such ingredient. 

23 ‘‘(3) UPDATES.—The Secretary shall, at a min24 imum, annually update the list under paragraph (1), 

25 including any— 


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1 ‘‘(A) determinations under subsection 

2 (d)(3); or 

3 ‘‘(B) new information that demonstrates 

4 that an ingredient fails to meet the safety 

5 standard, or requires restrictions on use to 

6 meet such standard. 

7 ‘‘(4) MANUFACTURER REQUIREMENTS.—Not 

8 later than 1 year after the date that an ingredient 

9 is placed on a list under subsection (b), any manu10 facturer using such ingredient in a cosmetic shall re11 formulate such cosmetic to— 

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

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

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

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

16 restrictions specified under paragraph (2). 

17 ‘‘(c) SAFE WITHOUT LIMITS LIST.— 

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

19 after the date of the enactment of this subchapter, 

20 the Secretary shall issue, by regulation, a list of in21 gredients that the Secretary has determined are safe 

22 for use in cosmetics, without limits or restrictions. 

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

24 Secretary may only include an ingredient on the list 

25 under paragraph (1) if the Secretary determines 


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1 that the ingredient meets the safety standard under 

2 section 614(a), regardless of— 

3 ‘‘(A) the type and form of cosmetic the in4 gredient is used in; and 

5 ‘‘(B) the concentration of the ingredient 

6 that is used in a cosmetic. 

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

8 Secretary shall annually update the list under para9 graph (1) and may redetermine whether an ingre10 dient distributed in commerce meets the safety 

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

12 information raises a credible question as to whether 

13 the ingredient continues to meet the safety standard. 

14 ‘‘(d) PRIORITY ASSESSMENT LIST AND RELATED

15 SAFETY DETERMINATIONS.— 

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

17 after the date of the enactment of this subchapter, 

18 the Secretary shall develop and publish a priority as19 sessment list of not less than 300 ingredients— 

20 ‘‘(A) which, because of a lack of authori21 tative information on the safety of the ingre22 dient, cannot be included on— 

23 ‘‘(i) the list under subsection (b) (re24 lating to prohibited and restricted ingredi25 ents); or 


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1 ‘‘(ii) the list under subsection (c) (re2 lating to ingredients that are safe without 

3 limits); and 

4 ‘‘(B) for which the Secretary has deter5 mined it is a priority to conduct a safety deter6 mination under paragraph (3). 

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

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

9 Secretary shall annually add at least 100 additional 

10 ingredients to such list until all ingredients that are 

11 used in the formulation or manufacture of cosmetics 

12 have been added— 

13 ‘‘(A) to such list; 

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

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

16 ‘‘(3) DETERMINATION OF WHETHER INGRE17 DIENT MEETS SAFETY STANDARD.— 

18 ‘‘(A) REVIEW OF PRIORITY INGREDI19 ENTS.—During the 2-year period following the 

20 date on which an ingredient is placed on the list 

21 under paragraph (1), the Secretary shall— 

22 ‘‘(i) collect data and information on 

23 such ingredient; and 

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

25 such ingredient. 


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1 ‘‘(B) DETERMINATION OF LIST PLACE2 MENT.—Not later than the end of the period 

3 under subparagraph (A), the Secretary shall 

4 issue a determination, based on the review and 

5 evaluation under such clause, that— 

6 ‘‘(i) the ingredient meets the require7 ments for inclusion on a list under sub8 section (b) (relating to prohibited and re9 stricted ingredients) or subsection (c) (re10 lating to ingredients that are safe without 

11 limits); or 

12 ‘‘(ii) insufficient information exists to 

13 place the ingredient on either such list. 

14 ‘‘(C) GUIDANCE IN THE CASE OF INSUFFI15 CIENT INFORMATION.—If the Secretary deter16 mines under subparagraph (B) that, with re17 spect to an ingredient, insufficient information 

18 exists to place such ingredient on either of the 

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

20 Secretary shall provide guidance on the data 

21 and information (including minimum data re22 quirements and safety testing protocols) that 

23 the Secretary requires to evaluate whether the 

24 ingredient meets the safety standard under secVerDate Mar 15 2010 01:12 Apr 02, 2013 Jkt 029200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\H1385.IH H1385

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1 tion 614(a) for purposes of placing such ingre2 dient on such a list. 

3 ‘‘(D) COMMENT PERIOD.—Upon issuing 

4 the determination under subparagraph (B), 

5 and, if applicable, the guidance under subpara6 graph (C), the Secretary shall provide a period 

7 of not less than 60 days for public comment on 

8 the determination before applying such deter9 mination to an ingredient, except that a shorter 

10 period for comment may be provided if the Sec11 retary— 

12 ‘‘(i) finds that it would be in the pub13 lic interest to have a shorter period; and 

14 ‘‘(ii) publicly declares the reasons for 

15 such finding. 

16 ‘‘(4) RESPONSE TO INADEQUATE INFORMA17 TION.—Not later than 18 months after the date that 

18 the Secretary issues guidance under paragraph 

19 (3)(C) with respect to an ingredient subject to a de20 termination under paragraph (3)(B), a brand owner 

21 using such ingredient in a cosmetic shall— 

22 ‘‘(A) reformulate such cosmetic to elimi23 nate the use of the ingredient; or 

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

25 and information specified in such guidance. 


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1 ‘‘(5) EVALUATION OF ADDITIONAL DATA AND

2 INFORMATION.—With respect to an ingredient, not 

3 later than 6 months after the Secretary receives the 

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

5 Secretary shall review such data and information 

6 and shall make a redetermination under paragraph 

7 (3)(B) for such ingredient, subject to the comment 

8 period under paragraph (3)(D). 

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

10 placed an ingredient on either of the lists under sub11 section (b) and subsection (c) by the end of the 5- 

12 year period beginning on the date that such ingre13 dient is first placed on the list under subsection (d), 

14 beginning on the first day after such period such in15 gredient may not be— 

16 ‘‘(A) used in a cosmetic; and 

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

18 or marketed for use in cosmetics. 

19 ‘‘SEC. 617. TREATMENT OF COSMETICS BASED ON INGRE20 DIENT LISTS. 

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

22 and (d)(4) of section 616, a brand owner may only dis23 tribute in interstate commerce a cosmetic that meets the 

24 safety standard under section 614(a). 


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

2 COSMETICS.— 

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

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

5 presume that the following cosmetics meet the safety 

6 standard under section 614(a): 

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

9 (relating to ingredients that are safe without 

10 limits). 

11 ‘‘(B) A cosmetic that is made solely of in12 gredients on the list under section 616(b)(1)(B) 

13 (relating to ingredients subject to restrictions) 

14 and the use of each of such ingredients in such 

15 cosmetic is in compliance with the restrictions 

16 on the use of such ingredients specified under 

17 section 616(b)(2). 

18 ‘‘(C) A cosmetic that is made solely of in19 gredients described under subparagraph (A) 

20 and subparagraph (B). 

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

22 that a brand owner demonstrate that a cosmetic 

23 meets the safety standard under section 614(a) (in24 cluding by requiring that the brand owner conduct 

25 safety testing, or request such safety testing from 


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1 relevant suppliers and manufacturers, of a cosmetic 

2 described under paragraph (1)) if the cosmetic— 

3 ‘‘(A) contains penetration enhancers, sensi4 tizers, estrogenic chemicals, or other similar in5 gredients; 

6 ‘‘(B) contains ingredients that react with 

7 each other or with other substances to form 

8 harmful byproducts; or 

9 ‘‘(C) the Secretary has any additional rea10 son to believe that such cosmetic does not meet 

11 the safety standard under section 614(a). 

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

13 Secretary requires that a brand owner demonstrate 

14 that a cosmetic meets the safety standard under sec15 tion 614(a), the Secretary shall provide the brand 

16 owner with guidance on the data and information 

17 that the Secretary requires to evaluate whether the 

18 cosmetic meets the safety standard under such sec19 tion. 

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

21 ACT.—If the Secretary fails to act by an applicable dead22 line under section 616 or this section, brand owners and 

23 manufacturers of an ingredient or a cosmetic affected by 

24 such failure of the Secretary to act shall issue to the Sec25 retary, the public, and each known customer of the ingreVerDate Mar 15 2010 01:12 Apr 02, 2013 Jkt 029200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6201 E:\BILLS\H1385.IH H1385

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1 dient or cosmetic, a written notice that a determination 

2 by the Secretary of the safety of the ingredient for use 

3 in cosmetics is pending. 

4 ‘‘SEC. 618. TREATMENT OF CONTAMINANTS. 

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

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

7 annually thereafter, the Secretary shall publish a list of 

8 contaminants of concern linked to severe acute reactions 

9 or long-term adverse health effects, including— 

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

11 contain contaminants of concern; 

12 ‘‘(2) combinations of ingredients that may cre13 ate contaminants of concern when such ingredients 

14 interact; 

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

16 from product packaging into a cosmetic; and 

17 ‘‘(4) any other contaminant of concern identi18 fied by the Secretary that are present in cosmetics. 

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

20 use the process described in sections 615 and 616 to evalu21 ate contaminants of concern for possible elimination or re22 striction in cosmetics. The Secretary shall require that a 

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

24 on the label of a cosmetic, in the same manner as an ingre25 dient under section 613. 


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1 ‘‘(c) REQUIREMENTS FOR TESTING.— 

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

3 the date of enactment of this subchapter, the Sec4 retary shall establish, by rule, requirements for test5 ing ingredients and cosmetics for contaminants list6 ed under subsection (a). 

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

8 paragraph (1) shall include— 

9 ‘‘(A) testing methods and applicable proto10 cols; and 

11 ‘‘(B) maximum allowable detection limits 

12 for each contaminant in an ingredient or cos13 metic. 

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

15 update the requirements under paragraph (1). 

16 ‘‘(d) SUPPLIER REQUIREMENTS.—Not later than 1 

17 year after the promulgation of the rule under subsection 

18 (b)(1), a supplier of an ingredient that is used in a cos19 metic shall, with respect to such ingredient— 

20 ‘‘(1) comply with the requirements under sub21 section (b)(1) for any ingredient listed under sub22 section (a); 

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

24 that— 


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

2 a cosmetic; 

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

4 contaminant of concern; and 

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

6 ‘‘(3) upon the sale of an ingredient to the man7 ufacturer, provide to the manufacturer specifications 

8 for the ingredient that— 

9 ‘‘(A) include the levels of contaminants 

10 present in such ingredient; and 

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

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

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

14 than 1 year after the promulgation of the rule under sub15 section (b)(1), a brand owner of a cosmetic shall, with re16 spect to each ingredient that the brand owner uses in a 

17 cosmetic— 

18 ‘‘(1) obtain, from each supplier or manufac19 turer of the ingredient, specifications for the ingre20 dient that include— 

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

22 in the ingredient; and 

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

24 test used to detect the contaminant; or 


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1 ‘‘(2) comply with the requirements under para2 graphs (1) and (2) of subsection (c) for the ingre3 dient, in the same manner as if the brand owner 

4 were a supplier. 

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

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

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

8 a cosmetic intended to be marketed in the United States 

9 shall submit electronically to the Secretary, for each cos10 metic that is intended to be marketed in the United 

11 States, a statement containing— 

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

13 owner; 

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

15 the cosmetic; 

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

17 ‘‘(4) the ingredient list as it appears on the cos18 metic label or insert, including the particle size 

19 range of any nanoscale cosmetic ingredients; 

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

21 the cosmetic label or insert; and 

22 ‘‘(6) the title and full contact information for 

23 the individual responsible for submitting and main24 taining such statement. 


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1 ‘‘(b) NEW COSMETICS.—Any brand owner that be2 gins to market a cosmetic after the date of the enactment 

3 of this subchapter shall comply with the requirements of 

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

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

6 on the date of the enactment of this subchapter. 

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

8 which the establishment begins to manufacture such 

9 cosmetic. 

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

11 shall notify the Secretary annually of any change to the 

12 information required under subsection (a). 

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

14 statement described under subsection (a), the Secretary 

15 shall notify the brand owner of the receipt of such state16 ment and assign a cosmetic statement number. 

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

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

19 statements are submitted under this section. 

20 ‘‘(f) ACCESS TO SAFETY INFORMATION.—The cos21 metic and ingredient statements collected under this sec22 tion shall be added to the publicly accessible database cre23 ated by the Secretary under section 615(b). 


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

2 OF ADULTERATED OR MISBRANDED COS3 METICS. 

4 ‘‘(a) NOTIFICATION OF ADULTERATED OR MIS5 BRANDED COSMETICS.— 

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

7 has reason to believe that a cosmetic, when intro8 duced into or while in interstate commerce, or while 

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

10 first sale of such cosmetic) after shipment in inter11 state commerce, is adulterated or misbranded in a 

12 manner that presents a reasonable probability that 

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

14 or component used in any such cosmetic) will cause 

15 a threat of serious adverse event shall notify the 

16 Secretary of the identity and location of the cos17 metic. 

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

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

20 and by such means as the Secretary may require by 

21 regulation or guidance. 

22 ‘‘(3) RESPONSIBLE PARTY DEFINED.—For pur23 poses of this subsection, the term ‘responsible party’ 

24 means a brand owner, manufacturer, packager, re25 tailer, or distributor of the cosmetic. 


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1 ‘‘(b) VOLUNTARY RECALL.—The Secretary may re2 quest that any person who distributes a cosmetic that the 

3 Secretary has reason to believe is adulterated, misbranded, 

4 or otherwise in violation of this Act voluntarily— 

5 ‘‘(1) recall such cosmetic; and 

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

7 as appropriate, to persons who may be affected by 

8 the recall. 

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

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

11 to believe that— 

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

13 may cause serious adverse event; 

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

15 ‘‘(C) the cosmetic is marketed, manufac16 tured, packaged, or distributed by an unregis17 tered brand owner; 

18 the Secretary shall have the authority to issue an 

19 order requiring any person who distributes such cos20 metic to immediately cease distribution of such cos21 metic. 

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

23 person who is subject to an order under paragraph 

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1 metic and provide notification as required by such 

2 order. 

3 ‘‘(3) APPEAL.— 

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

5 order under paragraph (1) may appeal such 

6 order to the Secretary within 24 hours of the 

7 issuance of such order. 

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

9 may include a request for an informal hearing 

10 and a description of any efforts to recall such 

11 cosmetic undertaken voluntarily by the person, 

12 including after a request under subsection (b). 

13 ‘‘(C) INFORMAL HEARING.—Except as pro14 vided in subsection (e), an informal hearing 

15 shall be held as soon as practicable, but not 

16 later than 5 calendar days (or less as deter17 mined by the Secretary) after such an appeal is 

18 filed, unless the parties jointly agree to an ex19 tension. 

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

21 filed under subparagraph (A), the Secretary 

22 may not amend the order to require a recall 

23 under subsection (d) until after the conclusion 

24 of the hearing under subparagraph (C). 


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

2 determines that inadequate grounds exist to support 

3 the actions required by the order under paragraph 

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

5 ‘‘(d) ORDER TO RECALL.— 

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

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

8 the Secretary determines that a recall of a cosmetic 

9 subject to an order under subsection (c) is appro10 priate, the Secretary shall amend the order to re11 quire a recall. 

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

13 paragraph (1) shall— 

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

15 will occur; 

16 ‘‘(B) require periodic reports to the Sec17 retary describing the progress of the recall; and 

18 ‘‘(C) provide for notice, including to indi19 viduals as appropriate, to persons who may be 

20 affected by the recall. 

21 In providing for such notice, the Secretary may 

22 allow for the assistance of health professionals, State 

23 or local officials, or other individuals designated by 

24 the Secretary. 


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

2 under this subsection may only be issued by the Sec3 retary or an official designated by the Secretary, and 

4 may not be delegated to another official or employee. 

5 ‘‘(4) DETERMINATION.—If the Secretary deter6 mines that inadequate grounds exist to support the 

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

8 the Secretary shall remove such amendment from 

9 such order. 

10 ‘‘(e) EMERGENCY RECALL ORDER.— 

11 ‘‘(1) IN GENERAL.—If the Secretary has cred12 ible evidence or information that a cosmetic subject 

13 to an order under subsection (c) presents an immi14 nent threat of serious adverse event, the Secretary 

15 may issue an order requiring any person who dis16 tributes such cosmetic— 

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

18 and 

19 ‘‘(B) to provide for notice, including to in20 dividuals as appropriate, to persons who may be 

21 affected by the recall. 

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

23 subject to an emergency recall order under this sub24 section shall immediately recall such cosmetic and 

25 provide notification as required by such order. 


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1 ‘‘(3) APPEAL.— 

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

3 such an order may appeal such order to the 

4 Secretary within 24 hours of the issuance of 

5 such order. 

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

7 may include a request for an informal hearing 

8 and a description of any efforts to recall such 

9 cosmetic undertaken voluntarily by the person, 

10 including after a request under subsection (b). 

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

12 hearing shall be held as soon as practicable 

13 after the appeal is filed under subparagraph 

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

15 such an appeal is filed, or fewer days (as deter16 mined by the Secretary), unless the parties 

17 jointly agree to an extension. 

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

19 determines that inadequate grounds exist to support 

20 the actions required by the order under paragraph 

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

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

23 subsection may only be issued by the Secretary or an 

24 official designated by the Secretary, and may not be 

25 delegated to another official or employee. 


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1 ‘‘(f) NOTICE TO CONSUMERS AND HEALTH OFFI2 CIALS.—The Secretary shall, as the Secretary determines 

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

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

5 have been, distributed and to appropriate State and local 

6 health officials. 

7 ‘‘(g) SUPPLY CHAIN INFORMATION.— 

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

9 that the Secretary has reason to believe is adulter10 ated, misbranded, or otherwise in violation of this 

11 Act, the Secretary shall request that the brand 

12 owner named on the label of such cosmetic (as re13 quired under section 602(b)(1)) submit all of the fol14 lowing information: 

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

16 the manufacturer, packager, supplier, or dis17 tributor from which such entity received the 

18 cosmetic or ingredients for manufacturing such 

19 cosmetic. 

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

21 any entity (including any retailer) that was pro22 vided with such cosmetic by the entity named 

23 on the label. 

24 ‘‘(2) COLLECTION OF ADDITIONAL SUPPLY

25 CHAIN INFORMATION.—In the case of a cosmetic 


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1 that the Secretary has reason to believe is adulter2 ated, misbranded, or otherwise in violation of this 

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

4 the public, the Secretary may request that any entity 

5 (including a supplier of an ingredient, manufacturer, 

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

7 of such cosmetic submit to the Secretary information 

8 that is similar to the information described under 

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

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

11 in supply chain of a cosmetic (including the brand 

12 owner named on the label of a cosmetic) shall— 

13 ‘‘(A) maintain records sufficient to provide 

14 the information described in subparagraphs (A) 

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

16 ‘‘(B) provide such information to the Sec17 retary upon the request of the Secretary. 

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

19 section shall be construed as limiting the authority of the 

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

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

22 ‘‘SEC. 621. PETITIONS. 

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

24 and publish a review, and, if appropriate, immediately re25 vise related, relevant information, including ingredient 


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1 lists, ingredient restrictions or prohibitions, or ingredient 

2 or cosmetic safety determinations, not later than 6 months 

3 after the date on which the Secretary receives from any 

4 individual or entity a reasonable petition— 

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

6 in cosmetics and list such ingredient on the list 

7 under section 616(b); 

8 ‘‘(2) to remove an ingredient from the list of in9 gredients that are safe without limits under section 

10 616(c); 

11 ‘‘(3) to add an ingredient to the priority assess12 ment list under section 616(d); or 

13 ‘‘(4) to add an ingredient to the list of contami14 nants under section 618. 

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

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

17 shall issue rules specifying the criteria which the Secretary 

18 will use to determine if a petition submitted under this 

19 section is a reasonable petition. 

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

21 EVENTS. 

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

23 EVENTS.—The Secretary shall require that the brand 

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

25 a cosmetic marketed in the United States submit to the 


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1 Secretary a report containing information received con2 cerning any serious adverse event associated with the use 

3 of the cosmetic. 

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

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

6 business days after information concerning the serious ad7 verse event is received at the place of business of the brand 

8 owner. 

9 ‘‘(c) CONTENT OF REPORT.—A report under sub10 section (a) shall include the following information, to the 

11 extent to which the brand owner submitting the report has 

12 been able to verify the information: 

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

14 the adverse health event. 

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

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

17 causing such effect. 

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

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

20 ‘‘(1) PUBLIC AVAILABILITY.—Subject to para21 graph (2), the serious adverse event reports collected 

22 by the Secretary under this section shall be sub23 mitted electronically and shall be made accessible to 

24 the public. 

25 ‘‘(2) PRIVACY.— 


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1 ‘‘(A) PERSONALLY IDENTIFIABLE INFOR2 MATION.—Notwithstanding any other provision 

3 of law, personally identifiable information in se4 rious adverse event reports provided to the Sec5 retary under this section, shall not— 

6 ‘‘(i) be made publicly available pursu7 ant to any State or other law requiring dis8 closure of information or records; or 

9 ‘‘(ii) otherwise be disclosed or distrib10 uted to any party without the written con11 sent of the Secretary and the person sub12 mitting such information to the Secretary. 

13 ‘‘(B) TREATMENT OF INFORMATION

14 UNDER PRIVACY ACT AND FOIA.—A report sub15 mitted to the Secretary under this section, shall 

16 be considered to be a record about an individual 

17 under section 552a of title 5, United States 

18 Code (commonly referred to as the ‘‘Privacy 

19 Act of 1974’’) and a medical or similar file the 

20 disclosure of which would constitute a violation 

21 of section 552 of such title 5 (commonly re22 ferred to as the ‘‘Freedom of Information 

23 Act’’), and shall not be publicly disclosed unless 

24 all personally identifiable information is re25 dacted. 


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1 ‘‘SEC. 623. NONCONFIDENTIAL INFORMATION. 

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

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

4 information submitted pursuant to this subchapter shall 

5 be made available to the public, including the following 

6 types of information: 

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

8 chemical substance, contaminant, or impurity that is 

9 an ingredient. 

10 ‘‘(2) All information concerning function, expo11 sure, toxicity data, health hazards, and environ12 mental hazards for a cosmetic. 

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

14 ‘‘(4) Fragrance, flavor, and colorants in a cos15 metic. 

16 ‘‘(b) CONFIDENTIAL INFORMATION.—The concentra17 tion of cosmetic ingredients used in a finished cosmetic 

18 shall be considered confidential business information and 

19 may not be made available to the public under subsection 

20 (a). 

21 ‘‘(c) PETITION FOR INFORMATION TO REMAIN CON22 FIDENTIAL.— 

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

24 a process for an entity to petition for nonconfidential 

25 information described in subsection (a) to remain 

26 confidential if the entity shows that there would be 


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•HR 1385 IH

1 a serious negative impact to the entity’s commercial 

2 interests if such information were disclosed to the 

3 public. 

4 ‘‘(2) LIMITATION.—The Secretary may not ap5 prove a petition under paragraph (1) to the extent 

6 that such petition would prevent the public disclo7 sure of— 

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

9 any chemical substance, contaminant, or impu10 rity that is an ingredient; 

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

12 that substance, contaminant, or impurity; or 

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

14 safety of that substance, contaminant, or impu15 rity. 

16 ‘‘SEC. 624. ANIMAL TESTING ALTERNATIVES. 

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

18 testing of ingredients and cosmetics, the Secretary shall— 

19 ‘‘(1) require, where practicable, alternative test20 ing methods that— 

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

22 to test the chemical substance; 

23 ‘‘(B) provide information that is equivalent 

24 or superior in scientific quality to the animal 

25 testing method; and 


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•HR 1385 IH

1 ‘‘(C) use fewer animals than conventional 

2 animal-based tests when nonanimal methods 

3 are impracticable, including the use of tests 

4 that combine multiple endpoints; and 

5 ‘‘(2) encourage, where practicable— 

6 ‘‘(A) estimation of toxicological properties 

7 of a chemical through the use of testing infor8 mation for one or more structurally similar 

9 chemicals where such estimates provide infor10 mation of sufficient scientific quality; 

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

12 conduct testing to avoid duplication of tests; 

13 and 

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

15 alternative test methods, in accordance with 

16 this subsection. 

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

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

19 this subchapter, and triennially thereafter, the Secretary 

20 shall publish a list of the alternative testing methods de21 scribed in subsection (a). 

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

23 ‘‘The Secretary shall conduct annual audits of ran24 dom samples of cosmetics to assess or test for acute nega25 tive reactions, pathogen hazards, contaminants, leaching 


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•HR 1385 IH

1 of packaging additives, mislabeling, or other relevant 

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

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

4 ‘‘The Secretary shall provide technical support to as5 sist small businesses in carrying out the requirements of 

6 this subchapter. 

7 ‘‘SEC. 627. INTERAGENCY COOPERATION. 

8 ‘‘(a) INTERAGENCY COUNCIL ON COSMETIC SAFE9 TY.—There is established an Interagency Council on Cos10 metic Safety for the purpose of sharing data and pro11 moting collaboration on cosmetic safety between the Food 

12 and Drug Administration, the National Institute of Envi13 ronmental Health Sciences, the Centers for Disease Con14 trol and Prevention, the Occupational Safety and Health 

15 Administration, and the Environmental Protection Agen16 cy. 

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

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

19 shall request and utilize ingredient and cosmetic toxicity, 

20 use, and exposure data from other Federal agencies. 

21 ‘‘SEC. 628. SAVINGS CLAUSE. 

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

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

24 regulation, requirement, or standard of performance that 

25 is different from, or in addition to, a regulation, requireVerDate Mar 15 2010 01:12 Apr 02, 2013 Jkt 029200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6201 E:\BILLS\H1385.IH H1385

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•HR 1385 IH

1 ment, liability, or standard for performance established 

2 pursuant to this Act unless compliance with both this Act 

3 and the State or political subdivision of a State regulation, 

4 requirement, or standard of performance is impossible, in 

5 which case the applicable provisions of this Act shall con6 trol. 

7 ‘‘SEC. 629. AUTHORIZATION OF APPROPRIATIONS. 

8 ‘‘There are authorized to be appropriated such sums 

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

10 of the fiscal years 2014 through 2018.’’. 

11 (b) ADULTERATED AND MISBRANDED COSMETICS.— 

12 (1) ADULTERATED COSMETICS.—Section 601 of 

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

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

15 (A) by striking ‘‘, except that this provi16 sion shall not apply to coal-tar hair dye’’ and all 

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

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

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

20 to comply with section 617(a). 

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

22 and— 

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

24 under section 616(b)(1)(A), and the manufac25 turer has not complied with section 616(b)(4) 


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•HR 1385 IH

1 with respect to such ingredient and such cos2 metic; or 

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

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

5 being used in a manner that violates the limit 

6 on use or concentration of such ingredient 

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

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

9 respect to such ingredient and such cosmetic. 

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

11 with respect to such cosmetic, is required to dem12 onstrate, under section 617(b)(2), that the cosmetic 

13 meets the safety standard and the brand owner has 

14 not yet submitted the required data under section 

15 617(b)(3).’’. 

16 (2) MISBRANDED COSMETICS.—Section 602 of 

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

18 U.S.C. 362) is amended— 

19 (A) in paragraph (a), by inserting ‘‘or fails 

20 to meet the requirements of section 613 or 

21 618(b)’’ before the period; and 

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

23 ‘‘(g) If it— 


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•HR 1385 IH

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

2 owner that failed to register and pay the appli3 cable fee as required under section 612; 

4 ‘‘(2) is brought to market, manufactured, 

5 packaged, distributed, or sold in retail by a 

6 brand owner, manufacturer, packager, dis7 tributor, or retailer, respectively, who fails to 

8 notify the Secretary as required under section 

9 620(a)(1); 

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

11 under section 620(c); 

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

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

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

15 fails to comply with good manufacturing prac16 tices prescribed by the Secretary under section 

17 614(b); or 

18 ‘‘(6) is brought to market by a brand 

19 owner who fails— 

20 ‘‘(A) to submit the statement required 

21 under section 619; or 

22 ‘‘(B) notify the Secretary of changes 

23 to information contained in such report, as 

24 required by such section.’’. 


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•HR 1385 IH

1 (3) ADDITIONAL PROHIBITIONS.—Section 301 

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

3 U.S.C. 331) is amended— 

4 (A) in paragraph (e), by inserting ‘‘612,’’ 

5 after ‘‘564,’’ each place it appears; and 

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

7 ‘‘(ccc) The failure of a brand owner, manufac8 turer, or supplier of a cosmetic or an ingredient for 

9 use in a cosmetic to submit and update data and in10 formation as required under section 615(a). 

11 ‘‘(ddd) The manufacture, importation, distribu12 tion, or marketing of an ingredient for use in a cos13 metic that is on the list under section 616(b)(1)(A). 

14 ‘‘(eee) The failure of a supplier of an ingredient 

15 for use in a cosmetic— 

16 ‘‘(1) to provide data and information as re17 quired by section 615(a)(4)(B); or 

18 ‘‘(2) comply with the testing requirements 

19 under section 618(c). 

20 ‘‘(fff) The failure of a manufacturer to comply 

21 with the requirements of section 618(d). 

22 ‘‘(ggg) The failure of a brand owner of a cos23 metic to comply with the requirement of reporting 

24 serious adverse events under section 622.’’. 


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•HR 1385 IH

1 SEC. 3. WORKER ISSUES. 

2 (a) IN GENERAL.—The Secretary of Labor shall pro3 mulgate an occupational safety and health standard under 

4 section 6 of the Occupational Safety and Health Act of 

5 1970 (29 U.S.C. 655) that requires the following: 

6 (1) MANUFACTURERS AND IMPORTERS.—Each 

7 manufacturer or importer selling any cosmetic for 

8 professional use shall— 

9 (A) obtain or develop a material safety 

10 data sheet described in subsection (b) for each 

11 such cosmetic or personal care product that— 

12 (i) the manufacturer or importer pro13 duces or imports; and 

14 (ii) includes a hazardous chemical, or 

15 a product ingredient associated with any 

16 chemical hazard, that is classified as a 

17 health hazard in accordance with the cri18 teria found in section 1910.1200(d) of title 

19 29 of the Code of Federal Regulations, and 

20 any successor regulations; and 

21 (B) make the material safety data sheet 

22 available to distributors and employers, includ23 ing salon owners, in English and, upon request, 

24 in other languages, including Spanish and Viet25 namese. 


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1 (2) DISTRIBUTORS.—Each distributor of a cos2 metic or personal care product for professional use 

3 shall distribute and provide material safety data 

4 sheets described in subsection (b) in the same man5 ner as a distributor of a chemical hazard is required 

6 to distribute and provide material safety data sheets 

7 under section 1910.1200(g) of title 29, Code of Fed8 eral Regulations, or any successor regulations. 

9 (3) EMPLOYERS.—Each employer, including 

10 any operator of a salon, shall— 

11 (A) have a material safety data sheet in 

12 the workplace for each cosmetic or personal 

13 care product for professional use that is used in 

14 the course of the employer’s business; 

15 (B) make such material safety data sheet 

16 available to all employees of the employer who 

17 are exposed or use the product to the same ex18 tent and in the same manner as material safety 

19 data sheets are required to be made available 

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

21 Federal Regulations, or any successor regula22 tions; and 

23 (C) upon request, provide employees with 

24 translations of such material safety data sheet 


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1 in other languages, including Spanish and Viet2 namese. 

3 (b) CONTENTS OF MATERIAL SAFETY DATA

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

5 personal care product for professional use described in this 

6 section shall— 

7 (1) contain the information required in a mate8 rial safety data sheet under section 1910.1200(g) of 

9 title 29, Code of Federal Regulations, or any suc10 cessor regulations, for each hazardous chemical, or 

11 product ingredient associated with any chemical haz12 ard, described in subsection (a)(1)(A)(ii); and 

13 (2) include the following statement: ‘‘This ma14 terial safety data sheet is also available in multiple 

15 languages by contacting the manufacturer, using the 

16 contact information provided on this sheet.’’. 

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

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

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

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

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

22 establishments listed under such definition. 

Æ 


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