I 

111TH CONGRESS 

2D SESSION H. R. 5786 

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 

JULY 20, 2010 

Ms. SCHAKOWSKY (for herself, Mr. MARKEY of Massachusetts, and Ms. BALDWIN) introduced the following bill; which was referred to the Committee 

on Energy and Commerce, and in addition to the Committee on Education and Labor, for a period to be subsequently determined by the 

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

the jurisdiction of the committee concerned 

A BILL 

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

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

purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Safe Cosmetics Act 

5 of 2010’’. 


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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: 

11 ‘‘Subchapter B—Regulation of Cosmetics 

12 ‘‘SEC. 611. DEFINITIONS. 

13 ‘‘In this subchapter: 

14 ‘‘(1) INGREDIENT.—The term ‘ingredient’ 

15 means a chemical in a cosmetic, including— 

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

17 functional effect; 

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

19 functional effect in the cosmetic but are present 

20 by reason of having been incorporated into the 

21 cosmetic as an ingredient of another cosmetic 

22 ingredient; 

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

24 reason of having been added to a cosmetic dur25 ing the processing of such cosmetic; 


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

2 of having been added to a cosmetic during proc3 essing for their technical or functional effect; 

4 ‘‘(E) contaminants present at levels above 

5 technically feasible detection limits; 

6 ‘‘(F) contaminants that may leach from 

7 container materials or form via reactions over 

8 the shelf life of a cosmetic and that may be 

9 present at levels above technically feasible de10 tection limits; 

11 ‘‘(G) the components of a fragrance, fla12 vor, or preservative declared individually by 

13 their appropriate label names; and 

14 ‘‘(H) any individual component of a botan15 ical, petroleum-derived, animal-derived, or other 

16 ingredient that the Secretary determines be 

17 considered an ingredient. 

18 ‘‘(2) PROFESSIONAL USE.—The term ‘profes19 sional use’ means the use of any cosmetic— 

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

21 the employment of such employee) of; or 

22 ‘‘(B) purchased by a consumer in, 

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

24 establishment that provides cosmetic treatment serv25 ices for humans. 


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1 ‘‘(3) REASONABLE CERTAINTY.—The term ‘rea2 sonable certainty’, when used in establishing a safety 

3 standard (as defined in paragraph (5)) for an ingre4 dient or cosmetic— 

5 ‘‘(A) means that no harm will be caused by 

6 aggregate exposure for a member of a vulner7 able population to that ingredient or cosmetic; 

8 and 

9 ‘‘(B) corresponds to the lower dose derived 

10 from— 

11 ‘‘(i) data demonstrating that exposure 

12 to all sources of the ingredient or cosmetic 

13 present not more than a 1 in a million risk 

14 for any adverse effect in the population of 

15 concern, at the lower 95th percentile con16 fidence bound; or 

17 ‘‘(ii) the amount of an ingredient or 

18 cosmetic shown to produce no adverse ef19 fects, incorporating an uncertainty factor 

20 of at least 1,000 and considering all 

21 sources of exposure. 

22 ‘‘(4) REPRODUCTIVE AND DEVELOPMENTAL

23 TOXICITY.—With respect to an ingredient or cos24 metic, the term ‘reproductive and developmental tox25 icity’ means that the ingredient or cosmetic causes 


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1 biologically adverse effects on the reproductive sys2 tems of female or male humans or animals, includ3 ing alterations to the female or male reproductive 

4 system development, the related endocrine system, 

5 fertility, pregnancy, pregnancy outcomes, or modi6 fications in other functions that are dependent on 

7 the integrity of the reproductive system. 

8 ‘‘(5) SAFETY STANDARD.— 

9 ‘‘(A) IN GENERAL.—The term ‘safety 

10 standard’ means— 

11 ‘‘(i) with respect to an ingredient, 

12 when the route of exposure is directly rel13 evant to a particular cosmetic use, a stand14 ard that— 

15 ‘‘(I) provides a reasonable cer16 tainty that no harm will result from 

17 aggregate exposure to the cosmetic or 

18 ingredient, including impacts on vul19 nerable populations, taking into ac20 count possible harmful effects from 

21 low dose exposures to the cosmetic or 

22 ingredient or from additive effects, 

23 where such evidence exists; and 

24 ‘‘(II) is requisite to protect the 

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1 ticipated adverse effects associated 

2 with the cosmetic or ingredient; and 

3 ‘‘(ii) with respect to a cosmetic, when 

4 the route of exposure is directly relevant to 

5 the use of the cosmetic, a standard that a 

6 cosmetic fails to meet if— 

7 ‘‘(I) the cosmetic would fail to 

8 meet the standard under clause (i) if 

9 the cosmetic was treated in the same 

10 manner as an ingredient under such 

11 clause; or 

12 ‘‘(II) one or more ingredients in 

13 the cosmetic fail to meet such stand14 ard. 

15 ‘‘(B) DETERMINATION OF SAFETY.—A 

16 cosmetic or ingredient shall fail to meet the 

17 safety standard under subparagraph (A)— 

18 ‘‘(i) unless the Secretary determines 

19 that there is a reasonable certainty that no 

20 harm will result from aggregate exposure 

21 to the ingredient or cosmetic, including im22 pacts on highly exposed or vulnerable pop23 ulations, taking into account, where evi24 dence exists, possible harmful effects 

25 from— 


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1 ‘‘(I) low dose exposures to the 

2 cosmetic or ingredient; or 

3 ‘‘(II) additive effects; or 

4 ‘‘(ii) if the Secretary determines nec5 essary to protect the public welfare from 

6 any known or anticipated adverse effects 

7 associated with the cosmetic or ingredient. 

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

9 ‘vulnerable populations’ includes pregnant women, 

10 infants, children, the elderly, people with com11 promised immune systems, and highly exposed popu12 lations, including workers employed by establish13 ments listed under paragraph (2) and cosmetic man14 ufacturing plants. 

15 ‘‘SEC. 612. REGISTRATION OF ESTABLISHMENTS AND REG16 ISTRATION FEES. 

17 ‘‘(a) DEFINITIONS.—In this section: 

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

19 ‘domestic establishment’ means an establishment lo20 cated in any State that manufactures, packages, or 

21 distributes cosmetics. 

22 ‘‘(2) FOREIGN ESTABLISHMENT.— 

23 ‘‘(A) IN GENERAL.—The term ‘foreign es24 tablishment’ means an establishment that man25 ufactures, packages, or distributes cosmetics 


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1 that are exported to the United States without 

2 further processing or packaging outside the 

3 United States. 

4 ‘‘(B) NOT CONSIDERED TO HAVE UNDER5 GONE FURTHER PROCESSING OR PACKAGING.— 

6 A cosmetic may not be considered to have un7 dergone further processing or packaging for 

8 purposes of subparagraph (A) solely on the 

9 basis that labeling was added or that any simi10 lar activity of a de minimis nature was carried 

11 out with respect to the cosmetic. 

12 ‘‘(b) REGISTRATION.—The Secretary shall require 

13 that any establishment engaged in manufacturing, pack14 aging, or distributing cosmetics for use in the United 

15 States register annually with the Secretary. To be reg16 istered— 

17 ‘‘(1) as a domestic establishment, the owner, 

18 operator, or agent in charge of the domestic estab19 lishment shall submit a registration to the Secretary; 

20 or 

21 ‘‘(2) as a foreign establishment, the owner, op22 erator, or agent in charge of the foreign establish23 ment— 

24 ‘‘(A) shall submit a registration to the Sec25 retary; and 


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1 ‘‘(B) shall include with the registration the 

2 name of the United States agent for the foreign 

3 establishment. 

4 ‘‘(c) SUBMISSION OF REGISTRATION.— 

5 ‘‘(1) IN GENERAL.—An establishment (referred 

6 to in this section as the ‘registrant’) shall submit a 

7 registration under subsection (b) to the Secretary 

8 containing, with respect to any cosmetics that the 

9 establishment manufactures, packages, or distrib10 utes— 

11 ‘‘(A) any information necessary to notify 

12 the Secretary of the name and address of each 

13 establishment at which, and all trade names 

14 under which, the registrant manufactures, 

15 packages, or distributes cosmetics; 

16 ‘‘(B) a description of the establishment’s 

17 activities with respect to cosmetics; 

18 ‘‘(C) the number of workers employed at 

19 the establishment; 

20 ‘‘(D) the gross receipts of sales; and 

21 ‘‘(E) the name and address of any com22 pany that supplies the establishment, if the es23 tablishment manufactures cosmetics, with any 

24 ingredient (including preservatives, fragrances, 

25 or any other chemical component of a finished 


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1 cosmetic product) and the name of the ingre2 dient supplied to such establishment by such 

3 supplier. 

4 ‘‘(2) NOTIFICATION OF CHANGES.— 

5 ‘‘(A) IN GENERAL.—The registrant shall 

6 notify the Secretary in a timely manner of 

7 changes to the information described in para8 graph (1). 

9 ‘‘(B) DEADLINE FOR CERTAIN

10 CHANGES.—The registrant shall notify the Sec11 retary of any change in the products, function, 

12 or legal status of each establishment at which 

13 the registrant manufactures, packages, or dis14 tributes cosmetics (including cessation of busi15 ness activities) not later than 60 days after the 

16 date of such change. 

17 ‘‘(d) PROCEDURE.—Upon receipt of a completed reg18 istration submitted under subsection (b), the Secretary 

19 shall notify the registrant of the receipt of such registra20 tion and assign a registration number to each registered 

21 establishment. 

22 ‘‘(e) LIST OF REGISTERED ESTABLISHMENTS.— 

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

24 shall compile and maintain an up-to-date list of es25 tablishments that are registered under this section. 


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1 ‘‘(2) REMOVAL AND SUSPENSION.—The Sec2 retary shall remove from the list under paragraph 

3 (1) the name of any establishment that fails to re4 register in accordance with this section and shall 

5 treat such removal as a suspension of the establish6 ment’s registration. 

7 ‘‘(3) APPLICATION OF FOIA.— 

8 ‘‘(A) LIST.—The list under paragraph (1) 

9 shall be subject to disclosure under section 552 

10 of title 5, United States Code. 

11 ‘‘(B) REGISTRATION DOCUMENTS.—Any 

12 registration documents submitted pursuant to 

13 this section shall not be subject to disclosure 

14 under section 552 of title 5, United States 

15 Code. 

16 ‘‘(C) OTHER INFORMATION.—Information 

17 derived from— 

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

19 ‘‘(ii) registration documents submitted 

20 pursuant to this section, 

21 shall not be subject to disclosure under section 

22 552 of title 5, United States Code, except to the 

23 extent that such information discloses the iden24 tity or location of a specific registrant. 


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1 ‘‘(f) FEE SCHEDULE.—A schedule of fees shall be de2 veloped by the Secretary to provide for oversight and en3 forcement of this subchapter. The fee structure shall— 

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

5 gross receipts or sales; and 

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

7 gross receipts or sales of more than $1,000,000. 

8 ‘‘(g) REGISTRATION CANCELLATION.—The Secretary 

9 may cancel the registration of any establishment under 

10 this section— 

11 ‘‘(1) if the information submitted by the estab12 lishment for such registration is incomplete, inac13 curate, or out-of-date; or 

14 ‘‘(2) if a registered establishment fails to up15 date such information promptly when there is a 

16 change in such information. 

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

18 ‘‘(a) IN GENERAL.—The Secretary shall require the 

19 label on each package of cosmetics, including cosmetics 

20 distributed for retail sale and professional use, to bear a 

21 declaration of the name of each ingredient in such cos22 metic in descending order of predominance. The Secretary 

23 may allow that the declaration of an ingredient present 

24 as a contaminant is not required if the contaminant is 

25 present at levels below technically feasible detection limits. 


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1 ‘‘(b) LABELING OF INGREDIENTS IN COSMETICS

2 SOLD THROUGH INTERNET COMMERCE.—Subject to sub3 section (d), the Secretary shall require— 

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

5 site of an Internet vendor, that the manufacturers 

6 and distributors of such cosmetic provide to such 

7 Internet vendor a list of the ingredients of the cos8 metic; and 

9 ‘‘(2) each Internet vendor to display the list of 

10 ingredients of each cosmetic sold by such vendor on 

11 the Web site of the vendor. 

12 ‘‘(c) TRADE SECRETS.—Notwithstanding any other 

13 provision of law, an ingredient required to be listed or la14 beled under this section shall not have protection as a 

15 trade secret. 

16 ‘‘(d) DEADLINE.—Not later than one year after the 

17 date of the enactment of the Safe Cosmetics Act of 

18 2010— 

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

20 sale shall be labeled in a manner that complies with 

21 the requirements under subsection (a); and 

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

23 venders shall comply with the applicable require24 ments of subsection (b). 


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1 ‘‘SEC. 614. COSMETIC AND INGREDIENT TESTING AND SAFE2 TY. 

3 ‘‘(a) PUBLICLY AVAILABLE COSMETIC AND INGRE4 DIENT TEST DATA.— 

5 ‘‘(1) SUBMISSION OF INFORMATION.— 

6 ‘‘(A) INITIAL SUBMISSION.—Not later than 

7 1 year after the date of the enactment of the 

8 Safe Cosmetics Act of 2010, manufacturers and 

9 distributors of cosmetics and ingredients shall 

10 submit to the Secretary (in an electronic format 

11 that the Secretary shall determine) all reason12 ably available information in the possession or 

13 control of the manufacturer or distributor that 

14 has not previously been submitted to the Sec15 retary regarding the physical, chemical, and 

16 toxicological properties of single or multiple 

17 chemicals listed on the cosmetic labels under 

18 section 613, including— 

19 ‘‘(i) functions and uses; 

20 ‘‘(ii) exposure and fate information; 

21 ‘‘(iii) tests of finished cosmetics; and 

22 ‘‘(iv) any other information used to 

23 substantiate the safety of such cosmetics 

24 or ingredients. 

25 ‘‘(B) NEW OR UPDATED INFORMATION.— 

26 Not later than 60 days after the date on which 


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1 new or updated information that is required 

2 under subparagraph (A) becomes available to a 

3 manufacturer or distributer, such manufacturer 

4 or distributor shall submit such information to 

5 the Secretary in the same form and manner as 

6 information submitted under subparagraph (A). 

7 ‘‘(2) AVAILABILITY OF INFORMATION.—The 

8 Secretary shall require that any manufacturer, dis9 tributor, or marketer of a cosmetic or ingredient (in10 cluding a fragrance or preservative) make available 

11 to any entity purchasing the cosmetic or ingredient 

12 (excluding an individual who is a consumer and who 

13 is purchasing the cosmetic or ingredient for personal 

14 use) all available information in the possession or 

15 control of the manufacturer, distributor, or marketer 

16 described in paragraph (1), within 90 days of receipt 

17 of the request from such entity. 

18 ‘‘(3) DATABASE.— 

19 ‘‘(A) INITIAL PUBLICATION.—Not later 

20 than 12 months after the date of the enactment 

21 of the Safe Cosmetics Act of 2010, the Sec22 retary shall publish a comprehensive, publicly 

23 accessible database containing all non-confiden24 tial information submitted under paragraph (1). 


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1 ‘‘(B) UPDATES.—Not later than 90 days 

2 after the Secretary receives new or updated in3 formation under paragraph (1)(B), the Sec4 retary shall update the database described in 

5 subparagraph (A) with such information. 

6 ‘‘(b) LISTS OF INGREDIENTS.— 

7 ‘‘(1) PROHIBITED AND RESTRICTED INGREDI8 ENTS.— 

9 ‘‘(A) LIST OF INGREDIENTS THAT ARE

10 PROHIBITED OR RESTRICTED.—Not later than 

11 2 years after the date of the enactment of the 

12 Safe Cosmetics Act of 2010, the Secretary shall 

13 issue, by regulation, a list of ingredients that 

14 are identified by the Secretary as— 

15 ‘‘(i) prohibited ingredients; or 

16 ‘‘(ii) restricted ingredients. 

17 ‘‘(B) UPDATES.—The Secretary shall con18 tinually update the list under subparagraph 

19 (A), including when— 

20 ‘‘(i) determinations under paragraph 

21 (3)(D) are made; or 

22 ‘‘(ii) new information becomes avail23 able demonstrating that an ingredient fails 

24 to meet the safety standard. 

25 ‘‘(C) INFORMATION SOURCES.— 


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1 ‘‘(i) USE OF AUTHORITATIVE INFOR2 MATION.—The list under subparagraph 

3 (A) shall contain ingredients that are 

4 known to be carcinogenic, mutagenic, or 

5 have reproductive and developmental tox6 icity, based on information from the Envi7 ronmental Protection Agency, the Inter8 national Agency for Research on Cancer, 

9 the National Toxicity Program through the 

10 National Institutes of Health, the Cali11 fornia Environmental Protection Agency, 

12 and other authoritative international, Fed13 eral, and State entities (as determined by 

14 the Secretary). 

15 ‘‘(ii) USE OF OTHER INFORMATION

16 SOURCES.—In identifying ingredients for 

17 purposes of the list under subparagraph 

18 (A), the Secretary shall use all reasonably 

19 available information, including new sci20 entific information and submissions from 

21 manufacturers and distributors of cos22 metics. 

23 ‘‘(D) PROHIBITED INGREDIENTS.—Ingre24 dients that are listed as prohibited under sub25 paragraph (A) shall include all ingredients that 


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1 the Secretary determines are unsafe for use in 

2 cosmetics in any amount because such ingredi3 ents fail to meet the safety standard defined in 

4 section 611(5). 

5 ‘‘(E) RESTRICTED INGREDIENTS.—Ingre6 dients that are listed as restricted under sub7 paragraph (A) shall include all ingredients for 

8 which the Secretary determines that limits on 

9 use or concentration are necessary to satisfy the 

10 safety standard defined in section 611(5). 

11 ‘‘(F) INGREDIENTS AND COSMETICS

12 FOUND TO INDUCE CANCER OR BIRTH DEFECTS

13 OR HAVE REPRODUCTIVE OR DEVELOPMENTAL

14 TOXICITY.— 

15 ‘‘(i) PRESUMPTION.—The Secretary 

16 shall presume that any ingredient or cos17 metic that induces cancer or birth defects 

18 or has reproductive or developmental tox19 icity when ingested by, inhaled by, or 

20 dermally applied to a human or an animal 

21 has failed to meet the safety standard (as 

22 defined in section 611(5)). 

23 ‘‘(ii) REBUTTAL.—The presumption 

24 under clause (i) may be rebutted only if 

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1 dient or cosmetic meets such safety stand2 ard. 

3 ‘‘(iii) PUBLIC COMMENT.—The Sec4 retary shall solicit public comment before 

5 making a determination under clause (ii). 

6 ‘‘(2) SAFE WITHOUT LIMITS.— 

7 ‘‘(A) IN GENERAL.—Not later than 2 years 

8 after the date of the enactment of the Safe Cos9 metics Act of 2010, the Secretary shall issue, 

10 by regulation, a list of ingredients that the Sec11 retary has determined are safe without limits 

12 for use in cosmetics. 

13 ‘‘(B) STANDARD FOR INCLUSION IN

14 LIST.—The Secretary may only include an in15 gredient on the list under subparagraph (A) if 

16 the Secretary determines that such ingredient 

17 meets the safety standard (as defined in section 

18 611(5)) regardless of— 

19 ‘‘(i) the type and form of cosmetic the 

20 ingredient is used in; or 

21 ‘‘(ii) the concentration of the ingre22 dient that is used in a cosmetic. 

23 ‘‘(C) UPDATE.—The Secretary shall up24 date the list under subparagraph (A) when new 

25 information becomes available. 


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1 ‘‘(D) CONSULTATIONS.—In determining 

2 whether a cosmetic or ingredient is safe, the 

3 Secretary shall consult hazard listings and as4 sessments from authoritative international, 

5 Federal, and State entities, including the enti6 ties listed in paragraph (1)(C)(i). 

7 ‘‘(E) REDETERMINATIONS.—The Secretary 

8 may redetermine whether a cosmetic or ingre9 dient distributed in commerce meets the safety 

10 standard if, in the judgment of the Secretary, 

11 new information raises a credible question as to 

12 whether the cosmetic or ingredient continues to 

13 meet the safety standard. 

14 ‘‘(3) PRIORITY ASSESSMENT LIST.— 

15 ‘‘(A) IN GENERAL.—Not later than 18 

16 months after the date of the enactment of the 

17 Safe Cosmetics Act of 2010, the Secretary shall 

18 develop a priority assessment list of not less 

19 than 300 ingredients— 

20 ‘‘(i) which cannot be included on the 

21 restricted and prohibited list under para22 graph (1) or the safe without limits list 

23 under paragraph (2) because of a lack of 

24 authoritative information on the safety of 

25 the ingredient; and 


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1 ‘‘(ii) for which safety determinations 

2 under subparagraph (D) shall be made. 

3 ‘‘(B) ADDITIONAL INGREDIENTS.—The 

4 Secretary shall add not less than 100 ingredi5 ents to the priority assessment list under sub6 paragraph (A) annually until all ingredients 

7 that are used in the formulation or manufac8 ture of cosmetics have been added to the pri9 ority assessment list, the safe without limits 

10 list, or the prohibited and restricted list. 

11 ‘‘(C) CONSIDERATIONS.—In developing or 

12 updating the priority assessment list under this 

13 paragraph, the Secretary shall take into ac14 count all relevant data with respect to ingredi15 ents including whether the ingredients— 

16 ‘‘(i) react to form harmful byproducts; 

17 ‘‘(ii) are found to be present in the 

18 body through biomonitoring; 

19 ‘‘(iii) are found in drinking water or 

20 indoor or outdoor air; 

21 ‘‘(iv) are a known or suspected neuro22 logical or immunological toxicant, res23 piratory asthmagens, or endocrine 

24 disruptor, or have other toxicological con25 cerns; or 


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1 ‘‘(v) persist in the environment or bio2 accumulate. 

3 ‘‘(D) DETERMINATION OF WHETHER IN4 GREDIENT MEETS SAFETY STANDARD.— 

5 ‘‘(i) IN GENERAL.—Not later than 24 

6 months after the date on which an ingre7 dient is placed on the priority assessment 

8 list under subparagraph (A), the Secretary 

9 shall issue, by rule, a determination of— 

10 ‘‘(I) whether the ingredient meets 

11 the safety standard (as defined in sec12 tion 611(5)) and can be placed on the 

13 safe without limits list under para14 graph (2); or 

15 ‘‘(II) whether to include the in16 gredient in the prohibited and re17 stricted ingredients list under para18 graph (1), to ensure that the safety 

19 standard is not violated. 

20 ‘‘(ii) RULEMAKING.—Before issuing 

21 final regulations under clause (ii), the Sec22 retary shall issue a notice of proposed rule23 making and provide a period of not less 

24 than 60 days for public comment on the 

25 proposed regulation, except that a shorter 


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1 period for comment may be provided if the 

2 Secretary— 

3 ‘‘(I) finds that it would be in the 

4 public interest to have a shorter pe5 riod; and 

6 ‘‘(II) states the reasons for such 

7 finding in the notice of proposed rule8 making. 

9 ‘‘(c) MANUFACTURER INFORMATION AND SAFETY

10 TESTING.— 

11 ‘‘(1) PROVISION OF INFORMATION.—A manu12 facturer of an ingredient or cosmetic shall provide to 

13 the Secretary, through a statement under paragraph 

14 (3), all information required to determine if an in15 gredient or cosmetic meets the safety standard. 

16 ‘‘(2) MINIMUM DATA REQUIREMENTS AND TEST

17 PROTOCOLS.—Not later than 1 year after the date 

18 of the enactment of the Safe Cosmetics Act of 2010, 

19 the Secretary shall establish minimum data require20 ments and test protocols to be used by manufactur21 ers to assess the safety of cosmetic ingredients that 

22 would ensure that statements under paragraph 

23 (3)(A) regarding compliance with the safety stand24 ard are based on sufficient and reliable data. 

25 ‘‘(3) STATEMENTS.— 


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

2 months after the date of the enactment of the 

3 Safe Cosmetics Act of 2010, each manufacturer 

4 or marketer of a cosmetic shall submit to the 

5 Secretary a statement signed by the chief exec6 utive officer of such manufacturer or marketer, 

7 based on available information after a good 

8 faith inquiry, that— 

9 ‘‘(i) the cosmetic and its ingredients 

10 meet the safety standard; or 

11 ‘‘(ii) there is insufficient data to de12 termine whether the cosmetic and its in13 gredients meet the safety standard. 

14 ‘‘(B) UPDATES.—Each manufacturer or 

15 marketer of a cosmetic shall update the state16 ment under subparagraph (A) when there be17 comes available significant new information re18 garding the safety, or lack thereof, of a cos19 metic or its ingredients. 

20 ‘‘(4) AUDIT.—The Secretary shall perform an 

21 annual comprehensive data audit on a statistically 

22 significant number of the statements submitted by 

23 manufacturers or marketers under paragraph (3). 

24 ‘‘(d) NANOMATERIALS IN COSMETICS.—The Sec25 retary shall— 


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1 ‘‘(1) monitor developments in the scientific un2 derstanding of any adverse health effects related to 

3 the use of nanotechnology in the formulation of cos4 metics; and 

5 ‘‘(2) consider scale specific hazard properties of 

6 ingredients when conducting or reviewing safety sub7 stantiation of cosmetic ingredients. 

8 ‘‘(e) PRODUCT TESTING AND REVIEW AUDIT.—The 

9 Secretary shall conduct annual audits of random samples 

10 of cosmetic products to assess or test for acute negative 

11 reactions, pathogen hazards, contaminants, or leaching of 

12 packaging additives, mislabeling, or other relevant issues 

13 of concern (as determined by the Secretary). 

14 ‘‘SEC. 615. MARKET RESTRICTIONS. 

15 ‘‘(a) FAILURE TO PROVIDE DATA OR MEET SAFETY

16 STANDARD.—No person shall manufacture, import, dis17 tribute, or market in commerce a cosmetic or an ingre18 dient for use in a cosmetic if the Secretary determines 

19 that— 

20 ‘‘(1) the person failed to provide information to 

21 the Secretary as required under this subchapter; or 

22 ‘‘(2) beginning 180 days after the date on 

23 which the Secretary places an ingredient on a list 

24 under section 614(b)(1)— 

25 ‘‘(A) the ingredient— 


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1 ‘‘(i) is on the list under section 

2 614(b)(1)(A)(i); or 

3 ‘‘(ii) is a cosmetic containing an in4 gredient on such list; 

5 ‘‘(B) the ingredient is on the list under 

6 section 614(b)(1)(A)(ii) and is being used in a 

7 cosmetic in a manner that violates the limit on 

8 use or concentration of such ingredient under 

9 section 614(b)(1)(E). 

10 ‘‘(b) FAILURE OF SECRETARY TO ACT.— 

11 ‘‘(1) ISSUANCE OF PENDING NOTIFICATION.—If 

12 the Secretary fails to act by an applicable deadline 

13 under section 614, a manufacturer or marketer of 

14 an ingredient affected by the failure to act shall 

15 issue to the Secretary, the public, and each known 

16 customer of the ingredient a written notice that a 

17 determination by the Secretary of the safety of the 

18 ingredient for use in cosmetics is pending. 

19 ‘‘(2) PROHIBITED USE.—If, by the last day of 

20 the 5 year period beginning on the date on which an 

21 ingredient is placed on the priority assessment list 

22 under section 614(b)(3), the Secretary has not made 

23 a determination under such section concerning 

24 whether such ingredient meets the safety standard, 

25 the ingredient may not be— 


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1 ‘‘(A) used in cosmetics; or 

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

3 or marketed for use in cosmetics. 

4 ‘‘SEC. 616. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

5 OF ADULTERATED OR MISBRANDED COS6 METICS. 

7 ‘‘(a) NOTIFICATION, NONDISTRIBUTION, AND RE8 CALL OF ADULTERATED OR MISBRANDED COSMETICS.— 

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

10 has reason to believe that a cosmetic, when intro11 duced into or while in interstate commerce, or while 

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

13 first sale of such cosmetic) after shipment in inter14 state commerce, is adulterated or misbranded in a 

15 manner that presents a reasonable probability that 

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

17 or component used in any such cosmetic) will cause 

18 a threat of serious adverse health consequences or 

19 death to humans shall, as soon as practicable, notify 

20 the Secretary of the identity and location of the cos21 metic. 

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

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

24 and by such means as the Secretary may require by 

25 regulation or guidance. 


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1 ‘‘(3) RESPONSIBLE PARTY DEFINED.—For pur2 poses of this subsection, the term ‘responsible party’ 

3 means a manufacturer, packager, retailer, or dis4 tributor of the cosmetic. 

5 ‘‘(b) VOLUNTARY RECALL.—The Secretary may re6 quest that any person who distributes a cosmetic that the 

7 Secretary has reason to believe is adulterated, misbranded, 

8 or otherwise in violation of this Act voluntarily— 

9 ‘‘(1) recall such cosmetic; and 

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

11 as appropriate, to persons who may be affected by 

12 the recall. 

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

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

15 to believe that— 

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

17 may cause serious adverse health consequences 

18 or death to humans; 

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

20 ‘‘(C) the cosmetic is manufactured, pack21 aged, or distributed by an unregistered facility; 

22 the Secretary shall have the authority to issue an 

23 order requiring any person who distributes such cos24 metic to immediately cease distribution of such cos25 metic. 


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1 ‘‘(2) ACTION FOLLOWING ORDER.—Any person 

2 who is subject to an order under paragraph (1) shall 

3 immediately cease distribution of such cosmetic and 

4 provide notification as required by such order, and 

5 may appeal such order to the Secretary within 24 

6 hours of the issuance of such order. Such appeal 

7 may include a request for an informal hearing and 

8 a description of any efforts to recall such cosmetic 

9 undertaken voluntarily by the person, including after 

10 a request under subsection (b). Except as provided 

11 in subsection (e), an informal hearing shall be held 

12 as soon as practicable, but not later than 5 calendar 

13 days, or less as determined by the Secretary, after 

14 such an appeal is filed, unless the parties jointly 

15 agree to an extension. After affording an oppor16 tunity for an informal hearing, the Secretary shall 

17 determine whether the order should be amended to 

18 require a recall of such cosmetic. If, after providing 

19 an opportunity for such a hearing, the Secretary de20 termines that inadequate grounds exist to support 

21 the actions required by the order, the Secretary shall 

22 vacate the order. 

23 ‘‘(d) ORDER TO RECALL.— 

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

25 subsection (e), if after providing an opportunity for 


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1 an informal hearing under subsection (c)(2), the 

2 Secretary determines that the order should be 

3 amended to include a recall of the cosmetic with re4 spect to which the order was issued, the Secretary 

5 shall amend the order to require a recall. 

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

7 paragraph (1) shall— 

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

9 will occur; 

10 ‘‘(B) require periodic reports to the Sec11 retary describing the progress of the recall; and 

12 ‘‘(C) provide for notice, including to indi13 viduals as appropriate, to persons who may be 

14 affected by the recall. 

15 In providing for such notice, the Secretary may 

16 allow for the assistance of health professionals, State 

17 or local officials, or other individuals designated by 

18 the Secretary. 

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

20 under this subsection shall be ordered by the Sec21 retary or an official designated by the Secretary. An 

22 official may not be so designated unless the official 

23 is the director of the district under this Act in which 

24 the cosmetic involved is located, or is an official sen25 ior to such director. 


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1 ‘‘(e) EMERGENCY RECALL ORDER.— 

2 ‘‘(1) IN GENERAL.—If the Secretary has cred3 ible evidence or information that a cosmetic subject 

4 to an order under subsection (c) presents an immi5 nent threat of serious adverse health consequences 

6 or death to humans, the Secretary may issue an 

7 order requiring any person who distributes such cos8 metic— 

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

10 and 

11 ‘‘(B) to provide for notice, including to in12 dividuals as appropriate, to persons who may be 

13 affected by the recall. 

14 ‘‘(2) ACTION FOLLOWING ORDER.—Any person 

15 who is subject to an emergency recall order under 

16 this subsection shall immediately recall such cos17 metic and provide notification as required by such 

18 order, and may appeal within 24 hours after 

19 issuance such order to the Secretary. An informal 

20 hearing shall be held as soon as practicable but not 

21 later than 5 calendar days, or less as determined by 

22 the Secretary, after such an appeal is filed, unless 

23 the parties jointly agree to an extension. After af24 fording an opportunity for an informal hearing, the 

25 Secretary shall determine whether the order should 


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1 be amended pursuant to subsection (d)(1). If, after 

2 providing an opportunity for such a hearing, the 

3 Secretary determines that inadequate grounds exist 

4 to support the actions required by the order, the 

5 Secretary shall vacate the order. 

6 ‘‘(3) NONDELEGATION.—An order under this 

7 subsection shall be issued by the Commissioner of 

8 Food and Drugs, the Principal Deputy Commis9 sioner, or the Associate Commissioner for Regu10 latory Affairs of the Food and Drug Administration. 

11 ‘‘(f) NOTICE TO CONSUMERS AND HEALTH OFFI12 CIALS.—The Secretary shall, as the Secretary determines 

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

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

15 have been, distributed and to appropriate State and local 

16 health officials. 

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

18 section shall be construed as limiting the authority of the 

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

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

21 ‘‘SEC. 617. PETITIONS. 

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

23 and publish a review, and, if appropriate, immediately re24 vise related, relevant information, including ingredient 

25 lists, ingredient restrictions or prohibitions, or ingredient 


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1 or cosmetic safety determinations, not later than 180 days 

2 after the date on which the Secretary receives from any 

3 individual or entity a reasonable petition— 

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

5 in cosmetics and list such ingredient on the list 

6 under section 614(b)(1); 

7 ‘‘(2) to remove an ingredient from the list of in8 gredients that are safe without limits under section 

9 614(b)(2); or 

10 ‘‘(3) to add an ingredient to the priority assess11 ment list under section 614(b)(3). 

12 ‘‘(b) REASONABLE PETITION.—Not later than one 

13 year after the date of the enactment of this Act, the Sec14 retary shall issue rules specifying the criteria which the 

15 Secretary will use to determine if a petition submitted 

16 under this section is a reasonable petition. 

17 ‘‘SEC. 618. COSMETIC AND INGREDIENT STATEMENTS. 

18 ‘‘(a) IN GENERAL.—Each establishment engaged in 

19 the manufacture of a cosmetic intended to be marketed 

20 in the United States shall submit electronically to the Sec21 retary for each cosmetic manufactured in the establish22 ment that is intended to be marketed in the United States 

23 a statement containing— 

24 ‘‘(1) the registration number of the manufac25 turing establishment where the cosmetic is manufacVerDate Mar 15 2010 02:47 Jul 21, 2010 Jkt 089200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6201 E:\BILLS\H5786.IH H5786

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1 tured or, if the same cosmetic is manufactured in 

2 more than 1 establishment, the registration number 

3 of each establishment where it is manufactured; 

4 ‘‘(2) the registration number of the establish5 ment responsible for distributing the cosmetic; 

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

7 the cosmetic; 

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

9 ‘‘(5) the ingredient list as it appears on the cos10 metic label or insert, including the particle size of 

11 any nanoscale cosmetic ingredients; 

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

13 the cosmetic label or insert; and 

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

15 the individual responsible for submitting and main16 taining such statement. 

17 ‘‘(b) NOTIFICATION OF CHANGES.—The establish18 ment shall notify the Secretary in a timely manner of any 

19 change to the information required under subsection (a). 

20 ‘‘(c) PROCEDURE.—Upon receipt of a completed 

21 statement described under subsection (a), the Secretary 

22 shall notify the establishment of the receipt of such state23 ment and assign a cosmetic statement number. 


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1 ‘‘(d) LIST.—The Secretary shall compile and main2 tain an up-to-date list of cosmetics for which statements 

3 are submitted under this section. 

4 ‘‘(e) LABELING OF NANOMATERIALS IN COS5 METICS.—The Secretary may require that— 

6 ‘‘(1) minerals and other particulate ingredients 

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

8 label or list if not less than 1 dimension is 100 

9 nanometers or smaller for not less than 1 percent of 

10 the ingredient particles in the cosmetic; and 

11 ‘‘(2) other ingredients in a cosmetic be des12 ignated with scale-specific information on a cosmetic 

13 ingredient label or list if such ingredients possess 

14 scale-specific hazard properties. 

15 ‘‘(f) ACCESS TO SAFETY INFORMATION.—The cos16 metic and ingredient statements collected under this sec17 tion shall be added to the publicly accessible database cre18 ated by the Secretary under section 614(a)(3). 

19 ‘‘(g) EFFECTIVE DATES.— 

20 ‘‘(1) IN GENERAL.—The provisions of this sec21 tion shall take effect 1 year after the date of the en22 actment of the Safe Cosmetics Act of 2010. 

23 ‘‘(2) APPLICATION TO NEW COSMETICS.—An 

24 establishment that begins to manufacture a cosmetic 

25 after the date of the enactment of the Safe CosVerDate Mar 15 2010 02:47 Jul 21, 2010 Jkt 089200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6201 E:\BILLS\H5786.IH H5786

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1 metics Act of 2010 shall comply with the require2 ments of subsections (a) and (b) not later than 6 

3 months after beginning to manufacture such cos4 metic. 

5 ‘‘SEC. 619. MANDATORY REPORTING OF ADVERSE HEALTH 

6 EFFECTS. 

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

8 EFFECTS.—The Secretary shall require that the manufac9 turer, packager, or distributer of a cosmetic whose name 

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

11 States submit to the Secretary a report containing infor12 mation received concerning any serious adverse event asso13 ciated with the use of the cosmetic. 

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

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

16 business days after information concerning the adverse 

17 event is received at the place of business of the manufac18 turer, packager, or distributer. 

19 ‘‘(c) CONTENT OF REPORT.—A report under sub20 section (a) shall include the following information to the 

21 extent to which the manufacturer, packager, or distributer 

22 submitting the report has been able to verify the informa23 tion: 

24 ‘‘(1) An identifiable patient. 

25 ‘‘(2) An identifiable report. 


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1 ‘‘(3) A suspect cosmetic. 

2 ‘‘(4) A serious and unexpected adverse event. 

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

4 ‘‘(1) PUBLIC AVAILABILITY.—Subject to para5 graph (2), the adverse health effects reports col6 lected by the Secretary under this section shall be 

7 submitted electronically and shall be made accessible 

8 to the public. 

9 ‘‘(2) PRIVACY.— 

10 ‘‘(A) PERSONALLY IDENTIFIABLE INFOR11 MATION.—Notwithstanding any other provision 

12 of law, personally identifiable information in ad13 verse event reports provided to the Secretary 

14 under this section, shall not— 

15 ‘‘(i) be made publicly available pursu16 ant to any State or other law requiring dis17 closure of information or records; or 

18 ‘‘(ii) otherwise be disclosed or distrib19 uted to any party without the written con20 sent of the Secretary and the person sub21 mitting such information to the Secretary. 

22 ‘‘(B) TREATMENT OF INFORMATION

23 UNDER PRIVACY ACT AND FOIA.—An adverse 

24 event report submitted to the Secretary under 

25 this section, shall be considered to be a record 


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1 about an individual under section 552a of title 

2 5, United States Code (commonly referred to as 

3 the ‘‘Privacy Act of 1974’’) and a medical or 

4 similar file the disclosure of which would con5 stitute a violation of section 552 of such title 5 

6 (commonly referred to as the ‘‘Freedom of In7 formation Act’’), and shall not be publicly dis8 closed unless all personally identifiable informa9 tion is redacted. 

10 ‘‘SEC. 620. NONCONFIDENTIAL INFORMATION. 

11 ‘‘(a) IN GENERAL.—Subject to subsection (b) and 

12 section 619(d)(2), all nonconfidential information sub13 mitted pursuant to this subchapter shall be made available 

14 to the public. The name, identity, and structure of a chem15 ical substance, contaminant, or impurity that is an ingre16 dient and all information concerning function, exposure, 

17 health hazards, and environmental hazards, and the func18 tions of ingredients in cosmetics shall not be considered 

19 to be confidential business information under this sub20 chapter. Fragrance, flavor, and colorants shall not be con21 sidered confidential business information under this sub22 chapter. The concentration of cosmetic ingredients used 

23 in a finished cosmetic shall be considered confidential busi24 ness information except as otherwise required in section 

25 613. 


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1 ‘‘(b) PETITION FOR INFORMATION TO REMAIN CON2 FIDENTIAL.— 

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

4 a process for an entity to petition for nonconfidential 

5 information described in subsection (a) to remain 

6 confidential if the entity shows that there would be 

7 serious commercial harm to such entity if such infor8 mation were disclosed publicly. 

9 ‘‘(2) LIMITATION.—The Secretary may not ap10 prove a petition under paragraph (1) to the extent 

11 that such petition would prevent the public disclo12 sure of— 

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

14 any substance referred to in subsection (a); 

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

16 that substance; or 

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

18 safety of that substance. 

19 ‘‘SEC. 621. SAVINGS CLAUSE. 

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

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

22 or enforce any regulation, requirement, liability, or stand23 ard of performance that is more stringent than a regula24 tion, requirement, liability, or standard of performance esVerDate Mar 15 2010 02:47 Jul 21, 2010 Jkt 089200 PO 00000 Frm 00039 Fmt 6652 Sfmt 6201 E:\BILLS\H5786.IH H5786

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1 tablished by this subchapter, including requiring the provi2 sion of a warning of risk, illness, or injury. 

3 ‘‘SEC. 622. ANIMAL TESTING ALTERNATIVES. 

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

5 testing of ingredients, the Secretary shall— 

6 ‘‘(1) require, where practicable, alternative test7 ing methods that— 

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

9 to test the chemical substance; 

10 ‘‘(B) provide information that is equivalent 

11 or superior in scientific quality to the animal 

12 testing method; and 

13 ‘‘(C) use fewer animals than conventional 

14 animal-based tests when non-animal methods 

15 are impracticable, including the use of tests 

16 that combine multiple endpoints; and 

17 ‘‘(2) encourage, where practicable— 

18 ‘‘(A) estimation of toxicological properties 

19 of a chemical through the use of testing infor20 mation for 1 or more structurally similar chemi21 cals where such estimates provide information 

22 of sufficient scientific quality; 

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

24 conduct testing to avoid duplication of tests; 

25 and 


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

2 alternative test methods, in accordance with 

3 this subsection. 

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

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

6 the Safe Cosmetics Act of 2010, and triennially thereafter, 

7 the Secretary shall publish a list of the alternative testing 

8 methods described in subsection (a). 

9 ‘‘SEC. 623. INTERAGENCY COOPERATION AND FUNDING. 

10 ‘‘There is established an Interagency Council on Cos11 metic Safety for the purpose of sharing data and pro12 moting collaboration on cosmetic safety among and be13 tween the Food and Drug Administration, the National 

14 Institute of Environmental Health Sciences, the Centers 

15 for Disease Control and Prevention, the Occupational 

16 Safety and Health Administration, and the Environmental 

17 Protection Agency. 

18 ‘‘SEC. 624. AUTHORIZATION OF APPROPRIATIONS. 

19 ‘‘There are authorized to be appropriated such sums 

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

21 of the fiscal years 2011 through 2015.’’. 

22 (b) ADULTERATED AND MISBRANDED COSMETICS.— 

23 (1) ADULTERATED COSMETICS.—Section 601 of 

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

25 U.S.C. 361) is amended— 


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1 (A) in subsection (a), by striking ‘‘, except 

2 that this provision shall not apply to coal-tar 

3 hair dye’’ and all that follows through ‘‘or eye4 brow dyes’’; and 

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

6 ‘‘(f) If it— 

7 ‘‘(1) was manufactured, packaged, or distrib8 uted by an entity that failed to register as required 

9 under section 612; 

10 ‘‘(2) was sold by an Internet vendor that failed 

11 to comply with the requirements of section 613(b); 

12 ‘‘(3) the person who manufactures, imports, 

13 distributes, or markets the cosmetic, or an ingre14 dient in the cosmetic, fails to comply with the appli15 cable requirements of section 615 (including failure 

16 to issue a notice required under section 615(b)(1)); 

17 ‘‘(4) is manufactured, packaged, distributed, or 

18 sold in retail by a manufacturer, packager, dis19 tributor, or retailer, respectively, who fails to notify 

20 the Secretary as required under section 616(a); 

21 ‘‘(5) is distributed in violation of an order 

22 under section 616(c); 

23 ‘‘(6) is not recalled as required by an order 

24 under subsection (d) or (e) of section 616; 


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1 ‘‘(7) is manufactured in a manner that fails to 

2 comply with good manufacturing practices for cos3 metics, as determined (and periodically updated), by 

4 the Secretary; or 

5 ‘‘(8) is manufactured by a manufacturer who 

6 fails to submit the statement required under section 

7 618 or notify the Secretary of changes to informa8 tion contained in such statement as required by such 

9 section.’’. 

10 (2) MISBRANDED COSMETICS.—Section 602 of 

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

12 U.S.C. 362) is amended in subsection (a), by insert13 ing ‘‘, fails to meet the requirements of section 

14 613(a), or fails to meet any requirements under sec15 tion 618(e)’’ before the period. 

16 SEC. 3. WORKER ISSUES. 

17 (a) IN GENERAL.—The Secretary of Labor shall pro18 mulgate an occupational safety and health standard under 

19 section 6 of the Occupational Safety and Health Act of 

20 1970 (29 U.S.C. 655) that requires the following: 

21 (1) MANUFACTURERS AND IMPORTERS.— 

22 (A) IN GENERAL.—Each manufacturer or 

23 importer selling any cosmetic for professional 

24 use shall— 


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1 (i) obtain or develop an expanded ma2 terial safety data sheet described in sub3 section (b) for each such cosmetic or per4 sonal care product that— 

5 (I) the manufacturer or importer 

6 produces or imports; and 

7 (II) includes a hazardous chem8 ical, or product ingredient associated 

9 with any chemical hazard, that has 

10 been indicated by authoritative bodies 

11 or scientific studies to be linked to 

12 health hazards including mutation, re13 productive or developmental toxicity, 

14 neurotoxicity, endocrine disruption, 

15 asthma, or other immunological tox16 icity; and 

17 (ii) make the expanded material safety 

18 data sheet available to distributors and 

19 employers, including salon owners, in 

20 English and, upon request, in other lan21 guages, including Spanish and Vietnamese. 

22 (B) PROFESSIONAL USE DEFINED.—In 

23 this paragraph, the term ‘‘professional use’’ has 

24 the meaning given such term in section 611 of 

25 the Federal Food, Drug, and Cosmetic Act. 


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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 expanded material safety 

4 data sheets described in subsection (b) in the same 

5 manner as a distributor of a chemical hazard is re6 quired to distribute and provide material safety data 

7 sheets under section 1910.1200(g) of title 29, Code 

8 of Federal Regulations, or any successor regulations. 

9 (3) EMPLOYERS.—Each employer, including 

10 any operator of a salon, shall— 

11 (A) have an expanded material safety data 

12 sheet in the workplace for each cosmetic or per13 sonal care product for professional use that is 

14 used in the course of the employer’s business; 

15 (B) make such expanded material safety 

16 data sheet available to all employees of the em17 ployer who are exposed or use the product to 

18 the same extent and in the same manner as 

19 material safety data sheets are required to be 

20 made available under section 1910.1200(g) of 

21 title 29, Code of Federal Regulations, or any 

22 successor regulations; and 

23 (C) upon request, provide employees with 

24 translations of such expanded material safety 


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1 data sheet in other languages, including Span2 ish and Vietnamese. 

3 (b) CONTENTS OF EXPANDED MATERIAL SAFETY

4 DATA SHEET.—An expanded material safety data sheet 

5 for a cosmetic or personal care product for professional 

6 use described in this 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)(i)(II); and 

13 (2) include the following statement: ‘‘This ex14 panded material safety data sheet is also available in 

15 multiple languages by contacting the manufacturer, 

16 using the contact information provided on this 

17 sheet.’’. 

18 SEC. 4. FDA SAFETY STANDARD AS IT RELATES TO OTHER 

19 ADMINISTRATIVE AGENCIES. 

20 (a) USE OF DATA FROM FEDERAL SOURCES.—The 

21 Secretary shall request and utilize ingredient toxicity, use, 

22 and exposure data from other Federal agencies as appro23 priate, to assist with developing the priority assessment 

24 list under section 614(b)(3) of the Federal Food, Drug, 


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1 and Cosmetic Act, and for reaching safety determinations 

2 under section 614(b)(3)(E) of such Act. 

3 (b) USE OF OTHER FEDERAL STANDARDS.—If any 

4 Federal agency has promulgated a standard for an ingre5 dient that satisfies the safety standard under section 611 

6 of the Federal Food, Drug, and Cosmetic Act, the Sec7 retary may adopt it for purposes of this Act or an amend8 ment made by this Act. 

Æ 


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