Safe Cosmetics Act

8/6/2019 Safe Cosmetics Act

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.....................................................................

(Original Signature of Member)

112TH CONGRESS1ST SESSION H. R.ll

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

Ms. SCHAKOWSKY introduced the following bill; which was referred to the

Committee onllllllllllllll

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.

Be it enacted by the Senate and House of Representa-1

tives of the United States of America in Congress assembled,2

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.3

(a) SHORT TITLE.This Act may be cited as the4

Safe Cosmetics Act of 2011.5

(b) T ABLE OF CONTENTS.The table of contents of6

this Act is as follows:7

Sec. 1. Short title; table of contents.

Sec. 2. Cosmetic regulation.

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SUBCHAPTER A ADULTERATED AND MISBRANDED COSMETICS

SUBCHAPTER BREGULATION 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 mis-

branded cosmetics.

Sec. 621. Petitions.

Sec. 622. Mandatory reporting of adverse health effects.

Sec. 623. Nonconfidential information.

Sec. 624. Animal testing alternatives.

Sec. 625. Product Testing and Review Audit.

Sec. 626. Resources for small businesses.

Sec. 627. Interagency cooperation.

Sec. 628. Savings clause.

Sec. 629. Authorization of appropriations.

Sec. 3. Worker issues.

SEC. 2. COSMETIC REGULATION.1

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

Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amend-3

ed4

(1) by inserting before section 601 the fol-5

lowing:6

Subchapter AAdulterated and Misbranded7

Cosmetics;8

and9

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

Subchapter BRegulation of Cosmetics11

SEC. 611. DEFINITIONS.12

In this subchapter:13



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(1) DOMESTIC ESTABLISHMENT.The term1

domestic establishment means an establishment lo-2

cated in any State that manufactures or packages3

cosmetics.4

(2) FOREIGN ESTABLISHMENT.The term5

foreign establishment means an establishment that6

manufactures or packages cosmetics that are ex-7

ported to the United States.8

(3) MANUFACTURER.The term manufac-9

turer only includes manufacturers that determine10

the final formulation of a cosmetic.11

(4) INGREDIENT.12

(A) IN GENERAL.The term ingredient13

means a chemical in a cosmetic, including14

(i) chemicals that provide a technical15

or functional effect;16

(ii) chemicals that have no technical17

or functional effect in the cosmetic but are18

present by reason of having been incor-19

porated into the cosmetic as an ingredient20

of another cosmetic ingredient;21

(iii) processing aids that are present22

by reason of having been added to a cos-23

metic during the processing of such cos-24

metic;25



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(iv) substances that are present by1

reason of having been added to a cosmetic2

during processing for their technical or3

functional effect;4

(v) the components of a fragrance,5

flavor, or preservative; and6

(vi) any individual component of a7

petroleum-derived, animal-derived, or other8

ingredient that the Secretary deems an in-9

gredient for purposes of this chapter.10

(B) TREATMENT OF CONTAMINANTS.11

For purposes of sections 614 through 617, the12

term ingredient also includes13

(i) contaminants present at levels14

above technically feasible detection limits;15

and16

(ii) contaminants that may leach17

from container materials or form via reac-18

tions over the shelf life of a cosmetic and19

that may be present at levels above tech-20

nically feasible detection limits.21

(5) MICROBUSINESS.The term microbusi-22

ness means a business23

(A) that is engaged in the manufacturing24

or packaging of cosmetics; and25



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(B) that has annual sales receipts for cos-1

metic products that do not exceed $2,000,000.2

(6) PROFESSIONAL USE.The term profes-3

sional use means the use of any cosmetic4

(A) by an employee (within the scope of5

the employment of such employee) of; or6

(B) purchased by a consumer in,7

a hair salon, nail salon, beauty salon, spa, or other8

establishment that provides cosmetic treatment serv-9

ices for humans.10

(7) REASONABLE CERTAINTY OF NO HARM.11

With respect to an ingredient or cosmetic, the term12

reasonable certainty of no harm means that no13

harm will be caused to members of the general popu-14

lation or any vulnerable population by aggregate ex-15

posure to the cosmetic or ingredient, taking into ac-16

count possible harmful effects from17

(A) low-dose exposures to the cosmetic or18

ingredient; or19

(B) additive effects resulting from re-20

peated exposure to the cosmetic or ingredient21

over time; or22

(C) cumulative exposure resulting from23

all sources, including both the cosmetic or in-24

gredient and environmental sources.25



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(8) REPRODUCTIVE OR DEVELOPMENTAL TOX-1

ICITY.With respect to an ingredient or cosmetic,2

the term reproductive or developmental toxicity3

means that the ingredient or cosmetic can contribute4

to biologically adverse effects on the development of5

humans or animals, including effects on the female6

or male reproductive system, the endocrine system,7

fertility, pregnancy, pregnancy outcomes, or modi-8

fications in other functions of the body that are de-9

pendent on the integrity of the reproductive system10

as well normal fetal development.11

(9) VULNERABLE POPULATIONS.The term12

vulnerable populations includes pregnant women,13

infants, children, the elderly, people with com-14

promised immune systems, and highly exposed popu-15

lations, including workers employed by hair salons,16

nail salons, beauty salons, spas, other establishments17

that provide cosmetic treatment services for humans,18

and cosmetic manufacturing plants.19

SEC. 612. REGISTRATION OF ESTABLISHMENTS AND REG-20

ISTRATION FEES.21

(a) REGISTRATION.22

(1) IN GENERAL.Beginning 1 year after the23

date of the enactment of this subchapter, and annu-24

ally thereafter, any establishment (except for micro-25



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businesses) engaged in manufacturing or packaging1

cosmetics for use in the United States shall register2

with the Secretary and pay to the Secretary the ap-3

plicable fee, as established under the fee schedule in4

subsection (e).5

(2) RULES FOR DOMESTIC AND FOREIGN ES-6

TABLISHMENTS.To be registered under paragraph7

(1)8

(A) as a domestic establishment, the9

owner, operator, or agent in charge of the do-10

mestic establishment shall submit a registration11

to the Secretary; or12

(B) as a foreign establishment, the owner,13

operator, or agent in charge of the foreign es-14

tablishment shall15

(i) submit a registration to the Sec-16

retary; and17

(ii) include with the registration the18

name of the United States agent for the19

foreign establishment.20

(3) NEW ESTABLISHMENTS.Any establish-21

ment that begins to manufacture or package a cos-22

metic after the date on which the requirements of23

paragraph (1) apply shall, not later than 60 days24

after the date on which the establishment began to25



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manufacture or package such cosmetic, register with1

the Secretary and pay the applicable fee, as required2

under paragraph (1).3

(b) SUBMISSION OF REGISTRATION.4

(1) IN GENERAL.In order to register under5

subsection (a), an establishment (referred to in this6

section as the registrant) shall submit to the Sec-7

retary, with respect to any cosmetics that the estab-8

lishment manufactures or package, all of the fol-9

lowing:10

(A) Any information necessary to notify11

the Secretary of the name, address, and legal12

status of each establishment at which, and all13

trade names under which, the registrant manu-14

factures or package cosmetics.15

(B) A description of the establishments16

activities with respect to cosmetics, including a17

list of all cosmetic products manufactured or18

packaged by the establishment and the func-19

tions of such cosmetics.20

(C) The gross receipts or sales for the es-21

tablishment from cosmetics.22

(D) The name and address of any com-23

pany that supplies the establishment, if the es-24

tablishment manufactures cosmetics, with any25



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ingredient and the name of the ingredient sup-1

plied to such establishment by such supplier.2

(2) NOTIFICATION OF CHANGES.When sub-3

mitting the annual registration, the registrant shall4

notify the Secretary of changes to the information5

described in paragraph (1).6

(c) PROCEDURE.Upon receipt of a completed reg-7

istration submitted under subsection (a), the Secretary8

shall notify the registrant of the receipt of such registra-9

tion and assign a registration number to each registered10

establishment.11

(d) LIST OF REGISTERED ESTABLISHMENTS.12

(1) M AINTENANCE OF LIST.The Secretary13

shall14

(A) compile, maintain, and update as ap-15

propriate, a list of establishments that are reg-16

istered under this section;17

(B) make such list publically available;18

and19

(C) remove from such list the name of20

any establishment that fails to register in ac-21

cordance with this section.22

(2) APPLICATION OF FOIA.23

(A) REGISTRATION DOCUMENTS.Any24

registration documents submitted pursuant to25



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this section shall not be subject to disclosure1

under section 552 of title 5, United States2

Code.3

(B) OTHER INFORMATION.Information4

derived from5

(i) the list under paragraph (1); or6

(ii) registration documents submitted7

pursuant to this section,8

shall not be subject to disclosure under section9

552 of title 5, United States Code, except to the10

extent that such information discloses the iden-11

tity or location of a specific registrant.12

(e) FEE SCHEDULE.A schedule of fees shall be de-13

veloped by the Secretary to provide for oversight and en-14

forcement of this subchapter. The fee structure shall15

(1) be prorated based on the establishments16

gross receipts or sales; and17

(2) only be assessed on companies with annual18

gross receipts or sales of cosmetics that exceed19

$10,000,000.20

(f) SUSPENSION AND C ANCELLATION OF REGISTRA-21

TION.22

(1) CRITERIA FOR SUSPENSION.Registration23

under this section is subject to suspension if the24

Secretary finds25



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(A) the information submitted by the es-1

tablishment for registration under subsection2

(a) is incomplete, inaccurate, or out of date;3

(B) the establishment fails to notify the4

Secretary of changes required under subsection5

(b)(2);6

(C) the establishment fails to pay reg-7

istration fees, as required under subsection (a),8

in a timely manner; or9

(D) the establishment violates any portion10

of this chapter.11

(2) SUSPENSION OF REGISTRATION.If the12

Secretary determines that an establishment is sub-13

ject to suspension under subsection (f) and that it14

is appropriate to suspend the registration of such es-15

tablishment, the Secretary shall16

(A) suspend the registration of such es-17

tablishment; and18

(B) provide a notice of suspension to such19

establishment.20

(3) CANCELLATION.If the establishment21

fails to correct the issue that resulted in the suspen-22

sion under paragraph (2) before the last day of the23

30-day period beginning on the date that the estab-24

lishment receives notice under such paragraph, the25



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Secretary may cancel the registration of such estab-1

lishment.2

SEC. 613. INGREDIENTS LABELS ON COSMETICS.3

(a) IN GENERAL.Subject to subsections (b) and4

(c), the Secretary shall require that the label on each pack-5

age of cosmetics (including cosmetics distributed for retail6

sale and professional use) bears a declaration of the name7

of each ingredient in such cosmetic in descending order8

of predominance.9

(b) ADJUSTMENTS FOR LABEL SIZE.10

(1) RULES FOR SMALL PRODUCTS.Not later11

than 6 months after the date of the enactment of12

this subchapter, the Secretary shall issue regulations13

that apply to any cosmetic for which the product14

packaging is not of sufficient size to bear or contain15

a label that meets the requirements of subsection16

(a).17

(2) REQUIREMENTS FOR PUBLIC DISCLO-18

SURE.Such regulations shall establish require-19

ments for listing ingredients on the label of such20

cosmetics and additional requirements for public dis-21

closure of the ingredients in such cosmetics.22

(c) SPECIAL RULE FOR CONTAMINANTS.The Sec-23

retary shall require, in the case of a contaminant, that24

a contaminant be declared on the label of a cosmetic, in25



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the same manner as an ingredient under subsection (a),1

if the contaminant is present at the lower of the following2

levels:3

(1) A level that is greater than one part-per-4

billion by weight of product formation.5

(2) A level that is greater than one percent of6

the restriction on the concentration for such con-7

taminant for such use, as determined by the Sec-8

retary under section 616(a)(2).9

(d) L ABELING OF N ANOMATERIALS IN COS-10

METICS.The Secretary may require that11

(1) minerals and other particulate ingredients12

be labeled as nano-scale on a cosmetic ingredient13

label or list if not less than 1 percent of the ingre-14

dient particles in the cosmetic are 100 nanometers15

or smaller in not less than 1 dimension; and16

(2) other ingredients in a cosmetic be des-17

ignated with scale-specific information on a cosmetic18

ingredient label or list if such ingredients possess19

scale-specific hazard properties.20

(e) L ABELING OF INGREDIENTS IN COSMETICS21

SOLD THROUGH INTERNET COMMERCE.The Secretary22

shall require23

(1) in the case of a cosmetic sold on the Web24

site of an Internet vendor, that the manufacturers25



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and distributors of such cosmetic provide to such1

Internet vendor a list of the ingredients of the cos-2

metic; and3

(2) that each Internet vendor display the list4

of ingredients of a cosmetic sold by such vendor on5

the Web page that is the primary Web page pro-6

viding information relating to the sale of such cos-7

metic on the Web site of the vendor.8

(f) TRADE SECRETS.Notwithstanding any other9

provision of law, an ingredient required to be listed on a10

label under this section shall not be treated as a trade11

secret.12

(g) APPLICATION.Beginning 18 months after the13

date of the enactment of this subchapter, the requirements14

of this section shall apply to15

(1) all cosmetics that are available for retail16

sale; and17

(2) manufacturers, distributors, and Internet18

vendors of such cosmetics.19

SEC. 614. SAFETY STANDARD AND GOOD MANUFACTURING20

PRACTICES.21

(a) SAFETY STANDARD.22

(1) IN GENERAL.Taking into account the ex-23

pected use of a cosmetic, the Secretary shall estab-24

lish a safety standard that, with respect to a cos-25



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SEC. 615. COSMETIC AND INGREDIENT SAFETY INFORMA-1

TION.2

(a) REQUIRED SUBMISSION OFALL SAFETY INFOR-3

MATION.4

(1) IN GENERAL.Manufacturers of cosmetics5

and ingredients shall submit to the Secretary (in an6

electronic format that the Secretary shall determine)7

all data and information that the manufacturer can8

access regarding the safety of the9

(A) ingredients listed on the cosmetic10

label under section 613 for a cosmetic; and11

(B) cosmetic itself.12

(2) REQUIRED INFORMATION.The required13

data and information under paragraph (1) shall in-14

clude, for each ingredient in a cosmetic and for the15

cosmetic, the following:16

(A) Functions and uses.17

(B) Data and information on the phys-18

ical, chemical, and toxicological properties of19

each such ingredient or cosmetic.20

(C) Exposure and fate information.21

(D) Results of all safety tests that the22

manufacturer can access or has conducted.23

(E) Any other information used to sub-24

stantiate the safety of such ingredient and cos-25

metic.26



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(3) DEADLINES.1

(A) INITIAL SUBMISSION.A manufac-2

turer shall submit the data and information re-3

quired under paragraph (1)4

(i) in the case of an ingredient or5

cosmetic which is marketed for sale in6

interstate commerce on or before the date7

of the enactment of this subchapter, not8

later than 1 year after such date; and9

(ii) in the case of an ingredient or10

cosmetic which is not marketed for sale on11

or before such date12

(I) not later than the end of the13

14-month period beginning on the14

date of the enactment of this sub-15

chapter; or16

(II) if the ingredient or cosmetic17

is first marketed for sale in interstate18

commerce after the end of the period19

described in subclause (I), not later20

than 60 days after the date on which21

such ingredient or cosmetic is first22

marketed for sale.23

(B) UPDATES.24



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(i) IN GENERAL.Subject to clause1

(ii), a manufacturer shall update the data2

and information submitted under subpara-3

graph (A) annually.4

(ii) ADVERSE HEALTH EFFECTS.In5

the case of information related to an ad-6

verse health effect that is suspected to be7

caused by an ingredient or a cosmetic, a8

manufacturer shall update the information9

not later than 60 days after receiving such10

information.11

(4) SUPPLIER INFORMATION.12

(A) USE OF SUPPLIER INFORMATION.13

In order to meet the requirements of paragraph14

(1) with respect to an ingredient, a manufac-15

turer may submit safety data and information16

provided by the supplier of the ingredient.17

(B) SUPPLIER PROVISION OF INFORMA-18

TION.If a manufacturer requests that a sup-19

plier of an ingredient provide to such manufac-20

turer any of the data and information described21

under paragraph (2), such supplier shall pro-22

vide such data and information to such manu-23

facturer not later than 90 days after receiving24

such request.25



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(b) DATABASE.1

(1) INITIAL PUBLICATION.Not later than 12

year after the date of the enactment of this sub-3

chapter, the Secretary shall publish a comprehensive,4

publicly accessible database containing all noncon-5

fidential information (as such term is used under6

section 623) submitted under subsection (a)(1).7

(2) UPDATES.Not later than 90 days after8

the Secretary receives new or updated information9

under subsection (a)(3)(B), the Secretary shall up-10

date the database under paragraph (1) with such in-11

formation.12

(c) REVIEW AND EVALUATION OF INFORMATION.13

(1) IN GENERAL.Based on the data and in-14

formation submitted under subsection (a)(1), avail-15

able from an authoritative source (as such term is16

defined in paragraph (3), including data described17

under section 627(b)), and such other information18

as the Secretary may have available, the Secretary19

shall review and evaluate the safety of cosmetics and20

ingredients of cosmetics that are marketed in inter-21

state commerce.22

(2) CONSIDERATION OF NANOMATERIALS.23

The Secretary shall24



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(A) monitor developments in the scientific1

understanding from any adverse health effects2

related to the use of nanotechnology in the for-3

mulation of cosmetic (including progress in the4

standardization of testing methods and specific5

size definitions for nanomaterials); and6

(B) consider scale specific hazard prop-7

erties of ingredients when reviewing and evalu-8

ating the safety of cosmetics and ingredients9

under paragraph (1).10

(3) AUTHORITATIVE SOURCE DEFINED.For11

purposes of this paragraph, the term authoritative12

source means13

(A) the Environmental Protection Agen-14

cy;15

(B) the International Agency for Re-16

search on Cancer;17

(C) the National Toxicity Program18

through the National Institutes of Health;19

(D) the California Environmental Protec-20

tion Agency; and21

(E) any other authoritative international,22

Federal, and State entity, as determined by the23

Secretary.24



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SEC. 616. LISTS OF INGREDIENTS AND REQUIRED RE-1

SPONSES.2

(a) PLACEMENT ON LIST.3

(1) IN GENERAL.Based on an initial review4

and evaluation of an ingredient under subsection (c),5

the Secretary shall place the ingredient on one of the6

following lists:7

(A) The prohibited and restricted list8

under subsection (b).9

(B) The safe without limits list under10

subsection (c).11

(C) The priority assessment list under12

subsection (d).13

(2) CONSIDERATIONS.In determining the14

placement of an ingredient on a list under sub-15

section (a), the Secretary shall consider whether the16

ingredient17

(A) reacts with other substances to form18

harmful contaminants;19

(B) is found to be present in the body20

through biomonitoring;21

(C) is found in drinking water or air;22

(D) is a known or suspected neurological23

or immunological toxicant, respiratory24

asthmagen, carcinogen, teratogen, or endocrine25

disruptor, or have other toxicological concerns26



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(including reproductive or developmental tox-1

icity); or2

(E) is known to persist in the environ-3

ment or bioaccumulate.4

(3) PRIORITIZIATION OF INGREDIENTS THAT5

ARE FOOD.In placing ingredients on the lists6

under paragraph (1), the Secretary shall prioritize7

the placement of ingredients that are food (as such8

term is defined under section 201(f)) on such lists.9

(b) PROHIBITED AND RESTRICTED LIST.10

(1) IN GENERAL.Not later than 2 years11

after the date of the enactment of this subchapter,12

the Secretary shall issue, by regulation, a list of in-13

gredients that are identified by the Secretary14

(A) as prohibited for use because the Sec-15

retary determines that such ingredients are un-16

safe for use in cosmetics in any amount because17

such ingredients fail to meet the safety stand-18

ard under section 614(a); or19

(B) as being subject to necessary restric-20

tions in use or concentration to allow the use of21

the ingredient in a cosmetic to satisfy the safety22

standard.23

(2) SPECIFICATION OF RESTRICTIONS.In the24

case of any ingredient listed under paragraph25



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(1)(B), the Secretary shall specify the restrictions on1

use or concentration that are necessary to satisfy the2

safety standard for such ingredient.3

(3) UPDATES.The Secretary shall, at a min-4

imum, annually update the list under paragraph (1),5

including any6

(A) determinations under subsection7

(d)(3); or8

(B) new information that demonstrates9

that an ingredient fails to meet the safety10

standard, or requires restrictions on use to11

meet such standard.12

(4) M ANUFACTURER REQUIREMENTS.Not13

later than 1 year after the date that an ingredient14

is placed on a list under subsection (b), any manu-15

facturer using such ingredient in a cosmetic shall re-16

formulate such cosmetic to17

(A) eliminate the use of the ingredient, if18

it is listed under paragraph (1)(A); or19

(B) modify the use of the ingredient if it20

is listed under paragraph (1)(B), to meet the21

restrictions specified under paragraph (2).22

(c) SAFEWITHOUT LIMITS LIST.23





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the Secretary shall issue, by regulation, a list of in-1

gredients that the Secretary has determined are safe2

for use in cosmetics, without limits or restrictions.3

(2) STANDARD FOR INCLUSION IN LIST.The4

Secretary may only include an ingredient on the list5

under paragraph (1) if the Secretary determines6

that the ingredient meets the safety standard under7

section 614(a), regardless of8

(A) the type and form of cosmetic the in-9

gredient is used in; and10

(B) the concentration of the ingredient11

that is used in a cosmetic.12

(3) UPDATES AND REDETERMINATIONS.The13

Secretary shall annually update the list under para-14

graph (1) and may redetermine whether an ingre-15

dient distributed in commerce meets the safety16

standard if, in the judgment of the Secretary, new17

information raises a credible question as to whether18

the ingredient continues to meet the safety standard.19

(d) PRIORITY ASSESSMENT LIST AND RELATED20

SAFETY DETERMINATIONS.21



the Secretary shall develop and publish a priority as-24

sessment list of not less than 300 ingredients25



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(A) which, because of a lack of authori-1

tative information on the safety of the ingre-2

dient, cannot be included on3

(i) the list under subsection (b) (re-4

lating to prohibited and restricted ingredi-5

ents); or6

(ii) the list under subsection (c) (re-7

lating to ingredients that are safe without8

limits); and9

(B) for which the Secretary has deter-10

mined it is a priority to conduct a safety deter-11

mination under paragraph (3).12

(2) ANNUAL ADDITION OF INGREDIENTS.13

After the list is developed under paragraph (1), the14

Secretary shall annually add at least 100 additional15

ingredients to such list until all ingredients that are16

used in the formulation or manufacture of cosmetics17

have been added18

(A) to such list;19

(B) to the list under subsection (b); or20

(C) to the list under subsection (c).21

(3) DETERMINATION OF WHETHER INGRE-22

DIENT MEETS SAFETY STANDARD.23

(A) REVIEW OF PRIORITY INGREDI-24

ENTS.During the 2-year period following the25



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date on which an ingredient is placed on the list1

under paragraph (1), the Secretary shall2

(i) collect data and information on3

such ingredient; and4

(ii) review and evaluate the safety of5

such ingredient.6

(B) DETERMINATION OF LIST PLACE-7

MENT.Not later than the end of the period8

under subparagraph (A), the Secretary shall9

issue a determination, based on the review and10

evaluation under such clause, that11

(i) the ingredient meets the require-12

ments for inclusion on a list under sub-13

section (b) (relating to prohibited and re-14

stricted ingredients) or subsection (c) (re-15

lating to ingredients that are safe without16

limits); or17

(ii) insufficient information exists to18

place the ingredient on either such list.19

(C) GUIDANCE IN THE CASE OF INSUFFI-20

CIENT INFORMATION.If the Secretary deter-21

mines under subparagraph (B) that, with re-22

spect to an ingredient, insufficient information23

exists to place such ingredient on either of the24

lists under subsection (b) or subsection (c), the25



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Secretary shall provide guidance to manufactur-1

ers on the data and information (including min-2

imum data requirements and safety testing pro-3

tocols) that the Secretary requires to evaluate4

whether the ingredient meets the safety stand-5

ard under section 614(a) for purposes of plac-6

ing such ingredient on such a list.7

(D) COMMENT PERIOD.Upon issuing8

the determination under subparagraph (B),9

and, if applicable, the guidance under subpara-10

graph (C), the Secretary shall provide a period11

of not less than 60 days for public comment on12

the determination before applying such deter-13

mination to an ingredient, except that a shorter14

period for comment may be provided if the Sec-15

retary16

(i) finds that it would be in the pub-17

lic interest to have a shorter period; and18

(ii) publically declares the reasons19

for such finding.20

(4) M ANUFACTURER RESPONSE TO INAD-21

EQUATE INFORMATION.Not later than 18 months22

after the date that the Secretary issues guidance23

under paragraph (3)(C) with respect to an ingre-24

dient subject to a determination under paragraph25



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(3)(B), a manufacturer using such ingredient in a1

cosmetic shall2

(A) reformulate such cosmetic to elimi-3

nate the use of the ingredient; or4

(B) provide the Secretary with the data5

and information specified in such guidance.6

(5) E VALUATION OF ADDITIONAL DATA AND7

INFORMATION.With respect to an ingredient, not8

later than 6 months after a manufacturer provides9

the Secretary with the data and information under10

paragraph (4)(B) the Secretary shall review such11

data and information and shall make a redetermina-12

tion under paragraph (3)(B) for such ingredient,13

subject to the comment period under paragraph14

(3)(D).15

(6) LIMITATION.If the Secretary has not16

placed an ingredient on either of the lists under sub-17

section (b) and subsection (c) by the end of the 5-18

year period beginning on the date that such ingre-19

dient is first placed on the list under subsection (d),20

beginning on the first day after such period such in-21

gredient may not be22

(A) used in a cosmetic; and23

(B) manufactured, imported, distributed,24

or marketed for use in cosmetics.25



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SEC. 617. TREATMENT OF COSMETICS BASED ON INGRE-1

DIENT LISTS.2

(a) IN GENERAL.Subject to subsections (b)(4)3

and (d)(4) of section 616, a manufacturer may only manu-4

facture a cosmetic for distribution in interstate commerce5

if such cosmetic meets the safety standard under section6

614(a).7

(b) PRESUMPTION RELATED TO THE S AFETY OF8

COSMETICS.9

(1) IN GENERAL.Subject to paragraph (2),10

for purposes of subsection (a), the Secretary shall11

presume that the following cosmetics meet the safety12

standard under section 614(a):13

(A) A cosmetic that is made solely of in-14

gredients on the list under section 616(c)(1)15

(relating to ingredients that are safe without16

limits).17

(B) A cosmetic that is made solely of in-18

gredients on the list under section 616(b)(1)(B)19

(relating to ingredients subject to restrictions)20

and the use of each of such ingredients in such21

cosmetic is in compliance with the restrictions22

on the use of such ingredients specified under23

section 616(b)(2).24



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(C) A cosmetic that is made solely of in-1

gredients described under subparagraph (A)2

and subparagraph (B).3

(2) EXCEPTIONS.The Secretary may require4

that a manufacturer demonstrate that a cosmetic5

meets the safety standard under section 614(a) (in-6

cluding by requiring that the manufacturer conduct7

safety testing of a cosmetic described under para-8

graph (1)) if the cosmetic9

(A) contains penetration enhancers, sensi-10

tizers, estrogenic chemicals, or other similar in-11

gredients;12

(B) contains ingredients that react with13

each other or with other substances to form14

harmful byproducts; or15

(C) the Secretary has any additional rea-16

son to believe that such cosmetic does not meet17

the safety standard under section 614(a).18

(3) GUIDANCE.If, under paragraph (2), the19

Secretary requires that a manufacturer demonstrate20

that a cosmetic meets the safety standard under sec-21

tion 614(a), the Secretary shall provide the manu-22

facturer with guidance on the data and information23

that the Secretary requires to evaluate whether the24



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cosmetic meets the safety standard under such sec-1

tion.2

(c) NOTIFICATION OF F AILURE OF SECRETARY TO3

ACT.If the Secretary fails to act by an applicable dead-4

line under section 616 or this section, a manufacturer of5

an ingredient or a cosmetic affected by such failure of the6

Secretary to act shall issue to the Secretary, the public,7

and each known customer of the ingredient or cosmetic,8

a written notice that a determination by the Secretary of9

the safety of the ingredient for use in cosmetics is pending.10

SEC. 618. TREATMENT OF CONTAMINANTS.11

(a) PUBLICATION OF LIST.Not later than 1 year12

after the date of the enactment of this subchapter, and13

annually thereafter, the Secretary shall publish a list of14

(1) ingredients used in cosmetics that may15

contain contaminants;16

(2) combinations of ingredients that may cre-17

ate contaminants when such ingredients interact;18

(3) contaminants that may leech from product19

packaging into a cosmetic; and20

(4) any other contaminant of cosmetics identi-21

fied by the Secretary.22

(b) REQUIREMENTS FOR TESTING.23

(1) IN GENERAL.Not later than 1 year after24

the date of enactment of this subchapter, the Sec-25



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retary shall establish, by rule, requirements for test-1

ing ingredients and cosmetics for contaminants list-2

ed under subsection (a).3

(2) CONTENTS.The requirements under4

paragraph (1) shall include5

(A) testing methods and applicable proto-6

cols; and7

(B) maximum allowable detection limits8

for each contaminant in an ingredient.9

(3) UPDATE.The Secretary shall annually10

update the requirements under paragraph (1).11

(c) SUPPLIER REQUIREMENTS.Not later than 112

year after the promulgation of the rule under subsection13

(b)(1), a supplier of an ingredient that is used in a cos-14

metic shall, with respect to such ingredient15

(1) comply with the requirements under sub-16

section (b)(1) for any ingredient listed under sub-17

section (a);18

(2) conduct similar testing on any ingredient19

that20

(A) the supplier expects may be used in21

a cosmetic;22

(B) the supplier suspects may contain a23

contaminant; and24

(C) is not listed under subsection (a); and25



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(3) upon the sale of an ingredient to the man-1

ufacturer, provide to the manufacturer specifications2

for the ingredient that3

(A) include the levels of contaminants4

present in such ingredient; and5

(B) are based on the results of the tests6

under paragraph (1) and paragraph (2).7

(d) MANUFACTURER REQUIREMENTS.Not later8

than 1 year after the promulgation of the rule under sub-9

section (b)(1), a manufacturer of a cosmetic shall, with10

respect to each ingredient that the manufacturer uses in11

a cosmetic12

(1) obtain, from each supplier of the ingre-13

dient, specifications for the ingredient that include14

(A) the level of each contaminant present15

in the ingredient; and16

(B) the detection limits of the analytical17

test used to detect the contaminant; or18

(2) comply with the requirements under para-19

graphs (1) and (2) of subsection (c) for the ingre-20

dient, in the same manner as if the manufacturer21

were a supplier.22

SEC. 619. COSMETIC AND INGREDIENT STATEMENTS.23

(a) IN GENERAL.Beginning 1 year after the date24

of the enactment of this subchapter, each establishment25



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engaged in the manufacture of a cosmetic intended to be1

marketed in the United States shall submit electronically2

to the Secretary, for each cosmetic manufactured in the3

establishment that is intended to be marketed in the4

United States, a statement containing5

(1) the registration number of the manufac-6

turing establishment where the cosmetic is manufac-7

tured or, if the same cosmetic is manufactured in8

more than 1 establishment, the registration number9

of each establishment where it is manufactured;10

(2) the registration number of the establish-11

ment responsible for distributing the cosmetic;12

(3) the brand name and the product name for13

the cosmetic;14

(4) the applicable use for the cosmetic;15

(5) the ingredient list as it appears on the cos-16

metic label or insert, including the particle size17

range of any nanoscale cosmetic ingredients;18

(6) any warnings and directions for use from19

the cosmetic label or insert; and20

(7) the title and full contact information for21

the individual responsible for submitting and main-22

taining such statement.23

(b) NEW COSMETICS.Any establishment that be-24

gins to manufacture a cosmetic after the date of the enact-25



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ment of this subchapter shall comply with the require-1

ments of subsection (a) beginning on the later of the fol-2

lowing:3

(1) The end of the 18-month period beginning4

on the date of the enactment of this subchapter.5

(2) The 6-month period after the date on6

which the establishment begins to manufacture such7

cosmetic.8

(c) NOTIFICATION OF CHANGES.The establish-9

ment shall notify the Secretary annually of any change10

to the information required under subsection (a).11

(d) PROCEDURE.Upon receipt of a completed12

statement described under subsection (a), the Secretary13

shall notify the establishment of the receipt of such state-14

ment and assign a cosmetic statement number.15

(e) LIST.The Secretary shall compile, maintain,16

and update as appropriate, a list of cosmetics for which17

statements are submitted under this section.18

(f) ACCESS TO SAFETY INFORMATION.The cos-19

metic and ingredient statements collected under this sec-20

tion shall be added to the publicly accessible database cre-21

ated by the Secretary under section 615(b).22



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SEC. 620. NOTIFICATION, NONDISTRIBUTION, AND RECALL1

OF ADULTERATED OR MISBRANDED COS-2

METICS.3

(a) NOTIFICATION OF ADULTERATED OR MIS-4

BRANDED COSMETICS.5

(1) IN GENERAL.A responsible party that6

has reason to believe that a cosmetic, when intro-7

duced into or while in interstate commerce, or while8

held for sale (regardless of whether such sale is the9

first sale of such cosmetic) after shipment in inter-10

state commerce, is adulterated or misbranded in a11

manner that presents a reasonable probability that12

the use or exposure to the cosmetic (or an ingredient13

or component used in any such cosmetic) will cause14

a threat of serious adverse health effects or death to15

humans shall notify the Secretary of the identity and16

location of the cosmetic.17

(2) M ANNER OF NOTIFICATION.Notification18

under paragraph (1) shall be made in such manner19

and by such means as the Secretary may require by20

regulation or guidance.21

(3) RESPONSIBLE PARTY DEFINED.For pur-22

poses of this subsection, the term responsible party23

means a manufacturer, packager, retailer, or dis-24

tributor of the cosmetic.25



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(b) VOLUNTARY RECALL.The Secretary may re-1

quest that any person who distributes a cosmetic that the2

Secretary has reason to believe is adulterated, misbranded,3

or otherwise in violation of this Act voluntarily4

(1) recall such cosmetic; and5

(2) provide for notice, including to individuals6

as appropriate, to persons who may be affected by7

the recall.8

(c) ORDER TO CEASE DISTRIBUTION.9

(1) IN GENERAL.If the Secretary has reason10

to believe that11

(A) the use of, or exposure to, a cosmetic12

may cause serious adverse health effects or13

death to humans;14

(B) the cosmetic is misbranded; or15

(C) the cosmetic is manufactured, pack-16

aged, or distributed by an unregistered facility;17

the Secretary shall have the authority to issue an18

order requiring any person who distributes such cos-19

metic to immediately cease distribution of such cos-20

metic.21

(2) CEASE DISTRIBUTION AND NOTICE.Any22

person who is subject to an order under paragraph23

(1) shall immediately cease distribution of such cos-24



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metic and provide notification as required by such1

order.2

(3) APPEAL.3

(A) 24 HOURS.A person subject to an4

order under paragraph (1) may appeal such5

order to the Secretary within 24 hours of the6

issuance of such order.7

(B) CONTENTS OF APPEAL.Such appeal8

may include a request for an informal hearing9

and a description of any efforts to recall such10

cosmetic undertaken voluntarily by the person,11

including after a request under subsection (b).12

(C) INFORMAL HEARING.Except as pro-13

vided in subsection (e), an informal hearing14

shall be held as soon as practicable, but not15

later than 5 calendar days (or less as deter-16

mined by the Secretary) after such an appeal is17

filed, unless the parties jointly agree to an ex-18

tension.19

(D) IMPACT ON RECALL.If an appeal is20

filed under subparagraph (A), the Secretary21

may not amend the order to require a recall22

under subsection (d) until after the conclusion23

of the hearing under subparagraph (C).24



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(4) V ACATION OF ORDER.If the Secretary1

determines that inadequate grounds exist to support2

the actions required by the order under paragraph3

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

(d) ORDER TO RECALL.5

(1) AMENDMENT.Except as provided under6

subsection (e) and subject to subsection (c)(3)(D), if7

the Secretary determines that a recall of a cosmetic8

subject to an order under subsection (c) is appro-9

priate, the Secretary shall amend the order to re-10

quire a recall.11

(2) CONTENTS.An amended order under12

paragraph (1) shall13

(A) specify a timetable in which the recall14

will occur;15

(B) require periodic reports to the Sec-16

retary describing the progress of the recall; and17

(C) provide for notice, including to indi-18

viduals as appropriate, to persons who may be19

affected by the recall.20

In providing for such notice, the Secretary may21

allow for the assistance of health professionals, State22

or local officials, or other individuals designated by23

the Secretary.24



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(3) NONDELEGATION.An amended order1

under this subsection may only be issued by the Sec-2

retary or an official designated by the Secretary, and3

may not be delegated to another official or employee.4

(4) DETERMINATION.If the Secretary deter-5

mines that inadequate grounds exist to support the6

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

the Secretary shall remove such amendment from8

such order.9

(e) EMERGENCY RECALL ORDER.10

(1) IN GENERAL.If the Secretary has cred-11

ible evidence or information that a cosmetic subject12

to an order under subsection (c) presents an immi-13

nent threat of serious adverse health effects or death14

to humans, the Secretary may issue an order requir-15

ing any person who distributes such cosmetic16

(A) to immediately recall such cosmetic;17

and18

(B) to provide for notice, including to in-19

dividuals as appropriate, to persons who may be20

affected by the recall.21

(2) RECALL AND NOTICE.Any person who is22

subject to an emergency recall order under this sub-23

section shall immediately recall such cosmetic and24

provide notification as required by such order.25



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(3) APPEAL.1

(A) 24 HOURS.Any person subject to2

such an order may appeal such order to the3

Secretary within 24 hours of the issuance of4

such order.5

(B) CONTENTS OF APPEAL.Such appeal6

may include a request for an informal hearing7

and a description of any efforts to recall such8

cosmetic undertaken voluntarily by the person,9

including after a request under subsection (b).10

(C) INFORMAL HEARING.An informal11

hearing shall be held as soon as practicable12

after the appeal is filed under subparagraph13

(A), but not later than 5 calendar days after14

such an appeal is filed, or fewer days (as deter-15

mined by the Secretary), unless the parties16

jointly agree to an extension.17

(4) V ACATION OF ORDER.If the Secretary18

determines that inadequate grounds exist to support19

the actions required by the order under paragraph20

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

(5) NONDELEGATION.An order under this22

subsection may only be issued by the Secretary or an23

official designated by the Secretary, and may not be24

delegated to another official or employee.25



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(f) NOTICE TO CONSUMERS AND HEALTH OFFI-1

CIALS.The Secretary shall, as the Secretary determines2

to be necessary, provide notice of a recall order under this3

section to consumers to whom the cosmetic was, or may4

have been, distributed and to appropriate State and local5

health officials.6

(g) SUPPLY CHAIN INFORMATION.7

(1) IN GENERAL.In the case of a cosmetic8

that the Secretary has reason to believe is adulter-9

ated, misbranded, or otherwise in violation of this10

Act, the Secretary shall request that the entity11

named on the label of such cosmetic (as required12

under section 602(b)(1)) submit all of the following13

information:14

(A) The name and place of business of15

the manufacturer, packer, or distributor from16

which such entity received the cosmetic or in-17

gredients for manufacturing such cosmetic.18

(B) The name and place of business of19

any entity (including any retailer) that was pro-20

vided with such cosmetic by the entity named21

on the label.22

(2) COLLECTION OF ADDITIONAL SUPPLY23

CHAIN INFORMATION.In the case of a cosmetic24

that the Secretary has reason to believe is adulter-25



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ated, misbranded, or otherwise in violation of this1

Act, to the extent necessary to protect the safety of2

the public, the Secretary may request that any entity3

(including a supplier of an ingredient, manufacturer,4

packer, distributor, or retailer) in the supply chain5

of such cosmetic submit to the Secretary information6

that is similar to the information described under7

subparagraphs (A) and (B) of paragraph (1).8

(3) M AINTENANCE OF RECORDS.Any entity9

in supply chain of a cosmetic (including the entity10

named on the label of a cosmetic) shall11

(A) maintain records sufficient to provide12

the information described in subparagraphs (A)13

and (B) of paragraph (1); and14

(B) provide such information to the Sec-15

retary upon the request of the Secretary.16

(h) SAVINGS CLAUSE.Nothing contained in this17

section shall be construed as limiting the authority of the18

Secretary to issue an order to cease distribution of, or to19

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

SEC. 621. PETITIONS.21

(a) IN GENERAL.The Secretary shall complete22

and publish a review, and, if appropriate, immediately re-23

vise related, relevant information, including ingredient24

lists, ingredient restrictions or prohibitions, or ingredient25



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or cosmetic safety determinations, not later than 6 months1

after the date on which the Secretary receives from any2

individual or entity a reasonable petition3

(1) to prohibit or restrict an ingredient for use4

in cosmetics and list such ingredient on the list5

under section 616(b);6

(2) to remove an ingredient from the list of in-7

gredients that are safe without limits under section8

616(c);9

(3) to add an ingredient to the priority assess-10

ment list under section 616(d); or11

(4) to add an ingredient to the list of contami-12

nants under section 618.13

(b) REASONABLE PETITION.Not later than 1 year14

after the date of the enactment of this Act, the Secretary15

shall issue rules specifying the criteria which the Secretary16

will use to determine if a petition submitted under this17

section is a reasonable petition.18

SEC. 622. MANDATORY REPORTING OF ADVERSE HEALTH19

EFFECTS.20

(a) SUBMISSION OF REPORT ON ADVERSE HEALTH21

EFFECTS.The Secretary shall require that the manufac-22

turer, packager, or distributor of a cosmetic whose name23

appears on the label of a cosmetic marketed in the United24

States submit to the Secretary a report containing infor-25



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mation received concerning any adverse health effect asso-1

ciated with the use of the cosmetic.2

(b) TIMING OF REPORT.A report under subsection3

(a) shall be submitted to the Secretary not later than 154

business days after information concerning the adverse5

health effect is received at the place of business of the6

manufacturer, packager, or distributor.7

(c) CONTENT OF REPORT.A report under sub-8

section (a) shall include the following information, to the9

extent to which the manufacturer, packager, or distributor10

submitting the report has been able to verify the informa-11

tion:12

(1) The identity of the individual experiencing13

the adverse health effect.14

(2) An identifiable report of such effect.15

(3) The name of the cosmetic suspected of16

causing such effect.17

(4) A description of the adverse health effect.18

(d) PUBLICAVAILABILITY AND PRIVACY.19

(1) PUBLIC AVAILABILITY.Subject to para-20

graph (2), the adverse health effect reports collected21

by the Secretary under this section shall be sub-22

mitted electronically and shall be made accessible to23

the public.24

(2) PRIVACY.25



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(A) PERSONALLY IDENTIFIABLE INFOR-1

MATION.Notwithstanding any other provision2

of law, personally identifiable information in ad-3

verse health effect reports provided to the Sec-4

retary under this section, shall not5

(i) be made publicly available pursu-6

ant to any State or other law requiring dis-7

closure of information or records; or8

(ii) otherwise be disclosed or distrib-9

uted to any party without the written con-10

sent of the Secretary and the person sub-11

mitting such information to the Secretary.12

(B) TREATMENT OF INFORMATION13

UNDER PRIVACY ACT AND FOIA.An adverse14

health effect report submitted to the Secretary15

under this section, shall be considered to be a16

record about an individual under section 552a17

of title 5, United States Code (commonly re-18

ferred to as the Privacy Act of 1974) and a19

medical or similar file the disclosure of which20

would constitute a violation of section 552 of21

such title 5 (commonly referred to as the22

Freedom of Information Act), and shall not23

be publicly disclosed unless all personally identi-24

fiable information is redacted.25



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SEC. 623. NONCONFIDENTIAL INFORMATION.1

(a) INFORMATION A VAILABLE TO PUBLIC.Subject2

to subsection (c) and section 622(d)(2), all nonconfidential3

information submitted pursuant to this subchapter shall4

be made available to the public, including the following5

types of information:6

(1) The name, identity, and structure of a7

chemical substance, contaminant, or impurity that is8

an ingredient.9

(2) All information concerning function, expo-10

sure, health hazards, and environmental hazards for11

a cosmetic., and12

(3) The functions of ingredients in cosmetics.13

(4) Fragrance, flavor, and colorants in a cos-14

metic15

(b) CONFIDENTIAL INFORMATION.The concentra-16

tion of cosmetic ingredients used in a finished cosmetic17

shall be considered confidential business information and18

may not be made available to the public under subsection19

(a).20

(c) PETITION FOR INFORMATION TO REMAIN CON-21

FIDENTIAL.22

(1) IN GENERAL.The Secretary shall create23

a process for an entity to petition for nonconfidential24

information described in subsection (a) to remain25

confidential if the entity shows that there would be26



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a serious negative impact to the entitys commercial1

interests if such information were disclosed to the2

public.3

(2) LIMITATION.The Secretary may not ap-4

prove a petition under paragraph (1) to the extent5

that such petition would prevent the public disclo-6

sure of7

(A) the name, identity, and structure of8

any chemical substance, contaminant, or impu-9

rity that is an ingredient;10

(B) all health and safety data related to11

that substance, contaminant, or impurity; or12

(C) any data used to substantiate the13

safety of that substance, contaminant, or impu-14

rity.15

SEC. 624. ANIMAL TESTING ALTERNATIVES.16

(a) IN GENERAL.To minimize the use of animal17

testing of ingredients and cosmetics, the Secretary shall18

(1) require, where practicable, alternative test-19

ing methods that20

(A) do not involve the use of an animal21

to test the chemical substance;22

(B) provide information that is equivalent23

or superior in scientific quality to the animal24

testing method; and25



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(C) use fewer animals than conventional1

animal-based tests when nonanimal methods2

are impracticable, including the use of tests3

that combine multiple endpoints; and4

(2) encourage, where practicable5

(A) estimation of toxicological properties6

of a chemical through the use of testing infor-7

mation for 1 or more structurally similar chemi-8

cals where such estimates provide information9

of sufficient scientific quality;10

(B) the formation of industry consortia to11

conduct testing to avoid duplication of tests;12

and13

(C) funding for research and validation of14

alternative test methods, in accordance with15

this subsection.16

(b) LIST OF ALTERNATIVE TESTING METHODS.17

Not later than 1 year after the date of the enactment of18

this subchapter, and triennially thereafter, the Secretary19

shall publish a list of the alternative testing methods de-20

scribed in subsection (a).21

SEC. 625. PRODUCT TESTING AND REVIEW AUDIT.22

The Secretary shall conduct annual audits of ran-23

dom samples of cosmetics to assess or test for acute nega-24

tive reactions, pathogen hazards, contaminants, leaching25



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of packaging additives, mislabeling, or other relevant1

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

SEC. 626. RESOURCES FOR SMALL BUSINESSES.3

The Secretary shall provide technical support to as-4

sist small businesses in carrying out the requirements of5

this subchapter.6

SEC. 627. INTERAGENCY COOPERATION.7

(a) INTERAGENCY COUNCIL ON COSMETIC SAFE-8

TY.There is established an Interagency Council on Cos-9

metic Safety for the purpose of sharing data and pro-10

moting collaboration on cosmetic safety between the Food11

and Drug Administration, the National Institute of Envi-12

ronmental Health Sciences, the Centers for Disease Con-13

trol and Prevention, the Occupational Safety and Health14

Administration, and the Environmental Protection Agen-15

cy.16

(b) USE OF DATA FROM FEDERAL SOURCES.For17

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

shall request and utilize ingredient and cosmetic toxicity,19

use, and exposure data from other Federal agencies.20

SEC. 628. SAVINGS CLAUSE.21

Nothing in this subchapter shall affect the right of22

a State, political subdivision of a State, or tribe to adopt23

or enforce any regulation, requirement, liability, or stand-24

ard of performance that is more stringent than a regula-25



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tion, requirement, liability, or standard of performance es-1

tablished by this subchapter, including requiring the provi-2

sion of a warning of risk, illness, or injury.3

SEC. 629. AUTHORIZATION OF APPROPRIATIONS.4

There are authorized to be appropriated such sums5

as may be necessary to carry out this subchapter for each6

of the fiscal years 2012 through 2016..7

(b) ADULTERATED AND MISBRANDED COSMETICS.8

(1) ADULTERATED COSMETICS.Section 601 of9

the Federal Food, Drug, and Cosmetic Act (2110

U.S.C. 361) is amended in paragraph (a)11

(A) by striking , except that this provi-12

sion shall not apply to coal-tar hair dye and all13

that follows through or eyebrow dyes; and14

(B) by adding at the end the following:15

(f) If it is manufactured in a manner that fails16

to comply with section 617(a).17

(g) If it is imported, distributed, or marketed18

and19

(1) it contains an ingredient on the list20

under section 616(b)(1)(A), and the manufac-21

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

with respect to such ingredient and such cos-23

metic; or24



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(2) it contains an ingredient on the list1

under section 616(b)(1)(B), such ingredient is2

being used in a manner that violates the limit3

on use or concentration of such ingredient4

under section 616(b)(2), and the manufacturer5

has not complied with section 616(b)(4) with6

respect to such ingredient and such cosmetic.7

(h) If it is manufactured by a manufacturer8

that, with respect to such cosmetic, is required to9

demonstrate, under section 617(b)(2), that the cos-10

metic meets the safety standard and the manufac-11

turer has not yet submitted the required data under12

section 617(b)(3)..13

(2) MISBRANDED COSMETICS.Section 602 of14

the Federal Food, Drug, and Cosmetic Act (2115

U.S.C. 362) is amended16

(A) in paragraph (a), by inserting or17

fails to meet the requirements of section 61318

before the period; and19

(B) by adding at the end the following:20

(g) If it21

(1) was manufactured, packaged, or dis-22

tributed by an entity that failed to register and23

pay the applicable fee as required under section24

612;25



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(2) is manufactured, packaged, distrib-1

uted, or sold in retail by a manufacturer, pack-2

ager, distributor, or retailer, respectively, who3

fails to notify the Secretary as required under4

section 620(a)(1);5

(3) is distributed in violation of an order6

under section 620(c);7

(4) is not recalled as required by an order8

under subsection (d) or (e) of section 620;9

(5) is manufactured in a manner that10

fails to comply with good manufacturing prac-11

tices prescribed by the Secretary under section12

614(b); or13

(6) is manufactured by a manufacturer14

who fails15

(A) to submit the statement required16

under section 619; or17

(B) notify the Secretary of changes18

to information contained in such report, as19

required by such section..20

(3) ADDITIONAL PROHIBITIONS.Section 30121

of the Federal Food, Drug, and Cosmetic Act (2122

U.S.C. 331) is amended by adding at the end the23

following:24



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(aaa) The failure of a manufacturer of a cos-1

metic or an ingredient for use in a cosmetic to sub-2

mit and update data and information as required3

under section 615(a).4

(bbb) The manufacture, importation, distribu-5

tion, or marketing of an ingredient for use in a cos-6

metic that is on the list under section 616(b)(1)(A).7

(ccc) The failure of a supplier of an ingredient8

for use in a cosmetic9

(1) to provide data and information as re-10

quired by section 615(a)(4)(B); or11

(2) comply with the testing requirements12

under section 618(c).13

(ddd) The failure of a manufacturer to comply14

with the requirements of section 618(d).15

(eee) The failure of a manufacturer, packager,16

or distributor of a cosmetic to comply with the re-17

quirement of reporting adverse health effects under18

section 622..19

SEC. 3. WORKER ISSUES.20

(a) IN GENERAL.The Secretary of Labor shall pro-21

mulgate an occupational safety and health standard under22

section 6 of the Occupational Safety and Health Act of23

1970 (29 U.S.C. 655) that requires the following:24



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(1) M ANUFACTURERS AND IMPORTERS.Each1

manufacturer or importer selling any cosmetic for2

professional use shall3

(A) obtain or develop a material safety4

data sheet described in subsection (b) for each5

such cosmetic or personal care product that6

(i) the manufacturer or importer pro-7

duces or imports; and8

(ii) includes a hazardous chemical, or9

a product ingredient associated with any10

chemical hazard, that is classified as a11

health hazard in accordance with the cri-12

teria found in section 1910.1200(d) of title13

29 of the Code of Federal Regulations, and14

any successor regulations; and15

(B) make the material safety data sheet16

available to distributors and employers, includ-17

ing salon owners, in English and, upon request,18

in other languages, including Spanish and Viet-19

namese.20

(2) DISTRIBUTORS.Each distributor of a cos-21

metic or personal care product for professional use22

shall distribute and provide material safety data23

sheets described in subsection (b) in the same man-24

ner as a distributor of a chemical hazard is required25



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to distribute and provide material safety data sheets1

under section 1910.1200(g) of title 29, Code of Fed-2

eral Regulations, or any successor regulations.3

(3) EMPLOYERS.Each employer, including4

any operator of a salon, shall5

(A) have a material safety data sheet in6

the workplace for each cosmetic or personal7

care product for professional use that is used in8

the course of the employers business;9

(B) make such material safety data sheet10

available to all employees of the employer who11

are exposed or use the product to the same ex-12

tent and in the same manner as material safety13

data sheets are required to be made available14

under section 1910.1200(g) of title 29, Code of15

Federal Regulations, or any successor regula-16

tions; and17

(C) upon request, provide employees with18

translations of such material safety data sheet19

in other languages, including Spanish and Viet-20

namese.21

(b) CONTENTS OF MATERIAL SAFETY DATA22

SHEET.A material safety data sheet for a cosmetic or23

personal care product for professional use described in this24

section shall25



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(1) contain the information required in a mate-1

rial safety data sheet under section 1910.1200(g) of2

title 29, Code of Federal Regulations, or any suc-3

cessor regulations, for each hazardous chemical, or4

product ingredient associated with any chemical haz-5

ard, described in subsection (a)(1)(A)(ii); and6

(2) include the following statement: This ma-7

terial safety data sheet is also available in multiple8

languages by contacting the manufacturer, using the9

contact information provided on this sheet..10

(c) PROFESSIONAL USE DEFINED.In this section,11

the term professional use has the meaning given such12

term in section 611(6) of the Federal Food, Drug, and13

Cosmetic Act, except to the extent that such term applies14

to a product that is sold as a retail product in any of the15

establishments listed under such definition.16


Safe Cosmetics Act

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