cosmetics and additional requirements for public dis-
closure of the ingredients in such cosmetics. 
‘‘(c) SPECIAL RULE FOR CONTAMINANTS.—The Sec-
retary shall require, in the case of a contaminant, that 
a contaminant be declared on the label of a cosmetic, in 
the same manner as an ingredient under subsection (a), 
if the contaminant is present at the lower of the following 
levels: 
‘‘(1) A level that is greater than one part-per- 
billion by weight of product formation. 
‘‘(2) A level that is greater than one percent of 
the restriction on the concentration for such con-
taminant for such use, as determined by the Sec-
retary under section 616(a)(2). 
‘‘(d) LABELING
OF
NANOMATERIALS
IN
COS-
METICS.—The Secretary may require that— 
‘‘(1) minerals and other particulate ingredients 
be labeled as ‘nano-scale’ on a cosmetic ingredient 
label or list if not less than 1 percent of the ingre-
dient particles in the cosmetic are 100 nanometers 
or smaller in not less than 1 dimension; and 
‘‘(2) other ingredients in a cosmetic be des-
ignated with scale-specific information on a cosmetic 
ingredient label or list if such ingredients possess 
scale-specific hazard properties. 
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‘‘(e) LABELING
OF INGREDIENTS
IN COSMETICS 
SOLD THROUGH INTERNET COMMERCE.—The Secretary 
shall require— 
‘‘(1) in the case of a cosmetic sold on the Web 
site of an Internet vendor, that the brand owner of 
such cosmetic provide to such Internet vendor a list 
of the ingredients of the cosmetic; and 
‘‘(2) that each Internet vendor display the list 
of ingredients of a cosmetic sold by such vendor on 
the Web page that is the primary Web page pro-
viding information relating to the sale of such cos-
metic on the Web site of the vendor. 
‘‘(f) TRADE SECRETS.—Notwithstanding any other 
provision of law, an ingredient required to be listed on a 
label under this section shall not be treated as a trade 
secret. 
‘‘(g) APPLICATION.—Beginning 18 months after the 
date of the enactment of this subchapter, the requirements 
of this section shall apply to— 
‘‘(1) all cosmetics that are available for retail 
sale (including such cosmetics for professional use); 
and 
‘‘(2) brand owners and Internet vendors of such 
cosmetics. 
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‘‘SEC. 614. SAFETY STANDARD AND GOOD MANUFACTURING 
PRACTICES. 
‘‘(a) SAFETY STANDARD.— 
‘‘(1) IN GENERAL.—Taking into account the ex-
pected use of a cosmetic, the Secretary shall estab-
lish a safety standard that, with respect to a cos-
metic or an ingredient in a cosmetic provides a rea-
sonable certainty of no harm (as such term is de-
fined in section 611(9)) from exposure to the cos-
metic or ingredient and protects the public from any 
known or anticipated adverse health effects associ-
ated with the cosmetic or ingredient. 
‘‘(2) STANDARDS FOR ESTABLISHING SAFETY 
STANDARD.—In establishing the safety standard 
under paragraph (1), the Secretary shall ensure 
that— 
‘‘(A) the likely level of exposure to all 
sources of the ingredient or cosmetic (including 
environmental sources) that will result under 
the safety standard presents not more than a 
one in a million risk for any adverse health ef-
fect in any vulnerable population at the lower 
95th percentile confidence interval; or 
‘‘(B) the safety standard results in expo-
sure to the amount or concentration of an in-
gredient or cosmetic that is shown to produce 
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no adverse health effects, incorporating an mar-
gin of safety of at least 1,000 and considering 
the impact of cumulative exposure from all 
sources (including environmental sources). 
‘‘(3) USE OF OTHER FEDERAL STANDARDS.—If 
any Federal agency has promulgated a standard for 
an ingredient that satisfies the requirements under 
paragraph (1), the Secretary may treat such stand-
ard as the safety standard under paragraph (1) for 
purposes of such ingredient. 
‘‘(4) APPLICATION
OF
SAFETY
STANDARD.— 
The Secretary may only determine that an ingre-
dient or a cosmetic meets the safety standard under 
paragraph (1) if there is a reasonable certainty of no 
harm from exposure to the ingredient or cosmetic. 
‘‘(b) GOOD MANUFACTURING PRACTICES.— 
‘‘(1) IN GENERAL.—The Secretary shall issue 
guidance prescribing good manufacturing practices 
for cosmetics and ingredients, including quality con-
trol procedures that the Secretary determines are 
necessary, and shall update such regulations as nec-
essary. 
‘‘(2) CONSIDERATION OF SMALL BUSINESS.—In 
developing the guidance under paragraph (1), the 
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Secretary shall consider how such practices will im-
pact small businesses. 
‘‘SEC. 615. COSMETIC AND INGREDIENT SAFETY INFORMA-
TION. 
‘‘(a) REQUIRED SUBMISSION OF ALL SAFETY INFOR-
MATION.— 
‘‘(1) IN GENERAL.—Brand owners of cosmetics 
shall submit to the Secretary (in an electronic for-
mat that the Secretary shall determine) all data and 
information that the brand owner can access regard-
ing the safety of the— 
‘‘(A) ingredients listed on the cosmetic 
label under section 613 for a cosmetic; and 
‘‘(B) cosmetic itself. 
‘‘(2) REQUIRED INFORMATION.—The required 
data and information under paragraph (1) shall in-
clude, for each ingredient in a cosmetic and for the 
cosmetic, the following: 
‘‘(A) Functions and uses. 
‘‘(B) Data and information on the phys-
ical, chemical, and toxicity of each such ingre-
dient or cosmetic. 
‘‘(C) Exposure and fate information. 
‘‘(D) Results of all safety tests that the 
brand owner can access or has conducted. 
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‘‘(E) Any other information used to sub-
stantiate the safety of such ingredient and cos-
metic. 
‘‘(3) DEADLINES.— 
‘‘(A) 
INITIAL
SUBMISSION.—A 
brand 
owner shall submit the data and information re-
quired under paragraph (1)— 
‘‘(i) in the case of an ingredient or 
cosmetic which is marketed for sale in 
interstate commerce on or before the date 
of the enactment of this subchapter, not 
later than 1 year after such date; and 
‘‘(ii) in the case of an ingredient or 
cosmetic which is not marketed for sale on 
or before such date— 
‘‘(I) not later than the end of the 
14-month period beginning on the 
date of the enactment of this sub-
chapter; or 
‘‘(II) if the ingredient or cosmetic 
is first marketed for sale in interstate 
commerce after the end of the period 
described in subclause (I), not later 
than 60 days after the date on which 
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such ingredient or cosmetic is first 
marketed for sale. 
‘‘(B) UPDATES.— 
‘‘(i) IN GENERAL.—Subject to clause 
(ii), a brand owner shall update the data 
and information submitted under subpara-
graph (A) annually. 
‘‘(ii) ADVERSE HEALTH EFFECTS.—In 
the case of information related to an ad-
verse health effect that is suspected to be 
caused by an ingredient or a cosmetic, a 
brand owner shall update the information 
not later than 60 days after receiving such 
information. 
‘‘(4) SUPPLIER AND MANUFACTURER INFORMA-
TION.— 
‘‘(A) USE
OF
SUPPLIER
OR
MANUFAC-
TURER INFORMATION.—In order to meet the re-
quirements of paragraph (1) with respect to an 
ingredient, a brand owner may submit safety 
data and information provided by the supplier 
or manufacturer of the ingredient or cosmetic. 
‘‘(B) SUPPLIER OR MANUFACTURER PRO-
VISION OF INFORMATION.—If a brand owner re-
quests that a supplier or manufacturer of an in-
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gredient provide to such brand owner any of the 
data and information described under para-
graph (2) or under section 617, such supplier 
or manufacturer shall provide such data and in-
formation to such brand owner not later than 
90 days after receiving such request. 
‘‘(b) DATABASE.— 
‘‘(1) INITIAL PUBLICATION.—Not later than 1 
year after the date of the enactment of this sub-
chapter, the Secretary shall publish a comprehensive 
database that— 
‘‘(A) is publicly accessible, including on the 
public Web site of the Food and Drug Adminis-
tration; and 
‘‘(B) contains all nonconfidential informa-
tion (as such term is used under section 623) 
submitted under subsection (a)(1). 
‘‘(2) UPDATES.—Not later than 90 days after 
the Secretary receives new or updated information 
under subsection (a)(3)(B), the Secretary shall up-
date the database under paragraph (1) with such in-
formation. 
‘‘(c) REVIEW AND EVALUATION OF INFORMATION.— 
‘‘(1) IN GENERAL.—Based on the data and in-
formation submitted under subsection (a)(1), avail-
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able from an authoritative source (as such term is 
defined in paragraph (3), including data described 
under section 627(b)), and such other information 
as the Secretary may have available, the Secretary 
shall review and evaluate the safety of cosmetics and 
ingredients of cosmetics that are marketed in inter-
state commerce. 
‘‘(2) CONSIDERATION
OF
NANOMATERIALS.— 
The Secretary shall— 
‘‘(A) monitor developments in the scientific 
understanding from any adverse health effects 
related to the use of nanotechnology in the for-
mulation of cosmetics (including progress in the 
standardization of testing methods and specific 
size definitions for nanomaterials); and 
‘‘(B) consider scale specific hazard prop-
erties of ingredients when reviewing and evalu-
ating the safety of cosmetics and ingredients 
under paragraph (1). 
‘‘(3) AUTHORITATIVE SOURCE DEFINED.—For 
purposes of this paragraph, the term ‘authoritative 
source’ means— 
‘‘(A) the Environmental Protection Agen-
cy; 
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‘‘(B) the International Agency for Re-
search on Cancer; 
‘‘(C) 
the 
National 
Toxicity 
Program 
through the National Institutes of Health; 
‘‘(D) the California Environmental Protec-
tion Agency; and 
‘‘(E) any other authoritative international, 
Federal, and State entity, as determined by the 
Secretary. 
‘‘SEC. 616. LISTS OF INGREDIENTS AND REQUIRED RE-
SPONSES. 
‘‘(a) PLACEMENT ON LIST.— 
‘‘(1) IN GENERAL.—Based on an initial review 
and evaluation of an ingredient under subsection (c), 
the Secretary shall place the ingredient on one of the 
following lists: 
‘‘(A) The prohibited and restricted list 
under subsection (b). 
‘‘(B) The safe without limits list under 
subsection (c). 
‘‘(C) The priority assessment list under 
subsection (d). 
‘‘(2) CONSIDERATIONS.—In determining the 
placement of an ingredient on a list under sub-
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section (a), the Secretary shall consider whether the 
ingredient— 
‘‘(A) reacts with other substances to form 
harmful contaminants; 
‘‘(B) is found to be present in the body 
through biomonitoring; 
‘‘(C) is found in drinking water or air; 
‘‘(D) is a known or suspected neurological 
or immunological toxicant, respiratory asth-
magen, carcinogen, teratogen, or endocrine 
disruptor, or have other toxicity concerns (in-
cluding reproductive or developmental toxicity); 
or 
‘‘(E) is known to persist in the environ-
ment or bioaccumulate. 
‘‘(3) PRIORITIZATION
OF
INGREDIENTS
THAT 
ARE
FOOD.—In placing ingredients on the lists 
under paragraph (1), the Secretary shall prioritize 
the placement of ingredients that are food (as such 
term is defined under section 201(f)) on such lists. 
‘‘(b) PROHIBITED AND RESTRICTED LIST.— 
‘‘(1) IN GENERAL.—The Secretary shall issue, 
by regulation, a list of ingredients that are identified 
by the Secretary— 
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‘‘(A) as prohibited for use because the Sec-
retary determines that such ingredients are un-
safe for use in cosmetics in any amount because 
such ingredients fail to meet the safety stand-
ard under section 614(a); or 
‘‘(B) as being subject to necessary restric-
tions in use or concentration to allow the use of 
the ingredient in a cosmetic to satisfy the safety 
standard. 
‘‘(2) INITIAL LIST.— 
‘‘(A) 
DEEMED
PROHIBITED
INGREDI-
ENTS.—Effective as of the date of enactment of 
this subchapter, the following ingredients are 
deemed to be listed pursuant to paragraph 
(1)(A) as prohibited for use: 
‘‘(i) Benzophenones (benzophenone, 
benzophenone-1, 
benzophenone-3 
aka 
oxybenzone). 
‘‘(ii) Octinoxate. 
‘‘(iii) Butylated Hydroxyanisole and 
Butylated Hydroxyoluen. 
‘‘(iv) Coal tar dyes (P-phenylenedia-
mine). 
‘‘(v) Cocamide Diethanolamine. 
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‘‘(vi) Dibutyalated Phthalate (Phthal-
ates DBP), Bis(2-ethylhexyl) Phthalate 
(DEHP). 
‘‘(vii) Toluene. 
‘‘(viii) Styrene or Styrene acrylates. 
‘‘(ix) Formaldehydes (Methylene gly-
col/methanediol/formaldehyde) and Form-
aldehyde-releasing preservatives (DMDM 
hydantoin, diazolidinyl urea, imidazolidinyl 
urea, methenamine, quaternium-15, and 
sodium hydroxymethylglycinate). 
‘‘(x) Triclosan. 
‘‘(xi) Lead acetate or other lead com-
pounds. 
‘‘(xii) Parabens (isoproylparaben, iso-
butylparaben, pheylparaben, benzylpara-
ben, pentylparaben, propylparaben and 
butylparaben). 
‘‘(B) FIRST INGREDIENTS LISTED BY REG-
ULATION.—Not later than 2 years after the 
date of enactment of this subchapter, the Sec-
retary shall promulgate by final regulation the 
list required by subparagraphs (A) and (B) of 
paragraph (1), to supplement the ingredients 
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deemed by subparagraph (A) of this paragraph 
to be listed pursuant to paragraph (1)(A). 
‘‘(3) SPECIFICATION OF RESTRICTIONS.—In the 
case of any ingredient listed under paragraph 
(1)(B), the Secretary shall specify the restrictions on 
use or concentration that are necessary to satisfy the 
safety standard for such ingredient. 
‘‘(4) UPDATES.—After promulgating the initial 
list pursuant to paragraph (2)(B), the Secretary 
shall, at a minimum, annually update the list under 
paragraph (1), including any— 
‘‘(A) 
determinations 
under 
subsection 
(d)(3); or 
‘‘(B) new information that demonstrates 
that an ingredient fails to meet the safety 
standard, or requires restrictions on use to 
meet such standard. 
‘‘(5) MANUFACTURER
REQUIREMENTS.—Not 
later than 1 year after the date that an ingredient 
is placed on a list under this subsection, any manu-
facturer using such ingredient in a cosmetic shall re-
formulate such cosmetic to— 
‘‘(A) eliminate the use of the ingredient, if 
it is listed under paragraph (1)(A); or 
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‘‘(B) modify the use of the ingredient if it 
is listed under paragraph (1)(B), to meet the 
restrictions specified under paragraph (3). 
‘‘(c) SAFE WITHOUT LIMITS LIST.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of the enactment of this subchapter, 
the Secretary shall issue, by regulation, a list of in-
gredients that the Secretary has determined are safe 
for use in cosmetics, without limits or restrictions. 
‘‘(2) STANDARD FOR INCLUSION IN LIST.—The 
Secretary may only include an ingredient on the list 
under paragraph (1) if the Secretary determines 
that the ingredient meets the safety standard under 
section 614(a), regardless of— 
‘‘(A) the type and form of cosmetic the in-
gredient is used in; and 
‘‘(B) the concentration of the ingredient 
that is used in a cosmetic. 
‘‘(3) UPDATES AND REDETERMINATIONS.—The 
Secretary shall annually update the list under para-
graph (1) and may redetermine whether an ingre-
dient distributed in commerce meets the safety 
standard if, in the judgment of the Secretary, new 
information raises a credible question as to whether 
the ingredient continues to meet the safety standard. 
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‘‘(d) PRIORITY ASSESSMENT LIST
AND RELATED 
SAFETY DETERMINATIONS.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of the enactment of this subchapter, 
the Secretary shall develop and publish a priority as-
sessment list of not less than 300 ingredients— 
‘‘(A) which, because of a lack of authori-
tative information on the safety of the ingre-
dient, cannot be included on— 
‘‘(i) the list under subsection (b) (re-
lating to prohibited and restricted ingredi-
ents); or 
‘‘(ii) the list under subsection (c) (re-
lating to ingredients that are safe without 
limits); and 
‘‘(B) for which the Secretary has deter-
mined it is a priority to conduct a safety deter-
mination under paragraph (3). 
‘‘(2) ANNUAL
ADDITION
OF
INGREDIENTS.— 
After the list is developed under paragraph (1), the 
Secretary shall annually add at least 100 additional 
ingredients to such list until all ingredients that are 
used in the formulation or manufacture of cosmetics 
have been added— 
‘‘(A) to such list; 
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‘‘(B) to the list under subsection (b); or 
‘‘(C) to the list under subsection (c). 
‘‘(3) DETERMINATION
OF
WHETHER
INGRE-
DIENT MEETS SAFETY STANDARD.— 
‘‘(A) REVIEW
OF
PRIORITY
INGREDI-
ENTS.—During the 2-year period following the 
date on which an ingredient is placed on the list 
under paragraph (1), the Secretary shall— 
‘‘(i) collect data and information on 
such ingredient; and 
‘‘(ii) review and evaluate the safety of 
such ingredient. 
‘‘(B) DETERMINATION
OF
LIST
PLACE-
MENT.—Not later than the end of the period 
under subparagraph (A), the Secretary shall 
issue a determination, based on the review and 
evaluation under such clause, that— 
‘‘(i) the ingredient meets the require-
ments for inclusion on a list under sub-
section (b) (relating to prohibited and re-
stricted ingredients) or subsection (c) (re-
lating to ingredients that are safe without 
limits); or 
‘‘(ii) insufficient information exists to 
place the ingredient on either such list. 
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‘‘(C) GUIDANCE IN THE CASE OF INSUFFI-
CIENT INFORMATION.—If the Secretary deter-
mines under subparagraph (B) that, with re-
spect to an ingredient, insufficient information 
exists to place such ingredient on either of the 
lists under subsection (b) or subsection (c), the 
Secretary shall provide guidance on the data 
and information (including minimum data re-
quirements and safety testing protocols) that 
the Secretary requires to evaluate whether the 
ingredient meets the safety standard under sec-
tion 614(a) for purposes of placing such ingre-
dient on such a list. 
‘‘(D) COMMENT
PERIOD.—Upon issuing 
the determination under subparagraph (B), 
and, if applicable, the guidance under subpara-
graph (C), the Secretary shall provide a period 
of not less than 60 days for public comment on 
the determination before applying such deter-
mination to an ingredient, except that a shorter 
period for comment may be provided if the Sec-
retary— 
‘‘(i) finds that it would be in the pub-
lic interest to have a shorter period; and 
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