,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #djge  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,novemb] #ah1 #bjae   
,mr4 ,sessions introduc$ ! foll[+ bill2 
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act to       
e/abli% new proc$ures & requirem5ts = ! 
regi/ration ( cosmetic manufactur+      
e/abli%m5ts1 ! submission ( cosmetic &  
+r$i5t /atem5ts1 & ! report+ ( s]i\s    
cosmetic adv]se ev5ts1 & = o!r purposes4
  #a4 ,%ort title & ref]5ces  7a7 ,%ort 
title ,?is ,act may be cit$ z !         
,cosmetic ,mod]nization ,am5dm5ts (     
#bjae4  7b7 ,ref]5ces to ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act ,except z      
o!rwise specifi$1 :5ev] 9 ?is ,act an   
am5dm5t is express$ 9 t]ms ( an am5dm5t 
to a section or o!r provision1 ! ref]5ce
 %all be consid]$ to be made to a       
section or o!r provision ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cja et seq474  #b4 ,table (  
cont5ts ,! table ( cont5ts = ?is ,act is

 z foll[s3 ,sec4 #a4 ,%ort title &      
ref]5ces4 ,sec4 #b4 ,table ( cont5ts4   
,sec4 #c4 ,def9itions4 ,sec4 #d4        
,regi/ration ( cosmetic manufactur+     
e/abli%m5ts4 ,sec4 #e4 ,cosmetic &      
+r$i5t /atem5t4 ,sec4 #f4 ,s]i\s &      
unexpect$ adv]se ev5t report+ =         
cosmetics4 ,sec4 #g4 ,good manufactur+  
practice4 ,sec4 #h4 ,safety             
sub/antiation = cosmetic +r$i5ts &      
nonfunctional con/itu5ts4 ,sec4 #i4     
,national ,cosmetic ,regulatory         
,databank4 ,sec4 #aj4 ,special rules4   
,sec4 #aa4 ,prohibit$ acts4 ,sec4 #ab4  
,national uni=mity = cosmetics4 ,sec4   
#ac4 ,importation4 ,sec4 #ad4 ,effective
 dates4  #c4 ,def9itions ,*apt] ,,vi    
7#ba ,u4,s4,c4 #cfa et seq47 is am5d$ by
 add+ at ! end ! foll[+3  #fjd4         
,def9itions ,9 ?is *apt]3 7#a7 ,cosmetic
 ,not)/&+ section #bja7;i71 = purposes (
 ?is section & sections #fja7;f71 #fje1 
#fjf1 #fjg1 #fjh1 & #hja7;a71 ! t]m     
cosmetic includes only articles describ$
 9 section #bja7;i77#a74  7#b7          

,e/abli%m5t  7,a7 ,! t]m e/abli%m5t     
means a place ( bus9ess :]e a cosmetic  
is manufactur$1 )\t fur!r process+      
outside or )9 ! ,unit$ ,/ates4  7,b7 ,a 
cosmetic %all n be consid]$ to h        
und]gone fur!r process+ = purposes (    
subp>agraph 7,a7 solely on ! basis t    
packag+ or o!r label+ 0 add$ or *ang$ or
 t any simil> activity ( a de m9imis    
nature 0 c>ri$ out ) respect to !       
cosmetic4  7,c7 ,! t]m dome/ic          
e/abli%m5t means an e/abli%m5t location 
9 any ,/ate4  7,d7 ,! t]m =eign         
e/abli%m5t means an e/abli%m5t location 
outside ! ,unit$ ,/ates4  7#c7 ,safe2   
safety  7,a7 ,! t]ms safe & safety1 )   
respect to a cosmetic1 mean ! cosmetic  
does n pres5t a significant risk ( s]i\s
 illness or injury to humans "u !       
conditions ( use recomm5d$ or sugge/$ 9 
! label+ ( ! cosmetic1 includ+ !        
limitation ( = pr(essional use only4    
7,b7 ,= purposes ( subp>agraph 7,a71 !  
t]m pr(essional means an individual :o--
 7i7 is lic5s$ by an (ficial ,/ate      

au?ority to practice 9 ! field (        
cosmetology1 nail c>e1 b>b]+1 & or      
e/hetics2 &  7ii7 is 9 compliance ) all 
requirem5ts ( ! ,/ate = su* lic5s+4  4  
#d4 ,regi/ration ( cosmetic manufactur+ 
e/abli%m5ts ,*apt] ,,vi 7#ba ,u4,s4,c4  
#cfa et seq471 z am5d$ by section #c1 is
 fur!r am5d$ by add+ at ! end ! foll[+3 
#fje4 ,regi/ration ( cosmetic           
manufactur+ e/abli%m5ts  7a7 ,9 g5]al   
7#a7 ,regi/ration ,! ,secret>y %all by  
regulation require t e dome/ic & =eign  
e/abli%m5t engag$ 9 ! manufacture ( a   
cosmetic int5d$ to be sold 9 ! ,unit$   
,/ates t is n exempt "u subsection 7e7  
be regi/]$ ) ! ,secret>y )9 #fj bus9ess 
days aft] ! fir/ comm]cial sale ( a     
cosmetic 9 ! ,unit$ ,/ates4 ,if a       
cosmetic is process$ 9 m ?an "o         
e/abli%m5t1 regi/ration %all be requir$ 
"u ?is section only = ! e/abli%m5t t    
p]=ms ! f9al portion ( ! manufactur+    
op]ation4 ,! s+le regi/ration %all cov] 
all su* cosmetics manufactur$ by !      
e/abli%m5t4 ,! regi/ration %all /ate    

only ! "n ( ! company or o!r            
organization "n ( ! e/abli%m5t1 ! city1 
/reet address1 ,/ate1 & c\ntry ( !      
e/abli%m5t1 & ! title1 email address1 & 
telephone numb] = ! (fice )9 !          
e/abli%m5t t is responsible = submitt+ &
 ma9ta9+ ! regi/ration4 ,= a =eign      
e/abli%m5t1 ! regi/ration %all include !
 contact in=mation = ! initial ,unit$   
,/ates ag5t ( ! e/abli%m5t4  7#b7       
,unique numb] ,! ,secret>y %all e/abli% 
& provide to ea* regi/rant "u ?is       
section a unique cosmetic e/abli%m5t    
regi/ration numb] )9 #ae bus9ess days   
aft] receiv+ ! regi/ration4 ,if !       
,secret>y does n provide a unique       
cosmetic e/abli%m5t regi/ration numb] )9
 su* #ae bus9ess days1 any requirem5t "u
 ?is ,act = su* numb] %all be deem$ to  
be inapplicable until #cj bus9ess days  
aft] su* numb] is receiv$ by ! p]son :o 
submitt$ ! regi/ration4 ,:]e m ?an "o   
p]son regi/]s ! same e/abli%m5t1 !      
,secret>y %all provide only "o unique   
e/abli%m5t regi/ration numb] = !        

e/abli%m5t4 ,! unique cosmetic          
e/abli%m5t numb] %all n be requir$ to be
 includ$ 9 cosmetic label+4  7b7        
,ma9t5ance ,! in=mation requir$ 9 a     
regi/ration "u subsection 7a7 or 9 an   
exi/+ regi/ration "u subsection         
7e77#a77;,a7 %all be ma9ta9$ z curr5t & 
accurate by ! regi/rant by )draw+ or    
am5d+ ! regi/ration )9 #fj bus9ess days 
aft] ! in=mation becomes no long] curr5t
 & accurate4  7c7 ,en=cem5t ,! ,secret>y
 %all en=ce ?is section "u section      
#cja7;ddd7 & %all n susp5d or revoke a  
regi/ration "u ?is section4  7d7 ,li/ ,!
 ,secret>y %all compile & ma9ta9 an     
up-to-date & publicly available         
electronic li/ ( e/abli%m5ts t are      
regi/]$ "u ?is section4  7e7 ,exemptions
  7#a7 ,9 g5]al ,regi/ration "u         
subsection 7a7 %all n be requir$ = any  
entity bas$ on su* entity op]at+ z--    
7,a7 an e/abli%m5t t z ( ! date (       
enactm5t ( ?is section is regi/]$ z a   
cosmetic e/abli%m5t "u "p #gaj ( title  
#ba1 ,code ( ,f$]al ,regulations 7z 9   

effect on su* date72  7,b7 a beauty %op 
or salon or spa2  7,c7 a cosmetic       
retail]1 includ+ any su* retail] t is-- 
7i7 an individual sales repres5tative2  
7ii7 a :olesale or retail di/ribution or
 sales facility2 or  7iii7 a ph>macy or 
o!r p]son or organization t-- 7,i7      
comp\nds cosmetics at a s+le location & 
adm9i/]s1 disp5ses1 or di/ributes su*   
cosmetics at retail f t location2 &     
7,,ii7 does n o!rwise manufacture or    
package cosmetics f t location2  7,d7 a 
heal? c>e provid]1 includ+ a hospital or
 cl9ic2  7,e7 a public heal? ag5cy or   
o!r nonpr(it entity2  7,f7 a hotel or   
o!r entity t provides complim5t>y       
cosmetics2  7,g7 a trade %[ or o!r v5ue 
:]e cosmetic samples are provid$2  7,h7 
an e/abli%m5t t manufactures1 prep>es1  
comp\nds1 or processes cosmetics = use 9
 rese>*1 tea*+1 or *emical analysis or  
pilot plant production2  7,i7 a h&craft$
 soap or cosmetic made 9 a home1 a      
community facility1 or a simil>         
e/abli%m5t2 or  7,j7 a bus9ess ) less   

?an #a1jjj1jjj annual net sales (       
cosmetics4  7#b7 ,additional exemptions 
,! ,secret>y may supplem5t ! li/ (      
exemptions "u p>agraph 7#a7 ) additional
 exemptions = p]sons & activities :]e ! 
co/ ( compliance exce$s ! safety b5efit 
to ! public4  4  #e4 ,cosmetic & +r$i5t 
/atem5t ,*apt] ,,vi 7#ba ,u4,s4,c4 #cfa 
et seq471 z am5d$ by sections #c & #d1  
is fur!r am5d$ by add+ at ! end !       
foll[+3  #fjf4 ,cosmetic & +r$i5t       
/atem5t  7a7 ,9 g5]al ,! ,secret>y %all 
by regulation require t e dome/ic       
e/abli%m5t & =eign e/abli%m5t engag$ 9 !
 manufacture ( a cosmetic int5d$ to be  
sold 9 ! ,unit$ ,/ates submit to !      
,secret>y1 = ea* cosmetic s manufactur$ 
9 ! e/abli%m5t1 except su* cosmetics    
manufactur$ by entities exempt$ by      
section #fje7;e7 f regi/ration "u       
section #fje1 )9 #fj bus9ess days aft] !
 fir/ comm]cial sale ( ! cosmetic1 a    
cosmetic & +r$i5t /atem5t4 ,! ,secret>y 
%all require ! /atem5t to conta9 only-- 
7#a7 ! unique e/abli%m5t regi/ration    

numb] ( ! manufactur+ e/abli%m5t :]e !  
cosmetic is manufactur$ or1 if ! same   
cosmetic is manufactur$ 9 m ?an "o      
e/abli%m5t1 ! unique e/abli%m5t         
regi/ration numb] ( ea* e/abli%m5t :]e x
 is manufactur$2  7#b7 ! br& "n or names
 = ! cosmetic2  7#c7 ! applicable       
cosmetic category or categories = !     
cosmetic2  7#d7 ! +r$i5ts 9 ! cosmetic  
79 accordance ) section #gja4c ( title  
#ba1 ,code ( ,f$]al ,regulations 7z 9   
effect on ! date ( enactm5t ( !         
,cosmetic ,mod]nization ,am5dm5ts (     
#bjae & includ+ any successor           
regulations71 & us+ ! "n ( ea* +r$i5t   
e/abli%$ "u subsection 7d71 if any71 9  
desc5d+ ord] ( pr$om9ance by weight1    
except t--  7,a7 flavors & fragrances   
may be designat$ z su*2 &  7,b7 all     
v>iations 9 color1 flavor1 or fragrance 
may be includ$ 9 "o /atem5t2 &  7#e7 !  
title1 email address1 & telephone numb] 
= ! (fice )9 ! e/abli%m5t t is          
responsible = submitt+ & ma9ta9+ !      
/atem5t4  7b7 ,unique numb] ,! ,secret>y

 %all e/abli% & provide to ! (fice      
submitt+ a /atem5t requir$ by subsection
 7a7 a unique cosmetic & +r$i5t /atem5t 
numb] )9 #ae bus9ess days aft] receiv+ !
 /atem5t4 ,if ! ,secret>y does n provide
 a unique cosmetic & +r$i5t /atem5t     
numb] )9 su* #ae-;bus9ess-day p]iod1 any
 requirem5t "u ?is ,act = su* numb] %all
 be deem$ to be inapplicable until !    
date t is #cj bus9ess days aft] su*     
numb] is receiv$ by ! (fice t submitt$ !
 /atem5t4 ,! unique cosmetic & +r$i5t   
/atem5t numb] %all n be requir$ to be   
includ$ 9 cosmetic label+4  7c7 ,*ange 9
 label+ ,an e/abli%m5t %all n be requir$
 to submit a new or revis$ /atem5t "u   
subsection 7a7 because ( a *ange 9      
label+ except to ! ext5t necess>y to    
ma9ta9 ! accuracy ( ! in=mation includ$ 
9 a /atem5t "u subsection 7a74  7d7 ,"n 
( +r$i5t ,= purposes ( ?is section &    
cosmetic +r$i5t label+ "u section #gja4c
 ( title #ba1 ,code ( ,f$]al            
,regulations 7z 9 effect on ! date (    
enactm5t ( ! ,cosmetic ,mod]nization    

,am5dm5ts ( #bjae & includ+ any         
successor regulations71 ! "n ( a        
cosmetic +r$i5t %all be ! "n1 if any1 9 
! mo/ rec5t edition ( ! ,int]national   
,cosmetic ,+r$i5t ,diction>y1 unless !  
,secret>y by regulation e/abli%es a     
diff]5t "n = ! +r$i5t4  7e7 ,ma9t5ance  
,! in=mation requir$ 9 a /atem5t        
submitt$ to ! ,secret>y "u subsection   
7a7 or 9 an exi/+ /atem5t "u subsection 
7g77#a7 %all be ma9ta9$ z curr5t &      
accurate by ! (fice t fil$ ! /atem5t by 
)draw+ or am5d+ ! /atem5t )9 #fj bus9ess
 days aft] ! in=mation becomes no long] 
curr5t & accurate1 except t no am5dm5t  
%all be requir$ = a *ange 9 ! ord] (    
pr$om9ance ( ! +r$i5ts or = any o!r type
 or category ( *ange = :i* ! co/s (     
am5d+ ! /atem5t exce$ ! safety b5efit to
 ! public4  7f7 ,en=cem5t ,! ,secret>y  
%all en=ce subsections 7a7 & 7e7 "u     
section #cja7;eee7 & %all n susp5d or   
revoke a cosmetic & +r$i5t /atem5t4  7g7
 ,li/ ,! ,secret>y %all compile & ma9ta9
 an up-to-date & publicly available     

electronic li/ ( cosmetics & +r$i5ts =  
:i* /atem5ts are submitt$ "u ?is        
section4 ,a /atem5t submitt$ pursuant to
 ?is section %all n be subject to       
disclosure "u section #eeb ( title #e1  
,unit$ ,/ates ,code4 ,! ,secret>y may   
make publicly available in=mation d]iv$ 
f su* /atem5ts t discloses ! names (    
+r$i5ts us$ 9 cosmetics & ! numb] (     
cosmetics 9 :i* a specific +r$i5t is    
us$1 b may n make publicly available any
 in=mation t relates to any +r$i5t t is 
exempt f public disclosure "u section   
#gbj4h ( title #ba1 ,code ( ,f$]al      
,regulations 7z 9 effect on ! date (    
enactm5t ( ! ,cosmetic ,mod]nization    
,am5dm5ts ( #bjae & includ+ any         
successor regulations71 or t discloses  
at :at e/abli%m5t a cosmetic is         
manufactur$4 ,at ! writt5 reque/ ( !    
director ( a ,/ate ag5cy responsible =  
regulat+ ! safety ( cosmetics /at+ good 
cause !re=1 ! ,secret>y may disclose to 
su* (ficial confid5tial bus9ess & trade 
secret in=mation conta9$ 9 a /atem5t &  

su* (ficial & o!r ,/ate employees :o h  
access to su* in=mation %all !n be      
subject to ! provisions ( section       
#cja7;j7 ( ?is ,act1 section #eeb7;b7 ( 
title #e1 ,unit$ ,/ates ,code1 & section
 #aije ( title #ah1 ,unit$ ,/ates ,code1
 ) respect to su* in=mation4  7h7       
,exemptions ,submission ( a /atem5t "u  
subsection 7a7 %all n be requir$-- 7#a7 
= a cosmetic = :i* z ( ! date ( enactm5t
 ( ?is section a cosmetic +r$i5t /atem5t
 has be5 submitt$ to ! ,secret>y "u "p  
#gaj ( title #ba1 ,code ( ,f$]al        
,regulations 7z 9 effect on ! date (    
enactm5t ( ! ,cosmetic ,mod]nization    
,am5dm5ts ( #bjae72  7#b7 = a cosmetic  
+r$i5t exempt f public disclosure "u    
section #gbj4h ( title #ba1 ,code (     
,f$]al ,regulations 7z 9 effect on !    
date ( enactm5t ( ! ,cosmetic           
,mod]nization ,am5dm5ts ( #bjae &       
includ+ any successor regulations72 or  
7#c7 by an entity to ! ext5t su* entity 
is exempt$ by section #fje7;e7 f        
regi/ration "u section #fje4  4  #f4    

,s]i\s & unexpect$ adv]se ev5t report+ =
 cosmetics  7a7 ,9 g5]al ,*apt] ,,vi    
7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by
 sections #c1 #d1 & #e1 is fur!r am5d$  
by add+ at ! end ! foll[+3  #fjg4 ,s]i\s
 & unexpect$ adv]se ev5t report+ =      
cosmetics  7a7 ,9 g5]al ,! ,secret>y    
%all by regulation require t a dome/ic  
or =eign manufactur]1 pack]1 or         
di/ributor ^: "n appe>s on ! label      
pursuant to section #fjb7;b77#a7 ( a    
cosmetic m>ket$ 9 ! ,unit$ ,/ates submit
 to ! ,secret>y "u subsection 7b7 a     
report conta9+--  7#a7 in=mation receiv$
 conc]n+ any s]i\s & unexpect$ adv]se   
ev5t 9 ! ,unit$ ,/ates alleg$ly         
associat$ ) ! use ( ! cosmetic = :i* x  
is reasonably likely t ! adv]se ev5t 0  
caus$ by ! cosmetic :5 us$ z recomm5d$  
or sugge/$ 9 ! label+2 &  7#b7 a copy ( 
! label = ! cosmetic4  7b7 ,submission (
 reports ,a report on an adv]se ev5t "u 
subsection 7a7 %all be submitt$ to !    
,secret>y n lat] ?an #ae bus9ess days   
aft] in=mation conc]n+ ! adv]se ev5t is 

receiv$ at ! place ( bus9ess label$ on !
 cosmetic pursuant to section           
#fjb7;b77#a74  7c7 ,requir$ cont5ts ,a  
report "u subsection 7a7 %all include   
all ( ! foll[+ in=mation3 7#a7 ,an      
id5tifiable pati5t4  7#b7 ,an           
id5tifiable report]4  7#c7 ,a suspect   
cosmetic or compon5t !re(4  7#d7 ,a     
s]i\s adv]se ev5t4  7d7 ,additional     
cont5ts2 supplem5tal report+ ,! p]son   
submitt+ a report "u subsection 7a7     
may--  7#a7 include p]t95t in=mation 9  
addition to ! in=mation li/$ 9          
subsection 7c72 &  7#b7 aft] submitt+ ! 
initial report1 supplem5t ! report )    
additional in=mation4  7e7 ,special     
rules  7#a7 ,protect$ in=mation ,a s]i\s
 & unexpect$ adv]se ev5t report 7includ+
 all in=mation submitt$ 9 ! initial     
report or add$ lat]7 submitt$ "u        
subsection 7a7--  7,a7 %all be consid]$ 
to be a safety report "u section #gef t 
is subject to ! provisions ( t section2 
&  7,b7 %all be consid]$ to be a record 
ab\t an individual "u section #eeb;a (  

title #e1 ,unit$ ,/ates ,code1 & a      
m$ical or simil> file ! disclosure ( :i*
 w\ld con/itute a violation ( section   
#eeb ( su* title #e1 & %all n be        
publicly disclos$ unless all p]sonally  
id5tifiable in=mation is r$act$4  7#b7  
,no treatm5t z admission ,! submission (
 a s]i\s & unexpect$ adv]se ev5t report 
9 compliance ) subsection 7a7-- 7,a7    
%all n be con/ru$ z an admission t !    
cosmetic involv$ caus$ or contribut$ to 
! adv]se ev5t2 &  7,b7 may be accompani$
 by a /atem5t t d5ies t ! report        
con/itutes an admission t ! cosmetic    
involv$ caus$ or contribut$ to ! adv]se 
ev5t4  7#c7 ,inclusion ( /atem5t 9      
public disclosure ,9 releas+ any report 
"u subsection 7a7 or portion !re( =     
public disclosure1 ! ,secret>y %all     
include any /atem5t "u p>agraph         
7#b77;,b74  7f7 ,label+ ,! label ( a    
cosmetic %all be> ! dome/ic telephone   
numb]1 email address1 or mail+ address  
?r\gh :i* ! p]son ^: "n & place (       
bus9ess appe> on ! label may receive a  

report ( a s]i\s adv]se ev5t4  7g7      
,exemption ,! ,secret>y may1 by         
regulation1 e/abli% an exemption to !   
requirem5ts "u subsections 7b7 & 7d7 if 
! ,secret>y det]m9es t su* exemption    
w\ld h no adv]se effect on public heal?4
  7h7 ,def9itions ,9 ?is section3 7#a7  
,! t]m s]i\s1 ) respect to an adv]se    
ev5t1 means--  7,a7 result+ 9-- 7i7     
dea?2  7ii7 a life-?reat5+ exp]i5ce2    
7iii7 inpati5t hospitalization2  7iv7 a 
p]si/5t & significant disability or     
incapacity2  7v7 a cong5ital anomaly or 
bir? defect2 or  7vi7 p]man5t           
disfiguration2 or  7,b7 requir+1 bas$ on
 reasonable m$ical judgm5t1 a m$ical or 
surgical int]v5tion to prev5t an outcome
 describ$ "u subp>agraph 7,a74  7#b7 ,! 
t]m unexpect$1 ) respect to an adv]se   
ev5t1 means n id5tifi$ on ! cosmetic    
label4  4  7b7 ,misbr&+ ,section #fjb ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cfb7 is am5d$ by add+ at
 ! end ! foll[+3  7g7 ,if x is a        
cosmetic t is m>ket$ 9 ! ,unit$ ,/ates1 

unless ! label ( su* cosmetic includes a
 dome/ic address or dome/ic phone numb] 
?r\gh :i* a report ( a s]i\s & unexpect$
 adv]se ev5t 7z su* t]m is us$ 9 section
 #fjg7 associat$ ) ! use ( su* cosmetic 
may be submitt$ to ! p]son describ$ 9   
section #fjg7;f74  4  #g4 ,good         
manufactur+ practice  7a7 ,prohibition  
,section #fja 7#ba ,u4,s4,c4 #cfa7 is   
am5d$ by add+ at ! end ! foll[+3  7f7   
,if x has be5 manufactur$ "u conditions 
t d n satisfy ! pr9ciples & /&>ds = good
 manufactur+ practice e/abli%$ "u       
section #fjh & z a result pres5ts a     
significant risk ( s]i\s adv]se heal?   
consequ5ces or dea? to humans4  4  7b7  
,pr9ciples & /&>ds ,*apt] ,,vi 7#ba     
,u4,s4,c4 #cfa et seq471 z am5d$ by     
sections #c1 #d1 #e1 & #f1 is fur!r     
am5d$ by add+ at ! end ! foll[+3  #fjh4 
,good manufactur+ practice  7a7 ,9 g5]al
 ,! ,secret>y may by regulation e/abli% 
pr9ciples & /&>ds = good manufactur+    
practice = ! manufacture ( cosmetics 9  
accordance ) p>agraphs 7a7 & 7d7 (      

section #fja4  7b7 ,notice & comm5t ,a  
regulation "u subsection 7a7 %all be    
promulgat$ only aft] provid+ notice & an
 opportunity = comm5t 9 accordance )    
*apt] #e ( title #e1 ,unit$ ,/ates      
,code4  7c7 ,good manufactur+ practices 
( o!r p>ties ,a manufactur] %all n be   
responsible "u section #fja7;f7 or ?is  
section = ! good manufactur+ practice ( 
its suppli]s4 ,a di/ributor %all n be   
responsible "u section #fja7;f7 or ?is  
section = ! good manufactur+ practice ( 
its manufactur]s4  4  #h4 ,safety       
sub/antiation = cosmetic +r$i5ts &      
nonfunctional con/itu5ts ,*apt] ,,vi    
7#ba ,u4,s4,c4 #cfa et seq471 z am5d$ by
 sections #c1 #d1 #e1 #f1 & #g1 is fur!r
 am5d$ by add+ at ! end ! foll[+3  #fji4
 ,cosmetic +r$i5ts & nonfunctional      
con/itu5ts t are safe = use 9 cosmetics 
7a7 ,9 g5]al ,a manufactur] or          
di/ributor ( a cosmetic may rely on ?is 
section to sub/antiate ! safety ( su*   
cosmetic4  7b7 ,safe +r$i5ts ,unless &  
until prohibit$ or limit$ by ! ,secret>y

 by regulation1 ! foll[+ +r$i5ts are    
deem$ to be adequately sub/antiat$ =    
safe use 9 cosmetics subject to !       
requirem5ts ( good manufactur+ practice3
  7#a7 ,color additives approv$ by !    
,secret>y = use 9 cosmetics1 )9 any     
limits e/abli%$ 9 su* approval4  7#b7   
,food additives approv$ by ! ,secret>y =
 direct addition to food = human        
consumption1 )9 any limits e/abli%$ 9   
su* approval4  7#c7 ,food +r$i5ts t h   
be5 det]m9$ by ! ,secret>y to be g5]ally
 recogniz$ z safe = direct addition to  
food = human consumption1 )9 any limits 
e/abli%$ 9 su* det]m9ation4  7#d7 ,food 
+r$i5ts = :i* monographs h be5 includ$ 9
 ! ,food ,*emicals ,codex = direct      
addition to food = human consumption1 )9
 any limits e/abli%$ 9 su* monographs4  
7#e7 ,ph>maceutical excipi5ts & inactive
 +r$i5ts approv$ or p]mitt$ by !        
,secret>y1 li/$ on a ,food & ,drug      
,adm9i/ration website = use 9 drugs =   
human consumption or = :i* monographs h 
be5 includ$ 9 ! ,h&book ( ,ph>maceutical

 ,excipi5ts1 )9 any limits e/abli%$ 9   
su* li/s or monographs4  7#f7 ,cosmetic 
+r$i5ts t h be5 review$ = safety by a   
qualifi$ nongov]nm5tal or gov]nm5tal    
exp]t sci5tific body1 includ+ !         
,cosmetic ,+r$i5t ,review ,exp]t ,panel1
 & t are ! subject ( a monograph publi%$
 9 a pe]-review$ sci5tific j\rnal1 )9   
any limits e/abli%$ 9 su* monographs4   
7#g7 ,fragrance +r$i5ts t h be5 review$ 
= safety by a qualifi$ nongov]nm5tal or 
gov]nm5tal exp]t sci5tific body1 includ+
 ! ,rese>* ,in/itute ( ,fragrance       
,mat]ials ,exp]t ,panel1 & t are !      
subject ( a monograph publi%$ 9 a       
pe]-review$ sci5tific j\rnal1 )9 any    
limits e/abli%$ 9 su* monographs4  7#h7 
,cosmetic +r$i5ts approv$ or p]mitt$ =  
use 9 cosmetics by any ( ! c\ntries li/$
 9 section #hjb7;b77#a77;,a7 z hav+ an  
adequate regulatory au?ority1 )9 any    
limits e/abli%$ by su* regulatory       
au?ority4  7c7 ,safe nonfunctional      
con/itu5ts  7#a7 ,def9ition ,a          
nonfunctional con/itu5t 9 a cosmetic is 

any sub/ance t-- 7,a7 has n be5         
int5tionally add$ z a sep>ate sub/ance2 
&  7,b7 s]ves no te*nical or cosmetic   
function 9 ! cosmetic4  7#b7 ,adequate  
sub/antiation ,! foll[+ nonfunctional   
con/itu5ts are deem$ to be adequately   
sub/antiat$ = safe use 9 cosmetics1     
subject to ! requirem5ts ( good         
manufactur+ practice & any limits or    
bans e/abli%$ by ! ,secret>y by         
regulation3  7,a7 ,! levels approv$ or  
p]mitt$ = nonfunctional con/itu5ts by ! 
,secret>y = color additives = cosmetic  
use & = food additives & g5]ally        
recogniz$ z safe food +r$i5ts = direct  
human consumption4  7,b7 ,! levels      
approv$ or p]mitt$ = nonfunctional      
con/itu5ts by ! ,secret>y = cosmetics & 
= food & food +r$i5ts = direct human    
consumption 9 compliance policy guides1 
guidance1 & website /atem5ts4  7,c7 ,!  
levels approv$ or p]mitt$ =             
nonfunctional con/itu5ts by ! ,secret>y 
or ! ,unit$ ,/ates ,ph>macopeia = oral  
nonprescription drugs4  7,d7 ,! levels  

approv$ or p]mitt$ = nonfunctional      
con/itu5ts by ! ,environm5tal           
,protection ,ag5cy = direct human       
consumption 9 dr9k+ wat]4  7,e7 ,!      
levels = nonfunctional con/itu5ts       
approv$ or p]mitt$ 9 cosmetics & human  
food & food +r$i5ts by any ( ! c\ntries 
li/$ 9 section #hjb7;b77#a77;,a7 z hav+ 
an adequate regulatory au?ority4  7d7   
,c5t] ,! ,secret>y %all e/abli% a       
program )9 ! c5t] ( ! ,food & ,drug     
,adm9i/ration ) prim>y responsibility = 
regulat+ cosmetics to evaluate & make   
det]m9ations1 by regulation1 on ! safe  
use ( cosmetics & +r$i5ts &             
nonfunctional con/itu5ts !re(4  7e7     
,application2 preemption ,a safety      
det]m9ation accept$ or made by !        
,secret>y or e/abli%$ "u ?is section    
%all apply 9 e ,/ate4 ,no ,/ate may     
e/abli% or en=ce a safety det]m9ation = 
a cosmetic or an +r$i5t or nonfunctional
 con/itu5t ( a cosmetic  7f7 ,effective 
date ( regulations ,any regulation or   
guidance by ! ,secret>y pursuant to ?is 

section conc]n+ ! safety ( a cosmetic or
 an +r$i5t or nonfunctional con/itu5t ( 
a cosmetic %all apply beg9n+ no e>li]   
?an ! date t is #b ye>s aft] ! date on  
:i* su* regulation or guidance is issu$ 
z f9al1 unless ! ,secret>y det]m9es1    
aft] public notice & an opportunity =   
public comm5t1 t an e>li] date (        
applicability is requir$ to prev5t s]i\s
 adv]se heal? consequ5ces or dea? to    
humans4  4  #i4 ,national ,cosmetic     
,regulatory ,databank ,*apt] ,,vi 7#ba  
,u4,s4,c4 #cfa et seq471 z am5d$ by     
sections #c1 #d1 #e1 #f1 #g1 & #h1 is   
fur!r am5d$ by add+ at ! end ! foll[+3  
#faj4 ,national ,cosmetic ,regulatory   
,databank  7a7 ,9 g5]al ,= ! purpose (  
consolidat+ in=mation p]ta9+ to !       
regulation ( cosmetic safety1 !         
,secret>y %all e/abli% & ma9ta9 9 ! c5t]
 ( ! ,food & ,drug ,adm9i/ration )      
prim>y responsibility = regulat+        
cosmetics a database1 to be kn[n z !    
,national ,cosmetic ,regulatory         
,databank1 conta9+--  7#a7 ! in=mation  

submitt$ to ! ,secret>y "u sections     
#fje1 #fjf1 #fjg1 & #fji2 &  7#b7 su*   
o!r in=mation p]ta9+ to ! regulation (  
cosmetics z ! ,secret>y deems           
appropriate4  7b7 ,availability ,9 !    
case ( in=mation 9 ! ,national ,cosmetic
 ,regulatory ,databank t is n subject to
 public disclosure "u section #eeb (    
title #e1 ,unit$ ,/ates ,code1 !        
,secret>y may none!less disclose su*    
in=mation to ! director ( a ,/ate ag5cy 
on writt5 reque/ by su* director        
demon/rat+ good cause = ! disclosure4 ,a
 director receiv+ in=mation pursuant to 
! prec$+ s5t5ce %all agree to limit to !
 disclosure ( su* in=mation by ,/ate    
(ficials & employees to ! same ext5t su*
 disclosure is limit$ ) respect to      
,f$]al (ficials & employees "u section  
#cja7;j7 ( ?is ,act1 section #eeb7;b7 ( 
title #e1 ,unit$ ,/ates ,code1 & section
 #aije ( title #ah1 ,unit$ ,/ates ,code1
 ) respect to su* in=mation4  7c7       
,preemption ,no ,/ate or political      
subdivision !re( may require submission 

( in=mation t is available 9 ! ,national
 ,cosmetic ,regulatory ,databank1 :e!r 9
 ! same or a diff]5t =mat4  4  #aj4     
,special rules  7a7 ,c]ta9 rules ,*apt] 
,,vi 7#ba ,u4,s4,c4 #cfa et seq471 z    
am5d$ by sections #c1 #d1 #e1 #f1 #g1   
#h1 & #i1 is fur!r am5d$ by add+ at !   
end ! foll[+3  #faa4 ,special rules  7a7
 ,contractors ,! p]son describ$ 9       
section #fjg7;f7 ) respect to a cosmetic
 7ref]r$ to 9 ?is section z !           
responsible p>ty7 may1 by agreem5t1     
au?orize a manufactur]1 di/ributor1 or  
pack] ( ! cosmetic or a ?ird-p>ty       
contractor to submit any requir$ report 
( a s]i\s & unexpect$ adv]se ev5t 7z su*
 t]m is us$ 9 section #fjg7 s long z !  
responsible p>ty directs to !           
manufactur]1 di/ributor1 pack]1 or      
?ird-p>ty contractor all su* adv]se     
ev5ts associat$ ) su* cosmetic t are    
report$ to ! responsible p>ty ?r\gh !   
address or telephone numb] describ$ 9   
section #fjg7;f74  7b7 ,exemptions ,!   
,secret>y1 on ! ,secret>y's own         

initiative or 9 response to a petition1 
may e/abli% exemptions f ! requirem5ts (
 sections #fja7;f71 #fje1 #fjf1 #fjg1 & 
#fjh--  7#a7 = ! effici5t &             
co/-effective implem5tation ( su*       
requirem5ts2 or  7#b7 :]e ! co/ (       
compliance exce$s ! safety b5efit to !  
public4  4  7b7 ,cosmetic def9ition     
,section #bja7;i7 7#ba ,u4,s4,c4        
#cba7;i77 is am5d$ by add+ at ! end !   
foll[+3 ,an article describ$ 9          
subp>agraph 7#a7 t is int5d$ only =     
topical ext]nal use to alt] ! appe>ance 
by tempor>ily affect+ ! /ructure or any 
function ( ! human sk91 & t is n !      
subject ( an approv$ new drug           
application "u section #eje1 %all1 =    
purposes ( ?is ,act1 be treat$ only z a 
cosmetic & n a drug44  7c7 ,color       
,additives ,section #gba7;f7 7#ba       
,u4,s4,c4 #cgi;e7f77 is am5d$-- 7#a7 by 
/rik+ 7f7 ,! ,secret>y %all & ins]t+    
7f77#a7 ,! ,secret>y %all2 &  7#b7 by   
add+ at ! end ! foll[+3  7#b7 ,a color  
additive1 includ+ mixtures !re(1 int5d$ 

= use 9 ext]nally appli$ cosmetics & n 9
 ! area ( ! eye is exempt f !           
requirem5ts ( ?is section if x is       
g5]ally recogniz$1 among exp]ts qualifi$
 by sci5tific tra9+ & exp]i5ce to       
evaluate its safety1 z hav+ be5 %[n     
?r\gh sci5tific proc$ures to be safe "u 
! conditions ( its int5d$ use4 ,not)/&+ 
! prec$+ s5t5ce1 ! ,secret>y may by     
regulation require c]tification ( bat*es
 "u subsection 7c7 = any su* color      
additive4  4  #aa4 ,prohibit$ acts  7a7 
,9 g5]al ,section #cja 7#ba ,u4,s4,c4   
#cca7 is am5d$ by add+ at ! end !       
foll[+3  7ddd7 ,! failure to regi/] a   
cosmetic e/abli%m5t z requir$ "u section
 #fje or to ma9ta9 ! regi/ration curr5t 
& accurate4  7eee7 ,! failure to submit 
a cosmetic & +r$i5t /atem5t z requir$ "u
 section #fjf or to ma9ta9 ! /atem5t    
curr5t & accurate4  7fff7 ,! failure to 
submit a s]i\s & unexpect$ adv]se ev5t  
report1 or to include on ! label ( a    
cosmetic ! dome/ic telephone numb]1     
email address1 or mail+ address ?r\gh   

:i* a report ( a s]i\s adv]se ev5t may  
be receiv$1 z requir$ "u section #fjg4  
4  7b7 ,in=mation security ,section     
#cja7;j7 7#ba ,u4,s4,c4 #cca7;j77 is    
am5d$ by ins]t+ #fje1 #fjf1 #fji1 aft]  
#egc14  #ab4 ,national uni=mity =       
cosmetics ,section #geb 7#ba ,u4,s4,c4  
#cgis7 is am5d$--  7#a7 by am5d+ !      
section head+ to read z foll[s3         
,national uni=mity = cosmetics2  7#b7 by
 am5d+ subsection 7a7 to read z foll[s3 
7a7 ,9 g5]al ,except z provid$ 9        
subsection 7b7 or 7d7 ( ?is section1 no 
,/ate or political subdivision ( a ,/ate
 may e/abli% or cont9ue 9 effect any    
requirem5t = label+ or packag+ ( a      
cosmetic4  2  7#c7 by am5d+ subsection  
7c7 to read z foll[s3  7c7 ,cosmetic    
safety ,no ,/ate or political           
subdivision ( a ,/ate may e/abli% or    
cont9ue 9 effect any law1 regulation1   
ord]1 or o!r requirem5t--  7#a7 relat+  
directly or indirectly to1 or rely+ ^u1 
a human heal? or safety evaluation ( a  
nonfunctional cosmetic con/itu5t1       

cosmetic +r$i5t1 or cosmetic 7z def9$ 9 
section #bja7;i77#a771 or relat+ 9 any  
way to ! safety /&>d & ! human          
heal?-bas$ requirem5ts1 evaluations1 &  
det]m9ations "u *apt] ,,vi1 ! ,poison   
,prev5tion ,packag+ ,act ( #aigj1 or !  
,fair ,packag+ & ,label+ ,act2 or  7#b7 
relat+ directly or indirectly to        
regi/ration or li/+ ( cosmetic          
facilities1 e/abli%m5ts1 cosmetics1 or  
cosmetic +r$i5ts1 report+ ( any         
in=mation relat+ to cosmetics includ+   
adv]se ev5t report+1 cosmetic           
manufactur+ processes or /&>ds includ+  
good manufactur+ practice1 cosmetic     
labels or label+ includ+ any g5]al or   
heal? relat$ w>n+s or public /atem5t1 or
 ! requirem5t ( any fees on cosmetic    
e/abli%m5ts1 cosmetics1 +r$i5ts1 or     
nonfunctional con/itu5ts4  2 &  7#d7 by 
repeal+ subsection 7e74  #ac4           
,importation ,section #hja7;a7 7#ba     
,u4,s4,c4 #cha7;a77 is am5d$ by add+ at 
! end ! foll[+3 ,if a cosmetic is be+   
import$ or (f]$ = import into ! ,unit$  

,/ates & ! import] does n pres5t bo? !  
unique cosmetic e/abli%m5t regi/ration  
numb] requir$ "u section #fje = !       
e/abli%m5t t p]=ms ! f9al portion ( !   
manufactur+ op]ation & ! unique cosmetic
 & +r$i5t /atem5t numb] requir$ "u      
section #fjf = ! cosmetic1 or !         
regi/ration or /atem5t numb] is n       
correct & accurate1 ! cosmetic %all be  
d5i$ entry44  #ad4 ,effective dates  7a7
  7#a7 ,! am5dm5ts made by sections #d1 
#e1 #f1 & #ac ( ?is ,act apply beg9n+ on
 ! lat] date (-- 7,a7 ! date t is "o ye>
 aft] ! ,secret>y ( ,heal? & ,human     
,s]vices promulgates f9al regulations   
implem5t+ su* am5dm5ts2 or  7,b7 ! date 
t is "o ye> aft] ! ,secret>y ( ,heal? & 
,human ,s]vices publi%es a notice 9 !   
,f$]al ,regi/] det]m9+ t an effective   
electronic sy/em has be5 e/abli%$ & is  
fully op]ational =--  7i7 ! submission (
 cosmetic manufactur+ e/abli%m5t        
regi/rations1 cosmetic & +r$i5t         
/atem5ts1 & reports ( s]i\s cosmetic    
adv]se ev5ts2 &  7ii7 ! ,national       

,cosmetic ,regulatory ,databank4  7#b7  
,until ! date applicable "u p>agraph    
7#a71 ! volunt>y e/abli%m5t regi/ration 
& volunt>y +r$i5t li/+ programs e/abli%$
 9 p>ts #gaj & #gbj ( title #ba1 ,code (
 ,f$]al ,regulations 7z 9 effect on !   
date ( enactm5t ( ?is ,act71 %all rema9 
effective & %all be fully implem5t$ by !
 ,secret>y ( ,heal? & ,human ,s]vices4  
7b7 ,! am5dm5ts made by sections #g & #h
 apply beg9n+ on ! date t is two ye>s   
aft] ! date ( enactm5t ( ?is ,act4  7c7 
,not)/&+ subsections 7a7 & 7b71 !       
am5dm5ts made by sections #e & #g %all n
 apply ) respect to a cosmetic          
manufactur] ) less ?an #e1jjj1jjj (     
annual net sales ( cosmetics until !    
lat] (--  7#a7  7,a7 ) respect to !     
am5dm5t made by section #e1 ! date t is 
#cf mon?s aft] ! date o!rwise applicable
 "u subsection 7a72 &  7,b7 ) respect to
 ! am5dm5ts made by section #g1 ! date t
 is #cf mon?s aft] ! date o!rwise       
applicable "u subsection 7b72 &  7#b7   
su* lat] date z may be det]m9$ by !     

,secret>y ( ,heal? & ,human ,s]vices4   
7d7 ,except z provid$ 9 subsections 7a7 
?r\gh 7c71 ?is ,act takes effect on !   
date ( enactm5t ( ?is ,act4