,i #aac? ,,congress #a/ ,session ,h4 ,r4 #ache ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #ba1 #bjac ,ms4 ,s*ak[sky 7= h]self1 ,mr4 ,m>key1 ,mr4 ,blum5au]1 ,ms4 ,*u1 ,mr4 ,cony]s1 ,mr4 ,ellison1 ,mr4 ,grijalva1 ,mr4 ,ha/+s ( ,florida1 ,mr4 ,huffman1 ,mr4 ,l[5?al1 ,mr4 ,mi*aud1 ,mr4 ,moran1 ,ms4 ,norton1 ,ms4 ,p+ree ( ,ma9e1 ,ms4 ,wass]man ,s*ultz1 & ,ms4 ,spei]7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,education & ! ,work=ce1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d title ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to ensure ! safe use ( cosmetics1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,safe ,cosmetics & ,p]sonal ,c>e ,products ,act ( #bjac4 7b7 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,sec4 #b4 ,cosmetic regulation4 ,sub*apt] ,a--,adult]at$ & misbr&$ cosmetics ,sub*apt] ,b--,regulation ( cosmetics ,sec4 #faa4 ,def9itions4 ,sec4 #fab4 ,regi/ration ( e/abli%m5ts & regi/ration fees4 ,sec4 #fac4 ,+r$i5ts labels on cosmetics4 ,sec4 #fad4 ,safety /&>d & good manufactur+ practices4 ,sec4 #fae4 ,cosmetic & +r$i5t safety in=mation4 ,sec4 #faf4 ,li/s ( +r$i5ts & requir$ responses4 ,sec4 #fag4 ,treatm5t ( cosmetics bas$ on +r$i5t li/s4 ,sec4 #fah4 ,treatm5t ( contam9ants4 ,sec4 #fai4 ,cosmetic & +r$i5t /atem5ts4 ,sec4 #fbj4 ,notification1 nondi/ribution1 & recall ( adult]at$ or misbr&$ cosmetics4 ,sec4 #fba4 ,petitions4 ,sec4 #fbb4 ,m&atory report+ ( s]i\s adv]se ev5ts4 ,sec4 #fbc4 ,nonconfid5tial in=mation4 ,sec4 #fbd4 ,animal te/+ alt]natives4 ,sec4 #fbe4 ,product ,te/+ & ,review ,audit4 ,sec4 #fbf4 ,res\rces = small bus9esses4 ,sec4 #fbg4 ,int]ag5cy coop]ation4 ,sec4 #fbh4 ,sav+s clause4 ,sec4 #fbi4 ,au?orization ( appropriations4 ,sec4 #c4 ,work] issues4 #b4 ,cosmetic regulation 7a7 ,9 g5]al ,*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq47 is am5d$-- 7#a7 by ins]t+ be=e section #fja ! foll[+3 ,a ,adult]at$ & misbr&$ cosmetics 2 & 7#b7 by add+ at ! end ! foll[+3 ,b ,regulation ( cosmetics #faa4 ,def9itions ,9 ?is sub*apt]3 7#a7 ,br& own] ,! t]m br& own] means ! entity responsible = br++ a cosmetic to m>ket4 7#b7 ,contam9ant ,! t]m contam9ant means un9t5d$ sub/ances1 su* z ^? t c orig9ate f s\rces outside ! *emical pa?way1 *emical processes1 /orage ( prim>y sub/ances1 in/ability ( ! packag+ or h>mful byproducts ( ! manufactur+ process4 7#c7 ,dome/ic e/abli%m5t ,! t]m dome/ic e/abli%m5t means an e/abli%m5t locat$ 9 any ,/ate t br+s a cosmetic to m>ket4 7#d7 ,=eign e/abli%m5t ,! t]m =eign e/abli%m5t means an e/abli%m5t t br+s a cosmetic to m>ket & exports ^? cosmetics to ! ,unit$ ,/ates4 7#e7 ,+r$i5t ,! t]m +r$i5t means a *emical 9 a cosmetic1 includ+-- 7,a7 *emicals t provide a te*nical or functional effect2 7,b7 *emicals t h no te*nical or functional effect 9 ! cosmetic b are pres5t by reason ( hav+ be5 incorporat$ into ! cosmetic z an +r$i5t ( ano!r cosmetic +r$i5t2 7,c7 process+ aids t are pres5t by reason ( hav+ be5 add$ to a cosmetic dur+ ! process+ ( su* cosmetic2 7,d7 sub/ances t are pres5t by reason ( hav+ be5 add$ to a cosmetic dur+ process+ = _! te*nical or functional effect2 7,e7 ! compon5ts ( a fragrance1 flavor1 or pres]vative2 & 7,f7 any individual compon5t t ! ,secret>y deems an +r$i5t = purposes ( ?is *apt]4 7#f7 ,manufactur] ,! t]m manufactur] means ! entity t produces +r$i5ts or comb9es "o or m +r$i5ts to produce a cosmetic product4 7#g7 ,microbus9ess ,! t]m microbus9ess means a bus9ess-- 7,a7 t is a br& own] z def9$ 9 ?is sub*apt]2 & 7,b7 t has annual sales receipts = cosmetic products t d n exce$ #b1jjj1jjj4 7#h7 ,pr(essional use ,! t]m pr(essional use means ! use ( any cosmetic-- 7,a7 by an employee 7)9 ! scope ( ! employm5t ( su* employee7 (2 or 7,b7 pur*as$ by a consum] 91 a hair salon1 nail salon1 beauty salon1 spa1 or o!r e/abli%m5t t provides cosmetic treatm5t s]vices = humans4 7#i7 ,reasonable c]ta9ty ( no h>m ,) respect to an +r$i5t or cosmetic1 ! t]m reasonable c]ta9ty ( no h>m means t no h>m w be caus$ to memb]s ( ! g5]al population or any vuln]able population by aggregate exposure to ! cosmetic or +r$i5t1 tak+ into acc\nt possible h>mful effects f-- 7,a7 l[-dose exposures to ! cosmetic or +r$i5t2 7,b7 additive effects result+ f repeat$ exposure to ! cosmetic or +r$i5t ov] "t2 or 7,c7 cumulative exposure result+ f all s\rces1 includ+ bo? ! cosmetic or +r$i5t & environm5tal s\rces4 7#aj7 ,reproductive or developm5tal toxicity ,) respect to an +r$i5t or cosmetic1 ! t]m reproductive or developm5tal toxicity means t ! +r$i5t or cosmetic c contribute to biologically adv]se effects on ! developm5t ( humans or animals1 includ+ effects on ! female or male reproductive sy/em1 ! endocr9e sy/em1 f]tility1 pregnancy1 pregnancy outcomes1 or modifications 9 o!r functions ( ! body t are dep5d5t on ! integrity ( ! reproductive sy/em z well normal fetal developm5t4 7#aa7 ,s]i\s adv]se ev5t ,! t]m s]i\s adv]se ev5t means-- 7,a7 an acute or *ronic response t results 9 dea?1 a life-?reat5+ exp]i5ce1 %ort- or long-t]m hospitalization1 a p]si/5t or significant disability or incapacity1 or a cong5ital anomaly or bir? defect2 or 7,b7 requires1 bas$ on a reasonable m$ical judgm5t1 a m$ical or surgical int]v5tion to prev5t an outcome describ$ above4 7#ab7 ,suppli] ,! t]m suppli] means ! entity t supplies +r$i5ts1 raw mat]ials1 or specific compon5ts ( a cosmetic product1 includ+ packag+4 7#ac7 ,vuln]able populations ,! t]m vuln]able populations includes pregnant wom51 infants1 *ildr51 ! eld]ly1 & highly expos$ populations1 includ+ work]s employ$ by hair salons1 nail salons1 beauty salons1 spas1 o!r e/abli%m5ts t provide cosmetic treatm5t s]vices = humans1 & cosmetic manufactur+ plants4 #fab4 ,regi/ration ( e/abli%m5ts & regi/ration fees 7a7 ,regi/ration 7#a7 ,9 g5]al ,beg9n+ #a ye> aft] ! date ( ! enactm5t ( ?is sub*apt]1 & annually !reaft]1 any br& own] 7except = microbus9esses7 engag$ 9 br++ a cosmetic to m>ket = use 9 ! ,unit$ ,/ates %all regi/] ) ! ,secret>y & pay to ! ,secret>y ! applicable fee1 z e/abli%$ "u ! fee s*$ule 9 subsection 7e74 7#b7 ,rules = dome/ic & =eign e/abli%m5ts ,to be regi/]$ "u p>agraph 7#a7-- 7,a7 z a dome/ic e/abli%m5t1 ! own]1 op]ator1 or ag5t 9 *>ge ( ! dome/ic e/abli%m5t %all submit a regi/ration to ! ,secret>y2 or 7,b7 z a =eign e/abli%m5t1 ! own]1 op]ator1 or ag5t 9 *>ge ( ! =eign e/abli%m5t %all-- 7i7 submit a regi/ration to ! ,secret>y2 & 7ii7 include ) ! regi/ration ! "n ( ! ,unit$ ,/ates ag5t = ! =eign e/abli%m5t4 7#c7 ,new e/abli%m5ts ,any br& own] t initially br+s a cosmetic to m>ket aft] ! date on :i* ! requirem5ts ( p>agraph 7#a7 apply %all1 n lat] ?an #fj days aft] ! date on :i* ! e/abli%m5t br+s a cosmetic to m>ket1 regi/] ) ! ,secret>y & pay ! applicable fee1 z requir$ "u p>agraph 7#a74 7b7 ,submission ( regi/ration 7#a7 ,9 g5]al ,9 ord] to regi/] "u subsection 7a71 an e/abli%m5t 7ref]r$ to 9 ?is section z ! regi/rant7 %all submit to ! ,secret>y1 ) respect to any cosmetics t ! e/abli%m5t br+s to m>ket1 all ( ! foll[+3 7,a7 ,any in=mation necess>y to notify ! ,secret>y ( ! "n1 address1 & legal /atus ( ea* e/abli%m5t at :i*1 & all trade names "u :i*1 ! regi/rant br+s cosmetics to m>ket4 7,b7 ,a description ( ! e/abli%m5t's activities ) respect to cosmetics1 includ+ a li/ ( all cosmetic products br\ght to m>ket by ! e/abli%m5t & ! functions ( su* cosmetics4 7,c7 ,! gross receipts or sales = ! e/abli%m5t f cosmetics4 7#b7 ,notification ( *anges ,:5 submitt+ ! annual regi/ration1 ! regi/rant %all notify ! ,secret>y ( *anges to ! in=mation describ$ 9 p>agraph 7#a74 7c7 ,proc$ure ,^u receipt ( a complet$ regi/ration submitt$ "u subsection 7a71 ! ,secret>y %all notify ! regi/rant ( ! receipt ( su* regi/ration & assign a regi/ration numb] to ea* regi/]$ e/abli%m5t4 7d7 ,li/ ( regi/]$ e/abli%m5ts 7#a7 ,ma9t5ance ( li/ ,! ,secret>y %all-- 7,a7 compile1 ma9ta91 & update z appropriate1 a li/ ( e/abli%m5ts t are regi/]$ "u ?is section2 7,b7 make su* li/ publicly available2 7,c7 remove f su* li/ ! "n ( any e/abli%m5t t fails to regi/] 9 accordance ) ?is section2 & 7,d7 indicate on su* li/ any e/abli%m5t :i* has _h its regi/ration susp5d$ or cancell$ by ! ,secret>y "u ?is section4 7#b7 ,application ( ,,foia 7,a7 ,regi/ration docum5ts ,any regi/ration docum5ts submitt$ pursuant to ?is section %all n be subject to disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code4 7,b7 ,o!r in=mation ,in=mation d]iv$ f-- 7i7 ! li/ "u p>agraph 7#a72 or 7ii7 regi/ration docum5ts submitt$ pursuant to ?is section1 %all n be subject to disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code1 except to ! ext5t t su* in=mation discloses ! id5tity or location ( a specific regi/rant4 7e7 ,fee s*$ule ,a s*$ule ( fees %all be develop$ by ! ,secret>y to provide = ov]sight & en=cem5t ( ?is sub*apt]4 ,! fee /ructure %all-- 7#a7 be prorat$ bas$ on ! e/abli%m5t's gross receipts or sales2 & 7#b7 only be assess$ on companies ) annual gross receipts or sales ( cosmetics t exce$ #aj1jjj1jjj4 7f7 ,susp5sion & cancellation ( regi/ration 7#a7 ,crit]ia = susp5sion ,regi/ration "u ?is section is subject to susp5sion if ! ,secret>y f9ds-- 7,a7 ! in=mation submitt$ by ! e/abli%m5t = regi/ration "u subsection 7a7 is incomplete1 inaccurate1 or out ( date2 7,b7 ! e/abli%m5t fails to notify ! ,secret>y ( *anges requir$ "u subsection 7b77#b72 7,c7 ! e/abli%m5t fails to pay regi/ration fees1 z requir$ "u subsection 7a71 9 a timely mann]2 or 7,d7 ! e/abli%m5t violates any portion ( ?is *apt]4 7#b7 ,susp5sion ( regi/ration ,if ! ,secret>y det]m9es t an e/abli%m5t is subject to susp5sion "u ?is subsection & t x is appropriate to susp5d ! regi/ration ( su* e/abli%m5t1 ! ,secret>y %all-- 7,a7 susp5d ! regi/ration ( su* e/abli%m5t2 & 7,b7 provide a notice ( susp5sion to su* e/abli%m5t4 7#c7 ,cancellation ,if ! e/abli%m5t fails to correct ! issue t result$ 9 ! susp5sion "u p>agraph 7#b7 be=e ! la/ day ( ! #cj-;day p]iod beg9n+ on ! date t ! e/abli%m5t receives notice "u su* p>agraph1 ! ,secret>y may cancel ! regi/ration ( su* e/abli%m5t4 7g7 ,recordkeep+ ,all e/abli%m5ts t are requir$ to regi/] "u ?is section %all ma9ta9 records t include a curr5t li/ ( suppli]s & manufactur]s1 if ! regi/rant does n manufacture or package its own product4 ,^? records %all be accessible by ! ,secret>y ^u reque/ = review or audit4 #fac4 ,+r$i5ts labels on cosmetics 7a7 ,9 g5]al ,subject to subsections 7b7 & 7c71 ! ,secret>y %all require t ! label on ea* package ( cosmetics 7includ+ cosmetics di/ribut$ = retail sale & pr(essional use7 be>s a decl>ation ( ! "n ( ea* +r$i5t 9 su* cosmetic 9 desc5d+ ord] ( pr$om9ance4 7b7 ,adju/m5ts = label size 7#a7 ,rules = small products ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is sub*apt]1 ! ,secret>y %all issue regulations t apply to any cosmetic = :i* ! product packag+ is n ( suffici5t size to be> or conta9 a label t meets ! requirem5ts ( subsection 7a74 7#b7 ,requirem5ts = public disclosure ,su* regulations %all e/abli% requirem5ts = li/+ +r$i5ts on ! label ( su* cosmetics & additional requirem5ts = public disclosure ( ! +r$i5ts 9 su* cosmetics4 7c7 ,special rule = contam9ants ,! ,secret>y %all require1 9 ! case ( a contam9ant1 t a contam9ant be decl>$ on ! label ( a cosmetic1 9 ! same mann] z an +r$i5t "u subsection 7a71 if ! contam9ant is pres5t at ! l[] ( ! foll[+ levels3 7#a7 ,a level t is great] ?an "o "p-p]-billion by weight ( product =mation4 7#b7 ,a level t is great] ?an "o p]c5t ( ! re/riction on ! conc5tration = su* contam9ant = su* use1 z det]m9$ by ! ,secret>y "u section #faf7;a77#b74 7d7 ,label+ ( nanomat]ials 9 cosmetics ,! ,secret>y may require t-- 7#a7 m9]als & o!r p>ticulate +r$i5ts be label$ z nano-scale on a cosmetic +r$i5t label or li/ if n less ?an #a p]c5t ( ! +r$i5t p>ticles 9 ! cosmetic are #ajj nanomet]s or small] 9 n less ?an #a dim5sion2 & 7#b7 o!r +r$i5ts 9 a cosmetic be designat$ ) scale-specific in=mation on a cosmetic +r$i5t label or li/ if su* +r$i5ts possess scale-specific haz>d prop]ties4 7e7 ,label+ ( +r$i5ts 9 cosmetics sold ?r\gh ,int]net comm]ce ,! ,secret>y %all require-- 7#a7 9 ! case ( a cosmetic sold on ! ,web site ( an ,int]net v5dor1 t ! br& own] ( su* cosmetic provide to su* ,int]net v5dor a li/ ( ! +r$i5ts ( ! cosmetic2 & 7#b7 t ea* ,int]net v5dor display ! li/ ( +r$i5ts ( a cosmetic sold by su* v5dor on ! ,web page t is ! prim>y ,web page provid+ in=mation relat+ to ! sale ( su* cosmetic on ! ,web site ( ! v5dor4 7f7 ,trade secrets ,not)/&+ any o!r provision ( law1 an +r$i5t requir$ to be li/$ on a label "u ?is section %all n be treat$ z a trade secret4 7g7 ,application ,beg9n+ #ah mon?s aft] ! date ( ! enactm5t ( ?is sub*apt]1 ! requirem5ts ( ?is section %all apply to-- 7#a7 all cosmetics t are available = retail sale2 & 7#b7 br& own]s & ,int]net v5dors ( su* cosmetics4 #fad4 ,safety /&>d & good manufactur+ practices 7a7 ,safety /&>d 7#a7 ,9 g5]al ,tak+ into acc\nt ! expect$ use ( a cosmetic1 ! ,secret>y %all e/abli% a safety /&>d t1 ) respect to a cosmetic or an +r$i5t 9 a cosmetic provides a reasonable c]ta9ty ( no h>m 7z su* t]m is def9$ 9 section #faa7g77 f exposure to ! cosmetic or +r$i5t & protects ! public f any kn[n or anticipat$ adv]se heal? effects associat$ ) ! cosmetic or +r$i5t4 7#b7 ,/&>ds = e/abli%+ safety /&>d ,9 e/abli%+ ! safety /&>d "u p>agraph 7#a71 ! ,secret>y %all ensure t-- 7,a7 ! likely level ( exposure to all s\rces ( ! +r$i5t or cosmetic 7includ+ environm5tal s\rces7 t w result "u ! safety /&>d pres5ts n m ?an a #a 9 a million risk = any adv]se heal? effect 9 any vuln]able population at ! l[] #ie? p]c5tile confid5ce int]val2 or 7,b7 ! safety /&>d results 9 exposure to ! am\nt or conc5tration ( an +r$i5t or cosmetic t is %[n to produce no adv]se heal? effects1 incorporat+ an m>g9 ( safety ( at lea/ #a1jjj & consid]+ ! impact ( cumulative exposure f all s\rces 7includ+ environm5tal s\rces74 7#c7 ,use ( o!r ,f$]al /&>ds ,if any ,f$]al ag5cy has promulgat$ a /&>d = an +r$i5t t satisfies ! requirem5ts "u p>agraph 7#a71 ! ,secret>y may treat su* /&>d z ! safety /&>d "u p>agraph 7#a7 = purposes ( su* +r$i5t4 7#d7 ,application ( safety /&>d ,! ,secret>y may only det]m9e t an +r$i5t or a cosmetic meets ! safety /&>d "u p>agraph 7#a7 if !re is a reasonable c]ta9ty ( no h>m f exposure to ! +r$i5t or cosmetic4 7b7 ,good manufactur+ practices 7#a7 ,9 g5]al ,! ,secret>y %all issue guidance prescrib+ good manufactur+ practices = cosmetics & +r$i5ts1 includ+ quality control proc$ures t ! ,secret>y det]m9es are necess>y1 & %all update su* regulations z necess>y4 7#b7 ,consid]ation ( small bus9ess ,9 develop+ ! guidance "u p>agraph 7#a71 ! ,secret>y %all consid] h[ su* practices w impact small bus9esses4 #fae4 ,cosmetic & +r$i5t safety in=mation 7a7 ,requir$ submission ( all safety in=mation 7#a7 ,9 g5]al ,br& own]s ( cosmetics %all submit to ! ,secret>y 79 an electronic =mat t ! ,secret>y %all det]m9e7 all data & in=mation t ! br& own] c access reg>d+ ! safety ( !-- 7,a7 +r$i5ts li/$ on ! cosmetic label "u section #fac = a cosmetic2 & 7,b7 cosmetic itself4 7#b7 ,requir$ in=mation ,! requir$ data & in=mation "u p>agraph 7#a7 %all include1 = ea* +r$i5t 9 a cosmetic & = ! cosmetic1 ! foll[+3 7,a7 ,functions & uses4 7,b7 ,data & in=mation on ! physical1 *emical1 & toxicity ( ea* su* +r$i5t or cosmetic4 7,c7 ,exposure & fate in=mation4 7,d7 ,results ( all safety te/s t ! br& own] c access or has conduct$4 7,e7 ,any o!r in=mation us$ to sub/antiate ! safety ( su* +r$i5t & cosmetic4 7#c7 ,deadl9es 7,a7 ,initial submission ,a br& own] %all submit ! data & in=mation requir$ "u p>agraph 7#a7-- 7i7 9 ! case ( an +r$i5t or cosmetic :i* is m>ket$ = sale 9 int]/ate comm]ce on or be=e ! date ( ! enactm5t ( ?is sub*apt]1 n lat] ?an #a ye> aft] su* date2 & 7ii7 9 ! case ( an +r$i5t or cosmetic :i* is n m>ket$ = sale on or be=e su* date-- 7,i7 n lat] ?an ! end ( ! #ad-mon? p]iod beg9n+ on ! date ( ! enactm5t ( ?is sub*apt]2 or 7,,ii7 if ! +r$i5t or cosmetic is fir/ m>ket$ = sale 9 int]/ate comm]ce aft] ! end ( ! p]iod describ$ 9 subclause 7,i71 n lat] ?an #fj days aft] ! date on :i* su* +r$i5t or cosmetic is fir/ m>ket$ = sale4 7,b7 ,updates 7i7 ,9 g5]al ,subject to clause 7ii71 a br& own] %all update ! data & in=mation submitt$ "u subp>agraph 7,a7 annually4 7ii7 ,adv]se heal? effects ,9 ! case ( in=mation relat$ to an adv]se heal? effect t is suspect$ to be caus$ by an +r$i5t or a cosmetic1 a br& own] %all update ! in=mation n lat] ?an #fj days aft] receiv+ su* in=mation4 7#d7 ,suppli] & manufactur] in=mation 7,a7 ,use ( suppli] or manufactur] in=mation ,9 ord] to meet ! requirem5ts ( p>agraph 7#a7 ) respect to an +r$i5t1 a br& own] may submit safety data & in=mation provid$ by ! suppli] or manufactur] ( ! +r$i5t or cosmetic4 7,b7 ,suppli] or manufactur] provision ( in=mation ,if a br& own] reque/s t a suppli] or manufactur] ( an +r$i5t provide to su* br& own] any ( ! data & in=mation describ$ "u p>agraph 7#b7 or "u section #fag1 su* suppli] or manufactur] %all provide su* data & in=mation to su* br& own] n lat] ?an #ij days aft] receiv+ su* reque/4 7b7 ,database 7#a7 ,initial publication ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is sub*apt]1 ! ,secret>y %all publi% a compreh5sive1 publicly accessible database conta9+ all nonconfid5tial in=mation 7z su* t]m is us$ "u section #fbc7 submitt$ "u subsection 7a77#a74 7#b7 ,updates ,n lat] ?an #ij days aft] ! ,secret>y receives new or updat$ in=mation "u subsection 7a77#c77;,b71 ! ,secret>y %all update ! database "u p>agraph 7#a7 ) su* in=mation4 7c7 ,review & evaluation ( in=mation 7#a7 ,9 g5]al ,bas$ on ! data & in=mation submitt$ "u subsection 7a77#a71 available f an au?oritative s\rce 7z su* t]m is def9$ 9 p>agraph 7#c71 includ+ data describ$ "u section #fbg7;b771 & su* o!r in=mation z ! ,secret>y may h available1 ! ,secret>y %all review & evaluate ! safety ( cosmetics & +r$i5ts ( cosmetics t are m>ket$ 9 int]/ate comm]ce4 7#b7 ,consid]ation ( nanomat]ials ,! ,secret>y %all-- 7,a7 monitor developm5ts 9 ! sci5tific und]/&+ f any adv]se heal? effects relat$ to ! use ( nanote*nology 9 ! =mulation ( cosmetics 7includ+ progress 9 ! /&>dization ( te/+ me?ods & specific size def9itions = nanomat]ials72 & 7,b7 consid] scale specific haz>d prop]ties ( +r$i5ts :5 review+ & evaluat+ ! safety ( cosmetics & +r$i5ts "u p>agraph 7#a74 7#c7 ,au?oritative s\rce def9$ ,= purposes ( ?is p>agraph1 ! t]m au?oritative s\rce means-- 7,a7 ! ,environm5tal ,protection ,ag5cy2 7,b7 ! ,int]national ,ag5cy = ,rese>* on ,canc]2 7,c7 ! ,national ,toxicity ,program ?r\gh ! ,national ,in/itutes ( ,heal?2 7,d7 ! ,cali=nia ,environm5tal ,protection ,ag5cy2 & 7,e7 any o!r au?oritative int]national1 ,f$]al1 & ,/ate entity1 z det]m9$ by ! ,secret>y4 #faf4 ,li/s ( +r$i5ts & requir$ responses 7a7 ,placem5t on li/ 7#a7 ,9 g5]al ,bas$ on an initial review & evaluation ( an +r$i5t "u subsection 7c71 ! ,secret>y %all place ! +r$i5t on "o ( ! foll[+ li/s3 7,a7 ,! prohibit$ & re/rict$ li/ "u subsection 7b74 7,b7 ,! safe )\t limits li/ "u subsection 7c74 7,c7 ,! priority assessm5t li/ "u subsection 7d74 7#b7 ,consid]ations ,9 det]m9+ ! placem5t ( an +r$i5t on a li/ "u subsection 7a71 ! ,secret>y %all consid] :e!r ! +r$i5t-- 7,a7 reacts ) o!r sub/ances to =m h>mful contam9ants2 7,b7 is f\nd to be pres5t 9 ! body ?r\gh biomonitor+2 7,c7 is f\nd 9 dr9k+ wat] or air2 7,d7 is a kn[n or suspect$ neurological or immunological toxicant1 respiratory a/hmag51 c>c9og51 t]atog51 or endocr9e disruptor1 or h o!r toxicity conc]ns 7includ+ reproductive or developm5tal toxicity72 or 7,e7 is kn[n to p]si/ 9 ! environm5t or bioaccumulate4 7#c7 ,prioritization ( +r$i5ts t are food ,9 plac+ +r$i5ts on ! li/s "u p>agraph 7#a71 ! ,secret>y %all prioritize ! placem5t ( +r$i5ts t are food 7z su* t]m is def9$ "u section #bja7;f77 on su* li/s4 7b7 ,prohibit$ & re/rict$ li/ 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is sub*apt]1 ! ,secret>y %all issue1 by regulation1 a li/ ( +r$i5ts t are id5tifi$ by ! ,secret>y-- 7,a7 z prohibit$ = use because ! ,secret>y det]m9es t su* +r$i5ts are unsafe = use 9 cosmetics 9 any am\nt because su* +r$i5ts fail to meet ! safety /&>d "u section #fad7;a72 or 7,b7 z be+ subject to necess>y re/rictions 9 use or conc5tration to all[ ! use ( ! +r$i5t 9 a cosmetic to satisfy ! safety /&>d4 7#b7 ,specification ( re/rictions ,9 ! case ( any +r$i5t li/$ "u p>agraph 7#a77;,b71 ! ,secret>y %all specify ! re/rictions on use or conc5tration t are necess>y to satisfy ! safety /&>d = su* +r$i5t4 7#c7 ,updates ,! ,secret>y %all1 at a m9imum1 annually update ! li/ "u p>agraph 7#a71 includ+ any-- 7,a7 det]m9ations "u subsection 7d77#c72 or 7,b7 new in=mation t demon/rates t an +r$i5t fails to meet ! safety /&>d1 or requires re/rictions on use to meet su* /&>d4 7#d7 ,manufactur] requirem5ts ,n lat] ?an #a ye> aft] ! date t an +r$i5t is plac$ on a li/ "u subsection 7b71 any manufactur] us+ su* +r$i5t 9 a cosmetic %all re=mulate su* cosmetic to-- 7,a7 elim9ate ! use ( ! +r$i5t1 if x is li/$ "u p>agraph 7#a77;,a72 or 7,b7 modify ! use ( ! +r$i5t if x is li/$ "u p>agraph 7#a77;,b71 to meet ! re/rictions specifi$ "u p>agraph 7#b74 7c7 ,safe )\t limits li/ 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is sub*apt]1 ! ,secret>y %all issue1 by regulation1 a li/ ( +r$i5ts t ! ,secret>y has det]m9$ are safe = use 9 cosmetics1 )\t limits or re/rictions4 7#b7 ,/&>d = inclusion 9 li/ ,! ,secret>y may only include an +r$i5t on ! li/ "u p>agraph 7#a7 if ! ,secret>y det]m9es t ! +r$i5t meets ! safety /&>d "u section #fad7;a71 reg>dless (-- 7,a7 ! type & =m ( cosmetic ! +r$i5t is us$ 92 & 7,b7 ! conc5tration ( ! +r$i5t t is us$ 9 a cosmetic4 7#c7 ,updates & r$et]m9ations ,! ,secret>y %all annually update ! li/ "u p>agraph 7#a7 & may r$et]m9e :e!r an +r$i5t di/ribut$ 9 comm]ce meets ! safety /&>d if1 9 ! judgm5t ( ! ,secret>y1 new in=mation raises a cr$ible "q z to :e!r ! +r$i5t cont9ues to meet ! safety /&>d4 7d7 ,priority assessm5t li/ & relat$ safety det]m9ations 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is sub*apt]1 ! ,secret>y %all develop & publi% a priority assessm5t li/ ( n less ?an #cjj +r$i5ts-- 7,a7 :i*1 because ( a lack ( au?oritative in=mation on ! safety ( ! +r$i5t1 _c be includ$ on-- 7i7 ! li/ "u subsection 7b7 7relat+ to prohibit$ & re/rict$ +r$i5ts72 or 7ii7 ! li/ "u subsection 7c7 7relat+ to +r$i5ts t are safe )\t limits72 & 7,b7 = :i* ! ,secret>y has det]m9$ x is a priority to conduct a safety det]m9ation "u p>agraph 7#c74 7#b7 ,annual addition ( +r$i5ts ,aft] ! li/ is develop$ "u p>agraph 7#a71 ! ,secret>y %all annually add at lea/ #ajj additional +r$i5ts to su* li/ until all +r$i5ts t are us$ 9 ! =mulation or manufacture ( cosmetics h be5 add$-- 7,a7 to su* li/2 7,b7 to ! li/ "u subsection 7b72 or 7,c7 to ! li/ "u subsection 7c74 7#c7 ,det]m9ation ( :e!r +r$i5t meets safety /&>d 7,a7 ,review ( priority +r$i5ts ,dur+ ! #b-ye> p]iod foll[+ ! date on :i* an +r$i5t is plac$ on ! li/ "u p>agraph 7#a71 ! ,secret>y %all-- 7i7 collect data & in=mation on su* +r$i5t2 & 7ii7 review & evaluate ! safety ( su* +r$i5t4 7,b7 ,det]m9ation ( li/ placem5t ,n lat] ?an ! end ( ! p]iod "u subp>agraph 7,a71 ! ,secret>y %all issue a det]m9ation1 bas$ on ! review & evaluation "u su* clause1 t-- 7i7 ! +r$i5t meets ! requirem5ts = inclusion on a li/ "u subsection 7b7 7relat+ to prohibit$ & re/rict$ +r$i5ts7 or subsection 7c7 7relat+ to +r$i5ts t are safe )\t limits72 or 7ii7 insuffici5t in=mation exi/s to place ! +r$i5t on ei!r su* li/4 7,c7 ,guidance 9 ! case ( insuffici5t in=mation ,if ! ,secret>y det]m9es "u subp>agraph 7,b7 t1 ) respect to an +r$i5t1 insuffici5t in=mation exi/s to place su* +r$i5t on ei!r ( ! li/s "u subsection 7b7 or subsection 7c71 ! ,secret>y %all provide guidance on ! data & in=mation 7includ+ m9imum data requirem5ts & safety te/+ protocols7 t ! ,secret>y requires to evaluate :e!r ! +r$i5t meets ! safety /&>d "u section #fad7;a7 = purposes ( plac+ su* +r$i5t on su* a li/4 7,d7 ,comm5t p]iod ,^u issu+ ! det]m9ation "u subp>agraph 7,b71 &1 if applicable1 ! guidance "u subp>agraph 7,c71 ! ,secret>y %all provide a p]iod ( n less ?an #fj days = public comm5t on ! det]m9ation be=e apply+ su* det]m9ation to an +r$i5t1 except t a %ort] p]iod = comm5t may be provid$ if ! ,secret>y-- 7i7 f9ds t x w\ld be 9 ! public int]e/ to h a %ort] p]iod2 & 7ii7 publicly decl>es ! reasons = su* f9d+4 7#d7 ,response to inadequate in=mation ,n lat] ?an #ah mon?s aft] ! date t ! ,secret>y issues guidance "u p>agraph 7#c77;,c7 ) respect to an +r$i5t subject to a det]m9ation "u p>agraph 7#c77;,b71 a br& own] us+ su* +r$i5t 9 a cosmetic %all-- 7,a7 re=mulate su* cosmetic to elim9ate ! use ( ! +r$i5t2 or 7,b7 provide ! ,secret>y ) ! data & in=mation specifi$ 9 su* guidance4 7#e7 ,evaluation ( additional data & in=mation ,) respect to an +r$i5t1 n lat] ?an #f mon?s aft] ! ,secret>y receives ! data & in=mation "u p>agraph 7#d77;,b7 ! ,secret>y %all review su* data & in=mation & %all make a r$et]m9ation "u p>agraph 7#c77;,b7 = su* +r$i5t1 subject to ! comm5t p]iod "u p>agraph 7#c77;,d74 7#f7 ,limitation ,if ! ,secret>y has n plac$ an +r$i5t on ei!r ( ! li/s "u subsection 7b7 & subsection 7c7 by ! end ( ! #e-ye> p]iod beg9n+ on ! date t su* +r$i5t is fir/ plac$ on ! li/ "u subsection 7d71 beg9n+ on ! fir/ day aft] su* p]iod su* +r$i5t may n be-- 7,a7 us$ 9 a cosmetic2 & 7,b7 manufactur$1 import$1 di/ribut$1 or m>ket$ = use 9 cosmetics4 #fag4 ,treatm5t ( cosmetics bas$ on +r$i5t li/s 7a7 ,9 g5]al ,subject to subsections 7b77#d7 & 7d77#d7 ( section #faf1 a br& own] may only di/ribute 9 int]/ate comm]ce a cosmetic t meets ! safety /&>d "u section #fad7;a74 7b7 ,presumption relat$ to ! safety ( cosmetics 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 = purposes ( subsection 7a71 ! ,secret>y %all presume t ! foll[+ cosmetics meet ! safety /&>d "u section #fad7;a73 7,a7 ,a cosmetic t is made solely ( +r$i5ts on ! li/ "u section #faf7;c77#a7 7relat+ to +r$i5ts t are safe )\t limits74 7,b7 ,a cosmetic t is made solely ( +r$i5ts on ! li/ "u section #faf7;b77#a77;,b7 7relat+ to +r$i5ts subject to re/rictions7 & ! use ( ea* ( su* +r$i5ts 9 su* cosmetic is 9 compliance ) ! re/rictions on ! use ( su* +r$i5ts specifi$ "u section #faf7;b77#b74 7,c7 ,a cosmetic t is made solely ( +r$i5ts describ$ "u subp>agraph 7,a7 & subp>agraph 7,b74 7#b7 ,exceptions ,! ,secret>y may require t a br& own] demon/rate t a cosmetic meets ! safety /&>d "u section #fad7;a7 7includ+ by requir+ t ! br& own] conduct safety te/+1 or reque/ su* safety te/+ f relevant suppli]s & manufactur]s1 ( a cosmetic describ$ "u p>agraph 7#a77 if ! cosmetic-- 7,a7 conta9s p5etration enhanc]s1 s5sitiz]s1 e/rog5ic *emicals1 or o!r simil> +r$i5ts2 7,b7 conta9s +r$i5ts t react ) ea* o!r or ) o!r sub/ances to =m h>mful byproducts2 or 7,c7 ! ,secret>y has any additional reason to believe t su* cosmetic does n meet ! safety /&>d "u section #fad7;a74 7#c7 ,guidance ,if1 "u p>agraph 7#b71 ! ,secret>y requires t a br& own] demon/rate t a cosmetic meets ! safety /&>d "u section #fad7;a71 ! ,secret>y %all provide ! br& own] ) guidance on ! data & in=mation t ! ,secret>y requires to evaluate :e!r ! cosmetic meets ! safety /&>d "u su* section4 7c7 ,notification ( failure ( ,secret>y ,to act ,if ! ,secret>y fails to act by an applicable deadl9e "u section #faf or ?is section1 br& own]s & manufactur]s ( an +r$i5t or a cosmetic affect$ by su* failure ( ! ,secret>y to act %all issue to ! ,secret>y1 ! public1 & ea* kn[n cu/om] ( ! +r$i5t or cosmetic1 a writt5 notice t a det]m9ation by ! ,secret>y ( ! safety ( ! +r$i5t = use 9 cosmetics is p5d+4 #fah4 ,treatm5t ( contam9ants 7a7 ,publication ( li/ ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is sub*apt]1 & annually !reaft]1 ! ,secret>y %all publi% a li/ ( contam9ants ( conc]n l9k$ to sev]e acute reactions or long-t]m adv]se heal? effects1 includ+-- 7#a7 +r$i5ts us$ 9 cosmetics t may conta9 contam9ants ( conc]n2 7#b7 comb9ations ( +r$i5ts t may create contam9ants ( conc]n :5 su* +r$i5ts int]act2 7#c7 contam9ants ( conc]n t may lee* f product packag+ into a cosmetic2 & 7#d7 any o!r contam9ant ( conc]n id5tifi$ by ! ,secret>y t are pres5t 9 cosmetics4 7b7 ,evaluation2 label+ ,! ,secret>y %all use ! process describ$ 9 sections #fae & #faf to evaluate contam9ants ( conc]n = possible elim9ation or re/riction 9 cosmetics4 ,! ,secret>y %all require t a contam9ant on ! li/ "u subsection 7a7 be decl>$ on ! label ( a cosmetic1 9 ! same mann] z an +r$i5t "u section #fac4 7c7 ,requirem5ts = te/+ 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is sub*apt]1 ! ,secret>y %all e/abli%1 by rule1 requirem5ts = te/+ +r$i5ts & cosmetics = contam9ants li/$ "u subsection 7a74 7#b7 ,cont5ts ,! requirem5ts "u p>agraph 7#a7 %all include-- 7,a7 te/+ me?ods & applicable protocols2 & 7,b7 maximum all[able detection limits = ea* contam9ant 9 an +r$i5t or cosmetic4 7#c7 ,update ,! ,secret>y %all annually update ! requirem5ts "u p>agraph 7#a74 7d7 ,suppli] requirem5ts ,n lat] ?an #a ye> aft] ! promulgation ( ! rule "u subsection 7b77#a71 a suppli] ( an +r$i5t t is us$ 9 a cosmetic %all1 ) respect to su* +r$i5t-- 7#a7 comply ) ! requirem5ts "u subsection 7b77#a7 = any +r$i5t li/$ "u subsection 7a72 7#b7 conduct simil> te/+ on any +r$i5t t-- 7,a7 ! suppli] expects may be us$ 9 a cosmetic2 7,b7 ! suppli] suspects may conta9 a contam9ant ( conc]n2 & 7,c7 is n li/$ "u subsection 7a72 & 7#c7 ^u ! sale ( an +r$i5t to ! manufactur]1 provide to ! manufactur] specifications = ! +r$i5t t-- 7,a7 include ! levels ( contam9ants pres5t 9 su* +r$i5t2 & 7,b7 are bas$ on ! results ( ! te/s "u p>agraph 7#a7 & p>agraph 7#b74 7e7 ,br& own] requirem5ts ,n lat] ?an #a ye> aft] ! promulgation ( ! rule "u subsection 7b77#a71 a br& own] ( a cosmetic %all1 ) respect to ea* +r$i5t t ! br& own] uses 9 a cosmetic-- 7#a7 obta91 f ea* suppli] or manufactur] ( ! +r$i5t1 specifications = ! +r$i5t t include-- 7,a7 ! level ( ea* contam9ant pres5t 9 ! +r$i5t2 & 7,b7 ! detection limits ( ! analytical te/ us$ to detect ! contam9ant2 or 7#b7 comply ) ! requirem5ts "u p>agraphs 7#a7 & 7#b7 ( subsection 7c7 = ! +r$i5t1 9 ! same mann] z if ! br& own] 7 a suppli]4 #fai4 ,cosmetic & +r$i5t /atem5ts 7a7 ,9 g5]al ,beg9n+ #a ye> aft] ! date ( ! enactm5t ( ?is sub*apt]1 ea* br& own] ( a cosmetic int5d$ to be m>ket$ 9 ! ,unit$ ,/ates %all submit electronically to ! ,secret>y1 = ea* cosmetic t is int5d$ to be m>ket$ 9 ! ,unit$ ,/ates1 a /atem5t conta9+-- 7#a7 ! regi/ration numb] ( ! br& own]2 7#b7 ! br& "n & ! product "n = ! cosmetic2 7#c7 ! applicable use = ! cosmetic2 7#d7 ! +r$i5t li/ z x appe>s on ! cosmetic label or ins]t1 includ+ ! p>ticle size range ( any nanoscale cosmetic +r$i5ts2 7#e7 any w>n+s & directions = use f ! cosmetic label or ins]t2 & 7#f7 ! title & full contact in=mation = ! individual responsible = submitt+ & ma9ta9+ su* /atem5t4 7b7 ,new cosmetics ,any br& own] t beg9s to m>ket a cosmetic aft] ! date ( ! enactm5t ( ?is sub*apt] %all comply ) ! requirem5ts ( subsection 7a7 beg9n+ on ! lat] ( ! foll[+3 7#a7 ,! end ( ! #ah-mon? p]iod beg9n+ on ! date ( ! enactm5t ( ?is sub*apt]4 7#b7 ,! #f-mon? p]iod aft] ! date on :i* ! e/abli%m5t beg9s to manufacture su* cosmetic4 7c7 ,notification ( *anges ,! br& own] %all notify ! ,secret>y annually ( any *ange to ! in=mation requir$ "u subsection 7a74 7d7 ,proc$ure ,^u receipt ( a complet$ /atem5t describ$ "u subsection 7a71 ! ,secret>y %all notify ! br& own] ( ! receipt ( su* /atem5t & assign a cosmetic /atem5t numb]4 7e7 ,li/ ,! ,secret>y %all compile1 ma9ta91 & update z appropriate1 a li/ ( cosmetics = :i* /atem5ts are submitt$ "u ?is section4 7f7 ,access to safety in=mation ,! cosmetic & +r$i5t /atem5ts collect$ "u ?is section %all be add$ to ! publicly accessible database creat$ by ! ,secret>y "u section #fae7;b74 #fbj4 ,notification1 nondi/ribution1 & recall ( adult]at$ or misbr&$ cosmetics 7a7 ,notification ( adult]at$ or misbr&$ cosmetics 7#a7 ,9 g5]al ,a responsible p>ty t has reason to believe t a cosmetic1 :5 introduc$ into or :ile 9 int]/ate comm]ce1 or :ile held = sale 7reg>dless ( :e!r su* sale is ! fir/ sale ( su* cosmetic7 aft] %ipm5t 9 int]/ate comm]ce1 is adult]at$ or misbr&$ 9 a mann] t pres5ts a reasonable probability t ! use or exposure to ! cosmetic 7or an +r$i5t or compon5t us$ 9 any su* cosmetic7 w cause a ?reat ( s]i\s adv]se ev5t %all notify ! ,secret>y ( ! id5tity & location ( ! cosmetic4 7#b7 ,mann] ( notification ,notification "u p>agraph 7#a7 %all be made 9 su* mann] & by su* means z ! ,secret>y may require by regulation or guidance4 7#c7 ,responsible p>ty def9$ ,= purposes ( ?is subsection1 ! t]m responsible p>ty means a br& own]1 manufactur]1 packag]1 retail]1 or di/ributor ( ! cosmetic4 7b7 ,volunt>y recall ,! ,secret>y may reque/ t any p]son :o di/ributes a cosmetic t ! ,secret>y has reason to believe is adult]at$1 misbr&$1 or o!rwise 9 violation ( ?is ,act volunt>ily-- 7#a7 recall su* cosmetic2 & 7#b7 provide = notice1 includ+ to individuals z appropriate1 to p]sons :o may be affect$ by ! recall4 7c7 ,ord] ,to cease di/ribution 7#a7 ,9 g5]al ,if ! ,secret>y has reason to believe t-- 7,a7 ! use (1 or exposure to1 a cosmetic may cause s]i\s adv]se ev5t2 7,b7 ! cosmetic is misbr&$2 or 7,c7 ! cosmetic is m>ket$1 manufactur$1 packag$1 or di/ribut$ by an unregi/]$ br& own]2 ! ,secret>y %all h ! au?ority to issue an ord] requir+ any p]son :o di/ributes su* cosmetic to imm$iately cease di/ribution ( su* cosmetic4 7#b7 ,cease di/ribution & notice ,any p]son :o is subject to an ord] "u p>agraph 7#a7 %all imm$iately cease di/ribution ( su* cosmetic & provide notification z requir$ by su* ord]4 7#c7 ,appeal 7,a7 #bd h\rs ,a p]son subject to an ord] "u p>agraph 7#a7 may appeal su* ord] to ! ,secret>y )9 #bd h\rs ( ! issuance ( su* ord]4 7,b7 ,cont5ts ( appeal ,su* appeal may include a reque/ = an in=mal he>+ & a description ( any ef=ts to recall su* cosmetic und]tak5 volunt>ily by ! p]son1 includ+ aft] a reque/ "u subsection 7b74 7,c7 ,in=mal he>+ ,except z provid$ 9 subsection 7e71 an in=mal he>+ %all be held z soon z practicable1 b n lat] ?an #e cal5d> days 7or less z det]m9$ by ! ,secret>y7 aft] su* an appeal is fil$1 unless ! p>ties jo9tly agree to an ext5sion4 7,d7 ,impact on recall ,if an appeal is fil$ "u subp>agraph 7,a71 ! ,secret>y may n am5d ! ord] to require a recall "u subsection 7d7 until aft] ! conclusion ( ! he>+ "u subp>agraph 7,c74 7#d7 ,vacation ( ord] ,if ! ,secret>y det]m9es t inadequate gr\nds exi/ to support ! actions requir$ by ! ord] "u p>agraph 7#a71 ! ,secret>y %all vacate ! ord]4 7d7 ,ord] ,to recall 7#a7 ,am5dm5t ,except z provid$ "u subsection 7e7 & subject to subsection 7c77#c77;,d71 if ! ,secret>y det]m9es t a recall ( a cosmetic subject to an ord] "u subsection 7c7 is appropriate1 ! ,secret>y %all am5d ! ord] to require a recall4 7#b7 ,cont5ts ,an am5d$ ord] "u p>agraph 7#a7 %all-- 7,a7 specify a timetable 9 :i* ! recall w occur2 7,b7 require p]iodic reports to ! ,secret>y describ+ ! progress ( ! recall2 & 7,c7 provide = notice1 includ+ to individuals z appropriate1 to p]sons :o may be affect$ by ! recall4 ,9 provid+ = su* notice1 ! ,secret>y may all[ = ! assi/ance ( heal? pr(essionals1 ,/ate or local (ficials1 or o!r individuals designat$ by ! ,secret>y4 7#c7 ,nondelegation ,an am5d$ ord] "u ?is subsection may only be issu$ by ! ,secret>y or an (ficial designat$ by ! ,secret>y1 & may n be delegat$ to ano!r (ficial or employee4 7#d7 ,det]m9ation ,if ! ,secret>y det]m9es t inadequate gr\nds exi/ to support ! am5dm5t made to ! ord] "u p>agraph 7#a71 ! ,secret>y %all remove su* am5dm5t f su* ord]4 7e7 ,em]g5cy recall ord] 7#a7 ,9 g5]al ,if ! ,secret>y has cr$ible evid5ce or in=mation t a cosmetic subject to an ord] "u subsection 7c7 pres5ts an imm95t ?reat ( s]i\s adv]se ev5t1 ! ,secret>y may issue an ord] requir+ any p]son :o di/ributes su* cosmetic-- 7,a7 to imm$iately recall su* cosmetic2 & 7,b7 to provide = notice1 includ+ to individuals z appropriate1 to p]sons :o may be affect$ by ! recall4 7#b7 ,recall & notice ,any p]son :o is subject to an em]g5cy recall ord] "u ?is subsection %all imm$iately recall su* cosmetic & provide notification z requir$ by su* ord]4 7#c7 ,appeal 7,a7 #bd h\rs ,any p]son subject to su* an ord] may appeal su* ord] to ! ,secret>y )9 #bd h\rs ( ! issuance ( su* ord]4 7,b7 ,cont5ts ( appeal ,su* appeal may include a reque/ = an in=mal he>+ & a description ( any ef=ts to recall su* cosmetic und]tak5 volunt>ily by ! p]son1 includ+ aft] a reque/ "u subsection 7b74 7,c7 ,in=mal he>+ ,an in=mal he>+ %all be held z soon z practicable aft] ! appeal is fil$ "u subp>agraph 7,a71 b n lat] ?an #e cal5d> days aft] su* an appeal is fil$1 or few] days 7z det]m9$ by ! ,secret>y71 unless ! p>ties jo9tly agree to an ext5sion4 7#d7 ,vacation ( ord] ,if ! ,secret>y det]m9es t inadequate gr\nds exi/ to support ! actions requir$ by ! ord] "u p>agraph 7#a71 ! ,secret>y %all vacate ! ord]4 7#e7 ,nondelegation ,an ord] "u ?is subsection may only be issu$ by ! ,secret>y or an (ficial designat$ by ! ,secret>y1 & may n be delegat$ to ano!r (ficial or employee4 7f7 ,notice to consum]s & heal? (ficials ,! ,secret>y %all1 z ! ,secret>y det]m9es to be necess>y1 provide notice ( a recall ord] "u ?is section to consum]s to :om ! cosmetic 01 or may h be51 di/ribut$ & to appropriate ,/ate & local heal? (ficials4 7g7 ,supply *a9 in=mation 7#a7 ,9 g5]al ,9 ! case ( a cosmetic t ! ,secret>y has reason to believe is adult]at$1 misbr&$1 or o!rwise 9 violation ( ?is ,act1 ! ,secret>y %all reque/ t ! br& own] nam$ on ! label ( su* cosmetic 7z requir$ "u section #fjb7;b77#a77 submit all ( ! foll[+ in=mation3 7,a7 ,! "n & place ( bus9ess ( ! manufactur]1 packag]1 suppli]1 or di/ributor f :i* su* entity receiv$ ! cosmetic or +r$i5ts = manufactur+ su* cosmetic4 7,b7 ,! "n & place ( bus9ess ( any entity 7includ+ any retail]7 t 0 provid$ ) su* cosmetic by ! entity nam$ on ! label4 7#b7 ,collection ( additional supply *a9 in=mation ,9 ! case ( a cosmetic t ! ,secret>y has reason to believe is adult]at$1 misbr&$1 or o!rwise 9 violation ( ?is ,act1 to ! ext5t necess>y to protect ! safety ( ! public1 ! ,secret>y may reque/ t any entity 7includ+ a suppli] ( an +r$i5t1 manufactur]1 pack]1 di/ributor1 or retail]7 9 ! supply *a9 ( su* cosmetic submit to ! ,secret>y in=mation t is simil> to ! in=mation describ$ "u subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a74 7#c7 ,ma9t5ance ( records ,any entity 9 supply *a9 ( a cosmetic 7includ+ ! br& own] nam$ on ! label ( a cosmetic7 %all-- 7,a7 ma9ta9 records suffici5t to provide ! in=mation describ$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a72 & 7,b7 provide su* in=mation to ! ,secret>y ^u ! reque/ ( ! ,secret>y4 7h7 ,sav+s clause ,no?+ conta9$ 9 ?is section %all be con/ru$ z limit+ ! au?ority ( ! ,secret>y to issue an ord] to cease di/ribution (1 or to recall1 a cosmetic "u any o!r provision ( ?is ,act4 #fba4 ,petitions 7a7 ,9 g5]al ,! ,secret>y %all complete & publi% a review1 &1 if appropriate1 imm$iately revise relat$1 relevant in=mation1 includ+ +r$i5t li/s1 +r$i5t re/rictions or prohibitions1 or +r$i5t or cosmetic safety det]m9ations1 n lat] ?an #f mon?s aft] ! date on :i* ! ,secret>y receives f any individual or entity a reasonable petition-- 7#a7 to prohibit or re/rict an +r$i5t = use 9 cosmetics & li/ su* +r$i5t on ! li/ "u section #faf7;b72 7#b7 to remove an +r$i5t f ! li/ ( +r$i5ts t are safe )\t limits "u section #faf7;c72 7#c7 to add an +r$i5t to ! priority assessm5t li/ "u section #faf7;d72 or 7#d7 to add an +r$i5t to ! li/ ( contam9ants "u section #fah4 7b7 ,reasonable petition ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all issue rules specify+ ! crit]ia :i* ! ,secret>y w use to det]m9e if a petition submitt$ "u ?is section is a reasonable petition4 #fbb4 ,m&atory report+ ( s]i\s adv]se ev5ts 7a7 ,submission ( report on s]i\s adv]se ev5ts ,! ,secret>y %all require t ! br& own] ( a cosmetic ^: "n appe>s on ! label ( a cosmetic m>ket$ 9 ! ,unit$ ,/ates submit to ! ,secret>y a report conta9+ in=mation receiv$ conc]n+ any s]i\s adv]se ev5t associat$ ) ! use ( ! cosmetic4 7b7 ,tim+ ( report ,a report "u subsection 7a7 %all be submitt$ to ! ,secret>y n lat] ?an #ae bus9ess days aft] in=mation conc]n+ ! s]i\s adv]se ev5t is receiv$ at ! place ( bus9ess ( ! br& own]4 7c7 ,cont5t ( report ,a report "u subsection 7a7 %all include ! foll[+ in=mation1 to ! ext5t to :i* ! br& own] submitt+ ! report has be5 able to v]ify ! in=mation3 7#a7 ,! id5tity ( ! individual exp]i5c+ ! adv]se heal? ev5t4 7#b7 ,an id5tifiable report ( su* effect4 7#c7 ,! "n ( ! cosmetic suspect$ ( caus+ su* effect4 7#d7 ,a description ( ! adv]se heal? ev5t4 7d7 ,public availability & privacy 7#a7 ,public availability ,subject to p>agraph 7#b71 ! s]i\s adv]se ev5t reports collect$ by ! ,secret>y "u ?is section %all be submitt$ electronically & %all be made accessible to ! public4 7#b7 ,privacy 7,a7 ,p]sonally id5tifiable in=mation ,not)/&+ any o!r provision ( law1 p]sonally id5tifiable in=mation 9 s]i\s adv]se ev5t reports provid$ to ! ,secret>y "u ?is section1 %all n-- 7i7 be made publicly available pursuant to any ,/ate or o!r law requir+ disclosure ( in=mation or records2 or 7ii7 o!rwise be disclos$ or di/ribut$ to any p>ty )\t ! writt5 cons5t ( ! ,secret>y & ! p]son submitt+ su* in=mation to ! ,secret>y4 7,b7 ,treatm5t ( in=mation "u ,privacy ,act & ,,foia ,a report submitt$ to ! ,secret>y "u ?is section1 %all be consid]$ to be a record ab\t an individual "u section #eeb;a ( title #e1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! #8#8,privacy ,act ( #aigd''7 & a m$ical or simil> file ! disclosure ( :i* w\ld con/itute a violation ( section #eeb ( su* title #e 7commonly ref]r$ to z ! #8#8,fre$om ( ,in=mation ,act''71 & %all n be publicly disclos$ unless all p]sonally id5tifiable in=mation is r$act$4 #fbc4 ,nonconfid5tial in=mation 7a7 ,in=mation available to public ,subject to subsection 7c7 & section #fbb7;d77#b71 all nonconfid5tial in=mation submitt$ pursuant to ?is sub*apt] %all be made available to ! public1 includ+ ! foll[+ types ( in=mation3 7#a7 ,! "n1 id5tity1 & /ructure ( a *emical sub/ance1 contam9ant1 or impurity t is an +r$i5t4 7#b7 ,all in=mation conc]n+ function1 exposure1 toxicity data1 heal? haz>ds1 & environm5tal haz>ds = a cosmetic4 7#c7 ,! functions ( +r$i5ts 9 cosmetics4 7#d7 ,fragrance1 flavor1 & colorants 9 a cosmetic4 7b7 ,confid5tial in=mation ,! conc5tration ( cosmetic +r$i5ts us$ 9 a f9i%$ cosmetic %all be consid]$ confid5tial bus9ess in=mation & may n be made available to ! public "u subsection 7a74 7c7 ,petition = in=mation ,to rema9 confid5tial 7#a7 ,9 g5]al ,! ,secret>y %all create a process = an entity to petition = nonconfid5tial in=mation describ$ 9 subsection 7a7 to rema9 confid5tial if ! entity %[s t !re w\ld be a s]i\s negative impact to ! entity's comm]cial int]e/s if su* in=mation 7 disclos$ to ! public4 7#b7 ,limitation ,! ,secret>y may n approve a petition "u p>agraph 7#a7 to ! ext5t t su* petition w\ld prev5t ! public disclosure (-- 7,a7 ! "n1 id5tity1 & /ructure ( any *emical sub/ance1 contam9ant1 or impurity t is an +r$i5t2 7,b7 all heal? & safety data relat$ to t sub/ance1 contam9ant1 or impurity2 or 7,c7 any data us$ to sub/antiate ! safety ( t sub/ance1 contam9ant1 or impurity4 #fbd4 ,animal te/+ alt]natives 7a7 ,9 g5]al ,to m9imize ! use ( animal te/+ ( +r$i5ts & cosmetics1 ! ,secret>y %all-- 7#a7 require1 :]e practicable1 alt]native te/+ me?ods t-- 7,a7 d n involve ! use ( an animal to te/ ! *emical sub/ance2 7,b7 provide in=mation t is equival5t or sup]ior 9 sci5tific quality to ! animal te/+ me?od2 & 7,c7 use few] animals ?an conv5tional animal-bas$ te/s :5 nonanimal me?ods are impracticable1 includ+ ! use ( te/s t comb9e multiple endpo9ts2 & 7#b7 enc\rage1 :]e practicable-- 7,a7 e/imation ( toxicological prop]ties ( a *emical ?r\gh ! use ( te/+ in=mation = "o or m /ructurally simil> *emicals :]e su* e/imates provide in=mation ( suffici5t sci5tific quality2 7,b7 ! =mation ( indu/ry consortia to conduct te/+ to avoid duplication ( te/s2 & 7,c7 fund+ = rese>* & validation ( alt]native te/ me?ods1 9 accordance ) ?is subsection4 7b7 ,li/ ( alt]native te/+ me?ods ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is sub*apt]1 & tri5nially !reaft]1 ! ,secret>y %all publi% a li/ ( ! alt]native te/+ me?ods describ$ 9 subsection 7a74 #fbe4 ,product ,te/+ & ,review ,audit ,! ,secret>y %all conduct annual audits ( r&om samples ( cosmetics to assess or te/ = acute negative reactions1 pa?og5 haz>ds1 contam9ants1 lea*+ ( packag+ additives1 mislabel+1 or o!r relevant issues ( conc]n 7z det]m9$ by ! ,secret>y74 #fbf4 ,res\rces = small bus9esses ,! ,secret>y %all provide te*nical support to assi/ small bus9esses 9 c>ry+ out ! requirem5ts ( ?is sub*apt]4 #fbg4 ,int]ag5cy coop]ation 7a7 ,int]ag5cy ,c\ncil on ,cosmetic ,safety ,!re is e/abli%$ an ,int]ag5cy ,c\ncil on ,cosmetic ,safety = ! purpose ( %>+ data & promot+ collaboration on cosmetic safety betwe5 ! ,food & ,drug ,adm9i/ration1 ! ,national ,in/itute ( ,environm5tal ,heal? ,sci5ces1 ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,occupational ,safety & ,heal? ,adm9i/ration1 & ! ,environm5tal ,protection ,ag5cy4 7b7 ,use ( data f ,f$]al s\rces ,= purposes ( ?is sub*apt]1 ! ,secret>y1 z appropriate1 %all reque/ & utilize +r$i5t & cosmetic toxicity1 use1 & exposure data f o!r ,f$]al ag5cies4 #fbh4 ,sav+s clause ,no?+ 9 ?is ,act affects ! "r ( a ,/ate or a political subdivision ( a ,/ate to adopt or en=ce any regulation1 requirem5t1 or /&>d ( p]=mance t is diff]5t f1 or 9 addition to1 a regulation1 requirem5t1 liability1 or /&>d = p]=mance e/abli%$ pursuant to ?is ,act unless compliance ) bo? ?is ,act & ! ,/ate or political subdivision ( a ,/ate regulation1 requirem5t1 or /&>d ( p]=mance is impossible1 9 :i* case ! applicable provisions ( ?is ,act %all control4 #fbi4 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ su* sums z may be necess>y to c>ry out ?is sub*apt] = ea* ( ! fiscal ye>s #bjad ?r\gh #bjah4 4 7b7 ,adult]at$ & misbr&$ cosmetics 7#a7 ,adult]at$ cosmetics ,section #fja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa7 is am5d$ 9 p>agraph 7a7-- 7,a7 by /rik+ 1 except t ?is provision %all n apply to coal-t> hair dye & all t foll[s ?r\gh or eyebr[ dyes2 & 7,b7 by add+ at ! end ! foll[+3 7f7 ,if x is manufactur$ 9 a mann] t fails to comply ) section #fag7;a74 7g7 ,if x is import$1 di/ribut$1 or m>ket$ &-- 7#a7 x conta9s an +r$i5t on ! li/ "u section #faf7;b77#a77;,a71 & ! manufactur] has n compli$ ) section #faf7;b77#d7 ) respect to su* +r$i5t & su* cosmetic2 or 7#b7 x conta9s an +r$i5t on ! li/ "u section #faf7;b77#a77;,b71 su* +r$i5t is be+ us$ 9 a mann] t violates ! limit on use or conc5tration ( su* +r$i5t "u section #faf7;b77#b71 & ! manufactur] has n compli$ ) section #faf7;b77#d7 ) respect to su* +r$i5t & su* cosmetic4 7h7 ,if x is m>ket$ by a br& own] t1 ) respect to su* cosmetic1 is requir$ to demon/rate1 "u section #fag7;b77#b71 t ! cosmetic meets ! safety /&>d & ! br& own] has n yet submitt$ ! requir$ data "u section #fag7;b77#c74 4 7#b7 ,misbr&$ cosmetics ,section #fjb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb7 is am5d$-- 7,a7 9 p>agraph 7a71 by ins]t+ or fails to meet ! requirem5ts ( section #fac or #fah7;b7 be=e ! p]iod2 & 7,b7 by add+ at ! end ! foll[+3 7g7 ,if x-- 7#a7 0 br\ght to m>ket by a br& own] t fail$ to regi/] & pay ! applicable fee z requir$ "u section #fab2 7#b7 is br\ght to m>ket1 manufactur$1 packag$1 di/ribut$1 or sold 9 retail by a br& own]1 manufactur]1 packag]1 di/ributor1 or retail]1 respectively1 :o fails to notify ! ,secret>y z requir$ "u section #fbj7;a77#a72 7#c7 is di/ribut$ 9 violation ( an ord] "u section #fbj7;c72 7#d7 is n recall$ z requir$ by an ord] "u subsection 7d7 or 7e7 ( section #fbj2 7#e7 is manufactur$ 9 a mann] t fails to comply ) good manufactur+ practices prescrib$ by ! ,secret>y "u section #fad7;b72 or 7#f7 is br\ght to m>ket by a br& own] :o fails-- 7,a7 to submit ! /atem5t requir$ "u section #fai2 or 7,b7 notify ! ,secret>y ( *anges to in=mation conta9$ 9 su* report1 z requir$ by su* section4 4 7#c7 ,additional prohibitions ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$-- 7,a7 9 p>agraph 7e71 by ins]t+ #fab1 aft] #efd1 ea* place x appe>s2 & 7,b7 by add+ at ! end ! foll[+3 7ccc7 ,! failure ( a br& own]1 manufactur]1 or suppli] ( a cosmetic or an +r$i5t = use 9 a cosmetic to submit & update data & in=mation z requir$ "u section #fae7;a74 7ddd7 ,! manufacture1 importation1 di/ribution1 or m>ket+ ( an +r$i5t = use 9 a cosmetic t is on ! li/ "u section #faf7;b77#a77;,a74 7eee7 ,! failure ( a suppli] ( an +r$i5t = use 9 a cosmetic-- 7#a7 to provide data & in=mation z requir$ by section #fae7;a77#d77;,b72 or 7#b7 comply ) ! te/+ requirem5ts "u section #fah7;c74 7fff7 ,! failure ( a manufactur] to comply ) ! requirem5ts ( section #fah7;d74 7ggg7 ,! failure ( a br& own] ( a cosmetic to comply ) ! requirem5t ( report+ s]i\s adv]se ev5ts "u section #fbb4 4 #c4 ,work] issues 7a7 ,9 g5]al ,! ,secret>y ( ,labor %all promulgate an occupational safety & heal? /&>d "u section #f ( ! ,occupational ,safety & ,heal? ,act ( #aigj 7#bi ,u4,s4,c4 #fee7 t requires ! foll[+3 7#a7 ,manufactur]s & import]s ,ea* manufactur] or import] sell+ any cosmetic = pr(essional use %all-- 7,a7 obta9 or develop a mat]ial safety data %eet describ$ 9 subsection 7b7 = ea* su* cosmetic or p]sonal c>e product t-- 7i7 ! manufactur] or import] produces or imports2 & 7ii7 includes a haz>d\s *emical1 or a product +r$i5t associat$ ) any *emical haz>d1 t is classifi$ z a heal? haz>d 9 accordance ) ! crit]ia f\nd 9 section #aiaj4abjj7;d7 ( title #bi ( ! ,code ( ,f$]al ,regulations1 & any successor regulations2 & 7,b7 make ! mat]ial safety data %eet available to di/ributors & employ]s1 includ+ salon own]s1 9 ,engli% &1 ^u reque/1 9 o!r languages1 includ+ ,spani% & ,vietnamese4 7#b7 ,di/ributors ,ea* di/ributor ( a cosmetic or p]sonal c>e product = pr(essional use %all di/ribute & provide mat]ial safety data %eets describ$ 9 subsection 7b7 9 ! same mann] z a di/ributor ( a *emical haz>d is requir$ to di/ribute & provide mat]ial safety data %eets "u section #aiaj4abjj7;g7 ( title #bi1 ,code ( ,f$]al ,regulations1 or any successor regulations4 7#c7 ,employ]s ,ea* employ]1 includ+ any op]ator ( a salon1 %all-- 7,a7 h a mat]ial safety data %eet 9 ! workplace = ea* cosmetic or p]sonal c>e product = pr(essional use t is us$ 9 ! c\rse ( ! employ]'s bus9ess2 7,b7 make su* mat]ial safety data %eet available to all employees ( ! employ] :o are expos$ or use ! product to ! same ext5t & 9 ! same mann] z mat]ial safety data %eets are requir$ to be made available "u section #aiaj4abjj7;g7 ( title #bi1 ,code ( ,f$]al ,regulations1 or any successor regulations2 & 7,c7 ^u reque/1 provide employees ) translations ( su* mat]ial safety data %eet 9 o!r languages1 includ+ ,spani% & ,vietnamese4 7b7 ,cont5ts ( mat]ial safety data %eet ,a mat]ial safety data %eet = a cosmetic or p]sonal c>e product = pr(essional use describ$ 9 ?is section %all-- 7#a7 conta9 ! in=mation requir$ 9 a mat]ial safety data %eet "u section #aiaj4abjj7;g7 ( title #bi1 ,code ( ,f$]al ,regulations1 or any successor regulations1 = ea* haz>d\s *emical1 or product +r$i5t associat$ ) any *emical haz>d1 describ$ 9 subsection 7a77#a77;,a77ii72 & 7#b7 include ! foll[+ /atem5t3 ,?is mat]ial safety data %eet is also available 9 multiple languages by contact+ ! manufactur]1 us+ ! contact in=mation provid$ on ?is %eet44 7c7 ,pr(essional use def9$ ,9 ?is section1 ! t]m pr(essional use has ! mean+ giv5 su* t]m 9 section #faa7f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 except to ! ext5t t su* t]m applies to a product t is sold z a retail product 9 any ( ! e/abli%m5ts li/$ "u su* def9ition4