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COMMISSION IMPLEMENTING DECISION

of XXX

on Guidelines on Annex I to Regulation (EC) No !!"#!$$% on &os'eti& odu&ts

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard t the Treat! n the "#nctining $ the E#r%ean Unin,

Having regard t Reg#latin (EC) N &'''**+ $ the E#r%ean Parliaent and $ the

C#ncil $ * Nve-er '**+ n c.etic %rd#ct.&, and in %artic#lar the third .#-%aragra%h

$ Article &*(&) there$,

/herea.0

(&) It i. e..ential that c.etic %rd#ct. ade availa-le n the Unin ar1et -e .a$e $r 

h#an health when #.ed #nder nral and rea.na-l! $re.eea-le cnditin. $ #.e2

T that end, Reg#latin (EC) N &'''**+ re3#ire. that, in rder t e.ta-li.h that a

c.etic %rd#ct i. .a$e #nder th.e cnditin., c.etic %rd#ct. #nderg a .a$et!

a..e..ent2

(') The %eratr de.ignated a. the re.%n.i-le %er.n in accrdance with Reg#latin (EC)

 N &'''**+ i. t en.#re that, $r each c.etic %rd#ct which i. t -e %laced n the

Unin ar1et, a c.etic %rd#ct .a$et! re%rt i. drawn #% n the -a.i. $ the relevant

in$ratin and in accrdance with the re3#ireent. laid dwn in Annex I t

Reg#latin (EC) N &'''**+2

() In rder t $acilitate the #nder.tanding $ the re3#ireent. $ Annex I t Reg#latin

(EC) N &'''**+ -! all #nderta1ing., and e.%eciall! .all and edi#4.i5e

enter%ri.e., the Reg#latin re3#ire. that the Ci..in ad%t. a%%r%riate

g#ideline.2

(6) Thi. 7eci.in .et. #t a%%r%riate g#ideline. n Annex I t Reg#latin (EC) N

&'''**+2 The! were devel%ed with the cntri-#tin $ the relevant .ta1ehlder.,

incl#ding re%re.entative. $ .all and edi#4.i5ed enter%ri.e.2

(8) The g#ideline. .h#ld a..i.t re.%n.i-le %er.n. in c%l!ing with their reg#latr!

-ligatin.2 Hwever, the! are nt eant t re%lace the 1nwledge and ex%erti.e $ 

the 3#ali$ied .a$et! a..e..r, a. re3#ired -! Article &*(') $ Reg#latin (EC) N

&'''**+, wh .h#ld reain the nl! %r$e..inal allwed t carr! #t the c.etic

 %rd#ct .a$et! a..e..ent a. de.cri-ed in Part 9 $ Annex I2

& O: ; 6', ''2&'2'**+, %2 8+2

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ANNEX

Guidelines on Annex I to Regulation (EC) No !!"#!$$% on t*e

Cos'eti& Podu&t Safet+ Reot

1" #  $TO%UCT#O$  

Article && $ Reg#latin (EC) N &'''**+ re3#ire. that a %rd#ct in$ratin $ile i. drawn #% $r each

 %rd#ct -e$re it i. %laced n the ar1et2 The %rd#ct in$ratin $ile .h#ld -e #%dated when nece..ar!

and 1e%t readil! acce..i-le, in electrnic r ther $rat, at the addre.. $ the re.%n.i-le %er.n given n

the la-el, t the c%etent a#thritie. $r ar1et .#rveillance %#r%.e. $r a %erid $ ten !ear. $llwing

the %lacing n the ar1et $ the la.t -atch $ the %rd#ct2

The .t i%rtant eleent $ the %rd#ct in$ratin $ile, $r a .a$et! %int $ view, i. the c.etic

 %rd#ct .a$et! re%rt re$erred t in Article &*(&)2 The ther eleent. are a clear de.cri%tin $ the c.etic %rd#ct, a de.cri%tin $ the ethd $ an#$act#ring and a .tateent n c%liance with gd

an#$act#ring %ractice, the %r$ $ the e$$ect. claied, and data n anial te.ting'2

/here the re.%n.i-le %er.n drawing #% the c.etic %rd#ct .a$et! re%rt i. nt the an#$act#rer $ the

 %rd#ct, the! .h#ld en.#re the! have acce.. t all the technical and .cienti$ic .1ill. nece..ar! t -tain

relia-le c.etic %rd#ct .a$et! in$ratin and an a%%r%riate .a$et! a..e..ent t den.trate that the

 %rd#ct the! are re.%n.i-le $r i. .a$e, in accrdance with Article $ Reg#latin (EC) N &'''**+2 The!

a! there$re need t invlve nt nl! the .a$et! a..e..r, -#t al. the an#$act#rer, the .#%%lier. $ raw

aterial., and ther technical ex%ert.2

In an! ca.e, the re.%n.i-le %er.n i. t en.#re that the intended #.e $ the c.etic %rd#ct and the

antici%ated .!.teic ex%.#re t individ#al ingredient. in a $inal $r#latin are ta1en int acc#nt in the

.a$et! a..e..ent= an a%%r%riate weight4$4evidence a%%rach i. #.ed in the .a$et! a..e..ent $r reviewing

data $r all exi.ting .#rce.= the c.etic %rd#ct .a$et! re%rt i. 1e%t #% t date in view $ additinal

relevant in$ratin generated .#-.e3#ent t %lacing the %rd#ct n the ar1et2

The c.etic %rd#ct .a$et! a..e..ent, a. .et #t in Part 9 $ Annex I t Reg#latin (EC) N &'''**+, i.

t -e carried #t -! a 3#ali$ied .a$et! a..e..r " The re.%n.i-le %er.n and the .a$et! a..e..r .h#ld wr1 

cl.el! tgether t en.#re that the .a$et! $ the %rd#ct i. %r%erl! a..e..ed and dc#ented and that the

a..e..ent i. 1e%t #% t date2 The re.%n.i-le %er.n and the .a$et! a..e..r .h#ld gather all the nece..ar!

in$ratin a. re3#ired -! Part A $ Annex I t Reg#latin (EC) N &'''**+2

The c.etic %rd#ct .a$et! re%rt .h#ld -e drawn #% in a tran.%arent wa! and .h#ld -e well4arg#ed and

ea.il! #nder.td2

The C.etic Prd#ct Sa$et! Re%rt i. an ex%ert %iece $ wr1 ade #% $ di$$erent d#le. and where the

in$ratin re3#ired #nder Part A a! -e .tred in di$$erent data-a.e.2 The re%rt, which .h#ld cntain, a.

a ini#, all the in$ratin indicated in Annex I t Reg#latin (EC) N &'''**+, .h#ld a%%ear #nder 

the .ae r .iilar heading. $r ea.e $ re$erence $ the c%etent a#thritie.2 Hwever, it a! -e .#$$icient

' Article &&(') $ Reg#latin (EC) N &'''**+2 Article &*(&) $ Reg#latin (EC) N &'''**+2

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t %rvide #nder each heading a clear re$erence t a dc#ent cntaining the in$ratin and readil!

availa-le in electrnic r %rinted $rat2

!, ANNEX  I TO  R EG-LATION  (EC) NO  !!"#!$$% . COSMETIC  PROD-CT  SA/ET0

R EPORT

In accrdance with Annex I t Reg#latin (EC) N &'''**+, the C.etic Prd#ct Sa$et! Re%rt i. t

cntain, &as a minimum’ , the in$ratin re3#ired #nder each $ the heading. $ Part A and Part 92

Part A ai. t gather all the data nece..ar! $r the .a$et! a..e..ent $ the %rd#ct, while Part 9 .et. #t the

rea.ning, .tarting $r the data, $r drawing cncl#.in. a. t the .a$et! $ the %rd#ct2

The .tr#ct#re and cntent $ the .a$et! re%rt .h#ld re$lect the re3#ireent. $ Annex I t Reg#latin (EC)

 N &'''**+2 Hwever, i$ the re%rt de. nt directl! cntain the re3#ired in$ratin, it .h#ld %rvide a

re$erence t anther readil! availa-le .#rce2

The re.%n.i-le %er.n i. t en.#re that the C.etic Prd#ct Sa$et! Re%rt i. 1e%t #% t date in the light $ 

additinal relevant in$ratin eerging a$ter the %rd#ct ha. -een %laced n the ar1et2 6

", PART A . COSMETIC PROD-CT SA/ET0 IN/ORMATION

Pat A of t*e &os'eti& odu&t safet+ eot is intended to gat*e t*e data ne&essa+ to o1e

t*at t*e &os'eti& odu&t is safe, T*e info'ation s*ould ena2le t*e safet+ assesso to &leal+

identif+ and 3uantif+4 2ased on t*e identified *a5ads4 t*e is6s a &os'eti& odu&t 'a+

esent to *u'an *ealt*, A *a5ad 'a+ aise4 fo exa'le4 fo' t*e a7 'ateials4 t*e

'anufa&tuing o&ess4 t*e a&6aging4 t*e &onditions of use of t*e odu&t4 t*e'i&o2iologi&al se&ifi&ations4 t*e 3uantities used4 t*e toxi&ologi&al ofile of t*e su2stan&es4

et&,

As Pat A of Annex I to Regulation (EC) No !!"#!$$% e3uies t*at t*e data listed unde its

*eadings ae o1ided as a 'ini'u'4 an+ dis&ean&+ 7it* egads to t*e e3uie'ents of 

Pat A s*ould 2e 8ustified,

Part A $ Annex I t Reg#latin (EC) N &'''**+ li.t. the data that i. t -e availa-le, &as a minimum'(

$r the .a$et! a..e..r t -e a-le t carr! #t the .a$et! a..e..ent2

In additin t the ini# data li.ted in Part A $ Annex I t Reg#latin (EC) N &'''**+, the .a$et!

a..e..r can #.e an! additinal data, where relevant2 On the ther hand, the!, r the re.%n.i-le %er.n, a!

cn.ider that, de%ending n the t!%e $ %rd#ct, .e $ the re3#ired data are nt relevant r nece..ar! t

a..e.. the .a$et! $ the %rd#ct (e2g2 %re.ervatin challenge te.t)2 In thi. ca.e, the a-.ence $ .%eci$ic data i.

t -e clearl! >#.ti$ied in Part A and the >#.ti$icatin i. t -e re%eated and validated -! the .a$et! a..e..r in

their rea.ning in Part 92 The re.%n.i-le %er.n .h#ld chec1 the %re.ence $ the re3#ired data r the

 >#.ti$icatin $r their a-.ence2

The data re3#ired -! Part A can -e drawn $r an! relia-le .#rce2 Exa%le. incl#de0 data $r .#%%lier.,

.cienti$ic literat#re, ex%erience gained with .iilar r ther %rd#ct categrie., re.#lt. $ .t#die. n the

6 Article &*(&)(c) $ Reg#latin (EC) N &'''**+2

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 %rd#ct it.el$ r n the .#-.tance. it cntain., availa-le data n .iilar $r#latin., r c%#ter del.2

The .a$et! re%rt .h#ld highlight the relevance $ the data in relatin t the %rd#ct2

The g#idance %#-li.hed -! the EU .cienti$ic cittee. cncerned with ri.1 a..e..ent, 8  a. well a. the

recendatin. $ natinal c%etent a#thritie. r %r$e..inal rgani.atin., a! %rvide $#rther 

hel%$#l .#%%rt2

",, 9uantitati1e and 3ualitati1e &o'osition of t*e &os'eti& odu&t

T*e ai' of t*at se&tion of t*e &os'eti& odu&t safet+ eot is to o1ide t*e exa&t

3uantitati1e and 3ualitati1e &o'osition of t*e finis*ed odu&t4 stating fo' t*e a7

'ateials, Ra7 'ateials ae su2stan&es o 'ixtues used in t*e 'anufa&tuing of t*e

&os'eti& odu&t, T*e intended fun&tion of ea&* su2stan&e is to 2e indi&ated,

The c%lete %rd#ct c%.itin i. t -e .%eci$ied, .tating the nae and identit! (3#alitative) $ each raw

aterial (incl#ding cheical nae, INCI, CAS, EINECSE;INCS, where %..i-le), and the a#nt $ each

raw aterial, .tating the weight %ercentage (3#antitative)2 Range. .h#ld nt -e #.ed, #nle.. thi. can -e

 >#.ti$ied (e2g2 vi.c.it! r %H ad>#.ter.)2 I$ cncentratin range. are #navida-le, txiclgical

cn.ideratin. and calc#latin. .h#ld -e -a.ed n the highe.t cncentratin $ig#re2 It a! al. -e #.e$#l t

indicate the .#%%lier(.) $ the raw aterial.2

All .#-.tance. entering int the c%.itin $ cercial ixt#re. .#%%lied a. raw aterial. (incl#ding

directl! added %re.ervative., antixidant., chelatr., -#$$ering agent., .lvent., ther additive., etc2) are t

 -e identi$ied and 3#anti$ied in the $r#la $ the $ini.hed %rd#ct2 Thi. al. a%%lie. t all .#-.tance.

indirectl! added t the %rd#ct, .#ch a. %re.ervative. #.ed $r %re.erving raw aterial.2 The intended

$#nctin $ each .#-.tance i. t -e indicated2

/hen cheicall! well4de$ined .#-.tance. are %re.ent, their 3#antit! and lec#lar $r#la .h#ld -e given

tgether with their anal!tical .%eci$icatin. (degree $ %#rit!, identi$icatin $ a>r i%#ritie., criteria and

te.t ethd. #.ed)2

/hen c%lex ingredient. are %re.ent, their nat#re and 3#antit! tgether with a clear de$initin $ the

ixt#re and the aterial(.) #.ed .h#ld -e given in rder t identi$! the .#-.tance. with regard t their 

c%.itin and e$$ect. (an#$act#ring and %#ri$icatin %rce..e., incl#ding %h!.ical, cheical, en5!atic,

 -itechnlgical and icr-ilgical .te%.)2 The %#rit! criteria and te.t ethd. #.ed .h#ld -e %rvided2

Exa%le. $ c%lex ingredient. incl#de th.e $ ineral, -tanical, anial r -itechnlgical rigin2 The

.c%e $ the in$ratin needed n c%lex ingredient., de%ending n their nat#re and rigin, i. ex%licitl!

li.ted in the Scienti$ic Cittee $r Cn.#er Sa$et! (SCCS)  Nte $ ?#idance2<

 

/hen a ixt#re $ -th cheicall! well4de$ined .#-.tance. and c%lex ingredient. i. %re.ent, the a-ve

g#idance al. a%%lie.2

/here an! $ragrance (r $lav#r) c%#nd c%ri.ing a ixt#re $ $ragrance (r $lav#r) ingredient. and

$#nctinal c%nent. with l$actr!, d#r4enhancing, d#r4%rtecting r -lending %r%ertie. i.

$r#lated and intentinall! added t a c.etic %rd#ct t i%art a .cent (r $lav#r) r t cver a

ald#r, it. identi$icatin i. t incl#de the nae and cde n#-er a. well a. the identit! $ the .#%%lier2

@#alitative and 3#antitative in$ratin a-#t reg#lated .#-.tance. in the $ragrance (r $lav#r) c%#nd

8 The SCCS. Nte. $ ?#idance $r the Te.ting $ C.etic Ingredient. and their Sa$et! Eval#atin, B th

Revi.in, SCCS&8*&&', and it. .#-.e3#ent #%date.2< SCCS Nte. $ ?#idance, %ara2 4

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and in$ratin relevant $r a .a$et! a..e..ent .h#ld -e di.cl.ed t the re.%n.i-le %er.n and the .a$et!

a..e..r, and .h#ld -e incl#ded in the .a$et! re%rt2

",!, P*+si&al#&*e'i&al &*aa&teisti&s and sta2ilit+ of t*e &os'eti& odu&t

T*e ai' of t*at se&tion of t*e &os'eti& odu&t safet+ eot is to des&i2e t*e ele1ant*+si&al and &*e'i&al se&ifi&ations of t*e su2stan&es o 'ixtues used and t*e &os'eti&

odu&t itself, T*ese se&ifi&ations ae &u&ial fo an aoiate safet+ assess'ent4 as t*e+

'a+ influen&e t*e safet+ of a &os'eti& odu&t, /o exa'le4 *+si&o:&*e'i&al oeties4 in

&o'2ination 7it* ot*e info'ation4 &an *el t*e safet+ assesso dete'ine t*e need to

in1estigate ele1ant toxi&ologi&al aa'etes,

In addition4 t*e *+si&o:&*e'i&al &*aa&teisti&s of t*e su2stan&es o 'ixtues and finis*ed

odu&ts set t*e 2en&*'a6 against 7*i&* t*e odu&ts and t*e a7 'ateials &an 2e

&onsideed a&&eta2le fo' a 3ualit+ oint of 1ie7,; 

T*at se&tion of t*e &os'eti& odu&t safet+ eot also e3uies an assess'ent of t*e sta2ilit+

of t*e &os'eti& odu&t4 unde easona2l+ foeseea2le stoage &onditions, T*e ai' is to

e1aluate if t*e sta2ilit+ of t*e &os'eti& odu&t affe&ts t*e safet+ and 3ualit+ of t*e odu&t4

and to use t*e info'ation to dete'ine its 'ini'u' dua2ilit+ and eiod:afte:oening

(PAO),

)"2"1" Ph*sical+chemical characteristics of su,stances or mi-tures

Thi. de.cri%tin i. t incl#de the .t relevant %h!.ic4cheical %r%ertie. $ each .#-.tance and ixt#re

cntained in the %rd#ct, $r exa%le0 cheical identi$icatin, %h!.ical $r, lec#lar weight, .l#-ilit!,

 %artitin ce$$icient, .#-.tance %#rit!, ther %araeter. relevant $r the characteri.atin $ .%eci$ic

.#-.tance. and ixt#re., and, $r %l!er., the average lec#lar weight and range2

/here relevant, the %article4.i5e di.tri-#tin c#rve $ .#-.tance. .h#ld -e incl#ded in the %h!.ic4cheical

characteri.tic., e.%eciall! $r nanaterial.2

C.etic. an#$act#rer. .h#ld en.#re that the .%eci$icatin. $ raw aterial. are %r%erl! dc#ented -!

their .#%%lier.2 S%eci$icatin. .h#ld -e availa-le $r each raw aterial act#all! #.ed in the %rd#ct2 9a.ed

n $#nctin, additinal .%eci$icatin. a! -e needed2 "r U a-.r-er., $r in.tance, the a-.r%tin .%ectra

.h#ld -e %rvided2

"r each de.cri%tin $ %h!.ic4cheical %r%ertie. and .%eci$icatin. ($r each .#-.tance and ixt#re

cntained in the %rd#ct), the re$erence ethd. .h#ld -e .tated in the .a$et! re%rt2

)"2"2" Ph*sical+chemical characteristics of the finished cosmetic product 

Thi. de.cri%tin i. t cntain the .%eci$icatin. $ the $ini.hed %rd#ct2 Each .%eci$icatin .h#ld -e given

with relevant liit., e2g" %H -etween 828 and

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"r each de.cri%tin $ %h!.ic4cheical %r%ertie. and .%eci$icatin. $ the $ini.hed %rd#ct, the re$erence

ethd. .h#ld -e .tated in the c.etic %rd#ct .a$et! re%rt2

)"2")" !ta,ilit* of the cosmetic product 

A. the re3#ireent i. t a..e.. the .ta-ilit! $ the c.etic %rd#ct #nder rea.na-l! $re.eea-le .trage

cnditin., i$ .ta-ilit! i. de%endent n .trage cnditin., in$ratin a-#t the.e cnditin. .h#ld -e

 %a..ed n thr#gh#t the .#%%l! chain, and, i$ relevant $r the end #.er, it .h#ld -e indicated n the

la-elling $ the %rd#ct2

The ethdlg! #.ed t deterine the %rd#ct. ini# d#ra-ilit! .h#ld -e de.cri-ed2 An! .%eci$ic

 %re.ervatin %reca#tin. .h#ld -e entined2

All availa-le data #.ed t >#.ti$! the indicated ini# d#ra-ilit! .h#ld -e li.ted in the .a$et! re%rt2 In

rder t deterine the cherence $ the .ta-ilit! .t#d! cnd#cted, and t chec1 the relevance $ the date $ 

ini# d#ra-ilit! ch.en $r the %rd#ct, the de.cri%tin $ the te.t. .%eci$ic t the .ta-ilit! .t#d! and the

re.#lt. $ th.e te.t. .h#ld -e incl#ded in the c.etic %rd#ct .a$et! re%rt2 In additin, the $llwing.h#ld al. -e %rvided0

(&) Evidence that the c%.itin $ the %rd#ct #.ed $r .ta-ilit! te.ting crre.%nd. t

the %rd#ct act#all! %laced n the ar1et=

(') The re.#lt. $ the %re.ervative e$$icac! .t#d!, e2g2 challenge te.t, i$ a%%lica-le=B 

() /hen a%%lica-le, the %erid4a$ter4%ening (PAO)+ and it. >#.ti$icatin2

The SCCS ha. recended that rele.ant sta,ilit* tests( adapted to the t*pe of cosmetic product and its

intended use( should ,e carried out" To ma/e sure that no sta,ilit* pro,lems are induced ,* the t*pe of 

container and pac/a0in0 used( ph*sical sta,ilit* tests are currentl* carried out ith inert containers and 

those intended to ,e used on the mar/et"&*

",", Mi&o2iologi&al 3ualit+

T*e ai' of t*at se&tion of t*e &os'eti& odu&t safet+ eot  is to dete'ine t*e a&&eta2le

'i&o2iologi&al se&ifi&ations of t*e a7 'ateials (su2stan&es o 'ixtues) and finis*ed

odu&t fo' a 'i&o2iologi&al oint of 1ie7, In a&&odan&e 7it* Annex I to Regulation (EC)

No !!"#!$$%4 ati&ula attention is to 2e aid to t*e 'i&o2iologi&al se&ifi&ations of 

&os'eti& odu&ts intended to 2e used on sensiti1e 2od+ ats and on se&ifi& oulations, In

addition4 info'ation egading 'i&o2iologi&al 3ualit+ is essential in ode to 8ustif+ t*e

effe&ti1eness of t*e ese1ation s+ste' and 8ustif+ t*e indi&ated 'ini'u' dua2ilit+ of t*e

B See .ectin 2 n Micr-ilgical 3#alit!2+ See Practical i%leentatin $ Article

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&os'eti& odu&t stoed unde aoiate &onditions and eiod:afte:oening (PAO) of t*e

finis*ed odu&t in te's of safet+,

The icr-ilgical .%eci$icatin. $ the raw aterial. (.#-.tance. r ixt#re.) and c.etic %rd#ct are t

$r %art $ the .a$et! a..e..ent2 Partic#lar attentin i. t -e %aid t the icr-ilgical .%eci$icatin. $ 

c.etic %rd#ct. intended t -e #.ed ar#nd the e!e., n #c#. e-rane. in general, n daaged .1in

(e2g2 .1in care %rd#ct. .#ita-le $r at%ic r irritated .1in), n children #nder three !ear. $ age, n elderl!

 %e%le r n %er.n. with c%ri.ed i#ne re.%n.e.2

)")"1" Micro,iolo0ical ualit* of su,stances and mi-tures

The ain %araeter. $r icr-ilgical 3#alit! are the riginal level $ cntainatin and the %..i-ilit! $ 

icr-ial grwth2 Partic#lar attentin .h#ld -e %aid t the raw aterial. (.#-.tance. and ixt#re.) .t

.#.ce%ti-le t icr-ial grwth (e2g2 water4-a.ed ixt#re., %rtein4rich aterial., %lant r anial raw

aterial.)2 On the ther hand, there are raw aterial. which d nt .#%%rt icr-ial grwth, e2g2 rganic

.lvent.2

)")"2" Micro,iolo0ical ualit* of the finished cosmetic product 

Cncerning icr-ilgical .#.ce%ti-ilit!, there i. a di$$erence -etween three %rd#ct categrie.0

(&) ;w icr-ilgical ri.1 %rd#ct. (e2g2 %rd#ct. with an alchl cntent '* 

,

 %rd#ct. -a.ed n rganic .lvent., highlw4%H %rd#ct.), $r which neither a

 %re.ervatin challenge te.t nr icr-ilgical 3#alit! te.t. n the $ini.hed %rd#ct

are nece..ar!2 A .cienti$ic >#.ti$icatin i. t -e %rvided, hwever=

(') Single4#.e %rd#ct., and %rd#ct. which cannt -e %ened (e2g2 $r which the

 %ac1aging allw. d.ing the %rd#ct with#t it cing in cntact with the air), $r 

which nl! icr-ilgical 3#alit! te.t. n the $ini.hed %rd#ct are nece..ar!2 A

.cienti$ic >#.ti$icatin i. t -e %rvided, hwever=

() All ther %rd#ct., $r which -th a %re.ervatin challenge te.t and icr-ilgical

3#alit! te.t. n the $ini.hed %rd#ct are nece..ar!2

S%eci$ic ?#ideline. n Micr-ilgical @#alit! $ the "ini.hed Prd#ct are %rvided in the SCCS Nte. $ 

?#idance2&' 

",

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A ta&e is a s'all 3uantit+ of an unintended su2stan&e in t*e finis*ed odu&t, Ta&es ae to

2e e1aluated 7it* egad to safet+ of t*e finis*ed odu&t, =*en ta&es of o*i2ited

su2stan&es ae esent4 e1iden&e of t*ei te&*ni&al una1oida2ilit+ ae also to 2e o1ided,

Ta&es &an oiginate fo' t*e follo7ing sou&es> i'uities in t*e a7 'ateials#su2stan&es?

t*e 'anufa&tuing o&ess? otential &*e'i&al e1olution#intea&tion and#o 'igation of 

su2stan&es in t*e odu&t t*at &ould o&&u unde no'al stoage &onditions and#o t*oug*

&onta&t 7it* t*e a&6aging 'ateial,

@e&ause su2stan&es 'a+ 'igate fo' t*e a&6aging to t*e fo'ulation4 t*e ele1ant

&*aa&teisti&s of t*e a&6aging 'ateial ae to 2e &onsideed,

In accrdance with %int 6 $ Annex I t Reg#latin (EC) N &'''**+, the .ectin n I%#ritie., trace.,

in$ratin a-#t the %ac1aging aterial i. t addre.. three .%eci$ic i..#e.0

(a) The %#rit! $ .#-.tance. and ixt#re.=

(-) In ca.e $ trace. $ %rhi-ited .#-.tance., evidence $ their technical #navida-ilit!=

(c) The relevant characteri.tic. $ the %ac1aging aterial, in %artic#lar %#rit! and

.ta-ilit!2

In %ractical ter., th.e eleent. a! -e inter%reted a. $llw.0

(a) Preci.e de$initin $ i%#ritie. and trace. (.ee 262&)=

(-) Evidence $ technical #navida-ilit! $ %rhi-ited .#-.tance. (.ee 262')=

(c) Ptential relea.e $ .#-.tance. $r the %ac1aging r %..i-le deteriratin $ the

 %rd#ct in cntact with the %ac1aging (.ee 262)2

"r the anal!.i. $ i%#ritie. and %ac1aging aterial, data $r .#%%lier. are $ cr#cial i%rtance and

.h#ld -e %re$erred2

)"3"1" Purit* of su,stances and mi-tures

The %re.ence $ #nintended .#-.tance., .#ch a. i%#ritie. and trace., can have an i%act n the .a$et! $ the

$ini.hed %rd#ct2 The c.etic %rd#ct .a$et! re%rt i. t incl#de data n the %#rit! $ raw aterial.

(.#-.tance. and ixt#re.) and the identi$icatin $ the txiclgicall! relevant #nintended .#-.tance.2 The.e.#-.tance. .h#ld -e ta1en int acc#nt in the .a$et! a..e..ent $ the %rd#ct2

I%#ritie. are #nintended .#-.tance. in raw aterial.2

A trace i. a .all 3#antit! $ an #nintended .#-.tance in the $ini.hed %rd#ct2

The %re.ence $ trace. in the $ini.hed %rd#ct can -e eval#ated in tw wa!.0

(d) thr#gh the .%eci$icatin.technical data $r each raw aterial, -a.ed n 1nwledge

$ the %rce.. $r an#$act#ring the raw aterial (rigin $ .#-.tance, %rd#ctin

 %rce.., .!nthe.i. r#te, extractin %rce.., .lvent #.ed, etc2)=

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(e) thr#gh a %h!.ic4cheical anal!.i. $ %..i-le i%#ritie. in raw aterial. and, i$ 

nece..ar!, in the $inal %rd#ct (e2g2 nitr.aine. which are %tentiall! generated

d#ring r a$ter the an#$act#ring %rce..)2

Trace. $ %rhi-ited .#-.tance. are dealt with in %aragra%h 262' $ the.e ?#ideline.2

Se trace. have reg#latr! cncentratin liit.2 "r the %re.ence $ trace. $ .#-.tance. that are nt %rhi-ited, and $r which there are n reg#latr! cncentratin liit., -#t which c#ld -e ex%ected t i%act

cn.#er .a$et!, the .a$et! a..e..ent need. t -e carried #t -! the .a$et! a..e..r2

)"3"2" E.idence of the technical una.oida,ilit* of traces of prohi,ited su,stances

/hile the %rced#re #tlined in %aragra%h 262& .h#ld -e $llwed $r all 1nwn i%#ritie. and trace. t

eval#ate their txiclgical i%act, $#rther inve.tigatin i. re3#ired $r %rhi-ited .#-.tance. %re.ent a.

trace. in the $ini.hed %rd#ct&2

/hen .#ch %re.ence i. technicall! #navida-le, the c.etic. an#$act#rer. are re3#ired t %rvide

evidence $ the technical #navida-ilit!2 That ean. the! have t >#.ti$! the %re.ence $ th.e trace. -! allnece..ar! ean.2 The %re.ence $ trace. $ %rhi-ited .#-.tance. .h#ld -e 1e%t a. lw a. i. rea.na-l!

achieva-le #nder gd an#$act#ring %ractice.2 In additin, the .a$et! a..e..r ha. t decide whether their 

level. are txiclgicall! acce%ta-le and whether the %rd#ct i. .till .a$e2

E.%eciall! in the ca.e $ nn4thre.hld gentxic and carcingenic .#-.tance. &6, the c.etic ind#.tr!

.h#ld 1ee% i%rving it. -e.t %ractice. in rder t eliinate the.e .#-.tance. (A;ARA %rinci%le &8) in the

$ini.hed c.etic %rd#ct2 The ain cncern i. t en.#re the %rtectin $ h#an health, a. re3#ired -!

Article $ Reg#latin (EC) N &'''**+2

Trace. generated -! the degradatin $ .#-.tance. within the $inal %rd#ct (.ta-ilit! i..#e.), -! %re.ervatin

r tran.%rt %r-le., r -! the interactin $ raw aterial. .h#ld -e avided thr#gh gd an#$act#ring %ractice., r %..i-l! thr#gh re4$r#latin $ the %rd#ct2

)"3")" The rele.ant characteristics of pac/a0in0 material 

Pac1aging aterial ean. the cntainer (r %riar! %ac1aging) that i. in direct cntact with the $r#latin2

The relevant characteri.tic. $ %ac1aging aterial. in direct cntact with the $inal %rd#ct are i%rtant $r 

the .a$et! $ the c.etic %rd#ct2 Re$erence t Reg#latin (EC) N &+8'**6 $ the E#r%ean

Parliaent and $ the C#ncil&

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The c-inatin $ %ac1aging aterial, $r#latin $ the c.etic %rd#ct and cntact with the external

envirnent a! have an i%act n the .a$et! $ the $ini.hed %rd#ct, d#e t the $llwing $actr.0

(a) interactin -etween the %rd#ct and the %ac1aging aterial=

(-) -arrier %r%ertie. $ the %ac1aging aterial=

(c) .#-.tance igratin $rt the %ac1aging aterial2

The in$ratin n relevant characteri.tic. $ the %ac1aging aterial. in direct cntact with the %rd#ct

.h#ld allw an e.tiatin $ %tential ri.1.2 Relevant characteri.tic. c#ld incl#de, $r exa%le, the

$llwing0

(a) c%.itin $ the %ac1aging aterial, incl#ding technical .#-.tance. .#ch a. additive.=

(-) technicall! #navida-le i%#ritie.=

(c) %..i-le igratin $r the %ac1aging2

Thi. in$ratin nl! indicate. the ha5ard2 It i. #% t the .a$et! a..e..r t eval#ate the ri.1 &D2 

St#die. n interactin..#ita-ilit! -etween $r#latin and %ac1aging allw te.ting $ the %tential

igratin $ .all a#nt. $ .#-.tance. $r the %riar! %ac1aging aterial t the %rd#ct2 The.e te.t. are

 %er$red #nder .%eci$ic and relevant te.t cnditin.2 There are, hwever, n .tandard %rced#re. $r 

c.etic %rd#ct.2 An a%%r%riate a..e..ent a! -e ade -a.ed n 1nwledge $ the $r#latin and

 %riar! %ac1aging aterial. and ex%erienced ex%ert >#dgent2

I$ igratin i. de%endent n .trage cnditin., the crrect cnditin. .h#ld -e indicated n the %rd#ct

la-elling2 I$ the $r#latin i. .en.itive t light r air, and w#ld degrade in a wa! that i%act. %rd#ct.a$et! r %rd#ct e$$icac!, a%%r%riate %ac1aging .h#ld -e #.ed2

",, No'al and easona2l+ foeseea2le use

T*e se&tion on no'al and easona2l+ foeseea2le use of t*e odu&t is essential fo t*e safet+

assesso to 2e a2le to dete'ine a ele1ant exosue s&enaio, T*e intended use s*ould 2e

aoiatel+ &o''uni&ated to t*e &onsu'e in ode to a1oid 'isuse of t*e odu&t,

In addition4 7anings and ot*e exlanations on t*e la2elling s*ould 2e &onsistent 7it* t*e

identified no'al and easona2l+ foeseea2le use4 and t*e easoning 8ustif+ing t*ei in&lusion

is to 2e gi1en,

A clear ex%lanatin $ the nral intended #.e and the rea.na-l! $re.eea-le #.e .h#ld -e %rvided2 "r 

in.tance, in the ca.e $ a .ha%, the nral intended #.e w#ld -e t #.e it n the .cal%= an (#nintended)

rea.na-l! $re.eea-le #.e w#ld -e $r it t -e #.ed a. a .hwer gel2 Inge.tin w#ld -e a clear i.#.e2

T thi. end, a %ractical a%%rach a! -e #.e$#l2 "r exa%le, ne c#ld incl#de a %ht $ the %ac1aging r 

the artwr1 in the c.etic %rd#ct .a$et! re%rt t .hw the %re.entatin $ the %rd#ct and it. intended #.e2

&D T eval#ate the ri.1, ne need. t cn.ider the ha5ard tgether with the ex%.#re, and thi. i. the d#t! $ the.a$et! a..e..r2

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It w#ld al. -e #.e$#l t a1e the lin1 with the warning. and la-elling, a. highlighted -! Annex I t

Reg#latin (EC) N &'''**+ n thi. %int2

",B, Exosue to t*e &os'eti& odu&t

T*e exosue assess'ent is an essential ele'ent of is6 assess'ent, T*e ai' of t*is se&tion isto 3uantif+ t*e a'ount of &os'eti& odu&t &o'ing into &onta&t 7it* t*e extenal ats of t*e

*u'an 2od+ o t*e teet* and t*e 'u&ous 'e'2anes of t*e oal &a1it+ unde no'al o

easona2l+ foeseea2le use fo ea&* use and t*e fe3uen&+ of use,

The a..e..ent $ ex%.#re t the c.etic %rd#ct .hall ta1e int cn.ideratin the $inding. regarding

nral and rea.na-l! $re.eea-le #.e #nder .ectin 8 $ Annex I t Reg#latin (EC) N &'''**+ in

relatin t a .et $ eleent. that are ex%licitl! li.ted in .ectin

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a..e..ing the ri.1 $r cn.#er., ex%.#re $ the .cal% with a $re3#enc! $ a%%rxiatel! nce a da! .h#ld

 -e cn.idered, wherea. $r hair dre..er. ex%.#re $ the hand. .everal tie. a da! .h#ld -e cn.idered)2

",;, Exosue to t*e su2stan&es

T*e assess'ent of t*e exosue to ea&* of t*e su2stan&es &ontained in t*e &os'eti& odu&t isne&essa+ in ode to assess t*e is6 asso&iated 7it* ea&* indi1idual su2stan&e, T*e o28e&ti1e

of t*at se&tion of t*e &os'eti& odu&t safet+ eot is to dete'ine t*e a'ount of ea&*

su2stan&e &o'ing into &onta&t 7it* t*e extenal ats of t*e *u'an 2od+ o t*e teet* and t*e

'u&ous 'e'2anes of t*e oal &a1it+ unde no'al o easona2l+ foeseea2le use4 fo ea&*

use,

Exosue to ea&* of t*e su2stan&es in t*e &os'eti& odu&t is &al&ulated fo' t*e exosue to

t*e final odu&t and t*e &on&entation of t*e indi1idual su2stan&es in t*e final odu&t, It is

ne&essa+ to &al&ulate t*is exosue in ode to assess t*e otential is6 fo' ea&* su2stan&e,

Ex%.#re t individ#al .#-.tance. i. calc#lated $r the 3#antitative c%.itin $ the %rd#ct2 /here

.#-.tance. are generated r relea.ed d#ring the #.e $ the %rd#ct, the ex%.#re .h#ld -e e.tiated and

ta1en int acc#nt in the .a$et! a..e..ent2

The ex%.#re cnditin. t each individ#al .#-.tance are deterined -! th.e $r the $ini.hed c.etic

 %rd#ct #nder 2

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)"9"1" 6eneral considerations concernin0 the to-icolo0ical profile as part of the safet*

assessment 

The relevant eleent. $ the txiclgical %r$ile $ each .#-.tance r ixt#re .h#ld -e de.cri-ed in detail

in the c.etic %rd#ct .a$et! in$ratin (Part A) and a..e..ed in the .a$et! a..e..ent (Part 9), -earing in

ind the ex%.#re .it#atin, the intrin.ic txicit! (r ha5ard) $ each .#-.tance, and the .%eci$ic cnditin.

$ #.e $ the %rd#ct2

H#an ex%erience., anial .t#die. r alternative ethd. t anial te.ting are hel%$#l in #nder.tanding the

health ri.1 $r h#an. ex%.ed t danger#. .#-.tance.2 "r the txiclgical %r$ile., txiclgical .t#die.

are #.ed t identi$! the ha5ard. which c#ld -e a..ciated with a ri.1 t h#an.2 It i. e..ential t cn.ider 

the 3#alit! and liitatin. $ the .t#die. that have -een %er$red2 The validit! $ a .t#d! .h#ld -e ta1en

int cn.ideratin in deterining whether there i. a need $r new in$ratin t #nder.tand the ri.1 t

h#an health'&2 St#die. cnd#cted in accrdance with internatinal g#ideline. are the .t #.e$#l, -#t

#n$rt#natel! nt all .t#die. eet the.e .tandard.2 Th#., the liitatin. $ .#ch .t#die. .h#ld -e cn.idered

in a..e..ing the txiclgical %r$ile $r each .#-.tance2

The .a$et! a..e..r .h#ld en.#re that the ex%eriental data c%l! with the re3#ireent. $ Article &B $ 

Reg#latin (EC) N &'''**+ cncerning anial te.ting2 The C#nicatin $r the Ci..in t the

E#r%ean Parliaent and the C#ncil n the anial te.ting and ar1eting -an and n the .tate $ %la! in

relatin t alternative ethd. in the $ield $ c.etic. #tline. the Ci..inK. inter%retatin $ th.e

re3#ireent.''2

)"9"2" To-icolo0ical profile of su,stances for all the rele.ant to-icolo0ical endpoints

The txiclgical %r$ile $r each .#-.tance i. deterined -! the ha5ard identi$icatin and the d.e4re.%n.e

characteri.atin2

The $ir.t e..ential .te% in devel%ing the txiclgical %r$ile i. t gather all the relevant in$ratin a-#t

the intrin.ic %r%ertie. $ the .#-.tance2 S#ch in$ratin .h#ld incl#de the $llwing0

(&) A. the .t val#a-le txicit! in$ratin, act#al te.t data $r in .i.o  r in .itro

.t#die. -tained in accrdance with C#ncil Reg#latin (EC) N 66*'**B la!ing

dwn te.t ethd. %#r.#ant t Reg#latin (EC) N &+*D'**< n the Regi.tratin,

Eval#atin, A#thri.atin and Re.trictin $ Cheical. (REACH)', recgni.ed

internatinal g#ideline., r .tandard. (e2g2 OEC7 Te.t ?#ideline.), and %er$red in

accrdance with gd la-ratr! %ractice %rinci%le.=

(') Exi.ting te.t data that have nt -een -tained in accrdance with the late.tad%tedacce%ted ver.in $ a te.t g#ideline r with gd la-ratr! %ractice

.tandard., -#t which are cn.idered valid=

()  #n .itro data r alternative data $r valid te.t .!.te., t -e #.ed a. a .creening

.t#d! t %redict txicit!=

'& H2:2 Llii.ch, E2 Andreae and U2 Tillann (&++D),  A s*stematic approach for e.aluatin0 the ualit* of 

e-perimental and ecoto-icolo0ical data2 Reg#l Txicl Pharacl '80&482'' See in %artic#lar %int 2& $ the C#nicatin2' O: ; &6', &282'**B, %2 &2

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(6) H#an data andr ex%erience2 It i. in general nt acce%ta-le t %er$r h#an

txiclg! .t#die. $r ha5ard identi$icatin, -#t, i$ data r ex%erience exi.t, the!

.h#ld -e incl#ded in the $inal a..e..ent=

(8) H#an (clinical) data, incl#ding data $r clinical trial. and a%%licatin. in ther 

ind#.trie. .#ch a. $d and edicinal %rd#ct.=

(

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(') Irritatin and crr.ivit!=

() S1in irritatin and .1in crr.ivit!=

(6) M#c#. e-rane irritatin (e!e irritatin)=

(8) S1in .en.iti.atin=

(

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A-.r%tin i. lin1ed t the -iavaila-ilit! $ a .#-.tance, and i. e..ential $r calc#lating the argin $ .a$et!2

S!.teic ex%.#re can -e calc#lated a.0

S!.teic ex%.#re d.e (SE7) External ex%.#re x a-.r%tin

A-.r%tin can cc#r thr#gh .everal external r#te.0 deral, ral and inhalatin2

I$ the intended ex%.#re $r the c.etic %rd#ct i. nt in line with the r#te $ ex%.#re in the .a$et! data,

r#te4t4r#te extra%latin .h#ld -e cn.idered2

(a) A-.r%tin a$ter   deral ex%.#re

The deral a-.r%tin6 $ a .#-.tance in a %rd#ct i. de%endent n -th intrin.ic $actr.

(e2g2 ;gPw, lec#lar weight) and it. -ehavi#r in the vehicle2 7eral in .i.o h#an

a-.r%tin $ a .#-.tance can -e e.tiated #.ing the data $r exi.ting in .i.o  anial

.t#die. and in .itro .t#die. n anial and h#an .1in2 /hen n ea.#reent data are

availa-le and n a-.r%tin rate can -e deterined #.ing a .cienti$icall! valid in silicoethd r de$a#lt a-.r%tin rate.,  a wr.t ca.e val#e $ &** .h#ld -e #.ed $r 

calc#latin $ the .!.teic ex%.#re28 In ca.e M/ 8** 7a and lg Pw i. .aller than

4& r higher than 6, a val#e $ &* deral a-.r%tin can -e cn.idered2

(-) A-.r%tin a$ter ral ex%.#re

/hen a rea.na-l! $re.eea-le #.e can entail inge.tin, the ral r#te .h#ld -e incl#ded

in the ex%.#re .cenari."

(c) A-.r%tin a$ter inhalatin

"r all .#-.tance. #.ed in .%ra! a%%licatin. and .e %wder., the inhalatin r#te i. t

 -e ta1en int cn.ideratin in deterining the .!.teic ex%.#re2

In additin, there a! al. -e a %..i-ilit! $ .ecndar! inhalatin ex%.#re where c.etic %rd#ct.

cntain vlatile .#-.tance. which can -e inhaled #nintentinall! in the ca.e $ direct #.e,  e2g2 tl#ene in nail

 %li.h, vari#. .#-.tance. cntained in nail delling gel., etc2

)"9"3" Consideration of s*stemic effects and calculation of the mar0in of safet*

The .a$et! a..e..ent $ a %rd#ct $r .!.teic txicit! i. highl! de%endent n data n each .#-.tance, .ince

there will -e n data n .!.teic txicit! $r the $ini.hed c.etic %rd#ct2

Ri.1 characteri.atin #.#all! invlve. an ex%ert eval#atin $ the %tential nn43#anti$ia-le adver.e e$$ect.,

$llwed -! calc#latin $ an #ncertaint! $actr r argin $ .a$et!2

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.te%. i. t -e d#l! >#.ti$ied2 An exa%le where thi. c#ld a%%l! w#ld -e the %re.ence $ a .#-.tance in the

c.etic %rd#ct at a lw level, with the ex%ected (wr.t ca.e) ex%.#re level. -eing -elw the a%%r%riate

thre.hld $ txiclgical cncern (TTC) val#e. D2 Anther exa%le c#ld -e the incl#.in $ $d aterial.

$r which a #ch higher innc##. inge.tin level i. 1nwn2

/hen the re3#ireent t calc#late the argin $ .a$et! cannt -e et, a di$$erent wa! $ ex%re..ing the .a$ed.e $r each .#-.tance a! -e a%%r%riate, where >#.ti$ied2 /hen a NOAE; i. nt availa-le, ther 

re$erence txiclg! val#e. .#ch a. N O-.erved E$$ect ;evel (NOE;), ;OAE;, ;we.t O-.erved E$$ect

;evel (;OE;), can -e #.ed t calc#late the argin $ .a$et!= 9enchar1 7.e (9M7) r irt#all! Sa$e

7.e (S7), #.ed t 3#ali$! and 3#anti$! a ri.1 in ther $ield., a! -e #.ed in the cntext $ c.etic

 %rd#ct. .a$et! a..e..ent, %rvided a relatin.hi% with ex%.#re i. e.ta-li.hed, -! c%aring the ex%.#re

$r c.etic. and the.e re$erence d.e.2

Otherwi.e, the .a$et! $ a %artic#lar .#-.tance in a %artic#lar %rd#ct cannt -e den.trated2

Accrding t the %rced#re. de.cri-ed in the SCCS Nte. $ ?#idance, B the argin $ .a$et! (MS) $r a

.%eci$ic r#te $ ex%.#re can -e calc#lated #.ing the $llwing $r#la0 

MS N4O-.erved4Adver.e4E$$ect ;evel (NOAE;) S!.teic Ex%.#re 7.e (SE7)

where the S!.teic Ex%.#re 7.e (SE7) i. -tained -! c-ining the external ex%.#re (g1g -wda!)

with the a-.r%tin rate (t!%icall! ex%re..ed in r gc'), $re3#enc! and retentin $actr.2

It i. generall! acce%ted that the argin $ .a$et! .h#ld -e at lea.t &** t declare a .#-.tance .a$e $r #.e in a

$ini.hed %rd#ct2

In the ca.e $ r#te4t4r#te extra%latin, the re.%ective -iavaila-ilit! via each r#te .h#ld ideall! -e

ta1en int cn.ideratin2 The a..#%tin $ &** ral -iavaila-ilit! ight vere.tiate the .!.teic

ex%.#re in a txicit! .t#d! via the ral r#te2 There$re, in the a-.ence $ data, it .h#ld -e a..#ed that

nt re than 8* $ an rall! adini.tered d.e i. .!.teicall! availa-le2 I$ there i. evidence t .#gge.t

 %r ral -iavaila-ilit!, $r exa%le i$ the .#-.tance i. a %rl! .l#-le %artic#late, it a! -e re

a%%r%riate t a..#e that nl! &* $ the adini.tered d.e i. .!.teicall! availa-le+2 /henever ral

a-.r%tin data are availa-le, the.e .h#ld -e incl#ded in the calc#latin.2

The NOAE; ch.en $r calc#lating the argin $ .a$et! i. ta1en $r lng4ter re%eated d.e txicit!

.t#die. (.#-4ac#te, .#-4chrnic, andr chrnic txicit! te.t., carcingene.i. te.t., teratgene.i. te.t.,

re%rd#ctin txicit!, etc2)2

The val#e #.ed will -e the lwe.t NOAE; -tained -! the .t %ertinent .t#d! with re.%ect t thecnditin. $ #.e $ the .#-.tance, t .%ecie. .en.itivit!, etc2

"r the c%lete txiclgical %r$ile, a NOAE; .h#ld -e deterined $r the .!.teic e$$ect.2 In general,

the lwe.t relevant NOAE; $ the .t relevant end%int i. .elected $r calc#lating the argin $ .a$et!2

D SCCS, SCHER and SCENIHR, O%inin n U.e $ the Thre.hld $ Txiclgical Cncern (TTC) A%%rach$r H#an Sa$et! A..e..ent $ Cheical S#-.tance. with $c#. n C.etic. and Cn.#er Prd#ct.,SCCP&&D&*B2

B SCCS Nte $ ?#idance, %ara 4D, %2 6

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The calc#latin $ the argin $ .a$et! -a.ed nl! n Median ;ethal 7.e (;78*) data derived $r .ingle

d.e te.t. (in.tead $ a NOAE; $r at lea.t .#-4ac#te te.t.) cannt -e #.ed t >#.ti$! .a$e #.e2

/hen the a-.ence $ -iavaila-ilit! can -e clearl! den.trated, the calc#latin $ the argin $ .a$et! i.

nt nece..ar!2 In the.e ca.e. the %..i-le lcal e$$ect. n .1in r #c#. e-rane. .h#ld .till -e

cn.idered2

)"9":" #mpact on the to-icolo0ical profile of certain characteristics of the su,stances or the

 product 

(a) Particle .i5e

The %article .i5e and it. di.tri-#tin c#rve can have an in$l#ence n the txicit! $ a

.#-.tance2 /hen it cannt -e excl#ded that the! have an i%act n the .a$et! $ the

$ini.hed %rd#ct, the! .h#ld -e incl#ded ang it. %h!.ic4cheical characteri.tic., and

 -e ta1en int acc#nt d#ring the .a$et! a..e..ent2 The .t recent .cienti$ic %inin. n

the .#->ect .h#ld -e $llwed (SCENIHR, SCCS)6*2

(-) I%#ritie. in the .#-.tance. and raw aterial.

I%#ritie. can have a a>r i%act n the verall txicit! $ an! .#-.tance2 It i. i%rtant

t chec1 the i%#ritie. %r$ile $ a .#-.tance t avid, r at lea.t a..e.., an! additinal ri.1 

$r the i%#ritie.2 In the a-.ence $ .a$et! data $r txiclgical .t#die., the thre.hld

$ txiclgical cncern (TTC)6& ight -e a #.e$#l tl $r a..e..ing the .a$et! $ certain

i%#ritie.2

/hen txiclgical .t#die. are #.ed t characteri.e the txiclgical %r$ile $ a .#-.tance,

the %#rit! and i%#ritie. %r$ile $ the .#-.tance #.ed in the txiclgical .t#die. .h#ld -e de.cri-ed2 I$ the -atche. act#all! #.ed in the $r#latin $ the c.etic %rd#ct d nt

have a c%ara-le i%#rit! %r$ile, the di$$erence. need t -e a..e..ed2

)"9";" Use of read#.ti$ied2

)"9">" #dentification of the sources of information

The deterinatin $ the txiclgical %r$ile re3#ire. a ini# $ in$ratin n the .#-.tance t -e

eval#ated2

Thi. in$ratin can -e cllected $r txiclgical .t#die.2 I$ data $r h#an ex%erience exi.t, the!

.h#ld -e ta1en int acc#nt2

6* See $r exa%le0 SCCS (Scienti$ic Cittee n Cn.#er Sa$et!), ?#idance n .a$et! a..e..ent $ nanaterial. in c.etic., SCCS&6B6&'= SCENIHR (Scienti$ic Cittee n Eerging and Newl!Identi$ied Health Ri.1.), O%inin n the .cienti$ic -a.i. $r the de$initin $ the ter nanaterial, B7ece-er '*&*2

6& R2 Lre., A2 ?2 Renwic1, 2 "ern, C2 ;2 ?alli, M2 ?i-ne!, H2 ?rei, R2 H2 ?#!, :2 C2 ;h#g#ent, :2 :2 M2 van

de Sandt,  Application of the threshold of to-icolo0ical concern ?TTC@ to the safet* e.aluation of cosmeticin0redients, "d and Cheical Txiclg! 68 ('**D), %%2 '8J'8

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Other tl. .#ch a. 3#antitative .tr#ct#re4activit! relatin.hi% (@SAR) r -ridging a%%rache. are nl!

e.tiatin. $ txicit!, and the weight $ evidence .h#ld -e .#-.tantiated and >#.ti$ied2

The $llwing .#rce. $ data .h#ld -e ta1en int cn.ideratin0

(a) Sa$et! and 3#alit! data which a! -e n $ile with the re.%ective .#%%lier. $ the rawaterial. in the $r#latin, and which the .#%%lier .h#ld .hare with the

an#$act#rer $ the c.etic %rd#ct2 Thi. i. an i%rtant eleent in cn.idering

the availa-ilit! $ relevant data t den.trate the .a$et! $ each c.etic ingredient

in the $inal %rd#ct $r#latin=

(-) I$ an %inin $ the SCCS exi.t., the NOAE; #.ed in the %inin .h#ld -e #.ed2

The .a$et! a..e..r .h#ld ta1e int acc#nt the .t #%4t4date .cienti$ic %inin=

(c) I$ an %inin $ anther a#thritative .cienti$ic cittee exi.t., the NOAE; #.ed in

the %inin c#ld -e #.ed, %rvided that the cncl#.in. and liitatin. are

a%%lica-le t the ex%ected #.e (the #.e ta1en int acc#nt $r calc#lating the argin$ .a$et! can -e di$$erent)2 The .a$et! a..e..r .h#ld ta1e int acc#nt the .t #%4

t4date .cienti$ic %inin=

(d) I$ n .cienti$ic %inin exi.t., it will -e nece..ar! t %rvide in$ratin t

characteri.e the txiclgical %r$ile $ each .#-.tance2 The data can -e -tained

$r .everal data-a.e. r literat#re (.ee A%%endix I)=6'

(e) Cla..i$icatin #nder Reg#latin (EC) N &'D''**B $ the E#r%ean Parliaent and

$ the C#ncil=6 

($) St#die. %er$red r -tained -! the an#$act#rer $ the %rd#ct=

(g)  #n silico %redictin (@SAR)=

(h) 9ridging a%%rach=

(i) A..e..ent. $ nn4c.etic #.e. $ the .#-.tance ($d.t#$$., $d additive, $d

cntact aterial., -icide., Regi.tratin, Eval#atin, A#thri.atin and Re.trictin $ 

Cheical. (REACH)Q) a! al. -e #.ed in rder t c%lete in$ratin n the

txiclgical %r$ile $ the .#-.tance2

(>) /hen availa-le, the CSR (Cheical Sa$et! Re%rt) r the r-#.t .t#d! .#arie.

.#-itted %#r.#ant t Reg#latin (EC) N &+*D'**< (REACH)2 

A n#-er $ .#-.tance. andr ixt#re. have nt -een .t#died .#$$icientl! t deterine all the %ertinent

txiclgical %araeter.2 "r the.e i..ing %araeter., r where the ri.1 characteri.atin i. -a.ed n an

a%%rach #.ing txiclgical data ac3#ired $r ther .#-.tance. ($r exa%le .iilar .tr#ct#re.) r $r #.e.

ther than c.etic. ($d, -icide., %harace#tical %rd#ct., etc"), >#.ti$icatin. .h#ld -e incl#ded in the

re%rt2

6' Several %#-licl! availa-le data-a.e. cntaining txiclgical data n .#-.tance. #.ed in c.etic. exi.t, and

are li.ted in A%%endix I t thi. ?#ideline26 O: ; 8, &2&'2'**B, %2 &, and ECHA. regi.tratin we-.ite0 htt%0a%%.2echa2e#r%a2e#regi.teredregi.tered4

.#-2a.%x2

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",%, -ndesia2le effe&ts and seious undesia2le effe&ts

T*e ai' of t*at se&tion of t*e &os'eti& odu&t safet+ eot is to 'onito t*e safet+ of t*e

odu&t afte it *as 2een la&ed on t*e 'a6et and to ta6e &oe&ti1e a&tion4 7*ee ne&essa+,

To t*is end4 t*e esonsi2le eson (in &olla2oation 7it* t*e disti2utos) is e3uied to set u

a s+ste' to &olle&t4 do&u'ent4 esta2lis* t*e &ausalit+ of and 'anage t*e undesia2le effe&ts&aused 2+ t*e odu&t afte its use in t*e -nion

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Additinal c.etvigilance data, .#ch a. .eri#. #nde.ira-le e$$ect. $ a nn4intended #.e a! al. %rvide

hel%$#l in$ratin that the .a$et! a..e..r .h#ld cn.ider2

",$, Info'ation on t*e &os'eti& odu&t

T*at se&tion of t*e &os'eti& odu&t safet+ eot allo7s t*e in&lusion of an+ additionalinfo'ation 7*i&* is not &o1eed unde t*e ot*e *eadings of Pat A of Annex I to Regulation

(EC) No !!"#!$$%4 2ut is &onsideed ele1ant in ode to &a+ out t*e safet+ assess'ent of 

t*e odu&t,

Thi. .ectin $ the c.etic %rd#ct .a$et! re%rt  .h#ld cntain ther relevant in$ratin, either 

relating t the %rd#ct r .iilar $r#latin., .#ch a. exi.ting .t#die. n h#an vl#nteer., r relating t

.%eci$ic .#-.tance., .#ch a. the d#l! cn$ired and .#-.tantiated $inding. $ ri.1 a..e..ent. carried #t in

ther relevant area.2

Thi. .ectin c#ld -e #.ed t re$er t in$ratin n .#-.tance. r ixt#re. al. #.ed in ther 1ind. $ 

 %rd#ct., .#ch a. $d and %harace#tical.2

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ther g#ideline. %#-li.hed -! the Ci..in .#ch a. th.e n the %erid $ tie a$ter %ening

la-elling8* and the la-elling $ ingredient. #nder 7irective D

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3")"1" !afet* E.aluation of !u,stances and +or Mi-tures

The .a$et! eval#atin $ .#-.tance. andr ixt#re. cn.i.t. $ three ain .te%.0

(&) ha5ard characteri.atin $ .#-.tance. and ixt#re.=

(') a..e..ent $ the lcal and .!.teic ex%.#re (cn.idering a-.r%tin data)=

() ri.1 a..e..ent $ .!.teic e$$ect. (calc#latin $ argin $ .a$et!) and ri.1 

a..e..ent $ lcal e$$ect. (.#ch a. .1in allerg!, .1in irritatin)2

"r $ragrance and $lav#r c%#nd., where in$ratin n their c%.itin i. cn$idential, a .a$et!

a..e..ent a! -e %rvided t the re.%n.i-le %er.n $r the $ini.hed c.etic %rd#ct -! the

an#$act#rer $ that ixt#re2 Ta1ing int acc#nt the cncentratin in the $inal c.etic %rd#ct and

it. ex%.#re %attern, the .a$et! a..e..ent $ the $ragrance and $lav#r c%#nd .h#ld -e %re%ared

$llwing the %rinci%le. de.cri-ed in Annex I t Reg#latin (EC) N &'''**+ and the.e g#ideline.2

An a%%r%riate dc#ent den.trating the .a$et! $ the $ragrance r $lav#r c%#nd .h#ld -e

 %rvided -! the .#%%lier t the re.%n.i-le %er.n $r the $ini.hed c.etic %rd#ct2

3")"2" !afet* E.aluation of the Cosmetic Product 

The .a$et! eval#atin $ the c.etic %rd#ct cver. three ain a.%ect.0

(&) S#ar! $ the ri.1 a..e..ent -a.ed n the lcal and .!.teic e$$ect. $ all

individ#al .#-.tance.ixt#re.8'=

(') Additinal a..e..ent $ the .a$et! $ the $r#lated %rd#ct, which cannt -e

a..e..ed -! a..e..ing the .#-.tance.ixt#re. .e%aratel!2 Thi. c#ld $r 

in.tance -e the $r#latin. .1in c%ati-ilit!, a..e..ent $ %..i-le

c-inatin e$$ect., .#ch a. ne ingredient that can increa.e the a-.r%tinrate $ anther ingredient, %..i-le e$$ect. that c#ld ari.e $r interactin

with %ac1aging aterial, r %..i-le e$$ect. d#e t cheical reactin. -etween

the individ#al .#-.tance.ixt#re. in the $r#lated %rd#ct8=

() Other $actr. that in$l#ence the .a$et! a..e..ent, .#ch a. .ta-ilit!,

icr-ilgical 3#alit!, %ac1aging, and la-elling, incl#ding #.e in.tr#ctin.

and %reca#tin. $r #.e2

The .%eci$ic a..e..ent $r c.etic %rd#ct. intended $r #.e n children #nder the age $ three

which i. re3#ired in accrdance with Reg#latin (EC) N &'''**+ .h#ld ta1e int acc#nt the

.%eci$ic recendatin. in the SCCS Nte. $ ?#idance286

 

In the .%eci$ic a..e..ent re3#ired in accrdance with Reg#latin (EC) N &'''**+ $r c.etic

 %rd#ct. intended excl#.ivel! $r #.e in external intiate h!giene, the %artic#lar characteri.tic. $ the

a%%licatin .ite al. are t -e ta1en int acc#nt2

8' "r %rd#ct. in the .ae range, where the nl! di$$erence ang di$$erent %rd#ct. i. the cl#ringagent, and that ha. n i%act n .a$et!, e2g2 $r li%.tic1. r ther cl#r a1e4#%, a c-ined %rd#ct.a$et! re%rt a! -e cn.idered, -#t i. t -e >#.ti$ied2

8 SCCS, SCHER, SCENIHR, Txicit! and A..e..ent $ Cheical Mixt#re., '*&'

htt%0ec2e#r%a2e#health.cienti$icGcittee.envirnentalGri.1.dc..cherGG&882%d$ 86 SCCS Nte. $ ?#idance, %ara 4D2, %2 8&2

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The .a$et! a..e..r a! acce%t, re>ect, r acce%t #nder .%eci$ic cnditin. the $r#latin #nder 

cn.ideratin2 A %rd#ct that de. nt c%l! with Reg#latin (EC) N &'''**+ i. t -e re>ected

and i. nt -e ar1eted2 Recendatin. -! the .a$et! a..e..r regarding the .a$e #.e $ the %rd#ct

.h#ld -e $llwed2

In rder t en.#re that the c.etic %rd#ct .a$et! re%rt i. 1e%t #% t date a. re3#ired -!

Article &*(&)(c) $ Reg#latin (EC) N &'''**+, the .a$et! $ the $ini.hed %rd#ct .h#ld -erea..e..ed reg#larl!2

/hen change. in the legal re3#ireent. cc#r (e2g2 re.trictin. $ ne $ the .#-.tance. incl#ded in

the $r#latin), it .h#ld -e chec1ed, ang.t ther. (e2g2 la-elling), whether the $r#latin .till

c%lie. with the law, and the .a$et! a..e..ent .h#ld -e reviewed and, i$ nece..ar!, #%dated2

The .a$et! a..e..ent .h#ld al. -e reviewed and, i$ nece..ar!, #%dated, where ne r re $ the

$llwing circ#.tance. a%%l!0

(a) new .cienti$ic $inding. and txiclgical data n the .#-.tance. are availa-le

which c#ld di$! the re.#lt $ the exi.ting .a$et! a..e..ent=

(-) change. cc#rring in the $r#latin r .%eci$icatin. $ raw aterial.=

(c) change. cc#rring in the cnditin. $ #.e=

(d) a ri.ing trend in ter. $ the nat#re, .everit! and $re3#enc! $ #nde.ira-le

e$$ect., -th #nder rea.na-l! $re.eea-le cnditin. $ #.e and in the ca.e $ 

i.#.e88

Str#ct#re. and %rce..e. .h#ld -e e.ta-li.hed t en.#re that the in$ratin relevant $r the #%date $ 

the c.etic %rd#ct .a$et! re%rt i. e$$icientl! exchanged -etween the re.%n.i-le %er.n and the

.a$et! a..e..r, and that the .a$et! a..e..r i. in a %.itin t intervene where an #%date i. nece..ar!2

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completion of a uni.ersit* course of theoretical and practical stud* in pharmac*( to-icolo0*( medicine

or a similar discipline or a course reco0nised as eui.alent ,* a Mem,er !tate'"

A %er.n wh ha. -tained 3#ali$icatin. in a third c#ntr! a! act a. a .a$et! a..e..r i$ the! have

c%leted &a course reco0nised as eui.alent to a uni.ersit* course of theoretical and practical 

 stud* in pharmac*( to-icolo0*( medicine or a similar discipline ,* a Mem,er !tate' 2

Pr$ i. t -e %rvided $ the .a$et! a..e..r. 3#ali$icatin (i2e2 c%! $ the di%la and, where

needed, %r$ $ e3#ivalence) laid dwn in Article &* $ Reg#latin (EC) N &'''**+2

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Refeen&es

• ATS7R ('**6)2 ?#idance Man#al $r the a..e..ent $ >int txic actin $ cheical

ixt#re.2 Atlanta, ?A0 ATS7R, U2S2 7e%artent $ Health and H#an Service.,

P#-lic Health Service2 E"SA ('**B) E"SA4@4'**

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• ;ret5 ;2:2, A%i A2M2, 9a-cc1 ;2, 9arra> ;2M2, 9#rdic1 :2, Cater L2C2, :arrett ?2,

Mann S2, Pan F2H2, Re T2A2, Ren.1er. L2:2, Scra$$rd C2?2, Ex%.#re data $r c.etic

 %rd#ct.0 $acial clean.er, hair cnditiner, and e!e .hadw, "d Che Txicl2 '**B

Ma!= 6

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Aendix I Hno7n Data2ases Containing Toxi&ologi&al Data on Su2stan&es -sed in Cos'eti&s

CheI7Pl#. ;ight W htt%0che2.i.2nl2nih2gvcheid%l#.cheidlite2>.%

CheI7Pl#. Advanced W htt%0che2.i.2nl2nih2gvcheid%l#.

C.etic. E#r%e Recendatin. W htt%.0www2c.etic.e#r%e2e#%#-licatin.4c.etic.4

e#r%e4a..ciatinrecendatin.2htl

IPCS Inche W  htt%0www2inche2rg%age.>ec$a2htl

P#-Med W htt%0www2nc-i2nl2nih2gv%#-ed

TxNet W htt%0txnet2nl2nih2gv

http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsphttp://chem.sis.nlm.nih.gov/chemidplus/http://www.inchem.org/pages/jecfa.htmlhttp://www.inchem.org/pages/jecfa.htmlhttp://www.ncbi.nlm.nih.gov/pubmedhttp://toxnet.nlm.nih.gov/http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsphttp://chem.sis.nlm.nih.gov/chemidplus/http://www.inchem.org/pages/jecfa.htmlhttp://www.ncbi.nlm.nih.gov/pubmedhttp://toxnet.nlm.nih.gov/