IL977 19-03-2014 (att.01) IFRA-Cosmetics Europe - Guidelines on Exchange of Information between...

7/23/2019 IL977 19-03-2014 (att.01) IFRA-Cosmetics Europe - Guidelines on Exchange of Information between Fragrance Sup…

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GUIDELINES ON EXCHANGE OF INFORMATION BETWEEN FRAGRANCESUPPLIERS AND COSMETIC MANUFACTURERS

COMPLIANCE WITH THE PRODUCT INFORMATION REQUIREMENTS OF ARTICLE 11OF THE EU COSMETICS REGULATION 1223/2009

COSMETICS EUROPEAND

INTERNATIONAL FRAGRANCE ASSOCIATION (IFRA)

Revised Versio !"#$

I% INTRODUCTION AND SCOPE

These gu!e"#es $%e #&e#!e! '(% &he e)*h$#ge (' s$'e&+ %e"$&e! ,%(!u*& #'(%-$&(# .e&ee# '%$g%$#*esu,,"e%s $#! -$#u'$*&u%e%s (' *(s-e&* ,%(!u*&s #ee!e! &( -ee& &he C(s-e&*s Regu"$&(# %eu%e-e#&s

The gu!e"#es *(#ss& (' &he '(""(#g se*&(#s

I I#&%(!u*&(#II A# (e%e (' &he #'(%-$&(# (# &he '%$g%$#*e *(-,(u#! &h$& #ee!s &( .e e)*h$#ge!III A# e),"$#$&(# (' &he -,(%&$#*e (' $ %e$s(#e! s$'e&+ e$"u$&(# $#! &he s&$&us (' &he s$'e&+ e$"u$&(% I4 A# e),"$#$&(# (' &he .$*5g%(u#! $#! -e$##g (' &he IFRA C(!e (' P%$*&*e $#! &s s$'e&+ s&$#!$%!s

'(% *(#su-e% e),(su%e &( *e%&$# '%$g%$#*e #g%e!e#&s4 Fu%&he% #'(%-$&(# &h$& *$# .e e)*h$#ge!4I A,,e#!) A6 76 C E)$-,"es (' &he ,%(!u*& #'(%-$&(# '(% $ '%$g%$#*e *(-,(u#!

The #'(%-$&(# $s !es*%.e! # ,$%$g%$,h II #ee!s &( .e $$"$."e &( &he *(s-e&* *(-,$#+ he# $ '%$g%$#*e

*(-,(u#! s se"e*&e! '(% $ *(s-e&* ,%(!u*&

The e)$-,"es ,%(!e! # &he $,,e#!*es A6 7 $#! C $%e #(& &( .e %eg$%!e! $s '(%-$" %eu%e-e#&s %eg$%!#g

&he '(%-$& use! '(% #'(%-$&(# e)*h$#ge Whe%e &he #'(%-$&(# # ,(#&s 1 8 s !e#&*$"6 (#e :(#& '(%-$&

sh(u"! .e $."e &( .e use! &( *(--u#*$&e &he #'(%-$&(# # (#e !(*u-e#&6 ' s( $g%ee! .+ &he '%$g%$#*e

su,,"e% $#! &s *us&(-e%

F(% &he ,u%,(se (' &hs !(*u-e#& $#! es,e*$""+ &h %eg$%! &( "$.e""#g %eu%e-e#&s (' &he EU C(s-e&*sRegu"$&(#6 $ '%$g%$#*e *(-,(u#! s $ -)&u%e (' '%$g%$#*e #g%e!e#&s $#! 'u#*&(#$" *(-,(#e#&s &h("'$*&(%+6 (!(u%;e#h$#*#g6 (!(u%;,%(&e*&#g (% ."e#!#g ,%(,e%&es6 '(%-u"$&e! $#! #&e#&(#$""+ $!!e! &( $*(s-e&* ,%(!u*& &( -,$%& $ s*e#& (% *(e% $ -$"(!(u%

II% THE INFORMATION

Gu!e"#es (# e)*h$#ge (' #'(%-$&(# .e&ee# '%$g%$#*e su,,"e%s $#! *(s-e&* -$#u'$*&u%e%s 8 Rese! e%s(# 201< 1



C(#'!e#&$"&+ The #'(%-$&(# ,%(!e! .+ &he '%$g%$#*e su,,"e% -us& .e h$#!"e! .+ &he *(s-e&* *(-,$#+# $ $+6 h*h %es,e*&s &he #&e""e*&u$" ,%(,e%&+ (' &he su,,"e% F(% e)$-,"e6 u#"ess (&he%se $g%ee!6*(--e%*$""+ se#s&e !$&$ =eg u$#&&$&e '(%-u"$&(# !$&$> sh(u"! (#"+ .e $$"$."e &( %egu"$&(%+ $#!s$'e&+ ,e%s(##e" '(% &he ,u%,(ses (' !e&e%-##g &he *(%%e*& "$.e""#g (' &he '#$" ,%(!u*& $#! '(% -ee&#g &he%eu%e-e#&s (' &he C(s-e&*s Regu"$&(# (% '(% (&he% s$'e&+ (% %egu"$&(%+ ,u%,(ses

C(#'!e#&$"&+ (' &he '%$g%$#*e '(%-u"$ s -,"*& The C(s-e&*s Regu"$&(# $*5#("e!ges &he *(#'!e#&$"&+

(' &he '%$g%$#*e '(%-u"$ $#!6 &he%e'(%e6 $ 'u"" !s*"(su%e (' &he '%$g%$#*e #g%e!e#&s s #(& "eg$""+ %eu%e!H(ee%6 &he '%$g%$#*e *(-,(u#! -us& s&"" .e *(#s!e%e! # &he s$'e&+ $ssess-e#& (' &he '#she! *(s-e&*,%(!u*&.

As $ -#-u-6 &he '%$g%$#*e su,,"e% -us& ,%(!e &he '(""(#g #'(%-$&(#

• The !e#&&+ (' &he *us&(-e%

• The ,%(!u*& &+,e

• The !e#&&+ (' &he '%$g%$#*e su,,"e%

• The !e#&&+ (' &he '%$g%$#*e *(-,(u#! &h &s #$-e =' $#+> $#! *(!e #u-.e%

• A %e$s(#e! e$"u$&(# (' &he s$'e&+ (' &he '%$g%$#*e *(-,(u#! '(% &s #&e#!e! use #*"u!#g &he ,%(!u*&

&+,e =$s !e'#e! # &he IFRA;RIFM QRA I#'(%-$&(#$" 7((5"e&>6 use ,$&&e%# $#! use *(#*e#&%$&(# '(% h*h &he '%$g%$#*e *(-,(u#! h$s .ee# $ssesse! 7%($! $#! -u"&,"e ,%(!u*& uses *$# .e *(#s!e%e! #(#e !e*"$%$&(#6 $s "(#g $s &he $ssess(% s s$&s'e! &h$& &he '%$g%$#*e *(-,(u#! s su&$."e '(% $"",%(!u*&s6 h*h -$+ *(-e u#!e% &h(se ,%(!u*& &+,es6 u, &( $ -$)-u- "ee" *(#s!e%e!

• A *e%&'*$&e (' *(-,"$#*e &h IFRA S&$#!$%!s *u%%e#&"+ # ,"$*e6 ge# &he *(--&-e#& (' C(s-e&*s

Eu%(,e -e-.e%s &( $!he%e &( &hese S&$#!$%!s I# *$se (' $# u,!$&e (' IFRA S&$#!$%!s6 #'(%-$&(#$.(u& $ *h$#ge! s&$&us (' &he '%$g%$#*e *(-,(u#! =eg #( "(#ge% *(-,"$#&> #ee!s &( .e ssue! &h#&he &-e '%$-e $s s&,u"$&e! .+ IFRA $#! '(%$%!e! &( &he *(s-e&* -$#u'$*&u%e%

• A s&$&e-e#& (' *(-,"$#*e (' &he '%$g%$#*e #g%e!e#&s use! # &he *(-,(u#! &h %e"e$#& EU *(s-e&*s

$#! *he-*$" "egs"$&(#s $s e"" $s Re*(--e#!$&(#s (' &he #!us&%+ he# $,,"*$."e

• A S$'e&+ D$&$ Shee& # *(-,"$#*e &h *u%%e#& %e"e$#& EU %egu"$&(#

• Re"$."e #'(%-$&(# (# &he ,%ese#*e $#! *(#*e#&%$&(# (' su.s&$#*es6 %egu"$&e! # &he A##e)es (' &heC(s-e&*s Regu"$&(#

• Whe%e $,,%(,%$&e6 $!!&(#$" #'(%-$&(# =,"e$se %e'e% &( se*&(# 46 Fu%&he% I#'(%-$&(#>

• The !$&e

• The #$-e6 u$"'*$&(# $#! sg#$&u%e (' &he s$'e&+ e$"u$&(%

A"" #'(%-$&(# *$# .e su,,"e! e&he% $ se,$%$&e !(*u-e#&s (% $ $gg%eg$&e! !(*u-e#&s

III% THE SAFET& EVALUATION AND THE ROLE OF THE SAFET& EVALUATOR

I# $!!&(# &( &he *e%&'*$&e (' *(-,"$#*e &h *u%%e#& IFRA S&$#!$%!s6 $#! .$se! (# C(--ss(# De*s(#(# A##e) I (' &he C(s-e&*s Regu"$&(# =2013/?@</EU>6 $ %e$s(#e! e$"u$&(# (' &he s$'e&+ (' &he '%$g%$#*e*(-,(u#! '(% &s #&e#!e! use sh$"" .e *$%%e! (u& .+ &he '%$g%$#*e su,,"e%

I# &hs ,%(*ess6 &he *(s-e&* -$#u'$*&u%e% sh$"" *(--u#*$&e &( &he '%$g%$#*e su,,"e% $!eu$&e #'(%-$&(#(# ,%(!u*& *$&eg(%+ $#! use ,$&&e%# '(% h*h &he '%$g%$#*e *(-,(u#! s #&e#!e!I!e$""+6 &he !ee"(,-e#& (' &he '%$g%$#*e *(-,(u#! sh(u"! &$5e #&( $**(u#& &hese e"e-e#&s '%(- &he s&$%& .+$ *"(se *(""$.(%$&(# .e&ee# &he s$'e&+ e$"u$&(% $#! &he ,e%'u-e%

S,e*'* $&&e#&(# sh(u"! .e ,$! &( &he u##&e#&(#$" ,%ese#*e (' ,%(h.&e! su.s&$#*es *(#s!e%e! $s&e*h#*$""+ u#$(!$."e u#!e% GMP ,%$*&*es

A!!&(#$" #'(%-$&(# (# &he #$&u%e (' ,(&e#&$" he$"&h h$$%!=s> (' &he u#!"u&e! '%$g%$#*e *(-,(u#!6$**(%!#g &( &he %u"es (' &he D$#ge%(us P%e,$%$&(#s D%e*&e =DPD> u#&" 'u""+ %e,"$*e! .+ &he C"$ss'*$&(#6

L$.e""#g $#! P$*5$g#g Regu"$&(# =CLP> =Bu#e 1s& 6 201> *$# .e %e&%ee! '%(- &he S$'e&+ D$&$ Shee& =SDS>




'(% &he se"e*&e! '%$g%$#*e *(-,(u#! The SDS "" !e#&'+ &he #g%e!e#&=s> %es,(#s."e '(% &he h$$%!=s> $#!

"e$!#g &( &he *"$ss'*$&(# (' &he '%$g%$#*e *(-,(u#!

I' #e #'(%-$&(# *(-es &( "gh&6 (% ' &he%e $%e *h$#ges # IFRA S&$#!$%!s (% # "egs"$&(#6 &he -,$*& (#e)s&#g '%$g%$#*es -us& .e *(#s!e%e! $#!6 ' #e*ess$%+6 #e $ssess-e#&s -us& .e ssue!The s$'e&+ e$"u$&(% # *h$%ge (' $ssess#g &he s$'e&+ (' &he '%$g%$#*e *(-,(u#! sh(u"! .e u$"'e! s-"$%

&( $ s$'e&+ $ssess(% (' $ *(s-e&* ,%(!u*& =see A%&*"e 10 2>6 e h("!#g $ !,"(-$6 (% (&he% e!e#*e (' '(%-$" u$"'*$&(#s $$%!e! (# *(-,"e&(# (' $ u#e%s&+ *(u%se (' &he(%e&*$" $#! ,%$*&*$" s&u!+ #,h$%-$*+6 &()*("(g+6 -e!*#e (% $ s-"$% !s*,"#e6 (% $ *(u%se %e*(g#e! $s eu$"e#& .+ $ Me-.e% S&$&e

The %("e $#! %es,(#s."&+ (' &he s$'e&+ e$"u$&(% -us& .e e-,h$sse! I& s &he %es,(#s."&+ (' &he '%$g%$#*e*(-,$#+ &( se"e*& $ ,e%s(# &h $,,%(,%$&e e),e%&se

As $# $"&e%#$&e &( &he $.(e %e$s(#e! e$"u$&(# (' &he '%$g%$#*e *(-,(u#!6 &he '%$g%$#*e su,,"e% $#! &he*(s-e&* -$#u'$*&u%e% -$+ $g%ee &h$& &he *(s-e&* -$#u'$*&u%e% "" *$%%+ (u& &he s$'e&+ e$"u$&(# $& &he"ee" (' &he s$'e&+ $ssess-e#& *$%%e! (u& (# &he '#she! *(s-e&* ,%(!u*& I# &hs *$se $#! u#!e% $,,%(,%$&e&e%-s (' *(#'!e#&$"&+6 &he '%$g%$#*e su,,"e% (u"! ,%(!e $ .%e$5!(# (' &he '%$g%$#*e *(-,(u#!

$**(%!#g &( $g%ee-e#&s .e&ee# &he su,,"e% $#! -$#u'$*&u%e%6 &(ge&he% &h $#+ #e*ess$%+ #'(%-$&(# (#*(-,(#e#&s

The s$'e&+ e$"u$&(% s %es,(#s."e '(% !e&e%-##g

• he&he% &he &()*("(g*$" !$&$ (# #g%e!e#&s $%e %e"e$#& $#! su''*e#&

• &he s$'e&+ (' &he '%$g%$#*e *(-,(u#! *(#s!e%#g &he &+,e (' &he ,%(!u*& $#! &s use *(#!&(#s

• he&he% $!!&(#$" #'(%-$&(# su,,(%&#g &he s$'e&+ =eg -$%5e& e),e%e#*e> *$# .e *(#s!e%e! '(% $

ge# #g%e!e#& (% &he '#she! '%$g%$#*e *(-,(u#!

The s$'e&+ e$"u$&(% -us&

• h$e %e*(g#e! *(-,e&e#*e # $#$"+ss6 e$"u$&(# $#! #&e%,%e&$&(# (' &()*("(g*$" !$&$

•h$e $**ess .(&h &( &he &()*("(g*$" $#! $#$"+&*$" #'(%-$&(# %e"e$#& '(% &he s$'e&+ (' &he '%$g%$#*e*(-,(u#!

• *(#s!e% &he s$'e&+ (' &he '%$g%$#*e *(-,(u#! #!e,e#!e#&"+ (' *(--e%*$" *(#s!e%$&(#s

The :u!ge-e#& (' &he s$'e&+ e$"u$&(% %e"es (#

• &he 5#("e!ge (' &he ,h+s*(;*he-*$" ,%(,e%&es (' &he #g%e!e#&s $#! QSAR s&u!es $$"$."e

• &he 5#("e!ge $#! e),e%e#*e (' &()*("(g*$" ,%(,e%&es $#! s$'e&+;#;use (' &he #g%e!e#&s

• &he hs&(%+ (' s$'e&+;#;use (' '%$g%$#*e *(-,(u#!s *(#&$##g &he s$-e (% s-"$% #g%e!e#&s

• &he e),e%& $ssess-e#& (' &he $,,%(,%$&e !$&$ $$"$."e (# $ #e (% #(e" #g%e!e#&

• ' #e*ess$%+6 &he %esu"&s (' $!!&(#$" !$&$ (.&$#e! e&he% (# (#e (% -(%e #g%e!e#&s (% (# &he '#she!

'%$g%$#*e *(-,(u#! &se"'

IV% THE IFRA STANDARDS FOR THE SAFE USE OF FRAGRANCES

The IFRA C(!e (' P%$*&*e ,%es*%.es S&$#!$%!s '(% &he s$'e use (' *e%&$# '%$g%$#*e #g%e!e#&s # *(#su-e%

,%(!u*&s $#! s .$se! (# $# e$"u$&(# .+ $# #!e,e#!e#& e),e%& ,$#e" =REPAN> (' &he s$'e&+ !$&$ $#!

,%('"es (' &hese '%$g%$#*e #g%e!e#&s

A *e%&'*$&e (' *(-,"$#*e &h *u%%e#& IFRA S&$#!$%!s s $# #&eg%$" ,$%& (' &he s$'e&+ #'(%-$&(# &( .e

su,,"e! .+ &he '%$g%$#*e -$#u'$*&u%e% H(ee%6 &he *e%&'*$&e !(es #(& %e,"$*e $ %e$s(#e! e$"u$&(# (' &he

s$'e&+ (' &he '%$g%$#*e *(-,(u#! '(% &s #&e#!e! use

The su,,"e%s -$+ e&he% !e*"$%e &he *(-,"$#*e (' &he '%$g%$#*e *(-,(u#! &h IFRA S&$#!$%!s # &he

,%(!u*& *"$ss ,%(!e! .+ &he *(s-e&* -$#u'$*&u%e% =(,&(# 16 A,,e#!) A> .$se! (# &he #&e#!e! use

*(#*e#&%$&(# (' &he *(-,(u#! # &he '#she! ,%(!u*& (% !s*"(se &he -$)-u- "-& (' &he '%$g%$#*e




*(-,(u#! # &he ,%(!u*& *"$ss ge# .+ &he *(s-e&* -$#u'$*&u%e% (% !s*"(se &he -$)-u- "-& # see%$"

,%(!u*& *"$sses =u, &( &he -$)-$" #u-.e% (' *"$sses !e#&'e! .+ IFRA 8 (,&(# 26 A,,e#!) A>

I# *$se (' $# u,!$&e (' IFRA S&$#!$%!s6 #'(%-$&(# $.(u& &he s&$&us (' &he '%$g%$#*e *(-,(u#! &h %eg$%!

&( &he #e S&$#!$%!=s> #ee!s &( .e ssue! &h# &( -(#&hs $'&e% &he $-e#!-e#& e#&e%s #&( '(%*e '(% #e

*%e$&(#s =h*h ge#e%$""+ s < -(#&hs $'&e% &he !$&e (' &he "e&&e% (' #(&'*$&(#> $#! '(%$%!e! &( &he *(s-e&*

-$#u'$*&u%e% '(% #*"us(# # &he ,%(!u*& #'(%-$&(#

C(s-e&*s Eu%(,e %e*(g#es &he IFRA/RIFM s$'e&+ ,%(*ess6 &he %esu"&#g S&$#!$%!s $#! &he IFRA C(!e ('P%$*&*e $s *e#&%$" e"e-e#&s # &he s$'e&+ $ssess-e#& (' $ '%$g%$#*e *(-,(u#! $#! s&%(#g"+ %e*(--e#!s &s-e-.e%s &( e#su%e *(-,"$#*e (' $"" &s *(-,(u#!s # use # -$%5e&e! '#she! ,%(!u*&s &h &he IFRA C(!e(' P%$*&*e

V% FURTHER INFORMATION

Fu%&he% &( &he #'(%-$&(# (# ,%ese#*e $#! "ee"s (' su.s&$#*es %egu"$&e! # &he A##e)es &( &he C(s-e&*s

Regu"$&(#6 #'(%-$&(# (# s,e*'* #g%e!e#&s &h$& $%e *(--(#"+ su.:e*& &( e#u%es -$+ .e ,%(!e! &h&he '%$g%$#*e *(-,(u#! $#!/(% &he '%$g%$#*e #g%e!e#& #'(%-$&(# $& &he %eues& (' &he *(s-e&*-$#u'$*&u%e% Ths "" '$*"&$&e &he s$'e&+ $ssess-e#& (' &he *(s-e&* ,%(!u*& $#! !e$"#g &h *(#su-e% *(#*e%#s # &he -$%5e&,"$*e =eg # *$se (' se#s&s$&(#>

The%e -$+ .e (**$s(#s he%e 'u%&he% #'(%-$&(# s %eu%e! &( $! #es&g$&(# (' *(#su-e% *(-,"$#&s (% $!e%se e''e*&s # &he -$%5e&,"$*e I# su*h *$ses6 &he '%$g%$#*e su,,"e% "" *(""$.(%$&e # $#+ #es&g$&(#s$#! su,,"+6 # *(#'!e#*e6 $#+ #'(%-$&(# #e*ess$%+ Ths #'(%-$&(# -$+ .e su,,"e! $s #e*ess$%+ &( &he%egu"$&(%+ $u&h(%&es6 -e!*$" ,e%s(##e" #es&g$&#g &he #*!e#& $s e"" $s &( &he &()*("(gs& (% eu$"e#&s$'e&+ ,e%s(# # &he *(s-e&* *(-,$#+

N(&h#g # &hese gu!e"#es ,%ee#&s -(%e *(-,%ehe#se e)*h$#ge (' #'(%-$&(# .e&ee# &he '%$g%$#*e

su,,"e% $#! &he *us&(-e%6 $s ,$%& (' &he% *(--e%*$" $g%ee-e#&

Gu!e"#es (# e)*h$#ge (' #'(%-$&(# .e&ee# '%$g%$#*e su,,"e%s $#! *(s-e&* -$#u'$*&u%e%s 8 Rese! e%s(# 201< <



A''edi AEXAMPLE OF A CONFORMIT& CERTIFICATE WITH IFRA STANDARDS

#% Idei* o+ ,-so.er/ C(s-e&*s Eu%(,e H$% C(-,$#+1 A He%-$##;De.%(u)11?0 7%usse"s

7e"gu-

!% Prod-, *'e/ Sh$-,((

0% Idei* o+ +r12r1,e s-''3ier/ C(-,$#+ )+<9 Ae#ue !e "$ P$%'u-e%e0?130 G%$sse

F%$#*e

$% Idei* o+ +r12r1,e ,o.'o-d/ N$-e =' $#+> A-.e% F"(e% C(!e Nu-.e% A7C ?@9

4% Assess.e Co,er1io o+5e +r12r1,e ,o.'o-d i ,os.ei, 'rod-,/ 0

6% Co+or.i* 7i5 ,-rre IFRA S1d1rds

1s& (,&(#Whe# use! # $ sh$-,(( $& 06 F%$g%$#*e *(-,(u#! A7C ?@9 *(#'(%-s &( A-e#!-e#& ))6 &he *u%%e#&"+$,,"*$."e S&$#!$%!s (' &he I#&e%#$&(#$" F%$g%$#*e Ass(*$&(# =IFRA>

Ths s$'e&+ e$"u$&(# $,,"es (#"+ &( &he use (' '%$g%$#*e A7C ?@9 # &he ,%(!u*& s&$&e! Use # (&he% ,%(!u*& &+,es (% $& hghe% *(#*e#&%$&(#s sh(u"! .e &he su.:e*& (' $ se,$%$&e s$'e&+ e$"u$&(# .+ &he su,,"e%

2#! (,&(#I# (%!e% &( .e # *(-,"$#*e &h &he )) A-e#!-e#& &( &he IFRA S&$#!$%!s6 &hs '%$g%$#*e *(-,(u#! sh(u"!#(& .e use! $& "ee"s e)*ee!#g &he '(""(#g (#es ,e% *$&eg(%+C"$ss 1 ) C"$ss 2 )C"$ss 117 )

The ,%ese#*e $#! *(#*e#&%$&(# # &he '%$g%$#*e *(-,(u#! (' #g%e!e#&s "s&e! # &he *u%%e#& IFRA S&$#!$%!s$%e $s '(""(s

CAS S-8s1,e Co,er1io (.29:2)

?@2;2?3 &%$#s;2;he)e#$" 200

01?;20;< G%$,e'%u& (" e),%esse! 00

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A''edi B

EXAMPLE OF AN EXCHANGE OF REGULATOR& INFORMATION FOR A FRAGRANCE COMPOUND(IN EUROPE)

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A''edi C

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