Issuu on Google+

The  IFRA  Compliance       1. General  description  of  the  IFRA  Standards   Q.  What  is  an  “IFRA  Standard”?   Q.  What  does  IFRA  compliance  mean  in  practice?   Q.  What  is  the  IFRA  policy  in  terms  of  unavoidable  traces  of  prohibited  materials?   Q.  How  many  Standards  have  been  implemented  by  IFRA  until  now?   Q.  How  many  fragrance  ingredients  does  it  make?   Q.  Why  are  some  ingredients  banned  whilst  others  are  restricted  ?   Q.  Does  the  timeline  provided  in  the  IFRA  Standard  relate  to  the  compliance  of  the  finished  product  with  the   latest  IFRA  Amendment?  



2. The  IFRA  Standards  Development  Process   Q.  How  do  you  create  the  IFRA  Standards?   Q.  Does  the  absence  of  an  IFRA  Standard  mean  that  the  fragrance  ingredient  is  100%  safe?    



3. The  QRA  methodology   Q.  What  is  the  QRA  methodology?   Q.  How  do  QRA  Standards  work?   Q.  What  is  the  difference  between  an  IFRA  category  and  an  IFRA  class?  




4. The  IFRA  Compliance  and  the  IFRA  Certificate  

  Q.   A   natural   extract   is   covered   by   an   IFRA   Standard.   Does   a   fragrance   formula   additionally   also   have   to     comply  with  the  IFRA  Standards  for  each    of  the  constituents  in  that  oil  ?   Q.  What  is  the  IFRA  Certificate  and  who  makes  this  document?   Q.  If  a  fragrance  becomes  used  in  an  application  different  from  that  for  which  an  original  IFRA  Certificate  has   been  made,  can  the  client  still  use  the  same  IFRA  certificate?    



More  things  to  know  about  the  Standards             IFRA UK Ivy Cottage Cosgrove MK19 7JJ


1. General  description  of  the  IFRA  Standards     Q.  What  is  an  “IFRA  Standard”?   IFRA   Standards   are   part   of   the   IFRA   Code   of   Practice   and   are   the   outcome   of   the   industry’s   self   regulated   risk   management   system   related   to   the   use   of   fragrance   ingredients.   This   self-­‐regulating   system  is  based  on  risk  assessments  carried  out  by  an  independent  academic  Expert  Panel.     This   Expert   Panel   is   made   up   of   renowned   independent   experts   from   fields   such   as   dermatology,   toxicology,  pathology  and  environmental  sciences.  Their  role  is  to  evaluate  the  data  on  a  fragrance   ingredient  to  ensure  the  current  accepted  use  level  is  still  valid,  in  turn  this  assures  the  safe  use  by   consumers.  In  cases  where  the  safety  assessment  does  not  support  the  current  use,  the  Expert  Panel   instructs  IFRA  to  issue  a  Standard.  There  are  three  types  of  IFRA  Standards:   -­‐ Standards  of  restriction;  limiting  the  use  of  fragrance  ingredients  to  a  certain  level   -­‐ Standards  of  prohibition;  banning  the  use  of  the  material  as  a  fragrance  ingredient   -­‐ Standards  of  specification;  establishing  purity  criteria  that  the  material  must  meet  to  enable   use  as  a  fragrance  ingredient.     The   IFRA   Standards   of   restriction   could   be   based   on   each   of   the   following   specific   toxicological   endpoints  which  consequently  is  reflected  in  ,  specific  risk  management  measures:   -­‐ Protection  against  induction  of  skin  sensitization  (a  term  related  to  skin  allergies)  via  the  QRA   methodology  (see  section  3).   -­‐ Protection   against   systemic   toxicity   (a   term   related   to   the   toxicity   of   a   substance   when   entering  the  body).   -­‐ Protection  against  photo  toxicity  (a  term  linked  to  chemically  induced  skin  effects  requiring   light  that  does  not  involve  the  immune  system).     All   members   of   IFRA   are   required,   as   a   condition   of   membership,   to   observe   the   IFRA   Code   of   Practice   and,   consequently,   to   comply   with   the   IFRA   Standards.   When   a   new   IFRA   Standard   is   published,   a   transition   period   is   granted   to   ensure   its   proper   implementation   by   the   industry:   this   transition   period   is   usually   2   months   for   new   submissions   and   14   months   for   existing   fragrance   compounds.   IFRA   Standards   are   published   on   a   2-­‐yearly   basis,   unless   there   is   an   urgent   need   for   action  at  which  point  the  industry  will  publish  a  new  standard  immediately.     Q.  What  does  IFRA  compliance  mean  in  practice?   In   practice,   to   'comply'   with   the   IFRA   Standards   means   that   a   fragrance   formula   does   not   contain   prohibited   fragrance   ingredients   nor   does   it   contain   restricted   fragrance   ingredients   beyond   their   safe   use   level.   Furthermore,   the   fragrance   compound   resulting   will   be   accompanied   by   an   IFRA   certificate  giving  the  safe  use  level  in  each  product  category.        


Q.  What  is  the  IFRA  policy  in  terms  of  unavoidable  traces  of  prohibited  materials?   Unavoidable  traces  of  prohibited  substances  might  be  acceptable  provided  that  these  traces  are  safe   based   on   individual   safety   considerations   and   intended   uses   determined   by   member   companies   within   any   applicable   regulatory   requirements.   If   a   company   does   not   have   the   internal   resources   necessary   to   assess   acceptable   trace   levels,   IFRA   recommends   that   this   evaluation   is   outsourced   to   a   consultant  who  specializes  in  safety  assessment  of  finished  fragranced  products.     Please,  consult  the  respective  IFRA  Standards  to  know  more  about  specific  trace  levels  enforced  by   IFRA.     Q.  How  many  Standards  have  been  implemented  by  IFRA  until  now?   At   the   time   of   the   47th   Amendment   (published   on   June   10th,   2013),   196   IFRA   Standards   are   implemented  (respectively  99  Standards  of  restriction,  80  Standards  of  prohibition  and  17  Standards   of   specification).   These   IFRA   Standards   are   publicly   available   and   can   be   consulted   on   the   IFRA   website.  The  IFRA  Standards  can  also  be  consulted   offline  by  downloading  the  overview  of  all  IFRA   Standards  (Excel  spreadsheet)  and  the  IFRA  Standards  Booklet  (pdf).       Q.  How  many  fragrance  ingredients  are  covered  by  IFRA  Standards  ?   This   is   not   an   easy   question   and   the   actual   number   of   fragrance   ingredients   covered   by   an   IFRA   Standard  is  difficult  to  estimate.  Hundreds  of  fragrance  ingredients  are  in  the  scope  of  the  IFRA  Risk   Management  system.  There  are  basically  three  reasons  for  this   • Some   IFRA   Standards   cover   more   than   one   fragrance   ingredient.   Indeed,   a   given   IFRA   Standard  might  restrict,  prohibit  or  set  specifications  for  a  full  group  of  substances  linked  by   chemical   similarities.   Additionally,   and   by   default,   all   stereoisomers   enter   in   the   scope   of   a   given  Standard:   -­‐ Chemical  groups  (e.g.  2,4-­‐Dienals):  some  Standards  cover  groups  of  chemical  substances   belonging   to   the   same   structural   family   although   the   molecular   weights   and   other   properties  of  these  substances  can  vary.   -­‐ Structural  isomers  (e.g.  o,m,p-­‐tolualdehydes):  some  Standards  cover  several  substances   that  only  differ  by  the  position  of  their  chemical  functions.   -­‐ Stereoisomers   (cis/trans   isomers,   enantiomers,   diastereoisomers):   some   Standards   cover  all  isomers  of  a  given  substance  as  the  safety  assessment  of  fragrance  ingredients   is   usually   conducted   on   mixtures   of   isomers.   Therefore,   unless   something   else   is   specified,    all  isomers  are  implicitly  covered  by  its  IFRA  Standard.     • Most  Natural  Complex  Substance's  (also  called  NCS  or  natural  extracts  )  contain  at  least  one   substance   covered   by   an   IFRA   Standard;   through   the   nature   and   the   concentration   of  their   constituents,   the   use   of   a   Natural   Complex   Substance   might   be   restricted   as   well   although   there  is  not  an  IFRA  Standard  for  each  NCS  that  contains  a  restricted  substance.  A  list  of  the   main   NCS's   and   their   constituents   covered   by   an   IFRA   Standard  as   reported   in   Annex   I   of   the   IFRA  Standards.  


  A   few   fragrance   ingredients,   called   Schiff   bases,   are   synthesized   by   combining   an   aldehyde   and   an   amine.   These   fragrance   ingredients   are   relatively   fragile   and   usually   disassociate   in   the   finished   product   and   return   in   part   to   the   starting   materials.   For   this   reason,   an   IFRA   Standard  covering  an  aldehyde  will  also  cover  all  the  Schiff  bases  made  with  this  aldehyde.   For  more  information  about  Schiff  bases,  please,  consult  Annex  II  of  the  IFRA  Standards.  

  Q.  Why  are  some  ingredients  banned  whilst  others  are  restricted  ?   IFRA  represents  the  fragrance  industry  and  is  well  aware  of  the  difficulties  that  the  implementation   of   IFRA   Standards   causes   to   the   perfumers   and   their   companies.   However,   IFRA   represents   a   responsible  industry  for  which  consumer  safety  is  the  first  priority. The  fragrance  industry  takes  its   regulation   seriously   and   is   committed   to   undertaking   its   responsibilities   thoroughly.   All   of   its   ingredients   are   rigorously   assessed   for   toxicity   and   IFRA   works   closely   with   regulators   and   stakeholders  to  issue  and  update  comprehensive  safety  standards.   Because   of   their   toxicological   profile   some   materials   need   to   be   covered   by   an   IFRA   Standard.   Amongst   them,   some   fragrance   ingredients   can   be   safely   used   under   a   given   concentration   in   the   finished  product  and  an  IFRA  Standard  of  restriction  is  established  to  control  the  consumer  exposure.   For   others,   the   establishment   of   a   safe   use   level   is   impossible   because   of   their   strong   toxicity.   In   this   case,  an  IFRA  Standard  of  prohibition  is  necessary.     Q.   Does   the   timeline   provided   in   IFRA   Standards   relate   to   the   compliance   of   the   finished   product   with  the  latest  IFRA  Amendment?   No  –  the  timelines  in  the  Standards  relate  to  the  compliance  (supply)  of  fragrance  compounds  only,   not  to  the  finished  product  in  the  marketplace.  This  is  explicitly  mentioned  on  each  Standard.       2. The  IFRA  Standards  Development  Process     Q.  How  do  you  create  the  IFRA  Standards?   The  fragrance  industry  spends  approximately  $8  million  (annually)  in  joint  research  on  the  safety  of   fragrances,  and  much  more  at  the  individual  company  level.     IFRA   provides   information   on   the   exposure   situation   such   as:   usage   concentration,   variety   of   use,   volume   of   use   chemical   composition   as   well   as   the   olfactory   profile   and   olfactory   potential   (importance)  of  a  fragrance  ingredient  to  the  Research  Institute  for  Fragrance  Materials  (RIFM),  the   scientific   arm   of   IFRA.   RIFM   then   prepares   comprehensive   dossiers   on   the   materials   including   all   available   safety   data   and,   if   necessary,   initiates   and   organizes   any   missing   safety   studies   on   the   fragrance  ingredient.       The  Standards  are  established  according  to  the  following  process  (see  Annex  I):    


1. IFRA   provides   information   on   the   exposure   situation   (usage   concentration,   variety   of   use,   volume  of  use),  chemical  composition  as  well  as  the  olfactory  profile  and  olfactory  potential   (importance)  of  a  fragrance  ingredient  to  RIFM;     2. RIFM   prepares   a   comprehensive   dossier   on   the   material   including   all   available   safety   data   and,   if   necessary,   initiates   and   organizes   any   missing   safety   studies   on   the   fragrance   ingredient;   3. The  RIFM  Panel  of  independent  experts,  evaluates  the  data  to  see  if  it  supports  the  current   use  level  to  make  sure  that  there  is  no  risk  to  the  consumer.  If  the  safety  assessment  does   not  support  the  current  use,  the  Panel  instructs  IFRA  to  issue  a  Standard1;     4. IFRA  prepares  a  Standard  in  accordance  with  the  Panel's  instructions  and  conclusions;     5. The  draft  Standard  is  consulted  with  the  IFRA  membership  and  stakeholders  for  a  period  of   about   a   month,   to   ensure   that   IFRA/RIFM   are   aware   of   all   data   on   the   material   and   to   provide   holders   of   additional   data   that   might   alter   the   outcome   of   the   Panel's   risk   assessment  with  the  opportunity  to  share  those  with  IFRA/RIFM;     6. If   no   additional   information   is   received   via   the   Consultation   phase,   the   final   Standard   is   published   in   a   notification   procedure   as   part   of   an   “Amendment   to   the   IFRA   Code   of   Practice”.       Q.  Does  the  absence  of  an  IFRA  Standard  means  that  the  fragrance  ingredient  is  100%  safe?   The   current   set   of   IFRA   Standards   is   a   list   of   ingredients   that   have   undergone   the   IFRA   Standards   Development   Process   and   were   found   to   be   needing   risk   management   measures   This   means   that   those   fragrance   ingredients   that   cause   or   are   supposed   to   cause,   adverse   effects   to   the   human   health  are  part  of  this  list.   This   includes   all   high   volume   fragrance   ingredients   and   those   with   “structural   alerts”   on   particular   toxicological  endpoints.  Practically  speaking,  all  fragrance  ingredients  have  not  been  fully  examined   by  RIFM  yet.  The  most  important  fragrance  ingredients,  sold  in  big  quantities  or  presenting  obvious   safety   issues   have   already   been   evaluated   but   more   time   is   needed   to   complete   the   safety   assessment  of  the  other  materials.  In  this  regard,  RIFM  launched  an  ambitious  program  intended  to   assess   the   safety   of   all   remaining   ingredients,   listed   on   the   IFRA   Transparency   list,   in   the   next   five   years.   In  the  interim,  The  IFRA  Code  of  Practice  prescribes  that  the  absence  of  an  IFRA  Standard  could  mean   that   the   material   is   safe   for   use   under   any   condition   or   it   has   not   been   assessed   yet.   For   this   reason,   and   in   addition   to   the   compliance   with   the   IFRA   Standards,   a   responsible   company   should   ensure   that   the   fragrance   ingredients   not   covered   by   an   IFRA   Standard   can   reasonably   be   used   in   the   fragrance  formula  based  on  all  available  data  at  hand.   On   this   last   point,   the   company   having   the   appropriate   staff   will   make   its   own   safety   assessment   using   reputed   toxicological   database   (e.g.   RIFM   database).   The   company   which   does   not   have   sufficient  resources  to  complete  this  exercise  is  advised  to  outsource  it  to  a  competent  consultant.    


3. The  QRA  methodology     Q.  What  is  the  QRA  methodology?   The   Dermal   Sensitization   QRA   (Quantitative   Risk   Assessment)   is   used   to   evaluate   the   risk   of   skin   sensitization  resulting  from  the  exposure  to  allergens  via  consumer  products.  This  methodology  was   adapted   to   fragrance   allergens   and   its   main   features   are   published   in   the   peer-­‐reviewed   journal   'Regulatory  Toxicology  and  Pharmacology'.  This  article  can  be  downloaded  from  the  RIFM  website.       All  IFRA  Standards  of  restriction  intended  to  protect  consumers  against  the  risk  of  skin  sensitization   are   based   on   this   methodology.   The   QRA   intends   to   prevent   individuals   from   getting   sensitized   to   fragrance  allergens  by  deriving  maximum  use  levels  for  11  consumer  product  categories.     Allergic   Contact   Dermatitis   (ACD)   is   a   skin   disease   involving   the   immune   system.   This   is   a   two   step   process:   1) an  induction  phase,  which  primes  and  sensitizes  the  immune  system  for  an  allergic  response,   and   2) an  elicitation  phase,  in  which  the  actual  allergic  response  is  triggered.  Elicitation  occurs  after   subsequent   exposures   to   the   skin   sensitizer   having   gone   through   the   induction   phase.     It  is  now  generally  accepted  in  the  scientific  community  that  both  the  sensitization  and  the  elicitation   phases   are   triggered   by   a   threshold   mechanism.   Preventing   induction   automatically   prevents   the   issue   of   sensitization   and   elicitation.   For   this   reason,   safe   use   levels   preventing   induction   are   established  for  each  allergen  via  an  appropriate  risk  assessment  methodology.     The  QRA  methodology  is  based  on  many  parameters  but,  before  all,  on  the  skin  sensitizing  potency.   The   potency   determination   is   the   usual   result   of   the   hazard   assessment   of   a   substance.  Skin   sensitizing  potency  can  range  from  very  weak  to  extreme  but  the  majority  of  fragrance  allergens  are   weak   sensitizers.   All   available   scientific   studies   on   the   skin   sensitizing   potency   are   combined   using   the   Weight   of   Evidence   (WoE)   approach   to   give   a   quantitative   value:   the   NESIL   or   “No   Expected   Sensitization  Induction  Level”.   The  NESIL  is  translated  in  terms  of  real  risk  for  the  consumer  by  taking  several  factors  into  account.   Together,   these   factors   make   the   Sensitization   Assessment   Factor   (SAF).   In   the   current   QRA   methodology  these  factors  are:   • The   inter-­‐individual   susceptibility;   some   people   are   more   sensitive   than   others   to   skin   sensitizers  which  can  be  due  to  genetic  predisposition,  age  or  skin  condition.   • The   matrix   effect;   some   products   are   more   aggressive   than   others   (e.g.   acid/alkaline   products,  

presence  of  certain  solvents,  additional  irritants,  etc).   • The  use  pattern;  the  area  where  the  skin  sensitizer  is  applied  and  the  amounts  of  product  used  

have  an  importance  in  the  sensitization  process  (e.g.  a  deodorant  applied  to  an  occlusive  and   sensitive  area  is  more  problematic  than  a  shampoo).    

The   QRA   methodology   combines   the   NESIL   and   the   SAF   to   define   a   maximum   use   level   for   each   fragrance  allergen  and  product  type  in  order  to  avoid  induction.  This  maximum  use  level  has  to  be   compared   with   the   real   exposure   to   this   allergen   on   the   marketplace   and   risk   management   measures,   in   the   form   of   an   IFRA   Standard,   will   be   proposed   where   the   exposure   observed   on   the   marketplace  goes  beyond  the  maximum  determined  use  level.     Q.  How  do  QRA  Standards  work?   Eleven   values   are   reported   in   every   QRA   Standard   –   one   per   IFRA   category.   A   product   type   can   be   linked  to  an  IFRA  category  by  consulting  the  IFRA-­‐RIFM  QRA  Informational  Booklet.  This  information   is  reported  in  all  details  between  pages  13  and  21  but  a  few  examples  of  product  types  for  each  IFRA   category   can   be   found   in   the   table   below.   For   more   information   on   the   QRA   methodology,   please,   consult  the  booklet  between  pages  32  and  36  (frequently  asked  questions).    

  These   QRA   values   are   the   maximum   use   levels   that   should   be   present   in   the   finished   consumer   product.  Important:  this  limit  applies  to  the  finished  consumer  product.  Two  strategies  are  possible   in  this  case:   -­‐ You  ask  your  client  (the  finished  product  manufacturer)  how  much  of  your  fragrance  he  plans   to  add  to  his  finished  product.   -­‐ You   provide   your   client   with   the   maximum   concentration   of   fragrance   that   he   can   add   to   his   formula.   This   maximum   concentration   is   determined   by   the   most   restricted   ingredient   of   your  composition.     For  instance,  an  eau-­‐de-­‐toilette  for  man  is  IFRA  category  3.  The  table  provided  below  is  an  excerpt  of   the   IFRA   Standard   set   for   alpha-­‐Amyl   cinnamic   aldehyde.   This   means   that   alpha-­‐Amyl   cinnamic   aldehyde   is   limited   at   3.6%   in   the   finished   eau-­‐de-­‐toilette.   If   your   client   told   you   that   the   finished   eau-­‐de-­‐toilette  will  contain  10%  of  fragrance,  this  means  that  your  fragrance  compound  should  not   contain  more  than  36%  of  alpha-­‐Amyl  cinnamic  aldehyde.      

Q.  What  is  the  difference  between  an  IFRA  category  and  an  IFRA  class?   An   IFRA   category   only   relates   to   sensitization   QRA   Standards,   it   is   a   way   to   classify   consumer   products   by   foreseeable   exposure   and   by   specificity   (a   cream   being,   for   instance,   a   chemical   environment  completely  different  from  an  hydroalcoholic  lotion).       IFRA   classes   are   a   subdivision   of  IFRA  categories   that   take   other   types   of   Standards   into   account   (i.e.   systemic   toxicity   and   phototoxicity.).   You   will   find   the   IFRA   classes   in   the   IFRA-­‐RIFM   QRA   Informational  Booklet  between  pages  25  and  30.       4. The  IFRA  Compliance  and  the  IFRA  Certificate     Q.  A  natural  extract  is  covered  by  an  IFRA  Standard.  Does  a  fragrance  formula  additionally  also  have   to  comply  with  the  IFRA  Standards  for  each    of  the  constituents  in  that  oil  ?   Yes,   compliance   of   a   fragrance   compound   includes   both   the   IFRA   Standard   covering   this   natural   extract  (e.g.  Ylang  ylang  essential  oil)  but  also  the  IFRA  Standards  of  all  of  its  components  (e.g.  Benzyl   alcohol,  Benzyl  benzoate,  Benzyl  salicylate,  Eugenol,  Farnesol,  Geraniol,  iso-­‐Eugenol).     Q.  What  is  the  IFRA  Certificate  and  who  makes  this  document?   The   IFRA   Certificate   is   a   document   established   by   the   fragrance   compound   manufacturer   for   its   customer.     It   means   that,   using   this   certificate,   a   fragrance   supplier   assures   to   his   customer   that   they   work   according  to  the  good  manufacture  practices  described  in  the  IFRA  Code  of  Practice.     This   certificate   can   be   completed   with   in-­‐house   expertise   at   the   fragrance   manufacturer   or   by   appropriately  educated  external  resources.       Q.   If   a   fragrance   becomes   used   in   an   application   different   from   that   for   which   an   original   IFRA   Certificate  has  been  made,  can  the  client  still  use  the  same  IFRA  certificate?   No,   the   IFRA   certificate   is   IFRA   class-­‐specific.   The   IFRA   compliance   has   to   be   recalculated   and   the   IFRA  certificate  redistributed  if  the  class  changes.  


5. More  things  to  know  about  the  Standards     Almost   all   IFRA   Standards   are   based   on   the   same   principle   and   their   implementation   is   relatively   straightforward.   However,   some   IFRA   Standards   are   tricky   or   present   exceptions.   Special   attention   should  be  paid  to  the  following  materials:     -­‐ Methyl   eugenol:   the   maximum   use   level   for   non-­‐skin   contact   products   applies   to   the   concentration   in   the   fragrance   compound   (and   not   in   the   finished   product).       -­‐ Acceptable   trace   levels   of   toluene   and   benzene   also   pertain   to   their   levels   in   fragrance   compounds.     -­‐ Methyl   heptine   carbonate   and   Methyl   octine   carbonate   are   linked:   they   have   different   maximum  use  levels  but  the  co-­‐use   of   these   two   fragrance   ingredients   should   not   go   beyond   100  %  of  what  is  allowed.   Example:   an   eau-­‐de-­‐toilette   for   woman   (IFRA   category   4),   containing   0.005   %   of   Methyl   heptine  carbonate  (maximum  use  level  =  0.01  %)  and  0.0015  %  of  Methyl  octine  carbonate   (maximum  use  level  =  0.002  %).  Both  ingredients  are  used  below  their  individual  maximum   use  levels  but  the  formula  is  not  IFRA  compliant  because  0.005  /  0.01  +  0.0015  /  0.002  =  50  %   +  75  %  =  125  %    beyond  the  limit  of  100  %.     -­‐ Rose  ketones  are  linked:  the  same  principle  applies  to  rose  ketones  but  all  rose  ketones  are   grouped   under   the   same   IFRA   Standard   and   are   limited   at   the   same   maximum   use   levels.   Nevertheless,   the   co-­‐use   of   several   rose   ketones   should   not   go   beyond   100   %   of   what   is   allowed.     -­‐ Phototoxic  substances:  as  of  today,  12  materials  are  restricted  due  to  their  phototoxic   properties  (5-­‐Acetyl-­‐1,1,2,3,3,6-­‐hexamethyl  indan  (AHMI),  Angelica  root  oil,  Bergamot  oil   expressed,  Bitter  orange  peel  oil  expressed,  Cumin  oil,  Grapefruit  oil  expressed,  Lemon  oil   cold  pressed,  Lime  oil  expressed,  Methyl  N-­‐methylanthranilate,  Methyl  β-­‐naphthyl  ketone,   Rue  oil,  Tagetes  oil  and  absolute).       These  12  materials  are  linked  by  the  same  principle:  the  co-­‐use  of  phototoxic  materials   should  not  go  beyond  100  %  of  what  is  permitted.       Furthermore,  the  citrus  oils  (Angelica  root  oil,  Bergamot  oil  expressed,  Bitter  orange  oil   expressed,  Cumin  oil,  Grapefruit  oil  expressed,  Lemon  oil  cold  pressed,  Lime  oil  expressed,   Rue  oil)  are  linked  by  the  IFRA  Standard  on  “Citrus  oils  and  other  furocoumarins-­‐containing   essential  oils  (Bergapten)”.    


In  case  you  determined  the  exact  content  of  bergapten  in  the  natural  oils  containing  them,   you  can  simply  apply  this  Standard  restricting  the  trace  level  of  furocoumarins  at  15ppm  in   the  finished  product.  If  you  did  not,  you  have  to  apply  the  individual  IFRA  Standards   developed  for  the  furocoumarins-­‐containing  essential  oils.      


IFRA Standards Q&A