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Chemical	
  Mixtures	
   1	
  
This is a summary of an “Opinion on Toxicity
and Assessment of Chemical Mixtures” expressed
by the three independent non-food Scientific
Committees of the EU Commission SCCS,
SCHER and SCENHIR.
	
  
Exposure to mixture (“cocktails”) of chemical substances: are
the health and environmental risks adequately evaluated?
Introduction
There	
   is	
   increasing	
   concern	
   in	
   the	
   general	
   public	
   about	
   the	
  
potential	
   toxic	
   effects	
   of	
   chemical	
   substance	
   mixtures	
   (in	
   the	
  
media	
  often	
  referred	
  to	
  as	
  “cocktail-­‐effects”).	
  
Humans	
   and	
   ecosystems	
   are	
   indeed	
   continually	
   exposed	
   to	
   a	
  
very	
  complex	
  mixture	
  of	
  chemical	
  substances,	
  the	
  composition	
  
of	
  which	
  is	
  always	
  changing.	
  However,	
  in	
  the	
  great	
  majority	
  of	
  
risk	
  assessments,	
  only	
  a	
  single	
  chemical	
  is	
  considered	
  and	
  there	
  
are	
   no	
   generally	
   applicable	
   guidelines	
   as	
   to	
   when	
   and	
   how	
  
assessment	
   of	
   combinations	
   of	
   chemical	
   substances	
   should	
   be	
  
carried	
  out.
Are there combined effects of exposure to chemical
mixtures?
Two	
  cases	
  should	
  be	
  considered	
  :	
  
	
  
1.1.	
  Substances	
  that	
  have	
  a	
  similar	
  mode	
  of	
  action	
  
When	
  substances	
  have	
  a	
  similar	
  mode	
  of	
  action	
  –	
  which	
  means	
  
that	
  their	
  adverse	
  effects	
  are	
  cause	
  by	
  similar	
  chain	
  of	
  events	
  –,	
  
their	
   concentration	
   can	
   be	
   added	
   together	
   to	
   predict	
   their	
  
combined	
   effect.	
   The	
   additivity	
   of	
   doses	
   is	
   assumed	
   over	
   the	
  
entire	
  range	
  of	
  concentrations,	
  including	
  those	
  below	
  the	
  level	
  
at	
  which	
  each	
  substance	
  has	
  no	
  observed	
  effect.	
  In	
  some	
  rare	
  
specific	
  cases,	
  antagonistic	
  (lower	
  than	
  the	
  sum	
  of	
  the	
  parts)	
  or	
  
synergistic	
  (greater	
  than	
  the	
  sum	
  of	
  the	
  parts)	
  effects	
  have	
  been	
  
observed,	
   but	
   in	
   general,	
   dose	
   addition	
   is	
   a	
   reasonable	
  
conservative	
  (protective)	
  default	
  approach.	
  
	
  
1.2.	
  Substances	
  that	
  have	
  different	
  modes	
  of	
  action	
  
With	
   mixtures	
   composed	
   of	
   chemical	
   substances	
   with	
   various	
  
modes	
   of	
   action,	
   there	
   is	
   good	
   evidence	
   that	
   the	
   effects	
   are	
  
higher	
  than	
  those	
  of	
  the	
  individual	
  components.	
  At	
  present,	
  the	
  
safety	
   margins	
   that	
   are	
   used	
   in	
   risk	
   assessment	
   of	
   single	
  
chemical	
  substances	
  could	
  be	
  insufficient	
  to	
  allow	
  room	
  for	
  the	
  
effects	
  for	
  all	
  possible	
  realistic	
  mixtures.	
  
However,	
   the	
   Opinion	
   of	
   the	
   Scientific	
   Committees	
   is	
   that,	
   for	
  
chemical	
  substances	
  that	
  act	
  independently,	
  no	
  robust	
  evidence	
  
is	
  available	
  and	
  it	
  is	
  very	
  unlikely	
  that	
  exposure	
  to	
  a	
  mixture	
  of	
  
such	
  substances	
  is	
  of	
  health	
  concern	
  if	
  the	
  individual	
  chemical	
  
substances	
  are	
  present	
  at	
  or	
  below	
  their	
  no	
  effect	
  levels.	
  	
  
If	
   the	
   mode	
   of	
   action	
   is	
   not	
   known,	
   as	
   is	
   the	
   case	
   for	
   many	
  
substances,	
  the	
  dose/concentration	
  addition	
  method	
  should	
  be	
  
preferred	
  over	
  the	
  independent	
  action	
  approach.	
  	
  
Should there be more specific assessment of risks for
chemical mixtures?
	
  
Specific	
  mixture	
  risk	
  assessment	
  is	
  indeed	
  necessary,	
  in	
  order	
  to	
  
avoid	
   underestimations	
   of	
   risks	
   that	
   might	
   occur	
   under	
   the	
  
classical	
   current	
   approach	
   that	
   takes	
   each	
   chemical	
   substance	
  
separately.	
  
Except	
   for	
   mixtures	
   composed	
   of	
   chemical	
   substances	
   with	
   a	
  
similar	
   mode	
   of	
   action,	
   current	
   evidence	
   does	
   not	
   show	
  
significant	
  mixture	
  toxicity	
  at	
  exposures	
  at	
  or	
  below	
  zero-­‐effect	
  
levels	
  of	
  the	
  individual	
  components.	
  	
  
Endocrine	
  disrupting	
  chemical	
  substances	
  (specifically	
  those	
  that	
  
are	
  affecting	
  sex	
  hormones)	
  are	
  often	
  mentioned	
  in	
  the	
  context	
  
of	
   chemical	
   mixtures,	
   since	
   they	
   have	
   effects	
   at	
   relatively	
   low	
  
concentrations,	
   although	
   larger	
   than	
   the	
   concentration	
   of	
   the	
  
hormones	
  that	
  they	
  are	
  affecting.	
  Since	
  concentrations	
  that	
  are	
  
found	
  in	
  people	
  are	
  very	
  low,	
  it	
  is	
  unlikely	
  that	
  there	
  is	
  an	
  effect	
  
of	
  chemical	
  mixtures	
  on	
  these	
  hormones.	
  
What are the effects of chemical substances mixtures
on the environment?
The	
   general	
   principles	
   of	
   the	
   risk	
   assessment	
   of	
   chemical	
  
substances	
   mixtures	
   is	
   also	
   applicable	
   in	
   the	
   context	
   of	
  
environmental	
   toxicology,	
   for	
   predicting	
   effects	
   at	
   population	
  
level,	
   although	
   the	
   concepts	
   of	
   	
   “independent	
   action”,	
   “dose	
  
additions”	
  and	
  “synergistic	
  action”	
  still	
  need	
  to	
  be	
  understood	
  at	
  
the	
  population	
  level.	
  At	
  the	
  level	
  of	
  communities,	
  an	
  additional	
  
concept	
  of	
  “synergism”	
  is	
  also	
  possible.	
  It	
  requires	
  an	
  approach	
  
based	
  on	
  the	
  understanding	
  of	
  ecology,	
  of	
  interactions	
  between	
  
species	
   and	
   their	
   environment,	
   and	
   of	
   indirect	
   effects.	
  
Consequently	
   there	
   is	
   a	
   need	
   for	
   improving	
   the	
   current	
  
knowledge	
  and	
  methodologies	
  for	
  the	
  ecological	
  risk	
  assessment	
  
of	
  chemical	
  substances	
  under	
  realistic	
  conditions.	
  
	
  
What are the major knowledge gaps?
One	
   major	
   gap	
   is	
   the	
   lack	
   of	
   knowledge	
   on	
   where,	
   how	
   often	
  
and	
  to	
  what	
  extent	
  humans	
  and	
  the	
  environment	
  are	
  exposed	
  to	
  
certain	
  chemical	
  mixtures	
  and	
  how	
  exposure	
  may	
  change	
  over	
  a	
  
person’s	
  lifetime.	
  	
  
For	
  many	
  chemical	
  substances,	
  there	
  is	
  no	
  good	
  information	
  on	
  
mode	
  of	
  action.	
  Interactions	
  of	
  chemical	
  substances	
  in	
  mixtures	
  
are	
   also	
   difficult	
   to	
   foresee,	
   particularly	
   for	
   long-­‐term	
   effects.	
  
Research	
   is	
   needed	
   to	
   define	
   criteria	
   that	
   could	
   predict	
  
potentiation	
  or	
  synergy.	
  
In	
   ecotoxicology,	
   the	
   problem	
   is	
   even	
   more	
   complex.	
   A	
  
knowledge	
  of	
  all	
  possible	
  modes	
  of	
  action	
  in	
  complex	
  biological	
  
communities	
   is	
   difficult	
   (if	
   not	
   impossible)	
   to	
   be	
   attained	
   and	
  
ecologically	
  relevant	
  endpoints	
  are	
  generally	
  broader	
  and	
  not	
  so	
  
specific (e.g.	
   toxicity	
   on	
   specific	
   organs,	
   etc.)	
   as	
   in	
   human	
  
toxicology.	
  
	
  	
  
You	
  can	
  find	
  this	
  summary,	
  along	
  with	
  a	
  more	
  detailed	
  one	
  
on	
  the	
  GreenFacts	
  website	
  at:	
  
http://www.greenfacts.org/en/chemical-­‐
mixtures/index.htm	
  
The	
  source	
  document	
  for	
  this	
  summary	
  can	
  be	
  found	
  on	
  the	
  
Europa	
  website:	
  	
  
http://ec.europa.eu/health/scientific_committees/all_opini
ons/index_en.htm	
  
	
  

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Exposure to mixture (“cocktails”) of chemical substances: are the health and environmental risks adequately evaluated?

  • 1. Chemical  Mixtures   1   This is a summary of an “Opinion on Toxicity and Assessment of Chemical Mixtures” expressed by the three independent non-food Scientific Committees of the EU Commission SCCS, SCHER and SCENHIR.   Exposure to mixture (“cocktails”) of chemical substances: are the health and environmental risks adequately evaluated? Introduction There   is   increasing   concern   in   the   general   public   about   the   potential   toxic   effects   of   chemical   substance   mixtures   (in   the   media  often  referred  to  as  “cocktail-­‐effects”).   Humans   and   ecosystems   are   indeed   continually   exposed   to   a   very  complex  mixture  of  chemical  substances,  the  composition   of  which  is  always  changing.  However,  in  the  great  majority  of   risk  assessments,  only  a  single  chemical  is  considered  and  there   are   no   generally   applicable   guidelines   as   to   when   and   how   assessment   of   combinations   of   chemical   substances   should   be   carried  out. Are there combined effects of exposure to chemical mixtures? Two  cases  should  be  considered  :     1.1.  Substances  that  have  a  similar  mode  of  action   When  substances  have  a  similar  mode  of  action  –  which  means   that  their  adverse  effects  are  cause  by  similar  chain  of  events  –,   their   concentration   can   be   added   together   to   predict   their   combined   effect.   The   additivity   of   doses   is   assumed   over   the   entire  range  of  concentrations,  including  those  below  the  level   at  which  each  substance  has  no  observed  effect.  In  some  rare   specific  cases,  antagonistic  (lower  than  the  sum  of  the  parts)  or   synergistic  (greater  than  the  sum  of  the  parts)  effects  have  been   observed,   but   in   general,   dose   addition   is   a   reasonable   conservative  (protective)  default  approach.     1.2.  Substances  that  have  different  modes  of  action   With   mixtures   composed   of   chemical   substances   with   various   modes   of   action,   there   is   good   evidence   that   the   effects   are   higher  than  those  of  the  individual  components.  At  present,  the   safety   margins   that   are   used   in   risk   assessment   of   single   chemical  substances  could  be  insufficient  to  allow  room  for  the   effects  for  all  possible  realistic  mixtures.   However,   the   Opinion   of   the   Scientific   Committees   is   that,   for   chemical  substances  that  act  independently,  no  robust  evidence   is  available  and  it  is  very  unlikely  that  exposure  to  a  mixture  of   such  substances  is  of  health  concern  if  the  individual  chemical   substances  are  present  at  or  below  their  no  effect  levels.     If   the   mode   of   action   is   not   known,   as   is   the   case   for   many   substances,  the  dose/concentration  addition  method  should  be   preferred  over  the  independent  action  approach.     Should there be more specific assessment of risks for chemical mixtures?   Specific  mixture  risk  assessment  is  indeed  necessary,  in  order  to   avoid   underestimations   of   risks   that   might   occur   under   the   classical   current   approach   that   takes   each   chemical   substance   separately.   Except   for   mixtures   composed   of   chemical   substances   with   a   similar   mode   of   action,   current   evidence   does   not   show   significant  mixture  toxicity  at  exposures  at  or  below  zero-­‐effect   levels  of  the  individual  components.     Endocrine  disrupting  chemical  substances  (specifically  those  that   are  affecting  sex  hormones)  are  often  mentioned  in  the  context   of   chemical   mixtures,   since   they   have   effects   at   relatively   low   concentrations,   although   larger   than   the   concentration   of   the   hormones  that  they  are  affecting.  Since  concentrations  that  are   found  in  people  are  very  low,  it  is  unlikely  that  there  is  an  effect   of  chemical  mixtures  on  these  hormones.   What are the effects of chemical substances mixtures on the environment? The   general   principles   of   the   risk   assessment   of   chemical   substances   mixtures   is   also   applicable   in   the   context   of   environmental   toxicology,   for   predicting   effects   at   population   level,   although   the   concepts   of     “independent   action”,   “dose   additions”  and  “synergistic  action”  still  need  to  be  understood  at   the  population  level.  At  the  level  of  communities,  an  additional   concept  of  “synergism”  is  also  possible.  It  requires  an  approach   based  on  the  understanding  of  ecology,  of  interactions  between   species   and   their   environment,   and   of   indirect   effects.   Consequently   there   is   a   need   for   improving   the   current   knowledge  and  methodologies  for  the  ecological  risk  assessment   of  chemical  substances  under  realistic  conditions.     What are the major knowledge gaps? One   major   gap   is   the   lack   of   knowledge   on   where,   how   often   and  to  what  extent  humans  and  the  environment  are  exposed  to   certain  chemical  mixtures  and  how  exposure  may  change  over  a   person’s  lifetime.     For  many  chemical  substances,  there  is  no  good  information  on   mode  of  action.  Interactions  of  chemical  substances  in  mixtures   are   also   difficult   to   foresee,   particularly   for   long-­‐term   effects.   Research   is   needed   to   define   criteria   that   could   predict   potentiation  or  synergy.   In   ecotoxicology,   the   problem   is   even   more   complex.   A   knowledge  of  all  possible  modes  of  action  in  complex  biological   communities   is   difficult   (if   not   impossible)   to   be   attained   and   ecologically  relevant  endpoints  are  generally  broader  and  not  so   specific (e.g.   toxicity   on   specific   organs,   etc.)   as   in   human   toxicology.       You  can  find  this  summary,  along  with  a  more  detailed  one   on  the  GreenFacts  website  at:   http://www.greenfacts.org/en/chemical-­‐ mixtures/index.htm   The  source  document  for  this  summary  can  be  found  on  the   Europa  website:     http://ec.europa.eu/health/scientific_committees/all_opini ons/index_en.htm