COMMUNICATION FROM THE COMMISSION TO THE COUNCIL The combination effects of chemicals Chemical mixtures
Date: 2012-05-31
Institutions: European Commission
Subjects: chemical product, environmental protection, health control, toxic substance

EUROPEAN COMMISSION 

Brussels, 31.5.2012  
COM(2012) 252 final 

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL 

The combination effects of chemicals 

Chemical mixtures 

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COMMUNICATION FROM THE COMMISSION TO THE COUNCIL 

The combination effects of chemicals 

Chemical mixtures 

1. 

INTRODUCTION 

In recent years there has been an increasing focus on the effects on human health and on the 
environment arising from exposure to many different chemicals. These effects are variously 
referred  to  as  combination  effects,  mixture  effects  or  cocktail  effects.  The  European 
Parliament has consistently drawn attention to the need to take account, in the context of EU 
chemicals' legislation, of the combined effects of different chemicals on human health and the 
environment. On 22nd December 2009, the Council, based in part on concerns arising from the 
Danish  toddler  study  (Box  1),  adopted  a  set  of  conclusions  on  the  "combination  effects  of 
chemicals"1. 

Box 1. Mixtures to which human populations are exposed 

In  2009,  The  Danish  authorities  published  the  results  of  a  study2  in  which  the  exposure  of 
toddlers  (2  year  old  children)  to  chemical  mixtures  in  the  form  of  multiple  endocrine 
disruptors  from  several  sources  were  examined.  The  study  examined  exposure  through  the 
food  chain,  through  indoor  air  and  dust,  through  clothes  and  shoes,  through  contact  with 
toys, through the application of health care and hygiene products and through contact with 
articles such as changing mats and bath mats. On the basis of the predicted concentration of 
the various substances the study concluded that there was a need to reduce exposure to anti-
androgen and oestrogen substances from food, indoor air and consumer products. 

The  Council  in  particular,  invited  the  Commission,  "…  to  assess  how  and  whether  relevant 
existing  Community  legislation  adequately  addresses  risks  from  exposure  to  multiple 
chemicals  from  different  sources  and  pathways,  and  on  this  basis  to  consider  appropriate 
modifications,  guidelines  and  assessment  methods,  and  report  back  to  the  Council  by  early 
2012 at the latest."  

The purpose of the present Communication is to respond formally to the invitation from the 
Council  and  in  particular  to  assess  whether  the  current  EU  legislation  which  is  built 
predominantly on the assessment of single substances and single sources, guarantees the high 
level of protection required by the Treaty. The challenge of dealing with chemical mixtures 
will also be taken-up in the context of preparing the future priorities for environmental policy. 

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Council  conclusions  on  combination  effects  of  chemicals.  2988th  Environment  Council  meeting 
Brussels, 22 December 2009. 
Survey  and  Health  Assessment  of  the  exposure  of  2  year  olds  to  chemical  substances  in  consumer 
products. Danish Ministry of the Environment, Environment Protection Agency, (2009) 

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Actions  taken  to  reduce  exposure  to  potentially  harmful  chemical  mixtures  will  also 
contribute to the achievement of the objectives in the Health for Growth programme3 

The  present  document  draws  heavily  upon  the  joint  opinion  of  three  scientific  Committees4 
(hereinafter "the Scientific Committees") and also takes into account a major study "State of 
the Art Report on Mixture Toxicity" financed by the Commission5 . 

2. 

MIXTURES

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 IN THE CONTEXT OF EU CHEMICALS LEGISLATION 

In the EU as in other parts of the world, chemicals' legislation  is built on the foundation of 
assessments carried out on individual chemical substances. These assessments are frequently 
used  as  the  basis  for  decisions  related  directly  to  the  individual  substances.  However,  in 
addition  to  the  rules  governing  the  assessment  and  management  of  individual  substances, 
there is also an extensive body of EU legislation dealing with various types of mixtures. 

2.1 Intentional Mixtures 

In  the  case  of  intentional  mixtures,  the  composition  of  the  mixtures  is  well  known  and  the 
assessments are based on the properties of the constituents supplemented, where appropriate, 
by tests carried out on the entire product. Examples of this type of legislation include rules for 
the  classification,  labelling  and  packaging  of  mixtures7,  rules  for  the  authorisation  of  plant 
protection products8, the rules governing the composition of cosmetics9, rules governing the 
approval  of  medicinal  products  for  human  use10  and  rules  governing  the  approval  of 
veterinary medicinal products11. 

2.2 Mixtures originating from a single source. 

Discharges  to  the  environment  during  the  production,  transport,  use  or  disposal  of  goods, 
often  contain  a  mixture  of  chemical  substances.  Where  the  composition  is  known  or  the 
components  can  be  identified  by  analytical  methods,  assessments  can  be  made  based  on 

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Proposal for a Regulation of the European Parliament and of the Council on establishing a Health for 
Growth Prpgramme, the third multi-annual programme of EU action in the field of health for the period 
2014-2020. COM(2011) 709 final. 
Toxicity  and  Assessment  of  Chemical  Mixtures.  Scientific  Committee  on  Health  and  Environmental 
Risks  (SCHER),  Scientific  Committee  on  Emerging  and  Newly  Identified  Health  Risks  (SCENHIR) 
and Scientific Committee on Consumer Safety (SCCS). Joint Opinion adopted on 14th December 2011. 
http://ec.europa.eu/health/scientific_committees/environmental_risks/opinions/index_en.htm 
Web 
http://ec.europa.eu/environment/chemicals/effects.htm 
The  terms  "chemical  mixtures",  "chemical  cocktails"  and  the  "combination  effects  of  chemicals"  are 
often  used  interchangeably.  For  reasons  of  clarity,  the  term  "chemical  mixtures"  will  be  used  in  the 
present document. 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures. OJ L 353, 31.12.2008, p. 1. 
Regulation  EC  No  1107/2009  of  the  European  Parliament  and  of  the  Council  of  21  October  2009 
concerning the placing of plant protection products on the market. OJ L 309, 24.11.2009, p. 1. 
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30th November 2009 
on cosmetic products. OJ L 342, 22.12.2009, p. 59. 
Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community code relating to medicinal products for human use. OJ L 311, 28.11.2001, p. 67 
Directive  2001/82/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community code relating to veterinary medicinal products. OJ L 311, 28.11.2001, p. 1 

Commission. 

European 

the 

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knowledge of the constituents. Where the composition is unknown an assessment would need 
to  be  based  on  tests  carried  out  on  the  whole  mixture.  There  are  very  few  examples  of  EU 
legislation  specifically  requiring  the  assessment  or  testing  of  whole  mixtures.  However,  the 
requirement set down in the Water Framework Directive12 for water bodies to achieve good 
ecological status as well as good chemical status entails a focus not only on the concentrations 
of individual chemicals but also on their effects in combination.  

2.3 Mixture of Chemicals originating from multiple sources and through multiple pathways. 

In relation to the assessment of multiple substances from multiple sources, which represents 
the  main  focus  of  the  concern  raised  by  the  Council,  there  are  only  a  limited  number  of 
examples  in  EU  legislation.  In  the  context  of  REACH13  guidance  has  been  developed 
concerning  the  assessment  of  multiple  sources  of  exposure  to  a  single  substance  and  in 
specific cases to the assessment of several closely related and similarly acting substances (e.g. 
different  salts  of  the  same  metal  or  a  number  of  closely  related  derivatives  of  organic 
substances14.  In  the  workplace,  employers  are  required  to  carry  out  an  assessment  of 
hazardous chemicals including an obligation to assess the risks presented by all such chemical 
agents  in  combination15  In  relation  to  the  establishment  of  maximum  levels  for  pesticide 
residues  in,  or  on,  food  and  feed  of  plant  and  animal  origin16  the  panel  on  Plant  Protection 
Products  of  the  European  Food  Safety  Authority  (EFSA),  developed  approaches  for  taking 
account of cumulative and synergistic effects when setting maximum residue levels (MRLs) 
for  pesticides  with  similar  modes  of  action17.  EFSA  is  also  developing  methodology  for 
pesticides with a dissimilar mode of action for occupational exposure18 

2.4 Conclusion 

In conclusion, where chemical mixtures are assessed and regulated under EU legislation this 
is  predominantly  in  relation  to  chemical  products  of  known  composition.  Some  complex 
mixtures  discharged/emitted  to  the  environment  from  a  single  source  (factory,  facility,  etc), 
are  also  subject  to  controls.  There  are  a  few  examples  of  assessments  and  controls  being 
carried  out  in  relation  to  several  substances  originating  from  different  sources  and  through 
different pathways but these are limited in their scope. Currently, within the framework of EU 
legislation, there is no mechanism for a systematic, comprehensive and integrated assessment 
of mixture effects taking into account different routes of exposure and different product types. 
Thus the recent study carried out in Denmark (see Box 1) highlighting the concerns associated 
with the exposure of toddlers to different endocrine disruptors could not, at present, trigger a 
comprehensive assessment within the context of EU legislation. 

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Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000, establishing a 
framework for Community action in the field of water policy. OJ L 327, 22.12.2000, p. 1. 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18th December 2006 
concerning the Registration, Authorisation and Restriction of Chemicals-REACH. OJ L 136, 29.5.2007, 
p. 1. 
http://echa.europa.eu/documents/10162/13632/information_requirements_part_e_en.pdf 
Council Directive 98/24/EC of 7th April 1998 on the protection of the health of workers from the risks 
related to chemical agents at work. OJ. L131, 5.5.1998, p11 
Regulation (EC) No 396/2005. OJ. L70, 16.5.2005, p1 
EFSA Journal 2008; 704: 1-85 http://www.efsa.europa.eu/en/efsajournal/doc/705.pdf and EFSA Journal 
2009; 7: 1167. http://www.efsa.europa.eu/en/efsajournal/pub/1167.htm 
http:www.efsa.europa.eu/en/supporting/pub/232e.htm 

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3. 

CAN  EXPOSURE  TO  SMALL  CONCENTRATIONS  OF  DIFFERENT  SUBSTANCES  HAVE 
NEGATIVE EFFECTS? 

We have seen in section 2 that there exists a very extensive corpus of legislation designed to 
ensure that the concentrations of chemical substances to which human beings or animals and 
plants,  are  exposed  are  within  safe  limits.  On  condition  that  the  legal  requirements  are 
respected,  this  means  that  although  we  (also  animals  and  plants)  are  exposed  to  small 
concentrations of many different chemicals none of these chemicals should be present above 
their individual safe limits. This being the case and in order to respond to concerns expressed 
by  the  Council,  we  need  to  examine  whether  or  not  a  mixture  of  chemical  substances, 
originating  from  different  sources  and  through  different  pathways,  in  which  each  of  the 
substances is present at very low concentrations , could have negative effects on human health 
or the environment.  

The  Scientific  Committees  indicated  that,  under  certain  conditions,  chemicals  present  in  a 
mixture will act jointly in a way that the overall level of toxicity is influenced. In particular, 
chemicals with common modes of action19 may act jointly to produce combination effects that 
are larger than the effects of each of the mixture components applied singly. However, in the 
case  of  substances  with  different  modes  of  action  (independently  acting20.),  the  Scientific 
Committees concluded that there is no robust evidence available to indicate that exposure to a 
mixture  of  such  chemicals  is  of  health  concern  if  the  individual  chemicals  are  present  at  or 
below  their  zero  effect  levels.  As  to  whether  the  possibility  of  exposure  to  mixtures  of 
chemical  substances  is  a  potential  cause  for  concern  (in  relation  to  human  health),  the 
Scientific Committees concluded that " if the intended level of protection is achieved for each 
individual  substance,  the  level  of  concern  for  mixtures  of  dissimilarly  acting  substances 
should be assumed to be negligible". 

However,  in  relation  to  ecological  effects,  the  situation  is  less  clear  and  the  Scientific 
Committees  concluded  that  "In  summary,  for  ecological  effects,  the  exposure  to  mixtures  of 
dissimilarly  acting  substances  at  low,  but  potentially  relevant  concentrations  should  be 
considered  as  a  possible  concern,  even  if  all  substances  are  below  the  individual  Predicted 
No Effects Concentrations (PNECs). Consequently there is a need for improving the current 
knowledge  and  methodologies,  and  developing  holistic  approaches  for  the  ecological  risk 
assessment of chemicals under realistic conditions." 

4. 

THE SCIENTIFIC CHALLENGE 

4.1. 

Identifying priorities 

As  indicated  in  the  previous  section,  exposure  to  mixtures  of  chemicals  even  when  these 
chemicals are present at low (real-world) concentrations may give rise to concerns. However, 
the  number  of  potential  combinations  of  the  tens  of  thousands  of  substances  currently  in 

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According to the Scientific Committees a Mode Of action is a plausible hypothesis about measurable 
key events by which a chemical exerts its biological effects. A common mode of action is defined by 
EFSA as "involving the same key events leading to an adverse health effect following interaction of the 
compound with its biological target[s] 
According  to  the  Scientific  Committees,  Independent  Action  occurs  where  the  modes  of  action  and 
possibly,  but  not  necessarily,  the  nature  and  sites  of  toxic  effects  differ  between  the  chemicals  in  a 
mixture and one chemical does not influence the toxicity of another. 

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commerce is astronomical and the attention of the risk assessors should be focussed on those 
situations where the potential for negative impacts is highest. The Scientific Committees have 
provided clear indications concerning the criteria and methodologies that could be applied to 
identify chemical combinations/mixtures that are priorities for further assessment (see Box 2). 

Box 2. Extract from detailed recommendations of the Scientific Committees in relation 
to setting priorities 

In view of the almost infinite number of possible combinations of chemicals to which humans 
and environmental species are exposed some form of initial filter to allow a focus on mixtures 
of potential concern is necessary. The following criteria are proposed for consideration: 

1) Human and/or environmental exposure at significant levels. 

2)  Chemicals  that  are  produced  and/or  marketed  as  multi-constituent  substances  or 
commercial mixtures with several components and/or active ingredients and/or substances of 
concern. 

3) Potential serious adverse effects of one or more chemicals at the likely exposure levels. 

4) Likelihood of frequent or large scale exposure of the human population or the environment. 

5) Persistence of chemicals in the body and/or in the environment. 

6) Known information of potential interaction at levels of human and environmental exposure. 

7) Predictive information that chemicals act similarly. 

8)  Particular  attention  should  be  paid  to  mixtures  for  which  one  or  more  components  are 
assumed to have no threshold for its effects. 

4.2. 

The scientific assessment of chemical combinations/mixtures 

When  a  particular  chemical  mixture  is  identified  as  a  priority  for  further  assessment  the 
Scientific  Committees  has  also  provided  detailed  advice  concerning  the  methods  that  are 
currently  available  for  assessing/predicting  the  toxicity  of  such  chemical  mixtures  (see  Box 
3).  

Box 3. Extract from detailed recommendation from the Scientific Committees in relation 
to assessment 

In view of the huge variety of human exposures to chemical mixtures, the default assumption 
in human risk assessment had been that the chemicals generally acted by dissimilar modes of 
action. In cases, however, where information is available to indicate a similar mode of action, 
a  dose/concentration  addition  approach  is  appropriate.  A  dose/concentration  addition 
approach,  if  applied  to  chemical  mixture  components  with  unknown  modes  of  action,  may 
result in an over-prediction of toxicity; using the independent action approach may however 
underestimate 
the 
dose/concentration  addition  approach  is  also  preferable  to  ensure  an  adequate  level  of 
protection. 

the  case  of  unknown  modes  of  action, 

toxicity.  Therefore, 

in 

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In  ecotoxicology,  any  approach  should  be  referred  to  specific  endpoints  and  to  defined 
taxonomic groups of organisms. […]A significant limitation of component-based approaches 
is that they are only applicable to mixtures of which the major components are known.  

4.3. 

Knowledge/Data gaps 

While  providing  extensive  guidance  regarding  the  identification  of  chemical  mixtures  of 
highest concern and the methodologies for assessing such mixtures, the Committees also drew 
attention to the many data and knowledge gaps that impede a more systematic and effective 
application of these methodologies (see Box 4). 

Box  4.  Extract  from  detailed  Recommendations  from  the  Scientific  Committees  in 
relation to knowledge gaps 

With  regard  to  the  assessment  of  chemical  mixtures  a  major  knowledge  gap  at  the  present 
time  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 
time. There is a need to better understand human and environmental exposures, both through 
the use of monitoring and modeling. 

For  many  chemicals,  there  is  no  good  information  on  mode  of  action.  Currently  there  is 
neither  an  agreed  inventory  of  modes  of  action,  nor  a  defined  set  of  criteria  on  how  to 
characterise or predict a mode of action for data-poor chemicals or how to group chemicals 
into assessment groups. 

Interactions21  of  chemicals  in  mixtures  are  difficult  to  foresee,  particularly  for  long-term 
effects. Research is needed to define criteria that predict potentiation or synergy.  

In  ecotoxicology,  the  problem  is  even  more  complex.  A  knowledge  of  all  possible  modes  of 
action that may occur in the different types of organisms of a complex biological community 
is  difficult  (if  not  impossible)  to  be  attained.  On  the  other  hand,  it  must  be  considered  that 
ecologically  relevant  endpoints  are  generally  broader  and  not  so  specific  (e.g.  toxicity  on 
specific organs, etc.) as in human toxicology. A full review of the literature should be made to 
prepare a state-of-the-art on mixtures biodegradation modelling. 

The  Committees  also  indicated  that  "the  REACH  Regulation  is  generating  the  largest 
database on chemicals in history and that this information could be used to reduce some of 
the current uncertainties………" 

4.4. 

Can  the  assessment  of  chemical  mixtures  be  carried  out  in  a  more  systematic 
way in the context of EU legislation? 

On the basis of the opinion from the Scientific Committees it appears that having identified a 
particular chemical mixture as a priority for further assessment, the scientific methodology is 
available for carrying out such assessments although there are currently many knowledge/data 
gaps  that  might  act  as  a  barrier  to  actually  applying  these  methods.  The  question  therefore 
remains as to whether the current state of knowledge is sufficiently robust to support a more 

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The Scientific Committees indicated that the term interaction describes the combined effect of two or 
more chemicals when it is stronger (synergistic, potentiating or supra-additive) or weaker (antagonistic, 
inhibitive, sub-additive) than would be expected on the basis of dose/concentration addition. 

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systematic  assessment  of  chemical  mixtures  in  the  context  of  EU  legislation.  The  Scientific 
Committees also provided clear recommendations with regard to this matter (see Box 5). 

Box 5. Extract from the Recommendation of the Scientific Committee in relation to the 
possibility to undertake assessment of mixtures in a more systematic way in the context 
of EU legislation 

In  many  cases,  knowledge  is  insufficient  for  a  robust  scientific  analysis.  If  toxicologically 
significant  interactions  can  be  excluded,  the  components  of  a  mixture  are  identified  and 
known mode of action information is available, either a dose addition or independent action 
model  should  be  applied.  This  set  of  information,  in  human  toxicology,  is,  however,  rarely 
available and, in most cases, very cost- and labour-intensive to generate. 

In ecotoxicology, the mode of action should be known for all the relevant taxonomic groups of 
aquatic and terrestrial ecosystems. Thus, the availability of information is even more limited; 
in addition, modes of actions considered dissimilar at the individual level may affect the same 
population  relevant  endpoint,  and  therefore,  the  dose/concentration  addition  model  may  be 
more appropriate for predicting effects at the population level. 

In  order  to  prioritize  chemical  mixtures  for  possible  assessment  it  is  first  necessary  to 
consider whether there is significant human or environmental exposure to the mixture or its 
components.  Unless  there  are  indications  of  a  significant  interaction,  a  dose/concentration 
addition model could be used if the components of the  mixture exert their biological  effects 
via  an  identical  or  similar  mode/mechanism  of  action.  If  the  mixture  components  act 
dissimilarly,  the  independent  action  model  would  be  applied.  It  further  appears  justifiable 
that  a  dose/concentration  addition  approach  should  be  used  as  default  approach  in  cases 
where neither mode of action nor dose-response information is available to ensure adequate 
conservatism in the assessment. 

In  addition  to  the  recommendations  referred  to  in  Box  5,  the  Scientific  Committees  also 
provided  a  decision  tree  that  could  be  applied  when  dealing  with  chemical  mixtures  (for 
further details see Scientific Committees' opinion). 

5. 

CONCLUSIONS  

5.1. 

In relation to the current situation 

(1) 

(2) 

Current  EU  legislation  does  not  provide  for  a  comprehensive  and  integrated 
assessment of cumulative effects of different chemicals taking into account different 
routes  of  exposure.  In  the  case  where  a  mixture  of  concern  is  identified  and  where 
such a mixture contains chemical substances regulated under different pieces of EU 
legislation,  no  mechanism  currently  exists  for  promoting  an  integrated  and  co-
ordinated assessment across the different pieces of legislation.  

In the case of chemicals with independent modes of action, the establishment of "safe 
levels"  based  on  the  assessment  of  individual  substances  appears,  in  relation  to 
human health, to provide a sufficient safeguard against possible negative effects from 
mixtures/combinations. 

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(3) 

(4) 

(5) 

(6) 

However,  where  chemicals  have  similar  modes  of  action  there  is  a  potential  for 
cumulative effects when such chemicals are present together in a mixture (even when 
the  concentration  of  each  substance  is  below  its  "safe  level")  and  then,  the 
concentration/dose addition approach is preferred in order to assure an adequate level 
of protection. 

In  relation  to  the  effects  on  wild  species  and  ecosystems,  the  situation  is  less  clear 
and the possibility  of  combination/mixture effects should be considered both in the 
case of independently acting chemicals as well as for chemicals with similar modes 
of action. 

Methodologies  for  the  identification  of  chemical  mixtures  of  potential  concern  as 
well  as  for  the  assessment  of  chemical  mixtures  are  available.  However,  there  are 
extensive  knowledge  and  data  gaps  (mainly  related  to  the  mode  of  action  and 
exposure  data)  that  limit  the  extent  to  which  mixtures  can  be  properly  assessed. 
Information  being  collected  in  the  context  of  EU  legislation,  in  particular  the 
REACH Regulation, will contribute to reducing current uncertainties. 

Notwithstanding the knowledge and data gaps it is possible to assess mixture toxicity 
in  a  more  systematic  manner  in  the  context  of  EU  legislation.  When  information 
regarding  the  mode  of  action  and  dose/response  is  not  available,  or  inconclusive,  a 
default  assumption  of  dose/concentration  addition  provides  a  higher  level  of 
protection  but  may  also  overestimate  negative  effects.  This  limitation  and  the 
additional costs it might imply shall be taken into account in the case where possible 
management measures are being considered 

(7) 

While not specifically addressed in the opinion from the Scientific Committees, the 
assessment  of  chemical  mixtures  must  be  carried  out  in  respect  of  the  principle  of 
reducing, refining and replacing testing on vertebrate animals. 

5.2. 

In terms of operational follow-up 

In the light of the above conclusions the Commission will: 

(1) 

(2) 

Establish an ad hoc working group of relevant services and associated Agencies and 
Authorities (EFSA, ECHA, EMEA and EEA) to strengthen co-ordination across the 
different  pieces  of  legislation  and  to  promote  the  integrated  assessment  of  priority 
mixtures,  taking  into  account  the  risks  of  human  and  environmental  exposure.  The 
ad-hoc  working  group  will  co-ordinate  the  work  of  bringing  together  the  data  and 
oversee the integrated assessment of priority mixtures. Any follow-up action would 
be  taken  in  the  frame  of  the  legislation  under  which  each  substance  is  currently 
regulated. 

Develop,  by  June  2014,  and  taking  account  of  the  opinion  of  the  Scientific 
Committees, technical guidelines to promote a consistent approach to the assessment 
of  priority  mixtures  across  the  different  pieces  of  EU  legislation.  Such  guidelines 
shall  not  replace  existing  rules  where  such  exist  nor  shall  they  impose  additional 
obligations or burdens on economic operators. The development of these guidelines 
will be co-ordinated by the ad-hoc working group referred to in point (1) above.  

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(3) 

Support  improved  understanding  of  the  chemical  mixtures  to  which  human 
populations and the natural environment are actually exposed by :  

(a) 

reviewing,  in  consultation  with  the  associated  Agencies,  the  monitoring  data 
which is currently collected under EU legislation or generated in the context of 
EU funded research projects22;  

(b)  promoting a more coherent approach to the generation, collection, storage and 
use  of  chemical  monitoring  data  in  relation  to  humans  and  the  environment, 
through  the  creation  of  a  platform  for  chemical  monitoring  data.  This  would 
help  identify  links  between  exposure  and  epidemiological  data  in  order  to 
explore potential biological effects and lead to improved health outcomes. 

(4) 

(5) 

(6) 

Examine  the  opportunities  for  addressing  some  of  the  other  knowledge  gaps,  in 
particular relating to (i) the mode of action of chemicals, (ii) grouping chemicals into 
categories  or  assessment  groups;  (iii)  predicting  interactions  and  (iv)  identifying 
chemical substances that are the main drivers of mixture toxicity. These actions may 
in part be supported through Horizon 2020, the future EU framework programme for 
research and innovation. 

Promote consistent and science-based approaches to the risk assessment of chemical 
mixtures at a global level by participating in relevant international activities This will 
help protect health and the environment as well as promoting the competitiveness of 
European industry. 

Publish  a  report  on  the  assessment  of  chemical  mixtures  by  the  end  of  June  2015, 
reviewing  the  progress  and  experience  associated  with  the  actions  identified  under 
points 1 to 5 above. 

In  carrying  out  the  actions  set  out  under  points  1-5  above  the  Commission  will  collaborate 
with the Member States and other stakeholders. The modalities of this collaboration will need 
to be defined and will, wherever possible, make use of existing structures. 

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Taking into account the actions of the European Environment and Health Action Plan {SEC(2004)729} 
/* COM/2004 416 final 

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