COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE FITNESS CHECK on endocrine disruptors of the COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Chemicals Strategy for Sustainability Towards a Toxic-Free Environment
Date: 2020-10-14
Institutions: Directorate-General for Environment, European Commission
Subjects: EU strategy, chemical product, chemicals legislation, endocrine disease, endocrine disruptor, environmental protection, product safety, public health, toxic substance

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   EUROPEAN COMMISSION  Brussels, 14.10.2020  SWD(2020) 225 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE FITNESS CHECK  on endocrine disruptors of the COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Chemicals Strategy for Sustainability     Towards a Toxic-Free Environment {COM(2020) 667 final} - {SWD(2020) 247 final} - {SWD(2020) 248 final} - {SWD(2020) 249 final} - {SWD(2020) 250 final} - {SWD(2020) 251 final}  
 
 
Endocrine disruptors are chemical substances of synthetic or natural origin that adversely affect the 
health  of  people  and  animals  by  altering  the  functioning  of  the  endocrine  system.  Exposure  to 
endocrine disruptors can occur from different sources, such  as food or everyday consumer products. 
Different  regulatory  approaches  to  managing  the  risks  posed  by  endocrine  disruptors  exist  because 
sector-specific  regulations  have  been  developed  at  different  points  in  time  and,  in  some  cases, 
incorporate different specific considerations. This raises questions about the overall coherence of the 
EU’s  legal  framework  on  endocrine  disruptors. The  fitness check  focussed  on  the  coherence  of  EU 
legislation in this area, and looked at whether the legislation is effective in delivering on its objective 
to  protect  human  health  and  the  environment  by  identifying  and  minimising  exposure  to  these 
chemicals. The other evaluation criteria (efficiency, EU value added and relevance) are also covered, 
but less extensively. 

Definition and horizontal approach to identifying endocrine disruptors   

The  definition  of  endocrine  disruptors  used  by  the  International  Programme  on  Chemical 
Safety/World Health Organisation (IPCS/WHO) is broadly accepted in EU legislation. It provides the 
basis  for  the  criteria  used  to  identify  endocrine  disruptors  under  the  Plant  Protection  Products 
Regulation  and  Biocidal  Products  Regulation.  The  IPCS/WHO  definition  is  also  used  to  identify 
substances  of  very  high  concern  for  human  health  and/or  the  environment  due  to  their  endocrine 
disrupting properties under the legislation on the registration, evaluation, authorisation and restriction 
of chemicals (REACH). 

Many  stakeholders  have  criticised  the  lack  of  a  horizontal  approach  to  identifying  endocrine 
disruptors.  Based  on  the  limited  number  of  substances  that  have  been  identified  as  endocrine 
disruptors  or  as  not  being  endocrine  disruptors,  the  fitness  check  could  find  no  evidence  of 
inconsistent  identification  across  the  legislation.  Nevertheless,  the  lack  of  a  unified  approach  to 
identifying  endocrine  disruptors  renders  decision-making  less  transparent  and  more  complex.  The 
criteria  for  identifying  them  under  the  Plant  Protection  Products  Regulation  and  Biocidal  Products 
Regulation may provide a starting point for a future cross-sectorial definition in EU legislation. 

Data requirements for identifying endocrine disruptors  

Overall, the findings of the fitness check show that there are differences in data requirements across 
different sectors. These reflect differing intended uses and exposure scenarios contributing to risk, as 
well  as  the  need to take  into  account proportionality with respect to socio-economic  and laboratory 
animal welfare considerations.   

The regulatory testing of chemicals relies predominantly on the use of OECD test guidelines which 
are not currently sufficient for addressing all the different ways in which the endocrine system might  
be  disrupted,  which  therefore  limits  the  ability  to  identify  endocrine  disruptors.  A  combination  of 
testing  methods  is  usually  required  to  generate  data  relevant  to  both  the  adverse  effect  and  the 
endocrine  activity,  and  which  can  then  be  used  to  identify  a  substance  as  an  endocrine  disruptor. 
However,  data  generated  by  so-called  ‘mechanistic’  tests,  which  can  determine  specific  endocrine 
activity,  are  currently  not  required  under  any  of  the  legislative  instruments  that  have  provisions  on 
data submission. This gap has been recognised and work is currently in progress to update the data 
requirements  under  the  Plant  Protection  Products  Regulation,  the  Biocidal  Products  Regulation  and 
REACH. The findings of the fitness check show that ready access to such data would also be helpful 
in other policy areas that have provisions for ensuring the safety of products placed on the EU market, 
but no specific data requirements.  

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Risk assessment and management 

One challenge for risk assessment is whether the effects of an endocrine disruptor are considered to 
have a threshold or not, and whether this can be established using current assessment methodology. In 
the  absence  of  scientific  consensus  on  the  threshold  question,  the  policy  options  for  managing 
endocrine  disruptors include  either  a  generic  approach  to risk  management  with  derogations  (as  for 
plant protection and biocidal products) or a case-by-case evaluation of whether a specific risk-based 
approach  can  be  applied,  as  done  under  REACH.  Certain  pieces  of  sectorial  legislation  (e.g.  for 
cosmetic  products  and  food  contact  materials)  lack  not  only  specific  provisions  for  assessing 
endocrine disruptors, but also specific guidance on how to deal with endocrine disruptors for which it 
is  not  possible  to  quantify  a  safe  (or  acceptable)  threshold.  In  practice,  in  cases  where  a  threshold 
cannot be established, the regulatory approach followed under EU legislation is to minimise exposure 
as far as possible, including the option to prohibit the use of a substance. 

There are only a few examples of risk assessments based on endocrine disrupting properties. In this 
limited number of cases, risks were identified following the standard risk assessment approach based 
on  exceedance  of  a  safe  threshold  for  endpoints,  which  were  not  necessarily  specific  to  endocrine 
disruption.  Regulatory  guidance  does  not  specify  how  potential  non-threshold  and  non-monotonic 
dose-response  properties  of  endocrine  disruptors  should  be  considered  in  a  risk  assessment,  except 
through the possible inclusion of additional uncertainty factors defined on a case-by-case basis. 

Across the EU's legislation on chemicals, the co-legislators have opted for different approaches to risk 
management,  depending  on  specific  policy  considerations  (generic  risk  approaches,  specific  risk 
approaches  or  risk/impact-benefit-based  approaches).  This  situation  has  been  criticised  by  many 
stakeholders,  who  expressed  concerns  that  differences  in  risk  management  measures  may  not  be 
justified.  Indeed,  the  rationale  for  some  of  the  differences  should  be  made  more  transparent  (e.g. 
possibilities  for  derogation  from  the  exclusion  criteria  for  biocidal  products  and  cut-off  criteria  for 
plant protection products). Despite differences in risk management approaches, however, this fitness 
check found no cases of inconsistent risk management for specific substances based on the lack of a 
horizontal  approach  to  identification  or  any  other  consideration  specific  to  endocrine  disrupting 
properties. This finding has to be qualified, however, by the limited number of endocrine disruptors 
risk managed due to their ED properties as examined in this Fitness Check. 

In  view  of  the  above  and  the  Commission’s  ambition  to  develop  a  'one  substance-one  assessment' 
process,  including  a  horizontal  approach  to  endocrine  disruptors,  consolidation  and  simplification 
options  should  be  explored,  as  should  better  communication  of  the  approach  to  the  public  and 
stakeholders.  Consolidation  would  also  provide  the  groundwork  for  systematically  assessing  and 
possibly managing the risks resulting from aggregate and combined exposures (mixtures) to different 
endocrine disruptors. A comprehensive framework for integrated exposure assessment would enable 
improved coordination of risk assessment and risk management measures across sectors.  

Many  sector-specific  and  product-specific  pieces  of  legislation  have  provisions  in  place  to  address 
risks posed by hazardous substances, but do not require the generation of toxicity data necessary to 
identify  the  hazard.  Some  pieces  of  sectorial  legislation  rely  primarily  on  REACH  for  identifying 
endocrine  disruptors  (e.g.  the  Medical  Devices  Regulation  and  the  Water  Framework  Directive), 
whereas others have further data requirements but do not yet specifically address endocrine disruption 
(such as the Food Contact Materials, Food Additives and Cosmetic Products Regulations). There may 
therefore be a need to strengthen the links between legislation that includes provisions for generating 

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data on substances, such as REACH, and sector- and product-specific legislation that relies on such 
data for risk management purposes. Possibilities for improved data sharing across legislation should 
also be explored. 

The findings of the fitness check suggest that differences in regulatory approaches between regulatory 
areas  have  had  an  impact  on  regulatory  efficiency,  particularly  in  cases  where  multiple  assessment 
and management procedures have focused on the same substances. The Commission and EU agencies 
working in this area have recognised the problem, and are increasing their efforts to coordinate across 
sectors. Additional efficiency gains could be obtained by further developing a horizontal approach to 
endocrine disruptors, including an increased  use of new methodologies and grouping approaches, in 
line with the objectives to minimise animal testing where possible. 

Protecting people and the environment  

The  EU's  strategic  approach  to  endocrine  disruptors  aims  to  ensure  a  high  level  of  protection  by 
minimising overall human and environmental exposure.  Increasing trends in some non-communicable 
diseases have been observed, and are suspected to be associated with exposure to endocrine disrupting 
substances.  However,  it  is  difficult  to  determine  to  what  extent  exposure  to  endocrine  disrupting 
substances  from  products  used  and  placed  on  the  EU  market  contributes  to  these  observed  adverse 
effects. Consequently, the fitness check could not draw conclusions on the effectiveness of legislation 
in  reducing  the  potential  impact  of  endocrine  disruptors  on  these  trends.  For  some  endocrine 
disruptors,  environmental  monitoring  data  and/or  human  biomonitoring  data  have  shown  that  the 
restriction measures put in place have been successful in  reducing releases into water bodies and/or 
people's  exposure,  respectively.  Information  on  substances  with  endocrine  disrupting  properties 
gathered  under  biomonitoring  programmes  will  be  essential  for  understanding  the  effectiveness  of 
control measures. Information on the levels of different substances in the body (including endocrine 
disruptors  and  mixtures  of  endocrine  disruptors)  may  also  be  useful  for  establishing  links  with 
biomarkers of effects related to endocrine system-related diseases.   

Vulnerable groups  

The critical role of hormones during sensitive life stages (such as embryonic development, puberty, 
pregnancy and menopause) means that foetuses, infants, adolescents, pregnant women and the elderly 
are  potentially  at  higher  risk  than  average  from  exposure  to  endocrine  disruptors.  Moreover,  early 
exposure during critical periods of development can affect health at a later stage of life. Since any age 
group, including the unborn, can be exposed to chemicals in consumer products, the default approach 
is  to  consider  all  ages  when  conducting  a  risk  assessment.  In  practice,  the  extent  to  which  this  is 
possible depends on the data available. It is therefore important that data requirements for assessing 
endocrine disruptors include methods that address sensitive life stages. Risks to vulnerable groups are 
currently  addressed  on  a  case-by-case  basis,  based  on  guidance  available  for  specific  legislative 
sectors.  This  indicates  that  there  is  an  opportunity  to  introduce  and  improve  the  consistency  of 
definitions  of  vulnerable  groups  across  legislation,  and  to  clarify  the  scientific  rationale  (degree  of 
exposure or biological susceptibility) for triggering specific provisions for vulnerable groups.  

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