COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Towards a comprehensive European Union framework on endocrine disruptors
Date: 2018-11-07
Institutions: European Commission, Secretariat-General
Subjects: EU law, EU policy, endocrine disease, endocrine disruptor, environmental protection, public health, research and development, scientific report, scientific research, single market

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 7.11.2018 COM(2018) 734 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Towards a comprehensive European Union framework on endocrine disruptors  
 
 
INTRODUCTION 

Endocrine  disruptors  are  chemical  substances  that  alter  the  functioning  of  the  endocrine 
system  and  negatively  affect  the  health  of  humans  and  animals.  They  may  either  be  of 
synthetic or natural origin. Exposure to endocrine disruptors can occur from different sources, 
such as residues of pesticides or consumer products used or present in our daily life. 

What is the endocrine system? 

The  endocrine  system  is  a  messenger  system  of  the  body.  It  uses  hormones,  signalling 
molecules  which  travel  through  the  bloodstream,  as  a  communication  tool  and  to  produce 
effects  on  distant  cells,  tissues  and  organs.  Hormones  are  essential  for  controlling  a  large 
number of processes in the body, from early ones such as embryonic development and organ 
formation, to the control of tissue and organ functions in adulthood. 
Concerns  about  endocrine  disruptors  have  been  growing  since  the  1990s1.  Following  the 
adoption  by  the  European  Parliament  of  a  Resolution  on  endocrine  disruptors  in  19982,  in 
December 1999 the Commission adopted the Community Strategy for endocrine disruptors3, 
which has been taken forward since then through action in the fields of research, regulation 
and international cooperation. 

Significant progress in understanding and regulating endocrine disruptors has been made, and 
the EU is today recognised as one of the global leaders in dealing with these chemicals. At the 
same time, societal concerns remain high.  

The Commission has always been and will remain committed to protect EU citizens and the 
environment  from  all  hazardous  chemicals.  In  this  context,  almost  twenty  years  after  the 
adoption of the Community Strategy of 1999, there is a need to update the EU approach on 
endocrine  disruptors  so  that  it  remains  state-of-the-art  and  continues  to  coherently  address 
these  substances  across  different  areas,  building  on  the  increased  knowledge,  the  achieved 
results  and  gained  experience.  To  this  end,  the  Commission  is  today  outlining  its  strategic 
approach  to  endocrine  disruptors  for  the  years  to  come,  with  the  ultimate  overall  goal  to 
ensure a high level of protection of EU citizens and the environment and, at the same time, to 
preserve  an  internal  market  which  delivers  for  consumers  and  where  all  EU  business  can 
thrive. 
This  Communication  addresses  the  requests  of  the  European  Parliament  and  the  Council4, 
follows up from the 7th Environment Action Programme5 and is framed by the international 
commitments to act on hazardous chemicals6. 

1  See  for  example  the  workshop  held  in  1996,  The  Impact  of  Endocrine  Disruptors  on  Human  Health  and 
Wildlife, co-supported by the European Commission. 
2 OJ C 341, 9.11.1998, p. 37. 
3 COM(1999) 706.  
4 See for example the European Parliament's resolutions of 14 March 2013 (P7_TA(2013)0091) and 8 June 2016 
(P8_TA(2016)0270)  and  the  Council  conclusions  on  the  protection  of  human  health  and  the  environment 
through the sound management of chemicals (19.12.2016). 
5 Decision No 1386/2013/EU of the European Parliament and of the Council of 20 November 2013 on a General 
Union Environment Action Programme to 2020 (OJ L 354, 28.12.2013, p. 171). 
6 See in particular: the United Nations’ 2030 Agenda for Sustainable Development (2015), the Parma declaration 
(2010)  and  the  Ostrava  declaration  (2017)  by  countries  in  the  European  Region  of  the  World  Health 
Organisation  (in  particular,  in  the  Parma  declaration,  endocrine  disruptors  were  listed  among  the  "key 
environment  and  health  challenges  of  our  time")  and  the  conclusions  of  the  third  and  fourth  sessions  of  the 
International Conference on Chemicals Management. 

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Section  1  describes  the  scientific  progress  made  on  endocrine  disruptors  in  the  past  twenty 
years.  Section  2  summarizes  the  actions  the  EU  has  taken  so  far  and  section  3  outlines  the 
Commission’s  proposed  approach  to  effectively  take  forward  the  EU's  policy  on  endocrine 
disruptors in the future. 

1. THE SCIENCE OF ENDOCRINE DISRUPTORS 

In  the  past  decades,  science  on  endocrine  disruption  has  advanced  significantly.  Many 
thousands of peer-reviewed scientific publications have become available since the adoption 
of  the  Community  Strategy  of  1999,  investigating  the  nature  of  endocrine  disruption,  its 
causes  and  its  consequences  for  human  health  and  wildlife  populations.  Progress  has  also 
been reported in publications by the European Commission, EU agencies, or in the context of 
activities co-ordinated by the Commission. 

Since 1999, the scientific evidence linking exposure to endocrine disruptors with human 
diseases  or  negative  impact  on  wildlife  has  become  stronger.  Furthermore,  scientific 
progress  has  brought  agreement  on  a  number  of  issues  which  are  relevant  to  understand 
endocrine disruption. There is now broad consensus on the definition provided in 2002 by the 
International  Programme on Chemical  Safety,  a joint programme  of various United Nations 
Agencies,  including  the  World  Health  Organisation,  whereby  an  endocrine  disruptor  is 
defined as "an exogenous substance or mixture that alters function(s) of the endocrine system 
and  consequently  causes  adverse  health  effects  in  an  intact  organism,  or  its  progeny,  or 
(sub)populations"7. 

Consensus also exists that the most sensitive window of exposure to endocrine disruptors is 
during important periods of development, such as foetal development and puberty8. Exposure 
to  endocrine  disruptors  during  these  periods  may  cause  permanent  effects  and  result  in 
increased susceptibility to diseases later in life. It is also generally recognised that endocrine 
disruptors can interfere with the endocrine system in different ways. So far, science has 
focused mainly on a limited number of endocrine modalities9. However, in recent years, it has 
been shown that other aspects of the endocrine system can be sensitive to endocrine disruptors 
as  well.  There  is  also  increasing  evidence  showing  that  endocrine  disruptors  can  work 
together to produce additive effects ("mixture effect", or "cocktail effect") so that exposure 
to a combination of endocrine disruptors may produce an adverse effect at concentrations at 
which  individually  no  effect  has  been  observed10  (even  if  this  effect  is  not  specific  to 
endocrine disruptors)11. 

However, knowledge gaps still exist. These relate in particular to: 

 

the  impact  that  exposure  to  endocrine  disruptors  has  on  the  development  of 
diseases and on wildlife. In this context, there is limited understanding of the specific 

7 International Programme on Chemical Safety (IPCS) (2002),  Global Assessment of the state-of-the-science of 
Endocrine Disruptors. 
8  United  Nations  Environment  Programme  (UNEP)  /  World  Health  Organization  (WHO)  (2012),  State  of  the 
science of endocrine disrupting chemicals. 
9 Oestrogen, androgen, thyroid hormone or steroidogenesis (EATS). 
10  UNEP  /  WHO  (2012).  See  also  for  example  Thrupp  TJ  et  al.  (2018),  The  consequences  of  exposure  to 
mixtures  of  chemicals:  Something  from  ‘nothing’  and  ‘a  lot  from  a  little’  when  fish  are  exposed  to  steroid 
hormones, Science of the total environment, volumes 619–620, 1 April 2018, pages 1482-1492. 
11 The European Food Safety Authority is preparing guidance on harmonised risk assessment methodologies for 
human  health,  animal  health  and  ecological  risk  assessment  of  combined  exposure  to  multiple  chemicals; 
European  Food  Safety  Authority  (EFSA)  (2013),  Scientific  Opinion  on  the  identification  of  pesticides  to  be 
included in cumulative assessment groups on the basis of their toxicological profile. 

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contribution  of  chemical  exposure  and  the  way  to  separate  it  from  other  possible 
causes of the negative impacts being investigated. Other factors are indeed also at play 
in  the  development  of  such  endocrine-related  disorders  (such  as  genetics,  nutrition, 
lifestyle, or other environmental factors) or impacts on wildlife (e.g. overexploitation, 
climate change); 
the  existing  controversy  as  to  whether  and  how  certain  toxicological  principles, 
such as the “safe threshold” principle – i.e. the dose below which no adverse effect 
is expected to occur – are applicable to assess the safety of endocrine disruptors12. 
A  share  of  scientists  is  of  the  view  that  a  safe  threshold  cannot  be  established  for 
endocrine disruptors;  
fully understanding combined exposure ("mixture/cocktail effect"); 
the  development  of  safer  alternatives  (including  non-chemical  approaches)  to 
substitute endocrine disruptors; 
the mechanism of endocrine disruption. 

 

 
 

 

Testing and the extent to which the science is able to inform regulators  

Another area where science has significantly progressed but needs to advance further is that 
related  to  the  development  and  validation  of  tests  methods.  Reliable  testing  is  indeed 
necessary  to  identify  endocrine  disruptors,  taking  account  of  the  different  ways  in  which 
endocrine disruptors can interfere with the endocrine system, and manage them appropriately. 
The  Organisation  for  Economic  Co-operation  and  Development  is  the  leading  recognised 
body  for  developing  internationally  agreed  test  guidelines13,  which  are  transposed  into 
relevant  EU  legislation  as  appropriate.  The  European  Food  Safety  Authority  looked  into 
existing test guidelines for endocrine disruptors in 2013. It concluded14 that a variety of tests 
were  (or  would  soon  be)  available  for  certain  endocrine  modalities  that  can  be  affected  by 
endocrine  disruptors15  in  mammals  and  fish,  with  fewer  tests  available  for  birds  and 
amphibians.  The  Authority  also  found  that:  tests  covering  other  aspects  of  the  endocrine 
system or other animal groups still needed to be developed and/or validated; that there are no 
suitable  predictive  models  for  some  endocrine-related  diseases  such  as  certain  hormonal 
cancers, or metabolic disorders/obesity and that no single study existed to assess the effects of 
exposure of mammals through the complete life cycle16.  

Furthermore, as in other fields of scientific research, also for endocrine disruptors there is the 
need to progress in the development of alternatives to animal testing: this would imply better 

12  Another  example  is  the  dose-response  relationship  for  endocrine  disruptors.  On  all  these  aspects,  see  in 
particular:  Joint  Research  Centre  (JRC)  (2013),  Key  scientific  issues  relevant  to  the  identification  and 
characterisation  of  endocrine  disrupting  substances  -  Report  of  the  Endocrine  Disrupters  Expert  Advisory 
Group; JRC (2013), Thresholds for Endocrine Disrupters and Related Uncertainties  - Report of the Endocrine 
Disrupters  Expert  Advisory  Group;  Beausoleil  et  al.  (2016),  Review  of  non-monotonic  dose-responses  of 
substances  for  human  risk  assessment;  Solecki  et  al.  (2017),  Scientific  principles  for  the  identification  of 
endocrine-disrupting chemicals: a consensus statement.  
13 The  test guidelines relevant  to endocrine disruptors are listed in the  Conceptual Framework  for Testing and 
Assessment of Endocrine Disrupters. 
14  EFSA  (2013),  Scientific  Opinion  on  the  hazard  assessment  of  endocrine  disruptors:  Scientific  criteria  for 
identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated 
by these substances on human health and the environment. 
15 Oestrogen, androgen, thyroid hormone or steroidogenesis (EATS).  
16  Scientific  guidance  exists  on  how  to  interpret  the  results  of  individual  tests  and  compile  all  the  available 
evidence  on  a  substance  to  evaluate  it  for  endocrine  disruption.  At  international  level,  the  reference  is  the 
document from OECD (2012), Guidance Document on Standardised Test Guidelines for Evaluating Chemicals 
for Endocrine Disruption. At EU level, specific guidance exists in the context of the different legal frameworks. 

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reliance  on  existing  data  (and  further  using  extrapolation  techniques17)  and  giving  more 
weight to mathematical modelling and new in vitro methods. 

2. EU POLICY AND REGULATION OF ENDOCRINE DISRUPTORS SO FAR 

Following  the  Community  Strategy  of  1999,  the  EU  has  developed  a  policy  response  to 
endocrine disruptors that is focused on promoting scientific research, effectively regulating 
endocrine disruptors and developing international cooperation in the field. 

EU research and development of test guidelines on endocrine disruptors 

Since 1999, the European Union's  Framework Programmes for  Research  and Technological 
Development  have  been  key  instruments  for  supporting  scientific  progress  in  the  field  of 
endocrine  disruptors.  Over  50  multinational  collaborative  projects  have  been  funded, 
receiving over €150 million from the EU. These projects aim to improve understanding of the 
endocrine mechanism of action, to identify adverse effects on human health and wildlife from 
exposure  to  endocrine  disruptors,  and  to  develop  tools  for  identification  of  endocrine 
disruptors and exposure assessment. A further €52 million has been allocated under Horizon 
2020 for projects on new testing methods for endocrine disruptors, to be attributed by the end 
of the year. 

In addition to research funded under Horizon 2020, a special effort was made in recent years 
to further improve the availability of test guidelines for identification of endocrine disruptors 
and address the testing weaknesses identified at EU and international level, under the auspices 
of the Organisation for Economic Co-operation and Development. More authoritative testing 
is an important way to improve the effectiveness of control. The European Commission has 
funded  several  activities  focusing  on  identifying  gaps  in  test  guidelines,  on  identifying 
possible  ways  to  fill  in  these  gaps,  on  setting  priorities  for  further  development  of  test 
guidelines, and on enhancing existing test guidelines or designing new ones18. 

How EU legislation addresses endocrine disruptors  

In parallel with scientific progress, in the past decades the EU has progressively updated its 
body  of  laws  regulating  chemicals,  with  the  aim  of  ensuring  a  high  level  of  protection  of  
human health, animal health and the environment, while ensuring the smooth functioning of 
the  internal  market.  EU  legislation  is  today  recognised  as  among  the  most  protective  in  the 
world  and  applies  to  all  chemical  substances,  including  those  with  endocrine  disrupting 
properties. 

The  EU  approach  is  based  on  high-level  scientific  advice  from  the  relevant  EU  risk 
assessment  bodies,  such  as  the  European  Chemicals  Agency,  the  European  Food  Safety 
Authority or the Scientific Committee on Consumer Safety, and  risk management decisions 
taken  by  the  Commission,  in  agreement  with  Member  States.  When  scientific  evaluation 
cannot  conclude  with  sufficient  certainty,  the  Commission  is  guided  by  the  so-called 
precautionary  principle  to  take  protective  measures  for  its  citizens  and  the  environment. 
Enforcement  of  legislation  is  carried  out  by  the  Member  States,  and  the  Commission 

17  One  example  is  "read-across",  which  allows  to  predict  information  for  one  substance  by  using  data  from 
another substance. 
18  Examples  include:  Setting  priorities  for  further  development  and  validation  of  test  methods  and  testing 
approaches for evaluating endocrine disruptors (2018); Development of a study protocol for thyroid disruptor 
testing in the mammalian system (to be finalised in 2019); Validation study to assess in vitro methods for thyroid 
disruptors (launched in 2017, ongoing). 

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facilitates  exchange  of  information  between  national  competent  authorities  to  improve  their 
enforcement activities19.  

Over recent years, the Commission has taken action against endocrine disruptors in line with 
the different requirements laid down in the relevant legislation. Specific provisions on how to 
address endocrine disruptors are now included in the legislation on pesticides20 and biocides21, 
chemicals  in  general  ("REACH  Regulation")22,  medical  devices23  and  water24.  These 
requirements  vary  depending  on  the  specific  legislation.  Other  legislation,  such  as  that  on 
food contact materials25, cosmetics26, toys27 or protecting workers at the workplace28, does not 
contain  specific  provisions  for  endocrine  disruptors.  However,  substances  with  endocrine 
disrupting properties are subject to case-by-case regulatory action on the basis of the general 
requirements of the legislation.    

Regulating endocrine disruptors: a few examples 

  The  Commission  has  recently  established  criteria  for  identifying  endocrine 
disruptors under the legislation on pesticides and biocides, based on the definition 
of  the  World  Health  Organisation29.  This  development  constitutes  a  milestone,  as 
criteria  to  identify  endocrine  disruptors  had  never  been  set  before  in  a  regulatory 
context.  In principle, no identified endocrine disruptor will be  allowed to be used in 
these  product  categories  in  the  future,  except  when  very  limited  derogation 
possibilities apply. 

  Under  REACH,  two  endocrine  disruptors  have  been  placed  in  the  list  of  substances 
requiring a specific authorisation to be placed on the market30. Another 13 substances 
have been identified as endocrine disruptors and are included in the Candidate list of 
substances  for  possible  inclusion  in  the  authorisation  list  in  the  future31.  Substances 

19 For example through the Rapid Alert System for dangerous non-food products. 
20 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). 
21 Biocides are used to control harmful organisms (examples are disinfectants)  - Regulation (EU) No 528/2012 
of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market 
and use of biocidal products (OJ L 167, 27.6.2012, p. 1). 
22  Regulation  (EC)  No  1907/2006  of  the  European  Parliament  and  of  the  Council  of  18  December  2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH)  (OJ  L  396, 
30.12.2006, p. 1). 
23 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices 
(OJ L 117, 5.5.2017, p. 1). 
24  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). 
25  Regulation  (EC)  No  1935/2004  of  the  European  Parliament  and  of  the  Council  of  27  October  2004  on 
materials and articles intended to come into contact with food (OJ L 338, 13.11.2004, p. 4). 
26  Regulation  (EC)  No  1223/2009  of  the  European  Parliament  and  of  the  Council  of  30  November  2009  on 
cosmetic products (OJ L 342 22.12.2009, p. 59). 
27 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ 
L 170, 30.6.2009, p.1). 
28  See  in  particular  Council  Directive  98/24/EC  of  7  April  1998  on  the  protection  of  the  health  and  safety  of 
workers from the risks related to chemical agents at work (OJ L 131, 5.5.1998, p. 11) and Directive 2004/37/EC 
of  the  European  Parliament  and  of  the  Council  of  29  April  2004  on  the  protection  of  workers  from  the  risks 
related to exposure to carcinogens or mutagens at work (OJ L 158, 30.4.2004, p. 50). 
29  Commission  Delegated  Regulation  (EU)  2017/2100  (OJ  L  301,  17.11.17,  p.1)  and  Commission  Regulation 
(EU) 2018/605 (OJ L 101, 20.4.2018, p. 33). 
30 The authorisation list of Annex XIV of REACH – substances concerned are for example certain phthalates, 
ethoxylates of nonylphenol and octylphenol. 
31 More information on the Candidate list is available on the website of the European Chemicals Agency. 

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with endocrine disrupting properties are also subject to restrictions32. For example, the 
Commission has recently obtained Member States' support33 on a proposal to forbid 
the presence of four phthalates – chemicals broadly used to make plastics softer34- in 
a variety of everyday products at levels of 0.1% or higher. Furthermore, more than 80 
chemical  substances  are  currently  being  evaluated  due  to  concerns  on  their  potential 
endocrine disrupting properties. 

  Under  the  legislation  on  water,  the  Commission  has  included  several  endocrine 
disruptors35 in the list of “priority substances” of particular concern36 for which 
environmental  quality  standards  and  emission  controls  apply.  Furthermore,  the 
Commission has included three endocrine disruptors in the "watch list" of substances 
for which Union-wide monitoring data should be gathered37. 

  Due to concerns of endocrine disruption, the chemical  bisphenol A is banned from 
use in baby bottles and other containers for foods for infants and young children, 
and very low migration limits are set for other food contact materials38. Bisphenol A is 
also subject to limit values in toys for young children under 36 months or intended to 
be placed in the mouth39 and paper used in receipts40. Very low limits for bisphenol A 
have also been set to protect workers from exposure through inhalable dust41.  
  Under  the  legislation  on  cosmetics,  specific  restrictions  or  bans  have  been  set  on  a 
number of preservatives with endocrine disrupting properties, in particular to protect 
infants and young children42. In addition, a substance used in sunscreens as a filter for 
ultraviolet  radiation  has  also  been  banned43  taking  into  account  in  particular  its 
potential endocrine disrupting properties.  

In order to realise the full potential of EU legislation that is relevant for endocrine disruptors, 
the Commission is currently working on actions in a number of areas. These include: 

  aiming to develop a horizontal approach for the identification of endocrine disruptors 
across EU legislation building on the criteria developed for pesticides and biocides;  
  updating  data  requirements  in  the  different  legislative  frameworks  to  improve 

identification of endocrine disruptors;   

32 See Annex XVII of REACH. 
33 The REACH  Committee, composed of experts from all  Member States,  supported the proposed measure by 
unanimity on 11 July 2018.  
34 Bis(2-ethylhexyl) phthalate, Benzyl butyl phthalate, Di-n-butylphthalate, Di-iso-butylphthalate. 
35 Such as brominated diphenylether, bis-(2-ethylhexyl) phthalate and tributyltin compounds. 
36  Last  updated  by  Directive  2013/39/EU  of  the  European  Parliament  and  of  the  Council  of  12  August  2013 
amending Directives 2000/60/EC and 2008/105/EC as regards priority substances in the field of water policy (OJ 
L 226, 24.8.2013, p. 1). 
37 Commission Implementing Decision (EU) 2018/840 (OJ L 141, 7.6.2018, p.9). The substances are:  17-alpha-
ethinylestradiol (EE2), 17-beta-estradiol (E2) and estrone (E1).  
38  Commission  Regulation  (EU)  No  10/2011  (OJ  L  12,  15.1.2011,  p.  1)  and  Commission  Regulation  (EU) 
2018/213 (OJ L 41, 14.2.2018, p. 6). 
39 Commission Directive (EU) 2017/898 (OJ L 138, 25.5.2017, p. 128). 
40 Commission Regulation (EU) 2016/2235 (OJ L 337, 13.12.2016, p. 3). 
41 Commission Directives 2009/161/EU (OJ L 338, 19.12.2009, p. 87) and (EU) 2017/164 (OJ L 27, 1.2.2017, p. 
115). The  latest review is based on the recommendation of 2014 of the Scientific Committee on Occupational 
Exposure Limits (SCOEL/SUM/113). 
42 Certain so-called "parabens", via Commission Regulation (EU) No 358/2014 (OJ L 107, 10.4.2014, p. 5) and 
Commission Regulation (EU) No 1004/2014 (OJ L 282, 26.9.2014, p. 5). 
43 3-Benzylidene Camphor  - Commission Regulation (EU) 2015/1298 (OJ L 199,  29.7.2015, p. 22), following 
the opinion of the Scientific Committee on Consumer Safety SCCS/1513/13. 

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  assessing how to improve the communication through the supply chain for endocrine 

disruptors under REACH in the context of the work on Safety Data Sheets44;   
taking  forward  the  scientific  assessment  of  endocrine  disruptors  in  order  to  take 
further regulatory action;  

 

  supporting data sharing and monitoring activities;  
  preparing guidance documents and reports;  
  and organising training for risk assessors and risk managers.  

Furthermore, a number of ongoing Commission initiatives currently being considered by the 
European  Parliament  and  Council,  or  in  the  process  of  being  implemented,  will  provide 
additional tools to deal with endocrine disruptors once fully in place. These include:  

 

 

 

 

the proposal for a Regulation on transparency and sustainability of risk assessment 
under  EU  food  law45,  which  aims  at  increasing  trust  in  the  regulatory  process, 
including for the assessment of substances suspected to be endocrine disruptors;  
the  European  Plastics  Strategy46,  which  aims  to  accelerate  the  substitution  of 
substances of concern, including endocrine disruptors, in order to promote recycling; 
the  proposal  to  revise  the  Drinking  Water  Directive47,  which  adds  three  endocrine 
disruptors48 to the list of parameters for determining the safety of drinking water; 
the  New  Deal  for  Consumers49  and  the  Goods  package50,  which  will  improve 
enforcement  of  product  safety  requirements  and  will  address  the  illegal  presence  of 
endocrine disruptors in a variety of products51;  

  and the update of the existing legal framework on  Occupational Safety and Health 
on  the  basis  of  robust  scientific  advice  to  protect  workers  exposed  to  hazardous 
chemicals, some of which have endocrine disrupting properties. 

International cooperation on endocrine disruptors 

The Commission and Member States actively participate to the work of the Organisation for 
Economic  Co-operation  and  Development,  thus  contributing  to  the  Organisation’s  efforts  in 
developing  internationally  agreed  test  guidelines  on  endocrine  disruptors  and  improving 
coordination on the international scene.   
The  Commission  and  Member  States  support  the  work  of  the  World  Health  Organisation52, 
the  Strategic  Approach  to  International  Chemicals  Management  and  the  United  Nations 
Environment Programme. The Commission and Member States also cooperate and exchange 

44  Safety  Data  Sheets  are  documents  provided  to  downstream  users  which  include  information  about  the 
properties of substances or mixtures. See the review of the REACH Regulation (COM(2018)116). 
45 COM(2018) 179.  
46 COM(2018) 28 and COM(2018) 32 – following up from the Circular Economy Action Plan COM(2015) 614. 
47 COM(2017) 753.  
48 Beta-estradiol; nonylphenol; bisphenol A. 
49 COM(2018) 183. 
50 In particular the Commission’s proposal for a Regulation on compliance with and enforcement of legislation 
(COM(2017) 795). 
51 A market surveillance exercise coordinated by the European Chemicals Agency's Enforcement Forum in 2018 
(Forum REF-4 Project Report - Harmonised Enforcement Project on Restrictions, ECHA-18-R-03-EN) revealed 
that 19.7% of the inspected toys and 3.6% of the inspected  childcare articles contained levels of phthalates not 
complying  with  the  legislation  (mainly  coming  from  outside  the  European  Economic  Area  or  of  unknown 
origin).  In  2017,  more  than  170  notifications  relating  to  non-compliant  products  as  regards  phthalates  were 
exchanged between Member States via the Rapid Alert System for dangerous non-food products.  
52  As  mentioned  before,  the  criteria  to  identify  endocrine  disruptors  under  the  legislation  on  pesticides  and 
biocides are based on the definition of the World Health Organisation. 

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information with international partners under the auspices of the World Trade Organisation as 
regards  EU  regulatory  developments  which  might  affect  trade53.  In  addition,  on  a  bilateral 
basis,  information  exchanges  have  taken  place  with  international  partners,  in  particular  the 
United States, Canada, Japan and recently also China. While having different approaches on 
how to deal with endocrine disruptors, all partners agree on the importance of addressing the 
matter as a priority54. Bilateral co-operation agreements with trade partners have also included 
setting up discussions on matters related to endocrine disruptors.  

3. TAKING FORWARD THE EU'S POLICY ON ENDOCRINE DISRUPTORS 

The  Commission  has  always  been  and  will  remain  committed  to  ensuring  a  high  level  of 
protection  of  EU  citizens  and  the  environment  from  endocrine  disruptors  and,  at  the  same 
time, to preserve an internal market which delivers for consumers and where all EU business 
can thrive.  

The  implementation  of  the  Community  Strategy  of  1999  has  put  the  EU  at  the  forefront  in 
understanding and regulating these hazardous chemicals. But in order to further progress and 
maintain  the  expected  high  level  of  protection,  it  is  important  to  ensure  that  the  EU 
framework continues to coherently address endocrine disruptors across different areas. 

The EU strategic approach on endocrine disruptors for the years to come should be based on 
the application of the precautionary principle and aim at: 

  minimising overall exposure of humans and the environment to endocrine disruptors, 
paying particular attention to exposures during important periods of development of an 
organism, such as foetal development and puberty;   

  accelerating  the  development  of  a  thorough  research  basis  for  effective  and 

forward-looking decision-making; 

  and promoting an active dialogue allowing all stakeholders to be heard and to work 

together. 

An approach that is coherent in regulating endocrine disruptors 

The legislative measures constituting the EU legal framework regulating chemicals have been 
developed at different points in time and have, in certain cases, different objectives. This has 
resulted  in  different  approaches  to  endocrine  disruptors,  depending  on  the  sector  being 
regulated,  and  has  raised  questions  as  to  whether  the  EU  legal  framework  regulating 
endocrine  disruptors  is  sufficiently  coherent.  Two  points  in  particular  deserve  special 
attention: 

Horizontal  approach  to  the  identification  of  endocrine  disruptors:  the  Commission 
considers that there should be a coherent approach to the identification of endocrine disruptors 
across  all  relevant  Union  legislation,  based  on  the  broadly  accepted  definition  of  the  World 
Health Organisation.  

The  recently  established  criteria  for  pesticides  and  biocides  constitute  a  first  step  in  that 
direction but EU legislation in other fields does not contain such criteria. 

53  This  was  for  example  the  case  when  criteria  were  developed  to  identify  endocrine  disruptors  under  the 
legislation on pesticides and biocides. 
54  The  U.S.  Environmental  Protection  Agency  operates  the  Endocrine  Disruptor  Screening  Program.  In  Japan, 
the Ministry of Health, Labour and welfare established a Committee on Health Effects of Endocrine Disruptors. 

8 

 
 
 
                                                           
It has been argued that horizontal criteria for the identification of endocrine disruptors should 
be laid down in  the legislation, for reasons  of legal  certainty  and to  avoid the potential risk 
that  a  substance  is  identified  as  endocrine  disruptor  under  one  piece  of  legislation  and  not 
under another one. This matter should be further considered.  

Regulatory consequences for endocrine disruptors: different regulatory approaches exist in 
different pieces of legislation for substances identified as endocrine disruptors.  

For  pesticides  and  biocides,  the  co-legislators  adopted  specific  provisions  “underpinned  by 
the precautionary principle”55 and based on a number of considerations. Taking for example 
into  account  the  specific  nature  of  the  products  in  question,  that  endocrine  disruptors  are 
substances  of  particular  concern,  and  that  scientific  uncertainty  remains  regarding  their 
assessment  (for  example  as  regards  the  existence  of  a  safe  limit  of  exposure),  they  decided 
that  once  it  is  proven  that  a  substance  is  an  endocrine  disruptor,  the  substance  in  principle 
cannot be authorised for use. There are very limited derogation possibilities.  

Under  REACH,  endocrine  disruptors  are  specifically  mentioned  as  substances  that  can  be 
identified as Substances of Very High Concern and, if prioritised, are subject to authorisation 
requirements. Restrictions can also apply to endocrine disruptors.   

Other legislative instruments, such as for example the Regulation on cosmetics, although they 
do not mention endocrine disruptors specifically, consider them like other substances that can 
negatively affect human health. 

Some stakeholders have argued that, in some areas, EU legislation does not provide adequate 
regulatory  approaches  to  address  endocrine  disruptors  effectively.  This  matter  deserves 
further examination. 

In line with  the Commission's  Better Regulation agenda  and the  commitment  to  ensure that 
EU laws remain fit for purpose, different evaluations have been carried out or are under way 
which are relevant, to different extents, for the topic of endocrine disruptors56. However, no 
single  evaluation  has  so  far  covered  all  the  different  vertical  and  horizontal  aspects  of 
endocrine disruptors.  

 The Commission will launch a Fitness Check to assess whether relevant EU legislation 
on  endocrine  disruptors  delivers  its  overall  objective  to  protect  human  health  and  the 
environment by minimising exposure to these substances.  

The Fitness Check will for the first time take a cross-cutting look at endocrine disruptors, 
building  on  scientific  evidence  and  the  significant  amount  of  data  already  collected  and 
analysed in the context of finalised and on-going evaluations. It will allow an analysis of how 
the  different  provisions/approaches  on  endocrine  disruptors  interact,  identify  any  possible 
gaps,  inconsistencies  or  synergies,  and  assess  their  collective  impact  in  terms  of  costs  and 
benefits  for  human  health  and  the  environment,  the  competitiveness  of  EU  farmers  and 
industry,  and  international  trade.  It  will  pay  particular  attention  to  those  areas  where 
legislation  does  not  contain  specific  provisions  for  endocrine  disruptors,  such  as  toys, 
cosmetics and food contact materials.  

55 Article 1(4) of Regulation (EC) No 1107/2009 and Article 1(1) of Regulation (EU) No 528/2012. 
56  Such  as  the  REACH  REFIT  evaluation,  the  REACH  Review  on  the  authorisation  route  of  substances  with 
endocrine  disrupting  properties  according  to  REACH  Art.  138  (7),  the  Fitness  Check  of  the  chemicals 
legislation,  the  evaluation  of  the  legal  framework  on  pesticides,  the  evaluation  of  the  7th  Environment  Action 
Programme, the Fitness Check of the water legislation, the evaluation of the legislation on food contact materials 
and the evaluation of the legislation on toy safety. 

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Particular  attention  will  be  paid  to  the  consistency  and  intensity  of  actions  to  protect 
vulnerable  population  groups  that  are  particularly  sensitive  to  endocrine  disruptors,  such  as 
the foetus or adolescents. The Fitness Check will allow for a comprehensive consultation of 
EU  citizens  and  stakeholders,  including  through  a  public  consultation.  Overall,  it  will  help 
assess whether legislation is  fit for purpose in  line with  Better Regulation requirements and 
feed into the reflection on whether legislative changes are necessary. 

An approach based on the most up-to-date scientific evidence 

EU decision-making is evidence-based. Continued support to research is therefore essential if 
the EU wants to further deepen understanding of endocrine disruptors and constitute a strong 
basis for effective policy-making.  
    In  its  future  framework  programme  for  research  and  innovation,  Horizon  Europe57,  the 
Commission  will  continue  to  ensure  the  necessary  support  to  research  on  protecting 
citizens  and  environment  from  exposure  to  harmful  chemicals,  including  endocrine 
disruptors, building on the work under the current framework programme, Horizon 2020.  

Particular  attention  should  be  paid  to  areas  where  knowledge  gaps  on  endocrine  disruptors 
still  exist,  as  identified  in  Section  1,  and  where  more  scientific  evidence  can  best  support 
improved policies.  

Several  proposed  research  strands  across  Horizon  Europe  are  very  relevant  to  endocrine 
disruptors. These include:  

 

 

 

research  for  the  further  development  of  hazard  assessment,  risk  assessment  and 
management  of  chemicals,  including  for  cocktail  effects,  and  for  the  collection, 
sharing and combination of required data;  
research  on  elimination  of  substances  of  concern  in  the  production  and  end-of-life 
phases;  support  to  the  development  of  safe  substitutes,  and  safe  and  cost-efficient 
production technologies; 
research on eco-innovation for prevention and remediation of environmental pollution 
from  hazardous  substances  and  chemicals  of  emerging  concern;  looking  also  at  the 
interface between chemicals, products and waste. 

An inclusive approach  

In order to be able to progress in effectively addressing endocrine disruptors, the Commission 
will follow an inclusive approach that is open, transparent  and brings together all interested 
parties.  The  Commission  stands  ready  to  listen  thorougly,  dialogue  cooperatively  and 
communicate proactively.  

This  is  also  relevant  for  international  cooperation  with  partners  outside  the  EU,  in  order  to 
keep  abreast  of  research  results,  ensure  efficient  use  of  resources  worldwide,  guarantee 
regulatory consistency reducing barriers to trade and ensure continued global leadership of the 
EU. 

57  COM(2018)  435  and  COM(2018)  436  –  see  in  particular,  in  the  second  pillar  on  Global  Challenges  and 
Industrial Competitiveness, the "Health" cluster (with a proposed budget of €7.7 billion) and the "Non-nuclear 
direct actions of the Joint Research Centre" cluster (with a proposed budget of  €2.2 billion). 

10 

 
 
 
 
                                                           
 The Commission will organise a Forum on endocrine disruptors on an annual basis. The 
Forum  will allow scientists  and public and private stakeholders with  expertise on endocrine 
disruptors  to  come  together  to  exchange  information  and  best  practices,  identify  challenges 
and build synergies, in order to inform the Commission's reflections.    

  The  Commission  will  step  up  its  support  to  the  work  of  relevant  international 
organisations and encourages Member States to do the same. Of particular importance is the 
need  to  provide  the  Organisation  for  Economic  Co-operation  and  Development  with  the 
necessary support to progress in the development of internationally agreed test guidelines.  

 The Commission will also explore possibilities for the inclusion of endocrine disruptors in 
the existing international system for classification of chemicals. This would bring a global 
solution to the identification of endocrine disruptors (similar to what already exists for other 
hazard classes such as mutagens, carcinogens, and substances toxic for reproduction). 

  In order to  provide EU citizens with  clear and comprehensive information they  can  rely 
on, the Commission will launch a one-stop shop web portal on endocrine disruptors. The 
portal  will  consolidate  and  streamline  all  the  information  on  endocrine  disruptors  currently 
present in different websites managed by the Commission and EU agencies. It will therefore 
constitute a single access point to information on endocrine disruptors, and will make it easier 
and more transparent  for citizens and stakeholders to  remain updated on the subject.  In line 
with  subsidiarity  considerations,  the  Commission  will  encourage  Member  States  which 
deem  it  necessary  to  develop  specific  information  and  educational  campaigns  on 
endocrine disruptors for the general public and vulnerable groups.  

4. CONCLUSION 

Almost  twenty  years  after  the  Community  Strategy  for  endocrine  disruptors  of  1999, 
endocrine  disruption  remains  a  global  challenge  and  a  source  of  concern  for  many  EU 
citizens.  While  significant  progress  has  been  achieved  over  the  past  two  decades  to  better 
understand and manage endocrine disruptors, it is important to step up the EU's efforts. 

The  Commission  remains  committed  to  protecting  EU  citizens  and  the  environment  from 
endocrine disruptors. To this end, the strategic approach outlined above aims to ensure a high 
level of protection of EU citizens and the environment and, at the same time, to preserve an 
internal market which delivers for consumers and where businesses can thrive.  

In line with  the Commission's  Better Regulation agenda  and the  commitment to  ensure that 
EU laws remain fit for purpose, the Commission is launching a comprehensive screening of 
the  existing  legislative  framework  on  endocrine  disruptors.  This  reflection  exercise  will 
allow an assessment of whether EU legislation on endocrine disruptors delivers on its overall 
objectives to protect human health and the environment.  It will ensure citizens' involvement 
and stakeholders' participation, including through a public consultation, and will support the 
Commission in  bringing the debate forward and  deciding whether changes to  the legislative 
framework are necessary. 

In  addition,  the  initiatives  announced  in  this  Communication  will  support  the  continuous 
progress of relevant scientific research, foster inclusive dialogue and cooperation with all 
interested parties and allow the stepping up of the implementation of existing policies on 
endocrine disruptors. 

The Commission invites the Parliament and the Council to support the initiatives outlined in 
this Communication and bring their own contribution to the debate, and similarly invites input 
from the European Economic and Social Committee and the Committee of the Regions. 

11