COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on endocrine disruptors and the draft Commission acts setting out scientific criteria for their determination in the context of the EU legislation on plant protection products and biocidal products
Date: 2016-06-15
Institutions: European Commission, Secretariat-General
Subjects: chemical product, dangerous substance, drafting of EU law, endocrine disease, environmental risk prevention, protection of plant life, public health

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 15.6.2016  COM(2016) 350 final   COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on endocrine disruptors and the draft Commission acts setting out scientific criteria for their determination in the context of the EU legislation on plant protection products and biocidal products {SWD(2016) 211 final} {SWD(2016) 212 final}  
 
 
1.  

INTRODUCTION 

Endocrine-disrupting  chemical  substances  ("endocrine  disruptors")  are  substances  that  alter 
the functions of the hormonal system and consequently cause adverse effects. As awareness 
of endocrine disruptors grew, so did public and political interest. The Commission responded 
with  a "Strategy for endocrine disruptors" in  1999.1 This  set out  a number of actions at EU 
level,  with  the  short-term  (research  and  international  cooperation),  mid-term  (test  methods) 
and long-term (regulatory) steps to take with the overall goal of minimising exposure.2 

In the specific areas of biocides3 and plant protection products4 the legislation determines the 
regulatory  consequences  for  endocrine  disruptors.  It  also  requires  the  Commission  to 
determine  how  the  criteria  for  endocrine  disruptors  should  be  defined,  by  drawing  up  acts 
"specifying scientific criteria for the determination of endocrine-disrupting properties".5 Plant 
protection  products  protect  plants  against  harmful  organisms  (examples  are  herbicides  or 
insecticides used  in  agriculture).  Biocides  contain and control  harmful  organisms (examples 
are disinfectants used in hospitals). 

The Commission has devoted particular attention to the task of developing criteria for these 
two areas. The result is reflected in two draft measures6 which will now be the subject of the 
established procedures with  (experts from)  Member  States and  other EU institutions, before 
final  adoption  by  the  Commission.  Though  different  procedures  apply  to  the  two  measures, 
the  Commission's  examination  of  the  issues  has  covered  both  areas  and  they  will  be  taken 
forward in parallel.7  

This Communication sets out the science-based decisions underlying the two draft measures, 
and is accompanied by an impact assessment which presents the state of the science regarding 
different criteria to identify endocrine disruptors. In addition, it provides information on the 
possible consequences.8 The impact assessment is based on a preliminary screening of active 
substances  approved  for  plant  protection  products  and  biocides  for  which  information  was 
available at EU level. It does not therefore constitute an evaluation of individual substances 

1   COM(1999)706 final, 17.12.1999. 
2   This is one of the aspects covered in the 7th Environmental Action Programme (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 ‘Living well, within the limits of our planet’, OJ L 354, 28.12.2013, p. 171). 
3   Regulation  (EU)  No  528/2012  of  the  European  Parliament  and  of  the  Council  concerning  the  making 

available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1). 

4   Regulation  (EC)  No  1107/2009  of  the  European  Parliament  and  of  the  Council  concerning  the  placing  of 

plant protection products on the market (OJ L 309, 24.11.2009, p. 1). 

7  

5   Article 5(3) of Regulation (EU) No 528/2012. 
6   Draft  Commission  Delegated  Regulation  setting  out  scientific  criteria  for  the  determination  of  endocrine-
disrupting properties  pursuant  to  Regulation (EU) No  528/2012  and Draft  Commission  Regulation  setting 
out specific scientific criteria for the determination of endocrine disrupting properties and amending Annex 
II to Regulation (EC) 1107/2009. 
In  the  context  of  plant  protection  products,  the  draft  text  is  voted  in  the  Standing  Committee  (regulatory 
procedure with scrutiny). In the context of biocidal products, a draft delegated act is discussed in a group of 
experts  of  Member  States.  Both  measures  involve  the  Parliament  and  the  Council,  albeit  in  different 
procedural constellations (draft measure in regulatory procedure with scrutiny and adopted delegated act). In 
order to ensure coherence between the two acts, the Commission will present both texts simultaneously to 
the EU co-legislators for them to exercise their control functions. 

8   SWD(2016) 211. 

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under  the  respective  legislation  (the  Regulations  covering  plant  protection  products  and 
biocidal products).9  

This Communication sets out the issues on which the Commission has reached a conclusion 
and  puts  these  in  the  broader  context,  while  also  stressing  that  parts  of  the  debate  are  not 
directly relevant to the Commission's specific task of determining criteria to establish what is 
and  what  is  not  an  endocrine  disruptor  (see  Section  2).  It  sets  out  the  implications  of  the 
setting of the criteria in the domains of plant protection products and biocides (section 3) and 
for other parts of the EU regulatory framework (Section 4) and recalls the other Commission 
actions on endocrine disruptors which are ongoing or pending (Section 5). 

The Commission's conclusions build on work with Member States, input from EU regulatory 
agencies, independent scientific committees advising the Commission, the Commission's in-
house  scientific  body  (the  Joint  Research  Centre10),  and  from  multilateral  and  bilateral 
scientific and regulatory cooperation with third countries, as well as extensive contacts with 
stakeholders over the past 15 years.11 

These discussions have shown the complexity of the topic: so too does the fact that no other 
country has so far adopted legally-binding scientific criteria to determine what is an endocrine 
disruptor. Against this background, the Commission conducted a thorough preparation of the 
measures,  which  it  was  unable  to  conclude  in  time  to  meet  the  legal  deadline  of  December 
2013.  Following  a  ruling  of  the  Court  of  Justice  of  the  European  Union  (General  Court)  in 
December  2015,12  the  Commission  reconfirmed  its  unequivocal  commitment  to  the  EU  co-
legislators to finalise its ongoing work, which by then was close to conclusion, and present the 
criteria before the summer 2016. 

2.   THE DEBATE ON CRITERIA FOR THE DETERMINATION OF ENDOCRINE DISRUPTORS AND 

THE COMMISSION'S CONCLUSIONS 

There are a number of key scientific issues which have been the subject of debate and study 
and  some  –  but  not  all  –  of  these  have  a  direct  bearing  on  the  draft  measures  on  plant 
protection  products  and  biocidal  products.  Several  issues  are  also  part  of  a  more  general 
debate about toxicology, rather than issues which concern endocrine disruptors alone. 

9   The  analytical  work  in  the  impact  assessment  draws  inter  alia  on  a  contracted  study  screening  nearly  all 
approved active substances for plant protection products (and the active substances for biocidal products for 
which  information  was  available  at  EU  level)  to  evaluate  the  impacts  associated  to  options  for  criteria  to 
identify endocrine disruptors under the Regulations on plant protection products and biocidal products. The 
screening was based on available evidence (no additional testing) and needed to be carried out in a limited 
time. The screening methodology was developed for the purpose of the screening exercise. The results of the 
screening  therefore  do  not  constitute  evaluations  of  individual  substances  to  be  carried  out  under  the 
respective legislations and in no way prejudge future decisions on active substances to be taken pursuant to 
these two Regulations.  

10   The  most  important  Joint  Research  Centre  scientific  and  policy  reports  are  the  reports  of  the  endocrine 
disrupters expert advisory group: "Key scientific issues relevant to the identification and characterisation of 
endocrine disrupting substances" (2013); and "Thresholds for endocrine disruptors and related uncertainties" 
(https://ec.europa.eu/jrc/en/publication/eur-scientific-and-technical-research-reports/thresholds-
(2013) 
endocrine-disrupters-and-related-uncertainties; 
https://ec.europa.eu/jrc/en/publication/eur-scientific-and-
technical-research-reports/key-scientific-issues-relevant-identification-and-characterisation-endocrine-
disrupting). 

11  More information on the multitude of EU activities is available on the dedicated Commission web portal: 

http://ec.europa.eu/health/endocrine_disruptors/policy/index_en.htm.  

12   Judgement in Case T-521/14, Sweden v Commission. 

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What is an endocrine disruptor? 

In 2002, the International Programme on Chemical Safety, a joint programme of various UN 
Agencies,  including  the  World  Health  Organisation,  made  an  authoritative  definition  of  an 
endocrine  disruptor  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".13  The  novelty  in  this  definition  was  the  introduction  of  a 
second  element.  The  usual  approach  to  defining  the  toxicity  of  chemical  substances  is  "end 
points"  –  whether there  is  an  adverse  effect.  The  new,  additional,  element  is  the  concept  of 
"mode of action", the way in which a chemical substance has an impact (see Figure).  

Figure  

As well as the adverse effect, the draft scientific criteria now being presented aim to introduce 
in  legal  form  this  concept  of  the  "endocrine  mode  of  action"  as  one  of  the  elements  to 
consider  when  determining  what  is  an  endocrine  disruptor  for  the  two  product  areas 
concerned.  

More specifically, the criteria set out that an endocrine mode of action is "the inherent ability 
of a substance to interact or interfere with one or more components of an endocrine system", 
without  necessarily  leading  to  an  adverse  effect.  In  line  with  the  opinion  of  the  European 
Food  Safety  Authority,  they  also  clarify  that  an  endocrine  mode  of  action  is  not  a 
(eco)toxicological hazard in itself.14 

Currently, the discussion on the endocrine mode of action centres on the hormonal systems of 
oestrogen,  androgen,  thyroid,  and  steroidogenesis  –  as  these  are  the  only  areas  where 
standardised  tests  exist.15  However,  in  order  to  be  ready  to  adapt  to  future  scientific 
developments, the draft measures are not limited to these hormonal systems. 

Defining the "adverse effect"  

One of the issues which the criteria needed to address is the definition of "adverse effect". The 
Commission  will  use  the  definition  provided  by  the  International  Programme  on  Chemical 
Safety. This is a "change in the morphology, physiology, growth, development, reproduction, 
or,  life  span  of  an  organism,  system,  or  (sub)population  that  results  in  an  impairment  of 

13   World  Health  Organisation  International  Program  on  Chemical  Safety,  Global  assessment  of  the  state-of-

the-science of endocrine disruptors, 2002, WHO/PCS/EDC/02.2. 

14   European  Food  Safety  Authority,  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, 28.2.2013, EFSA Journal 2013;11(3):3132, p. 17 ("EFSA(2013)"). 

15   See EFSA(2013), p. 29. 

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functional capacity, an impairment of the capacity to compensate for additional stress, or an 
increase in susceptibility to other influences."16 

The  challenge  in  practice  lies  in  assessing  the  potential  adversity  of  an  effect  at  sub-organ 
level (molecular or cellular level). The conclusion of the European Food Safety Authority in 
2013 was to make a distinction in terms of the degree of change observed: "expert judgement 
will  therefore  be  required  to  assess  on  a  case-by-case  basis  the  toxicological  relevance  of 
[…]  changes.  In  general,  transient,  inconsistent  and  minor  fluctuations  at  the  biochemical 
and  molecular  level  may  be  considered  adaptive  (i.e.  non-adverse),  whilst  sustained, 
consistent  and  permanent  changes  at  the  cell,  organ-  or  organism-level,  resulting  in 
pathology or functional impairment in vivo, as well as altered timing of development, may be 
considered adverse".17 The Commission is following this approach. 

The  criteria  also  underline  that  endocrine-related  adverse  effects  which  are  only  indirectly 
triggered by a non-endocrine-related toxicity are not adverse effects that are relevant for the 
identification of a substance as an endocrine disruptor.18 This clarification is necessary since, 
as the result of any generalized toxicity, there may be reactions of the endocrine system which 
would be the consequence rather than the cause of the specific adverse effect observed. 

How to determine causality 

The 2002 definition has at its heart the link between the mode of action and the adverse effect, 
(the  phrase  "and  consequently"  in  the  definition).  The  question  remains  about  the  extent  to 
which this link should be clearly established – the degree to which a strict causality should be 
required.  In  2013,  the  European  Food  Safety  Authority  concluded  that  there  has  to  be  "a 
reasonable  evidence  base  for  a  biologically  plausible  causal  relationship  between  the 
[endocrine  mode  of  action]  and  the  adverse  effects  seen  in  intact  organism  studies",  i.e.  a 
"reasonable  evidence  base"  to  determine  causality.  The alternative  would  have  been  a  more 
rigid approach to causality (asking, for example, for "conclusive" evidence of the connection). 
The Commission considers that in practice, it will be very difficult to demonstrate "conclusive 
evidence" of causality. Therefore, the Commission intends to follow a concept of a reasonable 
evidence ("biological plausibility") to determine causality. 

The relevance of "categories"  

The debate on criteria to determine what is an endocrine disruptor has sometimes included the 
idea to establish a system of "categories" of endocrine disruptors. These "categories" refer to 
varying  degrees  of  scientific  evidence  for  the  endocrine  mode  of  action,  the  adverse  effect, 
and the causality between the two (or indeed a combination of these elements).19 Categories 
that have been put forward are, for example, "suspected endocrine disruptors", or substances 
that  have  only  an  endocrine  mode  of  action  (i.e.  without  scientific  evidence  of  an  adverse 
effect). 

The Commission considers that establishing different categories of what may be an endocrine 
disruptor does not help to define what is an endocrine disruptor in the context of biocides and 
pesticides. Furthermore, such categorisation for pesticides and biocides would decrease legal 

16   World Health Organisation. International Program on Chemical Safety, Principles and methods for the risk 

assessment of chemicals in food. (Environmental Health Criteria), 2009. 

17   EFSA(2013), p. 16. 
18   Sometimes discussed as "specificity of the adverse effect". 
19   Such categories are used in some areas of chemicals regulation. The issue is not to be confused with potency 

categories (see below). 

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certainty for regulators and stakeholders, without established benefits in terms of protection of 
health and the environment.20 

The debate about a "safe threshold" for endocrine disruptors 

The  usual  way  of  determining  the  safety  of  a  chemical  substance  is  based  on  a  "safe 
threshold". The safe threshold gives the dosage below which no adverse effect is expected to 
occur.21  Usually,  once  this  level  is  established  experimentally,  a  safety  margin  is  added  by 
reducing the value to a small proportion of it – for example, 1% of the threshold previously 
established. This concept is used by regulators worldwide,22 but is nevertheless the subject of 
controversy in the area of endocrine disruptors – where there is a debate about whether a safe 
threshold can ever be established, or whether this can be left to case-by-case risk assessment. 
The Commission considers that answering the question of whether a threshold exists is neither 
necessary  nor  appropriate  when  defining  scientific  criteria  for  determining  what  is  an 
endocrine disruptor. 

The relevance of potency 

The potency of a chemical substance describes its ability to produce an effect at a particular 
dose level.23 In the EU general chemicals law used to classify chemical substances24 – which 
is  based  on  a  global  harmonised  system  –  potency  is  used  to  determine  which  category  of 
hazard a substance should fall into.25 Consideration of potency is needed in risk assessment, 
and can also be useful for prioritising and screening substances. 

However,  to  determine  what  is  an  endocrine  disruptor,  what  matters  is  solely  whether  a 
chemical is an endocrine disruptor at all (i.e. the identification of the hazard, as opposed to its 
subsequent characterisation). The Commission has therefore concluded that, for the specific 
purpose  of  setting  scientific  criteria,  it  is  not  necessary  to  include  considerations  of  how 
"potent"  an  endocrine  disruptor  is.  Potency  is  a  question  to  be  asked  only  once  it  has  been 
established  that  a  substance  is  an  endocrine  disruptor  at  all.  The  impact  assessment  report 
accompanying  this Communication addresses issues of potency, and identifies arguments in 
support  of  considering  potency.  However,  the  Commission  follows  the  broad  scientific 
consensus whereby potency should not be considered when identifying endocrine disruptors, 
but taken into account when evaluating the actual risk that endocrine disruptors may pose. 

Regulation by "hazard" or "risk"  

The  regulation  of  chemical  substances  can  be  approached  in  two  different  ways:  based  on 
hazard or based on risk. A hazard-based approach regulates substances on the basis of their 
intrinsic  properties,  without  taking  account  of  the  exposure  to  the  substance.  A  risk-based 

20   This  does  not  preclude  that  categories  are  applied  as  a  prioritisation  tool,  for  example  for  additional 

research. 

21   With  exceptions  such  as,  for  example,  certain  forms  of  mutagenicity  and  genotoxic  carcinogenicity.  With 
regard  to  these  endpoints,  current  risk  assessment  practice  applies  a  non-threshold  approach,  i.e.  it  is 
assumed that no amount of exposure is risk-free.  

22   EFSA  have  recalled  that  "for  most  toxic  processes,  it  is  generally  assumed  that  there  is  a  threshold  of 

exposure below which no biologically significant effect will be induced" (EFSA(2013), p. 16). 

23   Sugar compared to sweeteners may serve as an illustration. Both have the intrinsic property of being sweet. 
However,  the potency  of  most sweeteners  is  much  higher  than  sugar,  so that a  lower dosage  is  needed  to 
produce an effect. 

24   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 L353, 31.12.2008, p. 1). 

25   For example, harmful/toxic/fatal contact with the skin. 

6 

 
 
                                                            
approach factors in the exposure. A common analogy used is from the animal kingdom: a lion 
is intrinsically a hazard, but a lion safely constrained in a zoo is not a risk, since there is no 
exposure. In the area of chemical safety, there are several pieces of EU legislation that apply a 
hazard-based approach to toxicological safety, while others follow a risk-based approach.26 27 

The issue faced by the Commission in this exercise is to establish criteria to determine what is 
or  is  not  an  endocrine  disruptor  for  the  purposes  of  plant  protection  products  and  biocidal 
products – not to decide how to regulate these substances. The regulatory consequences have 
already  been  set  by  the  legislator  in  the  legislation  on  plant  protection  products  (2009)  and 
biocidal  products  (2012).  Under  this  legislation,  as  a  general  rule,  endocrine  disruptors  are 
banned on the basis of hazard28, without undergoing a specific risk assessment on the basis of 
considerations  of  exposure  (although  in  some  cases  derogations  –  either  hazard,  risk  or 
considering socio-economic issues – may apply on a case by case basis, as stipulated by the 
legislation).  

3.   WHAT  DO  THE  CRITERIA  MEAN  FOR  THE  REGULATORY  AREAS  OF  BIOCIDES  AND 
PLANT PROTECTION PRODUCTS? 

The  EU  legislation  for  biocidal  products  and  plant  protection  products  provides  that  active 
substances which are endocrine disruptors shall not be approved, unless – in the case of plant 
protection products – there is negligible exposure or – in the case of biocides – a negligible 
risk. In principle, the question whether an active substance of a plant protection product or a 
biocide  is  an  endocrine  disruptor  would  be  assessed  each  time  it  is  subject  to  an  approval 
procedure or a renewal procedure. In addition, all active substances used in plant protection 
products  and  biocidal  products  are  only  approved  for  a  limited  period  of  time,  and  their 
approvals are routinely reviewed. 

Some  of  the  adverse  effects  caused  by  endocrine  disruptors  (for  instance  effects  on 
reproduction)  have  been  assessed  for  many  years  which  means  that  in  practice  many 
substances where evidence as endocrine disruptors is available have been already banned in 
the EU. The new criteria will however allow for a more accurate and up to date assessment.  

In  order  to  ensure  quick  action  and  that  recent  scientific  developments  will  be  taken  into 
account,  the  more  accurate  scientific  criteria  will  be  applied  immediately,  except  for  cases 
where a draft Commission regulation has been voted on already but not adopted. In addition, 
in order to allow the assessment work to start, the Commission will today ask the European 
Food  Safety  Authority  and  the  European  Chemicals  Agency  to  start  looking  at  whether 
individual  approved  active  substances,  for  which  indications  exist  that  they  could  meet  the 
criteria  to  be  identified  as  having  endocrine  disrupting  properties,  are  endocrine  disruptors 
according to the criteria in the draft texts presented today. This would help to ensure that these 
two  regulatory  Agencies  would  be  ready  to  apply  those  criteria,  in  accordance  with  the 
applicable regulatory procedures, once the criteria enter into force.  

26   The  Commission  is  currently  conducting  a  "fitness  check",  under  the  REFIT  programme,  to  assess  these 
http://ec.europa.eu/smart-

aspects 
regulation/roadmaps/docs/2015_grow_050_refit_chemicals_outside_reach_en.pdf). 

in-depth 

more 

(see 

27   Generally, a risk-based approach allows consideration of proportionality when taking regulatory (i.e. risk-

management) decisions. 

28   Endocrine disruptors may be approved with risk-mitigation measures if strict conditions are met. 

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Updating the grounds for possible derogation to current scientific and technical knowledge  

Both  the  plant  protection  products  legislation  and  the  biocides  legislation  ban  active 
substances  having  endocrine  disrupting  properties  on  the  basis  of  hazard.  However,  some 
limited  exceptions  are  permitted.  The  biocides  legislation  allows  exceptions  based  on 
"negligible risk" and socio-economic considerations. The plant protection products legislation 
allows  exceptions  based  on  "negligible  exposure"  or,  in  certain  situations  and  under  strict 
conditions,  a  serious  danger  to  plant  health.  In  the  context  of  endocrine  disruptors,  the 
European  Food  Safety  Authority  has  supported  the  principle  of  a  risk-based  approach  for 
plant  protection  products.29  Scientific  and  technical  knowledge  has  been  evolving  and 
suggests that endocrine disruptors in this area could be assessed based on risk, like most other 
substances.  This  is  why  the  Commission,  in  line  with  the  mandate  given  by  the  co-
legislators30,  has  concluded  that  the  grounds  for  possible  derogations  for  plant  protection 
products  should  be  updated  so  as  to  refer – in  line  with  the  biocides  legislation – to 
"negligible  risk",  while  fully  maintaining  the  concept  of  a  hazard-based  ban  of  endocrine 
disruptors, thereby ensuring an equally high level of protection of health and the environment. 

4.   WHAT DO THE CRITERIA SET FOR BIOCIDES AND PLANT PROTECTION PRODUCTS MEAN 

FOR OTHER REGULATORY AREAS? 

The scientific criteria to determine what is an endocrine disruptor are being set to fulfil legal 
obligations under the EU legislation for biocidal products and plant protection products. The 
criteria only apply in these two regulatory areas, and do not have a direct legal consequence 
for other areas of EU law. The goal is to provide criteria to the relevant EU bodies (European 
Chemicals Agency, European Food Safety Authority, Commission) and Member States. 

As explained above, the criteria being put forward are fully in line with the definition of the 
World  Health  Organisation  International  Programme  on  Chemical  Safety  –  which  already 
exists and provides a common foundation for all areas of EU policy on chemical safety. The 
World Health Organisation definition is being applied already to identify endocrine disruptors in the 
context of other legislation and it can be expected that this will continue in the light of the adoption of 
the criteria by the Commission. 

In any event, the EU regulatory framework is already working with the notion of "endocrine 
disruptors"  (albeit  without  criteria  set  in  EU  legislation  to  define  what  is  an  endocrine 
disruptor). For example, the European Chemicals Agency has listed, in the "Candidate List of 
substances  of  very  high  concern  for  Authorisation",  substances  on  the  basis  solely  of  their 
endocrine-disrupting properties.31 The Scientific Committee on Consumer Safety has assessed 
the safety in relation to the endocrine-disrupting properties of various cosmetic ingredients.32 
And the Commission has listed endocrine disruptors in the context of the implementation of 

29   EFSA(2013), p. 47: "to inform on risk and level of concern for the purpose of risk management decisions 
[…] risk assessment (taking into account hazard and exposure data/predictions) makes best use of available 
information. Endocrine disruptors can therefore be treated like most other substances of concern for human 
health  and  the  environment,  i.e.  be  subject  to  risk  assessment  and  not  only  to  hazard  assessment".  This 
approach  was  supported  by  the  Scientific  Committee  on  Consumer  Safety,  an  independent  non-food 
scientific  committee  advising  the  Commission  (Memorandum  on  Endocrine  Disruptors,  16.12.2014. 
(SCCS/1544/14)). 

30   Article 78(1)(a) of Regulation (EC) No 1107/2009. 
31   http://echa.europa.eu/candidate-list-table. 
32   Examples are listed in SCCS/1554/14. 

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the  EU  water  quality  legislation33  and  restricted  the  placing  on  the  market  of  endocrine 
disruptors in the context  of REACH.34 The difference  with  the two policy areas covered  by 
the draft measures is that in these two policy areas there exists a legal obligation to define the 
criteria to determine what is an endocrine disruptor. 

5.   OTHER ACTIVITIES OF THE COMMISSION 

Looking  beyond  the  setting  of  scientific  criteria  to  identify  endocrine  disruptors,  the 
Commission will increase its efforts in the range of other activities ongoing in the three areas 
highlighted  in  the  EU  endocrine  disruptors  strategy,  with  a  view  to  continue  to  minimise 
exposure to endocrine disruptors in line with the 7th Environmental Action Programme. These 
activities could be further enhanced by developing fora to deepen information exchange and 
develop consensus in both the scientific and regulatory communities, in line with the strategy. 

Research 

Since  adoption  of  the  EU  endocrine  disruptors  strategy  in  1999,  the  EU  framework 
programmes for research have supported over 50 multinational collaborative research projects 
with  over  150m  EUR  in  funding.  Horizon  2020  is  supporting  further  research  to  advance 
knowledge  and  to  provide  solid  scientific  evidence  for  regulators  and  policy-makers  in  the 
area  of  toxicology.  A  key  initiative  will  be  the  European  Human  Biomonitoring  Initiative, 
which  will  be  a  European  knowledge  hub  for  the  measurement  of  human  exposure  to 
chemical  substances.  The  Joint  Research  Centre  has  also  an  important  role  to  play,  for 
example in the development of assessment methods and approaches and their translation into 
regulatory use.  

With  a  view  to  the  future,  the  Commission  considers  it  important  to  ensure  a  good  flow  of 
information  of  comparable  hazard  data,  biomonitoring  data,  and  surveillance  data  between 
Member  States  and  agencies.  This  would  also  contribute  to  addressing  issues  of  combined 
exposure.  35  A  web  platform  will  be  developed  by  the  Commission,  involving  EU  agencies 
and  Member  States,  to  serve  as  a  hub  to  strengthen  cooperation  and  the  exchange  of 
information. 

International cooperation 

The Commission is an active partner in the work at global level, in particular the Organisation 
for Economic Cooperation and Development (OECD), in addressing toxicological safety and 
in  particular  identifying  endocrine-disrupting  chemicals.  Today,  a  number  of  tests  for 
screening  and  testing  endocrine  activity  of  substances  have  been  validated  and  approved  as 
OECD test guidelines, but work is still ongoing. Additional comprehensive guidance has been 
prepared to help interpret the outcome of tests.  

The Commission considers that it is critical to continue and strengthen this work, on the basis 
of priorities set jointly with Member States in the OECD framework by 2018, in order to have 
the necessary range of validated tests available, at the latest by 2025. 

33   Annex I to Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on 

environmental quality standards in the field of water policy (OJ L 348, 24.12.2008, p. 84). 

34   Annex  XVII  to  the  Regulation  (EC)  No  1907/2006  of  the  European  Parliament  of  the  Council  of  18 
December  2016  concerning  the  Registration,  Evaluation  and  Authorisation  of  chemicals  (REACH)  (OJ  L 
396, 30.12.2006, p. 1). 

35   I.e. combined exposure toxicity involving several substances, sometimes referred to as "cocktail effect". 

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The Commission is also in regular contact with competent authorities in third countries. 

EU regulation 

As noted above, EU regulatory agencies, independent scientific committees, the Commission 
and  Member  States  already  look  at  endocrine  disruptors.  This  work  is  regulated  through 
sectoral  legislation  in  areas  including  the  human  health  (including  for  consumers  and 
workers),  animal  health,  and  the  environment.  Examples  are  the  EU  legislation  on 
occupational safety and health (where the legislation on chemical agents at work36 includes all 
chemical  agents,  including  endocrine  disruptors),  food  and  feed  safety  (where  toxicological 
risks, including those stemming from endocrine disruptors, are subject to comprehensive risk 
assessment),  and  consumer  products  (including  for  example  cosmetics  and  toys),  as  well  as 
environmental legislation. 

However,  clearly,  a  key  challenge  for  regulators  is  the  availability  of  good  scientific  data. 
Therefore,  the  Commission  will take  all  necessary  steps  to  ensure  that  data  requirements  as 
regards endocrine disruptors are reviewed – whether these data requirements are enshrined in 
EU  legislation,  guidelines  of  the  Commission,  or  guidelines  of  regulatory  agencies  and 
independent scientific committees. 

In  addition,  the  Commission  will  act  swiftly  in  order  to  further  implement  the  legal 
obligations in the EU acquis in relation specifically to endocrine disruptors. In particular: 

EU Cosmetics Regulation: According to the EU Cosmetics Regulation, the Commission has 
to "review this Regulation with regard to substances with endocrine-disrupting properties".37 
This  review  is  overdue.  A  screening  exercise  of  certain  cosmetic  ingredients  that  has  been 
contracted  by  the  Commission  is  close  to  completion.  The  Commission  will  present  the 
review by the end of the year. 

REACH: The authorisation of chemical substances under the REACH Regulation can follow 
two  alternative  pathways:  Where  a  safe  threshold  can  be  established,  the  authorisation  is 
granted  on  the  basis  of  a  controlled  risk.  Where  no  safe  threshold  can  be  established,  an 
authorisation  can  only  be  granted  "if  it  is  shown  that  socio-economic  benefits  outweigh  the 
risk to human health or the environment arising from the use of the substance and if there are 
no suitable alternative substances or technologies".38 The Commission was tasked to "carry 
out  a  review  to  assess  whether  or  not,  taking  into  account  latest  developments  in  scientific 
knowledge, to extend the scope of Article 60(3) [authorisation on the basis of socioeconomic 
benefits  instead  of  safe  exposure]"  to  endocrine  disruptors.39  Following  the  presentation  of 
scientific criteria today, this review can be finalised and the Commission will present it by the 
end of the year. 

Water  quality  legislation:  The  regulatory  framework  for  water  quality  refers  in  several 
instances  explicitly  to  endocrine  disruptors,  for  example  as  substances  to  be  in  particular 
considered as substances liable to cause pollution.40 The Commission has to regularly review 

36   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). 

37   Article  15(4)  of  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). 

38   Article 60(4) of the REACH Regulation (EC) No 1907/2006. 
39   Article 138(7) of the REACH Regulation (EC) No 1907/2006. 
40   For  example,  Article  2(31)  and  Annex  VIII,  point  4  to  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). 

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the list of priority (hazardous) substances41 and substances to be listed in the "watch list",42 as 
well  as  quality  parameters  for  water  intended  for  human  consumption.43  These  reviews  are 
ongoing in accordance with the applicable legislation. 

6.  

CONCLUSION 

The  adoption  of  criteria  to  identify  endocrine-disrupting  substances  will  fulfil  the  legal 
obligations under the plant protection products and biocides legislation. Once adopted, the EU 
regulatory system will be the first regulatory system worldwide to define scientific criteria for 
endocrine disruptors in legislation. 

The draft measures should now be looked at through the relevant procedures and be finalised 
quickly,  to  fulfil  the  legal  requirement  to  have  criteria  in  law:  The  Commission  calls  upon 
Member States and EU institutions involved in the further adoption process to work closely 
and constructively in order to swiftly adopt these texts.  

As  noted  above,  the  Commission  is  also  asking  the  relevant  agencies  to  immediately  start 
looking at individual substances, to accelerate the process once the criteria are in force. 

The  Commission,  in  close  cooperation  with  EU  regulatory  agencies  and  independent 
scientific  committees,  as  well  as  Member  States  and  EU  institutions,  is  committed  to 
continuing  to  ensuring  a  high  level  of  protection  of  health  and  the  environment  from 
toxicological risks, and believes that the two measures will represent an important step with 
respect to endocrine disruptors. 

41   Article 16(4) of Directive 2000/60/EC. 
42   Article  8b(2)  of  Directive  2008/105/EC  of  the  European  Parliament  and  of  the  Council  of  16  December 

2008 on environmental quality standards in the field of water policy (OJ L 348, 24.12.2008, p. 84). 

43   Article  11(1)  of  Council  Directive  98/83/EC  of  3  November  1998  on  the  quality  of  water  intended  for 

human consumption (OJ L 330, 5.12.1998, p. 32). 

11