REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE in accordance with Article 138(7) of REACH to review if the scope of Article 60(3) should be extended to substances identified under Article 57(f) as having endocrine disrupting properties with an equivalent level of concern to other substances listed as substances of very high concern
Date: 2016-12-20
Institutions: Directorate-General for Environment, European Commission
Subjects: European Chemicals Agency, chemical product, dangerous substance, endocrine disease, environmental protection, market approval, product safety, public health, scientific report

EUROPEAN 
COMMISSION 

Brussels, 20.12.2016  
COM(2016) 814 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE 

in accordance with Article 138(7) of REACH to review if  the scope of Article 60(3) 
should be extended to substances identified under Article 57(f) as having endocrine 
disrupting properties with an equivalent level of concern to other substances listed as 
substances of very high concern 

EN 

   EN 

 
 
 
 
  
 
1)  Introduction 

The REACH Regulation1 entered into force on 1 June 2007. Its main objectives are to ensure 
a high level of protection of human health and the environment, as well as the free circulation 
of  substances  on  the  internal  market  while  enhancing  competitiveness  and  innovation.  The 
Regulation  shifts  the  responsibility  to  manage  chemicals  risks  from  public  authorities  to 
industry.  Those  objectives  are  to  be  achieved  via  four  processes,  namely  Registration, 
Evaluation, Authorisation and Restriction.  

The authorisation process aims at ensuring the sound functioning of the internal market while 
assuring that the risks from substances of very high concern (SVHCs) included in Annex XIV 
are  properly  controlled  and  that  these  substances  are  progressively  replaced  by  suitable 
alternative  substances  or  technologies  where  these  are  economically  and  technically  viable. 
Article 60(2) states that "an authorisation shall be granted if the risk to human health or the 
environment  [..]  is  adequately  controlled''.  To  this  end,  manufacturers,  importers  or 
downstream  users  have  to  apply  for  authorisation  and  to  analyse  the  availability  of 
alternatives, considering their risks and the technical and economic feasibility of substitution. 
According to Article 60(3), Article 60(2) shall not apply to substances that are carcinogenic, 
mutagenic  or  toxic  to  reproduction  category  1A  or  1B  (CMR  Cat.  1A/1B)  or  to  substances 
meeting  the  criteria  in  Article  57(f)  for  which  it  is  not  possible  to  determine  a  threshold. 
Substances  falling  under  Article  57(f)  are  inter  alia  those  "having  endocrine  disrupting 
properties, for which there is scientific evidence of probable serious effects to human health 
or  the  environment  which  give  rise  to  an  equivalent  concern"  to  CMR  Cat.  1A/1B  or  to 
substances  which  are  persistent,  bioaccumulating  and  toxic  or  very  persistent  and  very 
bioaccumulating  (PBT/vPvB).  For  substances  identified  under  Article  60(3),  "authorisation 
may only be granted if it is shown that socio-economic benefits outweigh the risk to human 
health  or  the  environment",  as  specified  in  Article  60(4)  (the  so-called  'Socio-Economic 
Route').  

Article 138(7) of REACH requires that "by 1 June 2013, the Commission shall 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) to substances identified under Article 57(f) as 
having endocrine disrupting properties. On the basis of that review the Commission may, if 
appropriate, present legislative proposals." In other words, the Commission has to review the 
way  some  SVHCs,  namely  substances  “having  endocrine  disrupting  properties  […]  which 
give rise to an equivalent level of concern to those of other substances listed in points (a) to 
(e) [of Article 57]”2, that are CMR Cat. 1A/1B and PBT/vPvB substances, should be handled 
under the authorisation process and in particular whether endocrine disruptors should only be 
authorised through the Socio-Economic Route. 

The  review  clause  was  inserted  during  the  co-decision  process,  where  the  authorisation 
process  was  substantially  changed  from  the  Commission  proposal.  There  was  not  enough 
time to find a detailed agreement on whether endocrine disruptors should be authorised in all 
circumstances  through  the  Socio-Economic  Route.  Therefore  this  decision  was  entrusted  to 

1  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), establishing a 
European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 
793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and 
Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L396, 30.12.2006, p. 1). 

2  Article 57 (f) of REACH. 

2 

 
 
 
                                                            
the Commission through the review clause in Article 138(7) and postponed to 2013, as there 
was also an expectation that the scientific knowledge about endocrine disruptors might have 
evolved further to allow taking a clear position on this matter. 

The  purpose  of  this  document  is  to  review  whether  or  not,  based  on  the  current  scientific 
knowledge, there would be a need to change the legislative text as regards those substances, 
as required by Article 138(7). 

The Commission's conclusions build on work with Member States, input from EU regulatory 
agencies3, independent scientific committees advising the Commission, the Commission's in-
house  scientific  body  (the  Joint  Research  Centre4),  and  from  multilateral  and  bilateral 
scientific and regulatory cooperation with third countries, as well as extensive contacts with 
stakeholders over the past years5. 

2)  Context 

- What is an Endocrine Disruptor? 

For the purpose of this review the Commission is going to apply the WHO/IPCS definition of 
endocrine  disruptor:  "A  substance  having  endocrine  disrupting  properties  means  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". This is in line with the publication, on 15 June 2016, by the Commission 
of draft scientific criteria for the determination of endocrine disrupting properties pursuant to 
the legislation on biocidal products and plant protection products.6 

Endocrine disrupting substances can be identified as SVHCs under REACH based on Article 
57(f) provided that there is scientific evidence of probable serious effects to human health or 
the environment which give rise to an equivalent level of concern to CMRs Cat. 1A/1B and 
PBT/vPvBs. For an easier reading, it will be considered for the purpose of this document that 
the  abbreviation  "EDs"  covers  this  requirement,  i.e.  that  the  substances  concerned  are 
considered as being of equivalent concern. 

- Application for authorisation for ED substances  

Title  VII  of  the  REACH  Regulation  lays  down  the  provisions  governing  the  authorisation 
requirements for SVHCs listed in Annex XIV, the so-called ‘Authorisation List’, which may 

3  For example, 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)"). 

4  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" 
(2013) (https://ec.europa.eu/jrc/en/publication/eur-scientific-and-technical-research-reports/thresholds-
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). 

5  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.  

6  C(2016) 3751 projet and C(2016)3752 projet, 16 June 2016. 

3 

 
 
 
 
                                                            
include EDs. General information on authorisation is described further on the website of the 
European Chemicals Agency (ECHA)7.  

Once  a  substance  is  included  in  Annex  XIV,  a  manufacturer,  importer  or  downstream  user 
may  not  place  on  the  market  for  a  use  or  use  such  a  substance  unless  an  authorisation  has 
been granted for that use or the use is exempted (Article 56(1)).  

Applications for authorisation must be submitted to ECHA. The Risk Assessment Committee 
(RAC)  and  the  Socio-economic  Analysis  Committee  (SEAC)  of  ECHA  are  to  assess  the 
applications and issue an opinion. The decision to grant or refuse an authorisation is adopted 
by  the  Commission,  in  accordance  with  the  examination  procedure  applicable  to 
implementing acts. 

For an authorisation to be granted, one of the following conditions must be fulfilled: 

- 

- 

the  risks  from  the  use  of  the  substance  arising  from  the  intrinsic  properties  specified  in 
Annex  XIV  are  adequately  controlled,  as  documented  in  the  chemical  safety  report 
(commonly referred to as ‘Adequate Control Route’), or 

it  is  shown  that  socio-economic  benefits  of  continued  use  outweigh  the  risks  to  human 
health or the environment arising from the use of the substance and there are no suitable 
alternative  substances  or  technologies  (commonly  referred  to  as  ‘Socio-Economic 
Route’).  Only  this  second  route  applies  to  PBT/vPvB  substances  and  substances  of 
equivalent concern to these, as well as to CMR substances for which it is not possible to 
determine a threshold and to substances of equivalent concern to them. It was decided by 
the co-legislators that PBT/vPvB substances would be subject in all circumstances to the 
'Socio-Economic Route', as they exhibit the potential to distribute within the environment 
and  to  contaminate  environmental  compartments  distant  to  their  source.  This  leads  to 
uncertainties  about  the  prediction  of  their  environmental  concentrations  through  the 
normal predictive models. Their persistence and their bioaccumulating properties invoke 
the expectation that concentrations in the environment, by continuous releases, will keep 
increasing and eventually lead to toxic effects on organisms in the environment. 

- What is understood by "threshold" in the context of application for authorisation? 

As  indicated  above,  two  routes  for  authorisation  exist  in  REACH,  depending  on  the 
possibility  to  determine  a  threshold  or  not  for  an  SVHC  (with  the  exception  of  PBT/vPvB, 
which are always subjected to the ‘Socio-Economic Route’).  
For  human  health,  as  described  in  the  ECHA  guidance  document  R.88  "characterisation  of 
dose (concentration)-response for human health", the Derived No Effect Level (DNEL) can 
be  considered  as  an  "overall"  No-(Adverse)-Effect-Level  (NOAEL)  for  a  given  exposure 
(route,  duration,  frequency)  accounting  for  uncertainties/variability  in  these  data  and  the 
human population exposed. Consequently, exposure of humans should not exceed the DNEL. 
The  DNEL,  where  it  can  actually  be  derived,  can  be  considered  as  a  regulatory  threshold 
under REACH for authorisation purposes. 

For the environment, the concentration below which no adverse effects in the environmental 
sphere  of  concern  are  expected  to  occur  is  considered  to  be  the  Predicted  No-Effect 

7  http://echa.europa.eu/web/guest/regulations/reach/authorisation. 
8  https://echa.europa.eu/documents/10162/13632/information_requirements_r8_en.pdf/e153243a-03f0-44c5-

8808-88af66223258. 

4 

 
 
 
                                                            
concentration (PNEC).  The PNEC, where it can actually be derived, can be considered as a 
regulatory threshold under REACH for authorisation purposes. More details can be found in 
the  ECHA  guidance  document  R.109  "characterisation  of  dose  (concentration)-response  for 
the environment”. 

In  case  of  a  non-threshold  substance,  RAC  will  not  be  in  a  position  to  give  an  opinion 
whether safe (or acceptable) exposure levels can be reached as it is not possible to determine 
a  DNEL  or  PNEC,  and  therefore  authorisation  can  be  granted  only  if  it  is  shown  that  the 
socio-economic  benefits  outweigh  the  risk  to  human  health  or  the  environment  and  no 
suitable alternative substances or technologies are available.  

The  analysis  of  whether  or  not  a  threshold  can  be  set  is  the  responsibility  of  the  applicant, 
based on appropriate data to be provided in the application dossier. It is up to RAC to assess 
this  evaluation  and  to  give  an  opinion.  In  order  to  facilitate  the  Committee's  evaluation  of 
applications  for  authorisation,  the  RAC  has  occasionally  derived  ‘reference’  DNELs  for 
substances already included in Annex XIV (e.g. for DEHP for its reprotoxic properties) and 
‘reference’  dose-response  curves  for  non-threshold  carcinogens  (arsenic  and  hexavalent 
chromium  substances).  Those  reference  values  are  not  legally  binding  but  have  been 
developed by RAC mainly to provide predictability on how it would like the applicants’ risk 
assessment documented.  

Applicants  for  authorisation  of  uses  involving  non-threshold  substances  can  describe  the 
remaining  risk  (after  application  of  proposed  operational  controls  (OCs)  and  Risk 
Management Measures (RMMs)) quantitatively/semi-quantitatively based on information on 
dose-response,  or  qualitatively  if  dose-response  information  is  not  available.  RAC  is  then 
expected  to  give  an  opinion  on  the  appropriateness  of  the  proposed  OCs  and  RMMs  and 
whether  these  are  effective  for  attaining  the  exposure  levels  in  the  applicant’s  exposure 
assessment  and  assure  that  the  exposure  levels  are  as  low  as  technically  and  practically 
possible. This information on the remaining risk is an input to the socio-economic analysis, 
which SEAC will use when developing its view on the health and environmental impacts and 
its subsequent opinion on whether these are outweighed by the benefits of continued use. 

3)  Scientific aspects: what the science tells us on determining thresholds  

3.1. Existence or not of threshold for EDs 

As indicated in section 2, the threshold in the REACH context is the biological or practical 
threshold (e.g. the NOAEL or other thresholds10) that can be determined by experimentation 
and under which no adverse effects are supposed to occur and to which  uncertainty  factors 
are applied to determine the regulatory threshold (DNEL/PNEC).  

EFSA in 2013 stated that "the presence of homeostatic and cytoprotective mechanisms, and 
the redundancy of cellular targets, mean that a certain degree of interaction of the substance 
with the critical sites or their occupancy must be reached in order to elicit a toxicologically 
relevant  effect  (Dybing  et  al.,  2002).  Below  this  critical  (threshold)  level  of  interaction, 
homeostatic  mechanisms  would  be  able  to  counteract  any  perturbation  produced  by 
xenobiotic exposure, and no structural or functional changes would be observed. In certain 

9   

https://echa.europa.eu/documents/10162/13632/information_requirements_r10_en.pdf/bb902be7-a503-

4ab7-9036-d866b8ddce69. 

10  

See footnote 13. 

5 

 
 
 
 
                                                            
developmental stages, homeostatic capacity is limited and this will affect the sensitivity of the 
organism".11  

The  endocrine  disrupters  expert  advisory  group  of  the  Joint  Research  Centre  concluded  in 
2013 that "most experts considered that thresholds of adversity are likely to exist for EDs but 
may  be  very  low  for  individual  EDs,  depending  on  the  mode  of  action,  potency  and 
toxicokinetics  and  that  these  thresholds  may  be  particularly  low  during  foetal  development 
(i.e.  critical  windows  of  sensitivity)  due  to  the  immaturity  of  homeostatic  mechanisms,  the 
immature metabolism as well as the absence of some endocrine axes during sensitive periods 
of foetal life as compared to adult life stages. For these reasons some experts considered it 
uncertain  whether  there  is  a  threshold  during  development.  Several  experts  also  expressed 
the  view  that,  although  thresholds  may  exist,  it  might  be  difficult  to  estimate  with  any 
confidence the biological thresholds of adversity based on currently available standard tests. 
In  addition,  small  changes  in  hormone  levels  during  development  could  have  permanent 
serious consequences for the organism.  

Other experts expressed the view that a threshold of adversity for EDs might be lower in the 
developing organism than in the adult and the nature of the effect might be different (severe, 
permanent  change  in  the  foetus  versus  a  less  severe  effect  in  the  adult),  but  a  threshold  of 
adversity must exist and can be estimated with appropriate testing (involving developmental 
exposure)."12 

3.2. Related uncertainties  

Several  uncertainties  surrounding  the  determination  of  thresholds  were  highlighted  in  the 
debates  between  scientists.  Some  are  specific  to  EDs,  while  most  are  common  to  all 
chemicals. 

3.2.1 Testing methods 

The endocrine  disrupters  expert  advisory group of the Joint Research Centre noted in 2013 
"The  limitation  on  the  methods'  sensitivity  as  well  as  the  possible  lack  of  inclusion  of 
sensitive endpoints relevant to ED."13  

EFSA  in  2013  noted  that  "[…]  a  reasonably  complete  suite  of  standardised  assays  (for 
testing the effects of EAS [endocrine active substances]) is (or will soon be) available for the 
oestrogen,  androgen,  thyroid  and  steroidogenesis  (EATS)  modalities  in  mammals  and  fish, 
with fewer tests available for birds and amphibians. While downstream effects of disruption 
of  some  non-EATS  pathways/modalities  may  be  detectable  in  some  standardised  apical 
vertebrate assays, it is important to recognise that standardised mechanistic assays for non-
EATS modalities relevant to mammals, fish and other vertebrates are not or not yet available. 
For  invertebrates,  relevant  mechanistic  assays  are  lacking  from  the  OECD  testing  suite, 
mainly due to poor understanding of invertebrate endocrinology. Finally, a range of major 
taxa, e.g. reptiles or echinoderms have not yet been considered by OECD for any endocrine 
assay  development.  It  is  unknown  at  present  whether  it  will  be  possible  to  read-across  to 
untested groups from tests with other taxa."14 

11  
12  
13  
14  

EFSA(2013), p. 16. 
"Thresholds for endocrine disruptors and related uncertainties" (2013), p. 11. 
"Thresholds for endocrine disruptors and related uncertainties" (2013), p. 10. 
EFSA(2013), p. 2. 

6 

 
 
 
                                                            
In  addition,  in  relation  to  mammals,  EFSA  identified  as  the  significant  limitation  that  a 
weakness  “of  the  current  suite  of  test  methods  available  for  the  identification  of  EDs  (and 
therefore an area for  further  developing  it)  is the lack of a single study involving exposure 
through  the  complete  life  cycle  of  a  mammal,  from  conception  to  old  age  or  a  single  study 
involving developmental exposure with follow-up into old age”. 15 

EFSA further mentioned, relating in general to developmental toxicants including EDs, that 
“several recent review reports concluded that current mammalian tests do not cover certain 
endpoints  that  might  be  induced  by  exposure  during  foetal  or  pubertal  development  but 
emerge  later  in  life  like  certain  cancers  (breast,  prostate,  testis,  ovarian  and  endometrial) 
and effects on reproductive senescence”.16  

3.2.2 Critical window of exposure  

EFSA  in  2013  stresses  that  the  issues  of  "critical  windows  of  exposure"  are  "not  unique  to 
EAS  [endocrine  active  substances]  but  are  equally  applicable  to  substances  with  other 
mechanisms of action."17 

The  endocrine  disruptors  expert  advisory  group  of  the  Joint  Research  Centre  concluded  in 
2013 “[…] that there is an important difference in maturity and functionality of the endocrine 
system  between  pre-and  post-natal  life.  The  major  issue  the  absence  or  immaturity  of  the 
homeostatic mechanisms, the immature metabolism and the lack of feedback loops as well as 
the  absence  of  fully  developed  endocrine  axes  during  sensitive  periods  of  foetal  life  […]. 
These facts increase significantly the concerns in relation to the existence of a threshold of 
adversity  and  the  possibility,  if  it  exists,  to  be  determined  with  sufficient  confidence.  In 
addition,  a  small  change  in  hormone  levels  during  development  could  have  permanent 
serious consequences for the organism. 

Other experts [of the endocrine disruptors expert advisory group] expressed the view that a 
threshold of adversity for EDs might be lower in the developing organism than in the adult 
and the nature of the effect might be different (severe, permanent change in the foetus versus 
a less severe effect in the adult), but a threshold of adversity must exist and can be estimated 
with appropriate testing (involving developmental exposure). Finally other possibly sensitive 
life  stages  were  mentioned  like  puberty,  pregnancy  and  menopause  for  which  there  is  a 
considerable  lack  of  knowledge.  Non-consideration  of  these  life  stages  in  testing  protocols 
would  be  expected  to  increase  the  uncertainty  in  relation  to  threshold  existence  and/or 
reliable approximation of a threshold".18  

3.2.3 Non-monotonic dose responses and low dose effects  

EFSA in 2013 stresses that the issues of non-monotonic dose response (NMDR) relationships 
are  "not  unique  to  EAS  [endocrine  active  substances]  but  are  equally  applicable  to 
substances  with  other  mechanisms  of  action."19  Concerning  low  doses,  the  endocrine 
disruptors  expert  advisory  group  (EDEAG)  of  the  Joint  Research  Centre  acknowledged  in 

15  
16  
17  
18  
19  

EFSA(2013), p. 30. 
EFSA(2013), p. 37. 
EFSA(2013), p. 46. 
Thresholds for endocrine disruptors and related uncertainties" (2013), p. 9. 
EFSA(2013), p. 46. 

7 

 
 
 
 
                                                            
2013 "that there is still a lack of scientific consensus on the evidence for 'low dose responses' 
and this was reflected in the lack of consensus in the EDEAG".20 EFSA similarly "notes the 
lack of consensus in the scientific community as to the existence and/or relevance of low-dose 
effects and NMDRCs [non-monotonic dose response curves] in (eco)toxicology in relation to 
endocrine disruption, or other endpoints/modes of action."21 

4)  Policy aspects for the routes for authorisation of EDs under REACH 

The consequences in terms of possible regulatory action of whether a threshold for EDs exists 
can be separated into four main options: 

a)  All EDs do not have a threshold 

b)  EDs do not have a threshold, except where it can be demonstrated that a threshold exists  

c)  EDs have a threshold, except where it can be demonstrated that such a threshold does not 

exist 

d)  All EDs have a threshold  

Both,  options  a)  and  d)  are  ruled  out  in  the  light  of  the  on-going  debate  in  scientific 
community as set out in section 3. Options b) and c) are not fundamentally different as they 
require a case-by-case assessment. 

Based upon the information provided in the previous sections it may be difficult (albeit not 
impossible) to determine a safe threshold with reasonable certainty for EDs. 

As is the case for all substances subject to the authorisation requirement under REACH, it is 
the responsibility of the applicant to demonstrate that a threshold exists and to determine that 
threshold  in  accordance  with  Annex  I  to  REACH  and  it  is  up  to  the  RAC  to  assess  the 
validity  of  the  assessment  and  ultimately  decide  on  the  possible  existence  or  not  of  this 
threshold. 

However, in order to increase predictability and legal certainty for applicants, RAC has set on 
a  case-by-case  basis  reference  DNELs  for  threshold  substances,  or  reference  dose-response 
curves for non-threshold substances, which industry can use when applying for authorisation.   
This practice applies for EDs as for other substances. 

5)  Conclusions 

The current legislation in Article 60(3)(a) of REACH already lays down that for substances 
for  which  it  is  not  possible  to  determine  a  threshold,  the  'Adequate  Control  Route'  for 
authorisation is not possible.  

Based  on  the  information  provided  in  the  previous  sections,  it  is  concluded  that  it  is  not 
appropriate  to  extend  a-priori  the  scope  of  Article  60(3)  to  all  substances  identified  under 
Article  57(f)  as  substances  with  endocrine  disrupting  properties  which  have  an  equivalent 
level of concern.  

Consequently, Article 60(3) of REACH will continue to be applicable to those EDs for which 
it  is  not  possible  to  determine  a  threshold.  It  remains  the  responsibility  of  applicants  for 

20  
21  

Thresholds for endocrine disruptors and related uncertainties" (2013), p. 11. 
EFSA(2013), p. 46. 

8 

 
 
 
 
                                                            
authorisation  to  demonstrate  that  a  threshold  exists  and  to  determine  that  threshold  in 
accordance  with  Annex  I  to  REACH.  Even  though  this  might  be  particularly  difficult  for 
EDs, it cannot be excluded on the basis of current knowledge that it will be possible. It is up 
to  RAC  to  assess  the  validity  of  the  assessment  and  ultimately  decide  on  the  possible 
existence or not of this threshold. Furthermore, as for other substances, RAC may on a case-
by-case  basis  set  reference  DNELs,  or  reference  dose-response  curves,  which  industry  can 
use when applying for authorisation. Therefore, as under REACH as it stands today only the 
'Socio-Economic Route' can be used when a threshold cannot be determined, and considering 
the conclusion of the REACH Review that regulatory stability is desirable, the Commission 
will not propose a change to the legislation. 

9