Authorities to focus on substances of potential concern : roadmap for SVHC identification and implementation of REACH risk management measures : annual report, April 2017.
Date: 2017-04-17
Institutions: European Chemicals Agency
Subjects: European Chemicals Agency, activity report, chemical industry, chemical product, chemicals legislation, dangerous substance, database, environmental risk prevention, industrial research, public health, research and development, research method, risk management, toxic substance

Roadmap of SVHC identification and implementation 

of REACH risk management measures 

1 

Progressing together to identify 
substances of concern  

Roadmap for SVHC identification and implementation of REACH risk 
management measures - Annual Report 

April 2017 

 
 
 
 
 
 
 
Roadmap for SVHC identification and implementation of REACH risk management 
measures 

Reference: ECHA-17-R-06-EN 
ISBN: 978-92-9495-867-9 
Cat. Number: ED-AP-17-001-EN-N                                                                           
ISSN: 2443-6127 
DOI: 10.2823/143547 
Date: April 2017 
Language: English 
© European Chemicals Agency, 2017 

If you have questions or comments in relation to this document please send them (quote 
the reference and issue date) using the information request form. The form can be accessed 
via the ‘Contact ECHA’ page at: http://echa.europa.eu/contact 

European Chemicals Agency 

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland 
Visiting address: Annankatu 18, Helsinki, Finland

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

3 

Table of Contents 

Foreword .................................................................................................................... 5 

Executive summary .................................................................................................... 7 

1 

Introduction ......................................................................................................... 9 

2  Screening ........................................................................................................... 11 

3  Data generation and assessment ........................................................................ 17 

4  Risk management option analysis ...................................................................... 25 

5  Moving substances together to regulatory risk management ............................. 33 

5.1  Harmonised classification and labelling ................................................................................. 33 

5.2  Restrictions ....................................................................................................................... 35 

5.3  Authorisation process ......................................................................................................... 37 

ANNEX 1: PROGRESS MONITORING INDICATORS ....................................................................................... 45 

 
 
 
 
 
 
 
 
 
 
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Roadmap of SVHC identification and implementation 
of REACH risk management measures 

List of abbreviations  

Abbreviation 

Description 

ACT 

Art. 

CCH 

CLH 

CLP 

CMR 

CG 

CoRAP 

COM 

ECHA 

ED 

EG 

ELoC 

MS 

PBT 

(Q)SAR 

PACT 

PETCO 

POP 

RAC 

REACH 

RIME 

RIP 

RMOA 

SEv 

Activities Coordination Tool 

Article 

Compliance check under dossier evaluation 

Harmonised classification and labelling 

Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  of 
the  Council  of  December  2008  on  classification,  labelling  and 
packaging of substances and mixtures 

Carcinogenic, mutagenic, toxic for reproduction 

Coordination group 

Community rolling action plan 

Commission 

European Chemicals Agency 

Endocrine disruptor 

Expert group 

Equivalent level of concern 

Member State 

Persistent, bioaccumulative and toxic 

(Quantitative) structure-activity relationship 

Public Activities Coordination Tool 

Petroleum and coal streams 

Persistent organic pollutant 

Committee for Risk Assessment 

Regulation (EC) No. 1907/2006 of the European Parliament and of 
the  Council  concerning  the  Registration,  Evaluation,  Authorisation 
and Restriction of Chemicals 

Risk  Management  Expert  Meeting  of  Member  State  competent 
authorities 

Roadmap implementation plan 

Risk management option analysis 

Substance evaluation 

STOT RE 

Specific target organ toxicity – repeated exposure  

SVHC 

vPvB 

Substance of very high concern 

Very persistent and very bioaccumulative 

 
 
 
  
 
 
Foreword  

Welcome to this report on progress towards having all relevant substances of very high concern 
(SVHCs) on the Candidate List. It is the third such report where you can see details of progress 
and get an impression of the behind-the-scenes work that the Agency together with the Member 
States has been doing to identify the chemicals of most concern. It is also my last foreword, as 
my mandate as Executive Director of ECHA ends this year. For that reason, I want to take a step 
back  and  reflect  on  what  we  have  achieved  since  the  European  Council  adopted  the  SVHC 
Roadmap in February 2013. 

First of all, let’s not forget where we came from. Before REACH, hazardous chemicals consumed 
in Europe were regulated by around 40 pieces of legislation. Now, 10 years after the entry into 
force of REACH and four years after our collective agreement to ensure that the most hazardous 
substances are on the Candidate List, we have 173 SVHCs on the list, more than 200 substances 
with  a  harmonised  classification,  20  new  restrictions  and  over  500  substances  of  potential 
concern under further information generation and assessment. I’m proud of that progress – and 
I hope that you are too.  

Of course, we probably all wish that the process was even speedier – that is why we have decided 
to work more on groups of substances and in collaboration with the relevant sectors – and that 
the policy makers have less hesitation in putting forward new risk management proposals or in 
approving  the  decisions  related  to  SVHCs.  Some  companies  will  inevitably  be  negatively 
impacted  by  these  decisions,  but  others  will  work  on  alternatives  and  reap  the  benefits. 
Predictable and stepwise phasing out of the substances of most concern stimulates innovation 
in new substances and alternative technologies. 

I  also  need  to  mention the  one  fundamental  stumbling  block  for  everything  we  do  to  protect 
human health and the environment – that of the compliance of registrations with the REACH and 
CLP requirements. Put simply, if the data is insufficient for us to make an informed judgement 
about the risks of a chemical, then there are two significant consequences – we and the national 
authorities are wasting time chasing data on innocuous substances and, much worse, we may 
not be prioritising the substances that really are of most concern. This is not a new message. 
It’s one that I have made on almost every occasion when I have spoken or written about our 
work. The compliance of the data provided by companies has got to improve. The best companies 
do this well – they take pride in providing reliable data to us and to their customers and they 
see it as an integral part of their business strategy towards a sustainable future. I am sure that 
the  pressure  on  other  companies  to  follow  suit  will  only  grow,  but  I  for  one  am  becoming 
impatient for this to happen, on behalf of the citizens, in whose name we do this work.  

My  sincere  thanks  go  to  all  our  colleagues  in  the  Member  States  for  their  work  with  us  in 
identifying and addressing substances of concern. I am very pleased to see that, over time, more 
Member States have become involved, which is to everyone’s benefit.  

 
 
 
 
 
 
 
 
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Roadmap of SVHC identification and implementation 
of REACH risk management measures 

Thank  you  for  taking  the  time  to  have  an  interest  in  this  report  and  I  wish  you  –  and  my 
colleagues in ECHA and the Member States – the greatest of success in seeing this work through 
to its satisfactory conclusion: the effective risk management of the most hazardous substances 
in Europe. It’s an important and worthwhile objective, and one that I have been proud to work 
towards over the last 10 years. 

Geert Dancet 

Executive Director 

 
 
 
 
 
 
 
Executive summary 

Early in 2013, the Member States, the European Commission and ECHA agreed a plan 
to have all relevant currently known substances of very high concern on the Candidate 
List  by  2020.  We  are  now  half  way  to  that  goal.  Work  is  progressing  well  and  we 
continue to believe that the target will be met. 

To have the maximum effect in the shortest possible time, it is important to prioritise substances 
where  the  impact  on  human  health  and the  environment  is  highest,  and  to  identify  the  most 
effective  way  of  confirming  and  addressing  the  concerns.  This  objective  is  central  to  ECHA’s 
Integrated Regulatory Strategy and is done collaboratively with the Member States – which is a 
key element of the success of this work. It is equally important that companies can see which 
substances are going to be examined and when – they can then more efficiently play their own 
role in providing information to enable us to make proper selections. This is achieved by listing 
the substances being looked at in the Public Activities Coordination Tool (PACT)  

During  the  first  three  years  of  the  roadmap  implementation,  ECHA  and  the  Member 
States  have  already  addressed  all  the  substances  for  which  there  was  sufficient 
information on the hazard properties. In some cases, the authorities have concluded that 
they do not need further  risk management.  In all other cases, they are in the regulatory risk 
management processes – being identified as SVHCs, being subject to authorisation, having their 
classification harmonised, being restricted, or undergoing an analysis of the risk management 
options. The main focus of the work from now on is identifying substances which could be  of 
concern, but where more information is needed before concluding.  

Each  year,  ECHA  has  screened  the  full  REACH/CLP  substance  database  to  identify  potential 
substances for further work. From this exercise, around 900 substances have been proposed to 
the Member States for further manual screening and in the last three years, more than 600 of 
them have been scrutinised. In 2016, 184 were manually screened and 72 % needed follow-
up  action.  Usually  more  data  is  needed,  which  is  requested  either  as  a  result  of  a  dossier 
compliance check or a substance evaluation. This common manual screening has also brought 
the key actors together – 22 Member States contributed to the manual screening in 2016.  

More than 500 substances are currently having new data generated or are having data 
assessed. Almost half of them are having their dossiers’  compliance checked and for around   
85 % of them we need to clarify whether they have PBT, ED and/or CMR properties. In 2016, 
the data requested for substances in the Community rolling action plan (CoRAP) of 2012/2013 
started to arrive, and more will come in 2017. This data will increasingly enable us to confirm or 
refute the concern identified through screening and to initiate regulatory risk management where 
needed.  

Generating new data and concluding on hazardous properties takes time. However, experience 
shows that the final confirmation of the properties can be done swiftly - even for demanding PBT 
and ED cases. Integrating the different processes and bringing together the expertise of Member 
States  and  stakeholders  has  been  essential  to  achieving  this.  Most  substances  listed  on  the 
CoRAP with potential PBT or ED properties are first discussed in the PBT or ED Expert Group to 
identify the best possible testing. All substances proposed for SVHC identification due to their 
PBT and/or ED properties have also been discussed in these expert groups allowing more efficient 
decision-making.  

Due to the lack of information on the hazards of substances and on how they are used, it is more 
and more difficult to identify substances that warrant further scrutiny. Therefore, we move to 
working more with groups of structurally similar substances. This should speed up the process 

 
 8 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

because  it  should  allow  us  to  draw  conclusions  on  a  larger  number  of  substances.  But  it  also 
requires  more  cooperation  and  coordination  between  ECHA  and  the  Member  States.  Working 
with groups of substances will increase consistency of the authorities’ work. It also helps industry 
to avoid substituting substances of concern with substances that have similar properties.  

The number of RMOAs either under development or concluded slightly increased in 2016, with 
159 substances listed since 2013. Conclusions on 67 RMOAs have been published. Around half 
of those resulted in the conclusion that they be identified as substances of very high concern. 
Those RMOAs have all been followed by the submission of an Annex XV dossier.  

Since 2013, 15 Member States and ECHA have been involved in producing RMOAs. In 2016, the 
number of new RMOAs was lower than in previous years (16 RMOAs). This was partly because 
for  many  cases  further  hazard  information  was  needed.  In  addition,  the  new  screening  has 
reduced the need for them. It is worth noting that four of those RMOAs were developed for large 
groups  of  substances  (e.g.  sensitisers  in  textiles),  thereby  covering  a  much  larger  number  of 
individual  substances.  Nevertheless,  the  overall  number  of  RMOAs  is  substantially  less  than 
originally planned in the roadmap. This year ECHA, together with the Member States and the 
Commission, is reviewing how we implement the SVHC Roadmap, including the RMOA approach 
and its role. 

 
 
 
 
 
 
 
1  Introduction 

The Roadmap for SVHC identification and implementation of REACH risk management measures 
from  now  to  2020  (SVHC  Roadmap)  gives  an  EU-wide  commitment  for  having  all  relevant 
currently  known  substances  of  very  high  concern  (SVHCs)  identified  and  included  on  the 
Candidate List by 2020. 

Furthermore, it supports carrying out and further integrating other REACH and CLP processes 
with a view to starting further regulatory risk management where needed.  

The roadmap endeavours to conclude on all substances, either that: 

1.  they are of concern and these identified concerns need to be addressed; or  

2.  they are of lower concern and do not require further regulatory attention at the moment.  

Several  activities  may  need  to  be  combined  starting  from  screening,  data  generation  and 
assessment, RMOA to finally ending up (or not) in one of the REACH and CLP processes.  

Therefore, the SVHC Roadmap implementation work should also provide a strong basis for the 
work beyond 2020 to identify the substances which matter most and to timely and effectively 
address them under REACH and CLP.  

In  addition,  one  of  the  activities  started  in  2016  is  the  systematic  review  of  the  Roadmap 
implementation.  This  work  will  continue  in  2017  and  be  reported  in  the  annual  report  to  be 
published in 2018. This review evaluates how far we are with the work on the different substance 
groups (or types of hazard properties) and the functioning of the tools set up and agreed to be 
used in the implementation.    

More information on the roadmap and the roadmap implementation plan is available on ECHA’s 
website 1.  

Figure  1  gives  an  overview  of  all  the  activities  and  groups  of  the  REACH  and  CLP  machinery 
serving the SVHC Roadmap and ECHA’s integrated regulatory strategy 2.  

1 Available at: http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/svhc-
roadmap-to-2020-implementation 
2 Available at: https://echa.europa.eu/documents/10162/1564405/mb_59_2015_update_cch_en.pdf/713315f8-7cbd-
4782-a0aa-53621615b965  

 
 
                                           
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Roadmap of SVHC identification and implementation 
of REACH risk management measures 

Figure 1: REACH and CLP machinery serving ECHA’s integrated regulatory strategy and the 
SVHC Roadmap 3. 

3 Clickable version available at: http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-

 
 
 
 
                                           
2 Screening  

Integrating REACH and CLP 
processes to provide a solid basis 
for identifying substances of 
concern.  

Screening  to  find  potential  substances  of  (very  high)  concern  is  an  important  element  of  the 
SVHC Roadmap to 2020 implementation plan as well as an integral part of  ECHA’s integrated 
regulatory strategy to focus on the substances that matter most.  

Bringing processes together 

The  common screening approach is now the  main source feeding substances into REACH and 
CLP processes. These processes include compliance check, substance evaluation, authorisation 
and restriction under REACH, and proposals for harmonised classification and labelling under the 
CLP Regulation.  

By placing the prioritisation of substances at an early stage and by grouping similar substances 
together, the different REACH and CLP regulatory processes are brought together, which ensures 
a  more  consistent  way  of  approaching  substances  in  the  different  processes  and  increased 
efficiency.  

Compliance  check  has  been  further  integrated  into  the  common  screening  in  2016  with  new 
scenarios  developed  to  identify  potential  candidates  for  ECHA.  Substances  identified  for 
compliance check are therefore nowadays the result of both Member States’ manual screening 
and internal screening at ECHA. These are subject to the same prioritisation criteria as shortlisted 
substances with regards to exposure potential.  

In the third round of screening carried out in 2016, 288 substances were added to the shortlist 
as a result of IT-screening and a further 17 substances were added by Member States as a result 
of  their  own  national  prioritisation.  Of  these  305  substances,  184  were  picked  for  manual 
screening. As can be seen in Figure 2, the manual screening concluded that for about 72 % of 
substances follow-up action is needed. Some substances required two parallel regulatory actions 
so the number of outcomes is actually higher than the number of screened substances.  

concern 

 
 
 
 
 
 
 
 
                                           
 
 
 
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Roadmap of SVHC identification and implementation 
of REACH risk management measures 

Figure 2: Manual screening outcome per process and per property (2016) 4 

Several  substances  for  which  ‘currently  no  action’  was  indicated  as  an  outcome  are  actually 
substances for which a pending action on a structurally-related substance is ongoing. This clearly 
shows the importance of looking at substances together (as a group of related substances) and 
not anymore as individual substances.  

4 Further assessment refers originally to further assessment of PBT and ED properties and consultation of the expert 
groups. However it has been recently used to further investigate equivalent level of concern cases, for instance. 

 
 
 
 
 
 
 
                                           
      Behind the numbers – Screening of skin sensitisers 

Simple  numbers  do  not  always  tell  the  full  story.  When  poring  over  the  manual  screening 
results (as reported in the last few SVHC Roadmap annual reports) you will see that MSCAs 
have  manually  screened  about  40  substances  with  a  harmonised  classification  for  skin 
sensitisation.  

Given that there are about 800 registered skin sensitisers with a harmonised classification 
and  that  sensitisation  is  one  of  the  concerns  that  the  SVHC  Roadmap  specifies  should  be 
examined for possible SVHC identification, you might think that not much has been achieved 
so far.  

But this would be short-sighted as it does not take into account other processes and activities, 
particularly  the  work  done  to  prioritise  substances  before  manual  screening  to  focus  the 
resources on those cases where further work can be expected to bring most added value for 
the protection of human health.   

Of the 800 registered substances with a harmonised classification for skin sensitisation, about 
600 have reported uses only at industrial sites, including many uses as intermediates under 
strictly controlled conditions. That leaves only 200 substances with potential widespread uses 
by consumers and/or professionals outside industrial settings.  

But even that does not tell the full story, as many of these 200 or so substances are or have 
been under scrutiny in other processes. In fact, over 100 skin sensitisers have been included 
in manual screening, RMOA, CoRAP or on the Candidate  List,  although  not 
for  skin 
sensitising  but  other  hazard  properties.  This  leaves  about  90  substances  with  potentially 
relevant uses, which have not yet been examined. That is a far cry from the 760 you could 
initially be led to believe.  

In addition, few substances with only skin sensitising properties have been taken up so far 
for manual screening by Member States and/or moved to further regulatory action. If some 
respiratory sensitisers have been identified as equivalent level of concern to CMRs and placed 
on  the  Candidate  List,  this  is  not  the  case  for  skin  sensitisers.  However,  other  regulatory 
measures,  such  as  restriction,  have  been  proposed  or  initiated  based  on  work  carried  out 
under previous legislation or national activities.  

Even though not visible from the numbers, registered and harmonised skin sensitisers have 
been extensively scrutinised under the SVHC Roadmap and therefore systematic screening 
for  skin  sensitisers  by  ECHA  is  discontinued  for  the  time  being.  Lists  of  remaining  skin 
sensitisers are available for those Member States who wish to continue the work. 

Bringing substances together 

Over the last few years, ECHA and the MSCAs have manually screened hundreds of individual 
substances and many substances are either in one of our processes or recently regulated. It is 
becoming  more  common  that  when  a  new  substance  is  identified  for  further  work,  a  related 
substance has already been identified. ECHA has started to more actively identify these groups 
and relationships between substances.  

Working  with  groups  of  substances  from  the  start  and  helping  Member  States  focus  on 
substances with similar or the same properties as those they have worked on in the past will: 

• 

increase  efficiency  and  ensure  a  consistent  approach  to  similar  substances  as  we 
conclude for a higher number of substances within a shorter period of time;  

•  enhance the coherence of authorities’ work through all steps from generation of further 
information  (compliance  check,  substance  evaluation,  other  means  including  direct 
contacts  with  industry)  to  regulatory  risk  management  (harmonised  classification  and 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 14 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

labelling,  SVHC  identification  and  authorisation,  restriction,  but  possibly  also  actions 
under other legislation);  

•  avoid unnecessary testing 

•  maximise the use of available resources by avoiding overlaps or gaps of activities; and 

•  provide transparency and predictability towards industry.  

A grouping approach is also important to identify those  substances, for which there is clearly 
less  information  available  (e.g.  only  registration  with  intermediate  uses  or  C&L  notifications), 
but which could be potential substitutes to substances already identified for regulatory action.  

These  are  called  “supplementary  activities”  in  the  SVHC  Roadmap  Implementation  Plan.  The 
same applies for substances which are currently not on the EU market as such or in mixtures, 
but may be imported in articles. Without a grouping approach those substances would not be 
identified as early as needed to avoid regrettable substitution. 

The shortlist of substances developed in 2016 for Member States to  manually screen in 2017 
has been developed around groups of substances and experience will be gained on how to handle 
those.  This  work  will  be  one  of  the  major  developments  in  2017  and  beyond  in  identifying 
substances of potential concern.  

Grouping can be done in many ways, structural similarity is one but we also use read-across and 
categories built by registrants as well as established categories developed by other bodies (e.g. 
the OECD).  

Similar  uses  or  functions  can  also  be  used  to  group  substances  and  this  will  be  further 
investigated  in  2017.  This  work  will  need  to  be  developed  in  close  cooperation  with  Member 
States.  

Manual screening will likely involve further refinement of the groups as the boundaries of the 
group  may  change  throughout  the  different  regulatory  steps  based  on  further  information  as 
well as the needs of each individual regulatory process.  

Bringing actors of the SVHC Roadmap together 

22 Member States participated in the third round of manual screening with two Member States 
participating for the first time (LU and SI). Not all Member States participate in every round. So 
far,  23  Member  States  have  participated  in  manual  screening.  The  number  of  substances 
screened per Member State is reported in Figure 3. Since the start of the common screening, 15 
Member States have cooperated on over 20 substances sharing expertise and resources.  

 
 
 
 
Figure 3: number of substances screened per Member State and indicative process in 2016. 

As in previous years, ECHA ran a letter campaign for the substances shortlisted based on the IT 
screening in 2016. All registrants of the shortlisted substances were alerted to the fact that their 
substances might be under scrutiny by Member States and invited to review their dossiers with 
regard to identified potential hazards and their use and tonnage information.  

They were also encouraged to review and update their substance identity information and any 
read-across  they  might  have  applied,  if  needed.  The  aim  of  this  campaign  is  to  increase  the 
transparency and predictability of the screening process by letting registrants know that their 
substances were shortlisted as well as to trigger updates (40 % update in four months in 2016) 
of dossiers so that both authorities and registrants focus on the right substances. For instance, 
if some information on uses in the registration dossiers is not up-to-date, the exposure potential 
may be overestimated (see the Evaluation Report 5).  

Moving to working more with groups of substances will entail the need to bring people together 
as well. Different Member States will be brought together to collaborate on larger groups, sharing 
expertise and resources. Cooperation among registrants may also increase as well as cooperation 

5 Available at: https://echa.europa.eu/documents/10162/13628/evaluation_report_2016_en.pdf/f43e244f-7c90-75bd-
e1b2-3771bcb1f8e8  

 
 
 
                                           
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Roadmap of SVHC identification and implementation 
of REACH risk management measures 

between authorities and industry for some specific group of substances. One example of such 
cooperation is the petroleum and coal stream substances (PetCo) working group.  

Working together on groups of substances - PetCo working Group 

Petroleum  and  coal  stream  substances  (PetCo)  have  very  complex  and  variable/partly 
undefined composition (UVCBs). Those substances are of potential concern for human and 
environmental health due to their potential CMR and/or PBT properties, their high volume 
and the indication from the registration data that they are not just used as intermediates 
or in fuels, but also in other uses relevant for regulatory risk management.  

For this group of substances, the SVHC Roadmap notes that there is first a need to develop 
an  approach  on  how  to  address  them.  This  is,  as  in  past  years,  that  these  substances 
were put aside from the prioritisation and screening activities of authorities and NGOs due 
to their complexity. The PetCo working group was set up in 2015 to develop an approach 
to prioritise and address them and also to plan how to practically implement the approach. 
The  group  is  composed  of  Member  States,  the  Commission  and  interested  accredited 
stakeholders.  

PetCo substances are a clear example of a group of substances which need to be looked 
at  in  a  holistic  manner  due  to  their  similarity  of  structure  and  hazard.  The  approach 
developed allows lessons to be learned from the work done on a defined set of substances 
before looking at additional substances. This is to gain efficiency as those substances are 
so  closely  related  and  need  to  be  looked  at  together  to  avoid  duplicating  work  and 
potentially testing. 

The main steps of the approach have been agreed and the working group will now move 
to the implementation phase. The starting point is to prioritise substances based on their 
uses. Substances used by consumers and at professional settings were prioritised to focus 
first on the substances which matter most for the follow up regulatory processes.  

Substances used only as fuels and/or intermediates are considered to be of lower priority. 
Other than for intermediate uses, substances used at industrial settings are regarded as 
a medium priority. The second step in the approach is to consider the (potential) hazard 
of those substances where the benefits of looking at this group of substances together 
will be even more visible in the future and will ensure that substances of high but also low 
hazard concerns are identified.  

Besides  developing  the  approach,  the  work  on  PetCo  substances  has  already  been 
progressing  at  different  levels  such  as  updates  of  information  on  uses  provided  for 
petroleum  substances  (Concawe)  and  ongoing  for  other  substances.  In  2017,  Concawe 
will provide updated dossiers containing updated information on uses. An inventory of all 
substances falling under the approach is also available and industry has committed itself 
to keeping this up-to-date. Parallel assessment and regulatory work has started and will 
progress in 2017. 

Draft work plans on how to address those substances including a list of actions for the 
different actors have been developed and will be further discussed and followed up by the 
group in the future. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3  Data generation and assessment 

Bringing expertise and processes 
together to ensure swift generation of 
data on substances of potential concern 
and to smoothen the further regulatory 
processes.  

Bringing processes and expertise together 

For most of the substances that are currently being looked at by the authorities to assess and 
confirm the SVHC properties, there is a need first to generate further information, go for further 
assessment and/or propose harmonised classification and labelling. Substance evaluation and 
compliance check are the main tools for generating missing hazard information. 

Substances may be under different processes (as reflected in the numbers reported). However, 
in most cases, this work is done in parallel in an effort to use the best combination of the different 
tools to clarify the hazardous properties of those substances in as short time as possible. For 
instance,  all  substances  planned  in  the  CoRAP  for  future  substance  evaluation  will  undergo  a 
compliance check to ensure that standard information is available and to verify further the need 
for substance evaluation to generate additional information. Compliance check and substance 
evaluation  can  also  be  conducted  in  parallel  when  suitable  to  shorten  the  time  to  clarify  the 
concern. Consultation of the PBT and ED Expert Groups is usually done in parallel to substance 
evaluation  to  ensure  a  common  understanding  of  the  information  to  be  generated  before 
entering the decision-making stage of substance evaluation. 

The substance-specific discussions under the expert groups 6 have supported the assessments 
of  PBT  and  ED  properties  and  made  them  fit  better  for  regulatory  purpose.  Since  those 
assessments are scientifically challenging, it is truly beneficial to be able to discuss those cases 
among experts. Experience has shown that this increases the consistency of the assessments, 
and that it smoothens and speeds up decision making under the substance evaluation and SVHC 
identification processes.  

Around 85 % of the substances with potential PBT properties listed on the CoRAP 7 were discussed 
in  the  PBT  Expert  Group.  Of  the  CoRAP  substances    under  evaluation  in  2016,  all  those  with 
endocrine disruption as an initial concern were scheduled for discussion in the ED Expert Group, 
but as the evaluating Member State did not have sufficient resources  to prepare the  cases in 
time discussions only took place for around 60 % of them. All substances which Member States 

6 In addition to CoRAP substances, PBT and ED expert groups can discuss other substances including substances not in 
the scope of REACH (for example, biocides and veterinary medicine) 
7 Available at: http://echa.europa.eu/regulations/reach/evaluation/substance-evaluation/community-rolling-action-
plan 

 
 
 
 
 
 
 
 
                                           
 
 18 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

have proposed to include in the Candidate List due to their PBT and/or ED properties have first 
been discussed in the PBT and ED Expert Groups. 

Besides the assessment of PBT and ED properties of substances, the two expert groups discuss 
how  to  improve  methodological  aspects  of  the  assessment.  An  example  of  this  work  is  the 
ongoing update of the PBT guidance.  

Figure 4 gives an overview of substances under “generation of data and assessment” either via 
substance  evaluation or discussions in the PBT or  ED  Expert Groups per Member. 24 Member 
States have been active so far in substance evaluation whereas the number of Member States 
contributing to the PBT and ED Expert Groups are 19 and 9 8 respectively. 

Figure 4: Number of substances under assessment per Member State in the ED Expert Group, 
PBT Expert Group and substance evaluation. 

8 17 Member States participate to the ED Expert Group but so far only 9 Member States have brought substances for 
discussion. 

 
 
 
 
 
                                           
Bringing numbers together 

An overview of all substances under assessment from 2012, which corresponds to the set-up of 
the PBT Expert Group and the first cases under substance evaluation, until the end of 2016 is 
provided in Table 1 below. Some substances may be present and therefore counted under both 
substance evaluation and PBT/ED Expert Group. Note also that the ED Expert Group was set up 
only in 2014.  

Table 1: Overview of the number of substances under PBT and ED Expert Group and 
substance evaluation (2012 - 2016)     

Ongoing 
assessment 

Concluded 
assessments 

Postponed 
assessment 

PBT Expert Group 

ED Expert Group 

Substance evaluation 

109 

34 

172 

38 

13 

49 

11 

1 

- 

Total 

158 

48 

221 

In addition to the substances that are dealt with in substance evaluation and by the PBT and ED 
Expert  groups,  ECHA  has  since  2015  looked  at  250  high  priority  substances  (substances  that 
matter) under compliance check 9. For around 87 % of these substances the suspected concerns 
related to CMR and/or PBT properties. 67 of these are CoRAP substances for which substance 
evaluation has not yet been started.   

A summary of the information requested in ECHA decisions in 2016 is provided in Figure 5 as 
reported in the Evaluation Report5. The first results of the follow-up evaluations of data received 
after the compliance checks of high priority substances will not be available before the end of 
2017.  More  information  on  the  outcome  of  compliance  checks  is  available  in  the  Evaluation 
Report5.  

9 Substances on which ECHA has started a compliance check have been counted and not the number of 
dossiers. 

 
 
 
 
 
 
                                           
 20 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

Figure 5: Information requested in the 152 adopted ECHA compliance check decisions taken in 
2016 (Evaluation under REACH progress report 20165). 

Figure  6  provides  an  overview  of  number  of  substances  which have  been  or  are  assessed  for 
their CMR, PBT/vPvB, ED and sensitisation properties.  

 
 
 
Figure 6: Substances and properties under “assessment” (2012-2016)  

So far, the potential PBT/vPvB properties of 173 substances have been assessed under substance 
evaluation or discussed by the PBT Expert Group (or both of them). Similarly 73 substances with 
potential ED properties have been looked at. 116 CMRs and 50 sensitisers are (or have been) 
under assessment in the context of substance evaluation.  

Under substance evaluation, in most cases more than one property can be of concern for a single 
substance  (for  example,  one  substance  can  be  both  a  potential  PBT  and  a  potential  CMR). 
Therefore, the total number of substances under each concern is not equal to the total number 
of substances under evaluation.  

The final conclusion and confirmation on the PBT and ED properties can only be achieved through 
the  SVHC  identification  process  and  inclusion  on  the  Candidate  List.  Similarly  for  CMR  and 
respiratory  sensitisers,  the  final  conclusion  and  confirmation  can  be  achieved  through  the 
harmonised classification and labelling process and inclusion in Annex VI to the CLP Regulation. 
For further information on those processes, see section 5.  

 
 
 
 
 
 22 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

Behind the numbers – How many substances are under generation of 
data and assessment? 

540 substances are under generation of data or assessment either in substance evaluation 
(CoRAP), compliance check or one of the expert groups or under more than one activity 
(e.g. both in the CoRAP and under assessment in the PBT/ED Expert Groups).  

This  number  includes  both  ongoing  assessments  and  concluded  ones.  Among  the  540 
substances, 311 are either under substance evaluation and/or one of the expert groups. 

The  remaining  229  substances  are  under  compliance  check  and  considered  as  ongoing 
assessment.  

Moving substances together to regulatory risk management 

CMRs with harmonised  classification and PBT/vPvB  substances identified prior to REACH have 
been considered by the authorities in previous years for further regulatory risk management as 
reported in the two previous annual reports 10.  In some cases, the authorities have concluded 
that they do not need further risk management. In all other cases, they are in the regulatory 
risk management processes – being identified as SVHCs, being subject to authorisation, having 
their  classification  harmonised,  being  restricted,  or  undergoing  an  analysis  of  the  risk 
management options. New potential CMRs and PBT/vPvB substances are either under generation 
of data or assessment.  

Tables 2 and 3 report on the number of substances for which a conclusion has been made on the 
hazard properties under assessment in the context of substance  evaluation (Table 2) and the 
PBT/ED Expert Groups (Table 3).  

As already highlighted in the annual report 2015, few substances have been concluded so far 
and  among  those  very  few  fulfil  the  hazardous  properties.  Screening  criteria  need  to  capture 
potentially important borderline cases. Therefore, we also pick substances with weak indications 
of  the  PBT/ED  properties.  It  is  often  possible  to  confirm  that  they  do  not  fulfil  the  hazardous 
properties without further testing. Which is why the first concluded substance evaluation cases 
have often refuted the suspected properties (see Table 2).  

The confirmation of suspected PBT/ED properties normally requires discussion on the best testing 
strategy  and  generation  of  data.  The  first  conclusions  for  substances  for  which  data  were 
requested have been discussed in 2016, but more are expected to arrive from 2017 onwards.  

10 Available at https://echa.europa.eu/documents/10162/19126370/svhc_roadmap_2016_en.pdf/4c99ad17-fc00-
48f1-9ada-5c5945ee7b83 and 
https://echa.europa.eu/documents/10162/19126370/svhc_roadmap_2015_en.pdf/38512385-2a46-455e-b2cd-
3a52c1ad63f7 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                           
 
 
Table 2: Number of substances under substance evaluation and concluded per property and 
conclusions where relevant (2012 - 2016) 

Property 

Number of 
substances per 
property ongoing 

PBT 

ED 

CMR 

69 

49 

89 

Sensitiser  

37 

Total number of 
substances per 
property concluded 

Number of substances per property 
concluded  

Considered to fulfil 
the hazard 
properties 

Considered not to 
fulfil the hazard 
properties 

16 

11 

29 

17 

0 

2 

11 (2 12) 

13 (612) 

15 11 

811 

18 

4 

Most  of  the  substances  discussed  in  the  PBT  and  ED  Expert  Groups  are  substances  under 
substance evaluation, which explains why so few substances are also concluded at that level. It 
should  however  be  highlighted  that  once  data  are  available,  the  process  of  identifying  the 
substances as either PBT or ED can be very quick. For instance, three (groups of) substances 
that were discussed in the ED Expert Group in 2016 are already included on the Candidate List 
due to their endocrine properties. 

Generation of data and assessment of suspected PBT/vPvBs takes time  

In  2016,  the  first  two  cases  of  substances  for  which  data  requested  under  substance 
evaluation (CoRAP, 2012) were submitted by the registrant and brought by the evaluating 
Member States for discussion to the PBT Expert Group. Eight more cases (CoRAP 2012, 
2013)  for  which  new  data  was  generated  and  recently  submitted are  expected  to  be 
discussed in 2017. For most of these substances the evaluating Member States proposed, 
in line with the available guidance, a tiered testing starting from persistency.  After the 
first  data  submission,  there  may  be  another  tier  of  testing  for  bioaccumulation  and/or 
toxicity.  

The data generation takes considerable time. Since over time PBT substances accumulate 
in the environment, the experience gained so far by ECHA and the Member States will be 
used to reduce the overall time spent to identify and regulate these substances. 

11 One substance has been suspended awaiting the outcome of another substance evaluation. 
12 89 CMR under assessment, 29 concluded of which 11 considered to fulfil the hazard properties (among which 2 
newly identified or classification upgraded) and 18 not considered to fulfil the hazard properties. 
37 under assessment, 17 concluded of which 13 considered to fulfil the hazard properties (among which 6 newly 
identified or classification upgraded) and 4 not considered to fulfil the hazard properties. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                           
 
 
 
 
 
 24 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

Table 3: Number of substances concluded under the PBT and ED Expert Groups and 
conclusions where relevant (2012 - 2016) 

Property 

Total 
number of 
substances 
concluded 

Number of 
substances 
ongoing 

Number of substances concluded  

Considered to fulfil 
the hazard 
properties 

Considered not to fulfil the 
hazard properties 

PBT Expert Group  

ED Expert Group  

109 

34 

38 

13 

1 

8 

37 

5 

One  way  to  increase  efficiency  and  speed  up  the  process  is  to  look  at  structurally-similar 
substances  together  from  the  screening  onwards.  Groups  of  substances  are  already  being 
assessed during data generation and assessment processes (substance evaluation compliance 
check and PBT/ED Expert Groups) and this will most probably be strengthened in the future as 
screening  moves  towards  working  with  groups  of  substances.  This  helps  to  ensure  that  the 
generation  of  data  is  done  on  those  substances  which  can  be  used  later  on  to  clarify  the 
properties of other structurally-related substances.  

An  example  of  working  with  groups  of  substances  is  the  work  ongoing  on  perfluorinated 
substances where in addition to covering several substances at a time the work done will ensure 
regrettable substitution is avoided.  

Moving substances together – work on the group of PFASs 

Seven long-chained perfluorocarboxylic acids (PFCAs) were identified as SVHCs between 
2013 and 2016 (PBT or vPvB depending on the case). None of these are registered (yet) 
under REACH. However these substances are on the EU market in goods and found in the 
nature, living environment and also in humans.  

SVHC  identification  can  be  used  to  restrict  these  substances  in  articles.  It  also  gives  a 
clear signal to industry that these are not suitable alternatives.  

In  addition,  a  high  number  of  precursors  of  these  PFCAs  have  been  identified,  which 
together  with  the  PFCAs  are  the  target  of  regulatory  risk  management  work.  The  first 
restriction on part of the group (“PFOA”-related substances) is already agreed upon. 

Due  to  the  extreme  persistence  of  the  per-  and  polyfluoroalkyl  substances  (PFASs), 
exposure caused in the past will unfortunately remain in the environment for decades and 
for even longer. Learning from the experience on PFCAs, the short-chained PFASs (which 
are also extremely persistent), are now the focus of the joint work of the Member States, 
the Commission and ECHA to clarify their properties and move them forward to regulatory 
action,  where  necessary.  The  work  on  a  handful  of  substances  will  be  used  to  address 
tens, if not hundreds of precursors. 

 
 
 
 
 
 
 
 
 
 
 
4  Risk management option analysis 

Progress  in  identifying  substances 
of  concern  for  regulatory  action, 
together  with  authorities  and 
stakeholders 

The purpose of a risk management option analysis (RMOA) is to help authorities decide whether 
further regulatory risk management activities are required for a substance and if so, to identify 
the most appropriate instrument to address a concern.  

Sharing  the  RMOA  early  with  other  authorities  allows  them  to  give  an  early  input  on  the 
information available, concerns and/or views on the benefits and drawbacks related to the use 
of different risk management instruments.  

This  in  turn  provides  a  better  basis  to  decide  on  whether  and  how  to  proceed  with  further 
regulatory  risk  management  (RRM)  as  well  as  input  to  drafting  the  RRM  dossier.  The  RMOA 
process also allows early consideration and preparation by other authorities for the regulatory 
processes, which can lead to speeding up the formal opinion forming and decision making.  

Furthermore, it can be used to increase transparency and predictability of authorities’ work and 
by that help the stakeholders prepare for the regulatory processes. 

Bringing authorities together 

Since the start of the SVHC Roadmap in 2013, MSCAs and ECHA have been developing RMOAs 
for  substances  of  potential  concern,  many  of  which  have  come  from  the  manual  screening 
process mentioned in Section 2. Implementing the RMOA concept follows a quite standard path, 
with the process positively received by interested parties.  

Currently for 159 substances an RMOA is under development or concluded. 15 Member States 
have been represented in this RMOA work since 2013 when the work on the implementation of 
the SVHC Roadmap started. In some cases, RMOAs have been developed in cooperation between 
more than one member states. Figure 7 illustrates the split of the work on RMOAs per authority. 

 
 
 
 
 
 
 
 
 
 26 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

Figure 7: number of RMOAs per authority. 

Platforms such as the Risk Management Expert (RIME) and SVHC Human Health Coordination 13 
(SVHC CG HH) meetings play a role in bringing authorities together and ensuring these activities 
are coordinated. Authorities can exchange views through these platforms, which increases the 
common  understanding  on  how  to  best  regulate  substances  and  adds  harmonisation  to  the 
regulatory  actions  taken  on  (groups  of)  substances.  One  example  is  the  discussion  that  took 
place  on  how  to  regulate  substances  containing  impurities  of  very  high  concern  which  will  be 
integrated in the overall review of the SVHC Roadmap implementation that started in 2016. This 
review  and  its  outcome  will  be  further  reported  in  the  next  year  annual  report  of  the  SVHC 
Roadmap in 2018. 

13 Both RIME and SVHC HH CG description are available at: https://echa.europa.eu/addressing-chemicals-of-
concern/substances-of-potential-concern  

 
 
 
   
 
 
 
 
 
                                           
Substances containing impurities of very high concern – an example of 
working together by authorities 

The  SVHC  Roadmap  increases  the  focus  on  potential  SVHCs  due  to  the  presence  of 
impurities, and calls for a more systematic identification and assessment of these cases.  

The  “SVHC  Roadmap  to  2020  Implementation  Plan”  foresees  that  the  core  screening 
activities  should  identify  “(not  yet  scrutinised)  CMR  substances”  and  “sensitising 
substances” “which have harmonised classification due to group entries of Annex VI or due 
to constituents, impurities or additives which are in Annex VI”. 

In 2016, ECHA and 7 Member States (AT, BE, DE, DK, IE, NL, SE) worked together to focus 
on  the  issue  of  how  to  approach  potential  SVHCs  due  to  their  impurities,  based  on  the 
experience gained so far.  

Elements  to  consider  when  assessing  the  most  appropriate  risk  management  option  for 
substances containing impurities of very high concern were defined. A non-exhaustive list 
of possible prioritisation criteria for selecting such cases was put forward. 

Bringing substances together  

The experience so far is that authorities have not only addressed individual substances in RMOAs 
but have also focused on some groups of substances due to similar hazards and/or uses.  

The RMOA step supports cooperation among authorities who are looking at similar substances 
before entering one of the REACH/CLP processes. At the RMOA stage, authorities can share the 
workload, avoid overlapping work and ensure consistency of their actions on similar substances.  

Figure 8 gives the number of RMOAs concluded or under development from the implementation 
of the SVHC Roadmap in 2013 to the end of 2016 per hazardous property. Some RMOAs cover 
more than one substance (e.g. lead and its compounds) or even a group of substances having 
the same hazardous property (e.g. skin sensitisers in textile articles).  

For 67 RMOAs, a conclusion is available and for the remaining 92, the RMOA work is still under 
development.  In  2016,  17  RMOAs  were  concluded  and  intentions  for  16  new  RMOAs  were 
indicated. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 28 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

Figure 8: Number of RMOAs concluded and under development per hazardous property 
(February 2013 – December 2016 14) 

The majority of RMOAs are still for CMR substances with a harmonised classification. However, 
the number of RMOAs investigating substances with ED and PBT properties has been increasing 
steadily for two years now. On the contrary, the number of RMOAs analysing substances with 
sensitising properties is reducing.  

As more and more substances progress under either substance evaluation, compliance check or 
in  the  PBT  and  ED  Expert  Groups,  the  number  of  RMOAs  covering  substances  with  those 
properties can be expected to continue to increase. However, it should be kept in mind that, as 
the generation and assessment of information often takes substantial time, it will also take more 
time before the RMOAs can be concluded as reflected also in section 3. 

RMOAs  are  also  developed  for  groups  of  substances.  Examples  of  such  groups  are  the  RMOA 
submitted  on  skin  sensitisers  in  textile  articles  or  the  RMOA  on  isocyanates  submitted  by 
Germany for which the outcome was the need to restrict this group of substances due to their 
same hazardous properties and uses.  

In 2016, 4 of the 16 new intentions to initiate an RMOA were for groups of substances. They are 
C9-C14 PFCAs including their salts and precursors; perchloric acid and its salts; skin sensitising 
substances in textile articles; and phenol, dodecyl-, sulfurised, carbonates, calcium salts.  

The lower number of new RMOAs intentions in 2016 is partly due to the fact that for many cases 
further  hazard  information  is  needed  to  confirm  the  concern  first.  Furthermore,  common 
screening was not yet in place when the SVHC Roadmap was agreed. MSs are currently able to 

14 The data reported in the table are until the latest update of PACT in 2016 (20 December 2016). 

 
 
 
                                           
 
better  select  cases  to  the  RMOA  and  those  which  do  not  merit  the  assessment  of  risk 
management options are concluded already in screening phase. Nevertheless the overall number 
of  RMOAs  is  substantially  less  than  originally  anticipated  in  the  SVHC  roadmap.  Further 
discussion with Member States and the Commission is foreseen to identify the reasons for this 
difference compared to the original ambition and agree on how to address the situation.    

RMOA  on  a  group  of  substances  -  skin  sensitisers  in  textile  articles 
(started and completed in 2016) 

The RMOA on skin sensitisers in textile articles has the potential to have a wider regulatory 
impact.  The  bigger  picture  behind  this  RMOA  is  the  possible  future  regulation  of 
approximately 20 substances classified as skin sensitisers used in textile articles.  

Helen  Klint  from  the  Swedish  Chemicals  Agency  (Kemi)  explains  that  the  decision  to 
conclude  the  RMOA  suggesting  restriction  as  the  most  appropriate  regulatory  risk 
management  was  made  in  the  knowledge  that  not  all  of  the  information  needed  for  a 
restriction proposal has been gathered or analysed yet, at the RMOA stage.  

Kemi believes it is more beneficial to communicate the preliminary RMOA conclusion at as 
early  a  stage  as  possible,  rather  than  waiting  until  all  information  is  gathered/analysed 
before concluding the RMOA. A more comprehensive data gathering and analysis exercise 
will take place as part of the preliminary steps towards preparing a restriction proposal.  

Kemi  will  revisit  the  RMOA  at  the  beginning  of  2018  to  reflect  a  more  final  decision  on 
whether or not to move forward with a restriction proposal. This will also take into account 
progress  with  restrictions  proposals  for  CMRs  in  textile  articles  (COM)  and  tattoo  inks 
(ECHA). 

Link:https://www.kemi.se/files/8040fb7a4f2547b7bad522c399c0b649/report6-14-chemicals-in-
textiles.pdf.  

Bringing processes together 

There are several potential sources of RMOA candidates e.g. from manual screening or substance 
evaluation, both of which are carried out by Member State competent authorities (MSCAs). RMOA 
can also reflect the outcomes of the hazard assessment done in the context of the PBT and ED 
Expert  Groups.  Therefore,  RMOA  sits  at  the  interface  between  screening/substance 
evaluation/hazard assessment and regulatory risk management. RMOA can also come before or 
after  the  harmonised  classification  and  labelling  process.  In  addition,  RMOA  thinking  can  and 
should   be embedded in the whole process starting from screening. The RMOA will evolve as 
the substance moves from one step to the next.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 30 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

Interlinks between the ED Expert Group, RMOA and cooperation between 
authorities 

The Austrian work on the environmental endocrine disruptor assessment of heptylphenol 
progressed  in  parallel  with  the  elaboration  of the  RMOA,  in  collaboration  with Germany. 
The ED assessment was based on data for heptylphenol itself and on a read across to four 
very similar alkylphenols that had been assessed as endocrine disruptors by Germany.   

Running the ED assessment and RMOA processes in parallel worked well, as the conclusion 
on the hazard of a substance is one part of the RMOA. While the ED assessment progressed 
independently  from  the  RMOA  work,  the  RMOA  depended  on  the  result  of  the  ED 
assessment.  

The working assumption for the RMOA was that the ED criteria would be fulfilled for the 
substance.  The  right  timing  of  discussions  in  the  ED  Expert  Group  (through  written 
procedure) and RiME was important to get the most benefit from both consultations.   

Discussions on substance identity during the ED assessment phase also led to a broader 
scope in the SVHC identification (group entry for all 4-heptylphenols, branched and linear), 
which was identified as the best risk management option in the RMOA.  

The whole process of RMOA in combination with ED assessment took longer than a usual 
RMOA.  However,  Austria  was  able  to  finalise  the  ED  assessment,  RMOA  and  the  SVHC 
dossier within 10 intense months of work, which was shorter than if the steps had been 
taken in sequence.  

The  fruitful  cooperation  with  the  colleagues  from  Germany  was  very  helpful  during  the 
different phases of this work. 

Using  the  RMOA  approach  from  the  start  and  updating  the  RMOA  once  new  information  is 
available, helps to identify the best combination of processes for each case. It also reduces the 
number  of  steps  and  overall  time  needed  to  conclude  on  whether  or  not  the  (group  of) 
substances require further regulatory risk management and which option to take.  

Table 4 provides the number of RMOAs concluded per proposed follow-up regulatory action at 
the end of each year since the start of the SVHC Roadmap.  

For almost half of the substances (24), the proposed follow-up was identification as an SVHC. 
This is similar to what was already observed last year and confirms that the impact of the SVHC 
Roadmap starts to be visible particularly in identifying SVHCs.  

The number of RMOAs concluding on the need for other EU legislation and/or other measures 
has also increased, which confirms that the RMOA tool is open and can in practice serve other 
legislation than regulatory risk management under REACH and CLP. 

 
 
 
 
 
 
 
 
 
Table 4: Cumulative number of RMOAs concluded per proposed follow up regulatory action 
(February 2013 - December 2016) 

By end of 2014 

By end of 2015 

By end of 2016 

SVHC identification (authorisation) 

REACH restriction 

CLH 

Other EU-wide regulatory  action 

Other (e.g. non EU-wide and/or non - 
regulatory actions) 

No follow-up action 

5 

1 15 

1 

2 

1 

5 

16 

5 

2 

3 

2 

11 

24 

6 

4 

5 

3 

15 

Varying RMOA development time 

There is no deadline for performing an RMOA. It can be initiated by an authority at any 
point and the time it takes to carry out the RMOA can vary.  

The  main  factor  contributing  to  the  time  it  takes  is  the  complexity  of  the  case.  If  the 
hazardous  properties  of  the  substances  need  to  be  assessed,  this  can  take  longer  than 
with cases where the hazardous properties are already known. Consultation with industry 
and cooperation between the MSCAs can also lead to more time being needed, however 
this additional time is generally felt to be time well spent.   

Sometimes it can be difficult to conclude on the best RMO for substances, considering the 
specificities of the case itself. Resources available at the start of an RMOA may also be re-
allocated to tasks with regulatory deadlines, for example. Priorities in authorities can also 
change,  which  can  mean  that  the  focus  is  sometimes  moved  to  substances  of  higher 
priority. 

Engaging stakeholders  

Stakeholders can follow the substances undergoing RMOA in the Public Activities Coordination 
Tool (PACT). This provides increased transparency and greater predictability. Anyone who wants 
to know when a substance is on an authority’s radar for regulatory risk management can find 
this information at a very early stage.  

Stakeholders can see what substances are being analysed for possible further risk management 
before  they  become  part  of  a  formal  risk  management  process,  for  example,  harmonised 
classification and labelling, SVHC identification or restriction. Early awareness that a substance 
may be taken down a risk management route enables companies to assess how they are using 
the substance and whether or not it is possible to replace it with a safer alternative. It also gives 

15 One RMOA covering 11 substances, which is the reason why it is indicated as one only, even though there are 11 
entries in PACT. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                           
 
 
 32 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

more time for interested parties to prepare to contribute to the public consultations, which are 
run  during  the  formal  risk  management  processes.  Anyone  with  data  on  the  substance, 
information on safer alternatives or other material will have more time to prepare. Registrants 
also have the chance to make sure that their registration data is up to date. 

Another  consequence  of  publication  in  PACT  is  that  MSCAs  are  consulting  with  industry 
representatives,  stakeholders and national institutions/government departments. The benefits 
of working together with industry during the RMOA stage have clearly been highlighted by both 
authorities and industry Whereas this can prolong the time it takes to develop the RMOA, this 
additional time is generally felt to be time well spent. 

Consultation of stakeholders by authorities – The example of Germany  

The  Federal  Institute  for  Occupational  Safety  and  Health  (BAuA)  makes  every  effort  to 
engage  with  industry  during  the  RMOA  stage  by  opening  a  consultation  on  the  German 
RMOAs under development from their Helpdesk web pages. Frauke Averbeck from BAuA 
explains it is important that there is a balance between effective RMOA work by authorities 
and transparency.  

For  the  German  competent  authority,  the  main  benefit  of  these  consultations  is  the 
valuable information received, which Frauke explained can often be useful to understand 
the potential exposure to or release of the substance. Additional information received can 
also  give  a  “feeling”  about  alternatives  and  what  the  consequences  of  taking  particular 
regulatory risk management action are. This can be very valuable at the RMOA stage in 
order to arrive at a sound conclusion.  

Feedback suggests that BAuA’s efforts to consult during the RMOA drafting stage, are very 
much appreciated from a transparency point of view.  

Link:  http://www.reach-clp-biozid-helpdesk.de/en/REACH-en/SVHC-Roadmap-en/DE_RMOA-Liste-
en/DE_Stoffliste-en.html.  

 
 
 
 
 
 
 
 
 
5  Moving substances together to regulatory risk 

management  

The Commission has defined the SVHC Roadmap as a roadmap which will form a strong basis 
for further work of all authorities together on SVHC assessment and identification beyond 2020, 
but  which  also  should  ensure  progress  in  other  areas  of  REACH  (for  instance,  restriction). 
Therefore, the picture would not be complete if the regulatory follow up steps were not reported.  

An  RMOA  could  result  in  different  follow  up  REACH  and  CLP  regulatory  risk  management 
processes such as SVHC identification and inclusion on the Candidate List for eventual inclusion 
in Annex XIV (Authorisation List), restriction or harmonised classification and labelling proposals. 

Regulatory risk management activities are reported since the entry into operation of REACH in 
2008. The impact of the SVHC Roadmap on regulatory risk management activities in the early 
stages of implementation needs to be interpreted cautiously as part  of the  regulatory actions 
outlined below may still result from screening/RMOA activities before the SVHC Roadmap was 
implemented.  

In most cases, there will be a delay in time between when an RMOA is concluded and the actual 
start  of  a  formal  regulatory  process.  Moreover,  the  initial  conclusions  of  an  RMOA  for  a  given 
substance or group of substances can be updated with newly available information and/or further 
considerations by a Member State/ECHA (at the request of the European Commission). 

Member  States  may  also  carry  out  an  RMOA  outside  of  the  SVHC  Roadmap  implementation 
context  (for  example,  as  a  result  of  a  national  programme/national  priorities).  Additional 
information on regulatory activities is available on a yearly basis in ECHA’s General Report 16. 

5.1  Harmonised classification and labelling 

Substances  which  fulfil  the  criteria  for  carcinogenicity,  mutagenicity,  reproductive  toxicity  or 
respiratory sensitisation in any category, should normally be subject to harmonised classification 
and labelling (CLH). Classification of active substances in biocidal or plant protection products 
(BPs and PPPs) should also be harmonised. For all other hazardous substances, a harmonised 

16 Available at: http://echa.europa.eu/about-us/the-way-we-work/plans-and-reports  

 
 
 
 
                                           
 
 34 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

classification and labelling can be sought, if a justification is provided that shows such an action 
is required at an EU level. 

Figure 9 reports the number of proposals adopted by the Committee for Risk Assessment (RAC) 
from 2009 until December 2016 and Figure 11 shows the number of proposals submitted during 
the  same  period.  Numbers  are  further  broken  down  into  proposals  for  active  substances  in 
biocidal and plant protection products (BPs and PPPs) and other substances, mainly those subject 
to  REACH  registration.  As  can  be  seen,  the  majority  of  substances  subject  to  CLH  are  active 
substances in PPPs/BPs. The number of REACH substances for which a classification for new 17  
and existing CMRs 18 was adopted is also reported. 

Figure 9: Numbers of CLH opinions adopted by RAC from 2009 – December 2016 and a 
breakdown of REACH substances for which a CMR 1a or 1b and/or sensitiser proposals was 
included. 

Figure 10 gives an overview of Annex VI CLH dossiers submitted by each country.  

17 New CMR means the substances were not classified as CMR before. 
18 Existing CMR means the substances were already classified as CMR and the proposal was to amend something other 
than the CMR classification. 

 
 
 
 
 
 
 
 
                                           
Figure 10: Number of CLH proposals submitted per Member State (2008 – December 2016) 

5.2  Restrictions 

Restrictions limit or ban the manufacture, placing on the market or use of  certain substances 
that pose an unacceptable risk to human health or the environment.  

A Member State or ECHA, at the request of the European Commission or on its own initiative in 
certain  circumstances,  can  propose  restrictions  if  they  assess  there  is  a  risk  that  is  not 
adequately controlled and there is a need for action at the Union level. 

Table  5  gives  the  number  of  restriction  proposals  adopted  or  going  through  the  restrictions 
process from 2009 until December 2016. 

 
 
 
 
 
 
 
 36 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

Table 5: Number of restriction proposals adopted or going through the restriction process 

Step 

PBT 

ED 

CMR 

Sensitiser 

Other 

Restrictions included in Annex XVII 

Restriction process ongoing 

Sent to Commission, but not yet in 
Annex XVII 

Total (only the ones with 
substance scope in RoI) 

1 

0 

2 

3 

1 

0 

0  

1 

7 

1 

1 

9 

2 19  

0 

0 

2 

1 

1  

1 

3 

Figure 11 gives an overview of Annex XV restriction dossiers submitted per country. 

Figure 11: Number of restriction dossiers submitted per Member State and by ECHA  
(2009 – December 2016) 

19 One of the substances restricted is Chromium VI which is also a CMR substance, but is only considered here as a 
sensitiser as it is the scope of this restriction “Chromium VI in leather articles”. 

 
 
 
 
 
 
 
 
                                           
5.3  Authorisation process 

5.3.1  Introduction  

In 2008, the first substances of very high concern (SVHCs) under REACH were identified marking 
the start of the REACH authorisation process 20.  

Figure 12 gives an overview of the number of substances identified as SVHCs, recommended for 
inclusion in the Authorisation List (Annex XIV) and finally included on the Authorisation List from 
2008  until  the  end  of  2016.  These  numbers  are  further  explained  below  in  their  respective 
sections. 

Figure 12: General overview of the number of substances on the Candidate List, recommended 
for inclusion in Annex XIV (Authorisation List) and included in Annex XIV. 

5.3.2  SVHC identification 

A Member State or ECHA, at the request of the European Commission, can propose a substance 
to be identified as an SVHC. SVHCs: 

•  meet the criteria for classification as carcinogenic, mutagenic or toxic for reproduction 

(CMR) (category 1A or 1B); 

•  are  persistent,  bioaccumulative  and  toxic  (PBT)  or  very  persistent  and  very 

bioaccumulative (vPvB); or  

20 For more information on authorisation see: http://echa.europa.eu/regulations/reach/authorisation 

 
 
 
                                           
 
 38 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

•  are identified on a case-by-case basis for which there is scientific evidence of probable 
serious effects that cause an equivalent level of concern to CMR or PBT/vPvB substances. 

If identified as an SVHC, the substance is added to the Candidate List. The Candidate List includes 
candidate substances for eventual inclusion in the Authorisation List (Annex XIV). Furthermore, 
inclusion  of  a  substance  on  the  Candidate  List  creates  legal  obligations  for  companies 
manufacturing,  importing  or  using  such  substances,  whether  on  their  own,  in  mixtures  or  in 
articles. 

Since 2008, 173 substances have been identified as SVHCs and included on the Candidate List. 
The properties leading to inclusion on the Candidate List are listed in Figure 13. Some substances 
cover more than one hazardous property as illustrated below.    

Figure 13: Substances on the Candidate List and overview of their hazardous properties  

In 2016, five more substances have been identified and included on the Candidate List while the 
Member State Committee (MSC) could not reach a unanimous agreement on four cases which 
were  then  sent  as  MSC  opinions  to  the  European  Commission  for  final  decision-making  (see 
Table 6). 

 
 
 
 
 
 
Table 6: SVHC proposals discussed in 2016 and their outcome. 

Substances added to the Candidate List in 2016  

4,4’-isopropylidenediphenol (bisphenol A; BPA)  

Toxic for reproduction  

Nonadecafluorodecanoic acid (PFDA) and its sodium 
and ammonium salts 

Toxic for reproduction  
PBT 

p-(1,1-dimethylpropyl)phenol  

Endocrine disrupting properties - 
environment 

4-heptylphenol, branched and linear [substances with a 
linear and/or branched alkyl chain with a carbon 
number of 7 covalently bound predominantly in position 
4 to phenol, covering also UVCB- and well-defined 
substances which include any of the individual isomers 
or a combination thereof] 

Benzo[def]chrysene  (Benzo[a]pyrene) 

Endocrine disrupting properties - 
environment 

Carcinogenic 
Mutagenic 
Toxic for reproduction 
PBT 
vPvB 

Cases on which  the MSC could not reach unanimous agreement in 2016  

1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-
one               (3-benzylidene camphor, 3-BC) 

Endocrine disputing properties - 
environment 

4-tert-butylphenol (PTBP) 

Dicyclohexyl phthalate 

Endocrine disputing properties - 
environment 

Endocrine disputing properties – 
human health 

Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic 
anhydride, TMA) 

Respiratory sensitising properties - 
human health 

One case (hexamethylene diacrylate (HDDA), EC: 235-921-9) sent to the Commission for final 
decision making in 2015, was decided 21 not to be identified as an SVHC in 2016.  

Among  the  substances  being  concluded  as  fulfilling  article  57(f)  several  cases  are  due  to 
endocrine disrupting properties, which highlights that such substances can be identified by the 
Member State Committee and moved forward to further regulatory action.  

In  the  first  years  of  the  existence  of  the  candidate  list  inclusions  were  based  on  the  already 
confirmed hazard properties, i.e. CMRs with harmonised classification and PBT/vPvB substances 
identified  prior  to  REACH.  Since  2012  the  number  of  CMR  substances  included  per  year  has 
reduced while the number of other substances has stayed at a similar level or slightly increased. 

21 Implementing Decision (EU) 2016/2091: https://echa.europa.eu/documents/10162/e972b773-7541-
e9a7-4a85-4e209f0e5e97 

 
 
 
                                           
 
 40 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

This change relates to the fact that most substances for which potential concerns are identified 
first need further data generation and assessment before conclusions on their SVHC properties 
can be drawn (see also section 3 and the 2015 and 2016 annual reports). It can be expected 
that the new information generated via evaluation processes will bring new substances to the 
SVHC identification in coming years. 

Table 7: Overview of number of substances included in the Candidate list per properties (2008 
– 2016) 22  

2008 

2009 

2010  

2011  

2012 

2013 

2014 

2015 

2016 

CMR 

PBT/vPvB 

ED  

STOT RE  

Resp. Sens.  

8 

5 

0 

0 

0 

7 

6 

0 

0 

0 

16 

25 

59 

0 

0 

0 

0 

0 

1 

0 

0 

5 

2 

0 

3 

7 

2 

1 

3 

0 

5 

2 

1 

3 

0 

Total  

13 

13 

16 

26 

69 

13 

11 

3 

4 

0 

0 

0 

7 

1 

2 

2 

0 

0 

5 

Figure 14 gives an overview of Annex XV SVHC dossiers submitted per Member State. 

Figure 14: Number of Annex XV SVHC dossiers submitted per Member State and by ECHA. 

22 Note that each Candidate List entry has been counted only once i.e. the reasons (properties) for the identification 
have been counted separately (e.g. a substance being CMR and PBT/vPvB has been counted only under PBT/vPvB). 

 
 
 
 
 
 
 
                                           
5.3.3  Recommendation for and inclusion on the Authorisation List 

Substances  identified  as  meeting  the  SVHC  criteria  are  included  on  the  Candidate  List  for 
eventual  inclusion  on  the  Authorisation  List  (Annex  XIV  to  the  REACH  Regulation).  ECHA 
prioritises substances from the Candidate List to control the order in which the substances should 
be included in Annex XIV. The substances with the highest priority are recommended first for 
inclusion.  All  those  substances  not  recommended  as  well  as  newly  added  Candidate  List 
substances are considered in future rounds.  

According  to  Article  58(3),  priority  will  normally  be  given  to  substances  with  PBT  or  vPvB 
properties, or wide dispersive use, or high volumes 23. The prioritisation is made based mainly 
on information in the registration dossiers. However, information from public consultation on the 
SVHC identification and other REACH/CLP information is also considered. 

The  seventh  recommendation 24  was  sent  to  the  Commission  in  November  2016.  The  eighth 
recommendation  is  under  preparation  and  is  expected  to  be  sent  to  the  Commission  in  the 
beginning of 2018. 

Figure 15 gives an overview of the substances recommended by ECHA to be included in Annex 
XIV until the seventh recommendation as well as substances included on the Authorisation List 
(Annex XIV).  

Figure 15: Overview of number and properties of substances recommended for inclusion in 
Annex XIV and included in Annex XIV (2008 – 2016) 

23 Prioritisation approach available at: http://echa.europa.eu/addressing-chemicals-of-
concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list 
24 The substances on the seventh recommendation are available at: http://echa.europa.eu/addressing-chemicals-of-
concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list/previous-recommendations  

 
 
 
 
 
                                           
 42 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

Table 8 gives an overview and names of the substances recommended by ECHA to be included 
in Annex XIV until the seventh recommendation. It also lists those substances which have been 
included in the Authorisation List (Annex XIV) and which not. The Commission has indicated in 
the preambles of each proposed amendment to Annex XIV the reasons for not taking forward 
the substances that were recommended by ECHA.     

Table 8: Overview of substances recommended for inclusion in Annex XIV and 
substances included on Annex XIV (2008-2016)  

Date of 
recommendation 

Number of 
substances 
recommende
d 

Amendment  
of Annex 
XIV 

Number of 
substances 
included in 
Annex XIV  

(Groups of) 
substances 
included in Annex 
XIV  

1st  1 June 2009 

7 

1st (17 Feb 
2011) 

2nd  17 Dec 2010 

8 

2nd (14 Feb 
2012) 

3rd  20 Dec 2011 

13 

3rd (17 Apr 
2013) 

4th  17 Jan 2013 

10 

4th (14 Aug 
2014) 

5th  6 Feb 2014 

5 

6 

8 

8 

9 

1 

6th  1 July 2015 

15 

11 

5th Draft  
amendment 

(Groups of) 
substances 
not included 
in (draft) 
Annex XIV 
amendment 

[SCCP] 25 

Musk xylene, 
MDA,  
HBCDD,  
3 phthalates 

1 phthalate,  
2 arsenic 
substances,  
3 lead chromate 
substances,  
TCEP,  
2,4-DNT  

Trichloroethylene,  
7 chromium (VI) 
substances 

5 Cobalt (II) 
compounds 

Polymeric/crude 
MDA,  
Diglyme,  
EDC, 
MOCA, 
4 chromium (VI) 
substances 

4-tert-OPnEO 

1-bromopropane, 
7 phthalates, 
anthracene oil, 
CTPHT, 
4-NPnEO 

DMAC 

DMF 
ADCA  
Al-RCF and 
Zr-RCF 

4 boron 
substances 

7th  10 Nov 2016 

Total 

9 

67 

[n.a.] 

[n.a.] 

[n.a.] 

31 + 12 

31 +12 

15 

25 SCCP was recommended but not included as the substance was included in the POP Regulation 

 
 
 
 
 
 
 
 
                                           
5.3.4  Applications for authorisation and decisions on authorisation 

Once a substance is included on the Authorisation List (Annex XIV), companies must not place 
it on the market or use it themselves after the sunset date unless an  authorisation has been 
granted for a particular use.  

Companies who want to continue to use the substance after the sunset date need to submit their 
applications for authorisation to ECHA.  

The opinions of ECHA’s committees contribute to the decision-making process of the European 
Commission which decides whether or not to grant an authorisation for the uses applied for. 

Table 9 gives the number of applications for authorisations received from January 2013 until the 
end of December 2016 as well as the number of RAC/SEAC opinions and Commission’s decisions. 

Table 9: Number of applications for authorisation received from January 2013 – 
December 2016 

Substance 

DEHP and 
DBP 

Lead 
chromate 
pigments 
(yellow and 
red) 

HBCDD 

Diarsenic 
trioxide 

Trichloroethyl
ene 

Lead 
chromate 

Chromium 
trioxide 

Sodium 
dichromate 

Sodium 
chromate 

1,2-
Dichloroethan
e (EDC) 

Intrinsic 
properties 
in Annex 
XIV 

Received 
applications 

Applicants   Uses   RAC/SEAC 

opinions 
per use 

Commission 
decisions per 
use  

CMR 

8* 

10 

17 

17 

10 

CMR 

PBT 

CMR 

CMR 

CMR 

CMR 

CMR 

CMR 

CMR 

1 

1 

4 

13 

1 

25 

17 

2 

15 

1 

12 

12 

12 

13 

4 

15 

1 

61 

23 

4 

2 

5 

2 

5 

19 

19 

1 

41 

23 

3 

1 

21 

15 

1 

5 

17 

19 

2 

5 

5 

- 

- 

- 

- 

- 

 
 
  
 
 44 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

Chromium 
trioxide, 
Sodium 
dichromate 
and Potassium 
dichromate 

Potassium 
dichromate 

Ammonium 
dichromate 

Dichromium 
tris(chromate) 

Chromium 
trioxide; 
Dichromium 
tris(chromate) 

Strontium 
chromate 

Potassium 
hydroxyoctao
xodizincatedic
hromate 

bis(2-
methoxyethyl) 
ether Diglyme 

Arsenic acid 

Chromic acid 

Formaldehyde
, oligomeric 
reaction 
products with 
aniline 
(technical 
MDA) 

2,2-dichloro-
4,4’-
methylenedia
niline (MOCA) 

Total 

CMR 

CMR 

CMR 

CMR 

CMR 

CMR 

CMR 

CMR 

CMR 

CMR 

CMR 

1 

4 

3 

1 

1 

1 

1 

8 

1 

1 

1 

6 

4 

5 

2 

2 

10 

5 

8 

1 

1 

1 

3 

7 

4 

2 

4 

2 

2 

9 

1 

1 

2 

3 

4 

2 

2 

4 

2 

2 

1 

- 

1 

- 

CMR 

1 

1 

1 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

111 

195 

180 

119 

34 

 
 
 
Roadmap of SVHC identification and implementation 
of REACH risk management measures 

45 

Annex 1: Progress monitoring indicators 

Note that all progress monitoring indicators for the SVHC Roadmap are calculated starting with the implementation of 
the roadmap in 2013. 

Table 10: Progress monitoring indicators target and results 26 

Indicators 

Target 

Result 

Substance Screening 1: Percentage of substances 
identified for further work to clarify a concern (substance 
evaluation, CCH or proposed RRM (RMOA, CLH, other 
action) 

Substance Screening 2:  
Percentage of substances for which the outcome of manual 
screening has been substance evaluation and which ends up 
later in an RMOA. 

Assessment 1: Percentage of substances for further 
assessment (PBT/ED) or with need for advice which ends up 
in an RMOA/substance evaluation. 

RMOA1: 
Number of (groups of) substances subject to an RMOA 

RMOA2: 
Extent to which (percentage of)  RMOA conclusions resulted 
in regulatory follow-up 

-  27 

69.6% 

high 

high 

55 

0 

- 

16 28 

high 

84.8% 

With regard to substance screening around 70 % of 182 substances that were picked up by the 
IT based mass-screening were found to require further follow-up actions. This number is slightly 
lower than last year but as already indicated in the 2015 report this is linked to the fact that the 
same database is being searched for some years now with very similar scenarios (e.g. for CMR 
substances).  In  addition  for  several  substances  it  was  not  possible  to  conclude  the  manual 
screening  as  work  to  clarify  the  hazardous  properties  is  already  ongoing  under  one  of  the 
REACH/CLP  substances  on  a  very  similar  substance.  This  clearly  highlights  the  need  to  start 
working  on  groups  of  structurally  similar  substances  rather  than  on  single  ones.  In  total,  22 
Member States and EEA countries participated in the manual screening in 2016 which confirms 
the high interest from Member States in this activity. 

It  is  still  early  to  draw  any  conclusions  on  trends  and  effectiveness  regarding  substance 
evaluation as for most of the substances the process has not been completed, due to requests 
for further information. Between 2012 and 2016, 182 substances were evaluated and 49 (27%) 
evaluations  concluded.  Most  of  these  conclusions  were  for  substances  for  which  no  further 
information  was  requested.  For  20  concluded  cases,  the  evaluating  Member  State  considered 
that  further  regulatory  risk  management  may  be  needed.  It  is  also  still  too  early  to  draw 
conclusion on substances under assessment by the two expert groups as explained in the main 
report. 

The extent to which the risk management options analysis (RMOA) conclusions received follow-
up has however increased (84.8%); SVHC Identification and Restriction proposals were followed-
up in respectively 87% and 100% of the cases compared to the expected number of regulatory 

26 All progress monitoring indicators for the SVHC Roadmap are calculated starting with the implementation of the 
roadmap in 2013. 
27 The target is to have substance screening one indicator high and at least equal to the baseline which is set as 2014. 
28 16 new intentions but this covers 4 groups of substances and therefore cover many more than 16 
substances. 

 
 
 
  
 
 
                                           
 46 

Roadmap of SVHC identification and implementation 
of REACH risk management measures 

proposals. Two CLH proposals have also been followed up which is a positive increase compared 
to last year. The trend that now most RMOA conclusions receive follow-up clearly reflects that it 
simply takes time for Member States to turn a conclusion into actual follow-up action.  

Only 16 new intentions for RMOA were submitted however this covers 4 groups of substances 
and therefore cover many more than 16 substances. In addition it should be highlighted that a 
lot of work is done in clarifying concern of substances already at the level of screening which 
may conclude in no need for further action at present for the substances.

 
 
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