COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE Commission General Report on the operation of REACH and review of certain elements Conclusions and Actions Conclusions and Actions
Date: 2018-03-05
Institutions: Directorate-General for Environment, European Commission
Subjects: European Chemicals Agency, application of EU law, chemical product, dangerous substance, disclosure of information, environmental risk prevention, health risk, market approval, marketing standard, withdrawal from the market

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 5.3.2018  COM(2018) 116 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE Commission General Report on the operation of REACH and review of certain elements   Conclusions and Actions    {SWD(2018) 58 final}  
 
 
COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE 

Commission General Report on the operation of REACH and review of certain 
elements  

Conclusions and Actions 

(Text with EEA relevance) 

1. 

INTRODUCTION 

The EU's Regulation on the registration, evaluation, authorisation and restriction of chemicals 
(referred to as REACH)1 entered into force in 2007.  

REACH  puts  obligations  on  industry  to  collect  chemical  safety  information,  to  use  this 
information  to  develop  and  apply  appropriate  risk  management  measures,  to  communicate 
these  measures  to  users  of  chemicals  and,  finally,  to  document  this  in  registration  dossiers 
submitted to the European Chemicals Agency (ECHA). ECHA or Member States evaluate if 
the safety information is sufficient and, if not, require additional information.  

REACH also establishes two distinct EU risk management approaches:  

a)  Restrictions  enable  the  EU  to  impose  conditions  on  the  manufacturing,  placing  on  the 
market or use of substances;  

b) Authorisation is designed to ensure that substances of very high concern (SVHCs) are used 
safely while promoting substitution by suitable alternatives. 
One  initial  policy  driver2  for  REACH  was  the  slow  progress  in  completing  EU  risk 
assessments  and  implementing  the  risk  reduction  strategies  for  existing  chemicals3.  In 
addition, only 20% of these substances had a publicly available data set allowing a minimum 
screening  for  risk  assessment.  In  line  with  the  polluter  pays  principle4,  REACH  shifted  the 
burden  of  proof  to  industry,  making  it  responsible  for  the  safety  of  chemicals  along  the 
supply  chain.  In  addition,  authorities  should  focus  on  those  risks  which  industry  cannot  or 
does not manage appropriately. Protection of the environment and human health was another 
initial  driver  for  REACH,  which  was  complemented  by  the  objectives  of  ensuring  the  free 
circulation  of  chemicals  in  the  EU,  enhancing  the  competitiveness  and  innovation  of  EU 
industry and promoting non animal testing methods. The regulatory proposal was developed 
following  a  sequence  of  prior  evaluation  and  impact  assessment  similar  to  the  policy  cycle 
now applied in the Commission's Better Regulation5 guidelines.  

1 Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH) OJ L 396, 30.12.2006, p. 1. Corrected version in OJ L 136, 29.5.2007, p. 3. 
2 OECD (2015). Preliminary analysis of policy drivers influencing decision making in chemicals management. 
Series on Risk Management, No. 28. Document ENV/JM/MONO(2015)21. Appendix 6 concerns REACH 
3 100 106 substances marketed in the EU before 1981. These substances are now called phase-in substances. 
4 Article 191(2) of the Treaty on the Functioning of the European Union (TFEU). 
5 https://ec.europa.eu/commission/priorities/democratic-change/better-regulation_en 

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REACH also contributes to the EU meeting the World Summit Sustainability Development 
2020  goal6.  REACH  brought  together  and  aligned  the  body  of  chemicals  legislation 
established  over  the  previous  decades,  replacing  40  different  pieces  of  legislation  with  a 
single Regulation.  

Member States, ECHA and the Commission are required to regularly report on the operation 
of the Regulation7. The Commission also has to carry out a number of reviews by different 
deadlines8. In 2013 the Commission presented the first report covering REACH's first 5 years 
of operation and including certain reviews9.  

The  present  document  is  the  second  Commission  report  on  the  operation  of  REACH.  The 
evaluation  has  been  carried  out  as  part  of  the  programme  for  Regulatory  Fitness  and 
Performance  (REFIT)  in  accordance  with  the  Commission's  Better  Regulation  guidelines2 
and is accompanied by a staff working document10. This report also includes three reviews: 
one on possible registration of polymers11 and two on minimum information requirements for 
low tonnage substances (1-10 tonnes/year)12.  

2. 

FINDINGS OF THE EVALUATION 

2.1. 

Achievement of REACH objectives 

Some  10  years  after its  entry  into  force,  REACH  is  fully  operational  and  delivering  results 
towards achieving its objectives. Although progress towards the objectives is lagging behind 
initial expectations, it has steadily improved as experience was gained. 

REACH  provides  a  comprehensive  data  generation  and  assessment  system  for  chemicals 
manufactured and used in the  EU, designed to improve the protection of human health and 
the environment and positioning the EU as frontrunner in achieving the goal set for 2020 at 
the World Summit for Sustainable Development. REACH has also influenced legislation in 
third countries (e.g. Korea or China), although significant differences still exist and there is 
room  to  further  exploit  the  potential  of  REACH  to  serve  as  a  global  model  for  chemicals 
legislation. 

The main direct costs incurred under REACH so far are associated with registration and the 
communication  of  information  along  the  supply  chain.  These  are  estimated  at  EUR  2.3-2.6 
billion for the first two registration deadlines. Costs have been higher than anticipated (EUR 
1.7  billion),  in  particular  for  the  first  registration  deadline.  Additional  costs  result  from 
evaluation, authorisation and restrictions. The estimated scale of potential benefits for human 
health and the environment remains in the order of EUR 100 billion over 25-30 years. The 
overall  costs  seem  justified  by  the  results  observed  and  the  benefits,  that  are  starting  to 
materialise.  

6 WSSD goal: "By 2020, achieve the environmentally sound management of chemicals and all wastes 
throughout their life cycle, in accordance with agreed international frameworks, and significantly reduce their 
release to air, water and soil in order to minimize their adverse impacts on human health and the environment". 
7 See REACH Article 117 
8 See REACH Article 138 
9 COM(2013)49 and SWD(2013)25 
10 SWD(2018)58 
11 See REACH Article 138(2)  
12 See REACH Article 138(1) and 138(3) 

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The  evaluation  has  identified  a  number  of  shortcomings  and  key  issues  that  hamper  the 
achievement  of  REACH  objectives13.  A  number  of  improvements  in  the  efficiency  of  the 
REACH processes have been implemented or are being developed since 2013; nonetheless, 
further opportunities to improve and simplify have been identified, in particular for extended 
Safety Data Sheets, evaluation, authorisation and restriction. The issues requiring most urgent 
action are:  

  non-compliance of registration dossiers;  

  simplification of the authorisation process;  

  ensuring  a  level  playing  field  with  non-EU  companies  through  effective  restrictions 

and enforcement;  

  clarifying  the  interface between  REACH  and  other  EU  legislation,  in  particular  that 

on occupational safety and health (OSH) and on waste.  

Industry responsibility 

2.2. 
Manufacturers  and  importers  responded  to  the  registration  obligations  for  existing14 
substances by completing their registration dossiers on time and with no major disruptions of 
the  market.  However,  incentives  are  lacking  for  companies  to  update  their  registration 
dossiers and work is still needed to rectify important data gaps or inappropriate adaptations to 
testing.  Measures  to  support  SMEs  regarding  their  registration  obligations  have  been 
effective, though more could still be done. 

Compliance with the information requirements by registrants is considered insufficient. This 
is  related  to  two  main  causes:  (i)  the  legal  requirements  to  avoid  animal  testing  may  push 
registrants  to  use  alternative  methods  to  animal  testing,  even  if  not  justified;  and  (ii) 
difference  in  the  assessment  of  hazard  between  registrants  and  authorities.  In  addition,  the 
current  approach  to  evaluation,  including  ECHA's  decision-making  procedures,  should  be 
further improved.  

There  has  been  a  continued  increase  in  the  information  passed  through  the  supply  chain, 
though  it  needs  to  be  made  more  efficient  (e.g.  reduce  costs  of  producing  and  supplying 
Safety  Data  Sheets),  especially  for  SMEs.  Improvement  is  also  needed  in  the  ability  of 
companies to develop specific exposure scenarios, in particular for mixtures, and in helping 
with implementing the obligation to notify substances of very high concern in articles. 

REACH  applies  a  tonnage  triggered  approach  to  information  requirements  where  higher 
tonnage  leads  to  more  comprehensive  testing.  It  has  proven  to  be  proportionate  to  address 
substances already on the market. However, evidence suggests that further assessment of the 
affordability  of  registration  requirements  for  low  tonnage  substances  and  registration  of 
certain polymers could be warranted15. 

Compared to previous (i.e. pre-REACH) legislation, the broader exemption for research and 
development activities  and the reduced  information requirements for new substances below 
10 tonnes per year have stimulated the development of new substances.  

13 For further details, see SWD(2018)58 
14 Existing substances refer to "phase in" substances in accordance with article 3 point 20 of REACH. 
15 Further details see the SWD(2018)58 

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REACH enables citizens to ask companies whether the articles they supply contain SVHCs, 
but  this  provision  has  had  limited  use.  Where  it  is  used,  companies  struggle  with  its 
implementation. 

Authorisation is meeting its objectives to ensure proper control and foster substitution, where 
economically and technically feasible alternatives exist. Implementation should further gain 
in efficiency and aim to further reduce the administrative burden and business uncertainty for 
companies applying for authorisation, in particular for SMEs.  

The  authorisation  requirements  could  be  harming  the  competitiveness  of  EU  companies 
because articles imported to the EU are exempt from the authorisation  obligations. A better 
coordination and synchronisation of actions when enacting authorisation and restriction could 
further improve implementation. 

2.3. 

Action by Member States and the Commission 

Member  States  have  used  their  right  to  initiate  actions  under  evaluation,  authorisation  and 
restriction,  but  insufficient  resources  reduce  their  activities.  This  reduces  the  number  of 
substances  that  are  assessed  and  regulated  and  slows  down  the  process.  Member  States 
should ensure a more effective and harmonised enforcement of REACH, whereas the Rapid 
Alert  System  (RAPEX)  ensures  consumer  products  safety.  While  improvements  have 
occurred  through  concerted  efforts  in  ECHA's  Forum16,  national  enforcement  activities 
should be reinforced, including controls on imported goods. 
The  work  under  the  SVHC  Roadmap17  is  progressing  beyond  expectations.  Most  of  the 
substances  with  confirmed  SVHC  properties  have  now  been  assessed,  for  example  those 
which  are  persistent,  bioaccumulative  and  toxic  (PBTs)  and  carcinogenic,  mutagenic  and 
toxic  for  reproduction  (CMRs).  Addressing  data  gaps  from  registration  and  improving 
substance  evaluation  will  enable  identification  of  new  SVHCs;  at  the  same  time,  applying 
assessment of groups of similar substances could further speed up the process. 

The restriction procedure is generally working, though further improvements in efficiency are 
needed, as proposed in the actions below.  

When  analysing  the  coherence  between  REACH  and  other  EU  legislation,  some  critical 
elements have been addressed by the Commission18 in the interface with the Directive on the 
restriction  of  hazardous  substances  (RoHS)19  and  the  Regulation  on  persistent  organic 
pollutants  (POPs)20.  The  interface  between  REACH  and  OSH  legislation  calls  for  systemic 
solutions to address the main overlaps and discrepancies.  

Information needs for nanomaterials are currently being addressed by proposed amendments 
to  the REACH Annexes. Furthermore, the Commission  supports  research into  development 
of  alternative  methods21  and  promotes  the  use  of  human  biomonitoring  in  chemical  risk 

16 Forum for the Exchange of information on enforcement. 
17 Roadmap on Substances of Very High Concern, February 2013. 
18  http://ec.europa.eu/growth/sectors/chemicals/reach/special-cases_en 
19  Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic 

equipment. 

20  Regulation (EC) No 850/2004 on persistent organic pollutants, implementing the obligations of the Union 

under the Stockholm Convention. 

21 Further details see Annex 4 of the SWD(2018)58 

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assessment and management through initiatives such as the European Human Biomonitoring 
Initiative22 and the Information Platform for Chemical Monitoring23.  

2.4. 

ECHA 

ECHA  has  been  instrumental  in  the  implementation  of  REACH  and  has  now  built  up  a 
significant  competence  in  chemicals  management.  ECHA  has  established  a  user-friendly 
website  enabling  stakeholders  to  easily  access  the  world's  largest  database  on  chemicals. 
ECHA has  also established scientific cooperation with the European Food Safety Authority 
(EFSA) and the European Medicines Agency (EMA), as well as with other non-EU agencies, 
which should be further reinforced to ensure coherence and profit from synergies.  
Around 2020, the fee income of ECHA will be substantially reduced24 and the Commission 
will  need  to  assess  how  to  maintain  ECHA's  expertise  and  independence,  including  the 
scrutiny of working methods of the committees and mitigation of conflicts of interest. 

2.5. 

Potential for simplification and burden reduction 

Overall,  the  REACH  evaluation  has  not  identified  unnecessary  legal  requirements  and 
obligations given the needs and objectives pursued. There is a margin for simplification and 
burden  reduction  in  the  way  those  requirements  are  implemented  and  in  particular  for 
clarifying how they are to be fulfilled by the duty holders. However, simplification should not 
incur reductions in the level of protection of human health and the environment. 

Some margin for further simplification has been identified in several areas in relation to the 
information  requirements,  the  extended  Safety  Data  Sheets,  the  process  to  apply  for 
authorisation and the requirements for substances in articles. Appropriate actions are set out 
in the following chapter. 

3. 

ACTIONS 

3.1. 

Knowledge and management of chemicals throughout the supply chain 

The  lack  of  information  on  existing  chemicals  was  one  of  the  two  main  policy  drivers 
triggering  the  development  of  REACH.  Since  the  entry  into  force  of  REACH,  more 
information on the properties and uses of chemicals (e.g. by December 2017, ECHA received 
65  000  dossiers  for  approximately  17  000  unique  registered  substances)  is  available  and 
being  used  for  the  assessment  and  management  of  chemical  risks.  In  spite  of  this  positive 
trend, the lack of compliant information in the registration dossiers hampers the functioning 
of  other  REACH  processes  and  slows  down  the  achievement  of  the  REACH  objectives  for 
human health and environment. 

The  efficiency  and  effectiveness  of  the  evaluation  procedures,  implemented  by  ECHA,  its 
Committees, the Member States and the Commission, need to be improved. This will provide 
stronger  incentives  for  companies  to  update  and  bring  into  compliance  their  registration 
dossiers as required by REACH. 

22 HBM4EU 
23  IPCHEM 
24 Following the last registration deadline of 2018 

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Action 1: Encourage updating of registration dossiers 

The Commission in collaboration with ECHA, Member States and industry will identify why 
registrants  are  not  updating  their  dossiers  and  make  proposals  for  improvements  by  first 
quarter 2019, as appropriate. 

Action 2: Improve evaluation procedures 

ECHA  is  requested  to  significantly  increase  the  efficiency  of  the  evaluation  procedures  by 
2019 by:  

(1)  identifying  the  main  reasons  for  non-compliance  of  registration  dossier  and  developing 
remedies;  

(2) where appropriate, applying the various evaluation procedures in parallel;  
(3) systematically implementing a grouping approach25, where this is possible;  

(4) improving work-sharing across evaluation activities with Member States; and  

(5) improving decision-making procedures. 

REACH  extended  the  already  existing  Safety  Data  Sheets  by  adding  so-called  exposure 
scenarios.  This  has  led  to  improvements  in  communication  and  more  transparency  in  the 
supply  chain.  However,  many  companies,  in  particular  SMEs,  find  them  too  technical  and 
burdensome. In  addition, the poor  quality of exposure scenarios is  an obstacle to  providing 
safety information for mixtures. 

Action 3: Improving the workability and quality of extended Safety Data Sheets 

(1)  The  Commission  encourages  more  industry  sectors  to  develop  and  use  harmonised 
formats26  and  IT  tools  that  would  provide  more  user-targeted  information  and  simplify  the 
preparation  and  use  of  extended  Safety  Data  Sheets  as  well  as  facilitate  their  electronic 
distribution.  

(2)  The  Commission  will  consider  including  minimum  requirements  for  the  exposure 
scenarios for substances and mixtures in Safety Data Sheets and request ECHA to develop a 
methodology for Safety Data Sheets of mixtures. 

The need to better track chemicals of concern in materials and products in order to facilitate 
recycling  and  improve  the  uptake  of  secondary  raw  materials  is  discussed  in  the  chemical 
product  waste  communication27,  one  of  the  deliverables  of  the  Circular  Economy  Action 
Plan. Such tracking could also address the current difficulties for actors in the supply chain to 
fulfil the requirements for SVHCs in articles28. 

Action 4: Tracking substances of concern in the supply chain 

The Commission will gather evidence and assess options to address the challenges related to 
substances  of  concern,  as  discussed  in  the  chemical  product  waste  communication.  The 
assessment will consider, among others, whether and how a tracking system could contribute 
to improve the workability of information requirements for SVHCs in articles. 

25 Assessment of groups of substances with similar properties instead of individual ones 
26 As those developed by the Exchange Network on Exposure Scenarios (ENES) 
27 Options to address the interface between chemical, product and waste legislation COM(2018) 32 final and 
SWD(2018) 20 final 
28 Articles 7 and 33 of REACH 

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3.2. 

Enhanced risk management 

The  slow  progress  of  risk  assessment  and  implementation  of  risk  management  for  existing 
substances  was  another  main  driver  triggering  the  development  of  REACH.  Improved  risk 
management measures have been introduced in companies as a result of the registration and 
authorisation  requirements.  The  restriction  and  authorisation  processes  still  need  to  be 
implemented more efficiently and with quicker decision making.  

The  implementation  of  the  SVHC  roadmap  and  early  assessment  of  possible  regulatory 
measures through a voluntary regulatory management option assessment (RMOA) is proving 
an effective tool to ensure that, by 2020, all known relevant SVHCs are identified, along with 
possible  regulatory  measures.  The  focus  of  SVHC  identification  is  moving  towards 
substances  that  require  a  case-by-case  assessment  of  the  equivalent  level  of  concern 
condition29.  The  Commission,  together  with  ECHA  and  Member  States,  will  ensure  that 
criteria for such identification are developed and applied in a consistent manner.  

Moreover,  the  authorisation  process  is  seen  as  an  effective  driver  for  substituting  SVHCs 
along  the  supply  chain,  although  efforts  must  be  stepped  up  to  promote  substitution  of 
SVHCs, in particular among SMEs.  

Action 5: Promote substitution of SVHCs 

The  Commission,  ECHA  and  Member  States  will  step  up  support  activities  to  facilitate 
substitution of SVHCs.  Such activities  may include the promotion of capacity building  and 
collaborative  networks  and  promoting  R&D  investment  (EU,  Member  States  resources)  in 
sustainable chemicals and technology innovations. 

As  authorisation  has  become  operational,  a  number  of  practical  challenges  and  concerns 
have emerged that needed to be addressed. The ongoing efforts to simplify the authorisation 
process  should  continue  with  a  view  to  clarifying  the  requirements  and  make  the  process 
more workable and more predictable for applicants.  

When carrying out a RMOA, evidence is necessary to understand the practical workability of 
possible  regulatory  measures  (authorisation  or  restriction)  to  inform  the  decision-making 
process. This includes available socio-economic information such as the known uses, number 
and  size  of  actors  involved  in  the  supply  chains  as  well  as  available  information  about 
technical and economic feasibility of possible safer alternative substances or technologies.  

Action 6: Simplification for a more workable authorisation process 

The  Commission  will  continue  to  make  the  application  for  authorisation  process  more 
workable for operators, including for SMEs by: 
(1)  simplifying  the  applications  for  continued  use  of  SVHCs  in  legacy  spare  parts30  and 
further considering the case of low volume applications in 2018; 

(2) closely monitor and address difficulties related to applications for authorisation covering 
multiple operators; 

29 In accordance with Article 57(f) of REACH 
30 Uses of SVHC to produce legacy spare parts for repairing articles no longer produced after the sunset date 
(e.g. aircraft and motor vehicles)  

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(3) reducing fees for applicants in joint applications for authorisation while balancing the fee 
levels per use in order to better reflect the workload for ECHA committees in 2018. 

Action 7: Early socio-economic information for possible regulatory measures 

ECHA  in  co-operation  with  the  Commission  and  Member  States  will  consider  options  to 
further develop and use available socio-economic information for consideration at the RMOA 
stage. 

The  number  of  new  restrictions  has  so  far  not  met  the  original  expectations.  Although  the 
process has improved as a result of the actions initiated after the 2013 REACH review, there 
is  room  for  further  improvement  in  particular  to  identify  relevant  candidates  for  restriction 
and to increase Member State involvement.  

Action 8: Improve Restriction Procedure 

(1)  ECHA  is  requested  to  clarify  the  information  needed  from  the  public  consultations, 
including the minimum information to be submitted by industry when requesting derogations 
(time-limited or not) from restrictions.  

(2) ECHA is requested to identify relevant cases for restriction as part of its regular screening 
activities, considering also substances for which only national legislation exists.  

(3)  The  Commission  will  continue  its  efforts  to  identify  suitable  cases  for  restricting  CMR 
substances in consumer articles through a simplified procedure, according to Article 68(2). 

Action 9: Further enhance Member State involvement in the restriction procedure 

The  Commission  and  ECHA  will  work  with  Member  States  to  further  simplify  the 
requirements for submitting a restriction dossier and to increase Member State capacities to 
develop dossiers for new restrictions and provide constructive solutions such as encouraging 
joint dossiers prepared by several Member States and/or in cooperation with ECHA. 
Action 10: Frame the application of the precautionary principle31 

ECHA's  Risk  Assessment  Committee  and  Socio-Economic  Assessment  Committee  should 
ensure that their opinions indicate when scientific data do not permit a complete evaluation of 
risk. This should include what information is needed to address the uncertainties, the timeline 
for generating such information and provide an assessment of the potential consequences of 
inaction  to  enable  the  Commission  to  consider  if  action  is  warranted  on  the  basis  of  the 
precautionary principle, underpinned in the legal text of REACH. 

The interplay between authorisation and restriction is enshrined in REACH. It foresees that 
for substances subject to authorisation, ECHA should consider after the sunset date whether 
the use of such substances in articles poses risks to human health or the environment that is 
not  adequately controlled and, if so, should start a restriction procedure. There is a need  to 
expedite the assessment of the need for restrictions on imported articles containing substances 
subject to authorisation32 in order to ensure a level playing field between economic operators 
in and outside the EU. It should be explored if and how applying the authorisation procedure 
for  the  non-restricted  uses  of  SVHCs  to  achieve  comparable  risk  management  and 
substitution more efficiently and predictably. 

31 COM(2000)1 on the precautionary principle 
32 According to Article 69(2) of REACH 

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Action 11: Interplay between authorisation and restriction 

(1)  ECHA  is  requested  to  consider  systematically  the  preparation  of  a  restriction  dossier 
before the sunset date of each substance that is subject to authorisation and present in articles 
in accordance with Article 69(2).  

(2) The Commission, ECHA and Member States will assess the interplay between restriction 
and  authorisation  to  achieve  a  comparable  risk  reduction  more  efficiently  through  risk 
management and substitution. 

3.3. 

Coherence, enforcement and SMEs 

Further activities are needed to clarify the interface between REACH and other pieces of EU 
legislation; in particular work should continue on the interplay of REACH with occupational 
safety and health (OSH) legislation and with waste legislation33. 

Action 12: Interface REACH and OSH legislation 

The Commission will propose the following concrete steps to remove the overlaps and clarify 
the interface between REACH and OSH: 

(1)  How  to  use  REACH  tools  (e.g.  exposure  scenarios,  Safety  Data  Sheets)  to  enhance  the 
effectiveness of OSH legislation. 

(2)  Improve  the  coordination  of  national  enforcement  authorities  of  REACH  and  OSH 
legislation. 

(3) Align methodologies to establish safe levels of exposure to chemicals at the workplace by 
first quarter 2019.  

(4)  Enhance  the  role  of  ECHA's  risk  assessment  committee  (RAC),  involving  also  social 
partners, to provide scientific opinions under the OSH legislation while respecting the role of 
the Advisory Committee on Health and Safety at Work.  

Strengthening  the  enforcement  of  the  obligations  on  all  actors,  including  registrants, 
downstream users and in particular for importers, is necessary to ensure a level playing field, 
meet the objectives of REACH and ensure consistency with the actions envisaged to improve 
environmental  compliance  and  governance34.  Consistent  reporting  of  Member  State 
enforcement activities will enable a better assessment of this important aspect of REACH. 

Action 13: Enhance enforcement 

(1)  The  Commission  will  consider  by  first  quarter  2019  further  measures  (such  as 
recommendations,  guidance  documents,  training  and  pilot  projects),  under  the  relevant 
legislative instrument, to clarify and enhance the role of REACH enforcement authorities as 
well as customs authorities in the enforcement of REACH.  

(2) ECHA's Forum and Member States are requested to establish comparable parameters on 
enforcement.  On  the  basis  of  those  parameters,  Member  States  should  report  annually  to 
ECHA for the purpose of monitoring enforcement activities by Member States. 

33 Addressed by action 4 above. 
34 COM(2018) 10 EU actions to improve environmental compliance and governance 

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SMEs remain more vulnerable to the effects of REACH than large companies due to limited 
financial  and  human  resources,  especially  in  view  of  the  2018  registration  deadline,  where 
many more SMEs are expected to be involved than in previous registration deadlines as well 
as the challenges of downstream users. 

Action 14: Support compliance by SMEs 

ECHA  and  Member  States  are  requested  to  step  up  efforts  to  develop,  with  input  from 
voluntary  actions  by  industry  organisations,  tailored  guidance  and  support  instruments 
focused  on  the  needs  of  SMEs.  Such  instruments  may  include  collection  of  best  practice, 
generation of sector specific solutions and publication of documents in national languages. 

3.4. 

Fees and future of ECHA 

A  well-functioning  and  efficient  implementation  of  all  REACH  processes  needs  long  term 
financial and  resource  stability  so  necessary  competences  can  be  maintained  and  efficiency 
gained, while taking account of budgetary constraints. ECHA's funding after 2020 needs to 
be considered and Member States participation to ECHA work needs to be reinforced. Over 
the  period  2007  –  2020,  ECHA  funding  has  been  coming  from  fees  (70%)  and  from  a 
balancing subsidy (30%). After 2020, the income from fees (in particular from registration) is 
expected  to  drop  sharply.  The  sustainability  of  ECHA's  financing  therefore  needs  to  be  re-
assessed. 

Over the next years, it is expected that ECHA will become a European and global reference 
centre  for  the  sustainable  management  of  chemicals,  capable  of  serving  implementation  of 
more pieces of EU legislation, should the Commission make proposals in this respect. 

Action 15: Fees and the future of ECHA 

(1) Bearing in mind that budgetary constraints will remain also in the post 2020 Multiannual 
Financial Framework, the Commission will explore ways of guaranteeing ECHA mission and 
independence  and  to  assess  all  possible  options  for  financing  in  a  context  of  projected 
reduced fee income, including by containing expenditure. 

(2) ECHA is invited by 2019 to: 

i) reallocate staff to other areas of work following the completion of the registration process 
for phase-in substances to enhance the scientific and technical expertise related to the safety 
of chemicals as well as the evolving methodologies for their assessment; 

ii) continue to identify efficiency gains and propose targets. 

(3) Given the constraints identified above, the Commission will carefully assess whether to 
assign further tasks to ECHA and the associated resources.  

3.5. 

Need for further assessment 

The  reviews  related  to  registration  requirements  for  low  tonnage  substances  and  polymers 
(Article  138)  identified  the  necessity  to  assess  affordability  of  additional  registration 
requirements for the companies involved, especially given the number of SMEs who  might 
be affected. 
Action 16: Review of registration requirements for low tonnage substances and polymers35 

35 Review according to article 138(1), 138(2) and 138(3) of REACH. 

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The Commission will further investigate information necessary to assess the affordability of 
additional  information  requirements  for  low  tonnage  substances  or  to  identify  relevant 
polymers that could be subject to registration. 

The Commission will continue to monitor the impacts of the 2018 registration obligation on 
SMEs,  looking  at  overall  incurred  costs,  availability  of  chemical  substances  and  possible 
structural changes on the EU market. 

The Commission will examine various options to fill data gaps and to improve data quality, 
robustness and transparency in the context of REACH. This is part of a broader discussion on 
the  EU  approach  on  transparency,  quality  and  independence  of  data36,37  on  which  risk 
assessment and risk management decisions are based.  

For CMR substances for which no safe exposure levels exist, there is no consensus in the EU 
on what  level of risk  could  be considered as acceptable. Furthermore, the rules to  establish 
appropriate  risk  management  measures  for  such  substances  in  REACH  do  not  include  the 
concept of acceptable risk.  Reflections will continue on acceptable risk levels, and whether 
they can have a role in the relevant REACH processes. 

4. 

CONCLUSIONS 

The  REACH  Evaluation  concludes  overall  that  REACH  is  addressing  today's  citizens' 
concerns about chemical safety38.  

REACH  is  effective  but  opportunities  for  further  improvement,  simplification  and  burden 
reduction have been identified, which can be achieved by delivering the actions outlined in 
the  report.  Those  should  be  implemented  in  line  with  the  renewed  EU  Industrial  Policy 
Strategy39, Circular Economy Action Plan40and the 7th Environment Action Programme41. 

REACH  is  found  to  be  generally  coherent  with  other  EU  legislation  concerning  chemicals 
and delivers the international goals as intended. 

Implementation  is  still  on-going  in  all  areas,  with  some  key  milestones,  such  as  the  last 
registration deadline, still to be completed by June 2018. Many of the costs of REACH have 
been incurred and benefits are starting to materialise. 

The  REACH  evaluation  has  concluded  that  the  legal  requirements  and  obligations  are  well 
tuned to achieving the needs and objectives pursued. While this communication has identified 
a number of actions that will further improve REACH, there is currently no need to change 
its enacting terms. 

36 C (2017) 8414final –Communication on the European Citizens' Initiative related to glyphosate 
37 Roadmap on Transparency and sustainability of the EU risk assessment model in the food chain 
38 Eurobarometer survey on chemical safety 

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