REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS in accordance with Article 117(4) of REACH and Article 46(2) of CLP, and a review of certain elements of REACH in line with Articles 75(2), 138(2), 138(3) and 138(6) of REACH
Date: 2013-02-05
Institutions: European Commission
Subjects: European Chemicals Agency, animal experimentation, application of EU law, chemical industry, chemical product, dangerous substance, disclosure of information, environmental law, health control, nanotechnology, registration of a company

EUROPEAN 
COMMISSION 

Brussels, 5.2.2013  
COM(2013) 49 final 

General Report on REACH 

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

in accordance with Article 117(4) of REACH and Article 46(2) of CLP, and a review of 
certain elements of REACH in line with Articles 75(2), 138(2), 138(3) and 138(6) of 
REACH 

(Text with EEA relevance) 

{SWD(2013) 25 final} 

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

in accordance with Article 117(4) of REACH and Article 46(2) of CLP, and a review of 
certain elements of REACH in line with Articles 75(2), 138(2), 138(3) and 138(6) of 
REACH 

(Text with EEA relevance) 

1. 

INTRODUCTION 

Designed to ensure a high level of protection of human health and the environment, 
as well as the free circulation of substances on the internal market while enhancing 
competitiveness  and  innovation  and  to  shift  the  responsibility  to  manage  chemical 
risks  from  public  authorities  to  industry,  the  REACH  Regulation1  (hereinafter 
REACH) entered into force on 1 June 2007. At the time of adoption REACH raised 
major  challenges  and  questions  for  all  the  stakeholders  involved.  REACH  required 
new  forms  of  cooperation  to  share  information  among  companies,  enhancing 
communication along the supply chain as well as developing tools to guide and assist 
companies and public authorities in the implementation. 

its  obligations  with  24,675 

Five  years  after  REACH  entered  into  force,  key  milestones  for  its  implementation 
have  been  accomplished.  The  first  registration  deadline  in  2010  was  a  success, 
industry  met 
registration  dossiers  submitted, 
corresponding  to  4,300  substances.  In  result,  the  quality  of  data  available  for  risk 
management  has  been  significantly  improved  resulting  in  a  marked  decrease  of  the 
nominal  risk  for  the  registered  substances.  The  authorities  played  their  role,  for 
example  responding  to  thousands  of  questions,  the  majority  coming  from  SMEs, 
through the network of Helpdesks, available in all Member States. Founded in 2007, 
the  European  Chemicals  Agency  (ECHA)  is  now  fully  operational.  In  the  same 
period,  the  Commission  made  available  €  330  million  to  fund  research  and  other 
activities to develop alternative methods to animal testing. 

A number of reporting and review obligations fall on the Commission five years after 
the  date  of  entry  into  force;  this  Report  meets  these  obligations.  In  addition  it 
provides  a  platform  for  the  Commission  to  report  on  findings  from  some  more 
general  assessments  of  the  operation  of  REACH.  An  accompanying  Staff  Working 
Document2  provides  further  details  of  the  findings  used  for  the  conclusions  and 
recommendations in this Report. 
In  accordance  with  REACH3,  the  Commission  must  report  on  the  experience 
acquired with its operation and on the funding made available by the Commission for 
the development and evaluation of alternative test methods. REACH also calls upon 
the  Commission  to  review  the  requirements  relating  to  registration  of  low-tonnage 
substances,  to  report  on  the  need,  if  any,  to  register  certain  types  of  polymers,  to 

1 
2 
3 

OJ L 396, 30 December 2006, p. 1–849. 
SWD(2013)25 
Articles 75(2), 117(4), 138(2), 138 (3) and 138 (6). 

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assess  whether  or  not  to  amend  the  scope  of  REACH  to  avoid  overlaps  with  other 
relevant Union provisions and to carry out a review of ECHA. 

2. 

GENERAL CONCLUSIONS ON ATTAINMENT OF THE REACH OBJECTIVES 

2.1. 

Human Health and Environment 

REACH was adopted with the aim of ensuring a high level of protection of human 
health  and  the  environment,  including  the  promotion  of  alternative  methods  for 
assessment of hazards of substances, as well as the free circulation of substances on 
the  internal  market  while  enhancing  competitiveness  and  innovation.  REACH  is  a 
key element of the EU's commitment towards the implementation plan adopted at the 
2002 World Summit on sustainable development which aims to ensure that, by 2020, 
chemicals  are  produced  and  used  in  ways  that  lead  to  minimisation  of  significant 
adverse effects on human health and the environment. 

REACH  establishes  a  systematic  registration  of  substances.  The  registration  should 
document  safe  use  of  substances,  by  including  information  on  the  hazards  of  the 
substance  enabling  registrants  to  classify  and  label  them  and  identifying  risk 
management  measures,  and  communicate  this  information  down  the  supply  chain. 
For  substances  above  10  tonnes,  registrants  must  perform  a  chemical  safety 
assessment to identify if additional risk reduction measures are required.  

REACH improves the control of individual substances. Restrictions are designed to 
control  risks  not  adequately  controlled  by  industry.  With  respect  to  health  and 
environment, the authorisation process aims to ensure that risks from Substances of 
Very  High  concern  (SVHC)  are  controlled  and  that  those  substances  are 
progressively  replaced  by  suitable  alternatives  where  these  are  economically  and 
technically viable.  

Although  meeting  those  aims  would  require  the  use  of  animals  in  laboratory 
experiments,  REACH  sets  out  a  number  of  detailed  obligations  aiming  to  reduce 
animal  testing  and  provides  incentives  for  the  use  and  development  of  alternative 
methods for hazard assessment.  

In short, the health and environment objective of REACH is expected to be achieved 
through  (1)  better  knowledge  on  the  properties  and  uses  of  substances  resulting  in 
better  safety  and  control  measures,  reducing  exposure  and  hence,  the  negative 
impacts  on  human  health  and  the  environment;  and  (2)  the  use  of  less  dangerous 
alternative substances or technologies to SVHC. 

2.1.1.  Expectations from REACH  

The potential health and environment benefits (hereinafter "benefits") were assessed 
in  the  2003  REACH  impact  assessment4.  Benefits  of  REACH  arise  from  the 
application of appropriate risk reduction measures – by industry in the first instance 
and mandated by authorities in the second – enabled by a systematic collection and 
generation of information on hazards and uses of chemicals.  

The impact assessment provided an illustration of the potential scale of the expected 
long term health benefits due to these risk reduction measures. The positive effects of 
REACH  on  public  health  were  assumed  to  start  to  occur  10  years  after  the  start  of 

4 

Commission  Staff  Working  Paper  [REACH]  Extended  Impact  Assessment,  European  Commission, 
29.10.2003, {COM(2003)644}. 

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REACH  implementation,  i.e.  2018,  and  would  be  fully  observed  after  another  20 
years, with total health benefits due to REACH in the order of magnitude of EUR 50 
billion  over  the  30  years  period  (after  discounting).  The  long-term  benefits  of 
REACH  on  the  environment  were  estimated  by  another  study  to  be  up  to  EUR  50 
billion  over 
the 
methodological  difficulties  the  overall  conclusion  was  that  the  benefits  of  REACH 
were expected to far outweigh the costs. 

the  25  years  period  (after  discounting)5.  Notwithstanding 

2.1.2.  Findings 

As  expected,  five  years  after  the  entry  into  force  of  REACH,  it  is  still  too  early  to 
quantify  the  benefits.  Instead  the  Commission  has  looked  at  initial  trends  based  on 
the  examination  of  qualitative  information  and  a  representative  set  of  quantitative 
indicators. 

The  Commission  reviewed  those  key  drivers  which  are  already  operational  and  of 
particular  relevance  to  the  generation  of  the  benefits,  namely:  registration, 
information  in  the  supply  chain,  authorisation  and  restrictions.  Measures  that  help 
realise  the  benefits,  such  as  dossier  evaluation,  provision  of  guidance,  inspections 
and enforcement activities were also examined.  

The Commission notes that:  

– 

– 

– 

Increased  information  is  resulting  in  changes  in  classification,  with  the 
majority becoming more stringent. The quality of the information available for 
risk  assessment  has  already  improved  if  compared  with  the  pre-REACH 
situation. 

Increased  information  in  the  supply  chain  and  improved  safety  data  sheets  is 
resulting in more appropriate risk management measures, thus contributing to 
the  observed  reduction  in  nominal  risk,  and  has  benefited  end-users,  such  as 
article producers. 

Increased  obligations  on  SVHC 
listing  and 
Authorisation provisions have led to increased moves towards the substitution 
of those substances through the supply chain. 

the  Candidate 

through 

Progress towards meeting the human health and environment objective of REACH is 
therefore  materialising.  This  trend  is  expected  to  accelerate  as  the  remaining  key 
benefit drivers become fully operational. However, the Commission notes some key 
shortcomings which may hinder achievement of the benefits:  

– 

– 

– 

many  registration  dossiers  have  been  found  to  be  non-compliant,  including 
with regard to substance identity, as reported by ECHA; 

insufficient assessments by registrants of persistent, bioaccumulative and toxic 
(PBT)  and  very  persistent,  and  very  bioaccumulative  (vPvB)  properties,  as 
reported by ECHA; 

problems  with  regard  to  the  content  and  format  of  the  extended  safety  data 
sheet, as reported by industry. 

Therefore, the Commission: 

5 

Study:  The  impact  of  REACH  on  the  environment  and  human  health,  DHI,  commissioned  by  the 
European Commission, September 2005. 

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(a) 

(b) 

(c) 

(d) 

(e) 

asks Industry to improve the quality of registration dossiers first, by focusing 
on  the  elimination  of  any  non-compliance  and  by  promptly  updating  them 
when needed; 

encourages ECHA and Member States to increase efforts towards compliance 
with the information requirements for the dossiers; 

encourages ECHA and Industry to address the problems related to compilation, 
communication and use of extended safety data sheets and therefore to promote 
them as a central risk management tool;  

in liaison with ECHA, will gather further practical evidence on how to improve 
the basis for the identification of substances and determination of "sameness". 
If  appropriate, 
including 
implementing legislation; 

the  Commission  may  propose  measures, 

in  cooperation  with  Member  States  and  ECHA,  will  increase  its  efforts  to 
identify  relevant  SVHCs  building  on  the  Risk  Management  Option  (RMO) 
framework; 

2.2. 

Internal market and competitiveness 

From 1999 to 2009 the EU chemical industry grew slightly higher than the average 
rate for all manufacturing sectors, and has largely recovered from the crisis of 2008. 
The industry generates a positive trade balance and is particularly well-performing in 
high margin sectors of specialty chemicals.  

In  2003,  when  REACH  was  proposed,  the  EU  was  the  world's  largest  chemicals 
market with approximately 30 % of the global chemicals sales. Today it amounts to 
about 21 %, with China now being the largest chemicals market. However, the EU 
chemicals industry remains the world's largest exporter and its turnover has increased 
in absolute terms. 

The internal market is a key driver for growth and competitiveness for the chemicals 
industry  and  REACH  has  further  harmonised  it.  The  industry  acknowledges  the 
positive  economic  effects  for  their  business  even  if  some  barriers  remain.  In  this 
context  the  Commission  reminds  Member  States  of  the  need  for  a  consistent  and 
harmonised interpretation of all REACH provisions, notably the 0.1% concentration 
threshold  of  substances  of  very  high  concern  in  articles6.  Without  prejudice  to  the 
Commission's interpretation of these provisions and any pending proceedings against 
Member  States  for  failing  to  fulfilling  an  obligation  under  the  Treaties,  the 
Commission  invites  Member  States  and  other  stakeholders  to  quantify  potential 
environmental or health impacts, if any, of the current REACH provision. 

The  cost  of  REACH  registration  has  discouraged  some  companies  from  competing 
on  certain  substances'  markets,  which  in  these  cases  have  increased  market 
concentration  and  prices.  A  potential  positive  effect  is  that  greater  specialization 
amongst  chemical  suppliers  and  new  business  models  (like  chemical  leasing)  may 
increase  safety.  The  need  to  restructure  some  supply  chains  opens  opportunities 
which, due to financial and organizational constraints, SMEs are less likely to exploit 
unless properly supported.  

6 

Concentration of 0,1% weight by weight referred to in Articles 7 and 33 

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The registration has impacted also downstream users who are, in general, less aware 
of their role in REACH. Their situation has to be monitored further, especially in the 
context of future registration deadlines. In particular, attention has to be paid to the 
situation  of  article  producers  and  to  the  costs  related  to  the  administration  of 
REACH. Given that great majority of downstream users are SMEs, they should be a 
focus in improving the implementation of REACH 

It  is  believed  that  a  significant  number  of  SMEs  are  unaware  about  their  role  and 
obligations  related  to  REACH,  and  those  who  are  aware,  may  have  a  false 
impression of the exact scope of their duties, which calls for further action to support 
and guide these types of companies. The Commission's concern over the impact of 
REACH  on  SMEs  is  reinforced  by  the  recent  survey  showing  that  REACH  is 
considered by SMEs as one of the 10 most burdensome pieces of EU legislation7. 

Therefore the Commission: 

(a)  will explore ways to reduce the financial impact of the Regulation, in particular 
for SMEs, inter alia, by reviewing the distribution of registration fees to grant 
greater  reductions  to  SMEs  and  by  asking  ECHA  to  provide  more  specific 
guidance  on  transparency,  non-discrimination  and  fair  cost  sharing;  more 
specific  recommendations  from  the  Commission  to  reduce  the  impact  of  the 
Regulation on SMEs are presented in an annex to this report; 

(b) 

encourages  ECHA  and  Industry  to  address  concerns  about  transparency, 
communication  and  cost  sharing  in  the  Substance  Information  Exchange 
Forum  (SIEF),  to  intensify  collaboration  on  streamlining  procedures  and  to 
develop  user-focused  guidance,  all  with  special  attention  to  the  SMEs  and 
costs; 

(c)  notes  that  some  countries  are  adopting  certain  principles  of  REACH  in  their 
chemical  legislation;  acknowledges  that  the  regulatory  discrepancies  between 
EU and key markets remain, which may have an impact on the EU's external 
competitiveness;  will  continue  to  promote  REACH-compatible  legislation 
internationally. 

(d)  Acknowledges 

the  challenges 

faced  by  many  enterprises 

(including 
downstream  users)  that  will  be  first  time  subject  to  registration  and  related 
obligations  in  2013  and  2018.  Therefore  will  use  available  means  to  monitor 
the  preparedness  of  the  industry  ahead  of  the  next  registration  deadlines.  In 
addition, encourages Member States and ECHA to strengthen efforts in relation 
to prepare the industry for these crucial milestones. 

2.3. 

Innovation 

REACH  aims  to  enhance  innovation.  Communication  in  the  supply  chain  provides 
chemical  companies  with  new  information  about  their  customers  and  their  needs. 
Many  companies  state  a  positive  impact  of  that  information  on  innovation. 
Information generated for the registrations provide inspiration for the innovative use 
of existing substances.  

7 

Public Consultation: "Which are the TOP10 most burdensome EU legislative acts for SMEs?" held by 
the European Commission from 28.09.2012 to 21.12.2012. 

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REACH has had a positive impact on research into new substances, due to generally 
equal treatment of new and phase-in substances. The number of registrations of new 
substances has increased in line with the expectations before REACH was adopted. 

Another  innovation  incentive  in  REACH  is  the  product  and  process  orientated 
research  and  development  (PPORD)  exemption  from  registration.  This  has  been 
welcomed by the industry in general, but the Commission notes that only few SMEs 
have used PPORD so far.  

In  conclusion,  REACH  fulfils  its  objective  with  regard  to  innovation  even  if  as 
regards  for  example  R&D  intensity  an  innovation  gap  with  regard  to  the  US  and 
Japan  still  exists  and  pressures  from  the  emerging  economies  are  increasing.  The 
Commission  will  continue  to  monitor  the  effect  of  REACH  on  innovation,  in 
particular in new technological areas and will report by 1 January 2015. 

3. 

GENERAL  REPORT  ON  THE  EXPERIENCE  ACQUIRED  FROM  THE  OPERATION  OF 
REACH 

3.1.  Member States' reports on the operation of REACH 

Article 117(1) required Member States to report by 1 June 2010 on the operation of 
REACH in their respective territories.  

All Member States nominated competent authorities. In total, there are 40 competent 
authorities operating in the EU and EEA Member States, as 7 Member States have 
more than one authority.  

Competent  authorities  play  an  important  role  in  all  REACH  processes.  Effective 
communication and collaboration between them as well as with the Commission and 
other stakeholders is a key success-factor for smooth and unified implementation of 
REACH.  The  Member  States'  reports  show  that  most  of  them  consider  the 
cooperation as a positive experience.  

The reports also point out that competent authorities consider the resources and skill 
sets available to them for the purpose of their tasks as limited. 

Enforcement  is  the  sole  responsibility  of  the  Member  States  and  all  of  them  have 
nominated  enforcement  authorities.  The  Member  States'  inspection  activities  so  far 
importers  (23%),  only 
have  covered  manufacturers  (37%  of 
representatives  (3%)  and  downstream  users  (36%).  To  ensure  more  consistent 
enforcement  at  the  EU  level,  REACH  established  within  ECHA  the  Forum  for 
Exchange  of  Information  on  Enforcement.  This  forum  was  recognized  as  a  useful 
collaboration platform.  

inspections), 

The Commission:  

(a)  will  assist  the  competent  authorities  in  enhancing  in-house  skills,  e.g.,  by 
developing  and  sharing  tools  for  the  assessment  of  the  impacts  on  the 
innovation and competitiveness; 

(b) 

calls  on  Member  States  to  maximise  the  effectiveness  of  the  available 
resources  through  better  coordination  and  knowledge  sharing.  With  regard  to 
enforcement, focused actions and synergies with other EU legislation should be 
sought;  

(c)  will  develop  enforcement  indicators  in  liaison  with  the  Forum  and  calls  on 

Member States to monitor the effectiveness of the enforcement; 

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(d)  will  improve  the  reporting  template  and  will  clarify  the  role  of  customs 

authorities in the enforcement of REACH. 

3.2. 

ECHA report on the operation of REACH and CLP 

The  first  ECHA  report  was  submitted  in  June  2011  in  accordance  with  Article 
117(2).  It  shows  that  regulators  as  well  as  industry  have,  in  essence,  met  their 
obligations and that REACH is working well overall. Nevertheless, there are lessons 
to learn from the experience so far. 

ECHA identified three broad areas for improvement in the operation of REACH and 
CLP: 

– 

– 

– 

Industry needs to take full ownership of its registration dossiers and proactively 
work on their quality, even after submission to ECHA. 

Effective  communication  through  the  supply  chain  of  information  on 
substances  and  how  to  use  them  safely  needs  further  attention.  Means  to 
achieve it must be strengthened and tools to facilitate it must be developed or 
improved. 

Limited  resources  demand  effective  prioritisation  of  substances  for  further 
consideration  in  the  REACH  and  CLP  processes.  Further  use  of  registration 
information  should  be  facilitated  in  order  to  best  focus  authorities’  resources 
towards safe use of substances. 

Issues in all REACH areas have been found, some can be solved through optimising 
implementation  while  others  would  require  the  Commission  to  consider  proposing 
amendments  to  REACH.  ECHA  concludes  that  industry  now  primarily  needs 
stability  and  predictability,  and  does  not  advocate  changing  REACH  in  the  short 
term.  

3.3. 

Animal Testing  

The  key  findings  from  ECHA's  Article  117(3)  report  on  alternative  methods  to 
testing are: 

– 

– 

– 

– 

– 

– 

– 

90  %  registration  dossiers  have  been  submitted  jointly  and  there  is  good 
progress with the sharing of data; 

registrants have extensively used available provisions to waive tests; 

the quality of the justifications for not conducting animal tests is of concern; 

registrants in general did not propose unnecessary testing; 

the procedure of providing testing proposals works well;  

fewer  testing  proposals  than  expected  were  received,  although  in  part  due  to 
the inappropriate adoption of alternative approaches; and 

107  higher  tier  animal  tests  seems  to  have  been  conducted  without  a  testing 
proposal  

Overall,  €330  million  has  been  allocated  by  the  Commission  to  support  the 
development  and  evaluation  of  alternative  methods  in  the  period  2007-2011.  Nine 
Member  State  Competent  Authorities  reported  expenditure  of  more  than  €100,000 
each  per  year.  The  breakdown  in  spending  is  reported  in  the  staff  working  paper. 
Efforts should continue since there are still  gaps  in  providing  alternatives for some 

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complex  toxicological  endpoints.  Additional  attention  should  be  paid  to  the 
regulatory use of the results and to the education of users. 

The Commission recommends: 

(a)  ECHA  to  continue  efforts  on  dossier  evaluation,  improve  guidance  and 
communication  with  industry  to  enhance  the  quality  of  the  submitted 
justifications for use of alternative methods; and 

(b)  ECHA  to  evaluate  the  effectiveness  of  the  process  of  public  consultations  on 
testing proposals, these public consultations should further focus on alternative 
approaches and generate new relevant information. 

(c)  Member States to enforce compliance with testing proposal requirements 

The  Commission  will  oversee  the  spending  of  research  funding  on  alternative 
methods  to  encourage  their  development  in  line  with  the  relevant  section  of  the 
Commission  Communication  on  the  combination  effects  of  chemicals8,  taking  into 
account  the  need  for  regulatory  use.  The  Commission  will  also  coordinate 
internationally and across sectors, where relevant. 

3.4. 

Review of the requirements for registration of 1 to 10 tonnes substances and on 
the need to register certain types of polymers  

The registration requirements for substances in quantities of 1 to 10 tonnes have been 
assessed for their adequacy to identify hazards to human health and the environment. 
The  assessment  includes  consideration  of  the  identification  of  any  human  health  or 
environmental  classification  endpoint  sufficient  for  classification  under  CLP  and 
identification  of  appropriate risk management measures. The  Commission confirms 
that  the  information  requirements  are  less  than  those  of  an  OECD  Screening 
Information  Data  Set  (SIDS)  dossier  which  is  consistent  with  the  absence  of  a 
requirement for a chemical safety report. 

The Commission has at present insufficient information on the impact on innovation 
and  competitiveness  to  propose  changes  to  the  information  requirements  for 
substances produced in low tonnages.  

Similarly, the Commission is reviewing the need, if any, to register certain types of 
polymers.  At  present,  more  information  is  necessary  to  conclude  on  that  need  and 
feasibility. 

Given  the  potential  benefits  whilst  also  considering  the  costs,  the  Commission  will 
continue  to  work  in  these  areas  in  co-operation  with  Member  States  and  other 
stakeholders and come forward with a proposal, if appropriate, by 1 January 2015. 

3.5. 

Classification, labelling and packaging (CLP)  
The  CLP  Regulation9  sets  the  rules  for  classification,  labelling,  and  packaging  of 
chemical substances and mixtures at EU level. Its main objectives are to determine 
whether  a  substance  or  mixture  displays  properties  that  lead  to  a  classification  as 

8 

9 

Communication  from  the  Commission  [...]  The  combination  effects  of  chemicals  Chemical  mixtures, 
European Commission, {COM/2012/0252}, Section 5.2 (4) (i) and (ii). 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification,  labelling  and  packaging  of  substances  and  mixtures,  amending  and  repealing  Directive 
67/548/EEC  and  1999/45/EC,  and  amending  Regulation  (EC)  No  1907/2006  (OJ  L  353,  31.12.2008, 
p.1). 

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hazardous and to harmonise the standard symbols, phrases and packaging conditions 
that  should  be  used  to  inform  users.  For  substances  this  is  reported  in  the  REACH 
registration dossier.  

The  enforcement  of  CLP  is  closely  related  to  the  enforcement  of  REACH,  both 
facing similar challenges. Member States pursue their CLP inspections often as a part 
of  REACH  inspections.  Furthermore,  the  Forum  for  exchange  of  information  on 
enforcement,  managed  by  ECHA  undertakes  its  tasks  with  regard  to  both 
Regulations.  A  strong  and  harmonised  approach  towards  enforcement  of  CLP  and 
REACH throughout the EU is vital for delivering their objectives.  

Article  46(2)  of  the  CLP  Regulation  requires  Member  States  to  report  regularly  on 
the  results  of  official  controls  and  other  enforcement  measures  taken.  The  first 
reports submitted covered the period January 2009 to June 2011. Overall 26 Member 
States submitted reports which showed large variations in the level of detail and the 
issues addressed.  

Most  Member  States  co-operate,  co-ordinate,  and  exchange  information  and  have 
appropriate  sanctions  in  place  to  enforce  the  CLP  Regulation.  Most  also  have  an 
enforcement  strategy  in  line  with  the  strategy  developed  by  the  Forum.  The  total 
number of inspections concerning particular products and individual duty holders has 
steadily increased over the last three years. In terms of issues identified where further 
improvements  are  necessary,  compliance  with  the  legal  requirements  could  be 
substantially  improved  (generally  the  compliance  rates  amounted  to  70%),  and  the 
reporting by Member States needs further harmonisation.  

Compared  with  situation  before  the  CLP  Regulation  was  adopted,  the  Commission 
and all Member States are now - due to the reporting obligation - regularly updated 
on enforcement activities and compliance rates. This will allow to target enforcement 
activities  on  problematic  areas  and  to  further  develop  joint  enforcement  strategies. 
However, Member States might have to dedicate additional resources to enforcement 
and to the regular reporting to fully profit from the experience gained across the EU. 

It is expected that further development of the enforcement strategy of the Forum in 
relation with CLP will also have a positive effect on the effectiveness of enforcement 
in  improving  the  rate  of  compliance.  The  strategy  should  include  harmonised  and 
targeted  enforcement  projects,  and  an  element  of  awareness  raising  particularly 
focussed on SMEs. 

4. 

REVIEW OF ECHA 

The Commission has examined ECHA’s:  

– 

– 

– 

Effectiveness: the extent to which objectives set are achieved; 

Efficiency: the extent to which the desired effects are achieved at a reasonable 
cost; 

Economy:  the  extent  to  which  resources  are  available  in  due  time,  in 
appropriate quantity and quality at the best price.  

The  Commission  also  assessed  ECHA’s  role,  added  value,  acceptability  by 
stakeholders and location. 

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The review encompassed the start-up of ECHA, two major REACH deadlines and a 
key CLP deadline. However, substance evaluation activities had not started, nor had 
any authorisation applications been received. 

ECHA  had  a  successful  start-up,  contributed  to  by  a  swift  and  performing 
recruitment  policy,  the  strong  commitment  of  staff  and  management  alongside  the 
support of the Finnish authorities.  

ECHA  met  most  of  its  key  objectives  and  can  therefore  be  considered  as  effective 
with most stakeholders noting that ECHA performed well. The Agency was set up, 
handled  pre-registration  and  registration  effectively,  and  laid  down  the  foundations 
for  its  tasks  under  authorisation  and  restrictions.  It  also  delivered  most  of  the 
required guidance documents, initiated the activities of the network of REACH and 
CLP  national  helpdesks  and  the  Forum.  Dissemination  of  data,  usability  of  search 
tools on the ECHA website, provision of the data to Competent Authorities and the 
Commission, and communication and transparency in general, could have been more 
effective. 

Delivering the expected outputs was ECHA’s clear priority in the starting years. This 
meant  ECHA  coped  with  unexpected  circumstances.  In  addition,  ECHA  conducted 
activities not strictly required by REACH to support industry’s compliance with its 
obligations, for example, a campaign about Substance Information Exchange Forums 
(SIEF)  formation  and  organisation,  and  participation  in  the  Directors'  Contact 
Group10. The Commission acknowledges that overall efficiency was reduced by the 
complementary activities but agrees that this focus on delivery was the right choice 
for ECHA to make as it contributed to the overall effectiveness.  

ECHA’s strong engagement with industry stakeholders triggered some criticism that 
ECHA  appeared  to  favour  industry  over  other  stakeholders.  However,  it  is 
indisputable that the effectiveness of ECHA and the measure of success of REACH 
depend  on  the  ability  of  individual  companies  to  fulfil  their  obligations  and  on  the 
commitment  of  industry  as  a  whole.  The  Commission  is  convinced  that  ECHA’s 
approach in this regard is another example of a justifiable focus on effectiveness in 
the  start-up  phase.  Fully  aware  of  the  diversity  of  its  stakeholders  and  their  often 
conflicting  expectations,  the  Commission  is  confident  that  ECHA  will  continue  to 
strike  the  right  balance  between  independence  and  stakeholder  engagement  taking 
into account that it is now to be considered an agency at cruising speed. 

ECHA  showed  its  ability  to  be  flexible.  The  budget  planning  and  forecasting  were 
adequate.  Operational  adaptability  was  displayed  in  responding  to  new  situations 
through a risk management approach, re-allocation of resources where necessary and 
willingness to learn and adapt. 

The  Commission  considers  that  ECHA  should  now  play  its  central  role  in  the 
technical  and  administrative  management  of  REACH.  In  view  of  the  evidence 
gathered by the ECHA review, the Commission invites ECHA to: 

(a) 

(b) 

enhance  efficiency  and  economy  by  e.g.  further  prioritization  of  tasks  and 
improved cooperation between ECHA bodies ; 

continue and enhance stakeholder engagement activities, including SMEs as a 
separate target group taking into account their specific needs; 

10 

Information on these activities is provided by ECHA in its annual General Reports available on ECHA 
website: www.echa.europa.eu 

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(c) 

improve the sharing of information and data with the Commission and Member 
States' authorities where possible and compatible with confidentiality rules. 

The Commission recommendations should be put in place with the existing resources 
already allocated to the agency therefore they will not entail a budgetary impact over 
and above the appropriations already foreseen for the years to come. 

5. 

REVIEW OF THE SCOPE OF REACH 

The  Commission  has  analysed  links  between  REACH  and  more  than  a  hundred 
pieces  of  other  EU  legislation  with  a  view  to  identifying  and  assessing  overlaps 
between them.  

Overall, the Commission is of the view that the scope of REACH was set well and no 
major  overlaps  with  other  EU  legislation  have  been  identified.  Nonetheless,  some 
minor overlaps or potential overlaps were identified. In this context, the term overlap 
was  understood  as  encompassing  situations  where  two  pieces  of  EU  legislation 
regulate the same situation which may lead to instances of legal uncertainty or where 
legal requirements lead to unnecessary burdens on duty holders.  

In the registration area few minor overlaps or potential overlaps have been identified. 
These  will  be  addressed  on  a  case  by  case  basis.  In  the  restrictions  area,  where  a 
number  of  EU  sector-specific  legislations  lay  down  restrictions  of  substances  or 
categories of substances, some minor overlaps were identified. Taking into account 
the  existence  of  various  EU  legislation  containing  substance  restrictions,  the 
Commission considers useful to invite ECHA to develop an inventory of all existing 
restrictions in EU legislation on an individual substance basis.  

The  Commission  will  strive  to  minimise  or  avoid  overlaps  or  potential  overlaps 
through  

(a) 

(b) 

inviting ECHA to change guidance, if appropriate; and  

implementing legislation under REACH or other EU sector-specific legislation 
in  particular  when  considering  future  restrictions  and  substances  subject  to 
authorisation.  

In the event of REACH or other relevant EU  legislation  being open for revision in 
the  future,  the  Commission  will  address  any  remaining  areas  where  overlaps  were 
identified. 

In  addition  to  overlaps,  the  Commission  also  identified  certain  areas  where 
information generated under REACH processes could be used in the context of EU 
sector-specific legislation requirement. By the same token, the information generated 
for  the  purpose  of  EU  sector-specific  legislation  could  be  useful  for  REACH 
purposes11.  

6. 

NANOMATERIALS 

The  Second  Regulatory  Review  on  Nanomaterials  concluded  that;  "Overall  the 
Commission remains convinced that REACH sets the best possible framework for the 
risk  management  of  nanomaterials  when  they  occur  as  substances  or  mixtures  but 
more  specific  requirements  for  nanomaterials  within  the  framework  have  proven 

11 

Examples of synergies between REACH and other EU legislation are listed in SWD, Title 1.1. 

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necessary. The Commission envisages modifications in some of the REACH Annexes 
and encourages ECHA to further develop guidance for registrations after 2013". 

The Commission will make an impact assessment of relevant regulatory options, in 
particular  possible  amendments  of  REACH  Annexes,  to  ensure  further  clarity  on 
how nanomaterials are addressed and safety demonstrated in registration dossiers. If 
appropriate  the  Commission  will  come  forward  with  a  draft  implementing  act  by 
December 2013. 

7. 

CONCLUSIONS 

Based on the above findings the Commission considers that REACH functions well 
and  delivers  on  all  objectives  that  at  present  can  be  assessed.  Some  needs  for 
adjustments  have  been  identified,  but  balanced  against  the  interest  of  ensuring 
legislative stability and predictability, the Commission concludes that changes to the 
enacting terms of REACH will not be proposed.  

Within  the  current  framework,  however,  there  is  a  need  to  reduce  the  impact  of 
REACH on SMEs. The annex to this report sets out the measures that will contribute 
to this goal. 

There  are  many  other  opportunities  for  further  improvement  of  the  functioning  of 
REACH  by  further  optimizing  the  implementation  at  all  levels,  as  set  out  in  this 
Report and further described in the Staff Working Document. To achieve this, strong 
commitment  of  all  the  actors  involved  is  necessary;  therefore,  the  Commission 
undertakes to continue to work jointly with Member States, ECHA and stakeholders 
towards a successful implementation of REACH.  

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Annex 

List of specific recommendations from the Commission with the aim to reduce the 
administrative burden of REACH by SMEs while maintaining their ability to fulfil all 
REACH obligations 

•  ECHA  is  encouraged  to  provide  more  specific  guidance  on  transparency,  non-
discrimination  and  fair  cost  sharing  in  the  framework  of  SIEF  formation  and  operation. 
The  review  has  identified  specific  problems  in  relation  to  the  powers  of  lead  registrants 
which  role  is  more  frequently  exercised  by  larger  companies.  These  powers  could 
materialize  in  imposing  flat  fee  on  'letters  of  access'  and  charging  disproportionate 
amounts  for  the  administration  of  SIEF.  The  incentives  to  ensure  an  economically 
efficient SIEF administration must be made stronger.. 

•  The  Fee  Regulation  is  currently  being  reviewed  taking  into  account  the  results  of  the 
overall REACH review, in particular, those related to costs of REACH and its impact on 
competitiveness  and  innovation.  A  main  objective  of  the  revised  Fee  Regulation  is  to 
lower the costs for SMEs. 

•  ECHA and industry should develop more user-focused guidance, with special attention to 
SMEs.  The  review  has  identified  a  specific  problem  in  relation  to  the  vast  amount  of 
guidance  developed  to  support  the  implementation  of  REACH.  Only  a  fraction  of  the 
existing  guidance  is  targeted  to  specific  groups  of  companies.  REACH  is  applicable  to 
many different types of companies through the whole supply chain which has led to often 
rather complex guidance documents. 

•  ECHA  in  collaboration  with  the  industry  should  improve  the  guidance  for  protecting 
intellectual  properties  in  the  context  of  mandatory  exchange  of  information  in  the  value 
chain.  In  the  context  of  joint  registration  a  specific  problem  has  been  found  with  the 
disclosure  of  important  business  information,  which  in  some  cases  constitutes  the 
foundation  of  specific  companies.  More  specific  guidance  is  needed  to  disseminate  best 
practices among the industry on which information should be protected, and how best to 
achieve satisfactory protection. 

•  Similarly,  ECHA  should  develop  better  guidance,  especially  targeting  SMEs  and  less 
experienced  companies,  in  the  use  of  the  Use  Descriptor  System.  Currently  SMEs  often 
need external support driving up their compliance costs. Improper use of the system may 
result  in  significant  differences  between  suppliers  of  the  same  substance  in  the  required 
conditions for its use which limits the possibility to change supplier; leads to higher costs 
and reduced stability of supplies. 

•  ECHA and national REACH Helpdesks are called upon to develop specific activities and 
guidance  on  integrating  REACH  processes  early  into  the  R&D  and  other  innovation 
processes.  Some  innovative  companies  have  expressed  concerns  over  regulatory 
uncertainty.  While  a  number  of  innovation-friendly  mechanisms  are  present  in  REACH 
and a lot of information is being produced by ECHA and disseminated on the internet on 
the  exact  obligations,  these  mechanisms  and  information  sources  need  to  be  well 
advertised among innovating companies.  

•  The Commission will make further use of Enterprise Europe Network (EEN) to increase 
awareness of REACH along the supply chain and to improve the communication within 
the  supply  chain.  REACH  concerns  a  wide  variety  of  companies  and  a  significant 
proportion  of  businesses  in  Europe  qualify  as  downstream  users.  It  is  believed  that  a 
number of SMEs are unaware about their role and obligations related to the Regulation, 
and those who are aware, may have a false impression of the exact scope of their duties. 

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For  this  reason  wider  communication  and  awareness  raising  activities  will  be  pursued 
using established platforms of EEN and national REACH Helpdesks. 

•  Finally, 

the  Commission  will  continue 

the  administrative  costs  of 
implementation of REACH by SMEs and the quantity and quality of technical and legal 
support for SMEs provided by responsible implementing institutions. 

to  monitor 

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