Work programme 2010 : working for the safe use of chemicals across the EU.
Date: 2015-06-08
Institutions: European Chemicals Agency
Subjects: European Chemicals Agency, chemical industry, chemical product, industrial research, research and development

Work Programme 2010

Working for the safe use of 
chemicals across the EU 

 
 
  
LEGAL NOTICE 

The views or positions expressed in this Work Programme do not necessarily represent in 
legal terms the official position of the European Chemicals Agency. The European 
Chemicals Agency assumes no responsibility or liability for any errors or inaccuracies  
that may appear. 

Work Programme 2010

Working for the safe use of 
chemicals across the EU 

ECHA Reference:   ECHA-09-A-02-EN 

MB/56/2009 final 

Date:    

29/09/2009 

Language:  

EN 

© European Chemicals Agency 

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Table of contents 

List of Acronyms 

Presentation of the European Chemicals Agency 

Introduction: challenges and priorities for 2010 

Programme 1: Operational activities - Implementation of the REACH  

    Processes 

Activity 1: Registration, pre-registration and data-sharing 

Activity 2: Evaluation 

Activity 3: Authorisations and restrictions 

Activity 4: Classification and labelling 

Activity 5: Advice and assistance through guidance and helpdesk 

Activity 6: IT support to operations 

Activity 7: Scientific and practical advice for the further development of legislation 

Programme 2: ECHA’s bodies and supporting activities 

Activity 8: Committees and Forum 

Activity 9: Board of Appeal 

Activity 10: Communications 

Activity 11: Relations with EU institutions and international cooperation  

Programme 3: Management, organisation and resources 

Activity 12: Management  

Activity 13: Finance, Procurement and Accounting 

Activity 14: Human resources and infrastructure 

Activity 15: Informatics and communication technology 

Annexes  

Annex 1: ECHA Organisation 

Annex 2: Activity levels used for the work programme 

Annex 3: Estimated resources  

Annex 4: Procurement plan 

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ACSHW 
AD 
AST 
C & L   
CA 
CASPER 

CHESAR 
CLP 
COM 
EC 
ECHA   
EFSA   
EMEA   
EU 
EU-OSHA 
FAQ 
HR 
IAS 
IQM 
ISO 
IT 
IUCLID 
JRC 
MB 
MSC 
MSCA   
OECD   
PDB 
PEG 
PPORD 
(Q)SAR 
RAC 
REACH 
REACH-IT 
REHCORN 
SEAC   
SIEF 
SVHC   
UNECE SC GHS 

WP 

List of Acronyms  

Advisory Committee on Safety and Health at Work 
Administrator 
Assistant 
Classification and Labelling 
Contract Agent 
IT Characterisation Application for Selection, Prioritisation, 
Evaluation and Reporting 
Chemical Safety Assessment and Reporting tool 
Classification, Labelling and Packaging 
European Commission 
European Commission 
European Chemicals Agency 
European Food Safety Authority 
European Medicines Agency 
European Union 
European Agency for Safety and Health at Work 
Frequently Asked Questions 
Human Resources 
Internal Audit Service of the European Commission 
Integrated Quality Management 
International Organization for Standardisation 
Information Technologies 
International Uniform Chemical Information Database 
Joint Research Centre of the European Commission 
Management Board 
Member State Committee 
Member State Competent Authority 
Organisation for Economic Cooperation and Development 
Preliminary Draft Budget 
Partner Expert Group 
Product and Process Oriented Research and Development 
(Quantitative) Structure-Activity Relationships 
Risk Assessment Committee 
Registration, Evaluation, Authorisation and Restriction of Chemicals 
REACH-IT is the central IT system providing support for REACH 
REACH Helpdesk Correspondent Network 
Socio-Economic Analysis Committee 
Data Sharing & Substance Information Exchange Forum 
Substance of Very High Concern 
Subcommittee of United Nations Economic Commission for Europe 
on the Globally Harmonised System for classification and labelling 
of chemical substances and mixtures 
Work Programme 

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Presentation of the European Chemicals Agency 

Established  on  1  June  2007,  the  European  Chemicals  Agency  (ECHA)  is  at  the  centre  of  the 
new regulatory system for chemicals in the European Union (EU), set out in Regulation (EC) No 
1907/2006 of the European Parliament and the Council concerning the Registration, Evaluation, 
Authorisation  and  Restriction  of  Chemicals  (REACH).  At  the  beginning  of  2009,  REACH  was 
complemented by the Regulation on Classification, Labelling and Packaging of substances and 
mixtures  (CLP  Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  the  Council). 
These legislative acts are applicable in all EU Member States without the need for transposition 
into national law.  

The purpose of the REACH system is to ensure a high level of protection of human health and 
the  environment;  to  promote  alternative  methods  to  animal  testing  to  assess  the  hazards  of 
chemicals; to facilitate the free circulation of substances within the single market; and to enhance 
competitiveness  and  innovation.  In  practical  terms,  the  new  regime  is  expected  to  close  a 
knowledge gap concerning chemicals placed on the European market before 1981; to speed up 
the placing of safe and innovative chemicals on the market; and to make the risk management of 
these substances more efficient - in particular by shifting the burden of proof for identifying and 
controlling  risks  from  authorities  to  companies.  The  successful  implementation  of  REACH 
requires a well-functioning Agency, capable of delivering independent and high-quality science-
based opinions within strict legal deadlines, as well as of ensuring that the operational aspects of 
the  legislation  function  smoothly.  However,  the  efficient  operation  of  REACH  also  depends  on 
ECHA’s  institutional  partners,  in  particular  the  Member  States  of  the  EU,  and  the  European 
Commission. 

The purpose of the CLP Regulation is to ensure a high level of protection of human health and 
the  environment,  as  well  as  the  free  movement  of  substances,  mixtures  and  articles,  by 
harmonising the criteria for classification of substances and mixtures, and the rules on labelling 
and  packaging.  The  hazardous  properties  of  chemicals  include  physical  hazards  as  well  as 
hazards  to  human  health  and  to  the  environment,  including  hazards  to  the  ozone  layer. 
Furthermore, the CLP Regulation constitutes an EU contribution to the global harmonisation of 
criteria for classification and labelling, the latter having been developed within the United Nations 
(UN GHS).  

Both  regulations  should  contribute  to  fulfilment  of  the  Strategic  Approach  to  International 
Chemical Management (SAICM) adopted on 6 February 2006 in Dubai. 

ECHA’s Mission  

ECHA’s  mission  is  to  manage  all  REACH  and  CLP  tasks  entrusted  to  it  by  carrying  out  or 
coordinating  the  necessary  activities,  in  order  to  ensure  a  consistent  implementation  at 
Community  level  and  to  provide  Member  States  and  the  European  institutions  with  the  best 
possible scientific advice on questions related to the safety and the socio-economic aspects of 
the use of chemicals. This is achieved by ensuring a credible decision-making process, using the 
best possible scientific, technical and regulatory capacities, and by working independently in an 
efficient, transparent and consistent manner.  

ECHA’s Vision  

ECHA’s vision is to become the internationally recognised Agency on any question related to the 
safety  of  industrial  chemicals,  and  a  source  for  reliable  and  high  quality  information  on 
chemicals. ECHA will be a trustworthy, efficient and transparent regulatory authority and attract 
highly  motivated  and  talented  staff  by  applying  the  most  modern  administrative  practices  and 
staff policies. ECHA will be recognised as a reliable partner providing advice and assistance as 
needed. 

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Introduction 

This  Work  Programme  outlines  the  European  Chemicals  Agency’s  objectives  for  2010, 
which will be its third full year of activity. The Multi-Annual Work Programme 2009-2012, 
adopted in September 2008 by the ECHA Management Board, provides the basis for this 
annual Work Programme. The structure of the Work Programme has been revised since 
2009, and it is now divided across fifteen activities, each of which has a set of objectives 
and deliverables, as well as indicators, with which achievements can be followed up. 

The planning in this Work Programme is founded upon the baseline figures presented in 
Annex  2,  which  are  an  update  of  the  Commission  estimates  made  when  the  REACH 
Regulation  was  prepared.  It  should  be  underlined  that  the  baseline  numbers  are  still 
subject  to  a  high  degree  of  uncertainty,  meaning  that  a  constant  monitoring  of  the  work 
volume  is  required,  and  potentially,  a  re-allocation  of  priorities  and  resources  during  the 
year.  The  biggest  uncertainty  concerns  the  volume  of  registration  dossiers  and  C&L 
notifications  that  companies  will  submit,  followed  by  the  degree  of  efficiency  of  the 
REACH-IT  system.  As  such,  the  Agency’s  planning  for  2010  also  contains  contingency 
plans, which can be put in place should the baseline assumptions change remarkably.  

The  resource  estimates  are  based  on  those  of  the  Preliminary  Draft  Budget  adopted  by 
the  ECHA  Management  Board  in  February  2009.  However,  the  very  tight  budgetary 
situation eventually led to a much lower Commission request for ECHA. The final budget 
and the establishment plan for human resources will be adopted in December 2009 after 
the  Budgetary  Authority  (Council  and  European  Parliament)  has  authorised  the  final 
subsidy amount and the staff numbers for ECHA. The final budget will not only be based 
on the final amount of subsidy, but also on a re-estimate of the fee income over the entire 
year,  corresponding  to  the  updated  volume  of  registration  dossiers  ECHA  expects  to 
receive during 2010. Should the total revenue or authorised staff figures differ significantly 
from  the  current  estimates,  the  Work  Programme  will  be  adjusted  accordingly  in 
December 2009. 

ECHA’s challenges and priorities for 2010 

After  successfully  completing  the  rush  of  pre-registrations  in  2008,  ECHA  will  face  its 
second  crucial  deadline  on  30  November  2010.  By  that  date,  industry  has  to  submit 
registration  dossiers  for  all  high  volume  substances  and  for  certain  categories  of 
substances  of  concern.  Shortly  afterwards,  on  3  January  2011,  ECHA  faces  its  third 
deadline,  as  companies  have  by  that  date  to  submit  notifications  for  their  substances, 
irrespective  of  their  volume  of  production  or  sale,  in  order  to  permit  ECHA  to  set  up  a 
classification and labelling inventory.  

It  will  be  a challenge  for  the  Agency  to  handle the  steady  increase  of scientific  dossiers 
concurrently submitted by authorities: restriction proposals, proposals for the identification 
of  substances  of  very  high  concern,  or  proposals  for  harmonised  classification  and 
labelling.  ECHA  will  also  have  to  perform  timely  updates  of  the  candidate  list  of 
substances  of  very  high  concern  and  prioritise  those  substances  from  the  candidate  list 
which  it  will  recommend  for  inclusion  on  the  authorisation  list.  The  Agency  will  also 
process  the  first  restriction  proposals.  In  parallel,  ECHA  will  have  to  build  capacity  for 
upcoming  or  accelerating  operational  tasks,  namely  the  assessment  of  applications  for 
authorisations  and  the  science-based  evaluation  of  the  large  volume  of  registration 
dossiers  for  chemical  substances  that  will  have  been  received  by  the  2010  deadline. 
Moreover,  ECHA  has  to  provide  scientific  advice,  if  requested,  to  the  European 
institutions.  

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With regard to its biggest challenge linked to the first registration deadline, ECHA is facing 
uncertainty about the number of registration dossiers that will be received and will need to 
be processed. When setting up the REACH Regulation, the European Commission based 
its  impact  assessment  on  an  estimated  number  of  over  130  000  pre-registrations  for  a 
total of ca. 70 000 substances (ca. 30 000 chemical substances placed on the market and 
40 000  intermediates)1.  At  the  first  registration  deadline  in  2010,  25  000  registration 
dossiers  were  expected.  However,  last  year,  ECHA  received  more  than  2 700  000  pre-
registrations for some 150 000 substances, of which 250 000 pre-registrations for 50 000 
substances flagged an intention to register by the first deadline. An internal analysis of the 
pre-registration  data  predicted  that  the  number  of  registrations  in  2010  would,  in  all 
likelihood, be close to the estimate of the Commission, but that it could also be up to three 
times  that  number.  Consequently,  this  uncertainty  is  the  main  driver  of  ECHA’s 
contingency planning.  

In  any  case,  it  is  already  evident  that  most  dossiers  will  arrive  in  two  peaks,  one  in 
September - linked to the registration by lead registrants wishing to receive feedback from 
ECHA  before  other  SIEF  members  register  -  and  another,  in  November  -  linked  to 
registration by other lead registrants and by other SIEF members. Even if the number of 
registrations is the 25 000 originally expected, there will be a high need for staff to support 
the  submission  and  helpdesk  functions  during  these  peaks,  and  to  support  the  staff 
verifying the technical completeness of dossiers from October 2010 until February 2011. 
This  will  drag  some  scientific  and  administrative  resources  away  from  other  activities, 
affecting evaluation in the first instance -  due to the strong interaction with registration -, 
and in the worst case scenario, nearly all other activities. 

There is another exceptional workload in 2010, which will peak in December, linked to the 
deadline  of  3  January  2011  for  notifications  of  classification  and  labelling  of  dangerous 
chemical substances of any volume. ECHA has to establish and maintain a classification 
and  labelling  inventory  in  the  form  of  a  database,  which  will  be  generated  from  these 
these  submissions  will  be  a  specific  challenge, 
industry  notifications.  Receiving 
comparable  to  that  related  to  pre-registrations  in  2008,  as  the  number  of  notifications  is 
estimated  to  be  equally  high  (for  planning  purposes  a  number  of  2  million  is  used2).  As 
similar  uncertainties  apply  to  the  number  of  these  notifications  as  to  pre-registrations, 
ECHA must be prepared to process a much higher number than originally foreseen. 

As  a  safeguard  measure,  the  IT-systems  supporting  these  operations  will  be  scaled  for 
and tested with a much higher load factor than the current estimates indicate; and ECHA 
is considering solutions to face the human resources challenge, should a higher number 
of registrations and notifications arrive. To this end, ECHA will establish a contract with a 
provider  able  to  supply  extra  workforce  in  due  time,  to  buffer  unforeseen  peaks  in 
workload,  and  will  train  staff  from  other  parts  of  ECHA  to  assist  in  supervising  these 
personnel.  

As a consequence of the revision of the EC biocides legislation, for which the co-decision 
procedure was  initiated  in  20093, additional  tasks  will  be expected  of  ECHA.  ECHA  has 
informed the Commission of the need to obtain financial and human resources from 2010 
onwards,  given  the  time  needed  for  recruiting  and  training  scientific  experts  and  for 
adjusting the IT systems. The resources needed for these preparatory activities are not to 
be  covered  by  the  REACH  and  CLP  fees.    ECHA  will  thus  strive  to  closely  follow  the 
legislative  procedure  and  communicate 
the 
Commission. 

the  co-legislators  and 

its  needs 

to 

1 No statistics were available for the intermediates.  
2 The estimate was 130 000.  
3 (COM(2009)267) final. 

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As the scientific level of ECHA activities is linked to the capacity to recruit, train and keep 
highly  qualified  staff  for  scientific  and  technical  tasks,  specific  effort  is  planned  for  the 
recruitment  and  training  of  120  new  staff  members  in  2010,  mainly  with  a  scientific 
background,  and  this  will  be  enhanced  by  developing  staff  access  to  the  best  scientific 
know how and developing participation in the relevant international scientific communities. 

Other challenges for 2010 include adapting the Agency’s premises to its specific needs; 
securing  the  financial  circuits;  further  developing  management  capacities  and  methods; 
and enhancing the functionality and performance of existing (scientific) IT systems. 

In addition, in order to ensure the high quality and consistency of the decisions taken and 
opinions  formed,  ECHA  has  to  further  develop  and  refine  procedures  and  work 
instructions  that  document  its  main  processes,  and  train  new  staff.  This  is  an  ongoing 
activity,  which,  since  the  end  of  2008,  has  developed  into  a  corporate  quality  project, 
driven by the management, with the aim to conform to ISO 9001 standards in the coming 
years.  In  parallel,  ECHA  started  to  develop  an  Enterprise  Content  Management 
Programme in 2009 that will provide a solid base for managing documents, records and 
workflows, and will support the REACH-IT system. In 2010, these projects will continue to 
develop,  in  particular  leading  to  an  efficient,  operational  workflow  management,  and  the 
publication of the main quality procedures applied by ECHA.  

The  question  of  security  is  another  permanent  challenge  for  ECHA,  and  has  been 
addressed since the creation of the Agency. Information security has been considered as 
the main risk, and in 2008 an ISO 27001 project was launched, resulting in a three-year 
action  plan  based  on  a  risk  analysis  being  implemented  from  2008  to  2010.  In  practice, 
the prioritised aspects of physical security have, for example, been the physical protection 
of the staff, visitors and premises, and control of access. Business continuity is also being 
tackled  in  a  similar  way.  Nevertheless,  there  is  a  need  to  develop  a  comprehensive 
security  policy  and  a  risk  management  system  based  on  an  overall  risk  analysis  for 
ECHA.  A  risk  assessment  exercise  will  be  initiated  by  the  end  of  2009  and  resulting 
further  risk  mitigation  measures  will  be  implemented  from  2010  onwards,  to  safeguard 
security and the continuity of business in all circumstances. 

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Programme 1: 
Operational activities - 
Implementation of the REACH Processes 

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Activity 1: Registration, pre-registration and data-sharing 

1. Main challenges in 2010 

REACH is based on the principle that all manufacturers and importers of chemicals must 
identify  and  manage  risks  linked  to  the  substances  they  manufacture  and  market.  For 
substances produced or imported in quantities of 1 tonne or more per year per company, 
manufacturers and importers will need to demonstrate that they have appropriately done 
so  by  means  of  a  registration  dossier,  which  shall  be  submitted  to  the  Agency.  For 
substances  above  10  tonnes  per  year,  companies  also  have  to  complete  a  chemical 
safety report that includes exposure scenarios, leading to more precise estimates of risks 
and risk management measures. 

ECHA  checks  registrations  to  ensure  that  they  can  be  processed  (the  Business  Rules 
Check) and that they are technically complete (Technical Completeness Check). Invoices 
are  prepared,  taking  account  of  the  company  size,  type  of  registration  and  claims  for 
confidentiality.  Additional  work  may  also  be  needed  to  clarify  substance  identity. 
Companies  intending  to  register  new  (non-phase-in)  substances  must  also  submit 
inquiries  containing  substance  identity  data  which  is  checked  by  ECHA  and,  if  the 
substance is already registered, ECHA has to put companies in contact to facilitate data 
sharing  and  to  avoid  unnecessary  testing.  Should  the  parties  fail  to  reach  agreement, 
ECHA will make the decisions.  

In 2010 the expected number of registrations of existing (phase-in) substances and new 
(non-phase-in)  substances  is  approximately  25  000,  which  is  close  to  the  original 
Commission estimate. ECHA also expects to receive approximately 1 500 inquiries prior 
to  registration,  300  notifications  for  substances  undergoing  Product  and  Process 
Orientated  Research  and  Development  (PPORDs)  and  to  make  500  data-sharing 
decisions. These baseline figures are also presented in Annex 2.   

Nearly  all  registrations  are  triggered  by  the  first  registration  deadline  for  phase-in 
substances,  which  is  30  November  2010.  By  that  date,  companies  will  have  to  submit 
registration dossiers for their high volume substances of 1 000 tonnes per year or more, 
and for certain categories of substances of concern. The main challenge for ECHA is to 
ensure that systems and staff are in place and capable of handling this large but uncertain 
number  of  registrations.  While  peaks  had  been  anticipated  in  the  original  planning  for 
REACH, feedback from potential registrants now indicates that these peaks are going to 
be  much  more  pronounced  than  estimated.  It is now  assumed that  most  of  the 
registrations  are  likely  to  arrive  in  two  “peaks”  (lead  registrants  submitting  at  the  end  of 
summer, and non lead registrants submitting close to the deadline) rather than gradually 
building up throughout the year.  

Experience  with  pre-registration  and  with  work  over  the  past  year  suggests  that  the 
workload  is  going  to  be  significantly  higher  than  originally  anticipated  in  the  financial 
statement  prepared  for  the  REACH  legislation.  Contrary  to  the  assumptions  in  the 
financial  statement,  a  number  of  the  work  processes  are  not  and  will  not  be  fully 
automated,  so  a  significant  level  of  manual  processing  will  always  be  required  for  each 
registration.  This  impact  is  magnified  by  the  fact  that  registrations  will  arrive in peaks  as 
described above.  

ECHA has sought to clarify with industry what the high number of pre-registrations means 
for the expected number of registrations in 2010. Evidently, the number of pre-registrants 
during  the  pre-registration  phase  in  2008  has  slowed  down  the  creation  of  substance 
information  exchange  fora  (SIEFs)  and  is  also  making  communication  between  SIEF 
participants  more  difficult  than  expected.  Consequently,  by  mid-2009,  industry  has  only 

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been able to provide limited information about the number of SIEFs and SIEF participants 
who intend to submit registrations by the 2010 deadline.  

ECHA  has  performed  an  analysis  of  the  pre-registration  data,  to  determine  a  new 
estimate  of  the  number  of  registrations  for  the  first  registration  deadline.  This  analysis 
shows that the number of substances expected to be registered by 2010 - ca. 9 200 - is 
very  close  to  the  initial  estimate  made  before  the  REACH  processes  started  (8  730). 
Although  substance  and  registration  numbers  are  still  subject  to  confirmation  from 
industry,  there  is  a  much  higher  uncertainty  in  the  number  of  registrations  expected. 
Different  alternative  calculations  have  been  undertaken,  showing  that  the  registrations 
could  number  from  25  000  up  to  75  000.  Without  further  comprehensive  feedback  from 
industry,  the  planning  baseline  for  the  2010  Work  Programme  will  remain  at  25  000 
registrations for 2010.  

Currently,  certain  processes,  in  particular,  clarifying  substance  identity,  invoicing,  the 
technical  completeness  check,  drafting  of  regulatory  decisions,  the  determination  of 
confidentiality claims, and responding to helpdesk questions, require considerable manual 
work.  Despite  further  progress  with  automation  in  2009,  the  need  to  process  a  large 
volume of work manually will remain; of the processes listed, only invoicing is likely to be 
automated to a significant extent. Moreover, the resolution of IT-system failures requires 
human  intervention;  in  addition  the  IT-system  is  still  under  development  and  although  it 
will be thoroughly tested, it is unlikely to have been challenged by all the potential modes 
of failure before the complex submissions from lead registrants are received.  

Considering  the  degree  to  which  the  submissions  are  expected  to  peak,  and  the 
significant  amount  of  manual  work  that  will  still  be  required  to  process  them  then,  even 
assuming  that  ECHA  only  receives  the  25  000  registrations  originally  anticipated,  the 
additional resources needed to cope with the expected workload, particularly towards the 
end of the registration period, will be more than foreseen in the original estimates made 
before ECHA was created, and significantly more during the six-month period around the 
deadline.  This  requires  a  much  higher  workforce  than  previously  calculated  and  a 
substantial  influx  of  short-term  administrative  support  and  the  internal  redeployment  of 
staff will also be necessary for the peak period. 

2. Objectives and Indicators  

Objectives 

1.  All dossiers and data sharing disputes are processed, and PPORD notifications 
and  confidentiality  claims  evaluated,  according  to  the  standard  procedures 
adopted by ECHA and within the deadlines set in the REACH regulation. 

2.  Inquiries  are  processed  according  to  the  standard  procedures  adopted  by 

ECHA, within the target timeframe of 20 working days. 

3.  Decisions on registrations and PPORD notifications are of a high technical and 

scientific quality. 

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Performance Indicators & Targets 

Indicator 

Percentage of registrations, PPORD 
notifications, and data sharing 
disputes processed within the legal 
timeframe. 

Percentage of inquiries processed 
within the established timeframe (20 
working days). 

Number of appeals made by 
registrants and notifiers against 
decisions. 

3. Main outputs 

Target in 2010 

100 % 

Not less than 90 % 

Means and frequency 
of verification 
Time recorded in 
REACH-IT monthly 
reporting 

Time recorded in 
REACH-IT monthly 
reporting 

Not more than 10 % of 
decisions  

Monitoring responses 
to decisions monthly 

•  Contingency  plans,  for  increasing  the  capacity  to  process  the  expected  number 

and distribution of dossiers, to be ready by early 2010. 

• 

Increased numbers of staff trained within the Directorate of Registration & IT Tools 
and elsewhere in the Agency.  

•  Detailed and precise specifications developed for the enhancement of REACH-IT, 

so that the majority of procedures can be automated. 

•  Up-to-date manuals, guidance and other information for registrants. 

•  Dossiers  processed,  invoices  sent  and  payments  received,  according  to  the 

appropriate deadlines. 

4. Risks 

ECHA will be strongly challenged by the number and timing of submissions of registration 
dossiers, putting the registration process at risk.  

As  indicated  in  the  introduction,  even  if  the  2010  Work  Programme  is  still  based  on  the 
initial  estimate  of  25  000  registrations  by  the  2010  deadline,  there  is  a  risk  that  the 
number of dossiers will be much larger. Consequently, while using the original figures as 
a  baseline,  ECHA  is  preparing  contingency  plans  for  handling  50  000  and  75 000 
registration dossiers, for handling different degrees of performance of the IT system, for 
for  other 
handling  breakdowns  of 
circumstances disrupting business.  

the  REACH-IT  and  hardware  systems,  and 

The  contingency  plans  will  include,  in  addition  to  re-allocating  trained  internal  staff,  the 
engagement of much larger volumes of additional temporary staff and experts to deliver 
the  work  required.    Depending  on  the  situation,  ECHA  will  reprioritise  its  activities  to 
support registration processing for a limited time, whilst ensuring compliance with its other 
core tasks - as derived from its founding legislations.  Consequently, even if the number 

- 12 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
of  dossiers  submitted  is  close  to  the  original  plan,  ECHA  intends  to  ensure  that  more 
current  staff  are  trained  in  and  will  practise  performing  or  supervising  the  processes  of 
registration. Staff may then be reallocated to registration work at times of peak pressure. 

With regard to the risks associated with the REACH-IT system, it is already foreseen that 
many  of  the  functions  initially  missing  from  REACH-IT  will  have  been  successfully 
implemented  in  2009  and  early  2010:  these  include  further  automation  of  the  workflows 
for dossier submission, inquiry, confidentiality, data sharing and data dissemination. If one 
or  more  of  these  functions  were  to  fail,  ECHA  would  have  to  carry  out  the  processes 
manually, and consequently, would be significantly under-resourced. Therefore, staff will 
also be trained to execute certain tasks that will be automated by REACH-IT but may still 
fail.  The  failure  of  REACH-IT  can  also  be  more  widespread  and  affect  submission.  To 
cover this risk a fall-back solution is foreseen under Activity 6. 

- 13 -

 
 
 
Activity 2: Evaluation  

1. Main challenges in 2010 

The  REACH  Regulation  distinguishes  between  dossier  evaluation  and  substance 
evaluation.  Dossier  evaluation  is  further  subdivided  into  the  examination  of  testing 
proposals and the compliance check. 

ECHA  is  obliged  to  examine  all  testing  proposals  submitted  by  the  registrants  or  the 
downstream users, and to prepare a draft decision within the deadlines provided for in the 
REACH Regulation. For non-phase-in substances, the draft decision should be prepared 
within  6  months  and  for  phase-in  substances  registered  by  1  December  2010,  a  draft 
decision must be ready by 1 December 2012.  

In  addition,  ECHA  is  obliged  to  carry  out  compliance  checks  on  at  least  5%  of  the 
submitted  registrations  per  tonnage  band.  However,  due  to  the  large  variation  in  the 
number  of  dossiers  registered  per  year,  with  a  bulk  of  registration  dossiers  expected  in 
the  years  2010,  2013  and  2018,  the  legislator has  not  defined  a  timeframe  within  which 
the 5% target should be met. On the basis of registration dossiers and testing proposals 
submitted, ECHA will develop a multi-annual timetable for achieving the 5 % target for the 
compliance checks by December 2009. 

It is planned to initiate about 400 new dossier evaluations (sum of compliance checks and 
examination of testing proposals) and to take a decision on about 70 dossiers, during the 
year  2010.  These  numbers  also  include  about  50  dossiers  for  notified  new  substances 
where  the  Member  State  Competent  Authorities  did  not  finalise  the  decisions  on  further 
testing  and,  therefore,  it  is likely  that  for  these  substances,  the  available  information  will 
be  incomplete.  If  the  number  of  incoming  testing  proposals  is  considerably  lower  than 
anticipated  in  the  original  planning,  ECHA  may  increase  the  number  of  compliance 
checks  accordingly.  However,  the  need  to  reallocate  resources  to  support  Technical 
Completeness  Checks  close  to  the  first  registration  deadline  will  temporarily  affect 
ECHA’s capacity to process dossier evaluations in the last quarter of 2010.   

The first community rolling action plan for substances subject to substance evaluation has 
to  be  submitted  by  1  December  2011.  According  to  the  REACH  legislation,  the  Agency 
should develop criteria for prioritising substances for substance evaluation in coordination 
with  the  Member  States,  and  in  2010,  ECHA  will  continue  the  preparatory  work  in 
dialogue with the Member States. 

A  number  of  other  aspects  related  to  evaluation  under  REACH  also  need  to  be  further 
explored  in  order  to  ensure  that  the  evaluation  process,  including  interfaces  with  other 
REACH processes, can be made fully operational before the first registration deadline in 
2010.  These  include,  for  example,  the  criteria  for  the  selection  of  dossiers  for  dossier 
evaluation,  on  which  aspects  or  elements  of  the  registration  dossiers  the  compliance 
check  should  be  targeted,  the  interface  between  dossier  evaluation  and  substance 
evaluation, and the link between evaluation and risk management measures. 

In addition, further scientific and administrative capacity building is necessary to manage 
the  peak  workload  in  the  years  after  2010.  The  high  production  volume  phase-in 
substances  that  will  be  registered  by  1  December  2010  will  contain  the  highest  level  of 
information per dossier, and ECHA expects that a considerable part of this information will 
not have been generated using recent standard and quality assured testing methodology. 
This  will  inevitably  complicate  the  evaluation  of  the  dossiers  and  raise  complex  and 
scientifically challenging questions. ECHA will therefore continue to recruit staff, reinforce 
internal scientific competences and networks with external experts, develop strategies for 
effective  and  efficient  evaluations,  implement  a  supporting  IT  evaluation  tool,  and  train 
junior and senior staff.  

- 14 -

 
 
 
 
 
 
 
 
 
For  the  evaluation  process  there  is  a  need  to  continue  organising  training  events  and 
workshops  and  provide  advice  to  Member  States  on  their  role  in  the  evaluation 
processes.  There  is  also  a  need  to  support  industry  in  improving  the  quality  of  the 
registration dossiers. 

2. Objectives and Indicators 

Objectives 

1.    Scientifically sound draft decisions in compliance with the legal requirements are 

prepared. 

Performance Indicators & Targets 

Indicator 

Target in 2010 

Percentage of compliance checks 
treated within the legal timeframe. 

100 % 

Means and frequency of 
verification 
Quarterly internal report 

Percentage of testing proposals 
examined within the legal 
timeframe. 

Percentage of the draft decisions 
accepted unanimously by the MSC. 

100 % 

Quarterly internal report 

90 % 

Annual internal report 

Number of appeals lost. 

0 

Annual internal report 

3. Main outputs 

•  Evaluation  started  or  completed  for  around  400  dossiers  (compliance  checks 

and testing proposals). 

•  Agreement  with  Member  State  Competent  Authorities  on  the  targeting  of  the 
compliance checks. Targeting is a prerequisite for processing a high number of 
dossiers each year. 

•  Agreement  with  Member  States  on  the  criteria  for  prioritising  substances  for 
substance  evaluation,  in  order  to  prepare  for  the  submission  of  the  first  draft 
community rolling action plan for substance evaluation by 1 December 2011. 

•  Publication  of  the  annual  report  on  evaluation  as  required  by  the  REACH 

Regulation. 

•  Capacity building for dossier evaluation, including recruitment of additional staff 

and on-the-job training of junior staff. 

•  Continuation  of  knowledge  building  for  junior  and  senior  scientific  staff  through 
specific  training  programmes  and  seminars  on  selected  topics  in  the  fields  of 
toxicology, eco-toxicology and exposure assessment. 

- 15 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
•  Continuation of building up of ECHA scientific competences to address scientific 

questions arising from the evaluation process. 

•  Establishment  of  a  network  of  external  experts  to  provide  up-to-date  scientific 

expertise to the evaluation processes.  

4. Risks 

A first risk is linked to the quality of registration dossiers, which could delay the evaluation 
or  may  even  render  it  impossible.  While  the  experience  with  evaluating  dossiers  is  still 
limited, the ECHA Secretariat has observed major shortcomings which hamper the rapid 
processing  of  the  dossiers,  e.g.  in  relation  to  ambiguous  or  unclear  substance  identity 
(both  for  the  registered  substance  and  read-across),  missing  or  unclear  justifications 
when  applying  the  general  rules  for  the  adaptation  of  the  standard  testing  regimes 
according  to  Annex  XI  (waiving  statements),  and  incomplete  (robust)  study  summaries.  
ECHA will invest in communication and awareness-raising to avoid such problems. 

A  second  specific  risk  linked  to  the  evaluation  activities  -  which  require  a  high  level  of 
expertise  -  is  the  possible  difficulty  in  recruiting  sufficient  numbers  of  staff  with  the 
appropriate scientific backgrounds and levels of expertise in (regulatory) toxicology, eco-
toxicology and exposure assessment; even if the economic crisis would seem to facilitate 
recruitment. As a mitigation measure, the Agency has to be prepared to use substantial 
resources to train junior scientific personnel. 

A third risk is linked to the registration contingency plans, which, in some scenarios, may 
require the temporary redeployment of scientific and administrative staff to registration. 

- 16 -

 
 
 
 
 
 
 
 
 
 
 
Activity 3: Authorisations and restrictions  

1. Main challenges in 2010 

1.1 Authorisation 

In  October  2008,  ECHA  published  the  first  Candidate  list  of  substances  of  very  high 
concern  (SVHC)  and  is  committed  to  regularly  updating  it.  However,  further  revisions  of 
this  list  will  depend  upon  the  submission  of  Annex  XV  dossiers  prepared  by  either  the 
Member  States  or  ECHA,  on  the  request  of  the  Commission.  In  collaboration  with  the 
Member  State  Competent  Authorities  and  the  Commission,  ECHA  has  established  fixed 
submission  dates  for  new  Annex  XV  dossiers  of  SVHCs.    Given  the  public  consultation 
requirements,  it  will  take  between  four  and  five  months  for  ECHA  to  establish  which 
SVHCs  meet  the  criteria  to  be  placed  on  the  candidate  list.  Provided  that  additional 
substances will be added to the candidate list that fulfil the priority setting criteria or that 
new  information  will  have  become  available  that  would  warrant  prioritisation  of  the 
substances  that  ECHA  has  not  yet  prioritised,  a  new  recommendation  for  SVHCs  to  be 
included in the list of substances subject to authorisation (Annex XIV, ‘authorisation list’) 
will be prepared and submitted to the Commission in 2010.  

Based on the indications provided by Member States, ECHA estimates that it will process 
some 15 dossiers for the identification of SVHCs that were received in 2009, and around 
30 new dossiers to be received in 2010. 

On  1  June  2009,  ECHA  submitted  its  first  recommendations  for  the  authorisation  list  to 
the  Commission,  and  it  assumed  that  the  respective  Annex  XIV  will  be  adopted  by  the 
Commission  in  2010,  which  implies  that  the  applications  to  authorise  the  use  of  any  of 
these  substances  would  arrive  in  late  2011  or  early  2012.  Although  it  is  possible  for 
companies  to  apply  in  2010,  for  planning  purposes  it  is  currently  assumed  that  no  such 
applications  will  be  submitted  in  2010.  Nevertheless,  ECHA  will  ensure  that  the 
procedures for handling authorisation applications will be further developed and finalised 
to handle early applications, should these arrive. 

1.2 Restrictions  

On 1 June 2009 title VIII (Restrictions) of REACH entered into force.  In agreement with 
the  Member  State  Competent  Authorities  and  the  Commission,  ECHA  has  established 
fixed dates for submitting Annex XV dossiers for restrictions.   

Based on the indications from Member States and the Commission, ECHA estimates that 
six  Annex  XV  dossiers  proposing  restrictions  will  be  processed  in  2010.    It  is  also 
anticipated that ECHA, on request by the Commission, will review the available evidence 
to  re-examine  the  current  restrictions  on  phthalates  and  on  mercury  in  measuring 
instruments,  in  line  with  the  review  clauses  related  to  existing  restrictions  for  these 
substances in Annex XVII of REACH.  

For  both  authorisation  and  restriction  processes  there  is  a  need  to  continue  organising 
training events and workshops and provide advice to Member States on how to fulfil their 
tasks  in  preparing  Annex  XV  dossiers  for  substances  of  very  high  concern  or  for 
restrictions, and  in  processing  the  comments  received  during  public  consultations.  It  will 
also  be  necessary  to  provide  support  and  training  to  Member  State  Competent 
Authorities, in order to increase knowledge of the practical application of Socio-Economic 
Assessment  and  to  provide  further  guidance  on  the  selection  of  the  best  Risk 
Management  Options  for  SVHCs  and  other  substances  for  which  risk  management  is 
considered  necessary.  There  is  also  a  need  to  support  industry  to  ensure  good 
understanding  of  their  obligations  with  regard  to  the  restriction  and  authorisation 
processes, and of their possibilities to contribute effectively to these.  

- 17 -

 
 
 
 
 
 
 
 
 
 
 
 
2. Objectives and Indicators 

Objectives 

i) 

Authorisation 

1.  An  updated  candidate  list  of  substances  of  very  high  concern  (SVHC)  is 
prepared within five months of receipt by ECHA of dossiers from Member 
States, or the submission of dossiers prepared by ECHA on the request of 
the Commission. 

2.  ECHA provides support to the Commission, of high technical and scientific 
quality,  and  within  the  legal  timeframe,  in  the  selection  of  substances  for 
authorisation and in the authorisation application process. 

ii) 

Restrictions 

1.  ECHA prepares restriction proposals at the request of the Commission and 
handles all dossiers in the restriction process to a high degree of scientific 
and technical quality and within the legal timeframe. 

Performance Indicators & Targets 

Indicator 

Target in 2010 

Percentage of SVHC dossiers 
treated within the legal timeframe. 

100 % 

Means and frequency of 
verification 
Internal quarterly report 

Percentage of restriction dossiers 
treated within the legal timeframe. 
Level of satisfaction of the 
Commission, MSCAs and ECHA 
Committees with the quality of the 
scientific, technical and 
administrative support provided. 

100 % 

Internal quarterly report 

High  

Annual survey4

4 All surveys planned in this Work Programme, with the exception of the staff surveys, will be 
prepared by ECHA for external target groups. The results will be analysed by ECHA. 

- 18 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3. Main outputs 

• 

• 

• 

• 

• 

• 

• 

Two updates of the candidate lists published.  

Annex  XV  SVHC  dossiers  prepared,  following  the  requests  made  by  the 
Commission. 

Depending  on  the  availability  of  new  substances  on  the  candidate  list,  the 
submission  of  a  new  recommendation  for  inclusion  of  an  SVHC  in  the  list  of 
substances subject to authorisation (Annex XIV) will be prepared. 

Conformity reports on Annex XV restriction dossiers produced and submitted to 
the Committees for opinion formulation. 

Support provided to Commission for the review process of some of the existing 
restrictions.   

Annex XV restriction dossiers prepared on the demand of the Commission and 
submitted to the Committees for opinion formulation. 

Training  events,  workshops  and  advice  delivered  to  Member  States  to  help 
them  to  fulfil  their  tasks  in  preparing  Annex  XV  dossiers  and  in  responding  to 
comments received during public consultation.  

• 

Support provided to industry. 

4.  Risks 

A  first  risk  is  related  to  the  timing  and  volume  of  incoming  Annex  XV  dossiers  (from 
Member States) or requests from the Commission to prepare them. The above objectives 
may not be achieved if the Member States do not submit the planned Annex XV dossiers 
for SVHC or restrictions. Similarly, the Commission may not ask ECHA to prepare SVHC 
or restriction dossiers according to the planning above. On the other hand, the number of 
dossiers or requests may be higher than planned.  

In order to mitigate this risk, ECHA will continue to exchange information with the Member 
States and the Commission to have the best possible estimates on the timing and volume 
of incoming Annex XV dossiers (from Member States) or requests from the Commission 
to prepare them.  

If  there  are  fewer  requests  than  planned,  the  resources  could  be  used  elsewhere  in 
ECHA.  If  there  are  more  requests,  there  will  be  a  resource  strain  and  the  possible 
reallocation of resources in favour of this activity may be necessary.  

A final risk is linked to the registration contingency plans, which may, in some scenarios 
require the temporary redeployment of scientific and administrative staff to registration. 

- 19 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Activity 4: Classification and labelling (C&L) 

1. Main challenges in 2010 

Classification  reflects  the  hazards  of  chemicals  and  labelling  helps  ensure  that 
substances and mixtures are manufactured, used and disposed of safely. 

The  main  tasks  under  this  activity  for  2010  will  be  to  manage  the  proposals  for 
harmonisation  of  classification  and  labelling  of  substances.  ECHA  maintains  the 
Commission’s original estimate of approximately 90 proposals annually.  

Furthermore,  ECHA  will  have  to  establish  and  manage  a  C&L  inventory  based  on  C&L 
notifications  from  industry  which  constitutes  a  major  challenge  for  the  Agency.  There  is 
currently a high level of uncertainty related to the expected number of notifications as the 
C&L  has  to  be  notified  -  irrespective  of  the  production  volume  -  by  the  deadline  of  3 
January  2011.  The  original  estimate  was  about  130 000,  but  in  the  light  of  current 
indications  the  number  of  notifications  could  be  in  the  same  order  of  magnitude  as  the 
pre-registrations. For planning purposes an estimate of 2 million is used.  

ECHA will also provide support to MSCAs and guidance to industry. This includes further 
guidance  on  C&L  on  issues  not  dealt  with  in  the  current  guidance,  finalisation  of  the 
revision  of  the  guidance  on  proposals  for  harmonised  C&L  as  well  as  new  practical 
guidance on preparing and submitting notifications to the C&L inventory.  

In  addition  ECHA  will  run  an  awareness  campaign  to  inform  industry  about  the  CLP 
Regulation;  this  will  be  launched  at  the  end  of  2009  and  will  focus  on  the  obligation  to 
notify C&L.  

ECHA is also in charge of handling requests for the use of alternative names. Companies 
can request the use of an alternative chemical name for a substance in a mixture in order 
to  protect  confidential  business  information.  It  is  expected  that  the  number  of  these 
requests will be close to zero in 2010. 

2. Objectives and Indicators  

Objectives 

1.  All  proposals  for  harmonised  C&L  sent  by  the  Member  State  Competent 
Authorities (MSCAs) and industry are processed within the legal timeframe and to 
a high degree of scientific quality. 

2.  An intermediary C&L inventory will be published in December 2010. 

Performance Indicators & Targets 

Indicator 

C&L Inventory is operational and 
published. 
Proposals for Harmonised C&L 
processed within legal timeframe.  
Level of satisfaction of the MSCAs 
and RAC with the quality of the. 
scientific, technical and 
administrative support provided. 

Target in 2010 

December 2010 

100 % 

High 

Means and frequency of 
verification 
Through project 
management 
Internal quarterly report 

Annual survey 

- 20 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. Main outputs 

•  Support provided to the Member States through Guidance and the Helpdesk and 
to National Enforcement Activities through the Forum, in order to face the 2010-
2011 peak linked to the inventory and the dual classification system that will be 
in place for the period 2010 to 2015. 

•  Technical advice on notification of C&L to the inventory provided to industry, with 

an adequate helpdesk support (peak in 2010 linked to the inventory).  

•  Public campaign for notification of C&L to the inventory successfully completed. 

•  Evaluation of requests for the use of alternative names (Art. 24). 

•  Processing  of  proposals  for  harmonised  C&L  received  from  MSCA  and 

suppliers.  

•  First C&L inventory is published and operational.  

4. Risks 

The  main  risk  on  this  activity  is  the  high  uncertainty  about  the  number  of  notifications, 
which could even surpass the estimated 2 million, causing delays to or overloading the IT 
application  for  handling  C&L  notifications.  To  avoid  potential  problems,  a  back-up 
submission system will be developed in time.  

There  is  also  uncertainty  about  the  exact  number  of  proposals  for  harmonised  C&L 
because  of  a  backlog  of  proposals  on  87  substances  for  which  the  classification  was 
agreed  at  the  technical  level  under  the  previous  legislation  but  which  were  not  yet 
introduced  into  the  list  of  harmonised  classifications,  as  well  as  due  to  proposals  for 
classification of pesticidal and biocidal active substances. It will of course be known at an 
early  stage  whether  the  number  will  be  higher  due  to  the  Register  of  Intentions.  Should 
the number of proposals be considerably higher, it would have a clear impact on ECHA’s 
ability to process them properly. Therefore, ECHA will plan contingency measures to deal 
with  a  possibly  higher  number  of  dossiers,  e.g.  through  outsourcing  or  internal  re-
allocation of resources in the most optimistic scenario from other activities. 

A final risk is linked to the registration contingency plans, which may, in some scenarios, 
require the temporary redeployment of scientific and administrative staff to registration. 

- 21 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Activity 5: Advice and assistance through guidance and helpdesk  

1. Main challenges in 2010 

Since taking up its functions in 2007, the ECHA Helpdesk has been an operational part of 
the  Agency  with  well-established  routines  and  processes.  During  2010,  it  will  carry 
forward  its  regular  work  on  many  challenges:  it  will  continue  to  support  the  network  of 
national  helpdesks  (REHCORN)  and  its  tools  (REACH  Exchange  Platform,  RHEP)  in 
order  to  achieve  consistent  replies  at  European  level,  and,  when  needed,  to  provide 
timely and consistent replies on industry obligations under REACH and CLP. 

The  provision  of  advice  to  industry  and  to  authorities  via  guidance  will  be  a  priority  for 
ECHA in 2010, in particular, the timely completion of guidance documents relevant to the 
first  registration  and  C&L  deadlines.  Special  emphasis  will  be  put  on  those  guidance 
documents  that  need  to  be  published  with  a  view  to  the  deadlines,  in  order  to  allow 
industry to fulfil their obligations under REACH and CLP (e.g. the guidance on information 
requirements and chemical safety assessment). 

Whilst the continuation of this work will in itself be demanding, the 2010 peak in ECHA’s 
workload related to Registration and Classification and Labelling is likely to have a direct 
and major impact on guidance activities and on helpdesk activities. 

1.1 Helpdesk 

It  is  expected  that  the  number  of  questions  that  industry  (mainly  lead  registrants)  and 
national  helpdesks  will  address  to  the  ECHA  Helpdesk  in  2010  will  not  only  increase 
considerably but also that their content will cover a much wider scope than the questions 
received  by  ECHA  during  2008-2009  (i.e.  higher  than  the  15  000  questions  received  in 
2008).  

Furthermore, Helpdesk activities will be driven not only by regularly providing information 
on  REACH  and  CLP  obligations  to  industry  in  a  timely  and  efficient  manner  but  also  by 
the  occasional  difficulties  that  potential  registrants  and  companies  notifying  to  the  C&L 
inventory may experience during 2010.  

The  workload  of  ECHA’s  Helpdesk  will  also  be  determined  by  newly  developed  IT  tools 
and new the functionalities of existing IT tools needed for the submission of data, and a 
subsequent  number  of  queries.  Lastly,  the  uncertainties  regarding  the  expected  number 
of registrations and C&L notifications and the timing of the actual peak in their submission 
will turn accurate planning into a challenging task.  

Planned  Helpdesk  activities  will  consist  of  ECHA  providing  support  and  coordination  to 
the network of national helpdesks on REACH and CLP, which will be fully operational in 
early  2010.  The  CLP  helpdesk  network  will  mirror  the  structure  and  procedures  that 
currently already determine the REACH helpdesk network. This will increase the number 
of network participants from the current 38 to approximately 58. Moreover, the Secretariat 
support as well as ECHA’s contribution to questions submitted by national helpdesks via 
the  REACH  Exchange  Platform  (RHEP)  to  both  the  REACH  and  the  CLP  helpdesk 
network  will  need  to  be  increased  in  line  with  the  expected  increase of  their  activities  in 
view of the first registration and CLP notification deadlines.  

Following through the campaign “The clock is ticking – form your SIEF now”, initiated in 
2009, the ECHA Helpdesk will continue to focus its activities in 2010 on lead registrants 
preparing for joint submissions by 30 November 2010. To this end, ECHA has elaborated 
a  special  helpdesk  service  for  lead  registrants.  The  campaign  addressing  potential 
registrants  facing  the  2010  registration  deadline  will  itself  generate  further  work  for  the 
ECHA Helpdesk as well as for the national REACH helpdesks, as the latter are the first 

- 22 -

 
 
 
 
 
 
 
  
 
 
 
 
 
point of contact for companies having their seat in a given country. The efficiency of these 
services  also  relies  on  the  ability  of  the  Commission  to  respond  rapidly  enough  to  the 
questions that affect the legal interpretation of REACH.  

1.2 Guidance 

The overall guidance and awareness-raising actions on the obligations to classify, label, 
package and notify in line with the CLP rules will constitute a high priority for ECHA. This 
will  include  providing  practical  information  (guidance,  explanatory  information,  FAQs, 
training  activities,  etc.)  and  support  tools  that  will  assist  industry  in  all  aspects  when 
dealing  with  the  notification.  The  project  has  tight  time  constraints  and  the  information, 
tools  and  guidance  need  to  be  made  available  to  stakeholders  well  ahead  of  the 
notification deadline. The activity on guidance will scale down in the final months before 
the two crucial deadlines to permit support to the helpdesk in the peak period. 

While  updating  or  developing  guidance,  ECHA  will  follow  its  framework  for  guidance 
governance,  designed  to  efficiently  implement  cooperation  procedures  within  ECHA,  as 
well as to implement the consultation procedure with all parties involving Partner  Expert 
Groups (PEGs), ECHA’s Committees, as well as MSCAs in order to ensure the broadest 
possible  acceptance  of  guidance.  Closer  the  registration  deadline,  any  necessary  last 
minute changes to the guidance will be communicated to the stakeholders through other 
means (e.g. news alerts and FAQ via the website). 

1.3 REACH training 

REACH training events will continue to be organised in 2010 with a focus on the first half 
of the year. The objective is to provide support via training to selected audiences, charged 
with implementing the legislation, such as MSCAs, third countries and others, in order to 
achieve common implementation standards for the REACH and CLP regulations.  

2. Objectives and Indicators 

Objectives 

1.  The industry receives timely and efficient support from the Helpdesk, and through 
high quality guidance documents, for submission of their registration dossiers and 
CLP notifications. 

2.  Support is provided to the implementation of REACH in the Member States by the 

training of trainers. 

- 23 -

 
 
 
 
 
 
 
 
 
 
 
Performance Indicators & Targets 

Indicators 

Target in 2010 

Not less than 75% 

Means and 
frequency of 
verification 

Business Object 
report / monthly 

At least 3 

Annual report  

Not less than 75% 

Business Object 
report / monthly 

Not less than 75% 

Annual report 

High  

High  

Annual survey 

Participants  
feedback / Annual 

Percentage of Helpdesk questions 
answered within the established timeframe 
(on average15 days for questions other than 
those on the user management on REACH 
IT). 

Number of FAQ updates agreed with 
REACH and CLP helpdesk correspondents 
and published on the web. 

Percentage of feedback replies provided by 
ECHA to questions submitted to RHEP and 
CLP helpdesk exchange platform by 
national helpdesks, within the timeframe set 
by the originator of the question. 

Percentage of guidance documents 
published on the web according to the plan.  

Level of satisfaction expressed in feedback 
from guidance users. 

Level of satisfaction with quality of REACH 
training events. 

3. Main outputs 

Helpdesk  

•  Timely and consistent replies and support provided to industry on their obligations 
under the REACH and CLP Regulations, IT tools and ECHA-related processes.  

•  Helpdesk  requests  for  technical  advice  on  the  registration  and  C&L  notification 

processes answered. 

•  Special  support  to  registrants  and  notifying  companies  for  the  C&L  inventory  in 
particular during the peak time of joint submissions and before the first registration 
and C&L notification deadlines. 

•  Fully operational CLP helpdesk network established. 

•  Two  REHCORN  and  CLP  helpdesk  correspondents  meetings  (back  to  back) 

organised.  

•  FAQs  on  REACH  and  CLP-related  matters  updated  and  published,  following 

identification, discussion and agreement by the helpdesk network. 

•  FAQs on REACH IT and update of FAQs on IUCLID 5 updated and published. 

- 24 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Guidance  

•  Guidance documents, (initiated in 2009) published in 2010: 

o  Guidance on Registration (Quarter 1)  
o  Guidance 

information 

on 

requirements 

and 

chemical 

safety 

assessment/chemical safety report (Quarter 1 and Quarter 2) 

o  Guidance on substances in articles (Quarter 1) 
o  Guidance on Annex VI of the CLP Regulation (Quarter 1) 
o  Guidance on risk communication (Quarter 4) 
o  Guidance  on  authorisation  (following  its  hand-over  from  the  European 

Commission). 

•  The most important guidance documents or summaries thereof (e.g. “guidance in 

a nutshell”) will be made available in all official EU languages. 

•  Accessibility  of  the  guidance  improved  via  a  revamp  of  ECHA’s  website  and 

provision of documents such as fact sheets and explanatory notes. 

•  Stakeholder relations intensified through direct contacts, participation in meetings, 

and the organisation of workshops. 

REACH training 

•  Further  development  of  REACH  training  for  trainers  for  Member  States  and 

targeted third countries.  

•  Two  workshops/training  sessions  particularly  targeted  at  REACH  and  CLP 

national helpdesks organised. 

4. Risks 

For  the  Helpdesk,  the  main  risk  in  2010  is  linked  to  the  registration.  ECHA’s  workload 
estimates are based on the initial number of registrations and on previous experience in 
2008-2009. Developments could turn out very differently in 2010, as more SIEFs may be 
active and more complex questions may be raised than anticipated. A much higher than 
expected number, or more complex questions over the second half of 2010, could lead to 
an increase in the response time provided by ECHA. This could result in registrants and 
C&L notifying companies remaining uncertain of how to overcome unexpected difficulties 
with the submission of their dossiers by the deadline. 

Peaks in registration activity will directly affect the workload of the Helpdesk. In line with 
the  registration  contingency  plans,  ECHA  will  be  prepared  to  hire  interim  staff,    and 
reprioritise  its  registration-based  activities  to  support  the  Helpdesk  for  a  limited  time.  
ECHA intends to ensure that more of its staff is trained and versed in the principles and 
processes  of  the  Helpdesk.  Staff  may  then  be  reallocated  to  Helpdesk  work  at  times  of 
peak pressure. 

Furthermore, update or development of guidance documents, and their publication on the 
web,  requires  continuous  close  cooperation  between  many  different  players  in  ECHA 
Secretariat,  ECHA  scientific  committees  and  the  European  Commission,  as  well  as 
smooth cooperation with external partners and stakeholders such as MSCAs and PEGs. 
Against  this  complex  background,  delays  in  some  guidance  activities  planned  for  2010 
may  need  to  be  accommodated  in  order  to  facilitate  cooperation  and  common 
understanding among all parties.  

- 25 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
A last risk is linked to the registration contingency plans, which may require the temporary 
redeployment  of  scientific  and  administrative  staff  from  the  guidance  activity  to 
registration. 

- 26 -

 
 
 
  
Activity 6: IT support to operations 

1. Main challenges in 2010 

The  main  IT  tools  used  in  support  of  REACH  operations  are  REACH-IT  and  IUCLID 5. 
ECHA  is  also  developing  a  number  of  additional  specialised  applications  such  as  the 
Chemical  Safety  Assessment  and  Reporting  Tool  (CHESAR)  and  decision  support 
systems  for  priority  setting  and  reporting  (CASPER),  and  to  support  the  evaluation 
process (Odyssey). 

REACH-IT  is  an  online  system  that  manages  the  communication  between  industry, 
ECHA,  Member  States  and  the  Commission  as  well  as  ECHA’s  internal  workflows  in 
relation  to  the  REACH  processes.  It  also  aims  at  supporting  the  public  in  consulting 
databases and communicating online. REACH-IT is therefore essential for the successful 
implementation of the REACH legislation. 

The main challenge to the Agency in 2010 will be the processing of a very large number 
of  registrations  and  C&L  notifications.  Successful  processing  depends  upon  a  fully 
functional  REACH-IT  system.  Ensuring  that  REACH-IT  is  fully  functional  in  time  to  meet 
the  demands  that  will  be  placed  upon  it  is  the  critical  IT  support  challenge  of  2010. 
Consequently, the activities in 2010 will be focused on two main areas:  

• 

• 

the  successful  further  adaptation  of  the  existing  system  for  the  first 
registration  deadline  of  30  November  2010  and  the  subsequent  C&L 
notification deadline; and 
the  addition  of  functions  to  replace  manual,  resource  intensive  “work-
around” solutions put in place in 2008 when ECHA started operations. 

REACH-IT is not only concerned with registration or with use within the Agency. Subject 
to  the  main  priority  areas  above,  ECHA  intends  to  improve  dissemination  of  information 
on  chemical  substances  by  making  access  to  and  searching  within  the  website  easier. 
Workflows supporting the evaluation and the classification and labelling processes will be 
finalised.  In  addition,  a  specialised  application  (RIPE)  will  be  developed  to  support  the 
enforcement authorities in the Member States. Finally, ECHA intends to support outside 
users by providing translations of key help information within REACH-IT and parts of the 
supporting guidance. 

IUCLID  5  is  viewed  as  the  international  standard  tool  for  the  storage  and  exchange  of 
data on the intrinsic and hazardous properties of chemicals. Registration dossiers have to 
be  submitted  to  the  Agency  in  the  IUCLID  5  format  in  accordance  with  the  REACH 
legislation. In 2010, ECHA will continue to maintain and support IUCLID, developing new 
functions in response to user requirements, in close contact with the OECD and its OECD 
IUCLID  User  Group  Expert  Panel.  These  will  include  implementing  new  OECD 
harmonised templates for reporting results of studies assessing the properties and effects 
of  chemicals  and  allowing  the  results  of  chemical  safety  assessments  to  be  recorded 
directly in the database. 

CHESAR is intended to help prepare exposure scenarios and chemical safety reports that 
are required for some of the registrations and to provide practical tools for calculating the 
risks  of  chemical  emissions.  After  completion  of  the  first  version  at  the  end  of  2009, 
additional functions will be added in 2010 in time for the registration deadline, which will 
include  substance  profiling  (to  help  select  the  appropriate  assessment  approach), 
qualitative assessment methodology, interfaces with other external exposure assessment 
tools, and additional administration enhancements. 

- 27 -

 
 
 
 
CASPER allows the information needed for evidence-based priority setting required in a 
number of REACH processes to be collected, analysed and presented. The development 
will initially aim at assisting in the screening and the prioritisation of registration dossiers 
for evaluation to manage the peak workload in the years after 2010. 

The  evaluation  tool  Odyssey  supports  the  ECHA  Secretariat  in  dossier  evaluation  by 
guiding the evaluator to the most relevant issues of the registered substance dossier, and 
to the corresponding information in the guidance documents; by supporting the drawing of 
conclusions;  and  by  recording  the  outcome  of  the  evaluation.  The  tool  will  be  further 
developed  by  adding  more  functions  and  by  improving  existing  features  based  on 
practical experience. 

RIPE (REACH Information Portal for Enforcement) allows inspectors in Member States to 
access  necessary  information  from  REACH-IT,  such  as  selected  information  from 
registration dossiers, so that they can enforce REACH more effectively. The first release 
of  the  application  is  planned  for  the  end  of  2010  to  coincide  with  the  first  registration 
deadline for phase-in substances. 

The Agency will also work on IT tools (including the (Q)SAR toolbox and other screening 
and predictive systems) to help make better use of alternative computational approaches 
to  animal  testing.  The  Agency  will  work  with  the  current  Project  Coordination  Group, 
which  provides  scientific  and  technical  input  and  assesses  and  accepts  the  project 
deliverables.  The  group  consists  of  members  from  ECHA,  the  OECD  and  the  Joint 
Research Centre of the European Commission (JRC).   

2. Objectives and Indicators 

Objectives 

ECHA is able to receive and process all registration dossiers for phase-in substances 
and  all  C&L  notifications,  subject  the  first  registration  deadlines  in  2010  and  early 
2011,  with  the  assistance  of  a  well  functioning,  upgraded  REACH-IT  tool  and 
databases,  and  registrants  are  supported  by  specialised  IT-tools  (IUCLID  5  and 
CHESAR). 

Performance Indicators & Targets 

Indicator 

Target in 2010 

Percentage of software modules for 
the different IT tools completed 
according to schedule. 

Not less than 80% 

Means and 
frequency of 
verification 
Project planning: 
Monthly activity 
reporting 

- 28 -

 
 
 
 
 
3. Main outputs 

REACH-IT 

•  Before  June  2010,  a  re-engineered  REACH-IT,  scaled  and  tested  with  a  much 
higher  load  factor  to  process  the  high  number  of  dossiers  expected  to  arrive  for 
registration and C&L notification. 

•  A completed workflow for processing the C&L notifications received from industry, 
from  online  submission  to  dissemination  of  the  C&L  inventory  on  the  ECHA 
website. Key workflows for evaluation will be operational in time for 2011. 

•  An  improved  ECHA  website  making  information  on  the  properties  of  chemical 

substances available to the public.  

IUCLID 5 

•  Stakeholder  driven  upgrades  including  introduction  of  new  OECD  harmonised 
templates  for  reporting  study  results  and  improved  interfaces  between  IUCLID  5 
and other IT systems, in particular REACH-IT and CHESAR , facilitating electronic 
data exchange across IT systems in industry and regulatory bodies.  

CHESAR 

•  A new version with more functions, interfaces to more exposure assessment tools 
and  the  possibility  to  import  structured  information  from  the  CHESAR  Tool  into 
IUCLID 5 will be delivered well before the registration deadline. 

CASPER 

•  The first release of the tool is delivered to users for automatically identifying and 
prioritising  the  registration  dossiers  that  are  suitable  candidates  for  compliance 
checking in order to facilitate the evaluation process. 

RIPE  

•  The  first  release  of  the  application,  planned  for  the  end  of  2010,  will  cover 
functionalities  to  access  and  search  the  selected  submission  data  as  well  as 
prepare standard reports.  

4. Risks 

the  expected  number  of  dossiers  arriving 

REACH-IT  is  at  the  front  line  when  the  Agency  is  facing  a  high  degree  of  uncertainty 
concerning 
for  registration  and  C&L 
notifications.  In  addition,  as  these  dossiers  are  expected  to  be  submitted  shortly  before 
the  deadline,  the  performance  and  the  usability  of  the  system  could  be  put  at  risk. 
Therefore, an alternative IT system for submissions will be put in place to respond to any 
eventual disruption of critical functions and services.  

CHESAR  and  RIPE  are  developed  within  a  very  tight  schedule.  Therefore,  in  the 
development  of  the  tools,  meeting  the  delivery  dates  will  be  given  priority  over  the 
broadness of functionalities. 

A  third  risk  is  linked  to  the  registration  contingency  plans,  which  may  require,  as  far  as 
possible, the temporary redeployment of scientific and administrative staff to registration. 

- 29 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Activity 7: Scientific and practical advice for the further development of legislation  

1. Main challenges in 2010 

According to its mission ECHA shall provide Member States and the European institutions 
with  the  best  possible  scientific  advice  on  questions  related  to  the safety  and  the  socio-
economic  aspects  of  the  use  of  chemicals.  This  role  also  covers,  beyond  what  is 
described  under  other  operational  activities,  certain  horizontal  and  general  scientific 
issues, as well as the scientific and technical support ECHA will give to the Commission 
and other institutions in the development or revision of chemicals legislation.  

The  main  areas  in  which  ECHA  is  working  under  this  activity  cover  the  safety  of 
nanomaterials, the development of test methods (including alternative methods and non-
animal  approaches,  such  as  QSAR,  categories  and  read-across),  and  the  preparatory 
work  in  relation  to  the  forthcoming  Biocides  Regulation5.  So  far,  ECHA  has  had  very 
limited resources to invest in these areas but will continue to build up its capacities and 
planning  in  2010  with  a  view  to  becoming  more  a  prominent  actor  in  the  coming  years. 
This  activity  partly  depends  on  the  requests  received  from  the  Commission  or  other  EU 
institutions,  and  therefore,  the  implementation  of  these  tasks  also  partly  relies  on 
additional appropriate support from the Commission. 

2. Objectives and Indicators 

Objectives 

ECHA  has  improved  its  capacity  to  provide  scientific  and  technical  advice  on  the 
safety  of  nanomaterials  and  development  of  alternative  testing  methods  and  has 
provided scientific and technical advice to the Commission (and if appropriate to the 
other co-legislating institutions) on the proposed Biocides Regulation. 

Performance Indicators & Targets 

Indicator 

Target in 2010 

Level of satisfaction with the quality 
of the scientific, technical and 
administrative support provided to 
Commission.  

High  

3. Main outputs 

Means and frequency of 
verification 
Annual survey 

•  Advice in the field of nanomaterials, with a view to supporting the development of 

new methods and guidance for examining and assessing their safety. 

• 

• 

Improved scientific and technical capacity to deal with nanomaterials in REACH 
processes. 

Improved scientific and technical capacity to contribute to the development of test 
methods and non-animal methods and approaches. 

•  Support  to  the  co-decision  procedure  on  the  Biocides  Regulation  (subject  to 

appropriate resources being made available by the Commission). 

5 Proposal for a regulation of the European Parliament and the Council concerning the placing on 
the market and use of biocidal products (COM(2009)267 final) 

- 30 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
•  Practical  Work  Plan  and  start  of  its  implementation  ensuring  the  appropriate 
preparation  of  ECHA’s  role  and  tasks  under  the  Biocides  Regulation  (subject  to 
appropriate resources being made available by the Commission). 

•  Continued support for the amending of Annexes to REACH Regulation and, if 

relevant, the CLP Regulation. 

4. Risks 

It is difficult to estimate precisely the resources needed to carry out the above tasks and 
fulfilling the aforementioned objectives. ECHA must ensure the fulfilment of its objectives 
related to core REACH and CLP processes described under other activities. Therefore, in 
its  resource  planning  ECHA  can  only  reserve  a  limited  amount  of  expert  resources  for 
these  tasks.    In  addition,  the  high  workload  anticipated  for  core  REACH  processes  may 
lead to negative priorities under this activity. ECHA cannot predict with any certainty the 
number and complexity of the future requests from the Commission.  

It should also be noted that this activity may be affected by ECHA’s contingency plans for 
registrations. 

- 31 -

 
 
 
                                                                                                                                                                
 
 
 
 
 
Programme 2: 
ECHA’s bodies and supporting activities 

- 32 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Activity 8: Committees and Forum  

1. Main challenges in 2010 

The Committees (the Member State Committee, the Risk Assessment Committee and the 
Committee  for  Socio-economic  Analysis)  are  an  integral  part  of  ECHA  and  play  an 
essential role in carrying out its tasks, in particular for issuing science-based opinions in 
their  field  of  competence.  With  the  exception  of  the  MSC,  the  members  of  which  are 
appointed  directly  by  the  Member  States,  the  members  of  the  Committees  are  experts 
appointed  by  ECHA’s  Management  Board  on  the  basis  of  proposals  from  the  Member 
States. 

The  overall  workload  and  the  number  of  meetings  of  the  Committees  are  highly 
dependent  on  the  number  of  dossiers  and  draft  evaluation  decisions  submitted  to  the 
Committees, and in particular, on the complexity of the restriction cases. The objectives 
and targets mentioned below are based on the baseline figures described in Annex 2.  

The  expected  number  of  different  types  of  dossiers  submitted  by  MSCAs  or  ECHA,  (6   
restriction  dossiers,  30  Annex  XV  dossiers  for  identification  of  SVHCs,  90  proposals  for 
harmonised  classification  and  labelling),  and  some  70  draft  evaluation  decisions  being 
submitted to the Member State Committee, would result in around 20 Committee/Forum 
plenary meetings being needed in 2010, even though written procedures will be used to 
the extent possible. In addition, the Forum is expected to run at least five working groups 
that will need support. 

It is clear that the Committees are to face an increased workload in 2010 as the number 
of dossiers submitted by the MSCA, and the number of evaluation decisions, is constantly 
increasing.  The  quality  and  timeliness  of  the  opinions  adopted  by  the  Committees  will 
become a point of attention and therefore an appropriate quality assurance system has to 
be established.   

The  Forum  for  Exchange  of  Information  on  Enforcement  is,  as  are  the  Committees,  a 
formal  body  of  ECHA,  consisting  of  members  appointed  directly  by  the  Member  States. 
The 2010 deadline for registrations and the early 2011 deadline for C&L notifications for 
inventory  will  mean  that  the  importance  of  and  expectations  laid  on  the  Forum’s 
coordinated  enforcement  activities  by  the  stakeholders,  Member  States  and  the 
Commission  will  grow.  ECHA  is  committed  to  increasing  its  support  to  effective 
enforcement activities through establishing specific IT-applications for enforcers, providing 
reinforced secretarial support to the Forum and its Working Groups, organising training for 
trainers  of  inspectors,  and  through  developing  and  publishing  project  manuals  and  best 
practice guidelines for enforcement activities. 

2. Objectives and Indicators for 2010 

O

bjectives

1.  The  work  of  the  Committees  will  be  supported  efficiently  and  effectively  so  that 

• 
• 

they will be able  
the timelines given in the legislation, and  
to respect 
to deliver high quality scientific and technical opinion
support the final decision-making 
in a transparent manner while ensuring th

e necessary confidentiality. 

s and agreements that 

2

.  The  work  of  the  Forum  will  be  supported  efficiently  and  effectively  so  that  it  has 
been  able  to  strengthen  and  harmonise  further  the  enforcement  of  the  REACH 

- 33 -

 
 
 
 
 
 
 
 
 
 
 
 
and  CLP  Regulations  in  the  Member  States  in  a  transparent  manner  while 
ensuring the necessary confidentiality. 

Performance Indicators & Targets

Indicators 

Target in 2010 

Percentage of o
delivered in time.  

pinions / agre

ements 

N

ot less than 90 %

Percentage of unanimous MSC 
agreements.  

Percentage of Committee opinio
by consensus.

Not less than 80 % 

ns adopted 

Not less than 70 % 

High 

Means and 
frequency of 
verification 

A

nnual internal 
report 

Annual internal 
report 

Annual internal 
report 

Annual internal 
report 

Positive 

Annual survey  

High 

Annual survey  

High 

Annual survey  

Degree of Committee opinions taken on 
board in the final decision of the European 
Commission. 

Feedback from the Member States 
enforcement authorities and ECHA 
stakeholders on the added value of 
Forum activities. 

the 

Level of satisfaction of the Members and
other participants 
training and chairing) provided by ECHA t
the Committees and the Forum.  

with the support (including 

o 

Level of satisfaction of stakeholders, 
Competent Authorities and Members of the 
Committees with the overall transpare
and publication of the outcomes of 
Committee processes and the Forum 
activities. 

ncy 

3. Main outputs 

Outputs: 

General  
• 

Implementation  of  cooperation  procedures  with  relevant  scientific  bodies  and  EU 
ag

encies.  

•  Written  contracts  with  rapporteurs  and  experts  serving  the  working  groups 

handled. 

•  Renewal of appointment or replacement of the RAC and Forum members having 

served for

 three full years (by December 2010). 

- 34 -

 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
Member State Committee 

•  Agreements  on  draft  decisions  based  on  dossier  evaluations  (testing  proposals 
and compliance checks) for all draft decisions commented on by the MSCAs. 

•  Agreements on identification of Substances of Very High Concern.  
•  Opinions on further priority substances recommended to be included in Annex XIV 

(for authorisation). 

Committee for Risk Assessment 

•  Opinions  on  classification  and  labelling  dossiers  (according  to  both  Dangerous 

Substances Directive and CLP criteria). 

•  Opinions on first restrictions dossiers (if any conforming dossiers are submitted by 

MSCAs by the end of Quarter 1 of 2010). 

Committee for Socio-economic Analysis 

•  First  draft  opinion(s)  on  restriction  dossier(s)  prepared  (and  adopted)  (if  any 

conforming dossiers are submitted by MSCAs in 2009). 

Forum for Exchange of Information on Enforcement 

•  Practical  results  in  coordinated  enforcement  projects  as  proposed  by  the  Forum 
(e.g.  registration,  restrictions  etc)  and  development  of  guidance  for  REACH 
enforcers based on the experience from the first coordinated project. 

•  Advice on enforceability of proposals for restrictions. 

4. Risks 

Should  the  number  of  dossiers  be  significantly  higher  than  estimated,  more  written 
procedures will need to be used; meeting the deadlines and ensuring high quality will be 
highly  challenging,  will  require  a  very  high  commitment  from  members,  strong  MSCA 
support to individual members, and an increase in the Secretariat resources.  In order to 
be  ready  to  prepare  for  such  a  situation,  ECHA  will  liaise  closely  with  Member  State 
Competent Authorities to plan for the future workload.  

The ability of the rapporteurs of the Committees to deliver high quality work depends on 
the scientific and technical support given by the MSCAs and the ECHA Secretariat. The 
rapporteurs  for  the  first  dossiers  will  be  a  valuable  source  of  feedback  on  the  level  and 
quality of support necessary by them and ECHA should therefore actively seek their views 
and communicate possible concerns to the MSCAs early on.  

The  ability  of  the  Forum  members  to  agree  on  joint  activities  and  commit  resources 
depends  on  the  Member  States’  resources.  This  responsibility  pertains  solely  to  the 
Member  States  but  ECHA  should  continue  promoting  harmonised  enforcement  and 
supporting the joint Forum activities to the extent possible. 

It should also be noted that these activities may also be affected by ECHA’s contingency 
plans for registrations. 

- 35 -

 
 
 
 
 
 
 
 
 
 
Activity 9: Board of Appeal  

1. Main challenges in 2010 

The  Board  of  Appeal  (BoA)  decides  on  appeals  brought  against  certain  individual 
decisions  of  the  European  Chemicals  Agency.  It  is  a  new  body  created  by  REACH  to 
provide  legal  redress  to  the  parties  involved.  An  important  challenge  for  the  BoA  at  this 
early stage is to build up stakeholder confidence and raise understanding about the new 
appeal system created by REACH. Another key challenge for the BoA is to pave the way 
for its decisional practice within the novel legal framework of REACH. It is expected that 
the  BoA  will  often  be  confronted  with  the  task  of  deciding  on  new  and  complex  issues 
concerning  the  substantive  aspects  of  appeal  cases  brought  before  it,  for  which  very 
limited and only remotely relevant case law exists. 

The BoA’s workload will depend on several factors: the quality and number of decisions 
adopted by ECHA, the percentage of decisions adversely affecting one of the interested 
parties, and particularly the willingness of stakeholders to appeal against those decisions. 
Precise  estimates  regarding  the  number  and  types  of  appeals  are  extremely  difficult  to 
project.  

It is anticipated that most cases in 2010 will result from the preparatory activities carried 
out  by  industry  between  the  beginning  of  the  year  and  the  first  registration  deadline  (30 
November 2010) for phase-in substances, especially with respect to decisions related to 
data-sharing. 

Based on the ECHA 2010 baseline figures for decisions the BoA is required to have the 
ability to engage sufficient resources to deal with a base load of 100 cases and to have a 
well-prepared contingency planning for a higher number of appeals in place, including the 
calling upon alternates and additional members and reliance on adequate reserve lists of 
suitable candidates for support staff or experts who can be recruited or mobilised as soon 
as the need arises.  

2. Objectives and Indicators  

O

bjectives

High-quality decisions are adopted by the Board without undue delay.  

Performance Indicators & Targets

Indicators 

Target in 2010 

Percentage of cases concluded within 12 
months of their introduction. 

Level of stakeholder confidence in the 
appeal procedure. 

90 % 

High 

f

Means and 
requency of
verification 

Annual report of the 
Board 

Survey among 
stakeholders 

- 36 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. Main outputs 

•  Decisions (dependent on the number of appeals lodged). 

•  Effective  communication  with  the  parties  in  relation  to  appeal  proceedings  and 

with stakeholders. 

•  An  effective  and  user-friendly  database  of  decisional  practice  and  relevant  case-

law established on ECHA’s website.  

•  Access  to  online  information  and  adequate  guidance  on  the  appeal  procedure  in 
order  to  minimise  delays  or  rejections  caused  by  procedural  errors  provided  to 
potential appellants. 

•  Capacity building plan will be implemented. 

4. Risks 

The above planning for the Board of Appeal is achievable only if the number of appeals is 
not considerably higher than the estimate given above as the base load within the range. 
Should  the  number  of  appeals  be  considerably  higher  than  this  baseline,  the  requested 
resources are to be revised upwards. In order to mitigate the risk, the Registry will ensure 
– when needed and as far as is feasible –- that external interim support can be obtained. 
Conversely, should the number of appeals be substantially lower than the baseline for the 
foreseeable future, a number of new posts can be redeployed to the operational activity of 
the Agency. 

In addition, an uneven distribution of appeals over the year might lead to a situation where 
the BoA will not be in a position to examine all appeals within a reasonable time frame. 
Such  a  situation  could  cause  a  backlog  in  the  processing  of  appeals  and  consequently 
lower  stakeholder  confidence  in  the  work  of  the  BoA.  In  order  to  mitigate  that  risk, 
accurate  case  time  management  will  be  adopted,  and  if  needed,  the  setting  up  of 
additional  capacity  will  be  appropriately  considered  in  due  time  before  the  actual  peak 
occurs. 

- 37 -

 
 
 
 
 
 
 
 
 
 
 
 
Activity 10: Communications  

1. Main challenges in 2010 

ECHA’s  2010  communications  plan  seeks  to  establish  coherent  internal  and  external 
communications  strategies  and  processes  that  will  serve  as  a  robust  basis  for  the 
workload that is expected in 2010. The main challenge will be to support the achievement 
of  ECHA’s  business  objectives  by  ensuring  that  all  aspects  of  the  way  in  which  ECHA 
communicates  both  internally  and  externally  are  the  best  they  can  be.  ECHA  has 
numerous  and  heterogeneous  external  audiences  and  all  communications  must  be 
tailored  to  meet  their  needs.  A  further  challenge  will  be  to  manage  ECHA’s  developing 
reputation by consolidating its brand, reviewing all our contacts with the outside world to 
ensure  that  we  deliver  an  effective  service,  and  by  ensuring  that  crisis  communications 
plans are in place. An accurate and balanced presence in the media needs to be ensured. 
ECHA  needs  to  understand  its  key  stakeholders’  views  and  to  know  how  best  to 
communicate with them. Therefore, an early warning and media monitoring system will be 
put in place. 

In a rapidly growing Agency it is important to develop effective internal communication to 
ensure that all staff in ECHA have the information that they need to do their jobs well, that 
they feel part of a common corporate endeavour, and are ready to be redeployed in case 
of emergency. 

2. Objectives and Indicators  

Objectives 

1.  ECHA’s external audiences are communicated with effectively, and ECHA benefits 

from an accurate and balanced media presence. 

2.  All material (whether online or offline) that is produced for large numbers of small 
and  medium  sized  enterprises  or  the  general  public  will  be  translated  into  21 
official EU languages. 

3.  With  the  help  of  effective  internal  communication,  ECHA  staff  is  well  informed, 

have a sense of belonging, and feel part of a common corporate endeavour. 

- 38 -

 
 
 
 
 
 
 
 
 
 
Performance Indicators & Targets 

Indicators 

Target in 2010 

Level of website customer satisfaction. 

Very Good 

Means and 
frequency of 
verification 

Annual user 
surveys, quarterly 
web statistics 

Level of staff satisfaction with internal 
communications. 

Level of satisfaction expressed in customer 
surveys of publications readerships – 
newsletter, internal newsletter. 

Level of stakeholder satisfaction with their 
involvement. 

Publication of translations of guidance 
documents relevant to large numbers of 
small and medium sized enterprises (within 
an average period of three months after the 
original document, without validation).  

Good 

Annual staff survey 

Good 

Annual customer 
surveys 

Very good 

100% 

Survey on 
Stakeholder Days 

Internal quarterly 
report 

3. Main outputs 

•  ECHA internet and intranet sites rebuilt. 

•  External communications activities enhanced, with a new External 
Communications Strategy and Stakeholder Engagement Strategy.  

•  Risk and Crisis Communications Strategies prepared and executed. 

•  ECHA’s Press Office and proactive media management policy in place. 

•  Study into the communication of hazards and safe use of chemicals with the public 

across Europe begun. 

•  Translation of material published on the website and in hard copy in 21 

Community languages, in particular when the target audience is small enterprises 
and the general public. 

4. Risks 

The  primary  risk  in  the  communications  field  is  of  damage  to  ECHA’s  reputation.  That 
could be as a result of the sheer volume of work and any slowing down in response times 
to journalists and stakeholders that might result. New Press Officers are being recruited in 
2009/2010 to try to reduce the likelihood of that.  

There is also a risk of downtime when the migration of content from the old website and 
intranet to the new versions takes place; planning is underway to reduce the likelihood of 
this occurring. 

- 39 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Some of these activities can also be affected by the contingency plans that may need to 
be put in place to support the registration activities. 

- 40 -

 
 
 
 
Activity 11: Relations with EU institutions and international cooperation 

1. Main challenges in 2010 

1.1 EU institutions and other bodies 

In 2010 ECHA will continue its active cooperation with the European Parliament and the 
Commission by, inter alia, informing the institutions regularly of its activities and seeking 
counsel from the Commission on legal interpretation issues, in particular. Cooperation 
with other European agencies and scientific committees will continue and where 
necessary, Memoranda of Understanding may be established to provide a more formal 
framework for ECHA’s cooperation and coordination with them. The Rules of Procedure 
for cooperation with EFSA and the Advisory Committee for Health and Safety at Work to 
be adopted by the Management Board in accordance with Article 110 of the REACH 
Regulation by the end of 2009 will lay down the basis for intensive cooperation between 
ECHA and these two bodies. 

ECHA will discuss, and potentially develop, a co-operative work programme on (Q)SARs 
((Quantitative)  Structure-Activity  Relationships)  with  JRC,  building  upon  their  existing 
experience with QSAR tools. 

Cooperation with Member States will continue as an essential aspect of the Agency’s day-
to-day  work.  The  meetings  of  the  Competent  Authorities  of  the  REACH  and  C&L 
Regulations (CARACAL) will provide the main platform for consulting MSCAs, but ad hoc 
workshops  and  training  sessions  may  additionally  be  organised  when  necessary.  

1.2 International cooperation 

ECHA will continue its international activities in accordance with a detailed work plan 
developed jointly with the Commission and agreed by the Management Board in 2009. As 
in the previous year, this work plan will identify the fields in which ECHA will provide 
technical-scientific support to the European Commission in multilateral bodies working on 
the management of chemicals and will be determined by the annual calendar of such 
bodies.  

The  main  focus  will  continue  to  be on  cooperating  with  the  OECD  on  issues  relevant  to 
REACH implementation.  

In  2010  ECHA  will  continue  to  be  involved  in  two  OECD  projects  on  the  request  of  the 
European  Commission.  The  first  is  the  Global  Portal  to  Information  on  Chemical 
Substances (eChemPortal), an internet gateway, which aims at improving the availability 
of  hazard-related  data  on  chemicals  found  in  the  environment,  homes  and  workplaces, 
and  in  products  used  daily.  To  promote  worldwide  accessibility  to  data  and  to  achieve 
synergies  with  ECHA’s  own  dissemination  obligations,  the  Agency  is  co-managing  the 
project  with  the  OECD.  ECHA  will  also  play  an  important  role  in  hosting  the  portal  after 
completion of its development, which is scheduled for the second half of the year. 

Another important OECD project addresses (Q)SARs. These are methods for estimating 
properties  of  a  chemical  from  its  molecular  structure  and  may  provide  information  on 
hazards of chemicals, while reducing time, monetary cost and animal testing ECHA is co-
managing  the  development  of  the  (Q)SAR  Application  Toolbox  with  the  OECD  for 
practical applications of (Q)SARs in regulatory contexts. 

In  addition,  ECHA  will  continue  to  chair  the  OECD  IUCLID  User  Group  Expert  Panel 
which  was  originally  established  in  1999,  with  the  aim  of  enhancing  the  software  and 
collecting  user  requirements.  In  accordance  with  the  REACH  Regulation,  ECHA 
coordinates the further development of IUCLID with the OECD.  

ECHA  will  also  continue,  in  2010,  to  help  increase  the  preparedness  of  EU  candidate 
countries, and potential candidates and partner countries of the European Neighbourhood 

- 41 -

 
 
 
 
 
 
 
 
Policy  (ENP),  to  implement  REACH.  To  that  end,  ECHA  will  be  participating  in 
programmes  arranged  mainly  by  the  European  Commission  Technical  Assistance  and 
Information  Exchange  (TAIEX)  office,  as  well  as  activities  funded  from  the  EC’s 
Instrument  for  Pre-Accession  (IPA).  The  latter  programme  aims  to  carry  out  activities  to 
ensure that candidate countries and potential candidates can participate effectively in the 
activities of the Agency.   

Finally, ECHA will also provide scientific and technical support to the Commission on the 
multilateral  international  activities  such  as  the  Stockholm  Convention  on  Persistent 
Organic Pollutants and the technical work of the UNECE SC GHS. 

2. Objectives and Indicators  

Objectives 

1.  Conflicts  of  opinions  with  Scientific  Committees  of  other  Community  bodies  are 
prevented  through  the  sharing  of  information  and  through  the  coordination  of 
activities of mutual interest. 

2.  The  European  Commission  receives  high-quality  scientific  and  technical  support 

for its international activities, especially in multilateral bodies. 

Performance Indicators & Targets 

Indicators 

Target in 2010 

Means and 
frequency of 
verification 

Occurrence of conflicts of opinions with 
Scientific Committees of other Community 
bodies. 

Level of satisfaction of the Commission with 
the support given by ECHA on international 
activities. 

Joint IT projects (eChem portal and IUCLID 
5) with the OECD completed successfully.  

Only in well justified 
cases 

Internal evaluation 
report 

High 

Annual survey  

Annual report  

New release of 
eChem portal has 
been delivered to 
ECHA and a new 
release of IUCLID 5 
published by the 
end of 2010 

- 42 -

 
 
 
 
 
 
 
 
 
 
 
3. Main outputs 

• 

Implementation  of  the  practical  technical  cooperation  with  EFSA,  EMEA  and 
ACSHW and EU-OSHA6  and scientific committees of other Community bodies. 

•  Scientific  and  technical  support  to  the  Commission’s  work  on  the  Stockholm 

Convention on Persistent Organic Pollutants and the UNECE SC GHS.  

•  Actions  to  support  candidate  countries  for  EU  accession  and,  as  appropriate, 
potential candidates as well as ENP (European Neighbourhood Policy) partners to 
prepare for REACH implementation and participation in ECHA.  

•  Contacts with third countries and their respective authorities as appropriate.  

•  Scientific and technical cooperation with the OECD (continuation): 

o  The eChemPortal project delivered to ECHA by the end of 2010. 

o  The (Q)SAR Toolbox project progressing according to plan and to a high-
scientific  level;  the  second  version  of  the  Toolbox  released  by  the  end  of 
2010. 

o 

IUCLID  5  has  incorporated  all  user  requirements  prioritised  by  the  OECD 
IUCLID User Group Expert Panel in its meeting of September 2008. 

o  Task force on hazard assessment. 

o  Task force on exposure assessment.  

o  Harmonised Templates projects. 

o  Working party on nano-materials. 

o  Task force on Harmonized classification and labelling.  

4. Risks 

The  likelihood  of  potential  differences  of  opinions  with  scientific  committees  of  other 
Community bodies is very difficult to estimate. The nature of relevant cases can vary and 
affect the workload for ECHA accordingly.  

Concerning  international  cooperation,  the  workload  will  depend  very  much  on  the 
requests  made  by  the  Commission.  As  only  a  limited  amount  of  resources  can  be 
allocated  to  international  activities,  requests  for  cooperation  from  third  countries  will  be 
carefully  examined,  whereby  prioritisation  of  different  tasks  is  essential.  Should  the 
Commission  ask  ECHA  to  provide  additional  support  for  international  cooperation, 
additional resources would need to be allocated by the Commission to these activities and 
ECHA may have to outsource some of that support. 

This activity may also be affected by the contingency plans that could be triggered to 
safeguard the registration activity, particularly in the last quarter of 2010. 

6 European Food Safety Authority, European Medicines Agency, Advisory Committee on Safety 
and Health at Work and European Agency for Safety and Health at Work. 

- 43 -

 
 
 
                                                
 
 
 
 
 
 
 
 
 
Programme 3: 
Management, organisation and resources 

- 44 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Activity 12: Management 

1. Main challenges in 2010 

While the Executive Director of ECHA is responsible for the day-to-day administration of 
the Agency and the management of its resources, ECHA’s highest decision making body 
is  the  35-member  Management  Board,  which  adopts  the  Agency’s  multi-annual  and 
annual  work  programmes,  budget,  annual  report  and  internal  rules.  The  Management 
Board is also the appointing authority for the Executive Director, the Chair and members 
of the Board of Appeal and the members of the ECHA RAC and SEAC Committees.  The 
Secretariat  of  the  Management  Board  in  ECHA,  provided  by  the  Executive  Office,  will 
continue to ensure the smooth functioning of the Management Board meetings as well as 
the legality of its meeting procedures and decisions. 

The  Executive  Office  will  continue  to  support  the  Executive  Director  in  the  management 
and  the  horizontal  coordination  of  the  Agency’s  operations.  It  will  provide  organisational 
support  for  the  Directorates,  lead  the  quality  and  security  policies,  organise  document 
management and process initial requests for access to document. It will also support the 
Executive  Director’s contacts  with  the  European  institutions and  other  European  bodies, 
and will develop further links with the scientific community and academia. 

The 2010 registration deadline will reflect on the number of decisions to be taken by the 
Agency. ECHA’s legal advisors will need to give constant support to REACH operations to 
ensure that decisions are taken in accordance with legal requirements; and also defend 
the Agency in case of possible appeals. The Legal Affairs, established as a separate unit 
in  2009,  also  supports  the  Executive  Director  in  taking  decisions  in  review  procedures, 
e.g.  regarding  confirmatory  requests  for  access  to  documents  or  requests  to  accept 
confidentiality claims.  

ECHA  will  continue  the  establishment  and  implementation  of  the  integrated  quality 
management system (IQMS), based on the internationally recognised standard for quality 
management  systems 
its  underlying  process  approach. 
Considering  the  complex  nature  of  ECHA’s  processes,  the  work  to  put  in  place  the 
necessary  procedures,  work  instructions  and  other  quality  documents  will  continue  for 
some years beyond 2010, in accordance with the mapping done in 2009.  

(ISO  9001:2008),  and 

Further to a risk assessment workshop at the end of 2009, a corporate risk management 
system will be developed and an action plan for risk management will be implemented in 
2010.  Security  issues,  both  regarding  information  security  as  well  as  physical  security, 
remain  priorities  in  2010,  with  emphasis  placed  on  establishing  business  continuity 
management.  Ensuring  secure  communication  channels  with  Committee  Members, 
Member State Competent Authorities, as well as with external experts, will receive special 
attention.  ECHA’s  internal  auditor  will  conduct  audits  as  well  as  advise  the  Executive 
Director on control systems.  

Management  information  systems  will  be  further  developed,  including  those  relating  to 
planning and reporting, and document management. 

- 45 -

 
 
 
 
 
 
 
 
 
 
2. Objectives and Indicators 

Objectives 

1.  The  Agency  fulfils  all  its  statutory  obligations  with  regard  to  the  Management 

Board and the EU institutions. 

2.  The Agency continues the development of a structured quality and internal control 
system,  having  reviewed  its  risks  and  has  a  comprehensive  security  system  as 
well as a solid information management system in place. 

Performance Indicators & Targets 

Indicators 

Target in 2010 

Percentage of statutory documents 
submitted to the Management Board within 
legal deadlines. 

100% 

Level of implementation of the risk 
mitigation plan. 

Not less than 90% 

Percentage of quality procedures released 
to the public. 

Not less than 70% 

Number of “critical” findings by the auditors 
relating to the internal control system in 
place. 

Percentage of audit recommendations 
implemented within the deadline. 

Number of security incidents for which an 
inquiry by ECHA’s security services 
identified a leak of confidential information 

0 

100 % 

0 

Means and 
frequency of 
verification 

Quarterly internal 
report 

Annual internal 
report 

Quality Manager’s  
annual report 

Internal auditors 
annual report 

Internal auditors 
annual report 

Internal reports 

- 46 -

 
 
 
 
 
 
 
 
 
 
 
 
3. Main outputs 

•  Management Board meetings organised professionally.  

•  Regulatory  documents  for  planning  and  reporting  provided  and  adopted 

according to the agreed schedule. 

•  Quality  Management  System  documentation  developed,  with 

the  main 
operational  procedures  published  together  with  the  compulsory  part  of  the 
quality manual.  

•  Corporate  risk  management  system  published 

the 
implementation of a multi-annual, full scale risk management system, including a 
business continuity project.  

to  support 

internally 

• 

Internal  Audit  Capability  annual  work  plan  for  2010  implemented,  including    an 
update  of  the  IAS  risk  assessment  following  the  start  of  new  operations 
(authorisations, restrictions), and the follow-up of 2009 audits.  

•  Provision  of  strong  legal  support  to  ensure  that  ECHA’s  decisions  are  legally 
correct,  also  during  peak  periods;  provision  of  effective  defence  in  case  of 
appeals. 

•  Development of a corporate management information system featuring planning 

and monitoring as well as secure filing and electronic archiving.  

•  Development  of  EU  inter-institutional  relations,  for  a  better  link  with,  inter  alia, 

the EU Commission, the European Parliament and other Agencies. 

•  Coordination  of  requests 
Community legislation. 

for  access 

to  documents 

in  accordance  with 

4. Risks 

The  Agency  has  been  operational  for  rather  a  short  time,  during  which  the  security 
management has been intensively developed. The security management is being set up 
at the same time as the processes of the Agency are being established. Considering the 
speed with which the Agency has been set up and the limited resources, there is a risk 
that  the  risk  management  done  in  the  Agency  fails  to  address  all  the  risks  facing  the 
security  systems.  This  could  pose  a  risk  of  a  failure  relating  to  the  information  assets, 
which would have a high impact on ECHA’s reputation and could lead to liability claims, in 
particular as the source will be difficult to identify once all eligible external bodies obtain 
access to the data of the Agency. The Agency is aware of this and gives a clear priority to 
mitigating actions in this respect. 

Some of these activities may also be affected by the registration contingency plan. 

- 47 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Activity 13: Finance, Procurement and Accounting  

1. Main challenges in 2010 

The  Agency’s  main  challenge  in  the  financial  domain  in  2010  will  be  efficient  cash 
management. Of particular concern will be the adequacy of the cash inflow to cover the 
Agency’s  legal  obligations  throughout  the  year.  Originally,  no  Community  subsidy  was 
foreseen for the Agency from 2010 onwards in the current financial programming period 
(2007-2013) as the deadline for the first fee-generating registration wave was foreseen to 
be  30  June  2010.  However,  with  the  postponement  of  this  deadline  until  30  November 
2010  by  the  co-legislator,  the  bulk  of  fee  revenue  from  the  first  registration  wave  is 
expected  to  be  received  only  at  the  very  end  of  2010  and  in  the  following  year.  ECHA 
cannot rely on sufficient early submissions of registrations and corresponding fee income 
throughout  the  year,  as  the  experience  gained  so  far  from  the  pre-registration  phase 
shows  that  it  is  very  likely  that  registrants  will  wait  until  the  deadline  before  submitting 
their  dossiers.  The  anticipated  continuing  weakness  of  the  general  economic  situation 
reinforces this assumption.  

The  Agency’s  planning  has  been  based  on  the  assumption  that  the  budgetary  authority 
will grant a reimbursable temporary subsidy, which is high enough for ECHA to execute 
its  essential  tasks  under  REACH,  and  that  it  is  willing  to  review  the  situation  during  the 
year to increase that amount if the cash-shortfall is higher than predicted.   

The Agency will also be faced with the operative challenge of being able to swiftly process 
the expected high volumes of and peaks in the financial transactions in 2010. The number 
of fee invoice transactions and the amount of fee revenue to be cashed during the year is 
expected to grow dramatically and depends fully on the number of registrations and their 
distribution over the year. According to the baseline figures presented in Annex 2, there 
should  be  around  25  000  invoices  to  be  sent  to  registrants  by  the  end  February  2011. 
However,  as  already  discussed  in  the  preceding  chapters,  this  figure  could  perhaps 
change radically. In any case, as the Community subsidy requested was not foreseen in 
the financial perspectives, the Agency has to ensure that a sufficient volume of invoices is 
cashed  at  year-end  to  permit  the  repayment  of  the  subsidy  to  the  Commission  in  the 
course  of  2010  in  line  with  the  provisions  set  out  in  the  Agency’s  Financial  Regulation 
(Art. 16).  

In  addition,  it  is  expected  that  the  Agency  will  have  some  800  commitments  and  over 
3000 outgoing payment transactions as a result of its operational activities. 

2. Objectives and Indicators 

Objectives 

1.  The Agency has sound and as efficient as possible financial management. 

2.  Invoices  are  efficiently  generated  and  cashed  in  order  to  reduce  the  need  for 

subsidy during the entire year. 

- 48 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Performance Indicators & Targets 

Indicators 

Target in 2010 

Means and 
frequency of 
verification 

Number of reservations in the annual report 
of the European Court of Auditors. 

0 

ECA reports/ annual

Commitment rate. 

Not less than  98%  BO report on ABAC/ 

annual 

Payment rate. 

Not less than  70%  BO report on ABAC/ 

Cashed fee income.  

106,8 million euros 

Number of complaints against ECHA 
procurement procedures. 

0 

Surplus necessary for the reimbursement of 
the Community subsidy. 

100 % of the value 
of subsidy 

annual 

REACH report / 
annual 

Annual internal 
report 

2010 accounts 

3. Main outputs 

•  Rigorous budget and liquidity management.  

•  Efficient  accounting  work-flows  and  procedures  in  view  of  the  invoicing  peak 

related to the first registration deadline. 

•  Mechanism for managing and investing the Agency’s cash reserves implemented. 

•  System for procurement and contract management developed. 

•  Analytical (activities) accounting system in development. 

•  Follow  up  and  execution  of  the  budget  improved  to  reach  commitment  rate  of 

98%.  

4. Risks 

The  work  plan  of  the  Finance,  Procurement  and  Accounting  activity  is  realistic  if  the 
baseline figures of Annex 2 are valid. If the number of registrations or any other volume 
indicators  are  drastically  higher  than  estimated,  the  resources  could  be  insufficient  and 
appropriate  framework  contracts  need  to  be  employed  to  have  access  to  short  term 
assistance in a swift and flexible way.  

There  is  a  risk  that  the  budgetary  authority  will  ultimately  not  grant  the  temporary 
Community subsidy up to the level foreseen. In this case there is also a risk of having to 
scale down the operational activities. Close monitoring of the liquidity situation, effective 
cash-flow  planning  and  cooperation  with  the  Commission  services  will  be  undertaken  to 
mitigate the risk. 

As regards the repayment of the Community subsidy, there is a risk that due to a number 
of  circumstances  (e.g.  quality  of  the  submitted  REACH  dossiers,  the  bulk  of  the 

- 49 -

 
 
 
 
 
 
 
 
 
 
 
 
 
registration  dossiers  only  arriving  close  to  the  deadline)  the  amount  of  the  budgetary 
outturn account is insufficient to repay the Community subsidy of 2010 in 2011, and thus 
that  part  of  the  reimbursable  temporary  subsidy  becomes  a  net  subsidy  to  ECHA.  To 
reduce  this  likelihood  the  invoicing  procedures  will  be  streamlined  and  tuned  for  large 
volumes. A contingency plan will be ready to (re)deploy staff resources when this would 
be  needed,  while  close  contact  with  stakeholders  will  be  maintained  as  to  obtain  early 
indications on timing and volumes of registrations.   

- 50 -

 
 
 
Activity 14: Human resources and infrastructure  

1. Main challenges in 2010 

The main challenges for Human Resources in 2010 is continuing the extremely high rate 
of  selection  and  recruitment  (102  Temporary  Agents  and  18  Contract  Agents)  with  the 
additional  challenge  of  organising  written  tests  as  part  of  the  selection  procedure.  New 
staff  will  be  provided  with  relocation  support  and  the  high  volume  of  new  staff  will  also 
receive induction and initial training at the start-up-phase of their employment. 

The growing number of existing staff will continue to receive a high level of training based 
on  the  Learning  and  Development  Strategy  2009-2012  and  Training  Guidelines.  The 
implementation  of  performance  management  for  a  growing  volume  of  staff  (job 
descriptions,  objectives,  probation  reporting,  performance  appraisal,  promotions)  is 
challenging and resource intensive both for HR as well as for other units. 

The  HR  administration  capacity  and  payroll  will  be  scaled  up  to  cope  with  the  growing 
number of staff, in particular via the implementation of a new HR information system and 
related workflows.  

Specific and contingency measures could be required in case the number of submissions 
and registrations exceeds the estimates, or if more manual intervention is needed in the 
REACH  processes,  as  compared  to  the  initial  plans.  This  could  mean  the  need  for  the 
recruitment, training and management of a considerable number of temporary staff. If this 
occurs, it will also result in a substantial increase in logistics and IT support to host and 
accommodate these additional and temporary staff.   

A new Corporate Services Unit will be created at the beginning of 2010. The new unit will 
take over the responsibilities of the Facility Team as well as some technical tasks from the 
Executive  Office,  such  as  mail  registration  and  physical  archiving.  The  new  unit  has,  as 
one of its main responsibilities, the operation of the conference centre and other common 
facilities of the Agency, as well as the continuous challenge of providing office space and 
internal  services  for  an  estimated  580  persons  at  the  end  of  2010  (statutory  staff, 
Seconded National Experts, trainees, interims, consultants). The high volume of ECHA’s 
staff  and  assets,  in  particular  its  information  assets,  also  requires  the  highest  level  of 
security  and  safety.  The  new  conference  centre  and  its  support  staff  will  continue  to 
deliver high quality conference services.  

The principal challenge for the Human Resources and the new Corporate Services units 
will  be  to  deliver  a  significantly  higher  volume  of  services  without  a  corresponding 
increase  in  its  staff  numbers.  This  will  have  to  be  achieved  via  improved  information 
systems (e-HR) and workflows, more efficient procedures, further decentralisation of HR 
administration tasks (e.g. time and absence management) to line units and outsourcing.  

2. Objectives and Indicators  

Objectives 

1.  The  Agency  has  a  sufficient  number  of  skilled  staff  in  order  to  secure  the 
implementation  of  the  work  plan  and  offers  them  a  well  functioning  working 
environment. 

2.  The  Agency  has  sufficient,  secure  and  safe  office  premises  that  provide  efficient 
and safe working environment for the staff, and well functioning meeting facilities 
for the Agency bodies and external visitors. 

- 51 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Performance Indicators & Targets 

Indicators 

Target in 2010 

Percentage of establishment plan posts 
filled at the end of the year. 

Not less than  95% 

Percentage of selection procedures for the 
new posts for the year completed. 

100% 

Turnover of the Temporary Agents. 

Not more than 5 % 

Means and 
frequency of 
verification 

Annual internal 
report 

Annual internal 
report 

Annual internal 
report 

Level of satisfaction of the Committee, 
Forum and MB members with the 
functioning of the conference centre. 

High satisfaction 

Annual survey 

Average number of training days per staff 
member. 

10 

Annual internal 
report 

3. Main outputs 

Human resources 

•  An  estimated  50  selection  procedures  to  be  organised  with  written  tests  with  an 

estimated  1000  candidates,  and  120  recruitments,  without  counting  short-term 

staff needs to meet the peak workload at the end of 2010. 

•  30 % increase in the number of staff in payroll, with a corresponding increase in 

the  workload  in  the  area  of  HR  finance,  administration  and  performance 

management, without counting short-term staff needs to meet the peak workload 

at the end of 2010.  

•  Continued relocation support and induction training at the same level as in 2009. 

•  High  volume  of  training  (av.  10  days  per  staff  member)  provided  for  a  growing 

number of staff (+30 %).  

•  Management  of  an  important  increase  of  short-term  staff  (interim  and  contract 

agents) to meet the peak workload at the end of 2010. 

•  First steps towards competence-based HR management.  

Infrastructure 

•  Further renovation and other activities linked to the space needs of c. 580 persons 

by the end of 2010.  

•  Space  found  for  short-term  staff  linked  to  the  peak  workload  at  the  end  of  2010, 

and further office space in building taken over.  

•  Written manuals for technical systems in place.  

•  Health and safety activities for staff developed. 

•  Maintaining physical archives and creation of a documentation centre and library. 

- 52 -

 
 
 
 
 
 
 
4. Risks 

Human Resources 

A  main  risk  factor  to  human  resources  and  staff  recruitment  is  the  uncertainty  in  the 
financial  situation  in  2010,  and  the  eventuality  that  the  recruitment  pace  has  to  be 
postponed until the very end of the year due to budgetary constraints. This would have a 
major negative impact since it would jeopardize the operational capacities of ECHA at the 
moment when it would be most needed to meet the deadlines at the end of 2010.  

Due to the peak activities in 2010 requiring internal reallocation of staff and the possible 
reduction  of  the  resources  leading  to  insufficient  recruitment,  health  problems  linked  to 
stress  and  excessive  workloads  may  be  expected.  Flexible  work  programming  and 
objective  setting,  together  with  motivational  management  and  HR  practices  and  active 
policies  to  promote  a  balanced  work-life,  could  prevent  these  risks,  but  the  problems 
could also be alleviated by recourse to external contractors.  

Finally,  part  of  the  HR  activities  may  also  be  affected  by  the  contingency  plans  for 
registration. 

Infrastructure 

Contingency  planning  with  the  possibility  of  scaling  up  infrastructure  capacities,  within 
short time frames, is needed in order to be able to cope with the possible temporary need 
for 100 short-term staff from external contractors to help face higher volumes of work than 
anticipated.  

- 53 -

 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
Activity 15: Informatics and communication technology 

1. Main challenges in 2010 

The  main  IT  challenge  for  2010  relates  to  the  readiness  for  legal  deadlines  and  the 
expected  large  volumes  of  registration  dossiers  and  C&L  notification  submissions  by 
November/December. The readiness preparations will require continuous and large scale 
performance testing, the tuning of  REACH-IT  applications as well as  the assurance that 
the system is scalable and that reserve capacity and back-up solutions are aligned.  

In  2010,  also  several  strategic  products  resulting  from  projects  started  in  2009  will  also 
become  operational  (e.g.  CHESAR,  CASPER,  Odyssey,  Global  Portal,  etc.)  and  will  be 
supported by the IT team.  The Agency-wide Customer Relation Management system, the 
information system for the administration of human resources (e-HR) and the adoption of 
a centralized Enterprise Content Management system are high on the agenda for further 
development and implementation.   

Extension  of  the  technical  infrastructure  for  accommodating  the  planned  growth  of  staff, 
and the increased demand on technical resources, will continue to be a key challenge and 
strain the support services - such as the first line helpdesk and back office support.  Other 
back office developments are foreseen for the implementation of an Agency-wide Identity 
Management  System  and  for  the  registration  of  the  Agency  as  an  official  Certification 
Authority for proper Public Key Infrastructure implementation.  

As a part of the overall business continuity management of the Agency, Security and IT 
Business  Continuity  measures  will  continue  to  receive  due  attention  and  include  the 
activation of fully featured disaster recovery facilities, the further strengthening of security 
for IT systems and the fine tuning of the intrusion detection system.  

IT governance and project management will be further strengthened with additional staff 
being  recruited,  and  will  focus  on  the  refinement  of  Agency  Architectural  Guidelines, 
project  management  support  and  quality  assurance  aspects,  such  as  the  preparation  of 
procedures and guidelines as well as the formalisation of Service Level Agreements.  

2. Objectives and Indicators 

Objectives 

The staff, stakeholders and external clients are provided with continuous IT services 
including operational back-up systems. 

- 54 -

 
 
 
  
 
 
 
 
 
 
 
 
 
Performance Indicators & Targets 

Indicators 

Target in 2010 

Availability of operational systems for 
external customers (uptime).  

IT business continuity & disaster recovery 
plan operational in August 2010. 

Level of user satisfaction with internal IT 
services. 

3. Main outputs 

99 % 

100% 

High 

Means and 
frequency of 
verification 

Data centre 
statistics 

Annual disaster 
recovery, business 
continuity tests and 
management 
reporting 

Annual customer 
survey and ad hoc 
feedback 

•  Equipment for 120 incoming statutory staff and for staff on short-term contracts. 

•  Back-office,  storage  and  backup  and  restore  systems  upgraded  to  cater  for  staff 

growth. 

•  Core  systems  and  applications,  in  particular  REACH-IT,  hosted,  maintained  and 

operated during peak loads. 

•  Second generation REACH-IT infrastructure and flexible scalability implementation 

installed. 

• 

IT business continuity, and disaster recovery plans for core systems documented 

and tested. 

•  Architectural guidelines implemented, as defined in 2009. 

• 

IT  support  for  ECHA  applications,  including  REACH-IT  and  dissemination  and 

other web developments like Global Portal, provided. 

•  Fully featured data-warehousing environment created for the purpose of REACH-

IT  Dissemination,  Enforcement,  Global  Portal  and  support  to  internal  business 

processes. 

4. Risks 

A  much  higher  than  expected  number  of  registration  dossiers  and  C&L  notifications 
submitted  shortly  before  the  deadline  would  put  the  performance  and  usability  of  the 
systems  at  risk.  Intensive  performance  testing,  the  assurance  of  flexible  scalability,  the 
access  to  reserve  resources  and  contingency  plans  could  mitigate  this  risk  to  a  large 
extent.   

Security  aspects  will  receive  continued  attention  through  close  monitoring  and  proactive 
measures. A third risk is linked to the registration contingency plans, which may require, 
as  far  as  possible,  the  temporary  redeployment  of  scientific  and  administrative  staff  to 
registration. 

- 55 -

 
 
 
 
 
 
 
 
 
Annexes 

- 56 -

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Annex 1: ECHA Organisation 

- 57 -

 
 
 
 
 
Annex 2: Activity levels used for the Work Programme 

Baseline figures for 2010 

These figures will be revised before the end of 2009 if necessary, depending on the evidence gathered 
during the year 

ECHA main activities drivers 

Estimation for 2010 (9/2009) 

Dossiers arriving in 2010 

Substances 

Registration dossiers (including 
intermediates) 

PPORD notifications 

Inquiries 

Restriction proposals (Annex XV) 

Proposals harmonised classification and 
labelling (Annex XV) 

Proposals for identification as SVHC  
(Annex XV) 

C&L notifications 

ECHA decisions in 2010 

Decisions on dossier evaluation 

Decisions on data sharing  

Decisions on completeness check 

Appeals submitted in 2010 

Others 

Questions to be answered/harmonised 
answers (REACH Advice, REACH-IT, 
IUCLID 5, others) 

New staff vacancies to be filled 

9 200 
25 0007

300 

1500 

6 

90 

30 

2 million 

70 

500 

500 

100 

15 000 

120 

7 This number will be reviewed based on information from SIEFs and chemical associations. 

 
 
  
 
 
 
 
 
 
 
 
 
 
                                                 
ANNEX 3: Estimated resources for 2010 

•  Amounts differ from the respective budget lines as operational mission costs and training to external parties have been allocated across different activities. 
•  Activity  11  (Relations  with  EU  institutions  and  international  cooperation)  also  contains  amounts  of  BL3801  for  multi-annual  contracts  and  of  BL3901  for  the  

ear-marked IPA project. 

Activities (Title III of the Budget) 

Human Resources 

Final budget 

The numbering below refers to the WP 2010, not to the numbering in the budget 

AD 

AST 

CA 

Operational activities – Implementation of the REACH Processes 
General coordination, management and support 
Activity 1: Registration, pre-registration and data-sharing  

Activity 2: Evaluation 

Activity 3: Authorisations and restrictions 

Activity 4: Classification and labelling, SVHC 

Activity 5: Advice and assistance through guidance and helpdesk  

Activity 6: IT support to operations 

Activity 7: Scientific and practical advice to the further development of 
legislation 
ECHA’s bodies and supporting activities 

Activity 8: Secretariat, Committees and Forum 

Activity 9: Board of Appeal 

Activity 10: Communication  

Activity 11: Relations with EU institutions and international cooperation 

Management, organisation and resources 

Activity 12: Management 

Total 

Activities 13-15: Title II (Infrastructure and operating expenditure) 

Title I (staff expenditure) 

Total 

In Establishment plan: 

40 

62 

20 

14 

31 

25 

3 

17 

12 

10 

8 

21 

263 

25 

288 

426 

12 

9 

4 

3 

13 

5 

0 

8 

5 

8 

4 

14 

85 

53 

138 

8 

1 

1 

2 

4 

2 

3 

7 

0 

3 

31 

21 

52 

731.600 

608.419 

1.517.519 

177.519 

1.150.465 

10.598.925 

4.380 

2.990.158 

652.100 

5.695.309 

896.321 

1.329.500 

26.352.215 

12.915.200 

47.214.285 

86.481.700 

 
 
  
 
 
 
 
 
  
 
 
  
 
 
 
 
  
 
 
  
 
 
 
 
 
  
ANNEX 4: Procurement plan 

WP Activity 

Sub-activity 
(where 
applicable) 

Unit

Task or project 

Proposed 
budget in 
EUR 

Tentative 
procurement 
channel 

Foreseen 
date for 
launching 
procurement 

Foreseen 
date for 
contract 
signature 

 2.0: Evaluation 

Scientific 
support 

B1 

Service requests targeting specific 
questions coordinated by the 
scientific platforms and in support 
of Dossier Evaluation tasks 

250 000,00 

FWC 2008/02 
or negotiated 
procedure  

Q1-Q2 

Q2 

 2.0: Evaluation  Training 

B4  Training for junior and senior staff 

420 000,00 

FWC 2008/02 

Q1 

Q1 

 3.0: 
Authorisations 
and restrictions 

3.1 
Authorisation 

B2 

3.2 Restrictions 

B2 

 3.0: 
Authorisations 
and restrictions 
 3.0: 
Authorisations 
and restrictions 

Services to support development of 
Annex XV dossiers for SVHCs; to 
collect data for priority setting for 
authorisation, SEA Methodology 
development/increase knowledge 
base, RMM Methodology/increase 
knowledge  base 

Services to support development of 
restriction proposals (PFOS/PFOA, 
phthalates)  

1 100 000,00 

FWC 2008/02

Q1-Q2 

Q2-Q3 

300 000,00 

FWC 2008/02

Q1 (depends 
on request by 
COM)  

Q2 

B2  Miscellaneous  

100 000,00 

low-value  
procedures 

Q1-Q2 

Q2-Q3 

 
 
 
  
 
WP Activity 

Sub-activity 
(where 
applicable) 

Unit

Task or project 

Proposed 
budget in 
EUR 

Tentative 
procurement 
channel 

Foreseen 
date for 
launching 
procurement 

Foreseen 
date for 
contract 
signature 

 4.0: 
Classification 
and labelling 

 5.0: Advice 
and assistance 
through 
guidance and 
helpdesk 
 5.0: Advice 
and assistance 
through 
guidance and 
helpdesk 

B3 

Services to support ECHA to 
complete CLH dossiers provided 
by MSCA and other services 

160 000,00 

FWC 2008/02

Q1 or Q2 
(depends on 
discussion 
with MSCAs 
and COM) 

Q2-Q3 

Guidance 
updates 

A1 

Contracts (CLP & substances in 
articles, upgrade of the navigator 
regarding the CSA/CSR guidance, 
evaluation of Exposure Scenarios)  

350 000,00 

FWC 2008/02

Q3 

Q4 

A1  Miscellaneous 

755 500,00 

FWC/low-
value 
procedures 

Q3 

Q4 

 6.0: IT support 
to operations 

Consultants 

R3 

Tentative sample of profiles:     
Application Administrators (2) 
Data Warehouse Administrator 
DBA for Oracle-RAC 
DBA for Oracle  
Application Security Tester (5 
days/month) 
Specialist Consultants (e.g. 
Documentum, BMC) (2) 
Weblogic Administrators (2) 
Other profiles (3) 

2 000 000,00 

FWC2009/39 
for IT projects 
and FWC 
2009/40 for IT 
consultants 

Q1-Q4 

Q2-Q4 

 
 
  
  
 
WP Activity 

Sub-activity 
(where 
applicable) 

Unit

Task or project 

Proposed 
budget in 
EUR 

Tentative 
procurement 
channel 

Foreseen 
date for 
launching 
procurement 

Foreseen 
date for 
contract 
signature 

 6.0: IT support 
to operations 

IUCLID 5 

C1  Development of IUCLID 5.x 

700 000,00 

FWC 2008/02 
or FWC 
2009/39 

Q2 

4 000 000,00 

FWC 2009/39

Q2 

Q3 

Q3 

 6.0: IT support 
to operations 

REACH-IT next 
generation 

 6.0: IT support 
to operations 

REACH-IT 
derivatives 

 6.0: IT support 
to operations 

Chesar/ CSA 
Tool 

C1 

C1 

Implementation of redesigned 
REACH-IT NG system 
Consultancy (SW testing for 
different parts of REACH-IT, 
Dissemination, workflows, creation 
of plug-ins as ad-hoc solutions to 
support REACH-IT development) 

C1  Recruitment of programmers 

700 000,00 

FWC 2009/40

Q1 

Q1-Q2 

 6.0: IT support 
to operations 

Odyssey 

C1 

Recruitment of programming and 
webmaster services for Odyssey 
development and maintenance. 
Jointly with Unit B4. 

500 000,00 

FWC 2009/40

Q1 

Q2 

 6.0: IT support 
to operations 

 6.0: IT support 
to operations 

CASPER: 
Evaluation & 
data sharing 
support 
ECM / 
Documentum 
implementation 
projects 

C2 

Recruitment of 2 programmers and 
renewal of 1 part-time Oracle 
expert consultant  

440 000,00 

FWC 2009/40  
FWC DIGIT 

Q1 

Q1 

C1  Consulting for ECM projects 

4 000 000,00 

 6.0: IT support 
to operations 

Application 
hosting 

 6.0: IT support 
to operations 

HW, SW and 
Licences 

R1 

R3 

Outsourced hosting for Secondary 
Business Plan, Global portal, all 
other applications 

Miscellaneous purchase of HW 
and SW 

5 000 000,00 

3 000 000,00 

FWC 
2009/40, 
Hansel, DIGIT 
FWC 

Negotiated 
procedure 

FWC DIGIT/ 
HANSEL 

Q1 

Q1 

Q1-Q2 

Q2 

Q1-Q3 

Q2-Q4 

1 200 000,00 

FWC 2009/40

Q1-Q4 

Q2-Q4 

 
 
 
WP Activity 

 8.0: 
Committees 
and Forum 

 8.0: 
Committees 
and Forum 

Sub-activity 
(where 
applicable) 

Forum for 
Exchange of 
Information on 
Enforcement 
(Forum) 
Forum for 
Exchange of 
Information on 
Enforcement 
(Forum) 

Unit

Task or project 

Proposed 
budget in 
EUR 

Tentative 
procurement 
channel 

Foreseen 
date for 
launching 
procurement 

Foreseen 
date for 
contract 
signature 

C1 

RIPE - REACH Information portal 
for enforcement) - REACH IT part 

480 000,00 

FWC 2009/40

Q1 

Q1-Q2 

R3 

RIPE - hardware (tokens for 
enforcement users) 

250 000,00 

FWC DIGIT 

Q2 

Q3 

850 000,00 

FWC 2009/39

Q3 

Q4 

10.0: 
Communication 

Digital 
communications 

A3 

10.0: 
Communication 

Communication 
related-activities 

A3 

Website development (customer 
insight activities, further 
development) 

Framework Contract to cover 
different tasks related to 
communication activities of the 
Agency (2-4 years) 

Expected 
2000000 per 
year 

10.0: 
Communication 

11.0: Relations 
with EU 
institutions and 
international 
cooperation 

A3  Miscellaneous 

1 600 000,00 

A2/  
C1 

Miscellaneous + IUCLID 

400 000,00 

Tentative estimated value                 28 555  500,00

Open 
procedure 

FWC/low-
value 
procedures 

FWC/low-
value 
procedures 

Q1 

Q3 

Q1 

Q3 

Q1-Q2 

Q2-Q3 

 
 
 
  
  
  
 
  
 
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