1. Lessons learnt and challenges ahead
GPS / REACH conference
04 Oct 2011
Athens, Greece
L. Heezen
Manager Global Chemical Regulations

2. Content Next deadline 2013 Working in SIEFs
Industry guidance’s and tools for CSA development and ES communication
REACH legal remedies

3. Early estimates for 2013 registrations:
Next deadline 2013
Early estimates for 2013 registrations:
3 500 substances
Number of substances revised downwards compared to 2007 estimates
Lessons from 2010 registration: less substances than initially estimated, especially intermediates
Same ratio applied to 2013 estimates
new dossiers expected
Market intelligence needed to confirm

4. Working is SIEFs From pre-SIEF to SIEF (2010 experience)
Difficult to form a SIEF and get the work started
Use Substance Identity Profile (SIP) template
Guidance on SIEF formation
SFF not filling in its role
Recommendations to bypass
Companies reluctant to take the LR role
Cefic guidance for LR
Checklist SIEF tasks
Obligations and liabilities of LR
What are intentions of SIEF members?
Use SIEF codes: Leading, Involved, Passive and Dormant
Consortia formation did help
Cefic model REACH SIEF agreement

5. SIEFs: main challenges and learning's
Need for an efficient SIEF management process
Early, clear, transparent and regular communication to all SIEF members
Determine substance sameness and communicate to all SIEF members
C&L process
Data availability check
Agreement on LR and notification to ECHA
Cefic REACH model cooperation agreement
Report progress status
Joint/separate CSA/CSR

6. Countdown: optimal situation
Next deadline 2013
Countdown: optimal situation
Q2 2013
IUCLID I5Z
Members
Q1 2013
IUCLID I5Z
Leads
Q1-Q4 2012
Start CSA
Chemical Assessment
Substance ID Data sharing Hazard data
Q3-Q4 2011
SIEF work
30 May deadline
30 March 2013
End 2012: CSR ready
End 2011: i5 dataset
Now
towards 2013 deadline

7. SIEFs: main challenges and learning's
Use a project management tool e.g. Cefic Gantt chart including main tasks and timeline

8. SIEF: main challenges and learning’s
Consistent and efficient communication
SIEF Management can be done by LR or outsourced to service providers e.g. ReachCentrum
SIEF communication platform is key e.g. : LINKinSIEF
New tool based on experience made during the previous phase
Focus on practicability and user friendliness
For LR: Flexible surveys and centralized document storage. Support for compliance/liabilities
For SIEF members: Free; one single point for access SIEF information in a simple & secured way

9. SIEF: main challenges and learning’s
Cost sharing
Should be fair, transparent and non-discriminatory
Pay for the data you need(tonnage band, intermediate…)
Explanation of cost sharing system e.g. coverletter + early estimate if possible
When will SIEF members get the data? LoA procedure
Costs may include:
SIEF management
Preparation of IUCLID dossier, RSS, CSR
Generation of invoices, letters of access, etc.
Provision for reimbursement (with a threshold?)
Consult Cefic notes on cost sharing

10. SIEF: Main challenges & learnings
Procedure for LoA
DOSSIER
PREPARATION
SIEF agreement
signed
Invoice from LR
Received and
paid
LoA received
Sign up to JS
in REACH-IT
Submission of
Member dossier
After payment, companies need to get from the LR/consortia:
•Token
•Joint submission name
•Access to content of the LR dossier
•Letter of access
And prepare, complete and submit their own registration dossier!

11. SIEF: main challenges and learning’s
Handling new registrants in SIEF’s
SIEF that have submitted dossier in 2010:
LR sends out note with procedure to follow and timing to SIEF members
LR to assure the latest SIEF membership from REACH IT
Transparent SIEF communication including
clear cost sharing rules
Scope of LR dossier (CSR jointly prepared?)
SIEF agreement remains key!
Model agreement on Cefic web

12. 2013 registration: challenges
New SIEFs for 2013 will look different:
Expect fewer substances will be handled in consortia
Smaller companies will require registrations
less experienced?
less resources?
SIEF management challenges will become even more important
Substances are likely to be less data rich
Average cost per dossier could go up
Less experienced Lead Registrants to manage SIEFs

13. 2013 registration: challenges
New registrants:
Check if substance has been registered and contact LR/consortium
If not registered yet, consider forming SIEF leadership team
If needed, do careful selection of service provider
Do pre-SIEF steps as soon as possible. Don’t loose time with SIP and agreement
Use documents and tools on Cefic website
Use best practices and tools, don’t invent the wheel again!

14. Update of dossiers
When to update a dossier? What is „without undue delay‟ (Art 22) ?
Updates need time!
E.g. preparation of CSR may take more than one year!
Realistic time for companies
Case by case:
How foreseeable the change was
Difficulty of the update
Interim measures may be needed
Change of classification: if R50/53 companies should not wait for 2013

15. Dissemination
Dissemination of information from registration dossiers:
Some information already available on ECHA website (LR + individual)
Publication of Company names + details in the future
Disseminated information cannot be used for free
C&L inventory to be published by the end of the summer
 Check your dossiers to avoid publication of confidential information!

16. ES Development & Communication model
Legend
M/I = Manufacturer / Importer
DU = Downstream User
For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted.
M/I and DU partnership
via trade associations
Generic ES Development
Input of DU Associations
Development GES library
M/I and selected DU’s
Specific ES development
Input of selected customers
Use of Cefic ES template
Final Exposure Scenario (M/I)
M/I and/or M/I-DU Associations => determine strategy
Systematic assessment of safe uses (use of Tier1 tool)
Map uses and use conditions in supply chain
Initial ESs, ES titles and Use Descriptors
for safe uses only
M/I
Communicate Uses (ES titles, Use Descriptors)
to direct DU for further communication
in the supply chain DU
Use covered?
Yes DU
Wait for
final ES No or DU
Complete feedback form
Await decision M/I DU
Prepare CSA/CSR
Inform Agency
Communication to direct DU
Distribution
of e-SDS 16

17. Available tools on Cefic web
Newsletter: guidance on Use and ES development and Supply Chain Communication VCI Practical guide CSR eSDS
DUCC UseR template
SPERC s
Libraries use mappings
Preparation phase
Use communication holding letter
M/I and/or M/I-DU Associations => determine strategy
Systematic assessment of safe uses (use of Tier1 tool)
Map uses and use conditions in supply chain
Initial ESs, ES titles and Use Descriptors
Use and ES communication
IT tool requirements
for safe uses only DU
Use covered? DU
Wait for
final ES
Yes
Guidance on GES process + templates
M/I and DU partnership
via trade associations
Generic ES Development
Input of DU Associations
Development GES library
Guidance on SES process + templates
M/I and selected DU’s
Specific ES development
Input of selected customers
Use of Cefic ES template No or DU
Complete feedback form
Await decision M/I DU
Prepare CSA/CSR
Inform Agency
ES for preparations, DPD+
ESCom XML
ESCom phrases
Communication to direct DU
Distribution
of e-SDS
Final Exposure Scenario (M/I)‏

18. REACH legal remedies
REACH introduces a new authority, i.e. ECHA, as well as new competences of existing authorities, i.e. the Commission and national competent authorities.
Measures/decisions taken under REACH: potentially high adverse effect on industry (‘no data, no market’)
Need for legal certainty and internal administrative/judicial relief in timely manner and with minimum costs
Rights to challenge decisions: which legal remedies are available to companies adversely affected by these decisions by authorities?

19. Examples of REACH decisions
Registration
e.g. ECHA decision to reject a registration because it is incomplete
ECHA rejection of confidentiality claim
Dossier Evaluation
e.g. ECHA decision on testing proposal
Substance Evaluation
e.g. Member State CA decision on additional information to be generated
Authorisation
e.g. COM decision on authorisation application
Enforcement by Member States
e.g. decision to discontinue production due to REACH incompliance
Overall
e.g. ECHA accepts request for access to document 19

20. Legal remedies: overview
CoJ GC
ECHA
BoA / Ex. Dir.
Commission
National court
Preliminary ruling procedure
MS:
-Enforcement
- MSCA
GC: General Court
CoJ: Court of Justice

21. Thank You! lhe@cefic.be Cefic industry support:
Thank You!