1. ดูแลด้วยความรับผิดชอบ
RESPONSIBLE CARE
ดูแลด้วยความรับผิดชอบ
GPS – REACH Workshop
REACH – Evaluation, Authorization and Restrictions
Athens – Greece
4 October 2011
Annamaria Frascaria
Dow Belgium

2. Evaluation
3 independent evaluation processes with 3 different objectives:
Compliance check: is the information submitted in compliance with legal requirements?
At least 5% of the dossiers must go through this evaluation.
Several criteria to prioritise: one of this being separate registration (opt-out)!
Examination of testing proposals: to avoid unnecessary animal testing; permission to undertake certain tests by submission of a testing proposal. Testing proposals which include animal tests undergo public consultation (art 40.2). All testing proposals are examined.
Substance evaluation: to clarify whether the use of a substance may cause harm to human health or the environment. Substances selected by ECHA in cooperation with Member States. Prioritised substances are evaluated. Process will start in 2012.

3. MSCAs Evaluation Dossier evaluation Substance evaluation*
Evaluation of Testing Proposals
Compliance Check
Examine any information on a substance
The evaluation of registration information ensures that registrants meet the REACH information requirements and generate new information when necessary, while keeping animal testing to a minimum.
Draft decisions on further information
(Final decisions with potential involvement of MSC)
* Process in preparatory phase, evaluation to be started in 2012
MSCA = Member State Competent Authority; MSC = Member State Committee 3 3

4. Evaluation: compliance check
Are information requirements fulfilled in line with regulation?
Are adaptations of standard infomation requirements and related justifications in compliance with the rules (Annex VII to X and general rules in Annex XI)?
ECHA to issue draft decision within 12 months of the start of the compliance check
Draft decision may require registrants to submit further information
Clock start ticking for registrant only when draft decision becomes final and sent to registrant
Other possible outcomes:
Quality Observation Letters (suggestions to improve quality of dossier and submit a ‘spontaneous update’) – clock starts ticking at receipt
No further action required.

5. Evaluation: examination of testing proposals
Proposed test adequate and justified?
Unnecessary testing on animals avoided?
Possible outcomes:
Testing accepted as proposed with deadline for submission
Testing accepted but with changed testing conditions
Request to carry out additional testing
Testing rejected
If several registrants or downstream users of the same substance propose same test, agreement must be reached within 90 days on who performs the test otherwise ECHA decides.
Timing:
Non phase-in substances draft decision by ECHA within 180 days
Phase-in substances registered by Dec : Dec 1, 2012

6. EVALUATION : follow up actions
Registrant comment on draft decisions
After receiving a draft decision
Registrant may comment and provide dossier update within 30 days
ECHA may adapt draft decision
After Member State Competent Authority provides a proposal for amendment
Registrant may comment within 30 days on a proposal for amendments (and update dossier if appropriate)
During Member State Committee procedure
Registrant who received draft decision may participate in MSC initial discussion on draft decision
ECHA and Member States may adapt draft decision

7. Dossier Evaluation – challenge of next years
About 1000 Compliance Checks on HPV’s to meet the 5 % target
Selection is concern driven & random
580 dossiers with Testing Proposals received
Covering 1500 hazard endpoints
All of these to be examined by Dec 2012
ECHA carries out scientific evaluation & submits draft Decisions requesting further data from registrants 7

8. Dossier Evaluation – Prioritisation
Compliance check criteria set by REACH
opt-out of a dossier submitted jointly
records of 1-10 tons / year includes only physical-chemical data
substances included in the Community Rolling Action Plan (CORAP)
Compliance check selection based on concerns
according to the risk of non-compliance
depending on the impact of non-compliance on safe use
Compliance check random selection
provides an overview of the quality of records

9. Conclusion from evaluation reports
Tips for successful registration from
Identity of registered substance shall be clearly described
Adaptation to standard testing regime must meet conditions of Annex XI or column 2 of Annexes VII – X of REACH  sufficient justification should be provided
Robust study summaries should contain sufficient level  allow independent assessment
Classification and labelling should be in line with hazards identified or harmonized classification and labelling
Testing proposal shall be submitted for tests of Annex IX and X before undertaking it  potential enforcement actions
Make consistent and well justified Chemical Safety Reports

10. Scope, aim and outcome of dossier evaluation
Evaluation type
ECHA questions
ECHA examination conclusions
Numbers and timelines
Testing Proposal Examination
(TPE)
Proposed test adequate and justified?
Unnecessary animal testing avoided?
Article 40(3) draft decision:
Accept testing
Reject testing
Change test conditions
Request additional testing
All testing proposals
non phase-in: draft decision in 6 months
phase-in submitted by 1 Dec 2010: draft decision by 1 Dec 2012
Compliance Check (CCH)
Information requirements adequately fulfilled?
Adaptations adequately justified?
Article 41(3) draft decision:
Request further information
Other outcomes:
Quality Observation Letter – indicates elements to be improved
No further action
Select at least 5% of total received for each tonnage band
draft decision within 12 months of start CCH 10

11. Substance evaluation will start
ECHA is developing the first list of substances
MSCAs can identify candidates & ECHA add others from other REACH processes based on a priority setting
CoRAP ‘rolling’ 3-year list – proposal by end of 2011 – adoption Feb 2012
Member States to inform ECHA about capacity for evaluation
Substance evaluation is to clarify risk (i.e. to get extra hazard &/or exposure data) with a view to using regulatory instruments 11

12. Authorization: process and considerations
Candidate List expected to grow significantly during the next two years (statement from Commission of addition of 106 substances)
Communication and notification requirements exist when a substance is listed on the Candidate List
Art. 33
Art. 7
The first set of Substances (6) effectively subject to Authorisation was included already in Annex XIV: 12

13. Authorization: process – preparing an application
Pre-Notify intent
Allows better planning by ECHA
Indicates which substances and for which uses
Pre-submission meeting
To focus on technical requirements of dossier (not on the content of the application); ask clarification on how to prepare and submit an application
Prepare application
Who?
Manufacturer, Importer, DU or joint (no obligation to apply jointly).
Can DU apply individually, enough information?
For what?
One or more uses, one or more Les, group of substances (Annex XI, Sec 1.5)
Costs?
Fee part of application, calculated by use(s), substances, size of company 13

14. Elements of an application
Main elements – Art 62 of REACH
Substance identity
Applicants
Uses applied for
CSR (if not submitted as part of registration)
Analysis of Alternatives
Substitution Plan (if suitable alternatives available)
Additionally (application may include)
Socio-economic analysis
Justification for not considering certain risks to human health and the environment
Fee is part of the application!
Legally only SEA required for socioeconomic route but may be advisable for other routes as well.
Suitable : available at reasonable cost and in reasonable quantities.

15. Content : some reflections
USE
Use descriptor system as a basis
More case specific details may be required
Contact DU?
CSR/ES
CSR of registration dossier
For DU potential issues to get access
Letter of Access may be required?
AoA
Risks, technical and economical feasibility to be considered
CBI & Comp law
What if only little information on (eco)toxicity of alternatives? SP
Ultimate goal is substitution
Realistic timing!
Key to determine time of validity of authorisation
SEA
Mandatory only for SE route but sometimes advisable for other routes as well
Little expertise available
Resources potential issue!
Important to have a good communication with DU to know his use(s) and to crosscheck on analysis of alternatives and the substitution plan
Analysis of alternatives : consider all options to pre-empty comments of third parties later in the process
High level of detail required! Start preparing early!
Highly regulated sectors : substitution is a long process

16. Possible application packages
Adequate control
&
No suitable
alternative
Adequate control
&
Suitable
alternative
Socio-ec benefits
> risks
(No adequate control &
No suitable alternative)
Threshold substances
Threshold substances
Threshold &
Non-threshold substances
CSR
Analysis of Alternatives
SEA
Substance & Applicant info
CSR
Analysis of Alternatives
Substitution Plan
SEA
Substance & Applicant info
CSR
Analysis of Alternatives
SEA
Substance & Applicant info

17. Resources: ECHA website

18. Resources: CEFIC website

19. After submission
Draft opinions RAC + SEAC
Final opinions RAC + SEAC
Publication in OJ
Decision by Commission
Applicant may comment
Start of obligations to communicate in the supply chain
What if DU authorisation is granted and producers authorisation not? No access to material?
Open questions: What if authorisation is refused? What to do with stocks already in the supply chain?

20. Authorization: consider that...
It is a lengthy, costly and labour intensive process with a large degree of uncertainty
Alternatives available for all applications?
Can you (and your customers) switch before the application date? (concerted action  need to consider competition law issues)
If not, do you want to continue this business in Europe? Cost vs benefit?
Communicate with your customers / suppliers
‘Living process’: authorisation granted for a limited time  re-submission
Risk that time validity of authorisation is shorter than timing in your substitution plans : in other words once authorisation is granted you may already have to start preparing the re-submission before actually having had the possibilities to evaluate the alternatives.

21. Conclusions Applying for authorisation is new to everyone
Data sharing not a legal obligation
Large risk of infringement of anti-trust law
High level of detail required in the application dossier
Early start recommended!
Make use of opportunities to communicate with ECHA

22. Restrictions
Safety net in REACH, manage risks not sufficiently addressed by other processes
All uses of a restricted substance not specifically restricted under Annex XVII are allowed under REACH (except if also listed on Annex XIV or subject to other legislation) within the limits of the Exposure Scenarios of manufacturers’/importers’ registration.
Decision for the restriction based on the two following cumulative elements:
a) an unacceptable risk to human health or environment, and
b) the risk needs to be addressed at a community wide basis level.
List of all restricted substances (specifying restricted uses) in Annex XVII of REACH

23. Restrictions Not a new concept!
Existing restrictions in the Marketing and Use Directive (76/769/EEC) carried over to REACH.
Directive 76/769/EEC was repealed on 1 June 2009.
Pay attention to Article 67(3) referring to more severe national restrictions, to be maintained until 1 June 2013, provided they have been notified.
Broad scope:
Any substance on its own, in a preparation or in an article may be subject, where justified, to restrictions.
Can apply to manufacturing, placing on the market (including importing) and/or all uses or to specific uses.
No tonnage threshold for a substance subject to restriction provisions.

24. Exemptions: Restrictions in scientific research and development,
for on-site isolated and non-isolated intermediates,
in PPORD, if this as well as the exempted quantities are specified in the Annex XVII,
for the use of substances in cosmetic products, with regard to risks to human health within the scope of the Cosmetics Directive

25. Restrictions- process and timeline

26. Restrictions- stay up-to-date!

27. THANK YOU VERY MUCH
FOR
YOUR ATTENTION!!