The Appeals Processunder REACH/BPRand the Work of theECHA Board of Appeal(BoA)
Andrew FaseyTechnically Qualified Member ofthe ECHA Board of Appeal
Brussels
4 June 2014
© European Chemicals Agency, 2012. All rights reserved.
Andrew Fasey
• Technically Qualified Member of the Board of
Appeal
• Summary CV (and other members):
http://echa.europa.eu/about-us/who-we-
are/board-of-appeal/the-board-of-appeal/the-list-
of-the-members-of-the-board-of-appeal-and-the-
alternate-additional-members
• N.B. A non-lawyers presentation regarding a
‘quasi-judicial’ system (‘administrative review’)
http://echa.europa.eu© European Chemicals Agency, 2011. All rights reserved.
Presentation
• The Appeals Process
• Story So Far
• Story To Come?
• Personal Reflections & Conclusions
© European Chemicals Agency, 2011. All rights reserved.
Key Messages
• The system for appeals, the BoA, Registration,
Evaluation etc are all part of the system for
REACH/BPR
• BoA is independent and impartial
• Appeals are good for the system•Clarify grey areas
•Opportunity to correct mistakes
• BoA decisions may impact how REACH & BPR areimplemented; BoA decisions are thereforepotentially important to their operation
The Appeals Process
• Pre-registration
• Data sharing
• Registration
MSs
• Evaluation• Dossier evaluation
• Testing proposals
• Compliance checks
• Substance evaluation
• Authorisation
• Restriction
• Classification & labelling
Closed; no decisions
ECHA arbitration; BoA authority
Rejections; BoA authority
BoA authority
Only decisions based on
unanimity between all MS
may be subject to appeal
Outside BoA authority
Scope – BoA Competence (REACH)
© European Chemicals Agency, 2011. All rights reserved.
The Appeals Process in a ’Nutshell’*
7
Appeal againstECHA Decision(on ”X” date)– N.B. within3 months of
decision
Early processes(admissibility
checking;rectification;confidentiality
request)(X+ 1 month)
Announcement(see BoA website)
ECHA Defence(X+ 2 months)
Possibleinterventionapplications
ProceduralMeasures
(e.g. observationssought,
detailed questionsasked,
expert advicerequired)
Oral Hearing(if required)
Deliberations &Final Decision
(publication onBoA website)
*over 40 separate steps identified (applies to REACH & BPR)
Possible Outcomes (include…)
Rejecting the appeal (‘Appeal Dismissed’)
Supporting the appeal partly or totally (‘AppealUpheld’): Annul (part of) the ECHA decision and Remit the case back to the competent body of ECHA
or
Replace the ECHA decision
N.B. BoA may exercise any power which lies withinthe competence of the Agency
• ALWAYS: Suspension of the contested decision’seffects while the appeal is pending
• BoA decisions are ECHA decisions; can bechallenged by Appellant at EU General Court
The Story So Far
Statistics (unofficial - May 2014) (1)
• 42 appeals lodged:•6 decided in favour of Appellant
•6 decided in favour of Agency
•4 rectified by Executive Director
•15 withdrawn
•11 on-going
• Types of Appeals:•7 registration rejections
•16 registration revocations
•3 data sharing
•13 dossier evaluation (DEv)/compliance check (CCH)
•2 administrative charge/SME
•1 substance evaluation (SEv)
106/6/2014
Statistics (2)
6/6/2014 11
Statistics (3)
6/6/2014 12
What Does This Tell Us?
• Do not read too much into this
• 50/50 chance?•No
•And even if it did?
• Every decision taken on its merits
• The Appeals system appears to work:•Clarification of some issues
•Some companies get what they want
•Some ECHA decisions and approaches are confirmed
• Someone will always be unhappy, ‘nature of thebeast’
• BoA is independent and impartial?
6/6/2014 13
Decisions to Date
• Winners and losers?
•Yes, but...
• More importantly, every decision tells us (allstakeholders) something about
• interpretation of REACH and
• its implementation
• Stakeholders will of course focus on thoseelements favourable to their interests
• Please consider our decisions carefully and in full
6/6/2014INTERNAL 14
BoA: Success & Failure?
• BoA cannot be judged on its popularity
• Someone will always be unhappy
• The test is the quality, soundness androbustness of our decisions
• Feedback is positive so far but limited
• We welcome fair and analytical feedbackon our decisions
6/6/2014INTERNAL 15
Time Taken to Process Appeals
• Procedural complexity arising from e.g:
•need for observations from the parties on
submissions
•need for BoA to pose specific questions to the
parties
•confidentiality requests
•applications to intervene
•change of language requests
•translations
•applications to extend deadlines, etc.
6/6/2014INTERNAL 16
Time Taken to Process Appeals
• Requests for oral hearings
• Time necessary to arrange hearings
• Scientific and legal complexity of evaluation (and
other) decisions
• Balance the rights of the parties with need for speed
• Personnel factors; a BoA of 3 is vulnerable to any
unavailability
6/6/2014INTERNAL 17
Time Taken to Process Appeals: Issues
• Too long?
• How to best balance the need for expediencyagainst the rights of the parties?
• Too cautious so far?
• Role of oral hearings?
• Importance of Notice of Appeal•See Practice Directions
•BoA has no access to REACH-IT
•Feedback on Practice Directions welcome
• Accuracy and completeness; sometimes taken awhile to get the full and complete picture
6/6/2014INTERNAL 18
Effect of BoA Decisions
• Not BoA’s job to audit changes
• Previous BoA decisions will inform future ones
• Changes appear to have been made as a result ofappeals and BoA decisions, for example:• Invoicing
•Evaluation decisions
•Guidance
•Anecdotal evidence
• You may be able to judge better than us
• Changes seen?
6/6/2014INTERNAL 19
The Story To Come?
The Story to Come?
• Substance Evaluation•Complex?
•Political?
•New process and procedure
• Biocides•Something of an unknown
•Data sharing?
•SME decisions?
•We are prepared as far as we can be
• Dossier Evaluation• Intermediates
•RAAF
• Revocation of registrations?6/6/2014 21
Personal Reflections &Conclusions
6/6/2014 23
Breaking New Ground
• Procedural, legal, scientific and technical issues
are often being considered for the first time
• Many of the BoA’s tasks have no analogues
elsewhere from which to draw experience
• As issues are addressed and resolved in turn the
BoA should get more efficient.
• Every case, so far, brings with it something new
or different
• Complex decisions; read in their entirety
24
Looking Ahead (1)
1) Balancing legal versus technical considerations inlight of the objectives of REACH
2) Explore ways of working effectively in ECHAwithout compromising impartiality andindependence
3) Managing new appeals derived
from the BPR with the similar
resources as available for
REACH appeals
4) Substance evaluation
6/6/2014
25
Looking Ahead (2)
5) Planning with an unpredictable workload
6) Maintaining high level of knowledge on legal and
scientific developments
7) Procedural efficiency
8) Better understanding by stakeholders of the
appeals process
6/6/2014
Conclusions
• Appeals process gives potential for effective access to
legal redress to support the implementation of
complex pieces of legislation with some grey areas…
• The appeals process is part of the REACH/BPR system
• A vital role in the effective functioning of REACH/BPR
• Relatively early days still for BoA, ECHA &
stakeholders
• High quality decisions to date – maintain!
• Impartial feedback welcome
• Numbers of appeals are outside BoA control
• We will be impartial and independent© European Chemicals Agency, 2011. All rights reserved.
See
http://echa.europa.eu/web/guest/about-us/who-we-are/board-of-appeal
Contact information:
http://echa.europa.eu/web/guest/about-us/who-we-are/board-of-appeal/contact
Thanks for Listening
© European Chemicals Agency, 2011. All rights reserved.
Annex 1: Appeal Cases 2009-2014 (1)
Case No. File Date Appellant Keywords Result/decision date
A-004-2014
OPEN
16/05/2014 Collective appeal representing several
Appellants
Substance evaluation
A-003-2014
OPEN
17/04/2014 Aluwerk Hettstedt GmbH SME status
A-002-2014
OPEN
17/04/2014 Richard Anton KG SME status
A-001-2014
OPEN
15/01/2014 CINIC CHEMICALS EUROPE SARL Testing proposal
Information in other dossiers
A-022-2013
OPEN
12/12/2013 REACheck Solutions GmbH Registration
Completeness check
Absence of data sharing
A-021-2013
OPEN
20/11/2013 Zementwerk Hatschek GmbH Revocation of registration
number
A-020-2013
OPEN
11/11/2013 Ullrich Biodiesel GmbH Rejection of registration
A-019-2013
OPEN
25/10/2013 Solutia Europe sprl/bvba Statement of compliance
A-018-2013
CLOSED
23/10/2013 BASF SE Compliance check Final Decision 05/12/2013
Rectified by ED
A-017-2013
OPEN
14/10/2013 Vanadium R.E.A.C.H. Forschungs-
und Entwicklungsverein
Data-sharing
Permission to refer
A-016-2013
OPEN
15/10/2013 Marchi Industriale SpA SME status
'Linked enterprises'
Annex 1: Appeal Cases 2009-2014 (2)
Case No. File Date Appellant Keywords Result/decision date
A-015-2013
A-014-2013
A-013-2013
A-012-2013
A-011-2013
CLOSED
09/09/2013 Confidential Revocation of registration
number
Final Decision 01/04/2014
Withdrawal by Appellant
A-010-2013
CLOSED
29/08/2013 Tecosol GmbH Revocation of registration
number
SME status
Final Decision 22/01/2014
Withdrawal by Appellant
A-009-2013
A-008-2013
A-007-2013
CLOSED
15/08/2013 Hermann Trollius GmbH Revocation of registration
number
SME status
Final Decision 08/01/2014
Withdrawal by Appellant
A-006-2013
CLOSED
15/08/2013 Hermann Trollius GmbH SME status
Language of communication
Final Decision 08/01/2014
Withdrawal by Appellant
A-005-2013
OPEN
07/08/2013 Vanadium R.E.A.C.H. Forschungs-
und Entwicklungsverein
Data sharing
Permission to refer
A-004-2013
CLOSED
01/08/2013 Cromochim SpA Revocation of registration
number
SME status
Final Decision 05/12/2013
Withdrawal by Appellant
A-003-2013
CLOSED
08/05/2013 Poudres Hermillon Sarl Revocation of registration
number
SME status
Final Decision 14/01/2014
Withdrawal by Appellant
A-002-2013
CLOSED
19/04/2013 Distillerie DE LA TOUR. Revocation of registration
number
SME status
Administrative charge
Final Decision 21/05/2014
Appeal upheld
Annex 1: Appeal Cases 2009-2014 (3)
Case No. File Date Appellant Keywords Result/decision date
A-001-2013
CLOSED
08/02/2013 Infineum UK Ltd Compliance check
Substance identity
Final Decision 09/04/2014
Appeal dismissed
A-008-2012
CLOSED
02/10/2012 PPH UTEX Sp. z o.o. Compliance check
Substance identity
Final Decision 03/04/2014
Appeal upheld. Appeal fee refund
A-007-2012
CLOSED
28/09/2012 Italcementi Fabbriche Riunite
Cemento S.p.A. Bergamo
Substance identity
UVCB
Compliance check
Final Decision 25/09/2013
Appeal upheld
A-006-2012
CLOSED
20/09/2012 Momentive Specialty Chemicals B.V. Compliance check
Use of read-across data
Final Decision 13/02/2014
Appeal dismissed
A-005-2012
CLOSED
01/08/2012 SEI EPC ITALIA SpA Administrative charge
SME status
Final Decision 27/02/2013
Appeal dismissed
A-004-2012
CLOSED
05/07/2012 Lanxess Deutschland GmbH Compliance check
Testing involving animals
Final Decision 10/10/2013
Appeal dismissed
A-003-2012
CLOSED
25/05/2012 THOR GmbH Compliance check
Updated dossier
Final Decision 01/08/2013
Appeal upheld
A-002-2012
CLOSED
30/04/2012 BASF SE Testing proposal
Updated dossier
Final Decision 21/06/2012
Rectified by ED
A-001-2012
CLOSED
24/01/2012 Dow Benelux B.V. Compliance check
Rejection of suggested read-
across
Final Decision 19/06/2012
Appeal dismissed
Annex 1: Appeal Cases 2009-2014 (4)
Case No. File Date Appellant Keywords Result/decision date
A-006-2011
CLOSED
03/08/2011 5N PV GmbH Administrative charge
SME status
Final Decision 30/11/2011
Withdrawal by Appellant
A-005-2011
CLOSED
21/06/2011 Honeywell Belgium N.V. Compliance check
Testing involving animals
Final Decision 29/04/2013
Appeal upheld
A-004-2011
CLOSED
11/04/2011 Kronochem GmbH Rejection of registration
Registration fee
Final Decision 07/10/2011
Appeal dismissed
A-003-2011
CLOSED
21/02/2011 BASF SE Data-sharing
Permission to refer
Final Decision 27/05/2011
Withdrawal by Appellant
A-002-2011
CLOSED
11/02/2011 Feralco (UK) Ltd Rejection of registration
Incomplete dossier
Final Decision 31/03/2011
Rectified by ED
A-001-2011
CLOSED
11/02/2011 Feralco Deutschland GmbH Rejection of registration
Incomplete dossier
Final Decision 31/03/2011
Rectified by ED
A-001-2010
CLOSED
21/12/2010 N.V. Elektriciteits –
Produktiemaatschappij
Zuid-Nederland EPZ
Rejection of registration
Registration fee
Final Decision 10/10/2011
Appeal upheld
A-001-2009
CLOSED
16/09/2009 Specialty Chemicals Coordination
Center sa/nv
Rejection of registration
Incomplete dossier
Final Decision 31/10/2009
Rectified by ED