the appeals process under reach/bpr and the work of the .... andrew fasey ppt.pdfthe appeals process...

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