The Impact of the ECHA Board of Appeal

25-26 April 2017

Chemical Watch Expo 2017: REACH into the Future

Andrew Fasey

Technically Qualified Member,

ECHA Board of Appeal

Any opinions expressed in this presentation are the author’s own and do not necessarily reflect the views of the Board of Appeal.

2017

• 10 years of ECHA

• 100+ appeals received by the ECHA Board of Appeal (‘BoA’)

• BoA decisions and the appeals process have contributed significantly to the implementation and interpretation of REACH.

The Board of Appeal

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Introduction

• Established by REACH to decide on appeals against certain types of ECHA decisions:

– Registration

– Data sharing

– Dossier evaluation (compliance checks and examination of testing proposals)

– Substance evaluation

• Further competences under the Biocidal Products Regulation (BPR): data sharing, technical equivalence assessment, fees.

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Who Are We?

• An independent part of ECHA

• 3 members acting independently; no other duties inside ECHA

• Chair, Technically Qualified Member and Legally Qualified Member (1 scientist and 2 lawyers)

• Supported by a Registry (responsible to the Chair)

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Procedure

• The legal effects of the contested ECHA decision are suspended.

• Parties do not need to be represented by a lawyer.

• Please set out as clearly as possible why an ECHA decision is challenged, i.e. what the (legal) problem is.

• Please read the Rules of Procedure and the Practice Directions: https://www.echa.europa.eu/regulations/appeals

Notice of Appeal (3 months from ECHA

decision)

Intervention by interested parties

(3 weeks from announcement)

DefenceWritten exchanges

(if required)

Hearing(if required)

Final Decision

Announcement

(on website)

7

Registration (others than

SME)10% Data sharing

11%

Dossier evaluation

40%

SME (Reg)22%

Substance evaluation

17%

Appeals by type of contested decision

12

18

29

20

0

5

10

15

20

25

30

35

Num

ber

of

appeals

Outcome

• 100 cases so far (March 2017)

• 17 cases pending

• Numerous decisions with a ‘long shadow’

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• Final decisions (83 final decisions (6 BPR))

• Procedural decisions (interventions 50, confidentiality 19, stay 39, joinder 2)

• Procedural measures requesting parties’ input (e.g. observations, BoA questions)

• Exchange of communications

between the parties and BoA (~

4250, ~2400 from BoA)

• BoA output cannot however be

considered numerically

(Titanic or waters the Sahara…)

BoA ‘Output’

Legal decisions

Appeals process

Issues and Impact

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• Registration

• Data sharing

• Dossier evaluation

• Substance evaluation

• Nanoforms

Impact of BoA Decisions

The following includes simplifications. Please read the decisions for details (at this link).

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Registration (1)

‘One Substance, One Registration’ (OSOR)1

• REACH is based on OSOR principle.

• Individual registrations should not exist outside an existing joint submission.

• Completeness Check must be meaningful – not just whether there is some sort of text in each required field.

• Consequences:

– Separate individual registrations no longer accepted.

– New completeness check system – the presence of meaningful information is checked manually.

– Past registrations are now being reviewed to check if they are complete and comply with OSOR.

1 case A-022-2013

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Use of languages1

• ECHA communicated in English with a French registrant during the SME verification procedure.

• BoA found that registrants should receive communications in their own language unless they have specifically agreed to receive communications in English.

• No further appeals regarding language received since the BoA decision

1 case A-002-2013

Registration (2)

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Scope of risk assessment1

• A registered substance was CLP-classified as

dangerous to human health but not to the

environment.

• BoA found that if a substance is CLP-classified

registrants must perform a risk assessment for

other hazards as well.

1 case A-015-2014

Registration (3)

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Definition of ‘intermediate’1

• Diarsenic trioxide is used in zinc electrolysis to eliminate other metals from the solution by precipitating them out as copper concentrate.

• BoA found that whether a substance is used as an intermediate does not depend on the ‘main aim’ of the production process as a whole (e.g. zinc electrolysis).

• The assessment must look at the particular process the potential intermediate is used in to see if the definition of intermediate is met.

1 case A-010-2014

Registration (4)

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Data sharingData sharing

• So far 2 decisions under REACH, 1 under BPR

• BoA has found, for example, that:

– ‘every effort’ must be assessed based on the balance of efforts between the parties1

– costs must be shared in a fair, transparent and non-discriminatory way (e.g. no ‘early bird specials’)2

• Overall, data sharing decisions tend to be very facts-based and case-specific, depending on the evidence of ‘every effort’.

1 case A-005-20152 case A-017-2013

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Dossier Evaluation (DEv) (1)

Requirements for adaptation

Weight-of-evidence:

• ‘[T]he focus has to be meeting the information requirements for the respective endpoint, e.g. the key parameters need to be covered.’1

Read-across:

• Registrants should make a hypothesis (based on the requirements in Annex XI) and then show how the evidence supports it.

• BoA has clarified that the assessment of a read-across is a 3-part test:

1. demonstration of structural similarity,

2. properties are likely to be similar or follow a regular pattern, and

3. the similar properties are shown to be as a result of structural similarity.2

1 case A-014-2014, case A-003-20152 case A-006-2012

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Substance identity1

• One registration dossier can only cover one substance.

• The substance must be identified unambiguously.

• ECHA cannot decide for a registrant what substance it should register.

Animal welfare requirements

• Animal welfare rules apply to registrants and also to ECHA.

• Animal testing is the last resort (e.g. consider alternative methods, use tests requiring minimum number of animals).2

• When examining a testing proposal, in certain circumstances, ECHA should look into third-party registration dossiers.3

1 case A-008-2012 l 2 case A-005-2011 l 3 case A-001-2014

Dossier Evaluation (DEv) (2)

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Relationship between DEv and SEv1

• DEv should normally precede SEv.

• Registrants are not required to fulfil standard information requirements that do not apply to them (e.g. tonnage).

Follow-up to DEv decisions2

• If a registrant provides new and substantial information there should be a follow-up decision under Article 41.

• A statement of non-compliance (SONC), as addressed to the enforcement authorities, cannot be used to make

a decision instead.

1 case A-005-2014

2 case A-019-2013

Dossier Evaluation (DEv)(3)

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Substance Evaluation (SEv)(1)Proportionality

• Requests for further information must be proportionate.

• BoA applies the proportionality test of the EU courts adapting it to the regulatory sphere of REACH.

• SEv is intended to assess risks that may occur in reality and not only theoretically.1

General proportionality test:

A request for further information must:

1. Be appropriate and necessary to achieve the objectives pursued.

2. Be the least onerous (if several options).

3. The disadvantages caused must not be disproportionate to the aim pursued.

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(REACH) Proportionality:2

• Information requests must meet real information needs for the protection of human health and the environment.

• To show that an information request is necessary (part of the proportionality test), ECHA must establish:

1. that there is a potential risk,

2. that this risk needs to be clarified, and

3. that the requested information has a realistic possibility of leading to improved risk management measures.

1 cases A-005-2014, A-006-2014, A-009-2014, A-018-2014

Substance Evaluation (SEv)(2)

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‘Relevant conditions’ for persistence testing (Annex XIII)1

• Persistence is determined on the basis of the (intrinsic) potential of the substance to degrade in the environment, not on the basis of the actual behaviour of the substance in particular environmental conditions.

• ‘Relevant conditions’ does not mean the most frequent patterns of distribution of a substance in the environment.

• ‘Relevant conditions’ means the conditions that need to be applied to assess persistence

1 cases A-013-2014 and A-018-2014

Substance Evaluation (SEv)(3)

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Addressees of SEv Decisions1

• Registrants who submit a registration before the draft decision is sent to registrants for comments should be involved in the SEv procedure.

• Registrants who submit a registration after the draft decision was circulated for comments need not be involved.

• The costs of testing under SEv should be shared by all (present and future) registrants of a substance in a fair, transparent and non-discriminatory way.

1 case A-013-2014

Substance Evaluation (SEv)(4)

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Nanoforms (1)

• REACH makes no specific provision for information on nanoforms or nanomaterials.

• Five cases so far decided by the BoA (DEv cases; SEv appeals pending).

Definition of terms concerning nanoforms1

• By compliance check decisions ECHA requested substance identity information on the ‘forms’, ‘grades’ and ‘nanoforms’ covered by a registration.

• BoA found that terms such as ‘grades’ and ‘forms’ must be clearly defined in the interests of legal certainty.

1 cases A-008 to A-011-2015

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Substance identity of nanoforms1

• Registration for titanium dioxide – substance defined very broadly, including bulk form and all nanoforms.

• BoA found that detailed substance identity on crystal phases, nanoforms and surface treatment of nanoforms is not a standard information requirement.

• The registrant cannot have known what information to provide on nanoforms.

• A registrant is at liberty to give a broad definition of the substance it intends to register.

• A registrant must provide toxicological and ecotoxicological information covering the entirety of the registered substance.

1 case A-011-2014

Nanoforms (2)

Concluding Remarks

•25

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• BoA performs an independent review of ECHA decisions based on the legal pleas and arguments made and the evidence submitted.

• BoA mainly faces three types of situation:

– possible mistakes during ECHA’s administrative procedure,

– issues of interpretation of the REACH Regulation, and

– new information which comes to light.

• A difference in scientific opinion will not lead to annulment if there is no legal flaw. BoA does not repeat ECHA’s and the Member States’ scientific assessment.1

• BoA will verify if ECHA exercised its discretion correctly, e.g. if it took all relevant and available information into account.2

• BoA will verify if ECHA applied the REACH Regulation and wider EU legal rules correctly.3

1 e.g. case A-005-2011, case A-018-2014 l 2 e.g. case A-004-2015 l 3 e.g. case A-002-2013

Points to Note

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Conclusion

• BoA has produced a large body of robust, reasoned and (scientifically and legally) sound decisions.

• BoA decisions have impacted considerably the interpretation of REACH and its implementation by ECHA:

– Interpreting and clarifying provisions.

– Ensuring that registrants’ rights are respected during the administrative procedures.

– Ensuring that decisions are scientifically justified.

– Commission assesses BoA decisions when considering possible regulatory changes.

– Many more issues to come!

Thank you!

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Practicalities

• Information on BoA procedures, how to appeal and previous BoA decisions are available at https://www.echa.europa.eu/about-us/who-we-are/board-of-appeal

• Please read the Practice Directions to Parties before filing an appeal: https://www.echa.europa.eu/regulations/appeals