Substance & Dossier

Evaluations

Indiana de Seze

IBC legal REACH COnference, Brussels, 23 June 2015

Contents

Purpose of evaluation

Selection criteria

Process

Actors

Lessons

2

Purpose

Testing proposals (TPE): : avoid unnecessary generation of tests on

vertebrate animals

Dossier compliance check (CCH): compliance with information

requirements of REACH, i.e. annexes to REACH

Substance evaluation (SEV): address a concern

3

Selection criteria

1. TPE: ECHA has a duty to check 100% dossiers within certain

timeframe: nearly all TP approved

2. CCH: ECHA has a duty to check 5% dossiers annually. In 2014, 61%

found non compliant. Targeted CCH:

• Substance identity issues

• Areas of concern: endpoints considered highly relevant to risk management

and chemical safety.

• Substances listed in the Community rolling action plan (CoRAP)

3. SEV: CoRAP listing on initial grounds of concern

ECHA publishes a yearly report with statistics and overview of

evaluation activities

Shifts of ECHA activity peaks:

– 2014 focused on TPE of 2013 registrations

– 2013 focused on first substance evaluation decisions published in 2014

– 2015 focused on defence in challenged SEV decisions

4

Process (1)

Common to all three evaluation procedures, with singularities for SEV

Source: ECHA website/Steptoe & Jonson LLP 5

6

Process (2)

45 days

7

Process (3)

A-001-2014 CINIC Chemicals Europe (BoA, 10/06/2015)

Consultation does not need to be on the exact test (EOGRTS) as long

as end point is right (two-generation)

Agency’s process for considering information in other registrant’s dossier

was held too rigid: date of draft TPE decision sent to MSCAs was the

cut-off date after which a dossier update would not be taken into

consideration

8

Process (4)

30 days

30 days

30 days

Observer

60

days

9

Process (5)

Registrant updates dossier

according to decision within

deadline

Registrant doesn’t update

dossier according to decision

and within deadline

ECHA issues SoNC

ECHA notifies registrant

Process completed

Role of

BoA? Enforcement

by Member

State(s)

10

Challenging the final decision

Board of Appeal and its competence

Suspensive effect of appeal

Rectification by Executive Director

Science and legal/procedural aspects are reviewed

Registrants can challenge BoA decision before General Court of the EU

Decisions TPE CCH SEV

Rendered

(Recent interesting

cases)

Older interesting

cases

3

(A-001-2014;

A-007-2014)

18

(A-006-2015 UI;

A-011-2014

TDIC)

A-004-2012

A-005-2011

0

Pending (known)

(Cases to watch)

0 5 9

A-015-2015 (SAS)

A-009-2014 (Alb)

A-006-2014 (IFF) 11

Actors

Who can be an appellant?

– Non addressees?

– Separate or joint?

Who can be an intervener?

– ENGOs

– Co-registrants

– MS

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How to safeguard your rights under evaluation?

Engage early with competent authorities in charge

Request records of exchanges and meetings

Request evaluation report

Update your dossier as soon as concern is known

Inform ECHA of upcoming dossier updates

Engage with co-registrants

CCH and SEV are separate processes but with consequences on one

another

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Thank you