Maintaining your REACH Registrations: Dossier Quality, Evaluation and CoRAP

On-going actions required to ensure your REACH dossier is correctly updated

Welcome and Introduction

Overview of registrants’ duties beyond initial dossier submission

Registration: the dossier and its contents, supporting documentation, updates
Evaluation: dossier, substance, testing proposals; the evaluation processes

Evaluation

Dossier: Quality Observation Letters, ECHA decisions, requests for additional information
Substance: impact of CoRAP, engaging with the evaluating MSCA, possible outcomes
Testing proposals: who is responsible for generating the new data, justification for alternative strategies, draft and final decisions, making challenges

Issues with substance identity

Sameness
Appropriate and relevant testing
Impact of impurities and changes
Quality of analytical reports

Lunch

New, and reassessment of, existing data

Data overview from the Lead Registrant; confirming quality and impact
Impact of DNEL / PNEC, making changes, insufficient PBT/vPvB assessment
Read-across
Agreement with classification and labelling
CSR: updating, quality, consistency with IUCLID dossier, additional uses

Administration

Engaging with authorities, change in Only Representative status, using REACH-IT, preparing and submitting dossier updates, proactively staying up-todate, ECHA’s Evaluation Progress Reports, the new compliance check strategy

Close

Who should attend?

Every manufacturer, importer and Only Representative has REACH duties beyond the initial submission of a registration dossier. Maintaining your registration is an essential part of compliance, particularly as new information emerges about your substance or its uses. In addition, if your substance is on the Community Rolling Action Plan (CoRAP) for evaluation, has been selected for dossier evaluation, or contained testing proposals it is imperative that you understand how to manage the implications.

✓ Have you identified your ongoing duties?

✓ Do you know how evaluation affects you?

✓ How do you deal with new information?

This workshop is aimed at regulatory managers working in the chemical manufacturing and importing sectors. It will be of particular interest to those who have already submitted REACH registration dossiers.

Why attend?

All registrants are strongly encouraged to keep their dossiers in order, by submitting spontaneous updates to improve content and quality. ECHA also promotes the improvement of dossier compliance through its Compliance Check strategy. In addition, new information on your substances may have emerged since you submitted your IUCLID dossier, affecting your identified uses and Chemical Safety Report (CSR).

This workshop will help you:

✓ appreciate how to ensure your dossier is robust

✓ manage newly identified information or customer uses

✓ recognise how CoRAP and evaluation may affect you

✓ understand how to make updates and stay up-to-date.

The practical implications of the UK withdrawal from the EU will be discussed throughout the day. We use an informal style so there will be plenty of opportunity to quiz our experts throughout the day.

Next Steps

To find out more about REACHReady’s bespoke training, and to discuss your specific requirements, please call us on 0207 901 1444 or e-mail events@reachready.co.uk