Dossier evaluation is carried out by ECHA and seeks to instil confidence in the compliance of registrations. By the end of 2013, the Agency had completed compliance checks on 1,130 of the 19,772 registration dossiers (5.7%) submitted for the 2010 deadline.
Earlier this month ECHA announced that 69% of the evaluated dossiers were found to be non-compliant. The most common shortcomings were deficiencies in the substance identification information, and insufficient justification where studies had been waived or where information was missing from the Chemical Safety Report. This article explains dossier evaluation and how we can help.
Dossier selection process
REACH requires ECHA to evaluate at least 5% of the dossiers submitted per tonnage band, but the Agency may examine any registration dossier to ensure that the contents are in compliance. In this first series of dossier evaluation, the Agency used both random selection and electronic concern-based screening methods to identify dossiers, either for overall or for targeted compliance checks.
In an overall compliance check, ECHA looks to verify that the information necessary for the safe use of the substance is part of the registration dossier. For the targeted checks, the focus is on specific parts of the dossier. ECHA may escalate a targeted compliance check to an overall check if significant non-compliance which requires further assessment is identified. However, registrants are not routinely informed that their dossier has been selected for evaluation.
Results of dossier evaluation
There are three possible outcomes: a decision requesting more information, a Quality Observation Letter (QObL) recommending improvements, or no registrant action is required. QObLs and decisions are delivered electronically to the registrant’s REACH-IT message box; unfortunately ‘no action’ results are not currently communicated to the registrant, positive feedback which could prove useful.
While a QObL is not a formal part of the legal text it is a pragmatic approach taken by ECHA to indicate where the registrant can improve the dossier. The QObL also suggests a deadline for the voluntary update, normally between six and twelve months. The relevant Member State Competent Authority is informed; follow-up action is monitored by ECHA and reported to the Member State.
In the case of missing information, a draft decision triggers a more formal process. The registrant can participate in a conference call with ECHA within 10 days, and must submit any comments it has on the draft decision within 30 days. A Member State review follows: where amendments to the draft decision are proposed there is a second 30-day commenting round for the registrant, followed by a 60-day period for the Member State Committee to seek agreement on the decision. If there is disagreement in that Member State Committee the European Commission will take the final decision; where there is unanimous agreement, or no proposed amendments, the final decision is taken by ECHA.
What can you do? 
If you have already registered and have received a final decision you must submit the required information to ECHA in an updated dossier by the deadline set. If the decision is still in draft, the commenting procedure may still be open to you – keep an eye on the dates and the information in your REACH-IT inbox! We recommend making use of the conference call with ECHA as it can resolve many issues raised by the draft decision. We also suggest that you keep a copy of any comments you submit via the web-form.
Where a lead registrant receives a draft decision relating to shared information they should inform the members of the joint submission as soon as possible. Joint registrants are obliged to contribute to the shared costs arising directly from evaluation, such as the commissioning of new studies, in order to maintain their registrations.
If shortcomings in the quality of your dossier were identified, but the required information was deemed to be complete, you should have received a QObL – prompting you to make a spontaneous update.
Even if you don’t have a registration obligation until 2018, the results of this first round of dossier evaluation should help you improve your dossier to avoid formal decisions or Quality Observation Letters in the future.
Help from REACHReady
Whether you have already registered or still have an obligation, we will be running regular – Maintaining your REACH Registrations – workshops during 2014 to help you understand dossier quality requirements and the implications of evaluation and CoRAP. The day is designed to help you understand what action you need to take to maintain your registration dossier and ensure that you can achieve requests made by the authorities.
Please visit the training page on our website at http://www.reachready.co.uk/services_training.php to find out more or speak to Jo Lloyd at the Chemicals Northwest REACH conference on 4th June.
