News Details

ECHA plans increased scrutiny of REACH dossier ‘opt-outs’

Echa will manually check all new REACH registrations with ‘opt-outs’ from joint data submissions from 1 December, as part of efforts to increase scrutiny of such dossiers for completeness and compliance.

Under the regulation, companies choosing to opt out of data submitted jointly with co-registrants are required to provide “a proper justification” for the substance registration to be considered complete.

This is to see if companies provide a “justifiable reason” in cases where they want to submit their own data or when they have a dispute about access to data.

But a decision by Echa’s Board of Appeal (BoA) in March concerning a dispute over a joint registration for charcoal prompted Echa to start inspecting opt-out justifications manually, a spokesperson told Chemical Watch.

In the charcoal case, the BoA concluded that if a registrant decides to rely on a ‘complete opt-out’ and informs Echa and the lead registrant accordingly, the registrant cannot be prevented from making its separate submission part of the joint dossier and Echa must grant it access to the joint registration.

A complete opt-out requires “heightened scrutiny”, the BoA said, and Echa must “conduct a thorough completeness check of opt-out dossiers and prioritise them for a compliance check”.

‘Token’

Following the BoA recommendation, Echa changed its procedures on 17 May, providing a ‘token’ to access the joint submission to all registrants with full opt-outs and manually checking their justifications. Dossiers with full opt-outs are subject to the same level of completeness as the lead registrant dossier, Echa said.

From December however, the agency will manually check all new registrations with opt-out information, whether they are for a complete or partial opt-out. It estimates one percent of new registrations will have an opt-out.

The move follows a major revamp of REACH dossier compliance processes to improve data quality, announced by Echa in September. From January, it will send draft evaluation decisions to all registrants of a non-compliant dossier, not just the lead registrants.

Manual checks

To help registrants provide complete opt-out justifications for manual checks, Echa has developed templates in the latest version of Iuclid 6 software.

Registrants are advised to run the ‘validation assistant’ on their data before submitting their dossiers, the agency said.

If a justification is not complete, the registrant will fail the completeness check and will be given a deadline for providing the missing information. If it fails to do that, Echa added, the registration will be rejected.

Earlier results

Of 91,536 REACH registrations Echa has received so far, those with opt-outs have totalled 853, representing just less than one percent. Echa has manually checked 71 opt-outs since May.

In the majority of the cases – 61 so far – the opt-out justification has been that it is “disproportionately costly to submit the information jointly”. The second most common reason has been “disagreement on the selection of the information”, stated in 10 dossiers.

There have been no justifications based on “disclosure of commercially sensitive information likely to cause substantial commercial detriment”.