News Details

ECHA to review completeness of registrations

Apr 10 2016

Certain REACH registration dossiers will be reopened for a new completeness check. The first set will be the charcoal dossiers, which were recently subject to a decision by the Board of Appeal. The Agency will look at the completeness of information and whether the joint submission obligation has been fulfilled.

A recent Board of Appeal decision (A-022-2013) further clarifies the obligation for all registrants of the same substance to belong to a joint submission and to the role of ECHA in implementing this. It also clarifies that ECHA can request further information through a completeness check and revoke a registration if any missing information is not given within a specific deadline set by the Agency.

ECHA will now perform ‘fresh’ completeness checks for the individually submitted charcoal dossiers and make sure that they become part of the existing joint submission.

In addition, it will prepare to retroactively check all dossiers which may be in breach of the ‘one substance, one registration’ principle of REACH. This means that approximately 700 individual registrations submitted under the REACH Regulation will be reopened. These represent 1.5% of all registrations.

At the same time, ECHA will recheck the completeness of the dossiers in its database with regard to the information requirements to verify that the information provided is meaningful.

Companies are advised to check the relevance of the information that they have submitted and make sure that the ‘one substance, one registration’ principle is followed. They are encouraged to proactively update their registrations as soon as possible if needed.

If a dossier is found to be incomplete after the retroactive completeness check, the registrant will be given a reasonable amount of time to update their dossier with the missing information. This may also require discussions on joining the joint submission for the same substance. If they provide the information within the deadline and fulfil the joint submission obligation, they can remain on the market without interruption. Otherwise, the registration will lose its validity and the company will lose market access.

ECHA’s Helpdesk will assist companies that want to join the joint submission or share data. National helpdesks can support registrants in their own language. If the negotiations for sharing data and joining a joint submission fail after every effort to reach an agreement has been made, registrants can file a data-sharing dispute to ECHA free-of-charge.

Background

ECHA has taken and planned a number of measures that strengthen the joint submission obligation and the completeness check. After the new Implementing Regulation on joint submission of data and data sharing entered into force, the Agency made technical changes to REACH-IT to make sure that new registrations are not submitted separately if a registration for the same substance already exists.

In addition, an enhanced automated completeness check will be introduced later this year with the launch of the new version of REACH-IT. The revised completeness check will include a manual verification of certain data elements that cannot be checked automatically. This will prevent registrants from misusing the system by adding irrelevant information to bypass an information requirement, for new submissions and for updates of an existing registration.