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Hebei Lansheng Biotech Co., Ltd. ShangHai Yuelian Biotech Co., Ltd.

ECHA to review completeness of registrationsqrcode

Apr. 11, 2016

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Apr. 11, 2016
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. 


 
Source: ECHA

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