Intermediates Compliance Warning


ECHA raised serious concerns recently about the quality and compliance of 574 companies' registration dossiers, all of which relate to intermediate substances. The companies have been notified via REACH-IT and given 3 months to either rectify their dossiers or face regulatory sanctions.

REACH Article 3(15) defines intermediates as chemicals that are "manufactured for and consumed in or used for chemical processing in order to be transformed into another substance." If the on-site or transported isolated intermediate is "manufactured and used under strictly controlled conditions," REACH allows registrants to submit a dossier with no chemical safety report and reduced information on substance properties. This saves time, fees, and simplifies the registration procedure.

To be able to submit a reduced dossier, substances must both meet the definition of an intermediate and be appropriately contained during their life cycle. ECHA's criticism has centred on registrants failing to meet these criteria, as described in REACH legislation and ECHA's Guidance on Intermediates. Of the 5,500 registrants of intermediates, ECHA found 2,388 dossiers that failed in this regard, representing 760 substances. Several common reasons emerged for this...

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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