Upgrading a NONS dossier to a full REACH (Annex IX) registration dossier

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Client

A global construction product manufacturer.

Background

Previously registered under NONS (67/548/EEC), this construction material was automatically REACH registered at 10-100 tpa. However, the client wished to expand manufacturing to other EU sites and therefore asked bibra to prepare a fully-compliant Annex IX REACH registration dossier. The ‘spontaneous update’ of this REACH dossier would allow members (co-registrants) to manufacture at different sites across the EU.

Project goals

To support the client with all aspects of this REACH registration.

Approach

Tasks include project management, up-to-date literature searches, Data-gap-analyses (DGA), provision of data waivers, drafting IUCLID Endpoint Study Records (ESRs) and associated Endpoint Summaries, QSAR analyses to be included as part of a weight-of-evidence (WoE) argument, TK assessments, read-across justification documents, compilation of the Chemical Safety Report (CSR), development of DNELs and PNECs, the PBT/vPvB assessment and Classification and Labelling (C&L) proposals and drafting Guidance on Safe Use (GoSU).

Bibra has also provided the client with a temporary IUCLID instance, enabling the client and bibra scientists to work concurrently (via the web) on this REACH registration. This ensures the most efficient use of our time, therefore keeping resources and associated costs to a minimum and speeding up the registration process.