Countdown to phase-in registration deadline … only six months to go!

November 24th, 2017

Manufacturers and importers should already be well aware of the fast-approaching deadline under REACH to register phase-in substances supplied in EU within the tonnage ranges 1-100 t per year by 31 May 2018, now just six months away. ECHA continues to develop and progress the tools and guidance available to REACH registrants, and new updates to IUCLID and CHESAR are now available. In particular, registrants taking the role of Lead Registrant in a joint submission would be well-advised to get ready to make their submissions in good time well before the deadline. This is particularly important in view of the ‘manual checks’ now being made by ECHA after a dossier is submitted, because a registration might not be accepted/completed until after further work is done and a re-submission made, to correct specific issues.

In the 10-100 t per year tonnage bracket, in addition to more data requirements, a CSR complete with detailed use and exposure assessment must be included in the registration dossier. This often requires consultation with co-registrants in the joint submission or customers, and can take time, particularly if the exposure assessment reveals that new Risk Management Measures are necessary. Registrants should by now have relevant information assembled and assessments in progress.

Prospective registrants are in some cases finding unexpectedly that there appears to be no existing registration for them to join as a follow-on registrant.  For example, this may happen when a new substance identity has been selected for use in a phase-in registration, in order to comply with ECHA guidance. In this situation it might appear that no registration has been made for a particular CAS or chemical identity that had previously been in common usage within the industry and may have been pre-registered. Search tools on ECHA’s website or in REACH-IT can help in this situation, and also ECHA’s enquiry service. In some cases registrations are managed through an industry consortium and ChemicalWatch offers a useful searchable list of REACH Consortia which can be a useful contact point.

Contract research organisations may have high demand on lab capacity, so discovering a ‘data gap’ close to the registration deadline could present an issue. ECHA’s guidance documents provide information about how to use predictive (e.g. QSAR or read-across) methods appropriately to fulfil data requirements. If using read-across from data owned by another company, it is important to put in place the necessary rights of access in discussion with the data owner or publisher. ECHA, CEFIC and other groups offer guidance and advice to assist pre-registrants to prepare for the deadline.

“The clock is ticking!”

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