ILMA Compoundings June 2018 - 16

INDUSTRY RUNDOWN

International Insight
EU REACH Registration Period Ends
By James Eggenschwiler
As this article goes to press, the deadline for registering
preregistered substances under the European Union's
REACH is ending. For many in the chemical (and related)
industries, this comes with a breath of relief as the final
work is completed. For others, which is no small group,
registration continues in earnest. Some of these lastminute registrations are for late-decision substances that
might have been pre-registered, while others involve substances that are being added because of recent market
interest. No matter the reason, it seems appropriate to
talk about this and other matters that will now spring up
as part of "post-deadline" life under EU REACH.
THE INQUIRY PROCESS
When preregistration ended in 2017, the process of
initiating a registration for a new substance changed. The
preregistration scheme offered a self-directed invitation for
prospective registrants to identify their intent to register on
a substance-by-substance basis, then proceed to registration
during the appropriate period for their intended tonnage
band. With the close of the preregistration period, a structural process change was added - "Inquiry."
The impact of this step is the requirement that the
registrant identify the specific substance identity profile
(SIP) relevant to the intended registration and inquire of
the European Chemicals Agency (ECHA) for the agency's
agreement that the substance qualifies for registration with
respect to the SIP. But, unlike the informality associated
with preregistration, Inquiry requires a dossier that thoroughly demonstrates the "sameness" of the substance to the
SIP. Only once convinced of this sameness will ECHA grant
permission to proceed to registration.
As many registrants are aware, these latter months of
registrations have included an increasing scrutiny by ECHA
with regard to the appropriateness of substances (registered
or undergoing registration) to their corresponding SIP.
While some of the situations occurred during the registration process, others were announced by ECHA with

JUNE 2018

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retroactive impact - triggering the need for substantial
amendment of the registration. An increasing number of
these events were precipitated by ECHA creating one or
more subcategories of SIPs, which sometimes involved
assignment of newly created EC (European Community)
numbers and chemical names that in some cases pose potential conflicts with those assigned by Chemical Abstracts
(CAs). The Inquiry process carries this same potential.
This enhanced scrutiny by ECHA concerning SIP selection and conformity also adds a greater front-end obligation
to verify chemical identity. During the preregistration program, registrants frequently submitted minimal analytical
confirmation of identity. The Inquiry process changes that
by requiring multiple methods that can be cross-referenced,
allowing more certain substance-to-SIP sameness evaluation
and the improved identification of small differences. The
additional data and scrutiny are likely to add some costs to
registrants, and they add time to the registration process.
Once submitted, ECHA might provide quick approval, or
the agency might engage the prospective registrant with
questions or identify an alternative SIP - with which the
registrant might not agree.
Once ECHA permits the Inquirer to proceed to registration, a Registration Dossier must then be prepared and
submitted. The combination of the Inquiry Dossier and the
Registration Dossier expands the work necessary beyond
that required by the combined preregistration/registration
process, but not necessarily by a significant degree -
particularly when ECHA accepts the submitted data as
confirming the sameness of the substance to the selected SIP.
There, the primary difference is the cost of obtaining three
or four versions of analytical data, plus a small additional
expense for the two dossiers.
ENFORCEMENT
A second aspect to anticipate in the post-deadline experience
is a much broader and imminent risk of enforcement by
Member State Competent Authorities. Without minimizing other risks, the topics of Extended Safety Data Sheets
(eSDS), record keeping and registrant supply chain integrity
are among those likely to be raised early on.

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ILMA Compoundings June 2018

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