Denehurst Chemical Safety Ltd
EU and UK REACH Registration
The first and perhaps most obvious point is not to leave
everything to the last minute and to be ready to have a Registration in place
prior to the need to register.
It is possible to rush through simple Joint Submissions (where
someone has already successfully submitted a data set and is the 'Lead
registrant') and an Inquiry plus purchase of a Letter of Access can be done in
4 - 6 weeks depending on the time needed to obtain the analytical evidence (See
However, if the Inquiry indicates you are on your own, it can take
substantially longer to prepare a full dossier as Lead Registrant. Some data sets can be deferred by 'proposals'
or using 'study planned' options, but before the first tonne of a substance is manufactured
or imported in the UK or EU, you will need a reasonable understanding of
potential hazards to at least prepare a suitable SDS and correctly label.
If the substance is developmental or trials are needed, a PPORD is
possible (see PPORD page). This allows
quick options for import or manufacturer, but there are limitations and the
lifecycle needs to be known, making supply to wider professional or consumer
Either way, do not delay if import or manufacturer is known and even
if making an Inquiry or PPORD, there is certainly no future obligation to move
on to a full Registration.
The most contentious issue is the payment for access. REACH legal
text states that cost sharing and compensation for costs of data generated
previously should be ‘fair and equitable’. What is fair for one organisation is
very likely not going to be fair for another. There needs to be flexibility in
cost sharing and lessons from 2013 demonstrate that disputes can cost more
in legal fees and management time than the letter of access costs.
If buying a ‘letter of access’, the key item for EU REACH is the ‘token’.
The electronic token to allow access to joint submissions is provided by ECHA
and is obtained by the Lead Registrant.
When working as part of a Joint Registration, it is important
to ensure that a balance is struck between constructive cooperation and
caution. Those joining in an existing consortium or existing Joint Submission
may find established rules, systems and relationships. However, any new member
has the same rights as existing members with respect to REACH and data sharing
and can also attempt to make changes to existing systems; the commercial part
of SIEFs, Joint Submissions and consortia are subject to the same rules as any
other industry group.
However, it is recommended to try to fit into existing frameworks where
possible, remembering time and effort (and perhaps legal costs) making changes
to agreements diverts resources away from the more pressing need to register
and assess safety of substances.
Note that data access will be free 12 years after it is submitted to ECHA, but
there may still be some cost sharing issues for access to additional data,
collective exposure scenarios etc. Any SIEF or Joint Submission agreement
should take into account future activities and refunds may be applicable as new
income from later registrants is disbursed among earlier registration – check
these details in any agreement.
If not already registered, the data endpoints that need to be
addressed are linked to respective tonnage bands, as described in Annex VII,
VIII, IX and XI of EU REACH and is mirrored in UK REACH.
Note that Annex XI tels us that we must consider alternatives to
new testing and Article 25 of EU REACH reminds us that new animal testing is
only as a last resort.
UK REACH is even stronger on avoidance of animal testing and in the
UK it is illegal to perform animal tests on substances where data is already
available, even if data owners are refusing to share.
It is possible to cover many endpoints by using read-across or
modelling or justify not testing by requesting a waiver.
In a surprisingly large number of cases, the amount of testing required can be
quite low thanks to alternatives to testing. Guidance provided by ECHA
describes the ‘intelligent’ testing strategy to reduce the burden of testing
and to specifically avoid animal experiments.
Denehurst can provide support on waivers and testing if needed.
Advice on methods to avoid new animal work is provided without