CO2_2016 - page 60

Chimica Oggi - Chemistry Today
- vol. 34(2) March/April 2016
in anticipation of the 31 May 2018 deadline are due
to become available at the end of the quarter two
2016 (16). A very large number of registrations - up to
70,000, three times more than for either of the 2010
and 2013 deadlines - are anticipated leading up to the
2018 deadline (17). IUCLID 6 and REACH-IT updates are
centred on streamlining processes for both registrants
and ECHA, an intention is to alleviate the burden on
SMEs. Complaints about previous versions of IUCLID have
highlighted the lengthy and complicated installation. It is
intended that installation of IUCLID 6 will be simpler than
its predecessors. A new feature of IUCLID 6 will be the
Substance Identity Profile (SIP), which has been used in
the past (initially developed by Cefic) but it is soon to be
a compulsory feature. The purpose of the SIP is to define
what the substance is, and the scope of what can be
regarded as the same substance. This may include, for
example, an impurity profile of well-defined substances
and concentration ranges of UVCBs. Compulsory SIPs
should allow registrants (and ECHA) to more easily decide
or argue substance sameness owing to the defined scope
of substance covered by the registration.
Another effect the new software will induce is
strengthening of the OSOR principle as it will no longer
be possible to submit the same type of registration (e.g.
full or intermediate) separately to one that is already in
existence for the same substance. Therefore obtaining
a ‘free-ride’ by accessing data without permission to
do so and submitting a separate registration will be
prevented in that opting-out automatically qualifies
a dossier for evaluation, during which any data used
without permission should become apparent. Another
development in IUCLID 6 will be fewer free text fields and
more categorisation of data entry, this will inevitably aid
the autonomy of the dossier evaluation process.
Like many aspects of REACH, the List of Restrictions (Annex
XVII) is a progressive feature that is regularly amended
through the addition of Annexes, either updating existing
restrictions or adding new, stand-alone entries (18).
Delineating the growth of Annex XVII, the list has lengthened
to include 105 named substances (as at 07/01/2016)
or categories of substances from the original 84 since
restrictions entered into force on 1 June 2009, some of said
entries cover numerous substances. Further to the additional
entries, eight new amendments have been made to existing
entries. Many restrictions define a maximum concentration
of a substance or class of substances tolerated in mixtures
and articles. Toluene, for example, has a restriction in place
for adhesives and spray paints that are intended to be
supplied to the general public. The restriction states toluene
shall not be placed on the market in concentrations equal
to or greater than 0.1% by weight in the mentioned products
(19). Analytical testing is integral for the identification of
restrictions that are in breach.
The Rapid Alert System for non-food dangerous products
(RAPEX) acts as an information exchange system between
dependent data requirements concerning toxicological
and ecotoxicological tests is more flexible to allow for
the phasing out of and immediate obligation to avoid,
vertebrate animal testing - where possible. Such methods
may include in-vitro testing, quantitative or qualitative
structure-activity relationships (QSAR), the grouping of
substances and read-across (13).
At the time of writing, the new Implementing Regulation
on Joint Submission of Data and Data-Sharing in
accordance with REACH has just been published in the
Official Journal (6 January 2016) (14), which is directed
at reinforcing the transparency, non-discriminatory, and
fairness principles of joint data submission and data sharing
in the legal text of REACH. This Implementing Act builds
on the guidelines the Director’s Contact Group (DCG)
published, providing practical advice for registrants.
These DCG guidelines stressed the mentioned principles’
importance in SIEFs leading up to the 2018 deadline
(and will now need updating), particularly as many more
registrations by SMEs are foreseen (15). An intention is the
Implementing Act will be particularly relevant for parties
joining registrations that have already been completed.
A primary objective is reinforcement of OSOR, which is
effected by transforming the principle into a provision and
requiring joint registrations, where there is more than one
registrant for a substance. Although the option of fully or
partially opting out of joint submission (and remaining under
one registration) is still available, the intention is for more
information to be shared. This will be facilitated by the
other provisions: transparency and non-discriminatory, that
the Regulation will address.
Letters of Access (LoA) to data legally need to include full
itemisation of costs and data along with justifications including
proof of costs and reason for inclusion of the data with respect
to the specific requirements of the joining registrant’s obligations
under REACH – data that is not required under the Regulation
shall not be charged for. Additionally, the LoA is required to
include a reimbursement mechanism (i.e. upon the joining
of additional registrants purchasing data) and a cost-sharing
mechanism in the event a Substance Evaluation requires the
generation of more data. For existing LoA, reimbursement
mechanism and itemisation rights can be waived if all registrants
unanimously agree to do so, however new registrants may
request the above provisions to be applied to themselves; this
does not mean the provisions must be applied to the existing
registrants’ LoA. ECHA have the power to create one joint
registration from legacy registrations where the OSOR is in breach.
It is also possible for the OSOR provision to be implemented
retroactively, forcing previous separate registrations for the
same substance into one registration (excluding those for
full registrations and intermediate registrations for the same
substance, which are permitted to remain separate). Registrants
may now be under increased obligations and a proactive
approach is required to be in full compliance.
Developments in the software tools used to compile
and submit dossiers affecting the registration process
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