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Chimica Oggi - Chemistry Today
- vol. 34(2) March/April 2016
analysis. The outcome can be threefold: no action needed,
to be handled under other legislation or to be handled
under REACH/CLP. In the latter case again three possibilities
exist: the substance comes onto the Registry of Intentions
for harmonised classification and labelling, identification
as substance of very high concern or restriction. All these
processes have their own timing but in all cases a public
consultation takes place, allowing all stakeholders to
contribute to the process. In order to be considered by
the authorities, all information has to be delivered in the
dedicated public consultations.
ECHA introduced on its website the PACT (Public Activities
Coordination Tool) (7), which shows the substances for
which activities are ongoing in the field of regulatory risk
management, giving a signal to industry which dossiers
should be updated first in order to avoid decisions being
made on information that is not correct and that is much
more difficult to introduce in a later stage.
This PACT list is updated monthly and shows the activity,
the scope and the outcome. Knowing that on average
300 substances enter this screening exercise yearly, it gives
an indication of the additional workload. For
these substances it is clear as well that the
information should not come from the
manufacturer alone, but requires more
and improved communication in the
supply chain to understand better
the uses and the potential exposure
and wide dispersive use. All this
information will play a role a certain
moment in time, be it the initial
selection or the follow-ups under
specific regulatory risk management
measures. Given the potential
consequences for industry – both
manufacturers and downstream
users – it is extremely important that
industry understands the significance
and the rules of the game to
contribute in an efficient manner.
An iceberg is rarely far away from other icebergs. In
December 2015, the Commission launched the action
plan for the circular economy (8). It is clear that REACH will
play an important role in this. Although a much broader
concept looking at resource and raw materials efficiency,
it is clear that recycling of materials containing substances
of very high concern or legacy substances covered by
a restriction currently in place, will play a role in the
discussion. On top of this, we will be confronted again with
probably the weakest point in the REACH implementation
so far - the communication of the presence of substances
of very high concern within the supply chain. The exercise
will already be difficult for articles originally manufactured
in the European Union. For non-EU manufactured products
it will be even more difficult and will require intensified
communication towards the rest of the world on the
European restrictions and authorisations currently in
place. The limited number of notifications of imported
articles containing more than 0,1% substances of very
high concern is more than indicative to understand the
problem that recyclers will be confronted with. Targeted
communication campaigns will be necessary in order to
avoid systematic testing by recyclers.
that “double” registrations will be possible, without
joining the SIEF. Awaiting the new IT versions, the Agency
installed already manual checks, to guarantee a correct
implementation of the Commission’s decision.
IUCLID 6 will be more stringent on substance identity and
the analytical data to identify the substance. The possibility
is given to report better on constituents in multi-constituent
substances and in UVCB substances. And last but not
least the volume per use reporting is improved. With these
changes it is possible that dossiers that passed in 2010 or
2013 will not pass an update anymore and will require
additional clean-up and efforts to make them pass.
Authorisation and restriction is another subaqueous part
which is less known at the highest level in many companies,
unless by those already involved in these processes. In
the early years of REACH, the first substances of very high
concern were identified, in 2008, the heritage of the past
was handled. Substances that were already for some time
on the radar screen of authorities were introduced into
REACH just based on fitting the criteria
of article 57 in the legislation.
Since then a long path has been
followed with the Commission
communication on the Roadmap
of Substances of Very High
Concern in February 2013 (4) and
the implementation plan on the
ECHA website in December 2013
(5). Currently we see that an initial
IT screening is done by ECHA
followed by a manual screening
by Member States’ Competent
Authorities and ECHA. This IT
screening has been fine-tuned
over the years and is closely linked
to an evolution in ECHA, aiming for
more efficiency.
In the early years of ECHA, confronted
with a race against time to prepare the IT
tools, REACH-IT and IUCLID, to allow the pre-registration
and the first registrations, the development took place
in “silos”. Every directorate had to develop its ways of
working, in combination with the development of rules of
procedures for the different Committees. Now this is fully
crystallising out into a holistic approach. In fact registration
data, evaluation and regulatory risk management:
authorisation, restriction, harmonised classification and
labelling or other European wide measures are combined.
This clearly augments the efficiency of the Agency in
finding the substances that matter. The full concept is
clearly explained on the ECHA website on substances of
potential concern (6).
An IT screening followed by a manual screening will reveal
to authorities whether there is a need for more information
or not. If yes, further information can be obtained by
compliance check or substance evaluation, or an informal
assessment can take place by one of the expert groups. If
the information has been generated or when no additional
information is needed, the central question becomes is
there a concern? If not, then no action is needed, if yes,
the substance will undergo a risk management option
1...,53,54,55,56,57,58,59,60,61,62 64,65,66,67,68
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