Cahier Scientifique 02 | 2011 (PDF) - Revue Technique ...

CAHIER SCIENTIFIQUE | REVUE TECHNIQUE LUXEMBOURGEOISE 2 | 2011
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with not much experience gained so far. Substances with
PBT or vPvB properties came more and more into focus during
the last years and criteria had to be defined. A process
that is partly still on-going. A proposal of a PBT or vPvB substance
as SVHC requires quite a lot of data and analysis and
always bears some risk that the proposal is not accepted. In
contrast, criteria for CMR properties are well defined and
substances fulfilling these criteria are already regulated for
decades. Rejection of a SVHC identification proposal for a
substance with a harmonised classification as CMR is very
unlikely. As mentioned before, the Candidate List is currently
the only regulatory way for authorities to identify a
substance as PBT or vPvB. Therefore, an increase of such
substances in the Candidate List can be expected for the
future including proposal where the motivation lies outside
REACH, e.g. in the new regulation of biocidal products.
With the current round of proposals, for the first time, a
substance was proposed based on endocrine disrupting
properties according Art. 57(f) (equivalent level of concern).
Criteria and methods for the assessment of endocrine
disrupting properties are intensively under discussion
and urgently under development and implementation (e.g.
extended one-generation reproductive toxicity study); not
only in the scope of REACH but also under other EU and
international regulations like for plant protection products.
The number of endocrine disrupting SVHC identified according
Art. 57(f) will most likely increase in future, in particular
once clear guidance on criteria and more scientific
and legal certainty for this identification will be available.
Around half of the SVHC have been recommended so far
for Annex XIV, i.e. becoming most likely subject to authorisation.
Here, CMR is also the predominant hazard property
of the recommended SVHC. The underrepresentation of
PBT/vPvB properties might be surprising as the Candidate
List is a tool and the main REACH mechanism to identify
PBT/vPvB substances, and Art. 58(3) defines PBT or vPvB
properties as priority for Annex XIV inclusion. First of all, this
may be seen as a consequence of the fact that the share of
PBT or vPvB substances in the Candidate List is rather small.
However, it should also be kept in mind that not too much
weight was given to the inherent properties in the risk ranking
process. This was done to avoid a hazard driven ranking
which could result in a prioritisation of PBT/vPvB substances
with low volumes and low releases and consequently low
risk. Thus, ECHA’s prioritisation approach reflects a riskbased
and not a hazard-driven approach.
Regulatory effectiveness and other considerations strongly
impact the outcome of prioritisation. This is most evident
for the 3 rd Recommendation where most substances were
prioritised under consideration of regulatory effectiveness,
and on the other hand, a series of PBT/vPvB substances
with high priority were not prioritised at that stage due
to considerations of regulatory effectiveness (risk reduction
strategy for PAH containing substances). The generic
scoring approach developed by ECHA does aim to more
transparency when ranking by risk. In the end, however,
the fate of a SVHC with respect to its Annex XIV inclusion is
difficult to predict without considering regulatory effectiveness.
On one hand, using the grouping approach, SVHC
with very low or low risk, with other words negligible exposure
or even lacking any use in EU, are recommended
for Annex XIV inclusion in order to avoid replacement of
other (high priority) SVHC of this group. Here, possible replacement
candidates are identified as SVHC and recommended
for Annex XIV in parallel or subsequently to the
high priority SVHC of the same group. At the other hand,
substances with high scores are not recommended due to
consideration of regulatory effectiveness. The generic scoring
approach reflects the REACH regulation in that priority
should “normally” be given to substances with PBT/vPvB
properties, wide-dispersive use and/or high volumes (Art.
58(3)). Thus, any considerations taken additionally into account
somehow reduce the predictability regarding the fate
of SVHC. Nevertheless, these regulatory considerations are
necessary and transparency in this judgement process is
pursued by ECHA via the public consultation of the draft
recommendation, published documents and MSC involvement
in decision making.
As mentioned above, the authorisation title is a quite new
regime. In addition to the main function to select substances
for authorisation obligation, there are other functions for
which the impact in practice is not known, yet. The identi-