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

CAHIER SCIENTIFIQUE | REVUE TECHNIQUE LUXEMBOURGEOISE 2 | 2011
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_identified, on a case-by-case basis, from scientific evidence
as causing probable serious effects to human health or
the environment of an equivalent level of concern as
those above.
Regarding these latter “serious effects to human health
or the environment” (Art. 57(f)), no legally binding criteria
have been established yet and need to be developed.
However, the REACH text mentions PBT and vPvB
substances not fulfilling the criteria in Annex XIII REACH
and substances having endocrine disrupting properties as
examples. Guidance on the scientific criteria to assess a
substance for having endocrine disrupting properties according
to Art. 57(f) is not available yet but under development
(Federal Institute for Occupational Health and
Safety 2010; Federal Institute for Risk Assessment 2011;
Danish EPA 2011). The scientific WHO/IPCS 4 definition of
endocrine disrupters is widely accepted: “An ED alters
function(s) of the endocrine system and consequently
causes adverse effects in an intact organism, or its progeny,
or (sub)populations”. This definition had also been
included in the REACH Guidance for the preparation of
an Annex XV dossier on the identification of substances
of very high concern (ECHA 2007). In general, MS may
on a case-by-case basis apply different criteria for the
identification of SVHC according to Art 57(f), e.g. specific
human health properties like sensitisation or classification
for specific organ toxicity after repeated exposure (Federal
Institute for Risk Assessment 2010).
A general definition of SVHCs is not provided but the criteria
for identification basically indicate that irreversibility, the
absence of an effect threshold, and temporal and spatial
decoupling of release and incidence of effects are key characteristics.
In this regard, endocrine disruption may lead to
a variety of harmful effects and even exposure to very low
doses may lead to critical imbalances in the level of endogenous
hormones during development of the organism that
may result in irreversible effects later on in life. The REACH
guidance states that the consequences that may result from
endocrine disruption can be both serious and irreversible
and so endocrine disruptive effects should be considered as
being of equivalent concern.
The absence of a threshold means that a limit value, below
which adverse effects on human health or the environment
can be excluded, like the DNEL (derived no effect level) or
PNEC (predicted no effect concentration) cannot be established.
Most carcinogens and mutagenic substances lack an
effect threshold and CMR substances can induce seriously
adverse and normally irreversible effects. They show long
latency periods between low-level exposures and some
health effects. A quantitative comparison with the estimated
exposure level, e.g. the ratio predicted environmental
concentration (PEC) to PNEC, for the purpose of a risk assessment
is not possible under such circumstances. This is
also true for PBT and vPvB substances where the persistence
and bioaccumulation with time do not allow the estimation
of a concentration below which no effects on human
health or the environment may be expected. The release in
the environment and the appearance of effects are temporally
and spatially not linked. Once released in the environment,
exposure cannot be controlled anymore due to
their persistence (Merenyi et al. 2011). Prioritisation of PBT
and vPvB substances on the Candidate List for Annex XIV
reflects the fact that based on the persistent and bioaccumulating
behaviour, no establishment of a PNEC or DNEL is
possible and therefore risk to human health or the environment
cannot be adequately controlled. This discrimination
between a threshold and a non-threshold mode of action
is important for risk-based prioritisation of SVHC for Annex
XIV and also for the authorisation of a SVHC once included
in Annex XIV as detailed in the following section.
Once a substance entered the Candidate List, certain obligations
arise from the inclusion mainly related to the communication
along the supply chain (Art. 33) including the
update of safety data sheets by suppliers, distribution of
safe use instructions for articles (i.e. a product such as a
computer, a piece of furniture, etc.) with >0.1% SVHC by
suppliers, and notification to the ECHA of articles with >
0.1% SVHC and > 1 t/a (Art. 7(2)). The identification as
SVHC is currently also the only way for authorities to legally
identify a substance as PBT or vPvB. However, the main
function of the Candidate List under REACH is to provide
substances that can be selected to become subject to authorisation.