Annexes to this letter:
Technical aspects for the proposal.
UN GHS first, then CLP?
Understanding the need for action, we believe that the EU needs to do much more to secure that the
proposed changes for new hazard classes will be agreed at the UN level (UN GHS). While it is possible
for the EU to propose an update to UN GHS in line with the updated CLP, there is so far no guarantee
that the EU proposal will be accepted by all parties (a previous attempt by the EU on PBT failed). A
temporary divergence could then become a long-term deviation.
This is in contradiction with the ‘G’
and the ‘H’ of GHS. A stand-alone CLP proposal will disrupt global value chains and contradicts the
Strategic Approach to International Chemicals Management (SAICM) negotiations which calls for all
countries to implement the global UN GHS classification. If the Commission is serious in its
commitment to use the CSS to promote global standards, more needs to be done. Please be aware
that EU REACH already regulates all substances that would be covered by new hazard classes under
CLP (e.g. 57 substances have already been put on REACH Candidate List either for their endocrine
disrupting properties, PBT/vPvB or high persistence and mobility properties).
Assessment criteria
For substances with Endocrine Disrupting properties, we call for
criteria that fully reflect the WHO
(UN World Health Organisation) definition, both for category 1 and for category 2 sub-divisions,
taking into consideration the fact that the adverse effect should be a consequence of an endocrine
mode of action, with corresponding evidence available.
As to the classification of mixtures, we ask for pragmatic concentration limits to be introduced,
consistent with the classification of adverse effects (0.1% or higher, depending on the adverse effect
which, in principle, should already be classified under CLP).
We support the PBT/vPvB criteria consistent with existing REACH requirements. However, we need a
cautious approach for PMTs/vPvM. Several technical and policy discussions over the last two years
showed the complexity of defining mobility criteria under CLP. Unlike bioaccumulation (B) assessment
which includes a robust and definitive approach with enough discriminatory power, the same does
not apply for mobility (M) assessment. Because of that, it should be
allowed to use additional data
when assessing mobility.
Transition periods
The introduction of new hazard classes
will require a reassessment of all existing data on all
substances, as a basis to re-classify substances (as applicable). Once substances are reclassified and
relabelled, mixtures will have to be reclassified and relabelled in turn as well. The information on
substances will be delivered to downstream users (mixture formulators) over a certain period. It is
therefore essential to
introduce two successive transition periods for new hazard classes, in line
with the approach taken initially for CLP and later under the 2nd ATP to CLP when aquatic toxicity
criteria were introduced: at least
two years for substances and, as a second step,
at least three years
for mixtures.