Chemistry Reference
In-Depth Information
Although detailed criteria for hazard classification and labelling of substances have been
laid down under the CLP Regulation, particularly the specific criteria for CMR classification
requires expert judgement and consideration of many different factors (e.g., weight and
strength of evidence, mechanism or mode of action and its relevance to humans) included in
the available relevant experimental data and the additional reliable information.
Based on the experience from various national and international Expert Meetings, it seems
obvious that the interpretation of CMR data from experimental tests and epidemiological
studies by different Expert Meetings in ECHA and EFSA, i.e., the RAC and the Pesticide
Risk Assessment Peer Review (PRAPeR) meeting, does not necessarily lead to the same
opinion and proposal on classification, even though the same data have been evaluated. The
current RAC experience already indicates a significant number of borderline cases as being
particularly problematic. The workshop participants considered that the optimal solution
would be an involvement of the experts at an early stage. This requires coordination within
the rapporteur MS under the PPP process, as well as between EFSA and ECHA. Ideally, the
RAC opinion on harmonized classification and labelling should be the basis for the EFSA
conclusion on the cut-off criteria related to CMR properties; if this is not feasible in all cases,
the RAC opinion on the CMR classification should be at least available for the Commission
for their decision-making process on the approval. There is a special need for a common
interpretation of the criteria for the classification of substances for reproductive toxicity
(paternal and maternal toxicity, consideration of potency and setting of specific
concentration limits, developmental versus lactation effects, etc.).
When expert judgement and consideration of many different factors (e.g., weight and
strength of evidence, mechanism or mode of action and its relevance to humans) is needed,
common scientific understanding is essential under both regulations.
The workshop participants considered that the cooperation of the experts involved in both
processes is essential and encouraged ECHA and EFSA to consider this need when
establishing their processes. The ideal solution, particularly for borderline cases, would be to
organize a single detailed expert discussion that could feed into both processes. The
working procedures from RAC and EFSA already allow the participation of invited experts
and a set of consultations with the committees. ECHA and EFSA were requested to
coordinate the involvement of the relevant experts, ensuring that all relevant information is
available to the experts, and to establish mechanisms for facilitating the exchange of views
among the experts early in the process for identifying divergent interpretations, and
organize ad hoc expert discussion platforms in order to try to get consensus on the scientific
interpretation of the data.
The rapporteur MS under the PPP Regulation, acting as dossier submitter for the CLH
dossier, plays a key role in both processes. It is essential that when reporting the studies'
results, weight of evidence and its comparison with the CLP criteria, the MS experts
consider specifically the RAC needs and previous opinions on similar cases. Following the
RAC decision, the RAC Manual of Conclusions and Recommendations will be available to
the CAs in order to facilitate this process.
