Chemistry Reference
In-Depth Information
CLP report, and therefore, the same document can cover both assessments. For other hazard
classes, the DAR should also be the basis for the CLH proposal, and therefore, it seems
logical to integrate this information as well.
The workshop participants considered that for a better common scientific understanding, it
is essential to implement the same structure in the reporting and formatting of the DAR and
CLH reports. In fact, the proposed solution is to incorporate the weight of evidence and
comparison with the CLP criteria to be included in the CLH report as one of the
chapters/documents/elements of the new DAR structure. Additional considerations are
needed for facilitating the description of the key studies results in a way that could cover the
needs for the DAR and for the CLH report. The structure of the CLH report is defined in the
legislation (reference to Chemical Safety Assessment and Report under REACH) and
described further in the CLP guidance, which allows the required flexibility to
accommodate the dossier's specific needs. It should be kept in mind that the CLH process
also applies to biocides and industrial chemicals, that some substances have several uses
and that the CLH structure must be similar for all types of chemicals. However, as the
structure and level of detail of the CLH report will be periodically updated based on RAC
experience when processing the CLH dossiers, the specific input gained during the
discussions of the new DAR format can be used in the periodic revisions of the CLH report
format. In addition, specific guidance for preparing the CLH report as the hazard
identification chapter of the DAR for PPP active substances is required.
As an outcome of the ECHA workshop “On the way to CLH”, RAC, with the support of the
ECHA secretariat, is currently revising the structure of its opinions and particularly of the
background document presenting the detailed justification of the RAC opinion. The
background document is based on the original CLH report. On the other hand, the PPP
experts are currently discussing possible improvements to the structure of the DAR and
dossier. It was considered that ECHA and EFSA should be in close contact during these
developments in order to ensure mutual feedback and coordination between both
processes.
To complement the proposal mentioned above, it was also recommended that when
drafting the DAR annexes related to the robust study summaries and the assessment
summaries which constitute the basis for the hazard identification and risk assessment, both
intentions should be kept in mind and addressed, allowing the use of the text related to the
hazard identification as the starting point for the CLH report and DAR hazard identification
chapter.
It was also mentioned that currently some DARs do not contain a proper presentation of the
evidence related to the hazard identification and its comparison with the CLP classification
criteria. It was highlighted that this is an essential part of the CLH report and should be
specifically considered. The current RAC experience might offer further suggestions for
reporting the weight of evidence and the comparison of data with the criteria, and some
examples were presented during the workshop.
