Chemistry Reference
In-Depth Information
parallel processing of dossiers and which has been presented to Member States' competent
authorities.
4. Scientific and practical issues in the interpretation of studies and
reporting
Based on the criteria for the approval of active substances in PPP under the PPP Regulation
and the classification criteria regarding "Health hazards" under the CLP Regulation, the
following scope was proposed as a starting point for the discussion in breakout group 2:
scientific and practical issues in the assessment and interpretation of carcinogenicity,
mutagenicity and reproductive toxicity (CMR) studies, and requirements concerning
adequate preparation of dossiers (with respect to scientific content and formatting
according to the PPP Regulation and the CLP Regulation).
The main goals of breakout group 2 were:
1.
to
recommend solutions regarding formatting problems
with documents/dossiers
(e.g., how to facilitate compilation of CLH dossiers by the Rapporteur Member Stat,
how to integrate additional relevant documents from the pesticide process in these
dossiers, possibility of profits for CLH dossiers based on experience with previous
pesticide assessments);
2.
to discuss possibilities and
practicalities for submission of IUCLID 5 dossiers
in
addition to the dossiers for active substances under the PPP Regulation to facilitate the
preparation of dossiers for classification and labelling, as well as possible assistance for
approval;
3.
to
improve harmonized interpretation and reporting
of carcinogenicity, mutagenicity
and reproductive toxicity studies, discuss scientific principles of interpretation of
relevant studies. This shall contribute to avoiding conflicting interpretations and
different reporting of the same studies under the two processes.
4.1. Recommended solutions regarding formatting problems
The workshop participants recognized that although in the current DARs the purpose of the
substance evaluation is mainly to derive a basis for risk assessment (i.e., deriving
NOAELs/LOAELs and setting reference doses) this issue requires reconsideration due to the
new cut-off criteria settled in the PPP Regulation. The main intention of the CLH report is
hazard identification (i.e., assessment of the nature and severity of effects and the dose
response relationship to be compared with a defined set of criteria) including the specific
comparison of the available evidence with the CLP classification criteria.
Currently the structure of the DAR is under discussion and will be revised in the next few
years. A proposal for this revision was presented the break out group session.
For CMR substances, the DAR under the PPP Regulation would require a similar
assessment (hazard identification and comparison with the criteria) to that required for the
