Chemistry Reference
In-Depth Information
active substances in PPP should be submitted to the European Chemicals Agency (ECHA).
The proposals follow an agreed procedure with an initial accordance check which is
followed by a public consultation process and subsequent consideration of the proposal by
the Committee for Risk Assessment (RAC). The legislation requires the RAC to adopt an
opinion on the proposal.
The comments received during public consultation may have an impact on the subsequent
steps of the process. In a dialogue between the dossier submitter, RAC rapporteurs and
ECHA secretariat the best way to proceed will be decided in cases where substantial
comments and/or new information are received during the public consultation. In certain
cases this may lead to the withdrawal of the dossier and the submission of a revised version
by the Member State or to another public consultation on a re-submitted dossier based on
the RAC opinion. In other cases the RAC may indicate that the submitted information is
insufficient and that it does not allow an opinion to be issued on the classification and
labelling.
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The legislation requires the RAC to adopt an opinion on the proposal within 18 months. The
opinion is forwarded by ECHA to the Commission for a final decision on the harmonized
classification and labelling of the substance to be taken via comitology.
While the underlying database supporting a specific substance's assessment presented in
the DAR and CLH proposal can be assumed to be broadly similar, the nature (i.e., the level
of detail reported/presentation of study results) may differ as a result of the differing
guidance and objectives of the two processes. The judgments made in relation to a particular
piece of information may differ when considered under the hazard-based CLH process
compared with the risk-based authorization process. Therefore, the DAR for approval and
the CLH dossier for classification and labelling decisions may require different preparation
and presentation of the underlying data, and not all data will be equally relevant for both
decision-making procedures. To meet the regulatory objectives efficiently, both procedures
require dossier formats specifically tailored to the different regulatory processes. The PPP
Regulation requires a specific dossier structure and the CADDY electronic format system is
used, whereas under the CLP Regulation there is a legal requirement for use of IUCLID
(IUCLID 5 being the current version) which is a quite different electronic submission system
using structured files.
A close linkage between these two processes is therefore highly desirable, especially for new
active substances without existing, legally binding CLH in Annex VI of the CLP Regulation,
or for active substances already classified which have to be re-evaluated in the light of new
data that may necessitate revision of the existing classification and labelling.
The classification and labelling of active substances for human health endpoints is not only a
principal criterion for the approval of active substances, safeners and synergists, but also the
main basis for decisions on other regulatory categories and criteria established in the PPP
Regulation namely:
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ECHA conclusions CLH Workshop 16 February 2011, ECHA
