Chemistry Reference
In-Depth Information
CMR hazard classes) concerning active substances in PPP quickly and efficiently and, as far
as possible, within the same timeline as that of the risk assessment procedure. Based on a
discussion paper prepared in February 2010 by ECHA on the cooperation between ECHA
and EFSA in the assessment of hazard properties of active substances in PPP under the CLP
and PPP Regulations, and a discussion at the meeting in June 2010 of EFSA's Network with
the Member State authorities in the area of pesticides, the Pesticide Steering Committee,
the
following scope was proposed as a starting point for the discussion in breakout group 1:
Streamlining and integration of the review procedures for active substances in PPP for
approval under the PPP Regulation and for classification and labelling under the CLP
Regulation.
The main goals of breakout group 1 were
1.
to inform the discussion on
how the two processes could most efficiently be aligned
between Rapporteur Member States (RMS), EFSA and ECHA;
2.
to consider the
anticipated workloads
stemming from the PPP active substance
programmes in relation to the capacity of the
EFSA/ECHA process
with a view to
ensuring that appropriate planning, management and prioritization procedures can be
established;
3.
to
raise awareness in Member States
(i.e., Competent Authorities (CAs) responsible for
the evaluation of active substances in PPP and for their classification and labelling,
respectively) and to communicate the importance of the issue and possible solutions;
4.
to provide feedback on
a draft working document on processes
“Cooperation between
CAs in Member States, ECHA and EFSA in the assessment of CMR properties of active
substances in PPP under Regulations (EC) No 1107/2009 and 1272/2008” (based on the
ECHA discussion paper from February 2011 regarding the preparation of the CLH
report and the cooperation of the dossier submitter with RAC).
3.1. How the two processes could be aligned
Based on discussions held during the workshop, the following practical solutions were
identified for new or existing active substances without existing legal C&L or for substances
with legal C&L which have to be re-evaluated in consideration of new data for C&L:
The Rapporteur Member State for the active substance should identify as early as
possible in the evaluation process for approval or renewal of approval (preferably at the
end of the completeness check) the need for an initiation of the CLH procedure under
the CLP Regulation and should make a notification of intention for the CLH procedure
to ECHA at an early stage. The notifier should be encouraged to indicate the
classification and labelling in the PPP dossier.
Specific issues, such as substance ID, for both approval under the PPP Regulation and
inclusion under Annex VI of the CLP Regulation, should be solved as soon as possible
by direct contact between the RMS and EFSA/ECHA.
The RMS for the active substance could prepare in parallel:
