Chemistry Reference
In-Depth Information
the DAR for EFSA for developing conclusions on possible fulfilment of the
approval criteria to be sent to the Commission
a proposal for harmonized classification and labelling for ECHA in accordance
with the CLP Regulation, as well as ECHA's guidance and format requirements for
developing a RAC opinion on classification and labelling
Ideally, the CLH report should be ready and submitted one month before the DAR
in order to allow time for the accordance check.
EFSA and ECHA should aim to conduct their public consultations at the same time
(EFSA for 60 days and ECHA for 45 days) to streamline the processes.
The time schedule in EFSA for adopting the conclusions on fulfilment of the approval
criteria is 120-150 days from the end of the commenting process, after which the
Commission has 6 months for preparing its review report and a draft regulation.
ECHA and EFSA will follow closely and potentially participate in the deliberations
during each other's review process. To avoid duplication of work, leading actors of both
processes will keep each other informed on the progress, identify critical issues as early
as possible and, if necessary, organize joint discussions in dedicated ad hoc groups
assembling capable experts for the issue under consideration from both processes.
RAC will start the consideration for agreement on the opinion as early as possible
Although RAC formally has 18 months for providing their opinion, the scheduled
procedure should allow the adoption of the opinion on adequate classification well
before expiry of the 6 month period in which the Commission develops its review
report and draft regulation after receiving EFSA's conclusion on whether the active
substance is expected to fulfil the approval criteria in the PPP Regulation.
The above mentioned parallel, and partly joint, processing of the proposals - conclusion on
expected fulfilment of the approval criteria by EFSA and on harmonized classification and
labelling by ECHA - would assure that the RAC's opinion on fulfilment of the classification
criteria (in particular for the CMR hazard classes) is delivered in time for the Commission to
develop its review report and draft regulation (i.e., within 6 months of receiving EFSA's
conclusions).
3.2. Workloads from the PPP programmes in relation to the capacity of the ECHA
In order to ensure that any agreed aligned processes can deliver conclusions on harmonized
C&L in an efficient and timely manner there was also a need to consider:
the anticipated workloads stemming from the PPP active substance process and
the capacity of the ECHA process to deliver conclusions taking into account available
resources and other demands on those resources.
Proposals for harmonized classification of PPP active substances may be submitted from the
following EFSA work programmes:
new active substances: it is possible that a considerable number of new active
substance/ safener and synergist applications will be submitted each year;
