Chemistry Reference
In-Depth Information
system is developed, the alternative should be to request the companies to include in their
submission an IUCLID 5 dossier for the studies relevant for classification and labelling.
4.3. Improve harmonized interpretation and reporting
The ECHA and EFSA processes represent the scientific assessments of the available
information in order to establish solid scientifically based conclusions for supporting the
decision-making process by the European Commission. ECHA and EFSA have specific
mandates, defined in their respective regulations. The workshop discussions and the
conclusions presented below should be understood and implemented taking into account
the different and independent roles and mandates of ECHA and EFSA, and the European
Commission.
The conclusion that the CMR-related
cut-off criteria
for active substances to be included in
PPP are met is based on a conclusive scientific assessment on the substance with regard to
the fulfilment of the approval criteria proposed by EFSA
2
and on the opinion of ECHA. In
order to support such a conclusion early in the evaluation process under the PPP
Regulation, common interpretation of the classification criteria for CMR properties in both
contexts (EFSA and ECHA) would be an important prerequisite. Both agencies should
cooperate to achieve a common interpretation of the underlying studies, particularly in
terms of reliability and relevance, and to explain any divergence and deviation if needed.
Classification as CMR category 1A or 1B will exclude an active substance from approval and
subsequent use in PPPs (unless exposure is negligible in case of CR), whereas classification
as CMR category 2 allows approval. The credibility of the scientific assessments of CMR
properties could suffer if conclusions under the PPP Regulation and under the CLP
Regulation were inconsistent, e.g.:
if a CLP decision adopted by the Commission on the basis of a RAC opinion (CMR
category 1A or 1B) made it necessary to revoke an active substance approval, which
was adopted at an earlier time point or
if active substance approvals were declined earlier in the process on the grounds of an
RMS or EFSA proposal for CMR category 1A or 1B classification, but later a CLP
decision adopted by the Commission on the basis of the RAC opinion resulted in CMR
category 2 classification which would have allowed the approval of the active
substance.
Similarly, divergences in the answer to the question of whether a substance should be
classified as CMR category 2 or should not be classified would also have consequences at PPP
authorization level and even at active substance approval level (relevance of groundwater
metabolites). Harmonized application of the CLP criteria for CMR classification within the EU
Member States and by different Expert Meetings is therefore essential.
2
Article 12(2) of Regulation 1107/2009 lays down that "…the Authority shall adopt a conclusion in the light of current
scientific and technical knowledge using guidance documents available at the time of application on whether the
active substance can be expected to meet the approval criteria provided for in Article 4… "
