Chemistry Reference
In-Depth Information
4.2. Practicalities for submission of pesticide dossiers in IUCLID format
The OECD Expert Group on the Electronic Exchange of Pesticide Data makes an effort to
support the harmonization of the international submission formats used for pesticide
registration (Caddy, eIndex, ePRISM). This harmonized format is called GHSTS (Global
Harmonized Submission Transport Schema) and will be finalized in 2012. At present it is
not possible to submit a full document-based pesticide dossier from a company to the
authority using IUCLID 5, which is endpoint record-based. The answer should be found by
ECHA by evaluating the proposals collected in a public consultation.
The objective of this public consultation, organized in collaboration between OECD and
the ECHA, is to receive input and exchange ideas on the next generation of the IUCLID
software from stakeholders not represented at the OECD IUCLID User Group Expert
Panel.
After a few years of experience in using IUCLID 5 as a tool for collecting, storing and
exchanging information on chemicals in the OECD, and for national and regional
chemical review programmes, it is time to plan for the next generation of the IUCLID
software and to adapt it to fit the evolving needs of a growing user community.
Example developments could be the extension of IUCLID to specific information
relevant for pesticides or information on exposure and risks related to uses of
substances, or the development of several user interfaces adapted for a specific purpose
connected to the same core database.
This next generation of the IUCLID software might also be useful for the submission of a
future PPP dossier and/or a DAR, as well as the CLH report. The Harmonized Templates
were implemented to store structured data from studies on an endpoint record level. This
technique is used in IUCLID.
The content of the XML files according to the Harmonized Templates shall replace the
Tier II summary level (Word, PDF) to prevent a duplicate lifecycle management by the
companies of a text and of the corresponding structured data set.
Today the authorities have to produce a duplicate lifecycle management of a CLH text
and a technical CLH dataset in parallel over a long period. Why is it necessary to
produce two versions of a CLH dossier, a text processor
CLH dossier and the technical
IUCLID data file?
A mutual understanding of the needs and workload implications was the starting point for
this discussion. There is a clear benefit in having an IUCLID 5 dossier for all substances,
including PPP active substances, but on the other hand there is an additional workload for
the CAs when preparing an IUCLID 5 dossier from a dossier presented in a different format.
Over the long-term the OECD approach may provide a fully compatible solution and this
was recognized as the best solution.
The workshop participants recognized that the role of the PPP CAs should be equivalent to
the role of the REACH/CLP and biocide CAs: to revise and update the IUCLID 5 dossier
presented by the relevant companies. Therefore, before a fully compatible submission
