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	Standard formats and IUCLID

Due to the link of the Initiative to the refocused OECD HPV Chemicals Programme the presentation in terms of form and content of data in the SIDS Dossier and of the initial hazard assessment in the SIAR and SIAP will have to comply with the OECD Guidance Manual
(see http://www.oecd.org/ehs/hpv.htm).

The current Interim Guidance Manual does not prescribe any software that has to be used to produce the final documentation but “encourages” the use of IUCLID (International Uniform ChemicaL Information Database).

The Guidance Manual is currently under revision. In an Annex to the latest draft guidance for the use of IUCLID software is provided. This guidance was developed and provided by Cefic in collaboration with the Fraunhofer Gesellschaft of Germany.

Moreover, in the revised version of its Guidance Manual the OECD clearly states that the “use of IUCLID software is the preferred format for entering data, and developing a SIDS Dossier, using the standard templates. The dossier can be submitted as an exported electronic IUCLID file, as a hard copy printed directly from IUCLID, or as a copy that has been converted to the Word format. By using the IUCLID software for data collection, efficiencies are gained at the data submission stage. In addition, once an assessment has been finalised in OECD, the data in the SIDS Dossier can be transferred directly from IUCLID to UNEP Chemicals for publication. Step by step procedures for preparing a SIDS Dossier using the IUCLID software are given in Annex 2 to this chapter.”

However, the OECD recognised in its comments on the latest draft that “currently the IUCLID software is not entirely consistent with the templates in the Guidance Manual. (e.g., environmental transport has places to input data for Level I Fugacity for air, water and soil, but not sediment and biota. Also for Level III, there are places to input biota and soil, but not air or water. There should be appropriate places in the template to put all compartments calculated by both Level I and III. In addition, there should be a place in the environmental transport to place Henry’s Law constant, which is expected to be included.)”

For participating companies one of the two most immediate practical value of harmonised and internationally agreed datasets (the other being that duplication of effort is effectively being eliminated) is their recognition under the various national and regional programmes (e.g. the US EPA Challenge Programme, the European Existing Substances Regulation or REACH in a future EU regulatory framework).

In order to facilitate this process ICCA fully supports the position of the OECD, i.e. that IUCLID is the preferred format for entering data. However, ICCA is acutely aware that broad acceptance of the IUCLID software, particularly by small and medium sized companies and other infrequent users, would gain from making the software more user-friendly.