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A central task of the registrant is in the registration dossier to collect data on the identity and properties of the substance. The majority of the data should be collected by registrants in the SIEF frame together.
In practice, the data usually are but a few companies ("lead registrant and / or consortia) were collected and subsequently the cost of the work (acquisition of rights to existing studies, creation of new studies, and administrative expenses) divided among all registrants. Against the background of problems, both for cost-sharing as also occurred with regard to data quality, it still seems necessary that all registrants have sufficient basic knowledge of data collection.
As part of the workshop will explain why, which generates different paths, the data required to: - Qualified reunification and assessment of existing study results
- Use of alternative methods such as QSAR and "read across"
- Planning and implementation of new studies in accordance with the relevant EU regulations
- Test proposals
In addition to the specificity of situations in which received tests may be omitted and the reasons.
Ultimately, the data obtained form the basis for the evaluation of material properties. From an environmental perspective, just include the assessment of PBT and vPvB properties In accordance with Annex XIII of REACH or the assessment of endocrine properties as features to SVHC. The assessment of these two aspects in comparison to the classification / identification is relatively new and complex. Therefore, the workshop is to give the potential registrants also get a first insight into the valuation of these properties |
