A data gap analysis should be undertaken prior to the initiation of the dossier preparation, in order to provide sufficient scientific data for the assessment of all relevant aspects under REACH.
Documentation transfer of proprietary data held by industry
Conduct of literature searches for published data:
Physico-chemical data and analytical methods
Ecotoxicity, environmental fate data
Toxicity data obtained from animal testing
Human clinical and epidemiological data
Monitoring and emission data
Identification of relevant literature based on abstracts and acquisition of full documents
Archiving of literature items and compilation of data bases
Allocation to specific data requirements
Evaluation of data and reliability rating
Identification of data gaps
Commissioning and monitoring of experimental studies to fill any identified data gaps
Development of sophisticated read-across and waiving strategies
