Preparation REACH registration file 2017-09-08T10:15:11+00:00

Preparation REACH registration file

Data evaluation

ARCHE Consulting can assist you with compiling the technical dossiers required to register chemical substances under REACH and submitting them to the European Chemicals Agency. A technical dossier needs to contain at least all the information stipulated by the tonnage window.

Each literature item (relevant for human health or environment) needs to be screened in detail, either to verify the initial assignment (based on the literature search evaluation), or to re-assign any document to another data requirement. A reliability rating (based on the inherent quality of the methodology and results) needs to be made for every relevant data point. This quality screening procedure is based on the Klimisch  scoring scheme.

Data evaluation

IUCLID 6

All existing hazard characterisation studies need to be summarised in detail in a standardised reporting format, which will be provided in the form of IUCLID 6 when submitting the technical dossier to ECHA.

Existing information needs to be provided in the form of IUCLID 6, the platform to communicate with ECHA for the submission of a registration dossier. Apart from a description of the study itself and the results, it is necessary to record all relevant experimental conditions in order to demonstrate the reliability and validity of any particular study.

ARCHE Consulting has the necessary knowhow to draft Robust Summaries and prepare IUCLID entries.