http://echa.europa.eu/de/regulations/reach/substance-registration/the-registration-dossier
Das Registrierungsdossier
The registrant of a substance needs to compile all the required information in a registration dossier, which consists of two main components:
- A technical dossier, always required for all substances subject to the registration obligations
- A chemical safety report, required if the registrant manufactures or imports a substance in quantities of ten tonnes or more per year.
The registration dossier has to be prepared using the IUCLID 5 software application. IUCLID 5 implements the Harmonised Templates developed by the OECD and it is compatible with other chemical legislations around the world.
Once the dossier has been created with IUCLID 5, it has to be submitted to ECHA through REACH-IT.
Technical dossier
Manufacturers and importers have to collect all existing available information on the intrinsic properties of a substance as well as on its manufacture, uses and exposure.
The technical dossier contains information about:
- The identity of the substance
- Information on the manufacture and use of the substance
- The classification and labelling of the substance
- Guidance on its safe use
- (Robust) study summaries of the information on the intrinsic properties
- Proposals for further testing, if relevant
- For substances registered in quantities between one and ten tonnes, the technical dossier also contains exposure related information for the substance (main use categories, type of uses, significant routes of exposure)
Chemical safety report
This chemical safety report contains a detailed summary of information on the environmental and human health hazard properties of the substance, together with an assessment of exposure and risk where such an assessment is required.
Chesar is a tool developed by ECHA to help registrants perform the chemical safety assessment and generate the chemical safety report.
Bewertung: Alle europäischen Sprachen;Evaluation under REACH focuse
ECHA and the Member States evaluate the information submitted by companies to examine the quality of the registration dossiers and the testing proposals and to clarify if a given substance constitutes a risk to human health or the environment.
Evaluation under REACH focuses on three different areas:
- Examination of testing proposals submitted by registrants
- Compliance check of the dossiers submitted by registrants
- Substance evaluation
Once the evaluation is done, registrants may be required to submit further information on the substance.
Gemäß Artikel 54 der REACH-Verordnung veröffentlicht die ECHA bis zum 28. Februar jedes Jahres einen Bericht über die Fortschritte, die sie im vorangegangenen Kalenderjahr bei der Erfüllung ihrer Pflichten zur Bewertung erzielt hat. Die ECHA soll darin insbesondere Empfehlungen an potenzielle Registranten zur Verbesserung der Qualität künftiger Registrierungsdossiers aussprechen.
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