Registration process
Pre-registration:
The Pre-registration phase applies to materials, which already are on the market ("phase in materials"). Here the identity of the registrant, the identity of the material and the intended registration period according to the tonnage are announced to the chemical agency.
This Pre-registration phase begins 12 months after the entry into force of REACH and takes 6 months from 01.06.2008 untill 30.11.2008.
The publication of all Pre-registration data in the "Substance information Exchange forum" (SIEF) makes it possible for the registrant to find other enterprises, who want to register the same material and a group registration (OSOR) can be accomplished. To bio-test applies: Vertebrate animal test can not be repeated.
Registration:
The registration dossier is submitted to the chemical agency. Within 3 months (phase in materials) the agency examines the completeness of the dossier. After positive examination the dossier receives a registration number.
Each individual enterprise, legal entity and/or legal person is to be named.
The technical dossier
The technical dossier contains these information:
- identity of the registrant
- identity of the material
- information to production and all uses of the material
- classification and marking of the material
- guidelines for the safe use of the material
- study summaries of the accomplished tests
- basic summaries of the accomplished tests
- indication, which of the test was examined by an independent assesor, who was selected by the manufacturer or importer and has suitable experience
- test suggestions, if tests are necessary according to annex IX and/or X.
The Chemical Safety Report contains the following data:
part of A:
- overview of the risk management measures
- explanation that the risk management measures are accomplished
- explanation that the risk management measures are communicated
part of B:
- identity and physicochemical characteristics of the material
- production and uses
- classification and labeling
- behavior and the exposure in the environment
- evaluation of the endangerment of the human health
- evaluation of the endangerment of the human health by physical chemical characteristics
- evaluation of the endangerment of the environment
- PBT- and vPvB evaluation
- exposition evaluation
- description of risk