- Registration phases
- 4. What information you need
- Information requirements: 10 to 100 tonnes per year
Information requirements: 10 to 100 tonnes per year
To register a substance in the 10 to 100 tonnage band, you need to provide information specified in Column 1 of REACH Annexes VII and VIII, comprising certain physicochemical data, toxicological and ecotoxicological information. Column 2 specifies the adaptation possibilities for the specific properties. The required standard information set may also be adapted according to the general rules contained in Annex XI.
Furthermore, you need to document the results of your chemical safety assessment (CSA) in a chemical safety report (CSR) as requested in Annex I to REACH. You need to agree among co-registrants if the lead registrant will submit the CSR jointly or if individual registrants will submit their own CSRs separately. Also, you will preferably agree with your co-registrants on the appropriate classification and labelling.
Reliable conclusions on classification and PBT/vPvB assessment are cornerstones of a good CSA, since exposure assessment and risk characterisation are triggered by classification and fulfilment of PBT/vPvB criteria.
The obligation to prepare a testing proposal also applies when the potential registrants, as a result of the application of the rules in column 2 of the annexes, propose (higher tier) tests of Annexes IX or X as an alternative to the standard requirements of Annexes VII and VIII.
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