Information requirements: 1000 tonnes or above per year

To register a substance in quantities of 1000 tonnes or more per year, Column 1 of Annexes VII - X of the REACH Regulation provides the standard information requirements and 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.

In case a study, as listed in Annex X (whether or not involving vertebrate animals) is needed for registration, and is not available within the co-registrants, the potential registrants must first consider all alternative approaches to fulfil the information requirement. Only if an information requirement cannot be fulfilled otherwise, you need to agree on and prepare a testing proposal to be submitted as part of the joint registration dossier for ECHA’s consideration. While awaiting ECHA’s decision on it, you have to implement and/or recommend interim risk management measures to your downstream users.

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