REACH24H Consulting Group

Depending on the notification type and the tonnage band the minimum data requirements vary. There are three basic testing requirements, physico-chemical, toxicological and eco-toxicological testing. Certain eco-toxicological testing is required to be carried out within Chinese territory in approved Chinese laboratories. This includes testing on Chinese target organisms, particularly aquatic toxicity (e.g. Zebrafish). The types of notification are:

Scientific Record Notification: This is the simplest form of notification and requires minimal information.

Simplified Notification: An eco-toxicological test report is required with the required testing, which is dependent on the nature and properties of the substance. For example, if the substance is organic, the ready biodegradability of the substance would be required. For the case of an inorganic substance, a report of the acute aquatic organism toxicity is required. No eco-toxicological data is required for the special cases of simplified notification.

Regular Notification: For regular notification, the ‘Tonnage principle’ (Article 11 of the Measures) applies which requires more data as the tonnage band increases. The amount of physico-chemical testing is the same for all tonnage bands and the testing required depends on the physical state of the substance (solid, liquid or gas). The tonnage principle generally applies for the toxicological and eco-toxicological testing. For example, the number of eco- and toxicological tests for tonnage Band 4 are more than double those required for tonnage Band 1. Classification & Labelling of the substance according to GHS criteria is a necessity. A risk assessment report may also be required.

A summary of the data requirements are shown below: