Exposure based waiving and triggering of tests within REACH

A discussion paper within the Nordic projects on Information Strategies (NOIS)

image of Exposure based waiving and triggering of tests within REACH

The main objective with this work was to discuss and give guidance on when testing according to REACH may be omitted based on information on exposure. This includes interpretation of the terminology used for the specific exposure based waiving according to Column 2 of Annexes VIII-X in REACH and the general exposure based waiving according to Annex XI. In addition, it includes exposure based triggering of testing. Waiving of testing is considered to be risk-based rather than exposure-based. One issue with risk-based waiving is that the toxicological study under discussion for waiving is sometimes needed in order to decide whether the exposure is negligible. In order to waive testing it is necessary with detailed and extensive knowledge on exposure over the whole life-cycle. Information corresponding to an exposure scenario is needed even though this is only requested if the substance is a PBT eller vPvB or fulfils the criteria for classification.



Specific rules for adaptation (column 2) of standard information requirements

In the so called “specific rules for adaptation” in column 2 of Annexes VIII, IX and it is specified when and how testing may be adapted for specific endpoints. Some of these rules include exposure considerations.


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