Data gap analysis, read-across and waiving strategies
Once the information requirements as laid out in Annexes V to VIII have been established and the already existing data have been compiled and evaluated ARCHE experts can help you in making a list of clear data gaps and proposals to close these, considering both waiving and read-across arguments. In the framework of REACH several possibilities are anticipated to exempt (waiving) from conducting individual tests, when this step is adequately documented and justified.
Of importance here are:
- the theoretically generally anticipatable possibility, not to conduct tests when this is scientifically not necessary or technically not feasible, corresponding to Annex IX;
- consideration in Annex IX of the REACH-Regulation of general provisions for deviations from the standard testing programmes according to Annexes V to VIII, in particular the customized testing according to Chapter 3. According to Annex IX the tests according to Annexes VII and VIII can be waived, if in the chemical safety report corresponding exposure scenarios were developed;
- special waiving-conditions for individual tests (example: according to Annex VI.6.6.1: Exemption from the 28-day-test for non-relevant exposure of humans), as specified in Annexes VI to VIII (Column 2).
- Or exposure-based waiving could be considered. Which means here the exemption from the conducting of studies according to Annex VI, when the justification for the waiving is based on the fact that there is no relevant exposure of humans and environment to the substance to be registered.