Test data requirements for REACH – use of Waivers and alternative to testing
REACH registration does not require test data on all endpoints – it is sufficient to provide justified waivers or use justifiable alternatives. Annex XI of REACH makes this very clear.
Waivers for testing or use of non-laboratory data for hazard assessment (Chemical Safety Assessment) must be considered before performing new tests; this is especially important to avoid unnecessary animal testing.
Denehurst can provide services to reduce the impact of laboratory testing by assessing potential for waivers or use of non-laboratory data
Link to Laboratory Testing page
Waivers
It is not necessary to perform expensive laboratory tests for every endpoint listed. There is no obligation to perform every test on the lists provided in Annexes VII – X of REACH and within these Annexes, reasons for waivers are provided. Note that Annex XI of REACH describes how waivers and alternatives to testing can be considered.
Denehurst can help registrants with the justification for waivers or to help justify read-across and models to avoid excessive laboratory testing. There is an ethical requirement to minimise animal testing and it is important not to be drawn into testing on the basis that ‘it is only a couple of thousand Euros for each registrants, so may as well get it done’. As long as a waiver is thought through and can be justified, the worst that can happen in the future is that ECHA will ask for further justification or perhaps testing; registrants will be given time to do this and while new work is being performed, supply can continue.
In the absence of existing data, IUCLID data summary sections provide an opportunity for registrants to request waivers based on
- Study technically not feasible
- Study scientifically unjustified
- Exposure considerations
- Other justification
Whatever type of Waiver is selected, the IUCLID system that required a justification. These are generally sensible, but sometimes no suitable option is provided and ‘other’ needs to be selected and explained in the text field.
If using the ‘other’ option, this will alert the Regulatory Agencies and this part of the dossier will be scrutinised – for EU REACH, ECHA need a lot of convincing in some cases that anything other than a pre-listed option in the IUCLID justification is acceptable.
There are many examples of when waivers will apply, but these will be especially applicable for industrial uses of substances. The most extreme set of ‘waivers’ is the supply of intermediates under strictly controlled conditions and in these cases, data requirements are limited; however, if failing to meet ‘strictly controlled’, but there is still reasonable level of control, reduced testing is possible.