Regulatory Changes

ISSUE	DETAILS
Molecular Weight	Previously, an average MolWt >700 could be used to justify that a substance was not likely to bioaccumulate. However, now a MolWt average >700 with no more than 10% being <700 needs to be demonstrated (to justify that bioaccumulation is unlikely to occur) using GPC or other equivalent analytical data to present a molecular weight distribution.
Endocrine Disruptors	In the UK currently, all residual EDC’s need to be measured and stated to CEFAS, chemicals with EDC’s may incur a Product Warning and potentially a “Do Not Discharge” order.
Substances in Organic Solvents	There was a concern that were a substances was tested with organic solvent present that the biodegradation calculated for the test could be to a greater or lesser extent due to degradation of the solvent. Therefore biodegradation data which was obtained through testing a ‘blend’ (of solute in an organic solvent) now needs to be tested again with the solvent tested separately and a calculation done to get the active biodegradation result (see HOCNF Guidelines), or there is the option to not retest and accept a biodegradation figure of 0%. All data being generated for new substances in organic solvents should consider the solvent blank testing that is now required.
Sodium Tetraborate	In Norway there has been a change in Norwegian category from Red –> Black. Acceptable levels have changed from 7.5% –> 0.3% (the change to the substance no longer being PLONOR occurred several years ago).
Ethanol	Changed from PLONOR to no longer PLONOR, data are now required for the component. EOSCA holds a dataset for the substance which is available to members. Ethanol is still substitution free.