Overview
This month has produced the first indication of how the UK’s Agency for REACH, the Health & Safety Executive (HSE), will assess whether substances of very high concern (SVHCs) should be added to the ‘candidate list’ for future authorisation. There was already much interest in the HSE’s assessment process after the UK Government set out the criteria it would apply for the market of Great Britain in a new approach to SVHC assessment in December 2021. Under its new approach, the UK Government introduced a new “good candidate” threshold, in which “a substance should not be proposed for inclusion on the [UK REACH] candidate list unless it is a good candidate for the authorisation list”; and that “Regulatory Management Options Analysis (…) should be used to determine if inclusion on the candidate list is the correct route.”
The HSE assessment report published in February 2022 provides the first indication of how this test will be applied.
The HSE has assessed all of the 11 substances that were submitted for identification as SVHCs under EU REACH in 2021 to determine whether to follow the same path in the GB market. Of those 11, only four have been considered “priority substances or substance groups”, requiring progression to the Regulatory Management Options Analysis (RMOA). Calls for evidence have been issued for four substances that have been identified as requiring an RMOA, namely:
- Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety;
- 1,4-Dioxane;
- Small brominated alkylated alcohols; and
- Phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerisation, covering any individual isomers and/or combinations thereof.
Much of the commentary has been focused on the fact that the UK is not replicating the EU decisions. However, those watching the GB regulatory regime closely will not be surprised: there has been much talk of the UK’s more limited resources being deployed in a more targeted, risk-based manner.
Of course, this means increased scrutiny on those substances that are selected for an RMOA, and therefore it is particularly important that manufacturers, importers and downstream users of these substances take an active role in the call for evidence. The Steptoe chemicals and life sciences practice has significant experience representing client interests in consultations and calls for evidence, including participation in the independent UK’s first RMOA process, for PFAS, commenced in 2021.
Responses to the call for evidence are required by 10 April 2022, so prompt action is recommended.
