First chemical authorisation based on UK REACH agency opinion approved

The first chemical authorisation decision based on a UK REACH agency opinion has been published.

In January 2021, biotech company, MeiraGTx UK II, submitted an application to the Health and Safety Executive (HSE), which is acting as the agency for UK registration, evaluation, authorisation and restriction of chemicals (REACH), for the authorisation for industrial use of the substance of high concern (SVHC) 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO).

The chemical was previously listed under the EU chemical regulation REACH as a substance “subject to authorisation” due to its endocrine disrupting properties when it degrades in the environment.

The authorisation process of chemicals in the UK, now under UK REACH, continues to see the use of SVHCs phased out and replaced by safer alternatives where possible, and grants temporary use of substances on the list when relevant criteria are met post-brexit.

On 11 November, DEFRA minister Rebecca Pow, on behalf of the environment secretary, signed off on a decision to authorise MeiraGTx’s use of 4-tert-OPnEO as non-ionic surfactant, employed in the purification of antigens in in vitro diagnostics tests for infectious diseases, auto-immunity markers, bone metabolism, hepatitis and retrovirus, oncology and endocrinology.

Referring to the UK REACH agency’s opinion, under the HSE, Pow agreed that the review period (as referred to in Article 60(9)(e) of EUR 2006/1907) for the chemical should be set at 12 years.

The agency came up with this review period after assessing the “the clear socio-economic benefits” of the chemicals use, the “limited environmental risks” the agency felt the chemical posed which they said “would not result in discernible adverse environmental impacts at population level” and the fact that there are no “technically and economically feasible alternatives available”.

The report also took into account the time and resources needed for MeiraGTx to identify, invest in and implement alternatives amongst other limitations.

Pow said that she agreed with the agency’s recommendations. The Scottish Ministers and the Welsh Ministers also gave their consent to the decision in accordance with Articles 4A and 64(8) of EUR 2006/1907.

A spokesperson for MeiraGTx shed insights into the process, and told ENDS: “As this was the first application for a new authorisation under UK REACH, the process for application and approval was clearly evolving.

“This said, the UK HSE were open and transparent through the process and elicited feedback along the way.

“The process was rigorous, as befits any process regarding environmental authorisations and regulation. In this respect, while the whole process took just under two years, and required significant effort (including support from our consultants TSG), we believe that the new processes put in place by the UK HSE for the UK REACH Regulations are fair and appropriate.”

The spokesperson continued to express that the decision will support the development of MeiraGTx’s gene therapy programs, which are being used for a broad range of diseases.

They said: “Gaining this authorisation allows the unfettered development of our potentially life changing therapies.”

The HSE confirmed that this authorisation decision is the first to be taken under UK REACH based on an opinion formed by the UK REACH Agency, rather than previous decisions on transitional applications which were informed by the opinions adopted in respect of the EU REACH application by the European Chemicals Agency (ECHA).

The report was published on the government website this week.