Dear members, please note the below HSE consultations, including for DOTE and MOTE, for which MedTech Europe are also responding to under EU REACH. However, the constellation below is in the GB context. MTE have identified uses within the sector.  MedTech Europe will not be advocating on these substances in the UK, so you will need to respond in the GB context.

If you’re likely to be impacted, then you need to submit evidence of uses, availability of substitute substances, likely timelines to substitute/progress in substituting these substances and processes in place to limit emissions.

If no supporting evidence is provided, you could face a requirement for authorisation for use, or a restriction on uses under UK REACH.

If you’re impacted by these consultations and need to submit evidence to support calls for exemption, or longer transition timelines, then please let me know at regulatory@bivda.org.uk

UK REACH Authorisation List consultation

Draft recommendation for inclusion of substances in Annex 14.

In line with our obligations under the UK REACH regulation, HSE has today published a draft recommendation for inclusion of 3 substances in Annex 14.

The 3 substances included are:

• 2-ethylhexyl 10-ethyl-4,4- dioctyl-7-oxo-8-oxa-3,5- dithia-4- stannatetradecanoate (DOTE);
• Reaction mass of 2-ethylhexyl 2021) 10-ethyl-4,4- dioctyl-7-oxo-8- oxa-3,5- dithia-4-stannatetra decanoate and 2-ethylhexyl 10- ethyl-4-[[2- [(2- 11ethylhexyl)oxy]-2- oxoethyl]thio]-4-octyl-7- oxo-8- oxa-3,5-dithia-4- stannatetradecanoate (reaction mass of DOTE and MOTE); and
• tetraethyl lead (TEL)

Interested parties are invited to submit comments on these substances by 4 February 2026.

We welcome information specific to Great Britain (GB) on aspects covered in the background documents, as well as comments relating to consequences, alternatives and potential exemptions.

Following this, HSE will update the recommendation, taking account of any comments received and send to the Appropriate Authorities (the Defra Secretary of State and the Scottish and Welsh Ministers) for a decision.

The UK approach to the recommendation of substances for Annex 14

In addition to publication of the draft recommendation, HSE has published information about the approach taken to identify priority substances for inclusion in its recommendations including:

• Approach to recommendation of priority substances for inclusion in Annex 14 of UK REACH (2025)
• Technical rationale for the development of the recommendation (2025)

Links to these documents can be found in the related section of the consultations pages.

Additional substances

HSE is also inviting interested parties to submit GB specific information on:

• the reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥ 0.1% w/w 4-heptylphenol, branched and linear]
• 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol [with ≥ 0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2)]

This will be used to assist with future prioritisation work for recommendations to the Authorisation List (Annex 14).