Alison Potts’ comments on UK-REACH consultation, 2024

If you are involved in Regulatory Affairs, you will fall into one of two categories this week. Either you’ve been hearing about the UK REACH Consultation non-stop for the last week (CHEMUK, Chemical Watch, various newsletters and websites), or you’ve been blissfully ostrich-ing.

Regardless of which camp you fall in, the consultation is only open for 8 weeks (Closes 11th July 2024), so you definitely need to take some time to read, digest and then respond. You can find the consultation here: https://consult.defra.gov.uk/reach-policy/atrm-consultation​

It’s 35 questions, most of which require a long-form response. So prepare before you open the online form (or you’ll get fed up half-way through). You can see all the questions by opening the document called ‘UK REACH Consultation’, plan your responses in word (taking plenty of breaks!) and then copy/paste them into the online form.

I’m one of those people who reads all the impact assessments and associated documents, so I’m going to give a brief summary and raise a couple of discussion points below.

(i.e. New/Novel substances will still
require full registration).

Registration Requirements
o Hazard Classification and Labelling – No requirement to submit the underlying test data to support the classification
o Increased use and exposure information for all substances
o Enhanced requirements for use and exposure information for substances at 1-
10 tonnes which are CMR (cat 1A or 1B), STOT RE (Cat 1 or 2), Respiratory or Skin sensitisers, or
have a NOEC < 0.01 mg/L

Regulator Powers
o The introduction of ‘Transitional Evaluations’ to allow the regulator to request underlying
test data if they determine the hazard classification may warrant concern
o Compliance checks to remain at existing levels but be reprioritised based on use and exposure

Substance Groups
o The new ‘SIEFs’ – Introducing the provisions to make Joint Registration workable under
‘Substance Groups’ (known as SIEFs under EU REACH)

Streamlining REACH Processes
o Reducing the number of regular reports currently required from the HSE to the
UK Government (and other authorities)
o Removing duplicate processes and reducing the consultation period for the
REACH Restriction process
o Extending the vertebrate testing proposal requirements to all tonnage bands to ensure
duplicate or unnecessary animal testing is not carried out.

OK, there’s over 100 pages on why these policy points are (or aren’t) good ideas, and I’m not going
to type a dissertation in the newsletter. I could…. But I’ll spare you.

Suffice to say, the absolute highlight here is the removal of the substance test data. It’s stated
outright that the goal was to reduce costs, and removing the requirement to purchase all that test
data is estimated to knock off ~70% of the registration costs. The headline figure is a saving of
£2bn to industry. But given that we don’t know how many DUINs will actually become registrations,
the estimates actually vary from £1.3bn to £3.5bn, and that’s just stupid money! I mean, you could
buy enough bananas to fill 299.5 Olympic sized swimming pools with that kind of money. And I’m
pretty sure those are both internationally standard units of measure.

It’s a real win. But it’s not perfect.

The assumption is that the data underlying the classification is open source in the EU, so there
is no requirement to purchase, submit and store it again in the UK. However this removes the step
where the registrant validates that their Substance Identity Profile matches that of the data owner
and is therefore eligible to apply the data. The EU does not make the full SIP (analytical data)
available and we all know that CAS and EC number do not guarantee sameness.

In the long-term I worry that this proposal ties the UK to the EUs increasingly divergent REACH
model, where STOT classifications will to a growing extent fall under (for now) Endocrine
disruption, (and in future) immunotoxic, or neurotoxic classifications. It’s difficult to copy and
paste a classification when the classification scheme is fundamentally different.

But my base concern is that the UK REACH Regulation will still contain provision for the underlying
data. The ‘Transitional Evaluations’ are a mechanism for the HSE to ask the registrant to provide
the full data (or the data for any end point(s)) as required by the standard REACH Requirement.

This means that anyone using the ATRm is essentially gambling that they won’t be asked to provide
the data. If they are chosen for ‘Transitional Evaluation’ then all the costs are back on the
table.

The odds are good – estimated as 0.01% of substances undergoing Transitional Evaluation. You may
never be asked for the underlying data for any of your registrations. But when we know the costs
are hundreds of thousands, how lucky do you feel?

How do you budget for that kind of risk? And how will industry respond? Surely the more
registrations you hold, the greater the chances you’ll get a Transitional Evaluation. Can you get
insurance for that? Or do you limit your liabilities by setting a maximum number of registrations
based on what you can afford to cover, or limit your substances to those with low hazards and
minimal exposure to try and lower your odds? Is there an option to drop out of the market (and
registration) if you get a Transitional Evaluation and can’t afford the data?

Moving on, the focus is obviously on Use and Exposure. We knew this was coming (Defra and the HSE
have been pretty consistent in their discussion points over the last couple of years) – but it
doesn’t mean I can’t wince. This is the least understood part of existing REACH and that is
reflected throughout the UK consultation.

The document refers to “gathering currently unavailable information”, “registrants [needing to]
improve the information they provide to meet the regulatory expectations”, and acknowledging that
“use and exposure requirements would likely be more challenging for a smaller firm to comply with”.
(Incidentally 89% of UK chemical sector businesses are small or micro).

The use and exposure information isn’t currently lacking because the registrants ‘skipped that
section’. It’s missing because it is almost impossible to communicate it up the supply chain. The
regulation is written as if there are 3 or 4 steps from substance manufacture to end of life, but
in reality these supply chains are huge. It’s been 6 years since the last EU REACH deadline and
there is still no standardised way to communicate uses.

I despair that the UK authorities seem to think that the way to address gaps on uses and exposure
is to increase the data requirements. Training, guidance and standardised forms of
communication would be more effective methods for improving the available data.

I don’t think anyone disagrees that the aims of REACH – ensuring that chemicals are safe for
their intended uses, are correct. But taking elements of existing REACH that industry already
struggles to implement and increasing those requirements makes me question whether we’re truly
going to see benefits from this reform.

A lot of this consultation makes sense and it’s well reasoned. We should also recognise that DEFRA
and the HSE don’t have a lot of wiggle room here. They have to keep parity (maintain levels of
human and environmental protection) but they know that ‘Doing Nothing’ is unfeasible because of the
cost to industry. This consultation is well worth some thought and participation from as many of
you as possible.

My last comments are on the substances not covered by the consultation – the New/Novel substances.
They acknowledge that these new registrations will continue to be very expensive due to the data
costs. Regrettably the only concession made is that they believe the number of new registrations
will be comparatively low (versus transitional). It concerns me that those costs may be
prohibitive, and deter innovation and the development of safer alternatives in the UK chemicals
sector.

Again, here is the consultation: https://consult.defra.gov.uk/reach-policy/atrm-consultation,
Please make your voices heard.