Thinking the unthinkable about REACH and Biocides

I hope this finds you well amongst this global uncertainty. The word “unprecedented” is often used to describe the situation we all find ourselves in, and I think it genuinely is. Even in wartime, during both World Wars, we did not have so many businesses closed and so many civilians effectively under house arrest.

Among many interesting things, it has been heartening to see how well the chemical and chemical-using industries have responded to the Coronavirus Crisis, including many manufacturers switching to producing the WHO hand sanitiser based on ethanol and donating these to healthcare workers, large distributors working to transport materials pro bono etc.

Many smaller companies are finding that they are directly involved in the healthcare supply chain, e.g. through textile chemicals required for masks and hospital gowns, or that they can help in other ways such as donating surplus PPE.

We are lucky that Covid-19 coronavirus (as opposed to other coronaviruses) contains a fatty layer which can be destroyed physically by soap, other surfactants, alcohol, hydrogen peroxide or bleach.

The disruption to global supply chains has meant that if biocides which work through other mechanisms had been required, the UK and the EU would have been in a very precarious position.

This would inevitably be exacerbated by the speed of response from the regulators, as we have seen with Covid-19.

Several of my clients who are chemical and pharmaceutical distributors have seen that the hand sanitiser demand has soaked up supplies of all types of hand sanitiser, particularly those used in hospitals for very demanding situations such as surgery, and that there is actually a demand for these types of hand sanitiser as well as alcohol/peroxide based ones of the WHO.

However, trying to get the Competent Authority in the UK, the HSE, to appreciate this fact and permit the import of biocidal actives to cover the increase in demand has been difficult.

Briefly:

• They can only see the need for Covid-19 hand sanitiser, and not that this has used up stocks of other hand sanitiser
• They will not derogate for old proven biocides, which were not taken into BPR Article 95 on grounds of cost, to be imported and made into hand sanitiser
• Nor will they derogate for an existing biocidal active to be granted permission for use in human hygiene (because it’s not biodegradable – how is that going to alter the efficacy of a biocide? And if you can use it in a hard surface cleaner, it’s going to end up in a waste water treatment plant anyway).
• They have said they will wait for advice from the Health authorities before making any further derogations beyond the ones for alcohol hand sanitisers

To be clear, I am not saying this to attack the HSE, or to demand that they give in to my clients’ requests, because I can see that the HSE does have a point, that they have deregulated the hand sanitisers required specifically for Covid-19.

What this illustrates, however, is that the HSE don’t necessarily understand the knock-on supply chain effects of people using non-Covid-19 hand sanitiser for Covid-19. By the time the Healthcase authorities in the UK (a particularly bloated bureaucracy) realise there is a problem and communicate it to HSE, the need will be urgent.

And the HSE don’t seem to appreciate the need for distributors to move quickly to be able to import from e.g. India via sea transport, given the journey times. (And that’s before India went on Lockdown as well, which has reduced international trade to a trickle).

None of this apparent lack of understanding is the fault of any one individual who works in HSE (and I have to say personally that the people who staff the REACH and Biocides helplines are generally very helpful indeed).

It is not their job to get chemical supplies quickly from A to B, and unless someone in authority tells them to facilitate this, they will continue with their main role which is making sure everything is done safely, which to them is in compliance with the law as it currently stands.

As I said before, we have been lucky that Covid-19 is amenable to physical breakdown by a variety of cleaning products which are, or which can be made, freely available in the UK and EU.

Next time, during the next pandemic, we may not be so lucky.

Biocides regulation

One of the problems in the biocides market which this crisis has highlighted is the drastic reduction in the number of companies making biocidal actives as a result of the Biocidal Products Regulation, and its predecessor, the Biocidal Products Directive. Not only that, but often companies which make biocidal actives by reaction are still reliant on raw materials from outside the EU.

As an example, Chlorhexidine Digluconate is only made by 3 factories in the EU, and 2 of these import the chlorhexidine base from India, so there is only one complete supply chain for this important biocidal active in the whole of the EU. (It is widely used in hospital hand sanitisers).

One good thing about the Covid-19 crisis is that it is showing up these kinds of “weak links” in the chemical supply chain when it is not absolutely critical for public health. It is a warning that we need to seriously think about how we can cope with the next crisis, whether that is a pandemic, a war, or just a “trade war”, which can reduce supplies from overseas.

So how do we deal with all of this? How can we secure supplies of biocides and other essential chemicals so that the UK, the EU and other countries can operate individually in times of crisis, when we naturally revert to looking after ourselves first, before other people and other countries?

There are two aspects to this:

• How we deal with biocides
• How we regulate general chemicals

The reason we need to think about the chemical industry as a whole, as well as just biocide supply chains, is that the chemical industry mainly supplies itself, as I have mentioned in previous newsletters, and we don’t necessarily appreciate that substance x which we make then goes into formulation y, which is then used in mixture z which is on the frontline of the crisis.

Biocides can’t be made in a vacuum, our best protection against running out of them is to have a good, naturally-developed, “ecosystem” of chemical manufacturers and suppliers.

We also need to make sure that there is a healthy biocidal actives and formulations industry, which can make a wide range of products and respond to market demand quickly, including relying much less on imports.

A certain amount of biocidal regulation is perhaps inevitable these days, but it should be focussed on preventing resistance developing, and not on reducing the number of biocides and biocidal products available to society.

As I mentioned in last week’s newsletter, “Why having a variety of biocides available matters to human health”, we need a combination of allowing a much wider number of biocidal actives and biocidal products on the market, with a tightening on their use in non-essential applications such as household cleaners, and laundry detergents (they’re even marketing biocidal toothpaste now, when it surely should be on prescription from the dentist for people who really need it).

Here in the UK, we have a unique opportunity with Brexit to recast both the biocides and general chemical regulations to make them more pragmatic and to focus on what is important.

For regulating the use of biocides to try to prevent or delay resistance, I would deal with this under Restriction(s), that is ensuring biocidal products would not be allowed for sale to the general public and professional user, or for certain specific uses.

In terms of regulating biocidal cleaners per se, I would be very wary of doing this.

This may be a very unpopular idea, but why not let the market decide? We have seen that industry can operate and react much faster than regulators to problems. This would be easier if only biocides which have physical mechanisms, were available to the public (or perhaps with traditional disinfectants such as “Dettol” for first aid use).

It is not as if cleaners and sanitisers obviously require tight regulation in the way that medicines do.

(The other type of biocides handled under BPR, pesticides such as rodenticides could be handled under other existing regulations, e.g. by extending the Plant Protection Products regulations. And actives registration can be handled under REACH or whatever replaces it in the UK).

The other side of the equation is the availability of chemicals in the wider marketplace.

REACH regulation

The biggest issue in recent years has been the adverse effects of the REACH regulation. This has seen a massive decrease in the number of chemicals made in the EU, and corresponding increase in imports from outside the EU.

If we are to revert to being self-sufficient in strategic chemicals, that is those used directly and in making vital chemicals such as for water and sewage treatment, biocides of all types (cleaners, medicines, vet medicines, plant protection products etc), fertilisers to help ensure the food supply, and so on, we need to reverse this trend.

This is not to say that REACH has had some good points, for example the amount of data available has led to an increase in the accuracy of classification of chemicals, and therefore better Safety Data Sheets.

But REACH is an incredibly bloated and bureaucratic nightmare.

Use registration and exposure scenarios

The registration of uses, and the use of the Exposure Scenarios is of incredibly limited value in actually protecting people and the environment (another unpopular view, probably).

Exposure Scenarios are usually written by the people who write the registration (usually Regulatory Affairs people who work for a large company, or a consultancy). The purpose of an exposure scenario is to predict how people and the environment may be exposed to the chemical, and to provide guidelines on how the exposure can be minimised.

This means that they are far removed from how such exposure actually occurs, and in order to ensure minimum exposure, will tend to over-specify equipment to be used. After all, they do not have “skin in the game” themselves – it is unlikely to be their company having to invest in a very high specification powder handling system, proving the truth of the Thomas Sowell quote “It is hard to imagine a more stupid or more dangerous way of making decisions than by putting those decisions in the hands of people who pay no price for being wrong.”

It also conflicts with existing legislation on:

• occupational health and safety, which already provides for exposure limits in the workplace, and which has to be complied with locally, including estimating, and if necessary measuring actual exposure of workers
• trade effluent legislation, which gives emission limits to sewer
• environmental permitting legislation, which provides emission limits to air, sewer, surface and groundwater (if permitted at all), and waste

Since when has it been sensible to replace site-specific risk assessments, carried out by people actually on site, with generic assessments made by people who have never visited the factory in the first place?

Not forgetting that use registration and exposure scenarios also goes directly against over 2000 years of consumer practice and law, which can be summed up in two words, “caveat emptor”, let the buyer beware.

No supplier can truly understand the way in which their product is used, or provide for the actions of the end user, and this applies as much to chemicals as to any other type of goods.

It is also bad practice to provide Exposure Scenarios, because it reduces the responsibility which should rightly fall on the end user. The price of using a hazardous material is to use it responsibly, which has traditionally meant doing risk assessment of your actual use by your own people on your own site.

If downstream users are not doing this, then informing, educating (and prosecuting them) is the answer, which should be the job of the regulators, not providing them with a “painting by numbers” risk assessment, which by its very nature is likely to be overly precautionary.

SVHCs

The mechanism for the identification of SVHCs, Substances of Very High Concern, and Authorisation of such chemicals is based on a misunderstanding of how the chemical industry works, which can be summarised as:

“taking nasty things, and reacting them into useful, less nasty things for the consumer”

If hazardous chemicals are used inside industry, it should not be the job of the regulator to prevent this through Authorisation. Their use can be handled under existing safety and environmental legislation.

If something is so hazardous that it should not be made available to the public, it should be handed via a Restriction, as already happens on a blanket basis with Category 1 carcinogens, for example.

Chemical registration

Some form of chemical registration is likely to be required (as this has been agreed at the UN, EU-REACH is just the first time it was introduced).

As a colleague recently said in a meeting, the problem with NONS, the previous chemical registration regime, was that the big companies would make a NONS registration, and then there would be a lot of “free riders” who would piggy-back on that registration without paying for data, which was clearly seen as a problem.

However, with hindsight, this was a minor issue compared to the bad effects of the way in which REACH data costs have been shared by registrants. Most of this is structural, and has been inflicted on industry by the regulators, through:

• not requiring all existing data, which had already been paid for, to be deposited free of charge at ECHA for everyone to use
• One substance, One registration (preventing competition between Lead Registrants from lowering the price)
• bringing in registration for the highest tonnage bands first, instead of lowest tonnage band first (which would have automatically meant sharing low costs across the maximum number of participants)
• specifying the tests in each tonnage band in such a way as to make the cost per tonne disproportionately high, especially when the higher tonnage bands were registered first

This bad law was compounded by the regulators washing their hands of most data disputes, by refusing to limit or give guidance on cost sharing to prevent bad actors from profiteering (and there have been some, although most data holders have behaved honourably).

We also had the ironic situation where the costs to administer the cost-sharing system were sometimes higher than the data costs themselves.

Data costs, more than anything else, have impacted on the product ranges of the chemical companies I deal with.

And if anyone asks why we are much less able to cope with a crisis like Covid-19 than we used to be, REACH is the main answer, with BPR in second place.

Alternatives to REACH

Instead of REACH, I would place SDSs in with CLP, and run a UK-version of GHS. Restrictions could also be added to this regulation, which will mean that UK-GHS would cover exactly the same topics a CHIP used to.

The rest of REACH which ought to be kept, that is the need to register new chemicals and provide data, could comfortably be handled under NONS. This still exists in UK law, and can be quickly brought back into effect.

There would still be the apparent problem of obtaining registration data for the HSE, which I understand is up for discussion in the Brexit negotiations; and sharing data costs under NONS.

In order for the HSE to obtain the data for which has been deposited at ECHA, I would suggest the HSE take the following approach:

• Ask ECHA to provide copies of all the data to the UK Competent Authority, for free, on the proviso that they agree to the same data limitations to protect the rights of the data owners. After all, UK and EU companies have already paid for access to the UK market when we were part of the EU, and none of us should have to pay twice.
• In the event that ECHA are unwilling to do this, ask all Lead Registrants to deposit their IUCLID files with the HSE for free, and to provide lists of their data purchasers as well, so the HSE have the same information as ECHA.
• Only consider paying in to ECHA to keep access if neither approach is available. Alternatively, consider accepting REACH registration in the EU as being valid in the UK automatically, with only a notification requirement to the HSE in the UK required.

UK-REACH could be dispensed with altogether.

Occupational health is already covered more than adequately by existing legislation, and if there is concern about environmental impact from companies which are not already regulated under Environmental Permit, e.g. chemical formulators, then the EPR could be extended to cover these companies.

In terms of NONS cost sharing, perhaps the HSE could give guidance on cost sharing for new entrants in a more formal way than anything which was done under REACH, e.g. by providing a cost-sharing model, and capping administrative fees chargeable.

So my “unthinkable thoughts” on BPR and REACH actually involve making alternative arrangements, which would give much more market freedom while retaining the high quality of data we have become used to under both regimes.

I hope that this is an interesting set of ideas, and would welcome your thoughts.

Wishing you, your family and colleagues good health,

GHS Classification Courses from TT Environmental Ltd

6th April 2020

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