Biocidal Products (Health and Safety) (Amendment) Regulations 2022
(Limited Text - Ministerial Extracts only)
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Baroness Stedman-Scott
That the Grand Committee do consider the Biocidal Products (Health and Safety) (Amendment) Regulations 2022.
Relevant document: 16th Report from the Secondary Legislation Scrutiny Committee
The Parliamentary Under-Secretary of State, Department for Work and Pensions (Baroness Stedman-Scott) (Con)
My Lords, this draft statutory instrument was laid before Parliament on 18 October. It makes a technical change only and there are no policy changes. It relates to biocidal products, which are used to control harmful organisms and include disinfectants, insecticides and rodenticides. These products have important roles in protecting human health and critical infrastructure and it is therefore essential to society that legal supply of these products is not disrupted.
Although biocidal products are critical to society, they can pose risks to human health, animal health and the environment if used incorrectly. Therefore, to allow a biocidal product on to the GB market, a two-step authorisation process is in place. First, the active substances used in biocidal products must be approved. Approval involves a rigorous scientific evaluation to ensure safety and efficacy—a process which takes one to two years and costs approximately £180,000. If an active substance is approved, applications can be made to authorise biocidal products containing that substance.
This evaluation looks at the safety and efficacy of the formulation, a process which takes about a year and costs approximately £25,000. As noble Lords will understand, the applications are large dossiers of scientific data and require complex evaluation and assessment by a range of specialist scientific disciplines to ensure that there is no danger to human health, animal health or the environment.
The HSE operates a cost-recovery model so applicants bear the full cost of processing applications. Biocidal products are regulated under the Great Britain biocidal products regulation, which was retained following EU exit. The authorisation process in Great Britain is similar to that in the EU, except where references to the EU arrangements were replaced by domestic arrangements.
Also retained in the legislation are the legal deadlines by which applications should be processed. These legal deadlines were in place to ensure consistency across the EU over how long was given to process applications and to provide transparency to applicants. While the UK was still in the EU, a steady stream of applications was processed across EU member states although, even at that time, deadlines were often missed.
In preparation to meet our ambition for the HSE to become a world-class standalone chemicals regulator following the UK’s departure from the EU, significant investment has been made to increase the HSE’s capacity and capability and to embed new processes and procedures. Through a major transformation programme, the HSE’s headcount for its chemicals regulation division has increased by around 40%, with continued ongoing significant investment in people and IT.
As part of the EU exit preparations, transitional arrangements were put in place to ensure a smooth transition for business to the new domestic systems. These arrangements required businesses which had applications in process at the end of the implementation period to resubmit them to the HSE by deadlines in 2021 if they wanted to retain access to the GB market. Under these arrangements, biocidal products already on the GB market could continue to be made available until their application was processed. It was unknown at the time how many resubmissions would be made by applicants to access the GB market until the deadlines had passed.
However, I am pleased to report that over 70% of biocides applications seeking access to the UK market under the previous EU system have been resubmitted to GB. This clearly shows that industry has faith in the GB market and the HSE as the regulator but generates a greater workload than was originally anticipated. As a result, it is not possible to process the large one-off influx of biocidal product authorisation applications within the legal deadlines in place.
This issue has been compounded by the HSE’s loss of access to EU databases holding historical reports which contain scientific information relevant to processing these applications. A resolution should be in place by the time this information is required to process the applications. The HSE will also consider what future digital solutions may be required once a resolution has been implemented; however, the issue has caused some further delays in processing applications. Because these issues have arisen directly from the EU exit, the legal deadlines in the Great Britain biocidal products regulation amount to deficiencies in retained EU law. Therefore, the appropriate course of action available to the HSE is to make amendments through the statutory instrument under the powers to remedy deficiencies in the European Union (Withdrawal) Act 2018. The changes proposed by this statutory instrument are straightforward: the legal deadlines in place to process biocidal product authorisation applications will be temporarily extended by an additional five years. The period of five years has been derived from resource modelling from the transformation programme I referred to earlier. It represents the amount of time that the HSE forecasts it will take to address the backlog and to return to a position where applications can be processed within the original legal deadlines. I trust that it is understood that processing applications is not a rubber-stamping exercise and that it requires highly trained staff who simply cannot be brought in in large numbers at short notice.
The amendment to these legal deadlines should have no impact on businesses, and an extension of the deadlines themselves does not provide any additional cost to the applicant. Instead, this statutory instrument provides legal certainty that where biocidal products are on the GB market awaiting the outcome of their application they can remain there, which may not otherwise be the case had the legal deadlines been missed. This, in turn, also ensures that there is no disruption to the legal supply of essential biocidal products while the backlog of applications is cleared. A small number of new biocidal products authorisation applications will also be affected by this instrument. However, these applications will be prioritised to ensure that where businesses are waiting for authorisations before they can supply their products, they will not experience any delays.
Finally, this statutory instrument also adds an additional transitional measure which was an oversight in the previous EU exit statutory instruments. This allows a type of biocidal product authorisation application called “same product applications” to transition to GB and be treated in the same way as other applications. This also does not have any impact on businesses and is a technical correction to ensure that the biocide regime is now fully functioning as intended. I can confirm that consent to make this statutory instrument has been obtained from Ministers in the Scottish and Welsh Governments, in line with normal conventions. The regulation of biocides in Northern Ireland follows separate arrangements under the Northern Ireland protocol and is not affected by this instrument.
I hope that colleagues of all parties will join me in supporting the draft regulations, which I commend to the Committee.
Baroness Brinton (LD)
My Lords, I thank the Minister and civil servants for the details in the Explanatory Memorandum. I also put on record from these Benches that we too are pleased that arrangements have been made with devolved states; there have been two or three incidents recently where trying to box and cox between those in time to get things out has been problematic, but if that has been able to happen, that is fine.
I should say from these Benches that we do not have a problem with the content of the SI; that is absolutely fine. I just say that, helpfully, the Secondary Legislation Scrutiny Committee, in its 16th report for this parliamentary year, noted in paragraph 4 that
“the Explanatory Memorandum does not indicate what progress the HSE has made in the last three years in reducing the backlog, or whether HSE is building up its own database to prevent”
the problems. I therefore want to ask two questions arising from that. The Minister referred to improvements and understanding that there were pressures so, first, it would be helpful to know whether there is a specific figure available for that backlog and how it is has been reduced. Or is it in fact worsening—which I suspect may be the case—or is it static, having worsened before it came down? On the issue of the Government not being able to access the EU databases now, is there a timescale for the alternative arrangements? That will obviously also help to speed things up.
In reading the Explanatory Memorandum, I have to offer an award to the author in that it is beautifully written and one has to look quite hard to see the problem underlying why we are asked to make this technical SI arrangement. It would be fair to say that the sentence in paragraph 3.1:
“This instrument is formally prospective but will have some retrospective effect”—
in other words—
“this temporary future change will have some effect on past arrangements”,
is glorious and worthy of “Yes Minister”. But I understand the problem. Civil servants are helpfully trying to cover Ministers’ embarrassments, which I will come on to in a minute.
I note that there is a temporary extension for a period of five years to legal deadlines. I particularly turn to paragraph 7.8 in the Explanatory Memorandum, which refers to the “temporary backlog of applications”, and paragraph 7.9, which says that the Health and Safety Executive
“will not be able to meet the legal deadlines”.
The Minister said that the Government intend for us to have a world-class chemicals industry, with world-class safety arrangements. However, the arrangements that were put in place as a result of Brexit and the transitional period mean that a very large number of organisations have had to resubmit applications. I thought it was interesting in the context of Prime Minister Truss—one Prime Minister ago—vowing to scrap remaining EU laws by the end of 2023, that many people said would risk a bonfire of rights. However, it has also created, and will create, an enormous backlog of work for the Civil Service and government agencies. The scale and complexity of the task ahead will be difficult in the context of Civil Service cuts. Can the Minister say how her department and the agencies that report to her—in this instance, I obviously refer specifically to the Health and Safety Executive—will be protected from the proposed Civil Service cuts in order to deliver the extended timescale that is now listed in this particular SI?
This is not just the past Premier’s ambition: about 10 days ago, the Daily Express had a headline
“Brexit bonfire of EU laws set to go ahead with no delay as PM confirms date for axing”
the EU legislation. Can the Minister help to explain how not just this one statutory instrument, but the many thousands of statutory instruments can be in a bonfire by the end of 2023 when we are here today talking about the practical effects on one government agency—the Health and Safety Executive—to make it workable to catch up on the backlog? That is before this Government have even redefined the datasets they were using with the EU to make this job possible.
Baroness Sherlock (Lab)
My Lords, I thank the Minister for her introduction to these regulations, the noble Baroness, Lady Brinton, for her very interesting contribution, and officials for supplying some useful information.
As we have heard, these regulations are needed because the post-Brexit arrangements made for authorising biocidal products in Great Britain are not, shall we say, working quite as smoothly as one might have hoped at an early stage of the process. After Brexit, the process of authorising the “active substances” in biocidal products was transferred from the EU to the Health and Safety Executive. There was a three-year transition period during which products whose active substances had previously been authorised could continue to be sold in GB using the certification. These regulations propose that those products can carry on being sold in Great Britain until the end of 2027, whether or not the HSE has processed their application for authorisation—I hope I have that right; I read them several times but I would not swear to it. However, the Minister can correct me in her response if I have not.
The noble Baroness, Lady Brinton, mentioned the comments by the Secondary Legislation Scrutiny Committee, which helped us to understand that the big problem is in fact a huge backlog primarily caused by the fact that the HSE no longer has access to much of the data stored in EU databases on which previous assessments have been made. Therefore, we need this instrument to give legal certainty that at least until the end of 2027 biocidal products can continue to be sold and used legally while the HSE works its way through the backlog of applications for authorisation.
I too have some questions. First, when did the HSE know that it would not have access to the data in the relevant databases that was needed to make these assessments? Presumably, it was part of the negotiations for Brexit; did it know in plenty of time? If so, why were alternative arrangements not put in place for some time? Nobody could suggest that the Brexit process passed swiftly—I feel that it has been happening for most of my adult life, but even if it was not that long, it was not a speedy process. Was there not time to get ahead of the curve?
I would be interested in the response to the questions raised by the noble Baroness, Lady Brinton, about what the agency is doing to build up its own database and what progress it is making on reducing the backlog.
What assessment has been made of the possible risks of the HSE not having access to the data it needs to make timely and expert assessments of biocidal products? I understand that the EU was doing a rolling review of active biocidal substances, so presumably there are products awaiting authorisation that have not been reached. So their active substances had not yet been reviewed by the EU, yet, at the moment, these regs provide for them to be legally marketed until the end of 2027 without any HSE authorisation. Can the Minister therefore tell us what is the longest period a product could be on the market since either its active substances were approved either by the EU or the HSE?
What happens if evidence emerges that an active substance is not as safe as it had perhaps been thought or indeed as it was known to be when it was approved by the EU? I presume that the HSE or other bodies have powers to act if someone brings evidence to them saying, “Evidence has emerged that this product is not as safe as we thought it was.” However, since there will not be any guaranteed systematic review of the evidence for quite a long time, what if that evidence emerges elsewhere and is not drawn to the attention of the agency? Has a plan been put in place to consider the impact of that? If a product were to contain, say, two active substances which had been approved separately by the EU, how would we know if they would interact and whether the product is safe if the product is not being authorised by the HSE for, potentially, a number of years?
Finally, to follow on from the question from the noble Baroness, Lady Brinton, the HSE now has an enormous job to do. The Minister mentioned an increased head count. What I am interested in is whether she can assure the Grand Committee that her department has taken the view that the HSE has access to the numbers of people and the expertise that it needs to keep British people safe in this area. I look forward to her reply.
Baroness Stedman-Scott (Con)
I thank the noble Baronesses, Lady Brinton and Lady Sherlock, for their contributions. I shall try to answer those questions. If there are some that I cannot answer, I shall write and clarify at a later point.
First, the noble Baroness, Lady Brinton, asked about the backlog in the past three years. It is important to clarify that the HSE has been working on the backlog of biocidal product applications for only around a year. Three years is a misleading timeframe, because it fails to account for the EU exit implementation period and, after that, the time given to industry applicants to resubmit their applications to the HSE. In this year, the HSE has added the details of all resubmitted applications and associated data into their systems and initiated work on around 20% of these. This is in line with plans to clear the backlog of applications. The HSE’s operational planning assumptions are that it will commence 50 applications per year over the coming years, which means that, by the end of the five-year period, it anticipates having completed the roughly 200 applications received after the transition period or be on track to complete them with the normal timeframes in the legislation. After that, the HSE will return to operating within the existing deadlines so that the deadline extension can lapse.
The noble Baroness, Lady Brinton, also asked a question about having lost access to the EU databases. The EU databases contain certain historical information from the EU regime, which it would be too costly to recreate in Great Britain. Therefore, at the same time, the HSE is exploring options for how it can best operate the GB regime, on the assumption that this information will remain unavailable. Working on this is at an advanced stage, and appropriate solutions will be implemented as soon as they are fully developed and tested. I do not know how we would plan to communicate that once it is done, but I shall write to noble Lords.
Baroness Brinton (LD)
I am very grateful for the Minister’s response, but can I decode it as saying that the HSE is having to start again from scratch? It is not quite clear; I understand the part about not being able to use the EU databases, but do I understand that what is happening in the background is that we have had to start again completely from scratch with a completely blank sheet of paper?
Baroness Stedman-Scott (Con)
My understanding is that, with the information that the HSE has, it has to start from a very low point, but it will not be without anything—as I understand it. I am told that biocide evaluations are complex regulatory assessments involving a number of scientific specialisms, so developing solutions is inevitably taking some time. I am not sure that that answers the question that the noble Baroness has challenged us with—whether we are starting from scratch, or whether we have information with which we can start it off. In fact, I can now say that we are not starting from scratch, but I think that I owe both noble Lords a bit more on that, and I shall place a copy of a letter in the Library. They can be comforted that we are not starting from scratch, but I am not sure where we are starting from—but there we are.
The noble Baroness, Lady Brinton, asked about retained EU law. The Department for Work and Pensions and the Health and Safety Executive will continue to assess REUL to identify potential impacts. We are committed to ensuring that health and safety legislation continues to be fit for purpose and that our regulatory frameworks operate effectively following the sunset of the REUL—forgive me for not reading the term out in full.
The noble Baroness, Lady Sherlock, asked about mixing two authorised products into one—a chemistry set comes to mind when answering this question. The new product will require its own authorisation. It will not be allowed on the market until it has gone through its own risk assessment, biocidal product assessment and authorisation
The noble Baroness also asked when the Government found out that we had lost access to the EU databases. The EU withdrawal agreement provided that the UK would no longer have access to the relevant EU databases from the end of the implementation period. Since then, as I said, the HSE has been assessing a number of options to manage biocidal product authorisations, taking into account the loss of access to historical information in EU databases, such as use of publicly available information. I am sorry that it is not possible to give a timeline, but work is at an advanced stage and appropriate solutions will be implemented as soon as they are fully developed and tested.
The noble Baroness raised the issue of resources, which is important. The total budget for the HSE’s chemical regulation division has grown by 39%, from £22.4 million to £31.2 million between 2018-19 and 2022-23, reflecting the HSE’s need for increased resources for its post-EU exit responsibilities. The HSE’s current focus is on building out from our initial day one operating capacity and laying the foundations for its long-term future operation. The funding the HSE has received to date is sufficient to support that work, and I am not aware of any attempts to reduce it in the current climate.
The noble Baroness, Lady Sherlock, asked about the risks of leaving products on the market. There is a multi-regulator approach to the regulation of biocides not yet authorised under BPR using a jigsaw of legislation, including product safety law and earlier pesticides legislation. This provides proportionate powers for the appropriate authorities to take the regulatory action if products are identified that pose risk to people, animals or the environment.
The instrument will provide the necessary extension to the legal deadlines—
Baroness Sherlock (Lab)
On that last point, the question I was trying to ask—I probably phrased it very poorly—was that I realise that if information comes to the Government’s attention, by some tool or agency, a means will be found to do something about it. But it is quite possible that, for a product that has been on the market without review for a long time and is used around the world, evidence may have appeared elsewhere which has not been brought to the Government’s attention. The point about systematic reviews is that one presumably goes out looking at the evidence. Is there any concern that, the longer products are on the market, the greater the risk that some previously unclocked problem may arise?
Baroness Stedman-Scott (Con)
I will write to the noble Baroness about that. I would assume—correctly or incorrectly—that the Health and Safety Executive is keeping up with developments by other countries’ health and safety agencies, but let me write to the noble Baroness to clarify that point. If, when she gets the letter, she is still worried, she may come back to me and I will do further work on it.
To conclude, the instrument will provide the necessary extension to the legal deadlines to enable HSE to process effective biocidal product authorisation applications. This will provide legal certainty to businesses that biocidal products on the market awaiting their application to be processed can remain there. In turn, biocidal products essential to the functioning of society can continue to be made available and used. I commend the instrument.