Official Report 585KB pdf
Biocidal Products (Health and Safety) (Amendment) Regulations 2022
Our third item of business is evidence on a consent notification on the Biocidal Products (Health and Safety) (Amendment) Regulations 2022, which is a forthcoming United Kingdom statutory instrument on which Scottish Government consent to legislate is sought. The Scottish Parliament has a role, subject to a protocol, in the scrutiny of Scottish Government consent to UK secondary legislation in devolved areas arising from European Union exit.
There is a short reporting deadline on this notification, so today we will hear from the Scottish Government on its proposal to consent. We are joined by Màiri McAllan, who is the Minister for Environment and Land Reform, and the Scottish Government officials Dan Merckel, chemicals team leader, and Luigi Pedreschi, solicitor.
We have around 25 minutes for this item. Minister, I believe that you would like to make an opening statement and that you have a slight correction to make regarding the notification.
Thank you for the opportunity to make some opening remarks on the substance of the statutory instrument. I hope that they will be helpful, because the regulations are complicated. I will then address the error.
The SI relates to the control process by which biocidal products, which are mainly used to control pests or bacteria, or to protect people, animals, materials or articles from pests and bacteria, are considered for access to the Great Britain market. The overall purpose of the SI is to put in place temporary measures to allow the Health and Safety Executive to process the large number of applications that were received under the transitional arrangements following EU exit.
The GB regime—as I will refer to it—ensures that any products that are placed on the GB market are safe to use and efficacious. Suppliers or manufacturers of biocidal products have to apply for authorisation from the HSE to be able to sell or use their products, and must do so within specific timeframes. With the transitional arrangements under the GB regime, the HSE has received a very large influx of applications, which it cannot deal with within the legal deadlines as they stand. The SI purports to extend the deadlines for certain applications.
The authorisation procedure in the GB regime depends on the type of application that is being made. The changes made by the SI will affect the legal deadlines across various applications.
The Health and Safety Executive is confident that amending the regulations in the way that is proposed will allow it to process the applications that it has received within the extended deadlines. Applications will be processed on a rolling basis. Work has started already, and it is expected that the majority will have been processed before 31 December 2027—the new deadline.
The Scottish ministers consider that the situation should have been foreseeable. The events that have made the SI necessary were not of our choosing. However, given the situation at hand, we think that not agreeing to the extension, and thereby hindering the operability of the new GB regime, would pose a greater risk to the environment, public health, businesses, consumers and the economy than allowing the temporary extension. If consent were not granted, the practical implication would be that, as current evaluation deadlines pass, legally, large numbers of biocidal products would need to be phased off the GB market.
Thank you for giving me the time to set that out. I will now briefly address the error in the notification and the notification summary that we submitted to the committee on 23 September. The notification does not accurately describe one of the proposed legislative changes—it is a minor change compared with the overall effect of the SI.
I will explain it for the record, but this is very complicated, so please bear with me. The original notification stated that the SI introduced into the GB regime
“a new transitional provision”
that would
“allow applications to change or modify an authorisation made under the EU”
regime before the implementation day and that that would be transferred to the GB regime
“provided the application and relevant information have been resubmitted.”
However, the notification should have said that the new transitional provision will allow applications made to the HSE before implementation day, specifically under regulation 414/2013, which are subject to the simplified authorisation procedure, and for biocidal products that are identical to another product that is already authorised or under assessment, and that those should be resubmitted and considered for authorisation under the GB regime.
My officials inform me that that was a result of an oversight in drafting and that we let the committee know as soon as we could. I express my apologies for that oversight in what is clearly a very technically complicated piece of work.
10:45
Thank you for that explanation, minister, and for notifying the committee by letter so that we could consider that prior to today’s meeting.
The first questions come from Jackie Dunbar.
What are the current deadlines set out in the GB Biocidal Products Regulations? How will the proposals change those?
We know that this is technical. I will try to address each question in turn, and I have legal and policy colleagues here to help me with that.
I like to think of the timelines in the regime as being in two tiers. First, there are timescales for resubmitting applications in the transitional period. There was a 90-day period for applications for which the UK was originally the evaluating member state and a 180-day period if an EU member state was originally the evaluator. Once an application been resubmitted, that triggers a need for the Health and Safety Executive to validate it “without delay”. That is the term that is used in the legislation.
The applicant then has to pay a fee, for which I understand they have 30 days. Once that has been done, that triggers the period in which the HSE must consider the application. Previously, for certain applications that are touched by this SI, that would have been 365 days. We are now proposing that the deadline should be 31 December 2027, in order to give the HSE time to evaluate the influx of applications that it has received since EU exit.
That is the principal change. I ask my colleagues whether they have anything that they want to add.
I turn to my legal colleague, Luigi Pedreschi, to give a further answer on the question of timescales.
As the minister outlined, the GB regime sets out various deadlines by which an application must be authorised. The trigger point at the start of those timelines is the date on which the Health and Safety Executive notifies the applicant of the relevant fees. Those fees depend on the type of application in question.
As the minister said, the applicant, once notified, has 30 days in which to pay their fees. Once they have done that, the Health and Safety Executive must either accept or validate the application. The distinction between acceptance and validation depends on the type of application. The evaluation period begins thereafter. That will be 365 days for a standard national authorisation, but it might be shorter for a different type of application.
The proposed law postpones the date on which the HSE needs to notify applicants: it pushes it back to 31 December 2027. That means that, if an applicant is notified of the fees at that later date, the application evaluation period will run from that date onwards.
When an applicant is notified of the fees sufficiently in advance of 31 December 2027, so that the HSE can complete its evaluation before 31 December 2027, it must complete its evaluation by that date.
Minister, what discussions have you or the Scottish Government had with the UK Government about the impact of the loss of access to EU data on the HSE’s timescales for evaluating applications for authorisations?
I mentioned in my opening remarks that we are trying to work through what would be fair to call a situation that we did not want to find ourselves in and that is not of our making. Throughout the whole preparation process for EU exit, the Scottish Government made it absolutely clear that negotiated access to the EU chemicals database was important and should be pursued. Regrettably, that has not transpired, as the UK Government pursued the hardest of Brexits, and we no longer have access to the EU database.
However, the question was about the extent to which the Scottish Government has made representations to the UK Government. We did that throughout the preparations for Brexit.
Good morning. My question follows on directly from the previous one. Will the loss of access to that data result in delays in evaluating applications for authorisation in the longer term beyond this period?
I am hesitating, because it is difficult to predict with certainty what all the implications of EU exit will be across biocidal products and the chemicals regime. We are attempting to manage GB-wide processes as best we can. We have moved from a situation in which authorisation was done on an EU-wide basis. In some circumstances, we would have had mutual recognition between member states whereby, if something had been authorised in one country, it would have been recognised elsewhere. It is clear that that reduced the authorisers’ workload.
To give the committee some confidence, for normal applications, we would expect most of the required information to be on the face of the application. In those circumstances, not having access to the EU database should not hinder the authorisation process.
However, there is no doubt that it is a complicated situation and that it is sometimes very difficult to foresee what the problems might be before they arise.
A lot of chemical applications will be for on-label use but will involve a different permutation of the chemical application. They will have data sheets anyway, and, if companies have applied for use in the European Union, surely they will be submitting that information voluntarily, and the questions asked by the European Union will also apply to the HSE regarding the use of that chemical in the UK. Therefore, it should surely not slow things up that much.
On the latter point, if I understand you correctly, the information that is required for authorisation in the EU and in GB will be similar. As I said, for normal applications, we would expect the required information to be on the face of the application, so I would not expect delays for such applications to run beyond the transitional period, in which the delays are simply the result of a big influx of applications, rather than necessarily a lack of information on each application.
I want to check that I understand this. The application processes in the UK and the EU will run in tandem, so a lot of information that will be asked for will be similar. I cannot see how things will be slowed down for companies.
I will bring in my colleagues. I do not think that there is any guarantee that the processes will run in tandem. We have asked the HSE to consider the way in which they prioritise the applications that they get, but I do not think that running in tandem is something that—
I will bring in Dan Merckel on that. It is unlikely that most chemical manufacturers will see the UK as a big enough market to develop a product for. Surely they will do that for the UK and the EU in tandem.
I do not think that things will run in tandem. The thing to bear in mind is that there are many different kinds of applications here. There is not just one type of application, unfortunately. Where there is prior knowledge in the EU system that we might not have access to in the GB system, that could result in delays. However, with normal applications that are subject to the SI, that should not result in any delays, as the minister said. The information available in a data package as submitted should be sufficient to allow the HSE to conduct its evaluation.
As we have said all along and as the minister has said, it is a very complicated situation. There are lots of different kinds of applications and lots of different provisions to make sure that everything is assessed in time in the GB regime.
That is against the backdrop of a staggered approach in the EU whereby evaluations are driven entirely by when an application is made to a competent authority in a particular member state, which can happen at any time. It is also worth mentioning that delays in EU member states’ evaluations are common in the EU system.
There are competing elements that mean that it is difficult to compare the timescales in the two regimes.
That is interesting. From what I have heard, it sounds as though it would be possible to piggyback on EU applications, but you would be reliant on the information that the applicant provided to the EU, as opposed to the approvals database—is that correct?
Yes, I think so. If the applicant was interested in trading in the GB market as well as in the EU one, there would be nothing to prevent their submitting an application to both regimes.
But you would be reliant on the applicant as opposed to the approvals database.
On the volume of work, what discussions has the Scottish Government had with the UK Government about how it ensures that the HSE is sufficiently resourced to carry out its functions in this area effectively and to reduce delays in processing authorisations under the GB biocidal product regulatory regime?
As would be expected, a lot of work was done in preparation for EU exit and in anticipation of what the HSE would undertake on behalf of devolved ministers and the secretary of state, because it is our agent in such matters. There was a scaling up of the chemicals regulation division in the HSE to ensure that it had the resources. That was matched by financial resourcing being scaled up as well in preparation for the work that was coming.
To give some context for the five-year period, it is not that the HSE has just surmised that that is the amount of time that it will need. It is based on modelling of how quickly it is getting through applications as it is.
There has been a scaling up as part of EU exit preparations, and the time that is now being asked for is based on modelling of what the HSE thinks is possible.
How does that compare with the EU’s progress and pace in approvals—or, indeed, non-approvals? How will the delays that we are hearing about impact the Scottish Government’s ability to keep pace with the EU on that?
There is undoubtedly scope for a lack of alignment between the GB regime and the EU regime. Something could be approved in the EU and not in GB, and vice versa. Dan Merckel mentioned that the EU regime can be subject to delays as well.
The practical implications of a lack of alignment are different, depending on the type of product and whether it was on the market already prior to EU exit or whether it is a new product. It is all different, but there is scope for misalignment.
With the delay in evaluations, is there a danger that we will run behind the science? What assessment has been made of the potential risks of that to the environment and human health?
It is a good question. Because of the many different permutations—the different products, the different times that they have been on the market and the different conditions of use—it is difficult to answer it all in one go. However, I take a lot of comfort from the fact that the EU has informed the HSE that the active substance in the product that makes it biocidal will have been party to an EU-wide consideration. We have therefore been given comfort on the effect of the active substance.
11:00Different products are treated differently. A product that was already on the market prior to transition will be able to stay on the market a bit longer to allow the influx of applications to be processed, but the conditions of use will still be in place. A new product will not be able to be on the market until after that extended period. I take comfort in that, too.
That said, I will hand over to Dan Merckel to see whether he has anything to add. I should say, though, that this all comes back to a point that I made in my opening remarks, which is that we need a process of oversight and authorisation that works properly. Albeit that we do not want to be in this position, the risks to the environment, human health and the economy are made greater by not allowing that extension for authorisations to take place.
I have probably said everything that there is to say. Dan, do you want to say anything else?
I just want to emphasise something that the minister mentioned, which is that biocidal product regulation in GB and the EU is a two-tier system. All products that have a biocidal action because of active substances must be approved and must go through a rigorous safety and efficacy assessment to be placed on a list, and all approved active substances must be on that list.
When that evaluation takes place, the applicant must also submit one example of a product type in which the active substance is used, to check for safety in that product. The HSE has confirmed that all the active substances in the very large number of products that need to be evaluated have been through that process, which gives us a baseline of safety.
It might also be worth mentioning that, if we were to have intelligence that a product in the EU had not been authorised following evaluation by a member state, we would hope that the HSE would prioritise that particular product for evaluation here, if it was in the GB system.
We would hope that would be the case, too.
I want to ask about the potential for increased animal testing, which is something that has been raised in relation to the registration, evaluation, authorisation and restriction of chemicals regulation.
I am sorry, Mr Ruskell—I did not quite hear that question.
I just want to raise the issue of the potential for increased animal testing, which has been raised in relation to the implementation of REACH.
Mr Ruskell, could you elaborate further on that?
I raised this point with Michael Gove, who actually took it quite seriously. If there is an evaluation process, could that lead to increased animal testing if particular products, or any active ingredients within them, effectively have to be re-evaluated?
I see what you mean and why that would be a pertinent question in the context of chemicals regulation in general. However, in the case of this SI, because of the specific tweaks that it seeks to make to timescales, because of the fact that no new product will enter the market within the timeframe and because any existing product that has had its time on the market extended will do so under the current conditions of use, I am comfortable that there is no risk in that respect.
Dan Merckel might wish to add to that, but we might also be able to come back to you with more information.
I think that Dan has already given the answer, which is that all the chemicals sitting within the packet of chemicals looking for authorisation already had an on-label use. As they are already being used, they would not need to be tested and re-evaluated. Is that not what you said, Dan?
Yes. The applications are already there. Unless the applicant has put in a data waiver and has tried to demonstrate that they do not need to conduct a particular test, the testing has already been conducted in the particular cases that this SI addresses. That said, I understand the member’s point, which is a wider concern across the GB chemicals regime.
Liam Kerr wants to come in.
Given the potential for risk and significant delays in evaluating authorisations, why has the Scottish Government not engaged or consulted with stakeholders to assess the impact of the proposals?
I certainly agree with the first part of the question, about the potential for risks known and unknown. However, on the second part, we have had on-going engagement with stakeholders—industry, trade, and environmental NGOs—since 2017 through the Scottish chemical policy network. That is exactly the place for on-going consultation and engagement with stakeholders, whom we encourage at all stages of what is a complex journey to come forward and raise issues with us.
Forgive me, minister, but may I press you on that? The type 1 notification that you submitted to the committee says:
“these new measures are aimed solely at ensuring the functioning of the GB BPR and, therefore, we have not undertaken any engagement, or any formal consultation, about these specific amendments.”
That seems rather at odds with the answer that you have just given. Can you clarify the point?
Of course—I am happy to do so. The network was set up in 2017 as a forum in which stakeholders across industry, trade and ENGOs could approach the Scottish Government with concerns. It is not true to say that we did not consult. The forum is there, should stakeholders wish to raise matters with us, and we actively encourage them to do so.
Forgive me, minister, but the type 1 notification says that there has been no formal consultation.
I think that I understand what you are saying. You are saying that the opportunity is there, but the actual engagement and consultation have not, in fact, been carried out, as has been notified to the committee through the type 1 notification. Is that correct?
That is correct. The opportunity is there and has been since 2017. The network is a live forum, in which we engage reciprocally with stakeholders across the piece. What you have quoted is right.
I will hand over to Dan Merckel to say a little more about the decisions that were made about what, specifically, to consult on, and when. However, as I have said, that forum is there, and it operates well as a go-between for the Government and stakeholders.
I would emphasise that, as this is a cross-GB regime—obviously, the market for biocidal products goes across the whole of GB—it would arguably be better for any consultation to take place at the GB level. As the minister has said, we have in place a forum that allows stakeholders in Scotland to approach us with any issues that they might have. It is probably also worth mentioning that we were made aware of the issue only in May, which was quite late on, so we would not have had the chance to consult actively on it.
I hope that this is an easy question. We have had your written submission, but are you aware of any change to the instrument’s proposed laying date at Westminster? We believe that the date is 17 October. Is that still the case?
Yes, as far as I am concerned. I am not aware of any changes; the date in mind is 17 October, and officials have been engaging with the HSE on that.
I see that Dan Merckel does not have anything else to say on that, so, as far as we are concerned, the date is still 17 October.
Good. You seem to be confident about that, and a discussion has taken place.
Just for the record, given the short timescales involved, which have meant that the committee has had only a short time to consider the notification—roughly 10 or 11 days, instead of the 28 days that are normally available for scrutiny—why was the notification not sent to the committee until Friday 23 September?
I apologise to the committee for the short timescales that have transpired, which have been due to a combination of factors. First of all, as Dan Merckel mentioned, this is a GB-wide piece of work. We received drafts, which have then been changed. That is not anyone’s fault—it is just the nature of what we are doing. This is a complicated set of provisions that requires close consideration by officials and legal colleagues. The period of mourning the passing of Queen Elizabeth also affected when we could officially come to the committee.
I can only apologise for the delay and say that we are glad to be here today to give evidence.
Thank you for that, minister, and for acknowledging how complex this item is. It is important that the committee gets as much time as possible to examine it.
You have mentioned a combination of factors for the delay, including the death of Queen Elizabeth and the period of national mourning. If we were to make contingency plans for other royal or national events in the future, could we avoid such delays? Clearly, there is a lot of pressure on officials. Could anything be done differently to protect the timetable for scrutiny, which I am sure you will agree is important?
I absolutely agree. For our part, we commit to continually improving on the time taken to assess the drafts that we receive and for Scottish ministers to give their views on them and get everything to the committee. With the extraordinary event of the Queen’s passing, we all had to consider and deal with certain practical issues. It was quite an unusual situation, but, of course, we will have learned from it and hope that we will not have to deal with such instances very often. Certainly, we will have learned about interaction with committees during such periods. On the parts that were entirely in our gift, we commit to continually trying to improve.
Monica, I know that the minister does not need defending, but she came at fairly short notice today. This meeting was not planned until the latter part of last week, so the Government has shown the committee some flexibility, and I thank the minister for that.
As no member has indicated that they have further questions, I thank the minister and her officials for taking part.
We move to agenda item 4, which is consideration of the consent notification for the Biocidal Products (Health and Safety) (Amendment) Regulations 2022, which have yet to be laid. The Scottish Government proposes to consent to the instrument, as we addressed in our consideration of agenda item 3.
Several options are open to the committee, all of which would result in our sending a letter to the Scottish Government, stating our view. The first is that, if members are content, we can approve the proposal to consent. The committee will then write to the Scottish Government, indicating as much.
Secondly, members can approve the proposal to consent and, in the letter confirming that, seek further information on any further queries that they might have.
If members are not content with the proposal, the recommendations that we can make to the Scottish Government are listed in paragraph 9 of paper 3. We could indicate that the Scottish Government should not give consent and propose either that it produce an alternative Scottish legislative solution or that it request that the provisions be made in a UK SI laid in both Parliaments under the joint procedure, or we could indicate that the provision should not be made at all. I hope that I have made the options clear.
If members have no comments on the evidence that we have heard—and I am not seeing anyone leaping in to make a comment—I will move to the substantive question on this item. Is the committee content for the provision set out in the notification to be made in the proposed UK statutory instrument??
Members indicated agreement.
We are agreed. Gosh—that was simple and saved us from having a vote.
We will write to the Scottish Government to that effect by its deadline of 11 October 2022. Is the committee content to delegate authority to me to sign off a letter to the Scottish Government, informing it of our decision today??
Members indicated agreement.
I was hoping that Natalie Don was not about to say no there. We are agreed.
Minister, you can slip away now. I know that you are busy.
The Persistent Organic Pollutants (Amendment) (EU Exit) Regulations 2022
Agenda item 5 is consideration of another consent notification for a UK statutory instrument that has not yet been laid.
The Scottish Government proposes to consent to the instrument, which, as the clerk’s paper indicates, relates to the new UK chemicals regulatory regime for persistent organic pollutants.
As discussed under the previous agenda item, a protocol has been agreed between the Scottish Government and the Scottish Parliament for situations in which the Scottish Government proposes to consent to certain types of secondary legislation made by the UK Government as a result of EU exit. The protocol sets out how the Scottish Parliament may scrutinise such decisions. There is a statutory requirement that the Scottish Government’s consent be sought for this proposed instrument.
I refer members to the paper for this item. Again, multiple options are open to the committee on the consent notification. I will not go through them all again—they are exactly the same as those for the consent notification that we have just considered.
If members have no comments, I will move to the substantive question. Is the committee content that the provision set out in the notification be made in the proposed UK statutory instrument??
Members indicated agreement.
We are agreed. We will write to the Scottish Government to that effect. Is the committee content to delegate authority to me to sign off a letter to the Scottish Government, informing it of our decision today??
Members indicated agreement.
That concludes the public part of our meeting.
11:16 Meeting continued in private until 12:37.