Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025
(1 month ago)
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Baroness Merron
That the Grand Committee do consider the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025.
Relevant document: 17th Report from the Secondary Legislation Scrutiny Committee (special attention drawn to the instrument).
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)
My Lords, these regulations were laid before the House on 29 January. This draft SI uses powers conferred by the Retained EU Law (Revocation and Reform) Act 2023 to propose two reforms to the market authorisation process for regulated food and feed products in Great Britain. The first is the removal of the requirement for certain products to be reauthorised every 10 years, and the second is to allow authorisations to come into effect following ministerial decisions and to then be published in a public register, rather than prescribed by statutory instrument. The reforms are very much related to process.
These reforms are part of this Government’s mission to kick-start economic growth by increasing investment, driving up productivity and tackling regulatory barriers—something that I know noble Lords are concerned with. The UK food industry is worth some £245 billion in consumer spending annually. It is driving innovation, particularly as the UK’s growing engineering biology sector harnesses emerging technology to produce novel foods.
Regulated products are food and feed products that require safety assessment before they can lawfully be sold. The Food Standards Agency and Food Standards Scotland carry out this assessment and provide recommendations to Ministers across Great Britain on the authorisation of products. Innovation and growth across the food sector is increasing demand for authorisations. We need proportionate regulation to support investment, while maintaining safety and consumer trust. This statutory instrument removes requirements that are unnecessary for food safety without compromising it.
On renewals, certain authorised products must currently be reauthorised every 10 years. This SI removes that requirement. Instead, safety reviews will be carried out when necessary. The service will be more efficient if regulators focus on detailed reviews of products that potentially pose risk, instead of reassessing products that have many years of safe use.
The FSA and the FSS have earned public trust through rigorous risk analysis. These reforms build upon regulators’ existing powers to request safety information. They enable an efficient approach, where the regulators respond effectively to emerging risks. I emphasise that, where necessary, approvals can be modified, suspended or revoked. Food safety will continue to be the priority.
Although steady progress is being made, it is fair to say that the FSA and the FSS are not processing as many applications as are coming in. This is causing an increasing backlog, which is of concern. There are 481 current applications; although 97 applications have been completed since 2021, the caseload is growing, not reducing. Of those 481, about 100 are renewals, with almost 500 additional renewals expected in the next three years. This has to be dealt with. While the FSA and the FSS have implemented measures to improve the service within current legislation, it is essential that the service and the system are modernised. Removing automatic assessment for renewal allows a more targeted approach.
I turn to the removal of SIs. The second part of these reforms allows authorisations to come into force following ministerial decisions and to be published in a public register, rather than being prescribed by an SI. This will enable new products to be brought to market more quickly, without, I emphasise, compromising safety. Publishing authorisations together in online registers, rather than in complex legislation, will make finding information on authorised products more accessible than currently. This aligns with other UK regulators’ authorisation processes, such as for veterinary medicines and pesticides.
The FSA and the FSS provide scientific scrutiny through expert staff and independent scientific advisory committees. They provide safety assessments, risk management advice and recommendations for ministerial decisions. This process aligns with internationally recognised principles. The FSA and the FSS will publish risk assessments and authorisations, in line with their commitments to transparency. The statutory obligation to consult will not change, and authorisations will continue to be subject to public scrutiny.
I assure noble Lords that there has been extensive engagement with industry and consumer groups, including through public consultation. The reforms have received substantial support. The Secondary Legislation Scrutiny Committee was reassured by the FSA’s responses to questions raised during scrutiny. I have responded to those primary areas of focus in this opening speech.
These reforms prioritise efficiency and safety, focusing resources on innovative products. I hope noble Lords will feel able to support these reforms, which will create a service which manages risk in a proportionate fashion, without compromising our high food and feed safety standards. I beg to move.
Baroness Coffey (Con)
My Lords, I welcome these regulations, on several grounds. First, as the Minister mentioned, this is a deregulatory approach. There cannot be many regulations deemed to be deregulatory that have 104 pages, but 70 of those pages deal with revocations of existing legislation. That is to be welcomed.
I completely support that this will be a risk-based approach. I am conscious that consultations are ongoing on products being considered by the FSA under this approach. I am conscious that some may be concerned about removing the need for separate secondary legislation, which is a hangover from our days in the European Union, but this is perfectly routine.
I have a couple of questions for the Minister. First, I am conscious that the Food Standards Agency is a non-ministerial department, with the DHSC leading on this in government and in Parliament. Can she confirm whether DHSC Ministers will be making these decisions or whether it will be open to Defra Ministers?
Secondly, an issue that arose during the passage of what is now the precision breeding Act was concern that the devolved Administrations would be reluctant to have any GMO in products sold in their countries. The purpose of the United Kingdom Internal Market Act and the non-discrimination principle was to make sure that, where something had been given the go-ahead in England, say, it could be sold anywhere across the United Kingdom, respectful of the devolved Administrations but nevertheless giving consumers that choice. Will the UK Government fully assert the non-discrimination principle in the sale of future products? As I said, I support these regulations.
Baroness McIntosh of Pickering (Con)
My Lords, I support the comments made by my noble friend and concur entirely. I congratulate the Minister on bringing forward this streamlining and deregulatory process. However, I share some of the concerns put forward by the Secondary Legislation Scrutiny Committee.
My noble friend talked about GMO. I am personally very wary of GMO products: I would like to know if I were eating such a product or if such feedstuff was being fed to an animal that I may go on to eat. Can the Minister assure me that the removal of the renewals process will not lead to any information affecting the suitability of validation methods for GMOs being overlooked? Put simply, can the public and consumers rest assured that the processes that have been followed hitherto will be followed? How can the public be made aware of those processes and know that that is the case?
Baroness Bennett of Manor Castle (GP)
My Lords, in following the noble Baroness, Lady McIntosh, I echo her concerns about the labelling of GMOs, and I look forward to the Minister’s answer on that. I am afraid that I somewhat disagree with the noble Baroness, Lady Coffey, regarding the rights of the nations of these islands. They surely should have the right and ability to say that they want healthier food and the right to set higher standards for food than England may choose to.
Coming to the general point, I find it a little surprising that we have heard considerable celebration about reductions in red tape at a time when there are grave concerns among the public about the safety of our food supply, particularly the impacts of ultra-processed foods, which contain many of the substances that will be covered by these regulations, and in a society that has huge problems with the overall level of public health. Surely it is better to have so-called red tape than for people to become ill as a result of the food that they buy without knowingly putting themselves at risk.
As the Minister set out so clearly—I thank her for that—there are two chief changes here. The first is to remove the requirement for reauthorisation for certain products every 10 years. These are products that have previously been identified as high risk, which is why they are on the list: feed additives, and food and feed containing GMOs or smoke flavourings. We are taking away actions to monitor products that have been regarded as high risk. Secondly, as the noble Baroness, Lady McIntosh, said, we are removing parliamentary scrutiny by not requiring SIs. Building on what she said, will there be an accessible list somewhere that can easily be found by Members of the House and members of the public?
When we do not have the automatic 10-year authorisation, what will happen when an issue arises? I do not think that this has been covered very clearly at all. How will the Government alert the House to that issue? We have seen this happen in many areas before, and I expect that NGOs and researchers in universities would come to an individual Member of the House and they would have to batter away at trying to establish the issue, how big it is and what is happening. However, we and the NGOs have only limited capacity. How will the Government keep us and the public informed about what is happening when this starts to be an issue?
I thank the Secondary Legislation Scrutiny Committee for a very comprehensive piece of work on this SI. It is seven pages of quite detailed scrutiny, which contain a considerable number of expressions of concern. The committee is concerned that the Explanatory Memorandum did not fully explain the mechanisms to detect and monitor the risks in absence of a renewal process, which essentially addresses the issue I just raised about how we know.
Some of the discussion is about what happens in the testing of products if technology and our understanding change. We are in a period of rapid, massive change in our understanding of the operations and the biology of the human body. I have talked in other contexts about microbiotoxicity, where products impact on the human microbiome. That is a sentence that would not have made any sense 10 years ago, which reflects how fast our understanding of human biology has changed. We are just starting to get into understanding the virome—I recently hosted an event on phages—the bacteria and fungi in our body and how they interact with viruses and food. It is a very complicated and fast-moving area.
I have focused on the Food Standards Agency, which has a total of 1,582 members of staff in England, Wales and Northern Ireland. As the Minister has said, it is struggling with the number of applications that it is getting and, essentially, it does not have enough staff. If that is the case and there is this flood of new applications, how can we be reassured that attention will be given to things in that “Already done, don’t really have to think about it” pile, particularly when there are so many other biosecurity risks facing our country?
I declare that my comments have been informed by Beyond GM. It highlights that the Government Chemist, which is part of DSIT and hosted by the Laboratory of the Government Chemist—which is now, curiously, a privatised organisation—
“expressed the view that the renewals process”
needs to make sure that it has
“necessary scientific checks on the currency of validation methods”.
This is not just the biology changing but the understanding of our testing.
Finally, I offer a reflection on what we have seen happen in so many areas of public safety related to chemicals. Teflon is not a food additive, although it is an additive that has been unintentionally put in our food. PFAS were discovered in the 1930s; by the 1970s, companies including DuPont and 3M were aware of the risks and hid them. It was only in the 1990s that regulators and the public started to become aware of them. We have to be aware that we cannot trust giant multinational companies to declare to the Government and identify when a problem first starts to emerge. This has to be done by people acting for public good, not for private profit.
Baroness Walmsley (LD)
My Lords, as the Minister said, this SI does two things. It removes the requirement for 10-yearly renewals of regulated product authorisations and removes the requirement for regulated product authorisations to be prescribed in secondary legislation, instead allowing them to come into effect following a ministerial decision, presumably based on appropriate advice from the FSA.
As is not unusual, and as has been mentioned before, the Secondary Legislation Scrutiny Committee, in its 17th report of this Session, was critical of the Explanatory Memorandum. The efforts of this hard-working committee, which I admire very much, have filled in many of the gaps; however, I feel that it should not have been necessary for it to do this had the department provided a fuller and more helpful explanation of the protections. Is it not for officials to predict the concerns that might arise about new regulations, explain why the Government feel that they have been addressed and put that in the Explanatory Memorandum?
The Government assure us that the changes are intended to simplify the authorisation process and would create
“a more streamlined and effective regulatory regime”.
They cover three regulated product regimes: feed additives; food or feed containing, consisting of or produced from genetically modified organisms; and smoke flavourings. I believe that all these product groups may be subject to new evidence of health or environmental effects—either benefits or dangers—as time goes by. The FSA and the FSS have responded that they
“would continue to assess products at initial application stage to authorise them as safe to be placed on the market, and would maintain their powers to carry out safety reviews of authorised products already on the market at any time if new evidence or risks emerge”.
The words “at any time” are key, because they mean that those organisations do not have to wait 10 years to spot and assess a problem. This is reassuring.
However, as we have heard, Beyond GM was concerned that, in future,
“greater emphasis would be placed on the FSA’s post-market monitoring activities to ensure new evidence and risks are detected before harm occurs”.
I am familiar with the FSA system of horizon scanning in another context. It is thorough, gathering intelligence from international regulators, global networks and its own scientific advisory committee for horizon scanning. It also keeps abreast of analytical methodology and has a well-used incident reporting mechanism. As we speak, revocations of authorisations due to safety concerns reported through this mechanism have generally been actioned outside of the renewal process—in other words, it has not had to wait for 10 years. Can the Minister assure us that the FSA has sufficient resources to keep up this level of horizon scanning and subsequent action? I am clearly not the only Member of this Committee with concerns about this; the same submission from Beyond GM had concerns about it as well, in the light of recent budget cuts and staff shortages.
The FSA responded:
“An evidence-based review system will ensure already authorised products are reviewed based on risk and new evidence, rather than on a fixed timetable”.
This new risk-based system may well be a response to budget cuts, but it could also be justified by the fact that there is no point in wasting precious staff time on reassessing products that have consistently been found to be safe—and I mean “consistently”; one reassessment may not be enough in this field. Can the Minister tell us which of those two options it is? Of course, we might not have needed the Minister’s explanation if the EM had been more helpful.
There were submissions suggesting that GMOs should not have been treated in the same way as other products. The SLSC’s report contains the FSA’s explanation of the additional measures that are in place when GMOs are authorised initially and of how monitoring occurs post market approval. This includes the responsibility of the businesses—the producers, or the people putting the food together—to supply annual reports to the FSA and the FSS about environmental and any other risks that were not predicted at the start of the authorisation. Is the Minister confident that these reports are always sent and are complete? There may be vested interests in not having them complete.
There was a response from the Government Chemist, as we have heard, which was interesting. It considers that the renewals process, which is now being removed, provides important and necessary scientific checks on whether laboratory-based validation methods for GMOs remain current. In other words, it was not about the dangers of GMOs themselves but confidence in the laboratory procedures which assess them. The FSA response says that it will be relying on businesses, which will continue to be required to notify the FSA and the FSS if they have any new information which might affect the suitability of a validation method. Can we rely on businesses to know that and to report any concerns? Given that science is developing so fast in the world of biotechnology, is the Minister confident that we have a regular means of ensuring that we have the best, most up-to-date and accurate methodology, without having to rely on businesses telling us or on this being looked at every 10 years?
Lord Kamall (Con)
My Lords, I welcome the noble Lord, Lord Moraes, to his place. We served together in the European Parliament, of which he was a well-respected member. I thank the Government for sending out so many big guns—I think I count six on the Front Bench in this Room. I will not flatter myself that they are here for me, but I am impressed by how seriously the Government are taking this statutory instrument.
I thank the Government for addressing the concerns of the Secondary Legislation Scrutiny Committee. The noble Baroness, Lady Walmsley, rightly said that questions were not answered, but it is good that the Government were able to address those concerns, and we are grateful for that. Like my noble friends Lady Coffey and Lady McIntosh of Pickering, I think that these Benches generally welcome measures to streamline processes, but I understand potential concerns over the safety and oversight of regulated products. As the saying goes, one person’s safety standards may be another’s red tape. That was something that the noble Baroness, Lady Bennett, alluded to.
We welcome that there was a consultation between April and June 2024. I understand that, while there was broad agreement in principle, there were some concerns and disagreements, which I would like to ask the Minister about today. Before I do that, I shall pick up on the issue of GMOs. Let me clear—I have nothing in principle against GMOs, but for consumers it is important that there is labelling, so that they can make that choice in an informed way. When we were in the European Parliament and negotiating the Transatlantic Trade and Investment Partnership with the US and made the point about labelling GMOs, what was interesting was that the US negotiators would say, “That’s a non-tariff barrier”. If the Government intend to label GMOs, is that an issue that will be brought up in future trade negotiations? The Minister may not be able to answer that immediately, but perhaps she can write to us about it, or ask her colleague who is taking through trade issues at the moment.
The Government claim that these changes will provide businesses with quicker approval times, increasing the return on investment and stimulating innovation. That is of course to be welcomed, but we should always be aware of two things. What happens in the case of negative unintended consequences, and what happens if new evidence comes to light that shows that a product authorised under these terms presents previously unforeseen risks to public health or the environment? That is something that other noble Lords referred to. In a situation where regular renewals are no longer required, can the Minister assure your Lordships if and how products covered by this regulation will be reassessed, if any new data emerges that suggests that they are not as safe as originally thought, especially if these products are already on the market?
I understand that the Food Standards Agency and Food Standards Scotland have the power to conduct evidence-based reviews if new information surfaces, but can the Minister assure us that a less regular review mechanism will not compromise safety? I think that she mentioned the phrase “where necessary”. Can she put more meat on the bone and explain a bit more what that means? What mechanisms are in place to ensure that products remain compliant with safety standards over time? We know that regulation is often outpaced by innovation, so how do the FSA and the FSS plan to stay ahead of new risks or scientific developments with less regular oversight than these renewals once provided?
The second potential concern is that the Government do not appear to have conducted a formal impact assessment of these proposals. Given that these regulations will affect a significant number of products and legislative instruments, could the Minister tell noble Lords whether it is correct that no formal impact assessment was conducted and, if not, why not? Was there an informal impact assessment of any kind, and why was it decided that no formal impact assessment would be needed? Can the Minister assure the public that the full range of potential risks and benefits has been properly assessed?
Finally, as noble Lords may know, I spent 14 years in the European Parliament—not as long as my friend, the noble Lord, Lord Moraes. I was often frustrated by EU regulations, because they were more often than not based on the precautionary principle, or the over-precautionary principle, rather than the innovation principle. It is important that we get the balance between innovation and precaution right—I welcome that. I am not necessarily against divergence between UK and EU regulations, especially when it allows innovation, but could the Minister tell your Lordships what conversations the Government have had with EU counterparts and colleagues in Northern Ireland about the potential impact of these regulations on the Windsor Framework?
Overall, while these Benches welcome the regulations, I hope that the concerns expressed during the consultation, and today by other noble Lords, can be addressed by the Minister.
Baroness Merron (Lab)
My Lords, I thank noble Lords for their valuable and considered contributions to the debate today. I re-emphasise the main point I made in my opening comments: removing automatic renewal processes and statutory instrument requirements will not lower food safety or standards. I am grateful for the support from the noble Baroness, Lady Coffey, and for her bringing to bear her experience across relevant departments, as well as from the noble Baroness, Lady McIntosh, and the noble Lord, Lord Kamall.
I have heard a number of concerns, including from the noble Baronesses, Lady Bennett and Lady Walmsley. I understand the points made, and I hope that I can reassure them further from my opening comments. I am very happy to follow up where I have not got the ability, time or wherewithal to answer the questions.
The noble Baroness, Lady Coffey, asked about ministerial decision-making and the assertion of the non-discrimination principle. These reforms do not change what is in place to maintain the functioning of the internal market Act. Differences in approach will continue to be managed through the relevant common frameworks. I reassure not only the noble Baroness but other noble Lords that the FSA and the FSS are strongly committed to achieving a four-nation consensus, in line with our commitment to the food and feed safety and hygiene common framework. Decisions by Ministers in England—which will be from the Department of Health and Social Care, to the point brought up by the noble Baroness—as well as Scotland and Wales, will still be required for authorisations in their respective nations.
The noble Baroness, Lady McIntosh, asked about processes that will be followed with the removal of the renewals process. This SI does not change current GMO labelling requirements, which I know was another matter of concern to other noble Lords. Products that contain or consist of GMOs must be clearly labelled as defined in current legislation. Nothing will change in that regard. Following the reforms, businesses will continue to be required to notify the FSA and the FSS, if they have any new information which might affect the suitability of a validated laboratory-based method for the identification, detection and qualification of GMOs, something that the noble Baroness, Lady Bennett, was also concerned with.
To the point about the SLSC, it is suggested that the House may wish to consider the steps proposed to maintain parliamentary oversight. However, proportionate processes are in place for sufficient scrutiny of authorisation decisions, such as public consultation and the publication of safety assessments and authorisations. It is an important point that the authorisation process remains open and transparent. The SLSC recognised that this aligned with the processes used by other UK regulators.
Baroness McIntosh of Pickering (Con)
I do not wish to labour the point too much, but when a statutory instrument is presented to this Committee, we have the opportunity as parliamentarians to look at it. How will we be informed of the renewals if they are on a register? Do we have to ask someone to notify us? How do we know? At the moment, it is automatic; in future, it will not be.
Baroness Merron (Lab)
I understand the point the noble Baroness is making. I will turn to the point about the availability of information, which was also the point that the noble Baroness, Lady Walmsley, made. However, details of applications and authorisations will actually be more publicly available than they are currently. I hope that will be helpful. Of course, as we know, Ministers must provide reasoning if they disagree with FSA and FSS advice when they are making their decisions. In order for the public and anybody—including Parliament—to scrutinise regulated product applications and authorisations, all those tools and resources will be available.
The noble Baroness, Lady Walmsley, suggested a reporting mechanism. I am happy to look at that and will take into account what she said. But I say to noble Lords—and I know they know this—that statutory instruments are not the only way in which to hold matters to account, nor are they always the best way to ensure transparency and openness. We are seeking to be more transparent and ensure that we make this an easier place for industry, the public and others to work in—which most noble Lords welcomed.
Baroness Bennett of Manor Castle (GP)
There may be a legal obligation on companies to act, but we have seen again and again that, with the profits versus the costs of them identifying a problem and being prepared to go public and go to the Government about it, the legal requirement is not much of a safeguard.
Baroness Merron (Lab)
I understand that. It is why these reforms build on existing powers, whereby the FSA and FSS can request information for the review. It is of course in the interests of businesses to proactively provide it. As I mentioned in my opening remarks, where necessary, approvals can be modified, suspended or even revoked if a safety concern has been identified. That will not change.
To return to the point I was making previously, when, or if, new safety evidence emerges, it will inform whether authorised products are safe to remain on the market at any time, instead of—this is the reason for this statutory instrument—working to arbitrarily fixed renewal timetables, which burden industry and the public sector with comprehensive reviews for all products, whether they are needed or not, even when there is no evidence to suggest that one is needed. The evidence shows that this move is generally in the desired direction to be working.
The noble Baroness, Lady Walmsley, asked whether more should have been done in the Explanatory Memorandum to point out issues. As I listened to her, I wished that we could all predict what needs to be answered. Importantly, the FSA responded to all the questions raised by the SLSC, which was reassured by the responses. I hope that noble Lords agree that the FSA has been most helpful there.
On the question asked by the noble Baroness about sufficient resources and systems, it is anticipated that a relatively small number of authorisations will require a review on the basis of safety, as compared to the large number of renewals currently processed. I would expect that to be very manageable.
The noble Baroness also asked whether reports are always sent, whether they are always complete and whether that would give confidence. An evidence-based review system will ensure that already-authorised products are reviewed based on risk and new evidence rather than, as I said, on a fixed timetable. Reports are indeed provided and completed, but this change will make that even more doable and meaningful, and that is the reason for the change.
As I said earlier to the noble Baroness, Lady Walmsley, who made a suggestion about Written Statements being made, I will certainly take that away and reflect on it—as I will do for all of the points that were raised. With that, I thank noble Lords for their interest in and scrutiny of this SI.