My Lords, magnesium L-threonate monohydrate has recently been authorised as a novel food following a public consultation and a safety assessment by the Food Standards Agency, which concluded that it is safe under the proposed conditions of use. This instrument sets the purity criteria—that is, the required safety and quality standards—for this form of the mineral magnesium, to permit its use and sale in food supplements in England. The instrument is a routine and technical measure, which will ensure that food supplements regulations continue to operate effectively following the authorisation of novel substances for use in food supplements.
The regulatory approach taken here is well established. Where new substances are authorised, it is necessary to update the relevant legislation so that they can be used in practice, and to ensure that clear and enforceable quality standards are in place. Noble Lords will be aware that, under our existing legal framework, vitamins and minerals may be used in food supplements only if they are listed in legislation and meet appropriate safety and quality standards.
Magnesium itself is already a permitted mineral listed in legislation. However, different chemical forms of that mineral must also be specifically listed before they can be used. A related statutory instrument already laid under the negative procedure adds this substance to the list of permitted forms of magnesium. However, for food supplements containing this substance to be lawfully sold, purity criteria must also be established. An SI following the affirmative procedure is required to set the purity criteria for this substance in legislation. That is the sole purpose of the regulations before the Grand Committee today. The criteria specified in this instrument reflect the scientific specification assessed by the Food Standards Agency and will ensure that, where this substance is used, it is manufactured and marketed to a consistent and safe standard.
My Lords, I rise for the fourth and final time. I thank the Minister for presenting this statutory instrument with her usual clarity and purpose. On these Benches, the priority is a fair deal for consumers, which means that all food supplements must meet the highest possible standards of quality and safety. The Food Standards Agency has assessed this form of magnesium as safe and on that basis we do not oppose its authorisation, but we have one or two questions about how the purity criteria will work in practice.
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In simple terms, this SI is about allowing a new form of magnesium supplement on to the market, but only if it meets a clear and legally enforceable recipe. The Schedule sets out what that recipe looks like—how much of the active ingredient has to be present, how pure it must be and how little room there is for unwanted substances. That matters because, without those clear rules, consumers cannot be confident that what it says on the label is what is actually in the bottle. I have googled what it does, but I will not say it in Parliament in case I recommend something that I should not.
The timing is worth putting on the record. The affirmative instrument is deliberately set to start on the day after the related negative SI adds this form of magnesium to the list of permitted substances. That is exactly the sort of quiet technical co-ordination that most people never see, but it really matters if the system is to work. More broadly, although we understand the intention to facilitate market entry for novel foods, it is vital that these changes do not result in a fragmented regulatory landscape. We also need to understand whether decisions such as these are contributing to a pattern of divergence from EU norms. I feel that this is an appropriate moment to thank the Minister for her recent SPS drop-in, which feels highly relevant to this discussion.
I have three questions. First, one consultation respondent highlighted divergences between maximum levels permitted in the EU and those proposed by the FSA. Can the Minister explain the safety rationale for the UK’s chosen parameter, particularly given the point I made about maintaining consumer confidence? Secondly, the Government have opted not to include a statutory review clause because the impact is deemed to be very low. Without a mechanism of that nature, how will the department monitor whether these purity thresholds remain aligned? Finally, since no full impact assessment was produced, what specific guidance or additional resources are being provided to local enforcement bodies to ensure that they can accurately test for the specified purity and contaminant levels?
I look forward in advance to any replies, and I completely understand if the Minister wishes to write to me on any of those issues, because we are broadly in support.
My Lords, I thank the Minister for bringing forward this SI. These draft regulations are a purely technical measure, setting the purity criteria for magnesium L-threonate to be used in food supplements and for its legal sale and use, in compliance with the Food Supplements (England) Regulations 2003. This is a novel food. It was examined by the experts on the Advisory Committee on Novel Foods and Processes, which pronounced on its safety and uses. The current levels authorised in the novel foods authorisation are 250 milligrams of magnesium per day, which is roughly equivalent to 3,000 milligrams of magnesium L-threonate per day. This level was established based on health-based guidance values.
The Food Standards Agency consulted on this matter. I understand that concerns were raised during that consultation that the maximum level initially proposed for magnesium L-threonate in food supplements would result in a lower amount of base magnesium compared to the EU’s maximum level of 250 milligrams. This would have risked disadvantaging British businesses that market their products in the EU. The FSA, after consultation with outside organisations, agreed the level that we have before us, which is the same as the EU’s. On this occasion, UK scientists made that decision and it was not foisted upon us by the EU. The future, however, looks rather different.
The assessment of safety is not one set figure but a range, allowing this revision to a higher but still safe level. I commend the work of the independent experts in the ACNFP, whose assessment allowed this product to get approval. They get abuse from ignorant people, who complain that they do contract work for the food industry and therefore must be biased, but I do not want the Government to employ any so-called expert if he or she is not good enough to get contract work from an outside company. These are excellent people and I commend them.
My Lords, I thank noble Lords for their participation and questions in another short and sweet debate.
The noble Baroness, Lady Grender, asked about the EU and divergence, and the noble Lord just touched on that as well. To clarify, this form of magnesium has been approved as a novel food in the EU, where it can be used in food supplements. There are some minor differences between the EU’s and the Food Standard Agency’s assessments, but they do not create a material difference or any safety concerns. In the FSA’s view, the differences are due to differences in assessment style rather than in the product itself. In addition, the applicant has confirmed that the product, as manufactured, will comply with both the EU and GB specifications. That therefore does not give rise to any concerns regarding its trade between GB and the EU.
While we are on the EU, the noble Lord talked mainly about dynamic alignment and the legislation that will come with that, and asked for reassurances in that space. We are still in the middle of negotiations and I cannot go into the detail of them. They are not directly relevant to this statutory instrument, but the noble Lord knows that I am always more than happy to sit down, have a cup of tea and discuss these issues with him in detail as we move forward through the EU discussions. We know where we are on that.
Motion agreed.
Food law is a devolved matter. This instrument applies in England only. Wales and Scotland have made equivalent amendments to their food supplements regulations and Northern Ireland applies the existing EU equivalent regulations, as required by the Windsor Framework.
It is important to emphasise that this measure is enabling, not mandatory. It does not require any business to use this ingredient or change its products. The use of this new optional substance will initially affect only the applicant who requested this authorisation and who benefits first from a five-year exclusive use period. During this period, only the applicant may use and sell magnesium L-threonate monohydrate as a form of magnesium unless another business obtains authorisation based on its own data or with the applicant’s permission. In the longer term, other businesses will benefit from the authorisation of this substance, supporting choice and product innovation while maintaining robust safety standards.
Food supplements legislation is in scope of the UK-EU sanitary and phytosanitary agreement, which will involve alignment with EU legislation in this area. In this case, the substance has already been authorised for use in the EU, so we expect no change in practice for businesses when alignment takes place. We therefore consider it appropriate to proceed now, following the Food Standards Agency’s safety assessment, to allow this substance to be used in GB as soon as possible.
To conclude, these regulations fulfil our requirements to update food supplements regulations where new substances have been authorised for use in food supplements, and they continue to uphold high standards of safety and quality for consumers. I beg to move.
I would like to raise some broader concerns about food regulation. There has been much noise about the Government’s intentions for dynamic alignment with the EU. The sanitary and phytosanitary—SPS—agreement involves 18 key agri-food policy areas. The Government want us to believe that this deal will simply ease traffic at our ports, when in fact it requires adopting thousands of EU laws, including future changes to them, over which we will have no say whatever. This includes policies such as those approving or restricting food texturisers, enhancers and processing aids; dictating vitamin dosages, mineral concentrations and ingredient reporting; and authorising emerging food technologies, synthetic alternatives and lab-grown products. Many noble Lords across this House will have views and insights on each of these areas, but they will be denied any say. More broadly, the deal risks sacrificing areas of growth and progress, such as precision breeding and gene-editing, or the development of vaccination programmes for cattle against MTBC, mycobacterium tuberculosis complex.
What assurances can the Minister give that these successes will continue under the SPS agreement? Will she clarify what safeguards, if any, are in place to ensure parliamentary oversight of future changes and to protect parliamentary sovereignty over UK law? These are important considerations; they are not relevant to the measure before us, but we will face them in future if the SPS agreement goes ahead. It is important that we have a say and can make recommendations over regulations such as those before us today. I look forward to hearing the Minister’s response and, as I said at the beginning, we welcome these regulations.
Just to finish, the noble Baroness also talked about review periods, safety, and so on within that. Clearly, a lot of these areas are in the FSA’s area, and we in Defra—and, I know, the Department of Health and Social Care—meet regularly with our colleagues in the Food Standards Agency, because it is really important that we uphold standards and work very closely together. I will reference these concerns in our next meeting with the FSA, because the noble Baroness makes very important points that when we are bringing in new legislation around novel foods, we need to ensure that we are confident in their safety for the long term and that consumers are being suitably protected.
Having said all that, I remind noble Lords that this statutory instrument is very much a routine technical measure; it does not place any new burdens on businesses but ensures that use of the substance meets clear, consistent safety and quality standards. I thank noble Lords once again for their contributions and commend this SI to the Committee.