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Minerals and Food Supplements

Volume 494: debated on Tuesday 16 June 2009

This subject is familiar to me. Insomniacs will find that I have spoken on it in the past and that I led an Adjournment debate on it some years back. I will explain why there is an interest in my constituency in the subject, but first I shall set out a basic principle. I regard the consumption of food supplements in the same way as I regard the consumption of foods. It is largely a matter for the individual consumer to decide what they eat, based on advice from the Government about safety and an appropriate balance in the diet. Therefore, the key driver in this area should be the determination of safe levels of supplements that people should be entitled to consume. I am a libertarian in this matter and always have been.

However, the approach in this country differs from that taken in many other member states in the European Union, with which we are attempting to reach agreement on how to regulate the sector. Our approach is not common elsewhere in the European Union. Here, supplements can be purchased in a wide range of places: supermarkets, high street retailers, pharmacies and online. In some member states that take particularly restrictive approaches, these items, if available at all—many cannot be obtained at the dose level available in this country—are obtainable only through a pharmacist.

Therefore, when the European Union decided that we should seek to produce a single market for the products, it was entirely predictable that it would be hard to achieve that goal and impossible to achieve it through total consensus. I should make it clear that nevertheless I support the efforts to achieve that goal. It should be possible for a consumer in any part of the European Union to be assured of receiving a quality product and to be able to purchase it freely. That should be possible whether they are in our country or any other part of the Union. Furthermore, that would benefit companies operating in the UK—manufacturers and retailers—that are experienced in selling these quality products to consumers and that would welcome the opening up of opportunities elsewhere in the Union. It is certainly not my view that we should resist that process. However, I want to ensure that we do not sacrifice important UK consumer freedoms in achieving that goal.

As I said, I have a local interest in the matter. Although the company has gone through a variety of owners in my time as a Member of Parliament, it remains a substantial manufacturer in my area, and is now owned by Brunel Healthcare. Its site in Swadlincote is the No. 1 supplier of private-label vitamins and mineral supplements in the UK. It employs 180 staff. The impact on that business of the manufacturing of generic products, although by no means immaterial, will be relatively small. However, the parent company owns a collection of specialist health food brands that would clearly suffer from some of the possible consequences of the regulation.

The critical points that now need to be resolved—we are part-way through this process—are the maximum permitted levels of nutrients to be provided within supplements. The first test is safety: what is safe for a human being to consume? That is not an entirely straightforward question to answer. We have had difficulties in the past with the debate about vitamin B6. That has shown that achieving a degree of scientific consensus is not easy in an area that perhaps has not been subject to as much scientific scrutiny as others. Nevertheless, a reasonable body of research is available and it should be possible to produce a degree of certainty in this area.

The European Food Safety Authority has produced a list of safe levels for nutrients as part of the exercise. Understandably, however, that is not the whole answer, because those levels have to be moderated to take account of the quantities of nutrients present in other food sources and then assessed against the typical diets of European citizens. Those of us who travel reasonably freely will find that diets vary quite a lot across Europe. One might hope to be able to reach a standard position that says, for example, “This is how much fish oil might be consumed.” However, it is by no means obvious that that is common across the European Union; nor is access to sunlight, which is a critical issue in deciding on vitamin D, for example. It is necessary to take account of a range of factors. In relation to the kind of nutrients that a particular diet should contain, there are also important ethnic characteristics to consider.

Producing a solid set of recommendations with firm certainty about them will not be possible; there will be substantial variances. Therefore, the culture of how that is done is quite important. The temptation, which the industry feels people will give in to, is to set the limits at the lowest conceivable level, taking into account all the variables that might be present and disregarding the consumer’s own wish to make many of their own judgments. It is felt that one outcome would be to bar quite a number of products that British consumers have been used to having access to for a very considerable time, without any side effects that have concerned them up to now. It is not desirable for us to take that chance, so how we represent the UK position to the Commission is vital.

The Government, after a somewhat sleepy start a few years back, have been vigorous in arguing for the sector’s interests and discussing with the sector the implications of possible models of regulation. However, we must face the fact that we have relatively few allies. As I said, much of Europe operates on a different model for the distribution of the products. Out of self-interest perhaps or, to put it more charitably, genuine anxiety at the lack of familiarity with the availability of such products in their countries, many countries will be inclined towards setting very low maximum levels.

I want to suggest some ways through the situation. We should prepare the way for a solution that permits some UK exceptions to the maximum levels that may be agreed. We have had the intellectual argument—I strongly endorse it—as to the principles of how the regulation should be set. However, it is reasonably clear that we shall not be able to assemble a blocking vote to support our position, so how do we ensure that we proceed in a way that will not harm our industry or the interests of UK consumers?

First, clear communication to consumers about the function of supplements in any diet can help. The Government already promote the use of supplements in certain circumstances. Advice is given on the supplements that a woman ought to take during pregnancy and breastfeeding. However, we also give advice in respect of those whose sun exposure may be very low, children in certain circumstances and those of particular ethnic origins who may need to supplement their diet in certain ways.

The UK national diet and nutrition surveys of 1998 and 2003 showed various deficiencies in diet, on which any Government could provide proper advice. The surveys showed that 86 per cent. of UK adults consumed less than five portions of fruit and vegetables and that adults generally consumed less than one third of the recommended levels of fish oil. Dosages in the UK can be set in the context of robust information, permitting UK departures from any limits that vary materially from our current approach.

As I have discussed with industry participants, eating five portions of fruit and vegetables a day and consuming the correct amounts of various items—the perfect balanced diet—is how we should aspire to provide the nutrients that we need, but given the complex lives that many of our citizens lead, and the conflicting advice that some of them feel they receive about what they should eat, many of our aspirations will be thwarted. We must be realistic. Stronger communication can be provided about how to supplement inadequacies in diet.

Secondly, our northern location should, in any case, justify higher limits for certain supplements, such as those based around vitamin D. Clearly, we are different from Greece and southern Italy, and it is simply crazy to set a measure that ignores our climate and our geography.

Thirdly, we should ensure that the industry attaches appropriate warnings to items whose dose levels might be higher than the recommended maximum levels that emerge from the Commission process. Consumers should be allowed reasonable discretion based on a stronger knowledge of the place that a supplement might have in a diet. Part of the package that I am suggesting is more robust communication of any remaining risks, although, to be honest, such risks would be small, given the way in which we regulate the sector. Nevertheless, such measures would provide some reassurance to our European partners.

Finally, and generally, any limits that are set should permit revision based on new research and new models of consumer behaviour. Diet changes over time, and so, too, does sunlight. We must therefore accept a variety of factors as part of the matrix in determining policy. Any limits should not, therefore, be set in stone; there should be a process for revising them and bringing them closer to the reality of life on the day in question.

I turn now to the industry’s role. The industry must be realistic. Simply opposing the setting of maximum dosage levels and implicitly resisting the directive cannot be effective in the long term. We simply do not have the votes to carry that position, because the UK has few allies on this matter.

At some point—the expectation is that it will be early next year—the Commission will press ahead with its initiative. If the industry can agree a combination of a distinctive UK market difference, leading to derogation in certain aspects and backed by clear obligations, and some minor concessions on dosage levels—that important qualification will not be welcomed by the whole industry—a deal can perhaps be struck.

One difficulty has been the understandable unwillingness to define where the priorities lie in protecting the ramparts. Protecting everything that is currently available may not be a realistic position, but it may be possible to make some small concessions. If we do not take that approach, we will be forced to accept a position that will disadvantage our consumers and disable our manufacturers, who would otherwise be well placed to exploit single-market opportunities. Not taking such an approach will also distort a currently very diverse sector.

Major UK manufacturers will face a short-term, relatively minor loss and then, we hope, enjoy the benefit of a larger marketplace. Generally, it will be the smaller specialist retailers and manufacturers who suffer and whose distinct offerings will be removed. One large retailer with a strong higher-dose product range will also face major damage and challenges.

The industry and the Government have not always managed to work well together. We need a determined effort over the next six months to produce a sustainable UK position that protects what we have. Such steps do not suggest that we have lost the argument, and I myself powerfully expound the argument that safety is the bottom line in what we are doing. As I said at the start, I firmly believe that our approach has been right and that our sector is vigorous and competitive and that it serves consumers, but we must face the reality that others do not accept our philosophy and we must construct an appropriate and robust plan B.

It is a pleasure to be with you today, Mr. Wilshire. I congratulate my hon. Friend the Member for South Derbyshire (Mr. Todd) on taking on the issue, obtaining the debate and putting his case so well. This is not my policy area, but I have learned much in preparation for the debate, and my hon. Friend’s contribution has been interesting and informative.

I reassure my hon. Friend that the Government are aware of the concerns of the supplements industry, which have been raised today. Compared with other member states, the UK has a very liberal supplements market, which obviously pleases my hon. Friend. UK consumers therefore have a wide choice of products, including high-dose products that exceed recommended upper safe levels. The Government recognise that consumers who buy such products are extremely concerned that new regulations will reduce their choice.

The Government’s objectives are twofold. First, we want to maintain consumer choice in the UK and continue to protect consumers. Secondly, we want to minimise the impact of future proposals and regulations on the UK supplements industry.

The supplements industry in the UK has two main sectors, which have different views on the legislation. The first, which makes up 72 per cent. of the UK market, is represented by the Council for Responsible Nutrition and the Proprietary Association of Great Britain and is broadly supportive of the directive. The larger manufacturers represented by those organisations retail in the UK, but wish to expand their markets across the EU. The second sector, which makes up 20 per cent. of the market, comprises smaller companies and specialist shops and is represented by the Health Food Manufacturers Association and the National Association of Health Stores. That sector wants to preserve the current UK market and the wide range of products that are produced and sold by its members. It is more likely to be adversely affected by regulations on food supplements.

The European Commission proposed the food supplements directive to introduce a harmonised safety-based approach to food supplements and to promote free trade across member states. It came into force in July 2002 and has applied in full since 1 August 2005. As my hon. Friend explained, it provides for the setting of maximum levels for vitamins and minerals in food supplements. It recognises that it is necessary to set maximum safe levels, as excessive intakes of vitamins and minerals may have adverse effects. Safety is therefore the key driver.

The European Commission has yet to publish proposals for setting levels. However, over the past four years, there have been a number of initiatives at national and European level to inform the process. The Food Standards Agency, which is the lead Government department, has played an active role in that respect. The FSA board and Ministers originally agreed the UK’s negotiating position in 2005. That was done in the absence of Commission proposals and to allow the UK to begin discussions with its counterparts in other member states. The two-tier approach would achieve the Government’s objectives on food supplements and it remains our negotiating line. It would allow higher-dose products with appropriate warnings, as my hon. Friend said.

In 2006 the Commission published a technical discussion paper in which it raised questions about the setting of maximum levels for vitamins and minerals. The FSA discussed those with stakeholders before preparing a response to the Commission. In 2007 an orientation paper prepared by the Commission identified models that might be used to establish levels, taking into account intakes from the diet, and suggested that levels might not need to be established for all vitamins and minerals. That is an approach that the Government support, in line with the principles of better regulation. Commission working group meetings with member states, to discuss maximum levels, started in 2007.

To focus on setting levels, taking into account national intake data, the Commission has invited member states to take part in an ad hoc working group. The FSA is participating in that group along with Germany, Ireland, France, Denmark, Poland and the Netherlands. In contributing to that work the FSA is working in partnership with all sectors of the UK industry to carry out simulations using our national diet and nutrition survey data, and is presenting the work to the Commission and the ad hoc group.

We recognise the concerns of small and medium-sized enterprises and the potential impact that maximum levels may have on businesses and consumer choice. The FSA, in conjunction with the Department for Business, Innovation and Skills, has been working with the Health Food Manufacturers Association to consider the impact in a number of hypothetical scenarios. My hon. Friend has spoken about Brunel Healthcare and the potential impact on its business of the setting of maximum levels. I encourage the company to forward the information to the FSA, so that that can inform discussions with the Commission on the effect that the setting of such levels will have on UK companies. Of course, I hope that other companies will do the same.

Separately to that work, the industry has also actively participated in an analysis by the European Commission of the economic, social and environmental impact of the setting of maximum levels of vitamins and minerals that can be added to food supplements. The UK, along with Ireland, France, Germany, Italy, Poland and Denmark, was used as a case study in the work, which will inform the Commission’s impact assessment. My hon. Friend has noted that certain member states support much more restrictive levels than are currently available in the UK. The directive is clear about the idea that levels should be based on scientific risk assessment, taking into account intake of vitamins and minerals from the diet. The FSA is able to advocate that approach with its counterparts in other member states, and I would encourage the industry to do likewise.

The industry, however, must prioritise its objectives if the UK is to be successful in future negotiations. When the proposals are published, the Commission will hold a consultation on the proposed draft levels. The FSA will also undertake a consultation with its stakeholders before the Government position is finalised.

One element that might be considered is the degree of proportionality that should be applied to the matter. Risks in this area are tiny. In the debate on vitamin B6, for example, it was shown that there might be a short-term effect from taking the vitamin at extreme levels, but that it could be reversed relatively quickly just by ceasing dosage at that level. There is an issue of proportionality, concerning the genuine risk to consumers.

My hon. Friend makes an excellent point and I know that officials who have heard it will take it into consideration. It is envisaged by the Commission that the maximum levels will be reviewed where there is new scientific data to support that. As has been mentioned, the industry should not therefore assume that the levels are set in stone.

Although my hon. Friend has not mentioned this point today, the Government are aware that the industry also has concerns about nutrition and health claims. EC regulation 1924/2006, on nutrition and health claims made on foods, has applied from 1 July 2007. It requires claims to be authorised and listed for use on food products in the EU. That is an important consumer protection measure, to help consumers to make healthier choices by removing from the market misleading and false claims that might be made about food, including food supplements. The Government believe that the regulation should be proportionate, and we achieved a number of successes during the negotiations to make the claims legislation more proportionate.

One of the anxieties that the industry has in this context, which Brunel Healthcare has raised with me, is about the timing of the implementation of any obligation to discontinue certain claims. Obviously, repackaging products is an expensive business, and so is designing new products that are compliant. One issue, therefore, is whether implementation is to be instant or whether it should happen over a period of time, taking account of the realities of a business.

The Government are aware that the supplements industry continues to have concerns about the legislation, including those that my hon. Friend has just outlined, and particularly on the scrutiny that the European Food Safety Authority will apply to the claims that have been submitted for assessment. As a result of those concerns, the FSA has persuaded the Commission and the EFSA to work more transparently.

The Commission has enhanced access to papers on its website and the EFSA has begun a process of stakeholder engagement on its assessment practices. I hope that I have addressed the points raised by my hon. Friend today. The FSA meets regularly with all the sectors of the supplements industry to maintain an open dialogue on both supplements and health claims, and I urge them to continue to meet on the issues debated today. I reiterate the Government’s support for proportionate regulation. On the matter of maximum levels, we must re-emphasise that the aim is to protect consumers by setting levels based on safety, in addition to maintaining consumer choice.