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Lord Phillips of Sudbury: My Lords, before the noble Countess sits down, my point about large industrialists was precisely hers. The issue we are discussing affects small producers. My point was that if the very large pharmaceuticals were really interested in some of the products we are talking about, the outcome might be different.

Lord Colwyn: My Lords, it was my intention to intervene for a few minutes, but can I clarify whether this is a timed debate? Does the debate finish at 8.50, or may it run on?

Lord Grocott: My Lords, it is not a timed debate, although, as is normally the case with these matters, the usual channels try and put on in the dinner break something which will last for roughly an hour. It is not a science, it is an art. If we come to a conclusion within a reasonable time, we could move on to the Criminal Justice Bill, which contains important matters for debate as well.

Lord Colwyn: In that case, my Lords, perhaps I may have just two minutes. I have spoken on this issue for many years in your Lordships' House. Many of the commonly used ingredients that will be banned by the directive are more efficient than those that will be retained. There is no logical reason for their exclusion; it is entirely without scientific justification and certainly not in the best interests of the consumer.

A combination of a detrimental lifestyle with smoking, inner-city pollution, alcohol abuse, inadequate diet and other stresses with the problems of over-farming, pesticides and soil depletion seriously undermine normal health. Despite the many advances in healthcare, there is evidence that herbal, vitamin and mineral supplementation can help many of the problems associated with modern living—not only for those of us who do not achieve the recommended intake of nutrients but for the population as a whole if it is believed that the recommended intakes are not sufficient for optimal health.

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The Library has given me a copy of the regulatory impact assessment referred to in the Explanatory Notes. It describes the objective of the directive as a means of facilitating trade:

    "The Directive lays down a frame-work for Community rules on food supplements marketed as foodstuffs . . . in order to promote the free movement of trade . . . and ensure a high level of consumer protection".

These two objectives seem incompatible. The FSA was set up to protect the consumer, not to further trade, its remits being food safety and nutrition.

According to the RIA, the only downside of the regulations might be a reduction in consumer choice. Millions of consumers are concerned that the restrictions may affect their health and their right to look after their health.

The RIA makes no reference to the role of food supplements making good the mineral and vitamin deficiencies induced by soil depletion and their role in the maintenance of an efficient immune system.

In conclusion, the RIA presents four options as to how the directive should be incorporated into UK law. I am concerned that the FSA has not fully understood the implications of the directive. I am concerned that it has not grasped the clinical and scientific evidence of the importance of nutrition, a fact at last recognised by the American Medical Association in its advice that everyone—even healthy adults—is in need of supplementation.

I hope that the Government will take notice of this short debate. What is needed is an amendment that would allow member states to permit products on their own domestic market which were recognised by the competent authority as safe and appropriately labelled but which would otherwise lie outside the technical restrictions of the directive.

Baroness Oppenheim-Barnes: My Lords, one of my greatest concerns about this directive and the FSA is that consumers are thoroughly confused. They think that things they always thought safe may not be safe. The majority of consumers do not have a balanced diet. Many sectors of society, such as geriatrics, need to have a greater intake of vitamins in the form of medicines than other members of the community. These are all serious considerations.

I am concerned that people will stop taking what they need to take as a result of this confusion. Surely, this is just another step along the road to the situation where, in a few years' time, we will be telling consumers that they should buy only one orange and not two because they might have an excess of vitamin C.

Lord Monson: My Lords, when the Minister comes to reply, can he explain why the principle of subsidiarity referred to by the noble Earl, Lord Howe, and the noble Lord, Lord Beaumont of Whitley, has once again been treated with total contempt by the European Commission?

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Secondly, with reference to the last question posed by the noble Lord, Lord Phillips of Sudbury, is it not the case that the people of this country will still be able to obtain the vitamins and minerals in question from Norway, Switzerland, the Channel Islands and elsewhere, even if these wretched regulations are agreed to?

Lord Stoddart of Swindon: My Lords, I want to make two short points. First, we are being hurried along in this debate although many other noble Lords would like to speak. The Government, knowing that the resolution was down for debate, should have made adequate provision for the debate to take as much time as was needed, and should not have put it on in the dinner hour. Secondly, I presume that this is a single market matter. What proportion of the supplements are consumed in this country and how many are exported abroad?

Lord Warner: My Lords, this has been a stimulating debate. On occasion, the thought crossed my mind that some of your Lordships might be taking some of the supplements that we were discussing.

I cannot respond to all the points, but I shall try to pick up many of them along the way. I assure the noble Earl, Lord Howe, that I am not into denial. Although I was not previously involved in the issue, I do not believe that UK consumers and manufacturers have been let down, and I hope to persuade the noble Earl and others of that in the course of my remarks.

I recognise that the noble Lord, Lord Clement-Jones, stands ready to accuse me of complacency. However, as he told the Health and Social Services Journal that I am feisty and competitive, I believed that I ought to live up to that reputation along the way.

The noble Earl, Lord Ferrers, referred to whether we were dealing properly with Europe. As I recall, the Government have actually been at the heart of Europe, negotiating hard for United Kingdom interests. I recollect from memory that the noble Earl's party had some sort of internal difficulties about that issue. However, that was a long time in the past, I am sure.

The noble Lord, Lord Phillips, and a number of other noble Lords asked for statistics. I do not have all the statistics immediately to hand, but I will look into it and write to noble Lords. I do not believe that the issue is just about statistics, as I believe noble Lords will agree at the end of my remarks.

The debate has served to confirm that many noble Lords feel very strongly and that the public should have a right to continuing access to a wide range of supplements. That is both my personal view and that of the Government, and nothing in the regulations gives any support to the argument that a variety of supplements will not be available to members of the public—and a wide range of supplements, at that. That was the position adopted by the Food Standards Agency on behalf of the UK in the negotiations on the Food Supplements Directive. I share the views expressed by the noble Baroness, Lady Howarth, that FSA staff fought hard for the UK's interests. She put the record straight very effectively on that issue.

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The Government have always taken the view that the market should be open to all foods that are safe and properly labelled. That principle underpins our approach to all food legislation. We need to find the correct balance between our obligations to protect public health and the desire for wide consumer choice and the benefits of free trade.

My noble friend Lord Turnberg, in his clear and authoritative way, put the case for public safety that underpins the directive and regulations. He put the case for protecting the public better than I could. Not all the substances are safe for life, irrespective of duration and levels of consumption. That is a point that is often overlooked in this area.

The Government's responsibility is to ensure that appropriate food safety controls are in force and to promote honest and informative labelling in order to facilitate informed choice. It is for consumers to choose what they eat, and we know that they welcome a wide range of choice. Let me be clear that the Government do not wish to do anything that thwarts people taking responsibility for their own health by using food supplements that are safe to use.

The noble Earl, Lord Howe, raised the point that the legal principle should be that everything is allowed unless it is specifically forbidden. He complained that the directive ran shy of that. The establishment of a permitted list is an approach common in all food law—for example, for additives, nutrients and nutrient sources in products such as baby food. The extension of that particular principle to nutrients and nutrient sources used in food supplements is not therefore a departure in principle from current practice and was supported in the negotiations in Brussels by all 14 member states.

I am acutely aware of how important the availability of food supplements is to certain consumers as well as to businesses and individuals involved in the use, manufacture and sale of food supplements. I should like to make it clear that these regulations do not set the maximum limits for vitamins and minerals in food supplements, which is an area for further negotiations. I shall return to that issue. The Government have absolutely no desire unnecessarily to reduce consumer choice or unduly to restrict trade. That is why we will work hard to ensure that these maximum limits are based on safety and not nutritional needs.

Noble Lords should not underestimate the difficulty of the negotiations on the Food Supplements Directive. They were carried forward with great vigour and in full consultation with a wide range of interested parties. However, we should recognise that only in the Netherlands and the Republic of Ireland are there, as in the UK, diverse markets in food supplements. Those two other EU member states were the only ones sympathetic to our concerns over potential loss of products from the market.

I do not want to spend too much time going over old ground, although quite a few other noble Lords did go over old ground. It is important to understand that while the directive does not deliver all that the UK wanted, it was a lot better than it might have been and

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certainly was the best deal that we could achieve in the circumstances. At the time of the vote on the directive in the Council of Ministers the UK made a carefully considered judgment that if it had blocked the directive's adoption and forced further negotiations, that would very likely have resulted in a more rather than less restrictive regulatory framework.

It is important to note that most of the UK stakeholders we consulted, including all the major trade associations representing UK food supplements manufacturers, agreed and supported that position. This decision was not taken in a "hole in a corner" manner within the Government but with the industry. However, it is also important to recognise that, in negotiations, the UK secured a number of important concessions, notably inclusion of the derogation in Article 4(6) of the directive that allows us to permit the continued marketing in the UK of food supplements containing substances currently excluded from the permitted lists until 1st January 2010 where relevant criteria are met. That represents a very long transitional period. I thought that that achievement was rather underestimated in a number of noble Lords' contributions.

I should also like to bring to the attention of noble Lords—specifically the noble Earl, Lord Ferrers—one perhaps rather underplayed effect of the directive, which is that it will open up markets for products manufactured by UK business in other member states where those have previously not been permitted to be sold.

It has been suggested that the Government should go back to the negotiating table in Brussels with a view to securing an amendment to the directive. I do not know why those who suggest that think that we could achieve now what we could not achieve in the first place. The reality is that the Commission has secured a deal and will not reopen discussions. As regards the future effects of this directive in Europe, the Government's priority now is to make the best possible use of our influence and negotiating capital when we come in due course to negotiations on maximum limits for vitamins and minerals in food supplements.

As a member of the European Union the UK is obliged to implement the directive. We must recognise that, however much we wish that the directive were different, failure to transpose its requirements properly would be a serious breach of our obligations under the EC treaty and would result in infraction proceedings against the UK and in the likelihood of our facing heavy fines. Ultimately, implementation would be forced upon us. The Government do not think that that would be the most sensible way forward.

The implementing regulations, which have been debated so vigorously here today, make full use of the flexibility available to us under the directive; namely, they permit the continued marketing of food supplements until 1st January 2010, providing the relevant criteria are met; they do not require notification of marketing of new products; and they

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prohibit trade in non-compliant products from the latest possible date to allow sufficient time to enable them to be brought into line with the requirements of the new legislation.

I hope that noble Lords will also support the Government's welcome for the labelling requirements in the directive which will contribute to our commitment to promoting honest and informative labelling in order to facilitate informed consumer choice.

I am not brushing under the carpet the very legitimate concerns that have been raised today. The Government acknowledge that consumers and industry are worried about a number of issues. I am very well aware of, and sympathise with, concerns about the missing nutrients and nutrient sources that are currently excluded from the directive's "positive lists"; the expense and time involved in preparing dossiers to support the safety of these substances; the loss of particular product characteristics and the costs resulting from the reformulation of products in those cases where that may become necessary. But it is worth bearing in mind that the regulations do not cover natural sources of vitamins and minerals such as cod liver oil and that the lists of permitted nutrients in the regulations can be extended if satisfactory safety dossiers can be compiled by the industry.

We welcome the steps members of the industry are taking in a very responsible way to collaborate to ensure efficient and effective submission of safety dossiers and I am particularly pleased that discussions on dossier preparation are to take place between the European Food Safety Authority and representatives of the relevant interest groups. We certainly give that initiative our wholehearted support and hope that some simplification of dossier preparation will take place.

We must look to the future. I am aware that there is concern about the future setting of maximum limits for vitamins and minerals in food supplements and concern that that could have the effect of removing certain high-dose vitamin and mineral food supplements from the market at some time in the future. But, as I said, the directive does not set specific maximum limits for vitamins and minerals or other nutrients in food supplements. It agrees principles to be followed when they are established by future EC legislation. These are that maximum limits should take account of safety criteria and dietary intakes as well as due account of measures of nutritional need. I hope that everyone agrees that consumer safety should be the prime concern. That is certainly the Government's position. The Government's firm view is that maximum limits should be set at levels based on scientific risk assessments and should not be limited by considerations of nutritional need. Maximum limits should be set at levels that protect public health. The noble Lord, Lord Turnberg, made a number of comments very relevant to that. The Food Standards Agency continues to press that approach in Brussels.

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This is a very important issue for the Government, as well as for consumers and the food supplements industry. We recognise that there are many high-dose food supplements products on the UK market and that many UK consumers value those products highly. There is nothing in the regulations to suggest that people will lose access to those supplements in the immediate future. Simply engaging in Brussels bashing on the directive will not help British consumers and industry. What we need to do is to influence the outcome of the future negotiations on maximum limits in Brussels. It is crucial that food supplements manufacturers and retailers, as well as members of the public and noble Lords, make effective use of all legitimate means at their disposal. The safety-based regime we are calling for offers benefits to consumers in other countries as well as our own and to businesses across the EU. We need to get this message across. While negotiations on the existing directive are finished, there is still a lot to play for regarding the future setting of maximum limits.

The report of the Expert Group on Vitamins and Minerals has been mentioned. I commend its findings to the House. This group of independent experts has carried out a thorough review of currently available information on the safety of vitamins and minerals in food supplements. The handling was questioned by the FSA, but careful study of the FSA's press release suggests that the review was a balanced document that provided clear advice to consumers, to help them make informed choices.

I welcome the fact that the Food Standards Agency has recently had initial positive discussions with representatives of the food supplements manufacturing industry on actions that need to be taken as a result of the implications of the report of the Expert Group on Vitamins and Minerals. We are working very closely with the experts and the industry in that area. Not only do I welcome that work on behalf of UK consumers, who have a right to be able to make properly informed choices over the products that they might buy, but I welcome the discussions as a positive step taken by UK food supplements manufacturers in demonstrating to the rest of Europe that the industry is a responsible one. All that should help to put the UK in a strong position when it comes to entering into negotiations on maximum limits in due course.

I acknowledge the concerns expressed today over some of the potentially less positive effects that the regulations could have in future on consumer choice and the food supplements industry. However, the directive has been agreed and we are obliged to implement it. The Government's focus is now on the future and, in particular, on minimising restrictions on consumer choice and trade by pressing for a safety-based approach to the setting of maximum limits. Much of what I have said addresses the concerns of the noble Earl's Motion.

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