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Lord Clement-Jones: My Lords, we on these Benches very strongly support the Motion so well moved by the noble Earl, Lord Howe. Throughout

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dealings on the Food Supplements Directive, the Government's approach has been characterised by complacency. A prime example of that was on 20th January when a major debate took place in the other place on what was then the proposed Food Supplements Directive. The government amendment in that debate, as regards the Food Supplements Directive, stated that the Government were committed to allowing safe and properly-labelled food supplements to be freely marketed, welcomed the Government's intention to take advantage of flexibility to permit continued use of substances not on the permitted list where products comply with existing food safety legislation in the UK and noted, finally, that the long-term availability of products currently on the market will depend on future developments on maximum limits and lists of permitted nutrients.

Let us take each of those aspects in turn. First,

    "safe and properly-labelled food supplements to be freely marketed".—[Official Report, Commons, 20/1/03; col. 100.]

In fact, the directive takes off the market a whole range of supplements in the form of vitamins and minerals found to be safe. As a result of the establishment of the so-called positive lists, as the noble Earl, Lord Howe, pointed out, which dictate the nutrients and nutrient sources permitted for use in dietary supplements, the Food Supplements Directive will lead to the banning of nutrients such as boron, sulphur, vanadian, tin, germanium and so forth. All except germanium, sulphur and vanadian have been reviewed by the UK Expert Group on Vitamins and Minerals and have been given safe upper levels and found to be safe. Hundreds of sources of vitamins and minerals will also be banned which pose no threat to public safety, some 270 as calculated by the industry.

In the debate on 20th January, Hazel Blears claimed that reports of the imminent withdrawal of swathes of products are misleading. But a huge number of UK products will be affected. Just take the list provided to some of your Lordships by Holland and Barrett. Products equating to some 6 million worth of sales will have to be taken off the market by that retailer. The Department of Health in answer to a recent Written Question from me stated that up to 5 per cent of the market for food supplements may be affected. Based on a market of 450 million, that is an enormous 22.5 million.

Rather than pooh-poohing the claims of manufacturers and retailers about the threat that the directive poses to their businesses, the Government need to start vigorously arguing for an amending directive to add to the positive lists. What are the Government doing to promote such an amending directive?

In the debate on 20th January the government amendment welcomed the Government's intention to take advantage of flexibility to permit continued use of substances not on the permitted list where products comply with existing UK food safety legislation. That gave a quite misleading impression that the Government had secured substantial derogation to allow missing nutrients not on the positive lists when that was not the case; far from it.

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Continued use is allowed for certain substances if not in the annexes until December 2009 if safety dossiers have been submitted by July 2005. But, far from being a flexible system, the cost of preparing a dossier for submission is massive. The biological and toxicological data required for the technical section depend on an analysis and submission of a large array of data which have to be specially generated. The manufacturers say that those kind of data take two years or more to create and therefore could not be ready by the deadline of July 2005.

Even the Government in answer to Written Questions accepted that the cost of producing one dossier could be anything in the region of 80,000 to 250,000. Were the Government aware of those costs when they were debating the matter in January? In practice, it appears that fewer than a dozen dossiers are being produced. The Government, far from patting themselves on the back, should be urging their EU partners for a simplified process of approval of these dossiers.

In the debate on 20th January the Government claimed that the long-term availability of products currently on the market will depend on future developments on maximum limits and lists of permitted nutrients. Hazel Blears, the then Minister responsible said as regards maximum permitted limits:

    "The important thing is that the Government are engaged actively in the debate and are not simply throwing our hands up and saying that there is nothing that we can do".—[Official Report, Commons, 20/1/03; col. 102.]

She later added:

    "Our efforts will focus on getting a good deal for the UK on implementation. I accept that many consumers value the high-dose products on the UK market, but we are actively pressing for thorough scientific risk assessments. There is still a great deal to play for".—[Official Report, Commons, 20/1/03; col. 106.]

The UK Expert Group on Vitamins and Minerals recently completed an assessment exercise for the FSA. Its report was trumpeted by the FSA in a quite sensationalist way as saying that vitamins can damage your health, are a waste of money and could lead to cancer. That caused huge alarm among consumers. That was by our own UK agency. That bodes extremely badly for acceptance by the EU bodies of sensible upper limits.

If our own FSA had its way, vitamins such as B6 vitamin C and zinc would now be able to be sold only in far lower doses than hitherto. What valid safety reasons are there for reducing dosages of those vitamins and minerals? For instance, how many adverse reactions have been notified as a result of vitamin B6 consumption since advice was last given in 1997?

I recently asked a series of Written Questions relating to the UK expert group's report, to which I have not yet had a reply. These related to how the expert group's report was handled by the FSA's press office. Why were its recommendations for safe upper limits substantially different from other internationally respected organisations as regards safe upper limits?

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It is no wonder that consumers and manufacturers are so pessimistic about the outcome of this directive. At a meeting with industry representatives and the Minister for Public Health on Monday 9th June, the Food Standards Agency stated that the European Union is now likely to set maximum permitted levels for nutrients in food supplements on the basis of nutritional need—not safety.

The Government's support is needed to ensure that pressure from countries with a more restrictive approach does not prevail and that—where safe—supplements containing ingredients at current levels can continue to be sold.

In the mean time, there is great uncertainty on dose levels. When and if these regulations become law this August, no one will know what daily dose level of vitamins will be allowed. That makes it impossible for manufacturers who need to be able to plan for their products. There will be a huge impact on small and medium-sized enterprise suppliers. What account have the Government taken of that? We have a thriving health food industry in Britain.

Hazel Blears, in the debate I cited, said:

    "I am informed that the vitamins that people want to take will be available in the formulations . . . on the positive list. However, companies may be required to reformulate their products or submit dossiers if they want to carry on with a specific formulation".

That itself is also grossly complacent. Reformulation may be impossible. Some 20 per cent of food supplements in the UK contain one or more of the 270 prohibited ingredients. Some products of course contain more than one prohibited ingredient. In total, an estimated 5,000 products are affected. The costs are impossible to calculate.

The reformulated product, as pointed out by the noble Earl, Lord Howe, may not be as effective—for example, the form of selenium permitted by the EU SCF committee. The positive list of nutrient sources does not now include selenomethionine, which is found in broccoli. Ms Blears made the breathtaking claim:

    "we have been able actively to engage in those negotiations to make sure that we can retain UK consumers' rights to the supplements that they value, and ensure that they make those goods more widely available in future".—[Official Report, Commons, 20/1/03; cols. 105–06.]

That flies in the face of every analysis of the impact of the directive. The UK consumers affected are: pregnant women, those suffering from arthritis or osteoporosis, women during the menopause, those suffering from endometriosis, diabetics and so on. That is a huge swathe of patients and consumers.

In many areas, we on these Benches have argued for the precautionary principle to be applied to new and untried products and technology. But what possible reason can there be for introducing the restrictions contained in the directive for products which have had years of safe use? Is it because we must all be in thrall to new pharmaceuticals and are not allowed to rely on natural traditional remedies?

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I hope that as a result of this debate the Government and the FSA will redouble their efforts and achieve a satisfactory outcome for consumers and manufacturers of these food supplements.

8.15 p.m.

Lord Beaumont of Whitley: My Lords, on behalf of the Green Party, I express our support for the noble Earl and his efforts today. I do not wish to take up your Lordships' time at this time of day. This is a very important debate which, one would have thought, could have been timed for a better period than the dinner hour.

Nevertheless, I want to make two points. First, no matter what the FSA say, the Government cannot possibly say that they would have introduced this measure unless they were being forced to by the European Union. This is certainly an area where subsidiarity should have been allowed to prevail and we should have been allowed to conduct our own affairs in our own way.

Secondly, I would like to support briefly what the noble Lord, Lord Clement-Jones, said about the precautionary principle. The Government and the European Union appear to have introduced the precautionary principle as a justification. The precautionary principle is not, as the noble Lord said, there to be introduced and involved in things which have been going along for a long time without any proven harm of any kind. It is very bad and dishonest to use that particular argument in this case.

I hope that the noble Earl will have his way and that the House will decide that the Government must go back and renegotiate the measure. It is quite intolerable as it stands.

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