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20 Jan 2003 : Column 95—continued
Food Supplements Directive
Mr. Deputy Speaker (Sir Alan Haselhurst): I must advise the House that Mr. Speaker has selected the amendment in the name of the Prime Minister.
7.43 pm
Dr. Liam Fox (Woodspring): I beg to move,
- That this House notes that the Food Supplements Directive includes a list of nutrients and nutrient sources that may be used in supplements and that there are nearly 300 safe nutrient sources on the UK market which are missing from the list; further notes that unless full safety dossiers are submitted for consideration by the European Scientific Committee for Food by July 2005 these nutrients will be illegal; observes that the cost of commissioning research to include within a dossier, and the compilation of such dossiers, makes the task prohibitively expensive and that some 270 safe and popular nutrient sources will be lost to the UK industry and its consumers; and declines to approve the proposed statutory instruments implementing the Directive unless and until the Government secures an amendment to the Directive so as to allow to remain on the national market those products which would otherwise fall outside the Directive's technical restrictions; further notes that the Traditional Herbal Medicinal Products Directive would require dossiers to be submitted to the Medicines Control Agency and would impose costs of tens of thousands of pounds per product on manufacturers; regrets that it would not allow any overseas product which had not been on the European market for 10 years even if it were demonstrably safe; and urges the Government to renegotiate the main provisions of this flawed Directive.
The directives are important for two reasons, the first of which is specific to the directives themselves, and the second relates to the general burden of regulation. The directives will have specific effects on consumers' freedom of choice and on United Kingdom manufacturing and retail business. On the general burden of regulation, as my right hon. and learned Friend the shadow Chancellor pointed out recently, 4,642 new sets of regulations were introduced in the United Kingdom last year—one for every 26 minutes of each working day. That is not only a record, but an increase of nearly 50 per cent. on the number introduced in 1997. As well as the general burden of over-regulation, those directives reflect the European Union's increasing intrusion into areas of our national life and legislation where it has no place.
I shall first turn to the background to the two directives—first, the food supplements directive. In May 2000, the European Commission published a directive on food supplements, which was finalised in the spring of 2002 and published in the Official Journal on 12 July 2002. Its main provisions will be implemented over the next seven years. Although presented as essential to ensure consumer safety, the food supplements directive has been designed to standardise the different regulatory regimes for vitamin and mineral supplements across EU member countries. That may cause a slight liberalisation
of the market in France, Germany and some other countries, but it will mean the loss of a substantial number of products in the existing liberal markets—the United Kingdom and the Netherlands in particular—where millions of consumers have been using higher-dose vitamins and minerals for several decades. In March 2002, Conservative Members of the European Parliament voted against the food supplements directive.The second directive is that on traditional herbal medicinal products. Under Community legislation governing pharmaceuticals, no medicinal product may be placed on the market without having obtained a marketing authorisation. The draft directive on traditional herbal products provides for a new special procedure to apply to the authorisation of traditional herbal products. Products to which the proposal applies would be identified in a positive list, subject to their meeting certain conditions, including the need for safety to be demonstrated, a requirement to show a history of 30 years' use, the use of agreed medical indications and the need for labelling to include a clear statement that product efficacy is not proven, as well as other information on the safe use of the product. On 21 November 2002, the European Parliament voted for that directive at first reading, backing numerous amendments tabled by the Conservatives designed to protect individual choice as much as possible.
Mr. John Redwood (Wokingham): I am grateful to my hon. Friend for highlighting this crucial issue. Many of my constituents are angry that they will not be able to buy their normal products in the usual way, and shops are worried about the damage to their business. Does my hon. Friend agree that the fact that the Government cannot stop the EU doing such enormous damage to something that does not need fixing shows that they have absolutely no influence at all in Brussels?
Dr. Fox: It would be reassuring for me to tell my right hon. Friend that the Government have no influence—I imagine that that is true—but I am not sure whether they tried to use any influence in this instance, so I am not sure whether we can draw any inference from their inactivity.
We have some specific reservations about the food supplements directive. The first threat is that the directive introduces a system of maximum permitted levels for nutrient content. Those levels are expected to be set substantially lower than the scientifically assessed upper safe level. That process will start with a cautious assessment of the safe level by the EU Scientific Committee for Food. That level will then be further reduced by the European Commission to take into account risk management factors, such as nutrient intake from other dietary sources and population reference intakes. Political considerations at the relevant EU Standing Committee will then come into play, with probably the Governments of France, Germany and other countries seeking to block everything, except the lowest possible dose levels in line with their existing markets.
Millions of British consumers regularly use higher-range vitamins and minerals. Removing those products from general sale will not stop consumers wanting them. A good example might be the generally high doses of
vitamin C available in this country. If we harmonise down to the sort of level used in countries such as Italy, we might find that a couple of fruit smoothies from the House of Commons canteen gives us a higher does than recommended by the EU. What is to stop the outrageous and incredibly creative step of consumers taking two tablets instead of one? That directive is complete bureaucratic nonsense. As Consumers for Health Choice has put it,
- "such action would raise a very real moral hazard by forcing consumers to seek"—
- "from unregulated outlets such as overseas mail-order companies and the Internet, putting consumer safety at risk."
Mr. Mark Todd (South Derbyshire): Will the hon. Gentleman set out how British manufacturers such as Peter Black in my constituency currently have access to the German, French and Austrian marketplaces, to which he referred as liberalised in this process? Currently, I believe that they are not able to sell into those marketplaces satisfactorily.
Dr. Fox: I referred to the United Kingdom and the Netherlands as liberalised. I referred to France and Germany as much more restrictive, which is entirely in line with what the hon. Gentleman says. I fear that, rather than liberalising and allowing German and French consumers access to the products currently available to UK consumers, the exact opposite process will occur, with greater restriction of the markets in the United Kingdom to bring them into line with the restricted availability in other countries. The directives will be designed to suit the already restrictive practices in other countries, not the liberal trading environment of the United Kingdom. It will be against the interests of British consumers and British manufacturers.
The practical effect of the detailed proposals in the second directive on herbal medicines would remove many safe and popular products from the marketplace, as some products have not been on the market for the necessary period. The imposition of the extraordinarily arbitrary 30-year period would jeopardise the position of products introduced over a period of nearly three decades and prevent all future innovation. No new products could be brought to market, even if they had been available for many years in another non-EU country with a good safety record. The directive would not allow products that were combinations of otherwise legal ingredients—for example, existing mixtures of herbs with nutrients such as vitamins and minerals—leaving some of those products, which represent an important section of the UK market, in a regulatory vacuum.
On top of all that, the cost of the new framework would be completely beyond many small manufacturers, forcing them out of business. What do we want the Government to do?
On the food supplement directive, the Government must immediately use every opportunity to persuade the Commission and the Governments of other EU member states to allow the most liberal possible interpretation of the legislation. The Government must also force an early review of the procedures of the EU Scientific Committee on Food so that the requirement to submit dossiers for nutrients currently not on the permitted list is not overly burdensome and expensive. Above all, the Government must work now for an amendment to the directive that would allow those safe supplements, which would otherwise lie outside the directive's technical restrictions, to remain on the UK market. As the Health Food Manufacturers Association put it
- "What is needed is a system whereby the SCF can accept minimum data requirements for such products, based on their history of safe use. The UK Government should be arguing for this in Brussels."
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