Source - Daily Telegraph

Will your vitamins be banned from the shelves after August?
(Filed: 08/02/2005)

A question of choice

New EU rules on supplements have made big headlines and attracted vocal opposition. Barbara Lantin sifts fact from fiction and explains how consumers will be affected

If you are among the 43 per cent of the population who take vitamins, minerals or other food supplements, you may well be feeling a little alarmed and confused. On August 1, the European Food Supplements Directive takes effect. From then, the only vitamins and minerals that can be sold in Britain will be those on a list of permitted substances, or those for which an application to be added to this "positive" list has been made.

Supporters of the legislation will tell you it is long overdue and will protect consumers who, until now, have bought food supplements without any guarantees that they contain what they say on the packet or that they are safe.

According to the Government, "all of the vitamins and most of the minerals currently on sale in the UK will still be available" and dosages, which have yet to be decided, will be based on research by the Food Standards Agency and the European Scientific Committee on Food.

Campaigners fighting the legislation say around 300 nutrients - minerals or compound sources of minerals or vitamins - will be banned, affecting about 5,000 products and causing problems for the millions who use food supplements. They argue that years of use prove that these ingredients are safe and that the directive is ill-conceived, as the "positive" lists have simply been copied from legislation that regulates baby foods.

There are fears that dose levels will be dramatically reduced once this part of the directive comes into effect in two years. British consumers can buy higher-dose products than available in some EU countries. If levels typical in France or Germany prevail, some people will have to swallow a handful of tablets to take the dose they now get in one pill. Or they will turn to the unregulated internet.

A challenge to the directive has been mounted in the European Court of Justice in Luxembourg by trade associations representing health-food manufacturers and health stores. They argue that the directive is unnecessary, will restrict choice and cause many companies to go out of business. Judgment may take several months.

Will I still be able to buy my regular multivitamin after August 1?

Yes, but it is possible that the exact formulation may change slightly. For example, the minerals boron - a trace element that is thought to help the body make use of the glucose, fats, oestrogen and other minerals, such as calcium, copper and magnesium, in the food we eat - and vanadium, a trace element which is found in foods and isn't thought to be needed for good health, are not on the positive list. Boots has decided to remove boron from its Multivitamins A-Z, but with, it claims, "no detriment to the product". Other manufacturers are keeping boron in their formulations because an application has been made to have it included in the positive list and they are allowed to continue using it until a decision is reached by the EU.

With vanadium, the position is different. Because manufacturers have decided that this is not worth saving, no application to have it permitted has been made and it will disappear from supplements. Some manufacturers have found themselves in a tricky position: on the one hand, they are fighting to keep existing formulations, and on the other, trying to reassure consumers that even if things change, they will be no worse off.

I take 100mg of vitamin B6 daily to keep my PMS under control and 2,000mg of vitamin C a day through the winter. Will I still be able to buy high-dose supplements?

Yes, for the time being, but things could change. Maximum dosage levels are likely to be introduced in 2007 and nobody knows what these will be. However, there are some clues. In 2003, the Expert Group on Vitamins and Minerals published a report on safe upper limits (SUL) for 31 substances. It recommended an SUL of 10mg for B6, based on fears - which campaigners say are groundless - of possible nerve damage at higher doses. Interestingly, the European Scientific Committee on Food has suggested a level of 25mg. In France and Germany, the maximum doses are generally lower than in Britain. This could mean having to swallow 10 tablets of vitamin C to get the 2,000mg dose.

Some people have been swallowing high doses of vitamins and minerals for years and feel better for it. If these products weren't safe, surely we'd know by now?

It took the world a long time to work out that cigarettes were dangerous, and while nobody is suggesting vitamin pills are in the same league, many people believe that some protective legislation is overdue. Vitamins may be as old as food itself, but the forms in which they are now delivered are new and the doses much higher. As the Expert Group on Vitamins and Minerals says: "It has been argued that since vitamins and minerals are essential for human health, it is not appropriate to assess them in the same way in which other chemicals added to food are assessed. However, since there is much evidence that excessive intakes of some vitamins and minerals can cause harm, it is not appropriate to exclude essential nutrients from the safety assessment that is applied to other chemical substances which are added to foods."

So what vitamins and minerals are banned under the directive?

No vitamins are banned, but six minerals now used in food supplements are excluded - tin, silicon, nickel, boron, cobalt and vanadium. Some of these will continue to be included until the EU rules on their safety.

More significantly, many modern, widely used sources of vitamins and minerals are not on the positive list. According to campaigners, these deliver nutrients in a form that makes them easy to absorb. The conventional formation for iron - ferrous sulphate - is allowed. But iron bisglycinate, a newer formation that can be taken in smaller doses and is less likely to cause stomach problems, is not.

Some of these substances may eventually be permitted, but some will not. One highly bio-available source of selenium has been rejected by the Scientific Committee on Food. The Government has played down the role of banned chemical sources, but some experts fear that if they cannot be used, product quality and effectiveness will be compromised.

If a nutrient is not on the positive list, is it lost for ever?

Not necessarily. Manufacturers have until July to submit a "safety dossier", setting out why a particular nutrient should be included, and can continue using the nutrient until 2009 or until the EU rules, whichever is sooner. However, the necessary research and documentation can cost between