Positive Health Online

On 27 September 2001 the Council of Ministers reached political agreement on the European Directive on Food Supplements. At the time of writing, the measure is now going for a second reading in the European Parliament.

European legislation overrides domestic UK legislation. Now that the Food Supplements Directive is becoming law, it will have to be enforced by the UK. Even if UK legislation continues to permit the sale of our current range of vitamin and mineral supplements, they will still be illegal if the Food Supplements Directive says so.

The Directive is split into different sections, called Articles. Each Article deals with a different aspect of the Directive. Article 2 deals with the scope of the Directive, whilst Article 5 deals with the setting of maximum permitted levels of supplements.

There are also two Annexes attached to the Directive that specify what ingredients will be allowed on to the marketplace, both by generic name (i.e. selenium) and the specific ingredient of that mineral (e.g. selenium yeast).

In addition, there is a European Committee called the Scientific Committee on Foods (SCF). This Committee is the body that advises the upper safe levels of all products and ingredients that are placed on the market. The final decisions are then made by the EU Commission and the Standing Committee for Foodstuffs.

Why Does the Food Supplements Directive Raise Concerns?

Article 2
Article 2 has been extended to cover all supplements that possess nutritional or physiological activity. On the face of it this is a welcome development – but only if the rest of the Directive is appropriate. We are nervous about Article 2 because of the implications of Article 5, as below.

Article 5
Article 5 should specify a method of determining the maximum permitted levels of supplement ingredients. Unfortunately, it doesn't. Article 5 can be interpreted in an almost infinite number of ways – most of which would result in the prohibition or reformulation (to a lower potency) of the majority of products that are currently available on the UK market.

We believe that it is irresponsible to accept a directive that is deliberately ambiguous in its wording.

Had the Directive not been agreed by January, then the Presidency of the EU would have moved on to Spain. We understand that Spain might have promoted a very restrictive wording of Article 5, probably limiting all nutrients to 3 x RDA (recommended daily allowance).

There was concern that this might have been approved by other Member States and that 3 x RDA is a lot worse than the current proposals. We understand this concern, and accept that it is real. However, we cannot believe that the UK population, or the UK Government, would have accepted such a draconian restriction on supplements, and a real possibility of overturning the whole legislation would have presented itself. Instead we now have this nebulous directive that declares open season on all high potency supplements, without actually saying so.

The Two Annexes to the Directive

Annex 1
Annex 1 specifies the vitamins and minerals that will be permitted on to the marketplace. The interpretation is very strict and only vitamins and minerals that are considered to be essential are currently allowed, with minerals such as boron and sulphur omitted. Also missing are tin and vanadium, along with other trace elements.

If a vitamin or mineral is missing from Annex 1 once this directive becomes law, then sales of that vitamin or mineral will become illegal – whatever the UK Government position happens to be.

Annex 2
Annex 2 specifies the form of vitamin or mineral that will be permitted. As an example, selenium is a permitted mineral, but there are many different selenium salts on the market; for instance ascorbate, citrate, ethanolamine phosphate, fumarate, glycinate, lysinate, malate, picolinate, succinate, yeast, selenocysteine, selenomethionine and selenous acid.

We list these forms of selenium because all of them will become illegal under this directive.

As another example, these are the forms of magnesium that will become illegal: amino acid chelate, arginate, ascorbate, aspartate, butyrate, caprylate, chloride-fumarate, citrate, citrate-malate, cysteinate, ethanolamine phosphate, fumarate, gallate, glutamate, glycinate, ketoglutarate, lactate, lysinate, malate, methionate, niacinate, orotate, pantothenate, phosphate, phosphoserine, pyruvate, salicylate, succinate, tartrate, taurate and yeast.

The National Association of Health Stores (NAHS) has compiled a list of nearly 300 ingredients that are currently used in food supplements that will become illegal if this directive is enforced. Whilst industry is preparing dossiers for submission to the SCF for approval, only 35 such ingredients are covered. The submissions may not be successful, but even if they are, we still face losing over 250 legitimate ingredients – for no good reason other than the bureaucrats who devised this law decided to use the PARNUTS1 legislation for their sources of permitted nutrients – they consulted the food manufacturers rather than qualified nutritionists.

Annex 3:
Click here for a full list of the ingredients not included in this list.

The Scientific Committee for Food (SCF)

As if all the above wasn't bad enough, the SCF will play two crucial roles that relate directly to this directive.

1. The SCF will determine the upper levels for each nutrient. These figures will be used by the Commission to set maximum permitted levels for supplements. The maximum permitted level is almost bound to be lower than the upper level for reasons we cannot go into in this document;

2. The SCF will consider whether to permit specific nutrients, and also forms of nutrients, on to the market.

The SCF is supposed to establish upper levels through risk analysis using sound science. However, it has already released a provisional determination that vitamin B6 should be restricted to 25mg. Worryingly, they have used a piece of dubious research2 as justification for this remarkably low amount. This report, the only one ever published that reports toxicity of B6 at such low doses, has long been acknowledged as seriously flawed.

The UK has established the Ad Hoc Advisory Expert Group to determine its own upper levels. Whilst these may be used to influence the SCF in Europe, the final say is from the SCF. So if our Ad Hoc Group recommends 200mg for vitamin B6, and the SCF remains at 25mg, the Food Supplements Directive will mandate 25mg at best, and probably a much lower figure in practice; the 25mg allowance of B6 will be reduced further still by the Commission when it sets the maximum permitted levels for supplementation.

The SCF has also specifically banned four nutrients from being on the EU market. These nutrients are selenium yeast, selenomethionine, chromium yeast and chromium picolinate. If the SCF can ban these ingredients, which have been safely on the UK market for years, if not decades, there is serious doubt that another 300 ingredients will be approved within the next 18 months.

Summary of the Problems Arising

If this directive is accepted in its current form, we face a number of extremely serious concerns:

1. Article 2 could encompass the majority of our product range, and a restrictive directive would completely decimate our industry;

2. Article 5 mandates nothing. We do not want to spend the rest of our lives hoping that the EU will be benevolent to higher dose supplements. We know that most of Europe doesn't want them and we believe that Article 5 will be interpreted in a draconian fashion;

3. Annex 1 omits several important and legitimate nutrients;

4. Annex 2 omits hundreds of safe and legitimate nutrient forms;

5. The SCF has already determined very low levels for B6, and may do the same for other safe and legitimate nutrients;

6. The SCF has already banned four safe and legitimate nutrient forms, and may well deny permission for another 300 that are currently on the UK market;

7. The above combination will completely stifle product development and innovation;

8. The above combination will prevent competition, as smaller companies will be unable to compete with the conglomerates in a restricted marketplace;

9. The above combination will result in the removal of safe and legitimate products that the UK practitioners and consumers have been using safely for decades;

10. The above combination will result in the unnecessary closure of many smaller manufacturers, nutrition-based practices and health food stores throughout the UK.

Derogation – A Last Hope?

Derogation is an eleventh-hour concept that may provide some hope. If the Directive is adopted in its current form, the UK can push for exclusion to sections of the Directive. There would be a level playing field for Member States, but each country would be permitted to have higher supplement levels, if it so desired.

On first consideration this appears attractive. However, if the UK is successful in achieving derogation from Article 5, there are two immediate problems:

1. The UK would still have to comply with the upper levels set by the SCF (remember 25mg for B6);

2. The UK would still have to comply with the Annexes (remember the 300 missing nutrients).

Derogation is not an answer unless the UK is also allowed to derogate from upper levels advised by the SCF (we would use the Ad Hoc Group recommendations) and from the restrictive Annexes.

It is inconceivable that this will be permitted.

Also – of less concern, but still potentially a problem – derogation is at the discretion of the Member State. At the moment the UK Government is firmly on the side of upper levels as established by sound science. However, we must remember that due to previous scientific recommendations, current official UK Government advice is that taking vitamin B6 in excess of 10mg per day is harmful.

There is also no guarantee that there will be no further general policy changes at some time in the future.

Conclusion

At the time of writing we have two urgent tasks:

1. We must endeavour to get as many of the missing nutrients on to the approved list as possible, and we now have less than 18 months to complete the task. One obstacle to our success in this is that it will cost an estimated £80,000-£130,000 per dossier. The fact that this, in total, represents more than the profits of the entire UK industry should put into perspective our chances of success;

2. We must endeavour to ensure that the maximum permitted levels of those nutrients that remain are safety levels based on sound science, and not bureaucratic, administratively convenient RDAs.

Meanwhile we may have a seven-year derogation on products not on the list, in other words we can continue to use 'unapproved' products that are currently in use, for the next seven years, after which they will become illegal if they are not on the approved list by early 2003. It's up to all of us to rescue what we can from this debacle.

References

1. No, this is not a new type of food! The acronym relates to a draft Commission directive – Substances that may be added for a specific nutritional purpose in foods – for PARticular NUTritional uses.

Basically, there is a list of vitamin and mineral substances (VMS) that is in existence, and currently relates to sectors such as baby milk and cereal-based foods. It controls the ingredients in such substances. The fears of extending the influence of this list, such as using it as a basis for VMS, sports products, diet foods and diabetic food, have now been realized.

2. Dalton K and Dalton MJT. Characteristics of pyridoxine overdose neuropathy syndrome. Acta Neurologica Scandinavia. 76: 8-11. 1987.

How the EU Directive was Drafted

European legislation is based on Napoleonic Law. This maintains that everything is forbidden unless it is specifically permitted. Thus when setting up the legislation for the control of vitamins and minerals, a positive list had to be set up which defined those permitted nutrients.

The bureaucrats assigned to this task utilised an existing piece of legislation called PARNUTS – Substances that may be added for a specific nutritional purpose in foods – (for PARticular NUTritional uses) dealing with ingredients used in baby milk and cereal-based foods. Most of these were cheap materials used to fortify foods in order to restore them up to a minimum nutritional value, most of the natural nutrients having previously been removed in the refining process. So with no reference to anyone expert in the field of nutrition other than these manufacturers, the positive list was created. This is why we now find that about 350 nutrients are missing from the list, of which 60 are basic elements such as sulphur and boron and the rest are nutritional formulae of these and other substances. Despite a seven year period of derogation, all will be ultimately deemed illegal unless they are added within the next 18 months, through acceptance of submissions of technical dossiers each supporting an individual element or formulation. So far manufacturers have put together only 30 in total.