FROM:			www.SilentMajority.co.UK
FILE NAME:		EU & FOOD SUPPLEMENTS 020304.rtf

From UK Assoc of Health Stores
Ralph Pike  3-4-02

The Food Supplements Directive
and why it is bad for us all.

EU
 legislation overrides domestic UK legislation. If and when the Food Supplements Directive becomes 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 become 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 onto 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 only body that can approve all products and ingredients that are placed on the market. Without SCF approval, the product will not be permitted on sale. 

So why do we consider the Food Supplements Directive to be bad for us?

Article 2 looks like being 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 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 of most 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. 

If the Directive is not agreed by January, then the Presidency of the EU moves onto Spain. We understand that Spain might promote a very restrictive wording of Article 5, probably limiting all nutrients to 3 x RDA.

There is concern that this will be 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, will accept such a draconian restriction on supplements.

Consider vitamin B6 limited to 4.8mg per dose, or vitamin C limited to 180mg. The UK consumer won’t accept it, and we believe that it is better to fight for what we believe to be morally and scientifically correct, rather than cravenly compromise and hope that we get lucky.

There are two Annexes to the Directive

Annex 1 specifies the vitamins and minerals that will be permitted onto 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 and this directive becomes law, then sales of that vitamin or mineral will become illegal – whatever the UK Government position is.

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; such as 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.

What’s that? You don’t sell selenium? 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, fumurate, gallate, glutamate, glycinate, ketoglutarate, lactate, lysinate, malate, methionate, niacinate, orotate, pantothenate, phosphate, phosphoserine, pyruvate, salicylate, succinate, tartrate, taurate, yeast

The 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!

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 onto the market.

The SCF is supposed to establish Upper Levels through risk analysis using sound science. However, they have already released a provisional determination that vitamin B6 should be restricted to 25mg. Even worse, they have used a fatally flawed piece of research (Dalton K, Dalton MJT, Acta Neurologica Scandinavia 1987;76:8-11) as justification for this ridiculously low amount.

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 remain 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 4 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, what hope is there for adding another 300 ingredients within the next few years?

In Conclusion.

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 don’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 have already determined ridiculously low levels for B6, and may do the same for other safe and legitimate nutrients
6.	The SCF have 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 consumer has been using safely for decades
10.	The above combination will result in the unnecessary closure of health food stores throughout the UK

Derogation - A Last Hope?

Derogation is an 11th 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 set 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, the official UK Government advice is that taking vitamin B6 in excess of 10mg per day is harmful.

And what if general policy changes at some time in the future?

Final Conclusion.

The only acceptable outcome for the UK consumer, retailer and manufacturer is a directive that doesn’t require the removal of safe and legitimate products from our marketplace – or no directive at all.
END

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