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EU Food Health Claims Regulation: Problems For Supplements


The European Union is discussing a Europe-wide regulation for what in legislative parlance is called "health claims", those things that can be said about a food's or a food supplement's relation to health and disease.

The EU - just as national governments - is showing a highly schizofrenic attitude in relation to this matter: On the one hand, the conncection between food and health is becoming more and more obvious - even government programs promote prevention of serious illness by healthy eating habits, we're supposed to eat ever more fruits and vegetables to get the nutrients we need to stay healthy - really difficult in the era of fast food and big macs - but on the other hand, instead of promoting and stimulating discussion about foods and their influence on health, the EU seems intent to clamp down on communication.

Any "claim", as it's called, any indication of or hint of a food's relation to health or disease prevention is to be approved, and it can only be given the official stamp "in accordance with the highest scientific standards".

Now who would profit from such a rule? Certainly not consumers who want to find out what's new on the table and what to eat to stay fit. And for sure not those who think that supplements might be part of the answer to stay healthy. As a matter of fact, it looks as if supplements - already under the gun from an earlier EU directive - will be the big losers under this new EU proposal. Unlike the food multinationals, supplements manufacturers, especially the smaller and medium sized businesses that make up the bulk of the species, will be unable to compete in the "claims" arena. They simply won't be able to tell any more what their products are good for.

Cui bono? Can you say food multinationals?

Nigel Fawkes from the UK explains what the regulation will mean for supplements.

EU Proposal for Nutrition and Health Claims Regulation

…And you don’t believe you’re on the eve of destruction..?
It all sounds so reasonable. No doubt many well-meaning people were in agreement. But, if the EU’s current proposals for the ‘regulation’ of Nutrition and Health Claims is passed into law, it could mean the end of the health supplements market as we know it.

This is no idle threat either. The Commission is trying to fast track this legislation so that it is a fait accompli by the time the 10 new countries join the EU on 1 May 2004.

The Proposal

David Byrne, the EU commissioner for Health and Consumer Protection, says the regulation

‘will allow both industry and consumers to benefit from the correct use of claims. Consumers will receive accurate and meaningful information while producers will be able to use serious and scientifically substantiated claims as a marketing tool… furthermore will enable operators to compete on a fair and equal basis in all EU Member States’.

This sounds wonderful, and I am sure most people would see no immediate problem with it. BUT, as ever, the devil is lurking in the detail and it is utterly disingenuous. It has clearly been thought up in order to control a perceived problem in the food market, but will also automatically be imposed on the food supplements market (because of course food supplements are governed by food law).

Food supplements are invariably intended for a purpose, and what the new regulation proposes is that it will become illegal to give any clue on the label as to what that purpose is.

Under existing regulations, this has also been a source of frustration and confusion, because of the conflicting pulls of Food and Medicines law, but an acceptable modus vivendi has been established by the use of ‘maintenance’ claims (eg ‘helps maintain joint mobility’). The Food Labelling Regulations 1996 require that “the name used for the food shall be sufficiently precise to inform a purchaser of the true nature of the food and to enable the food to be distinguished from products with which it could be confused” (Regulation 8). Brussels, however, now proposes to remove what little latitude exists to help and inform the customer, on the basis that these statements are ‘vague and meaningless’.

We know that such claims are all the law allows – but even this is due to be revoked.

Up until now the law has permitted (and common sense has encouraged) companies to indicate on their packaging and in their literature, what and who the product is for. ‘Pure Marine Collagen for Joints’, ‘Help to Guard Against Winter Ailments’, ‘Helps Reinforce Healthy Eye Function’ etc … as long as they hold evidence for the claims they are making, and the description does not wander over the borderline and make an implied medicinal claim. All these explanations are now about to become illegal. Furthermore, if the product name indicates a purpose – perhaps being prefixed ‘Prosta… ‘ ‘Osteo…’ or ‘Mena…’ such names themselves will also become illegal.

Safe, popular and effective products could therefore be made illegal in their current form by the thousands. The resulting chaos and expense of label changes and new names, which contain no explanation as to purpose, will be a nightmare. Mail order catalogues, brochures and advertising will become impossible. The market will surely crash…

How is Brussels being disingenuous? In this Regulation, Brussels suggests it will allow companies to make more claims and give more details than before. However each claim – and the exact form of words used - must first have received specific approval. These are the ‘serious and scientifically substantiated claims’ referred to by David Byrne above. But the problem is that the burden of proof Brussels will require is being placed so high that very few companies will have the resources or budgets to cope with the system. As the draft Regulation states in para 29 of the recitals ‘Health claims should therefore only be approved …after a scientific evaluation of the highest possible standard’. By this they mean evidence of efficacy of the order of a Drugs licence – and we all know the enormous costs and research time spent by Pharmaceutical companies…

The measure appears even more disproportionate when you consider that under the EU’s own traditional herbal medicines Directive (the THMPD), claims of a much higher order will be permitted on the basis of traditional use and without any new evidence of efficacy. However, Food Supplements, in order to stay as they are, and saying what they currently do on the packaging, are going to be required to submit data virtually equivalent to that required to license a drug.

As a ‘Regulation’ this draconian piece of EU legislation would become law without even needing to be approved by Westminster. ‘Regulations’ (as opposed to ‘Directives’*) are passed by the EU legislature direct into law and our national government has no say. Once published they become law automatically after six months, and all the indications are that – unless we can stop it – this will be passed by May and be law by Christmas.

And in case your flesh is not yet crawling … the draft Regulation ends: ‘An extended assessment on this proposal is not recommended as the proposal has already been subject to extensive consultation with Member States and Stakeholders. Their opinion has been taken into account and is reflected in the proposal. Moreover, the proposed provisions only pertain to voluntary additional information (claims) made by the food producer. Further consultation is not planned’.

This Regulation has crept up without its full implications being widely recognised. This has much to do with the EU legislation overload with which the industry is already battling. Yet, if we do not defeat it, the outlook for the Health Supplements Industry is bleak. Small and innovative companies will go out of business because they are forbidden to suggest the purpose of their products on the shelf. Magazines will fold because advertising will not be able to say anything, and mail order companies will fold because it will be illegal for them to describe the benefits of their products. All that will remain will be a core group of standard vitamins and minerals, each carrying the approved, generic EU wording, and a few supplements for which the larger and better resourced manufacturers have invested heavily in gaining EU claims approval.

What can be Done? This is a purely political matter, so write to the Prime Minister, your MP and especially your MEP and to the Food Standards Agency - and pressure them to stop this Nutrition and Health Claims Regulation.

The government, the NHS and all right minded people want us to take more responsibility for our health. Knowledge of nutrition and of supplements can play a vital role in this. But, just as the message is beginning to get through, it seems as if Brussels were going to stop it in its tracks and return us to a dark age of ignorance, hear-say and deprivation.

The Regulation has been conceived in haste, is being rushed through for all the wrong reasons, and no one has properly considered its disproportionate and nonsensical effect on the Food Supplements market.

Go on – complain now – or very soon it will be too late.

*(A ‘Directive’, as per the ‘Food Supplements Directive’ on the other hand, does require UK parliamentary approval).

Nigel Fawkes
26 Feb 04

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