Extracted from letter 10 Feb 2005, by David C Hinde LLB, Legal Director of ANH (Alliance For Natural Health) - and the following applies not only to those taking supplements in the EU but in the US and ANZ.
"There has been much misunderstanding, and dare I say it, misinformation, regarding the EU Food Supplements Directive and ANH’s legal challenge to it. It is vital to understand what is going on and I am going to attempt to put you in the picture.
What’s wrong with the Food Supplements Directive? 6 key things principally;
1) The FSD reverses the burden of proof as regards showing that food supplements are safe. Previously a food supplement could generally be sold as food unless the Regulator could prove scientifically that it is unsafe. (This is the position in the USA for example under DSHEA). Now in the EU it will be for the manufacturer to prove at great cost that it is harmless before he can sell it.
2) It creates a very restricted list (known as the “positive list”) of allowable nutrients which favours synthetic nutrients over those much closer to how they are found in nature.
3) It will set what are anticipated to be very low maximum doses of nutrients.
4) In order to get on the "positive list" of allowable nutrients a technical and very costly dossier will required which may or may not be acceptable to the EU Regulators
5) If a nutrient (or its source) is not on the restricted list it will be banned across the EU from 1 Aug 2005 regardless of the fact that it was previously allowed to be sold in various EU Member States for many years
6) At present the FSD only applies to vitamin & minerals. However it is a framework Directive and is intended in time to apply to all nutrients and their sources. So the negative pattern applying now to vitamins and minerals will in time be applied to all nutrients.
Now, under the guise of a harmonisation, we end up with a measure which will ban many nutrients presently on sale in the EU. The Directive thus defeats the whole purpose for which many people take food supplements, namely to supplement their diet in order to promote optimal well being through the addition of key vital nutrients which they cannot get in their normal diets any more (unless they happen to live in an organic tropical paradise).
The UK Govt when it undertook its Regulatory Impact Assessment (measuring the impact of the implementation of the FSD in the UK) concluded that on balance the FSD had a negative cost / benefit for the UK and conceded that the ban on nutrients which are currently allowed to be sold in the UK (unless they get requalified by submission of a dossier) was “unnecessary”.
We are looking at the ban of around 75% of the vitamin and mineral sources currently on the EU market. This will translate into a banning of some 300 vitamin and mineral ingredients and possibly around 5000 products currently available. If this is what is happening to vitamins and minerals now what will happen to all other nutrients in the future?
Talks on this very matter are going on between Australia & NZ right now.
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