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European Legislation Regarding Vitamin and Mineral Supplements

There is nothing simple about the situation with EU directives and alternative medicine, it is a hotch potch of misinformation, illogic, bureaucratic wranglings, dirty work by the drug companies, disinterest by most MPs and a wealth of misunderstanding by the general public and the Medical Profession.

We have not even scratched the surface here but we will try harder to keep you informed.

Scroll down to see the latest information.  Feb 2008

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The links on the right will give you some historical background, they are emotive but not that informative about the reality of the situation, updating this page is a priority!, so watch this space.

LATEST NEWS Sept. 07

Read an open letter To The Prime Minister, published in The Guardian, from Consumers for Health Choice and endorsed by many "celebrities"

Codex is possibly the biggest threat to natural Medicine, read the latest news on Natural Matters Website

January 2007

the last few years have seen much jockying for positions on both sides and some rather obvious political skulduggery from the anti supplement brigade, the Medicines Control Agency (MCA) whose job was to monitor the safety of Pharmaceutical Drugs, a job that some people thought they were not doing very well. had an overnight metamorphosis into the MHRA (Medicine and Herbal Regulatory Agency), they suddenly became experts in herbal medicine.

The current situation is available on Consumers for Health Choice web site.

Their latest missive to consumers can be viewed here

May 2007

The following are short excerpts from the CHC site

* The Food Supplements Directive, 2002/46/EC, which deals with the regulation of Vitamin & Mineral food supplements.

It has already passed into law and came into force across Europe on 1st August 2005.  As it currently stands, the Directive will lead to the banning of many valuable, safe and popular nutrients and bio-available nutrient sources.  At the end of 2006 we will have further information on the setting of dose levels for nutrients.  There are already indications that the EU will wish to impose unnecessarily low levels - in line with those favoured by France and Germany. 

* The European Parliament adopted the Traditional Herbal Medicinal Products Directive and it was implemented in the UK on 30th October 2005.  

No further 'medicinal herb' products can be launched without THMP (Traditional Herbal Medicinal Products) registration or marketing authorisation (licence) but existing products (sold legally) can remain until the transitional period ends in 2011.  The Directive aims to push herbal remedies into the same formal regulatory environment of pharmaceutical medicines.  Product registration under this directive is only open to those finished products (not the ingredients) capable of demonstrating at least 30 years use - 15 of which must be within EU - and claims bearing a 'traditional use' caveat, will be restricted to mild self-limiting conditions.  Such actions threaten the continued availability of many herbal products as well as the accessibility of herb and nutrient mixtures. 

Feb 2008

Latest news from Alliance for Natural Health

The EU takes it's next steps on controlling food supplements
22/02/2008

The aim of the EU Food Supplements Directive (FSD), being a framework directive, is to harmonise the food/food supplements industry across the European bloc, one small bite at a time. They’re doing it gradually over a protracted period, under the guise of consumer safety, in the hopes that it’ll all happen so slowly we won’t notice the slow but steady decimation of the natural health industry that many of us are reliant on for our health. The gameplan is to see natural health being swallowed up by the big food and pharma corporations. Compare any large natural health industry trade show today with one from 5 or 10 years back and you’ll see that the process is already well underway. Consumers, more than any other group, have the power to reverse this trend.

Vitamins and minerals were first off the starting blocks and, in Europe, we’ve witnessed the imposition of the draconian, restrictive ‘positive list’, the ANH legal challenge in the European Court of Justice (ruled on in 2005) which helped in particular to save natural sources of vitamins and minerals, the once extensive ‘derogation list’ (which is rapidly being whittled down) and now the ham-fisted and quasi-scientific way in which Maximum Permitted Levels (MPLs) are being handled.

We continue to challenge the proposed European approach to MPLs, which is set to otherwise become the blueprint for what will be done globally through the Codex Alimentarius Commission. The risk assessment approach being used was initially heralded as one that would be much fairer and less restrictive than a ‘multiples-of-RDA’ approach favoured by many European countries like Germany, France and Denmark. But we can now see the levels, using these new methods, are no better than the RDA approach – and in some cases may be even worse (more restrictive)! The authorities would have us believe that consumers are in danger of exceeding their maximum safe dose if they consume the beta-carotene present in just one and a half carrots or the selenium in more than two brazil nuts. These are just two examples amongst a number of other travesties to essential nutrients. Watch that shopping trolley, loading up at the fruit and veg section could put you at risk of vitamin and mineral overdose! We don’t think so…

However, next up for harmonisation in Europe are the all-important group of phytonutrients or ‘botanicals’. This category encompasses a large section comprising non-vit consumers are choosing to take to supplement their diets, as a means of boosting antioxidants, resolving certain ailments and optimising their health.

In December 2007 the European Food Safety Authority (EFSA) released a draft guidance document on how botanicals and botanical preparations in food supplements should be classified and invited comment from stakeholders across the EU through an electronic consultation that closed on 15th February 2008 (ANH news 6/12/07). The guidance document hinges on safety and risk assessment and categorises some 860 herbs between two lists. Between both lists you’ll find everything from alfalfa to artichokes, clove to castor oil and pineapple to patchouli – nestled among herbs that are known to have safety issues if consumed over prolonged periods, especially at high dosages (e.g. Aristolochia).

The ANH responded to the consultation and have issued the following release:

PRESS RELEASE: for immediate release

22 February 2008

ONEROUS LAWS FOR BOTANICALS THREATENS CONSUMER CHOICE

Last Friday, 15 February, the European Food Safety Authority (EFSA) closed the doors on its public consultation concerning approaches to the regulation of botanical products as food supplements in the EU. The Alliance for Natural Health (ANH) was among several organisations and governments responding to the consultation and has indicated its concern that large numbers of plant-derived products or botanicals, which pose no risk to human health, and have numerous benefits, will be forced through an onerous risk assessment procedure. The proposed procedure is likely to be cost-prohibitive for smaller companies that have been the main pioneers and innovators within the natural health industry. Many of the larger companies have little interest in such products, which are currently freely available on the EU market as food supplements.

Dr Robert Verkerk, executive and scientific director of the ANH, said “With the trend for increasing simplification of western diets, including the over-consumption of simple carbohydrates and inadequate diversity of fruit and vegetables, botanical supplementation is an important tool for the enhancement of people’s diets.  It makes no sense to limit freedom of choice for those who choose to take responsibility for their health.”

The ANH is concerned that EU control over natural healthcare – and particularly the imposition of unnecessarily and often prohibitively high data thresholds to keep products on the market – is going to unfairly and disproportionately affect the availability of safe, beneficial products already on the market.

Another European Directive, the Biocidal Products Directive, has already banned a wide range of natural essential oils, including eucalyptus, tea tree, thyme and citronella, for use as insect repellents and personal deodorants. Without this choice, consumers are forced to use synthetic versions widely available in major multiples. The ban on the products came into force on 1 September 2006 after natural product suppliers were unable to afford the cost of submitting dossiers for EU approval.

Dr Verkerk added, “If the industry doesn’t work to achieve a fairer regulatory regime which grandfathers in botanicals that have had long histories of safe use, a similar fate to natural oils used as repellents and deodorants could befell dozens of key botanicals used in food supplements across the EU.”

The ANH was successful last August in getting the European Commission to agree that usage of natural sources of vitamins and minerals was outside the scope of the EU Food Supplements Directive. Despite this concession, there is a substantial risk for non-vitamin and mineral containing botanicals falling foul of the prescriptive and onerous European regulatory framework for natural health products.

CONTACTS

Dr Robert Verkerk
Executive & Scientific Director
Alliance for Natural Health