Following the release in Dec 2007 of the draft guidance document on how botanicals should be classifed, the ANH have issued this release at the close of the EFSA electronic consultation period.
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 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-vitamin and mineral, plant-derived nutrients. Many companies selling herbal products are reliant on the FSD to bring their products to your shelves and now these products are potentially at risk. The high cost, exclusion of polyherbal and combination products, and the medicinal regime offered by the Traditional Herbal Medicinal Products Directive has meant that this is not an amenable route for smaller companies or companies selling poly-herbal products. It is therefore imperative to keep the FSD open as the legal framework for the huge variety of botanical products that increasing numbers of 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. 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:
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.
Dr Robert Verkerk Executive & Scientific Director Alliance for Natural Health
NOTES TO EDITOR
European Food Safety Authority
For further information about the EFSA consultation on botanicals, please see:
Biocidal Products Directive Note on ban effective from 1 September 2006 from UK competent authority, the Health & Safety Executive: http://www.hse.gov.uk/biocides/1septdeadline.htm
European Chemicals Bureau website concerning biocidal products: http://ecb.jrc.it/biocides
About the Alliance for Natural Health
The Alliance for Natural Health (ANH) is a UK-based, international, non-governmental organisation, founded in 2002, that is working on behalf of consumers, medical doctors, complementary health practitioners and health product suppliers worldwide, to protect and promote natural healthcare, using the principles of good science and good law.
The ANH’s principal objective is to help develop an appropriate legal-scientific framework and environment for the development of sustainable approaches to healthcare, while helping to promote natural health. Within this setting, consumers and health professionals should be able to make informed choices about a wide range of health options, and in particular those that relate to diet, lifestyle and non-drug-based or natural therapies, so that they may experience their benefits to the full while not exposing themselves to unnecessary risks.