Members
e-Letter Issue 2 (June 2007)
In This Issue
What is the European Food Supplements Directive?
CODEX UPDATE: “Germany in November” 2007
What is the European Food Supplements Directive?
The stated objective of the EU Food Supplements Directive is to support and assist trade in food supplements between European Member States by “harmonizing” the laws for food supplements throughout the European Union and to protect consumers from unsafe products.
The Directive passed into law throughout the European Union in 2002 and, after exhaustive legal challenges, succeeded to go into effect across the European Union on August 1, 2005. As an important note, it is only the first of several European Union Directives to impact the natural healthcare sector.
So? What’s the Problem?
There are four components to this Directive which present significant concerns.
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Only food supplement ingredients that are included on an arbitrarily established positive list (see WINHS.ORG Newsletter of May, 2007) for vitamin and minerals are allowed. Nearly two thirds of currently available vitamin forms have NOT been included and face the risk of only being allowed for sale if they are approved and then licensed as medicines (a process far too costly for most food supplement manufacturers); Enter the Pharmaceutical companies who will continue to create worthless drug/chemical versions of these, etc.
*In 2007 the European Commission will most likely issue further restrictive positive lists for Other nutrient groups including essential fatty acids, amino acids, phytonutrients, antioxidants, etc.
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An “application process” system has been incorporated to enable nutrient sources, initially only vitamins and mineral forms, which have been in use prior to 10 June 2002 but have been excluded from the “positive list” to be allowed if scientific dossiers are fully prepared and accepted by the European Food Safety Authority.
(Regarding the "Scientific Dossiers"; see www.foodsupsinfo.net for details.
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Maximum doses of nutrients will be set in due course and these levels are likely to be unnecessarily low; and,
- Positive lists are likely to be applied to nutrients other than vitamins in due course, such as essential fatty acids, amino acids, plant extracts, enzymes, fatty acids, etc.
In October of 2003, two trade organizations from the United Kingdom and the Alliance for Natural Health initiated a legal challenge to the proposed prohibition of the excluded vitamin and mineral forms in the High Court in London. The case was referred to the European Court of Justice in Luxembourg on 30 January 2004.
An oral hearing was then heard in the EU Court of Justice on 25 January 2005, during which the senior advisor to the Court, the Advocate General, referred to this application process to the positive list as “as transparent as a black box”.
On 5 April 2005, the Advocate General handed down his opinion to the Court recommending that the EU Food Supplements Directive be annulled owing to ‘fatal flaws’ within it.
On 12 July, the very day that the applications process formally closed, the European Court handed down its ruling. To the surprise of many, the Court upheld the EU Food Supplements Directive though addressing a number of the key complaints over the prohibition of non-positive list vitamins and minerals.
CODEX UPDATE: “Germany in November” 2007
The Codex Committee on Nutrition and Foods for Special Dietary Uses, (CCNFSDU), will meet for the 29th session in Bad Neuenahr, Germany from November 12th to the 16th of this year (2007).
The Committee, established in 1966 and hosted by a Secretariat permanently located in Germany, is responsible for studying nutritional problems referred by the Codex Alimentarius Commission. The committee also has the power to draft provisions on nutritional aspects for all foods and develops guidelines, general principles, and standards for foods for special dietary uses.
Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), one of 27 Codex Alimentarius Commission committees, develops international guidelines and standards for foods including: infant formula, cereal-based foods for infants, gluten-free foods and dietary supplements.
Last year instead of meeting in Germany the CCNFSDU Committee met in Thailand with the Thai government co-hosting the session along with the German Secretariat.
In the upcoming November ‘07 session seven topics are to be discussed, including:
- Claims for Nutrient Content (fibre),
- Draft Standard for Gluten-Free Foods,
- Nutrition Compounds Intended for Infants and Young Children,
- Proposed Draft Recommendations on the Scientific Basis of Health Claims,
- Discussion papers on Nutrient Reference Values for Labeling Purposes,
- Amending the Codex General Principles for the Addition of Essential Nutrients to Foods and
- Establishment and application of Risk Analysis Principles by CCNFSDU.
This seventh item on the agenda on “risk analysis” may be the most critical for consumers, practitioners and manufacturers concerned with protecting access to dietary supplements.
According to Dr. Robert Verkerk, Executive Director of the Alliance for Natural Health and the Scientific Director of the American Association for Health Freedom (AAHF), a more scientifically rational risk/benefit analysis needs to replace the existing practices which include flawed methods of risk assessment for nutrients. If this change to an improved practice for risk analysis is not made the values of vitamins and other dietary supplements will be measured using unnecessarily low dosage ceilings which will be applied and could restrict very large numbers of people worldwide from accessing dosage levels that are beneficial to health
At meetings of the International Alliance of Dietary/Food Supplement Associations (www.iadsa.org), "the single coordinated voice speaking on behalf of over 9,500 companies and their 55 trade associations across six continents" acts on the interests of the largest manufacturers and pharmaceutical companies, but does not represent the interests of consumers and health practitioners.
The only Health Freedom organization represented at the Committee meeting was the US-based International Non-Governmental Organization (INGO), the National Health Federation (NHF), which was established in 1955. At the Thailand committee meeting the NHF team was comprised of AAHF's Scientific Director, Dr. Robert Verkerk of the ANH in the United Kingdom, Dr. Wong Ang Peng, President of the Society of Natural Health in Malaysia who has previously attended a CCNFSDU meeting as part of the Malaysian delegation, and Ingrid Franzon, ANH Campaign Manager from Sweden.
According to Dr. Verkerk, the Thailand discussions on infant formula and foods occupied nearly 75% of the committee’s time, with the crucial agenda items impacting Dietary Supplements not beginning until after dinner on the last day of the Committee Meetings.
It appeared that the continued low priority for these agenda items over successive CCNFSDU meetings may have been in fact engineered by the Codex Secretariat in order to allow the European Commission to further progress their own regulations in these areas so that, once completed, these EU regulations could act as models for future Codex standards.
“This year’s meeting can best be described as an industrial and geographic polarization. It is deeply disheartening to see the views of delegations from small countries and those of INGOs like the NHF, backed by many thousands of consumers, being trampled on by the EC bloc and other big countries, who seem much more concerned with the problems of big business rather than the interests of consumers,” said Ingrid Franzon.
In November 2007 in Germany, the United States will be represented at the meeting by U.S. Delegate Barbara O. Schneeman, Director of the FDA's Office of Nutritional Products, Labeling and Dietary Supplements, and Alternate Delegate Allison Yates, Director of the USDA's Beltsville Human Nutrition Research Center.
What you Can and Should do
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Take the time needed to learn the facts. Don’t rely exclusively on anyone’s interpretations of the legislation or their opinions. Personally read the actual documents themselves (keep a good word dictionary and a law dictionary on hand).
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Have a good look at the WINHS website and return frequently to see which of the issues presented you consider most important - and let your representatives in government know your concerns - in writing!
- If you are an American citizen, click the following links to find your Congressman and Senator.
- If you are a citizen of a country in Europe, find your Member of the European Parliament (MEP) by clicking here.
- If you are a British Subject or UK citizen, find your MEP by clicking here.
- If you are an Irish citizen, find your MEP by clicking here.
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The World Institute of Natural Health Sciences (WINHS) is a non-profit, worldwide institution established to facilitate the defence and support of the natural and alternative health care industries; their sciences, and the individual's right of access.
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