Health Supreme by Sepp Hasslberger

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October 03, 2006

Supplements: Consumer Advocates, Scientists, Criticize EU Approach

The European Commission issued a discussion paper earlier this year, asking for input from interested parties regarding the details of how to cap nutrient dosage levels in foods and nutritional supplements.


At the time, Paul Taylor, a consumer advocate who lives in the UK, commented:

The Health and Consumer Protection Directorate-General states that it is keen to obtain the view of stakeholders on how these issues might be addressed and says that it is issuing the paper as a part of the consultation process. The paper asks a number of specific questions on which the Commission is seeking comments, and a dedicated e-mail box has been created for responses SANCO-VITAMINS-AND-MINERALS@EC.EUROPA.EU which should reach the Commission by 30 September 2006.

Significantly perhaps, the paper concludes with an Annex giving examples of existing models for the setting of maximum amounts of vitamins and minerals in foods. These include a model developed by the French Agency of Food Safety (AFSSA); a model developed by the Danish Institute of Food and Veterinary Research; the German Federal Institute for Risk Assessment’s “Derivation of Maximum Levels of Vitamins and Minerals Added to Foods Based on Risk Assessment”; ILSI Europe’s ‘Vitamins and minerals: a model for safe addition to foods’; and ERNA / EHPM’s “Vitamin and Mineral Supplements: A Risk Management Model”. Of these, the ERNA/EHPM is the only model that appears to bear any real resemblance to what we would advocate, but this is still less than satisfactory and sets maximum supplement levels of 2mg for manganese and 15mg for zinc. Moreover, given that the other models all appear to be restrictive and highly conservative it would appear that the ERNA/EHPM model has only been included as a token gesture. As such it is now abundantly clear which road the European Commission is trying to push things down.

Paul's alert prompted me to work out and submit to the Commission some comments that stress the necessity of taking into account the positive side of nutrition, instead of focusing exclusively on the - highly unlikely - side effects of 'overdosing' on nutrients. These comments were submitted by the Italian consumer group La Leva di Archimede.

Two Dutch scientists who specialize in questions of environmental risks argue much along the same lines in a paper soon to be published in the journal Environmental Liability, but already submitted to the European Commission as part of this consultation process. Their work benefited from a grant by the International Nutrition Company (INC).

The paper, titled Food Supplements and Fortified Foods: a Scientific and Managerial Rejoinder to EC Policies shows how the proposed legislative restrictions of nutrient dosages in foods and supplements will actually worsen, instead of protecting, consumer health - quite apart from discouraging innovation in nutritional science and healthy food products. The Dutch scientists Hanekamp and Bast argue that regulation of supplements and nutrition in general should not be "before the fact" with hugely complicated and restrictive sets of rules that stifle both choice and innovation, but that an "after the fact" approach would be much more appropriate. They introduce the concept of Normal Intended Use, the recommended use as described on a product label, as a central feature for the regulation of supplement dosages. Supplements must be safe in conditions of normal use they argue.

Although the EHPM/ERNA generated model of dosage regulation is not perfect, says Bert Schwitters, CEO of International Nutrition Company, it should very well be put to use in an effort to regulate and manage the risks of nutrient concentrations in foods, in the context of Normal Intended Use. Only by showing that the food industry is capable of implementing and following a set of regulations - even industry generated ones - can the push for top-down legislative control of health foods be headed off. The health food industry, in other words, has to demonstrate it can be trusted with the responsibility to regulate itself by actually following a set of rules, such as the EHPM/ERNA risk model, if it wishes to avoid the restrictive and at times destructive interference by law makers and regulators.

"The discussion about the assessment and management of micronutrients has become somewhat of an academic, extra-industry affair. It's very theoretical, hypothetical and academic, although the word academic is an overstatement in view of the thin scientific varnish that covers most models and the related discussions. Today, the EHPM/ERNA Model and its 'competing counterparts' are floating in the higher extra-industrial political, regulatory and semi-scientific echelons. Industry should kick in and respond by putting the EHPM/ERNA Model to use and test it in the setting it was designed for: risk management in and by Food Business Operators."

Alliance for Natural Health

Another entity that responded to the EU Commission with a detailed submission is the Alliance for Natural Health (ANH), situated in the UK but representing medical doctors, complementary health practitioners, consumers as well as food manufacturers and distributors from all over Europe. The Alliance's director Dr Robert Verkerk says that the EU authorities' approach to risk assessment and management will lead to inconsistent outcomes and in some cases to restrictions on dosage that may prevent optimal amounts of nutrients from being available to consumers.

"The EC and EFSA appear to be prematurely seeking to establish limits on allowed vitamin and mineral ingredients (and soon phytonutrients, essential fatty acids, amino acids, and other groups of nutrients) (under Article 4 of the Food Supplements Directive) as well as limits on dosages (Article 5) when proper methodologies for risk assessment, and more specifically risk/benefit assessment, have yet to be defined and validated properly.

Such an approach can only be made to work if extremely and disproportionately precautionary approaches are adopted, and while these can be justified for environmental chemicals and other toxins, there is no evidence of adequate justification for their use in the case of nutrients which are consumed primarily for their beneficial properties."

The entire ANH document - Consultation response to the European Commission Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs - is available here.


EU Food Supplements - Will Directive Worsen Consumer Health?

EU Food Supplements - Dutch Scientists Oppose Restrictive Legislation

EU Food Supplements - ANH Says Risk Assessment Models Erroneous

Here is the UK government's response to the EC discussion paper


posted by Sepp Hasslberger on Tuesday October 3 2006
updated on Tuesday December 21 2010

URL of this article:


Related Articles

Food Supplements in Europe - What is the Problem?
The European Union has issued a Directive to regulate the commerce of food supplements, which is in the process of being implemented in the member states. If reading the referenced text does not tell you what problems this directive might bring to your ability to either buy or sell supplements in one of the European Community member states, don't feel alone. That is a problem most observers have and I... [read more]
April 21, 2004 - Sepp Hasslberger

Are RDA Nutrient Levels Safe?
RDAs or Recommended Dietary Allowances of vital nutrients such as vitamins and minerals, are being promoted by health authorities as the level of consumption at which we may feel comfortable about having "taken care of our needs" - but is that really the truth? Developed during the wartime 40s, the purpose was to identify a diet that would allow US soldiers to fight as well as those staying home to... [read more]
March 02, 2004 - Sepp Hasslberger

Risk Free Vitamins - How Safe is Safe Enough?
Recent legislative proposals on at least three continents have centered around the perceived need to ensure the safety of natural health products, such as supplements containing vitamins and minerals. Canada has proposed drug-style regulations for supplements. In the US, a proposal termed S 722 seeks to increase the FDA's powers to remove supplements from circulation. Australia recalled 1600 diverse health products in an unprecedented prelude to - what else -... [read more]
February 03, 2004 - Sepp Hasslberger

Food Supplements: German Risk Institute Takes Dim View
The German Federal Institute for Risk Evaluation, formerly the Federal Office for Consumer Health Protection, has established a risk assessment model for deducing maximum safe levels of nutrients provided in supplements and fortified foods, according to a recent report of The report was published in two parts, one dealing with minerals, the other with vitamins, both available in PDF format - so far only in German language (Minerals here)... [read more]
January 20, 2005 - Sepp Hasslberger

Food Supplements: Too Much Precaution May Be Bad For Your Health
After the passage, in 2002, of Europe-wide regulations for food supplements, the Alliance for Natural Health has argued before the European Court of Justice that vitamin and mineral supplements are innocent - not to be condemned or worse eradicated by bureaucratic red tape. The court decided in July 2005, surprisingly disregarding the opinion of its own Advocate general, who had called for the directive to be declared illegitimate, commenting that... [read more]
October 13, 2005 - Sepp Hasslberger

The Dark Side of Precaution: Preventing Prevention
The precautionary principle mandates intervention to save the environment and - most importantly - our health from degradation in the case of a pressing danger, even if all the scientific data are not yet on hand. It is invoked when we face threats from chemicals, radiation or other causes. The principle seems important, yet it is difficult to find an authoritative definition. The European Union has issued a communication in... [read more]
July 09, 2006 - Sepp Hasslberger




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