Codex Commission Agrees on Supplement Safety Approach
According to a report on Nutraingredients.com, the Codex Alimentarius Commission, which was meeting in Geneva in the past week has endorsed the decision of the Committee on Nutrition and Special Dietary Foods to set dosage limits for vitamin and mineral products along the lines of scientifically determined safe levels rather than the minimum requirements known as the RDAs.
The Committee on Nutrition which meets in Germany decided in November last year that safety should be the measure for dosage limits rather than RDA levels, as I reported at the time.
This is in line with a recent decision of the European Court of Justice which condemned Germany for its administrative practice of arbitrarily declaring all supplements containing vitamins at dosages of more than three times the RDA to be medicines requiring pharmaceutical registration, thus effectively banning these products from being imported into Germany.
To be sure, there are still countries where health authorities believe that nutrients should be given only in the tiniest quantites, barely enough to keep the worst deficiencies at bay. But the future is clearly brighter than that. We may after all find nutrients in sufficient dosage to keep illness at bay and - yes - to help healing those degenerative conditions that are due to "too little, too late" in our nutrient intake.
Much remains to be done in this field of international legislation and health.
First of all, scientific evaluation of the safety of vitamins has - so far - been a rather arbitrary affair, and it needs to be brought up to speed. See my previous article: Risk Free Vitamins - How Safe is Safe Enough?
Secondly, the Codex Nutrition Committee is still considering whether to institute a so-called "positive list" system, one of the worst features of the European Food Supplements Directive. In practice, a "positive list" is a fixed number of ingredients that may be used to make supplements, removing from the market many of today's more advanced formulations and making innovation a nightmare. Many small and medium size manufacturers - SMEs - in this sector would vanish as they could no longer compete with the multinational pharmaceutical giants on price, and there would be no way to compete with a flexible and innovative approach to formulating health products.
Thirdly, there is another important stumbling block in the way - the prohibition against associating health benefits with nutritional products, being discussed at the Codex Alimentarius Labelling Committee. South Africa has challenged the Committee's restrictive attitude towards health related information, saying it is not in accord with the latest scientific research. While health claims have been monopolized by pharmaceutical legislation in many countries and consequently have been prohibited for foods, there is a good case to allow such information. Scientific studies prove that nutrients are of great importance in maintaining good health, so why not say it?
In any case, let's applaud that decidedly positive decision of Codex, before we throw ourselves into the battle on the remaining fronts. Here is the article about the latest Codex decision and some links to further information...
Codex backs safety approach to maximum levels
(Original on Nutraingredients.com)
- 7/1/2004 - The Codex Alimentarius Commission, meeting in Geneva this week, has endorsed draft guidelines on vitamin and mineral supplements that recommend basing maximum levels of nutrients on safety rather than the RDA. It is expected to be a strong signal to countries still using RDA to inform maximum nutrient levels.
The breakthrough, reached by the Committee on Nutrition and Foods for Special Dietary Uses (CNFSDU) at a meeting in Germany last year, has now been ratified by the committee at step five of the eight-step Codex decision-making process. Maximum levels are of key importance to the supplement industry as they determine the amount of nutrients allowed in supplements. Some countries such as Norway, Malaysia, Thailand, and much of Latin America, still require that the vitamins or minerals contained in a supplement should not exceed 100 per cent of the recommended daily intake determined by the FAO.
However many countries now base the maximum levels on safety, and upper safe levels, rather than RDA. This allows for formulas to contain significantly higher amounts.
The decision by Codex to also follow such an approach is a major victory for the industry, according to the International Alliance of Dietary Supplement Associations (IADSA).
"This is probably the single biggest decision to take place in the dietary supplements industry. Its impact is on the same level as DSHEA in 1994 (US regulation) and the EU Food Supplements Directive of 2002," Simon Pettman, executive director of IADSA, told NutraIngredients.com last year.
The Codex vote to remove RDA will send out a strong signal to those governments still backing RDAs. This could significantly improve global trading for supplement makers.
Codex Alimentarius, set up by the UN's Food and Agriculture Organization and World Health Organization, establishes standards for regulation for the 170 member countries, as well as the World Trade Organization. It can therefore be influential, particularly in areas without current standards in place and for new members to WTO, such as China.
"We know that some countries in Latin American have been closely following the decisions. Some Mexican regulators even came to our recent conference in Prague to learn more about risk assessment," said David Pineda, in charge of regulatory affairs at IADSA.
"The Codex guidelines are important because they offer standards that are harmonized at an international level. Facilitating global trade is after all one of the main reasons for the creation of Codex."
He added that there is still significant work to be done on other aspects of the guidelines.
The new text will now be circulated to members for comment from governments and observers, and discussed further (step seven) at the next meeting of the Codex Nutrition Committee, taking place in Bonn in November. The breakthrough, reached by the Committee on Nutrition and Foods for Special Dietary Uses (CNFSDU) at a meeting in Germany last year, has now been ratified by the committee at step five of the eight-step Codex decision-making process.
See also related articles on Codex and vitamin safety:
posted by Sepp Hasslberger on Sunday July 4 2004
updated on Wednesday December 8 2010
URL of this article:
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