December 31, 2003
The November Codex agreement to abandon Recommended Daily Amounts (RDAs) as the basis of upper limits in supplements in favour of scientific risk assessment will reverberate around the world, particularly in developing nations.
The debate within Codex —the World Health Organization?s representative body in the supplements area—has raged for the better part of a decade. Although the decision will not become an official giudeline for at least two years, it will have an effect almost immediately in developing nations, where supplements regulations are being formulated for the first time.
The decision is itself influenced by an expanded European Union?s commitment to scientific risk assessment. It will likely add weight to the case for maximum liberalisation in the EU?s yet-to-be-decided upper safe limits, according to one industry observer. It all augers well for an industry that has long battled against the use of RDA multiples as a means of establishing supplement ingredient maximum intake levels.
?We never expected to achieve so much this year,? said Simon Pettman, executive director of the International Alliance of Dietary Supplement Associations, which represents 43 national food supplements associations worldwide. ?It was down to a whole range of factors: the enlargement of the EU; regional conferences and education programmes; the absence of a disruptive extremist element; the growing strength of the industry?s scientific arguments. All these factors made a difference in getting the 75-80 per cent vote.?
The decision was unanimously welcomed by the industry.
?Today?s decision represents the single most important development in the ongoing effort to open the world?s markets to safe, healthy products that have the potential to enhance the quality of life for billions around the globe,? said Mark A. Le Doux, board member of the Council for Responsible Nutrition in the US. ?It is an excellent example of what can happen when the US and EU work in concert for the common good.?
?It?s a great result because it underlines the need for safety over need, so that has to be good for both the industry and the consumer,? said Janet Rees, principal regulatory officer at Solgar UK. She said it was no surprise that Codex would fall in line with Europe eventually. ?It means European principles being established at the moment will reverberate around the world in the coming years.?
Ian Newton, director of business development and regulatory affairs at DSM Nutritional Products, lauded the decision but warned regulatory change may not come as quickly as some hoped in an environment where the influence of Codex was waning. ?It is bringing Codex in line with the prevailing thought on this matter by many recognised bodies such as the Institute of Medicine in the US and the European Food Safety Authority. But now that the EU is moving ahead by itself, I am not sure Codex has the same relevance it had in the past. Nevertheless, it is a very good step forward and it has finally broken the logjam that has existed for eight to 10 years.?
The Challenge Ahead
Countries in Asia, Africa and Latin America are only beginning to develop laws to deal with food supplements. For this reason, groups like IADSA are instituting education campaigns via member associations in many countries.
?The challenge now is to educate governments about what risk assessment means,? Pettman said. ?Governments were utilising the 1xRDA option in the Codex text to justify their laws. But who could argue when they were selecting from the Codex text? Now that option is gone and the promise of global harmonisation is that much closer.?
Some are hopeful that the larger countries in regions such as South America and Asia, like Brazil, Japan and China, can act as anchors for their respective regions. If they can develop risk-based upper limits, the smaller surrounding countries will follow suit in a kind of domino theory.
Dr Rose Schreitle, head of regulatory affairs at the German Medicines Manufacturers Association, noted scientific risk assessment was unlikely to become as arbitrary as the manner in which RDAs were often employed, even in post-Supplements Directive Europe.
?There is still space for interpretation in safe upper levels,? she said. ?It is up to individual countries to determine how large safety margins should be and how they interpret input from other food sources. Conservative countries will choose the higher safety margin and more liberal countries will choose smaller margins.?
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