The Codex Alimentarius commission, charged with developing world trade standards for the food supply chain, has been debating guidelines for vitamins and mineral supplements for more than 10 years.
In 2003, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CNFSDU) made an historic agreement to base maximum levels on safety and risk assessment rather than recommended daily allowance (RDA) of nutrients.
But although the new guidelines containing this article have now reached step eight - the final stage - of the decision-making process, ratification at the Codex Alimentarius Commission meeting in Rome, running from 4-9 July, is no longer so certain.
Small changes to the text of the guidelines have been submitted by Australia, China and Venezuela, and despite their relatively minor impact to the overall impact of the standards, they could force the committee to take several steps backwards.
This, fears the international supplement industry association IADSA, would result in delaying the ratification of the guidelines by at least a year, during which time, many countries will be left without an established reference on which to base new national rules.
IADSA is particularly concerned that Codex will lose its influence on how national laws set the maximum levels of vitamins and minerals allowed in supplement products.
While the guidelines are not binding on any member country of the UN, they can be influential, particularly where nations have not yet established rules in this area.
"It is important that they [the Codex guidelines] are brought in this year. Different countries are looking at revising their regulations, including Thailand, which is about to apply 100 per cent RDA," noted David Pineda, regulatory affairs manager of IADSA.
Norway, Malaysia, and much of Latin America also currently require that the maximum level of each vitamin/mineral contained in a supplement should not exceed 100 per cent of the recommended daily intake determined by the FAO.
But the industry insists that levels should be based on risk assessment, using upper safe levels instead of RDA, thereby allowing for higher, and more effective doses.
Pineda says that technical comments should not be taken into account at this late stage of the Codex decision-making process.
"The consensus was reached last year and they are now coming back on issues already discussed. It is too late but if Codex wants to reconsider the comments, the Commission won't adopt the text and will send it back to the committee," Pineda told NutraIngredients.com.
"This means at least one year's delay," he added.
During this time, Mexico will be looking at revision of its laws and for new members to WTO, such as China, Codex standards are likely to be key to future policy.
The guidelines will have more influence when officially ratified than in draft form.
"At committee level the decision is clear but often people who go to the commission aren't clear on all the details," said Pineda. "National associations are now speaking to governments to brief them on the issues."
Among the amendments submitted, Australia wants to insert one word that would make sure that the standards only apply to those countries where supplements are regulated as food, while Venezuela wants to add 'varied' to a reference to 'balanced diet'.
The decision by Codex to follow a risk assessment approach to maximum levels rather than one based on RDA was considered by IADSA director Simon Pettman to have as much impact as DSHEA in 1994 (US regulation) and the EU Food Supplements Directive of 2002.
"There is nothing more critical than this for many manufacturers. This is fundamental to whether their products can enter international markets," Pettman said last year.