The guidelines, under discussion by Codex committee members for more than 10 years, recognize vitamin and mineral supplements as a food category, and are expected to expand markets for supplement makers.
"You can't underestimate the impact of these guidelines. They create a global category of vitamin and mineral supplements - in many countries there is no such category in place," said Simon Pettman, executive director of the International Alliance of Dietary Supplement Associations (IADSA).
Codex Alimentarius, established by the United Nations in 1961, establishes guidelines to harmonise trade in food and although the standards are not binding, they tend to influence less liberal markets and those without a regulatory framework in place, particularly common in supplements.
Pettman told NutraIngredients.com that more than 60 countries worldwide, including China, India, Taiwan and Mexico, are currently looking at introducing new or amended regulations for vitamin and mineral supplements.
"This means more than 50 per cent of the global population," he said.
One element of the new Codex guidelines is set to be particularly influential for the supplement industry - the basis for setting permitted levels of vitamins and minerals. Last year the committee working on the draft guidelines agreed that maximum levels should be based on risk assessment rather than RDAs (recommended dietary intake), currently used by a number of countries but resulting in significantly lower levels than those based on risk assessment.
However the natural health campaigners Alliance for Natural Health (ANH), which has released a documentary this week describing the threat posed by Codex guidelines, fears that the method for setting maximum levels currently being investigated by a FAO/WHO committee will be based on previously developed systems that it believes are scientifically flawed. These would set the levels much lower than those currently used by many consumers.
The group has commissioned independent risk assessment scientists at the Netherlands-based HAN Foundation to develop new methods for vitamins and minerals.
However John Hathcock, vice president of scientific and international affairs at the US trade association the Council for Responsible Nutrition (CRN), said: "The risk assessment values for vitamins and minerals is always severalfold higher than reference dietary intakes. Of course the risk assessment system could be abused, like any other, but the RDAs are already very low."
Hathcock noted that the FAO/WHO risk assessment project attempts to harmonise risk assessment methodology across nations but "specifies no numbers whatsoever".
Hathcock also said that consumer groups claiming that the Codex guidelines would lead to restrictions on supplements were misinformed.
"There are a lot of people who don't understand what Codex does and how far the WTO powers extend. Codex does not force any country to adopt these guidelines, and the WTO will only force a country to raise standards up to Codex, rather than down from domestic policy."
Around 85 of the 172 members of Codex Alimentarius are in Rome this week at the body's Commission meeting, and they were largely in favour of adoption of the guidelines, which also cover packaging, labelling and sources of vitamins and minerals.
The Commission agreed to amend the text following a request from Australia that the word 'only' be added to section 1.3 so that it would read: "These guidelines apply only in those jurisdictions where products defined in 2.1 are regulated as foods."
Comments submitted by China that the guidelines should take into account the dietary limitations of each country were included in the minutes but not in the text. Making such changes would have required taking the guidelines back to the committee discussions stage.
"After more than 10 years of discussion it was felt that to bring the text back to the nutrition committee, when a consensus had already been reached last year, would jeopardize the guidelines," said David Pineda, director of regulatory affairs at IADSA.
He added that the concerns went far beyond the scope of non-binding international standards, and would be more suited to national discussions.
The US-based National Health Federation (NHF), the only consumer organisation with NGO status at Codex, claimed that the Chinese comments were substantive and therefore should have been addressed at the committee level.
FAO is expected to produce a report in a few months on its risk assessment methodology but it will be several years before this is adopted.