After 12 years of negotiations, the Codex guidelines on vitamins and minerals adopted in Rome in July are generally regarded as a boon for international supplements manufacturers — as well as for consumers the world over.
Despite this, many consumer activists have derided Codex because they see it as diminishing consumer choice by advocating ?safe upper limits? for supplements doses. But that is not the way the accord is viewed by insiders.
?There is nothing in the guidelines that would restrict freedom of choice for consumers,? David Pineda told FF&N from Brussels. Pineda is regulatory affairs manager for the International Alliance of Dietary/Food Supplement Associations, which sat in on the talks. ?What?s most beneficial is it will relax regulations in other countries, and there will be positive effects for the US, Japan and other countries in favour of having more open regulations.?
That sentiment is echoed by the American Herbal Products Association (AHPA), which has heard many US companies express concern that the Codex guidelines could affect access to supplements. ?Codex can affect a country?s domestic laws by forcing them to be relaxed, but only if those laws are more restrictive than a Codex standard or guideline,? said AHPA president Michael McGuffin. ?The rights of American consumers are protected by DSHEA — and only the Congress can amend US laws.?
Countries that do not currently have domestic supplements regulations — mostly in Asia and Latin America — are most likely to use Codex as a template for creating their own domestic rules.
In Europe, Codex guidelines have been influential in directing the course of pan-European Food Supplements legislation that is now in place, and which, in theory, harmonizes regulations across all European Union member states.
However, there are some, like AHPA, that are concerned the European legislation is too restrictive and may adversely affect further Codex negotiations. In a statement AHPA said: ?Once all 25 EU members generate uniform regulations under the EU Directive on Food Supplements, it can be expected that they may work to make the Codex guidelines quite similar. The effect in (European) countries with more conservative laws today will be that product selection for citizens there will be expanded.?
Perhaps the larger victory for the industry is the establishment of upper safe limits based on scientific risk assessment rather than multiples of recommended daily allowances. Earlier drafts had based it on RDA multiples. Still, the finalization of upper safe limits is years off, perhaps 10 or more, Pineda said.
?In many countries, the dosages are based on low multiples of RDAs — Germany is the wonderful example of that,? said John Hathcock, vice president of scientific and international affairs for the Washington, DC-based Council for Responsible Nutrition, which has worked closely on the Codex issue for years. ?At this time, if products are being traded that exceed the RDA-based limits, countries and companies can reject them. Under Codex they can?t do that.?
Hathcock said consumers will benefit from Codex, and that health-freedom activists are misguided in condemning the agreement because of the upper safe limits proviso. Many activists reject the notion of any upper limits, period. Hathcock sees them as inevitable.
?With risk assessment at least you have the prospect of getting it right because a scientific approach is employed at every step of the way. This can?t be said with RDA multiples. That?s the big bugaboo some activists refuse to recognize,? he said.
?In terms of international supplements trade, there are many stumbling blocks and Codex can only make it better,? Hathcock added. ?But this will only occur if we are all supremely diligent with regard to making sure any numerical values that are set for use under Codex are done on a scientific basis and are not a back door to somebody?s RDA limits.?
He cited vitamin C as an example. If a maximum upper limit of 2,000mg per pill were established, then a pill bottle could be marketed in any of the 172 Codex countries. If an importing country rejected the product on high dosage grounds, it would be subject to a complaint by the World Trade Organization. If a country?s regulations are set at less than 2,000mg, a conflict will arise because of its WTO obligations to meet international standards for imported products (like Codex).
If a small country tries to restrict domestic production, it would not be able to restrict imports because of Codex, and that may have the effect of killing off their domestic industry.
?If, on the other hand, a country wants to accept a product that exceeds the Codex standard, who?s going to complain?? Hathcock said. ?Nobody ever goes through the WTO to make a nation more restrictive. The WTO is there to force countries to reduce artificial trade barriers.?
Beginning this November, the Codex Nutrition Committee will begin discussing further guidelines, including how to apply risk analysis and scientific standards. This process is expected to take as long as a decade.