Codex—U.S. and global implications

By James J. Gormley
Codex Alimentarius is Latin for “food code” or “food law”. The Codex Alimentarius Commission (CAC) is one of the international bodies recognized by both international treaties and the World Trade Organization (WTO) for establishing global food standards.

According to the advocacy organization Public Citizen, recent international trade agreements have caused a radical change in the impact of Codex. The General Agreement on Tariffs and Trade (GATT) of 1994 and other treaties have altered the nature of Codex standards by “designating Codex as the international body” establishing internationally recognized food safety standards for use in trade.

After global trade negotiations in 1994, several international agreements were established, agreements that were intended to blur the lines of distinction among different national regulatory requirements regarding public health and food safety and to eliminate barriers to international trade.

According to the New Zealand Food Safety Authority, “Codex standards are considered scientifically justified and are accepted as international yardsticks,” wrote the New Zealand authority in 2001. WTO member standards that differ from Codex standards may be challenged as trade barriers if they only allow lower levels that serve to restrict trade.

Critics Voice Concerns
According to the Center for International Development at Harvard University: “These measures are criticized by some who claim the agreements are too invasive and deny them sovereignty of domestic regulation. Others assert that the agreements do not go far enough and domestic regulation is often a form of protectionism. Developing countries protest that the standards promoted in the agreements lack their input and are dominated by the interests of developed countries.”

“In the highly contentious debate over genetically modified foods,” wrote the Center, “some non-governmental organizations argue that these agreements” make it hard for countries to make their own decisions as to, for example, simply banning or allowing GMOs for sale in their country.

Others have criticized Codex’ use of the same standards that apply to toxic chemicals and environmental hazards with food and dietary supplements.

Some observers have said that Codex’ application of the precautionary principle—banning something because it might be harmful—is hypocritical: it is applied to dietary supplements, where it is not needed, but it is not applied to toxic additives, where it is needed.

Other issues at stake
Codex is looking at what forms and potencies of vitamins and minerals should be allowed for international trade, allowing individual nations to restrict other forms and potencies. Codex does not currently address other ingredients used in dietary supplements.

Calls for inclusion of DHA (docosahexaenoic acid) and ARA (arachidonic acid), and exclusion of partially hydrogenated fats and high fructose corn syrup, in infant formula standards have seemingly fallen on deaf ears, as have many other issues, say some, including concerns about GMOs.

Sustainability is another issue on the Codex horizon that may impact how some U.S. companies operate in terms of ingredient sourcing and also in terms of rising global demand for eco-friendly harvesting and production.

So how does Codex affect me?
Codex can affect you in a few ways:
1. Its guidelines regarding risk assessment have the potential to support low potencies for nutritional ingredients; that impacts what is available on store shelves if the U.S. products have had to be dumbed down based on low potencies allowed in Europe and supported by Codex. Large companies that export rely on economies of scale that will encourage them to formulate for the broader world market with restricted forms and potencies.

2. There is the real risk that the US government may copy some of these foreign and international trade standards as maximum levels for its own citizens, thus restricting our right to buy the full range of currently available dietary supplements.

3. Codex’ foot-dragging on GMOs and unhealthful ingredients (such as trans fats and high fructose corn syrup) will encourage functional food and beverage manufacturers to continue to use these controversial cheap, fattening and sweetening substances.

Gormley Take-Away: While Codex apologists are telling you we have nothing to worry about and “the sky is falling” alarmists are saying that we have everything to worry about, very real concerns and opportunities, such as those outlined above, could get lost in the shuffle. Solution? Stay tuned to what our industry associations are saying about Codex but also stay tuned to what credible consumer health advocacy organizations are saying (such as Citizens for Health). That way, you will have different perspectives that are not always 180 degrees apart and which, together, offer you a balanced view, whether pro, con or wait-and-see.

IADSA miasma

By James J. Gormley
Nine additives have been adopted by the Codex Alimentarius Commission (Codex) at levels proposed by the Brussels, Belgium-based International Alliance of Dietary/Food Supplements Associations (IADSA).

The following (mainly synthetic) additives have all been adopted as part of the official Codex General Standard for Food Additives (GSFA) at IADSA’s recommended levels of use in food supplement products: acesulfame potassium; aspartame; castor oil; cyclamates; neotame; polysorbates; polyvinyl alcohol; saccharin; and sucralose.

The result, which came at the recent Codex Alimentarius Commission in Rome, follows an active campaign by IADSA to push for the final adoption of these additives.

Last year, at meetings of both the Codex Additives Committee and the Codex Commission, IADSA managed to prevent the deletion of four additives including erythrosine, a cherry-pink/red synthetic coal tar dye banned for most uses in Norway and the US. IADSA also reportedly played a role in “successfully [raising] the levels of an additional three—BHA, BHT and carnauba wax.”

Most of the additives that IADSA has been campaigning for are far from natural and, in some cases, are either banned in certain countries (e.g., erythrosine) or are associated with negative and toxic effects.

For example, aesulfame K stimulates insulin secretion, possibly aggravating reactive hypoglycemia. In several rodent studies, it also produced lung and breast tumors, leukemia and chronic respiratory disease, even when less than the maximum doses were given. The Material Safety Data Sheet (MSDS) for aesulfame K indicates that it may be toxic to kidneys and the liver.

Cyclamates were banned as carcinogenic by the US Food & Drug Administration (FDA) and by Britain, Sweden, Denmark, Germany and Finland in 1969.

As far as neotame goes, like aspartame, some of the suggested concerns include gradual neurotoxic and immunotoxic damage from the combination of a formaldehyde metabolite (which is toxic at extremely low doses) and an excitotoxic amino acid.

According to the Environmental Defense Fund’s Chemical Scorecard, polyvinyl alcohol is suspected to be toxic to the gastrointestinal system and the liver and is a neurotoxin. Its main uses are as an adhesive or thickener in latex paints, hairsprays and glues; as a fiber reinforcement in concrete; and to help make Elmer’s glue.

Although the hazard warning regarding cancer was lifted for saccharin in 2001, questions about sucralose’s adverse effects are multiplying and there is a 2006 Citizen Petition calling for the FDA to revoke the approval of this compound due, in part, to reported adverse effects. Sucralose is a highly processed chemical sweetener manufactured with chlorine in a factory in McIntosh, AL, in a process that releases such toxins into the environment as cyclohexane.

Of course for every report questioning safety and asserting dangers, manufacturers of these synthetic chemicals will produce volumes of supportive data and folders bursting with positive scientific and regulatory opinions—so I am not going to waste your time, here, by attempting to issue a battery of specific challenges regarding these artificial compounds.

What I would ask is this, however:
1. Are US natural products companies truly in support of the use of artificial and synthetic chemical additives?
2. Are international organizations, such as IADSA, properly representing the will of the US dietary supplement industry, or of European “pharma-tritional” interests by pushing for these chemical additives?

If the answer is ‘no’ to either of these questions (or to both), then I would invite you to speak with your colleagues, vendors, suppliers and customers and to insist that organizations which claim to represent you do, in fact, just that.

If the answer is ‘yes’ to either or both of these questions, however, then I think we, as an industry, have much larger questions—and problems—to consider than these.

Are we truly the natural products industry—which embraces and encourages natural choices, natural ingredients and sustainable practices—or are we “the chemicals industry” that just so happens to have some natural products and ingredients.

I sure thought I was joining the former in early 1995 when I entered the health-food industry, as we called it then.

What about you?

[adapted from an editorial which originally appeared in the July 2007 issue of Nutrition Industry Executive magazine]