Update on Codex Alimentarius

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What It Is; How It Works

Significant controversy and a lot of questions surround “Codex,” the shorthand name for both “Codex Alimentarius” and “The Codex Alimentarius Commission.” This commentary provides information to help clarify the meaning and significance of Codex and provide an update on the current situation.

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The Codex Alimentarius (Latin for “food code,” or “food book”) is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. Its texts are developed and maintained by the Codex Alimentarius Commission. The Codex Alimentarius is recognized by the World Trade Organization as an international reference point for the resolution of disputes concerning food safety and consumer protection.

The Codex Alimentarius Commission, based in Rome, Italy, was created in 1963 by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) to develop the food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Program that make up the Codex Alimentarius. According to the Commission, its purposes are protecting the health of consumers, ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations.

The U.S. Codex Office in the Food Safety and Inspection Service of the United States Department of Agriculture houses and provides staff support for the United States representatives to the Codex commission. The U.S. Codex Office staff also works closely with the U.S. delegates to various Codex Commission committees, as well as government agencies, members of Congress, non-governmental agencies and members of the public. The US Codex Office can be contacted at uscodex@fsis.usda.gov.

In its publication, “Understanding The Codex Alimentarius” the Commission lists over 4000 standards, guidelines and practice codes that it has promulgated in ten subject matter areas including: commodity standards; commodity-related guidelines and codes of practice; general standards and guidelines on food labeling; general codes and guidelines on food hygiene; guidelines on food safety risk assessment; standards, codes and guidelines on contaminants in foods; standards, guidelines and other recommendations on sampling, analysis, inspection and certification procedures; maximum limits for pesticide residues; food additives provisions; and maximum limits for veterinary drugs in foods (ftp://ftp.fao.org/codex/Publications/understanding/Understanding_EN.pdf ).

Each one of the areas addressed by Codex involves controversies but one, the Guidelines for Vitamin and Mineral Food Supplements, adopted in 2005, has been especially controversial.

Vitamin and Mineral Supplements

In 1996, the German Codex delegation put forward a proposal that no herb, vitamin or mineral should be sold for preventive or therapeutic reasons, and that supplements should be reclassified as drugs. This proposal set off massive global outrage among supplement producers and consumers whose protests halted its implementation. The intention behind the German proposal continues to color the global supplement debate today. Through its prism, each guideline looks like another effort to restrict consumer access to supplements.

Between 1996 and 2005, Codex committees worked to develop what became the official Codex Guidelines for Vitamin and Mineral Food Supplements, adopted in Rome on July 4, 2005. These Guidelines have also been the subject of considerable controversy. The Guidelines do not ban any supplements, but subject them to labeling and packaging requirements, set criteria for establishing maximum and minimum dosage levels, and require that safety and efficacy be considered when determining ingredient sources. They also assert that consumers can get the nutrients they need from food. Each of these aspects of the Guidelines alarms and angers significant numbers of supplement users.

Organized supplement producer groups generally support the Guidelines. FAO and WHO state that the Guidelines are “to stop consumers overdosing on vitamin and mineral food supplements.” The Codex Alimentarius Commission (CAC) has said that the Guidelines call “for labeling that contains information on maximum consumption levels of vitamin and mineral food supplements.” The WHO has also said that the Guidelines “ensure that consumers receive beneficial health effects from vitamins and minerals’” In the context created by the 1996 German proposal, however, these official sentiments sound to many supplement consumers like efforts to restrict their use of food supplements.

The International Alliance of Dietary/Food Supplement Associations (IADSA), originally created in 1997, just after the German proposal to severely restrict dietary supplements, brought together the food supplement sector in Codex Alimentarius discussions. Its member associations include the manufacturers of the vast majority of supplements worldwide. The Alliance supported the 2005 Guidelines, under discussion by Codex committee members for more than ten years, because they reversed a number of the requirements of the original German proposal. Specifically, the 2005 guidelines eliminated herbs from the definition of food supplements, recognized vitamin and mineral supplements as a food rther than a drug category, and eliminated restricting vitamins and minerals in supplement products to the low amounts contained in the Recommended Dietary Allowances. IADSA also expected the guidelines to expand global markets for supplement makers.

Consumers and some producers, however, feared that the Guidelines would eliminate important supplement products and smaller producers. The debate presents a clash between the principle of biochemical individuality—each individual has a unique nutrient intake need— versus the notion of a standard that works for most individuals. The first concept, biochemical individuality, leads to a highly diverse supplement market. The second, dietary standards that fit most individuals, leads to a narrower market that producers believe will reach more consumers by making more sales.

While Codex worked on its supplement Guidelines, the European Union adopted and advanced a directive on dietary supplements. This directive, set to become final on January 1, 2010, seemed to reflect the thinking of the earlier German proposal, further upsetting supplement consumer groups. The fact that some officials simultaneously occupied key positions in Germany, in the EU, and in the Codex bureaucracy further inflamed the situation. Opponents of the Codex supplement Guidelines noted similarities between the EU’s Food Supplements Directive and the Codex Alimentarius Guidelines for Vitamin and Mineral Supplements and the original German proposal, creating even greater concerns about future access to supplements.

DSHEA

In this context many dietary supplement supporters, both consumers and producers, feel that only the U.S. Dietary Supplement Health and Education Act (DSHEA) stands between consumers and the effort of regulatory authorities to take supplements they want and need away from them. DSHEA, enacted in the U.S. in October 1994, acknowledged that millions of consumers believe dietary supplements may help to augment daily diets and provide health benefits. Congress’s intent in enacting DSHEA was to meet the concerns of consumers and manufacturers and to help ensure that safe and appropriately labeled products remain available to those who want to use them. Congress stated that there may be a positive relationship between sound dietary practice and good health, and that, although further scientific research is needed, there may be a connection between dietary supplement use, reduced health care expenses, and disease prevention.

The provisions of DSHEA define dietary supplements and dietary ingredients; establish a new framework for assuring safety; outline guidelines for literature displayed where supplements are sold; provide for use of claims and nutritional support statements; require ingredient and nutrition labeling; and grant FDA the authority to establish good manufacturing practice (GMP) regulations. The law also requires formation of an executive-level Commission on Dietary Supplement Labels and an Office of Dietary Supplements within the National Institutes of Health.

Thus, DSHEA amounted to positive recognition of dietary supplement consumers and producers and provided the primary protection against the loss of access to these products by consumers.

No formal rules of the World Triad Organization or guidelines of Codex or any combination can force the United States to change the provisions of DSHEA. Only formal legal action within the united Stated can change DSHEA for American consumers and producers.

The Regulatory Triangle : American , European and International law

The United States Dietary Supplement Health and Education Act of 1994 (DSHEA), the Directive 2002/46/EC of the European Parliament and Council of 10 June 2002 relating to food supplements, and the Codex Guidelines for Vitamin and Mineral Food Supplements create a regulatory triangle that must be sorted out to understand the national and international dietary supplement controversy. The same frame work applies to all issues created by or contained within any guidelines, standards or codes of practice created by Codex.

The relationship between Codex and DSHEA is tangential. The same is true of the European Union (EU) Supplement Directive, the third part of the international supplement regulatory triad affecting American food consumers. The EU Directive is tangential to both DSHEA and Codex. Together these laws, regulations and guidelines create a complex matrix navigable by well-heeled corporations and trade associations that see markets as the essential form for controlling modern civilized behavior. The matrix is virtually impenetrable by underfunded individuals, citizens groups, and anyone else who puts health and well-being ahead of market efficiency and money. Here is how it works:

Each nation has its own food rules—laws, regulations and accepted practices. The US has DSHEA. In order to promote international trade, Codex tries to get national acceptance by its more than one hundred seventy country members of common guidelines for international trade purposes. These rules are totally voluntary but are accepted as one way to satisfy the treaty-created World Trade Organization requirement, which stipulates that no WTO member country can use its food rules to intentionally exclude the food products of another country. Codex could have adopted the more open provisions of DSHEA as its international guidelines for supplements but did not. Instead, it adopted a significantly more restrictive set of principles.

The EU also adopts food regulations—the Dietary Supplement Directive, for example, final provisions of which will become effective in the EU on January 1, 2010—and urges countries to conform their products to these provisions. The Directive is significantly more restrictive than the Codex Guidelines. Countries tend to resist pressure from each other, including pressure from the EU. Failing to pressure countries into following its Directive, the EU then goes to the voluntary Codex organization and uses that system to get voluntary acceptance of EU provisions for regulation of supplements.

Codex adopts guidelines and asks its member countries to replace their food rules with them. The initial German supplement proposal sought heavy, European-style restrictions on supplements. The 2005 Codex Guidelines appear to be as far as the EU initiatives could go in the face of solid global opposition, including opposition from both the manufacturers and consumers of supplements worldwide. The EU now seems to be using its Directive to gain more supplement restrictions than the Codex Guidelines gave it. Some of its provisions appear to be an interference with international trade rules but it is unlikely that supplement manufacturers will, and consumers lack the resources to challenge it.

The U.S. and other countries use the same stratagem for their special interests. For example, when high fructose corn syrup—now linked by some to the U.S. obesity and other epidemics, particularly in children—was first proposed as a food additive, FDA was reluctant to approve it. (Sugar and artificial sweetener interests opposed it.) The corn growers went to Codex and got a “purely voluntary” Codex standard that permitted its use.

Corn industry lobbyists then came back to the FDA, effectively saying, “Codex Alimentarius, the international voice of food standards, has adopted high fructose corn syrup, so it must be good; and besides, your policy is or should be to harmonize your laws with the international preferences,” that is, adopt Codex guidelines in place of your own food rules. FDA acquiesced. High fructose corn syrup became ubiquitous. Americans, especially children, got less healthy.

Forces seeking to level the playing field for dietary supplements in international trade are attempting the same strategy. In response, the forces seeking the broadest degree of supplement product diversity—products designed to respond to the biochemical individuality of all persons—have thus far persuaded Congress to prohibit FDA from harmonizing its supplement rules with Codex. The struggle over undermining or strengthening that prohibition goes on today. The battle lines are drawn around several issues.

Specific Conflicts

Europeans say individuals can get all the nutrients they need from food. They say only certain supplements, those proven safe and effective, can be sold (a positive list). They also say certain other substances cannot be sold (a negative list). The U.S. has no positive list. It does not assert that all necessary nutrients are in food. Nutrients are presumed safe unless FDA proves them harmful. Congress set these policies through DSHEA. FDA, however, disagrees with DSHEA and continues to try in every way to undermine it.

FDA is the food safety consultant to the U.S. representative to Codex on matters of food, including supplements, safety and quality. It joins with the EU—which has twenty-seven Codex country votes—to attempt to move the whole world toward the EU position, namely that you can get all the nutrients you need from food; that supplements must have upper limits because they are dangerous in high doses; and that risk assessment used on inherently dangerous chemicals like drugs and food additives should be used on vitamins and minerals. Codex has adopted such a voluntary proposal with support from the international dietary supplement industry, led by the large companies in the American supplement industry.

Smaller companies in the global supplement industry, many of whom are already suffering from the effects of the Codex rule, are creating different products for U.S. and European markets. They are marginalized in the global debate by their lack of money for lobbying. Now Codex is putting heavy pressure and large resources into getting nations to adopt the Codex supplement Guidelines worldwide. The U.S. will not adopt the Codex Guidelines if DSHEA and the anti-harmonization legislation remain in place.

As a result, various “Save DSHEA” and anti-harmonization campaigns have gotten underway. The entire issue is complicated by the fact that many large dietary supplement manufacturers—particularly those that are subsidiaries of pharmaceutical companies—support adopting the Codex supplement standard worldwide. Adopting that standard would create a unified international market for their supplement products, which would not necessarily be an optimal situation for human health but which would make a great deal of business sense for manufacturers.

In fairness, it must be said that the Codex standard being pushed by the large dietary supplement manufacturers is significantly better than that proposed by the Codex staff at the beginning of the process. Still, that standard is loudly opposed by vocal elements of the health freedom community who, while arguing animatedly among themselves, unanimously support the importance of biochemical individuality and letting individuals pursue what they consider to be optimum nutrient intakes for themselves.

Diverse Views

Much of what makes interested consumers uneasy results from this three-way fight between the large supplement manufacturers and the factions of the health freedom community who are abetted by most small manufacturers and retailers. Here are some examples of the various positions in the supplement debate.

The International Alliance of Dietary/Food Supplement Associations (IADSA) supports the 2005 Codex Guidelines. According to IADSA representatives, “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.” In IADSA’s view, Codex Guidelines, although not binding, tend to influence less liberal markets and those without a regulatory framework in place, particularly common in supplements. In 2005, more than sixty countries worldwide, including China, India, Taiwan and Mexico, more than 50 percent of the global population, were considering adoption of new or amended regulations for vitamin and mineral supplements.

The National Health Federation (NHF) opposes the 2005 Codex Guidelines. NHF is a Codex-recognized consumer organization with the right to attend and speak out at Codex meetings. According to NHF, “Codex guidelines and standards will inevitably supersede domestic laws, including the Dietary Supplement Health and Education Act of 1994.”

Commenting on Codex, the National Health Federation “opposes the current Codex member states who wrongly believe that consumer health will be enhanced by: (1) denying that dietary supplements can benefit normal, healthy people; (2) incorrectly defining dietary supplements as only those vitamins and minerals that the body cannot manufacture itself; (3) restricting the upper limit amounts of vitamins and minerals, particularly by referring to currently crude and archaic medical beliefs about nutrients; (4) restricting any physiological benefit information for consumers; (5) restricting the lower limit amounts of vitamins and minerals that may be consumed by individuals; and (6) creating “positive” and “negative” lists of dietary supplements” (http://www.thenhf.com/codex_overview.htm).

The National Health Federation “supports a Codex process that will free up health knowledge and products for the entire world. A free-market system of choice and knowledge would avoid the errors of central planning that sets standards, however well intentioned, into stone. With the doubling time of knowledge constantly accelerating, mankind cannot afford the “luxury” of getting stuck in health standards established in the 20th Century while new health knowledge and products are discovered almost daily. We also wish that such discoveries continue. The best way to ensure such progress and advancing health is to keep the planners and bureaucrats from straitjacketing dietary supplements with medievalist thinking and restrictions.”

The Alliance for Natural Health (ANH), based in the U.K., also opposes Codex, noting, “There are strong links between the interests of Codex and those of the World Trade Organization (WTO), which can impose heavy fines and sanctions against non-compliant countries. Genuine concern for consumer health and welfare comes second to serving the interests of multinational food and drug companies. Codex poses a direct threat to our freedom to access natural foods, herbs and dietary supplements and to take personal responsibility for our own health and welfare.”

ANH manages a food/dietary supplement campaign focused on reversing Codex policy on food/dietary supplements that set very low maximum daily doses for supplements as foods; uses flawed risk assessment methods; forces therapeutic nutrients into drug category; and sets requirements for clinical trials to substantiate health claims that would be too expensive for small companies. The bottom line is that the Codex approach provides a passport system for big corporations and acts as an obstacle to freedom of speech for smaller ones. The ANH campaign also opposes setting of unnecessarily low Nutrient Reference Values, which seriously understate requirements for long-term optimum health for given subpopulations, age groups and genders.

Another group, the Natural Solutions Foundation (NSF), which has applied for Codex NGO status, opposes Codex, warning, “More and more people are turning to natural health products globally. The ’wellness‘ trend is a major trend in today’s society. The more natural health products people use, the fewer drugs they buy. The pharmaceutical industry, which is part of the ‘Sickness Industry’, fears the inevitable shift toward natural health care. Instead of accepting the will of the people and rethinking the future of the pharmaceutical industry, the industry has decided upon an unethical course of action: the use of deception and deceit to eliminate natural health products completely. Codex Alimentarius is a shrewd vehicle for protecting the pharmaceutical industry from the loss of income it stands to suffer due to the inevitable growth of natural healthcare” (http://www.healthfreedomusa.org/?page_id=157).

NSF argues that DSHEA protects America from Codex Alimentarius., noting that “The Dietary Supplement Health and Education Act (DSHEA, 1994), an American law classifying our supplements and herbs as foods (which can have no upper limit set on their use), was passed by unanimous Congressional consent following massive grass-roots support organized by health food stores. Millions of American activists told Congress, in no uncertain terms.” Many other groups take stands that are variations of these positions.

2009 Amendments to the Codex supplement Guidelines

In 2009, Codex adopted amendments to the supplement guidelines that included Recommendations on the Scientific Substantiation of Health Claims; Nutritional Risk Analysis Principles; Provisions on Gum Arabic; the definition and table of conditions of dietary fiber; and the use of eight food colors in food supplements. These amendments were also met with controversy, generally reflecting the positions of the various groups on the underlying supplement Guidelines. Some consumer advocates questioned the idea of adding food colors to supplements, the standard adopted for substantiation of health claims, and the use of risk analysis approaches originally designed for evaluating toxic substances rather than the biochemistry analysis they say is more appropriate for nutrients.

IADSA said of the 2009 amendment that the new Nutritional Risk Analysis Principles provide “a solid framework for the potential future application of the risk assessment method by Codex for the use of vitamins, minerals and other substances in food supplements.” IADSA, along with the major supplements companies, welcomed the risk analysis amendments as being in line with its own recommendations. The Natural Solutions Foundation condemned the risk analysis approach. This debate will continue in the various forums attempting to regulate dietary supplements.

Codex is a forum in which large debates about pubic food policy, which are dominated by powerful economic interests and governments, are conducted. Consumer, citizen, and small business groups are essentially blocked from serious influence on these debates within Codex. However, the excluded groups have demonstrated the ability to influence international food policy by their actions at the grass roots and community organizing level. It is here that the concerned citizens who lack the power of institutions and money can make a significant difference. Consumers can get a safer, more reasonably priced, healthy food supply if they demand it.

Bibliography

1. Codex Alimentarius: how it all began. Food and Agriculture Organization of the United Nations website. http://www.fao.org/docrep/v7700t/v7700t09.htm.

2. Agreement on the Application of Sanitary and Phytosanitary Measures World Trade Organization. http://www.wto.org/english/docs_e/legal_e/15sps_01_e.htm.

3. Understanding the Codex Alimentarius Preface. Third Edition. Published in 2006 by the World Health Organization and the Food and Agriculture Organization of the United Nations. ftp://ftp.fao.org/codex/Publications/understanding/Understanding_ EN.pd.

4. Codex Alimentarius Commission 28th Session, FAO Headquarters, Rome, Italy, 4-9 July, 2005. Official report. ftp://ftp.fao.org/codex/alinorm05/al28_41e.pdf.

5. Codex Guidelines for Vitamin and Mineral Food Supplements.

6. UN commission adopts safety guidelines for vitamin and food supplements United Nations News Centre. Published 11 July 2005. http://www.un.org/apps/news/story.asp?NewsID=14974&Cr=codex&Cr1#.VOH2_Cw5uq0

7. Natural Products Association Position Papers Codex Alimentarius. http://www.naturalproductsassoc.org/site/Search?query=codex&imageField.x=16&imageField.y=8.

8. Responses to Questions about Codex and Dietary Supplements http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformation/ucm113860.htm.

9. Center for Science and the Pubic Interest Codex Comments on various issues. http://www.google.com/search?hl=en&q=CSPI+Codex&btnG=Search&aq=f&oq=&aqi=

10. Alliance for Natural Health CODEX—government and corporate control of our food supply? http://www.anhcampaign.org/campaigns/codex.

This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly magazine of the Weston A. Price Foundation, Fall 2009.

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