WalterGuidelinesOverview05 | American Holistic Health Association

Overview – 2005

Codex Guidelines for Vitamin and Mineral Food Supplements
by Suzan Walter

Codex Alimentarius
In the early 1960s, two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO), established Codex Alimentarius (Codex). The stated purpose of Codex Alimentarius (Latin for “Food Code”) is to establish a set of international standards for food quality and safety to protect the health of consumers and ensure fair practices in the international food trade.

Codex Ruling Body
The Codex Alimentarius Commission (CAC) is the top level body that oversees all Codex activities. Delegations from the 172 member countries meet annually in alternate years at FAO headquarters in Rome and at WHO headquarters in Geneva. A country’s delegation at a Codex session must be led by a government official or employee of that country. It is this individual who controls who speaks for that delegation.

Each country has one vote, which is cast by its chief delegate. However, the Codex Procedural Manual dictates that consensus, not voting, is the preferred method for approving changes. The Codex definition of consensus was clarified in 2004, but implementation of this is not uniform among all Codex session chairs.

Non-governmental organizations (NGOs) may also attend Codex sessions. Although such organizations may express their opinions, these viewpoints are not weighed in the final decisions.

While Codex reserves the right to hold sessions in secret, sessions are normally open. An individual not part of a country or NGO delegation may attend a Codex session as an observer, but observers are never allowed to speak to the assembly.

Unsanctioned photos, filming and/or recording of a Codex session are prohibited. This prohibition is strictly enforced.

Codex Committees
The CAC assigns projects to Codex committees, which meet annually to draft the requested standards, guidelines, and recommendations. Most committees are hosted by a member country, which is responsible for the cost of the committee’s maintenance and administration and for providing its chairperson.

A trade standard being drafted goes through up to eight formal steps before it is sent on to the CAC for finalization and activation. This process often takes many years.

Traditionally Codex “standards” were considered mandatory regulations, while “guidelines” were optional suggestions. Because Codex does not have power to enforce the trade standards it develops, acceptance of standards and guidelines by member countries was not an issue.

Everything changed in 1995 when the World Trade Organization (WTO) was created. Each country joining the WTO had to commit to abide by all WTO trade regulation agreements and international trade standards. This included granting the WTO the authority to enforcement trade dispute decisions coming out of the WTO Dispute Settlement Process by imposing compulsory trade sanctions against the losing country. As a result of Codex’s designation as the body for setting food-related international trade standards and the WTO’s stance that it would not differentiate between Codex standards, guidelines, and recommendations, all Codex documents (standards, guidelines, and recommendations) became elevated to mandatory international trade standards enforceable by the WTO.

Vitamin and Mineral Supplements
In 1991, the CAC gave the German-based Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) an assignment to draft guidelines for vitamin and mineral supplements. This assignment was considered appropriate, as dietary supplements fall within the Codex definition of food, which is “any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drink, chewing gum, and any substance which has been used in the manufacture, preparation or treatment of ‘food’ but does not include cosmetics or tobacco or substances used only as drugs.”

This document ultimately became the Codex Guidelines for Vitamin and Mineral Food Supplements (also called Guidelines). It took until 2004 for the Guidelines to progress though the eight required steps. The most difficult issue to resolve was how to set safe upper limits. The final choices came down to recommended daily intake or scientifically established risk assessment. The CCNFSDU that drafted this document finally selected the latter in 2003.

Guidelines Concerns
Many people are very concerned that the Guidelines are a serious threat to continued free access to dietary supplements of choice. They believe that important aspects of the Guidelines are not well defined and that the CCNFSDU delegates did not fully understand exactly what they were approving.

1) Guidelines PREAMBLE
The Guidelines Preamble defines a very limiting role for vitamins and minerals as only for supplementation of the daily diet. This is not consistent, however, with the WHO (one of the parent organizations of Codex) 2002 publication, “Diet, Nutrition and the Prevention of Chronic Diseases,” that specifically references the preventive value of vitamins and minerals. The influential European Union delegate to CCNFSDU blocked attempts to correct this inconsistency.

2) Guidelines SCOPE 1.3
Codex is supposed to promote “harmonization” of trade standards among all countries. The Guidelines Scope states that this document applies only to countries designating vitamins and minerals as food. Countries designating vitamins and minerals as drugs are thus exempted from having to abide by the regulations in the Guidelines. This is inconsistent with the Codex goal for drafting trade standards to be used by all countries.

3) Guidelines COMPOSITION 3.1.1
The Guidelines state that vitamin and mineral food supplements can include only vitamins and minerals whose status is recognized by FAO/WHO. However, this list of vitamins and minerals is not defined. What is the list the CCNFSDU delegates were approving? A search of FAO and WHO websites uncovers mention of most commonly used vitamins and minerals if you consult a variety of different documents. However, no one document mentions all vitamins and minerals. If only one document ends up as the official “list,” this could eliminate a number of vitamin and mineral products currently available by removing them from what is allowed for trade between countries and, in many cases, inside a country’s own borders.

4) Guidelines COMPOSITION 3.2.2 (a)
The section of the Guidelines expected to have the most significant impact on the future of what levels of potency are allowed in dietary supplement products is the criterion by which the maximum amounts of vitamins and minerals that will be allowed in a supplement product are determined. While the Guidelines state these amounts will be set by “upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data,” there is no designation as to what organization will create the risk assessment protocol.

Some individuals are very concerned that the manipulation and/or selective use of scientific “facts” could result in the upper limits being set too low.

This month (May 2005), a FAO/WHO expert panel will meet to define a scientifically-based nutrient risk assessment. Since this panel is convening under the auspices of The International Programme on Chemical Safety, many anticipate that dietary supplements will inappropriately be handled as toxic substances.

5) CCNFSDU not informed of WTO use of Guidelines
During the November, 2004, CCNFSDU session that moved the Guidelines to Step 8 of the document approval process, the delegates were specifically told that the Guidelines were optional. Under Codex procedures, this is true. However, the delegates were not informed that the WTO can use any Codex document, including the Guidelines document when it is finalized, as a mandatory trade standard.

Many foresee that finalized Guidelines could be used by a future WTO Dispute Settlement panel to find a country whose dietary supplement potency levels are higher than those allowed by the Guidelines guilty of not being in harmony with international trade standards. If the United States were found guilty in such a case, then the Dietary Supplement Health and Education Act (DSHEA) laws would have to be changed to be more restrictive (eliminating availability of a number of dietary supplement products) or the U.S. would have to pay huge trade sanctions each year. Historically, the U.S. has changed its laws when required by the WTO. As WTO Dispute Settlement panels tends to level the trade playing field, this scenario looms as a possibility.

Guidelines scheduled for CAC finalization
The finalization of the Guidelines is on the agenda for the CAC session that will convene July 4, 2005 in Rome.

Suzan Walter, president of the American Holistic Health Association, researched how the Codex Alimentarius and the World Trade Organization function and applied this information to track the potential impact of the document Codex Guidelines for Vitamin and Mineral Food Supplements. She attended the Codex Committee on Nutrition and Foods for Special Dietary Uses sessions as an observer in 2002, 2003, and 2004 and continues working to try to validate true facts in the face of conflicting information being presented by opposing groups. Suzan created an educational website to explain these matters to the U.S. public and offer a variety of points of view. This website was converted to the Codex Section of the AHHA website.