Europe: Codex and the European Food Supplements Directive (EFSD).

International trade agreements have caused a radical change in the nature of Codex. NAFTA and GATT, in addition to the Uruguay Round Agreement, have jointly changed the implications of Codex Alimentarius standards by "designating Codex as the international body establishing presumptively trade-legitimate food safety standards."

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Under the Uruguay Round Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), regulatory requirements that differ from Codex standards may be challenged as trade barriers. In this way, Codex standards are a threat to the sovereignty of U.S. law and to U.S. products because other countries can now challenge an FDA standard or U.S. law (i.e., DSHEA) as a trade barrier if the standard or law differs from Codex.

Threats to Sovereignty of U.S. Law (i.e., DSHEA)

In approving the Uruguay Round trade agreements, Congress wrote that "[n]othing in this Act shall be construed (A) to amend or modify any law of the United States, including any law relating to (i) the protection of human, animal, or plant life or health. In addition, the Statement of Administrative Action approved by Congress when it implemented the Uruguay Round agreements specifically listed the FDCA (Food Drug and Cosmetic Act) as a federal environmental and health measure that is not touched by these agreements. Therefore, FDA is not allowed to adopt Codex standards that do not comply with U.S. law and the statutory requirements set forth in the FDCA, including DSHEA.

The European Food Supplements Directive

In 2002, the European Union (EU) issued a directive to regulate the commerce of food supplements, also known as the European Food Supplements Directive (EFSD). The EFSD created a list of allowed vitamin and mineral ingredients. All nutrients not on this "positive list" will be banned EU-wide as of August 1, 2005, unless a detailed dossier for each nutrient is submitted (at an estimated cost of $20,000 to $290,000 per ingredient for which safety data is not readily available). These dossiers must be submitted via an EU member state to the European Food Standards Agency (EFSA) by July 12, 2005.

The immediate effect of the directive will be to ban about 300 of the 420 or so forms of vitamins and minerals present in around 5000 products currently on the U.K. market. The ban will have a similar effect on products in such countries as Sweden, the Netherlands, Ireland and others, which also have strong markets for food supplements.

Restricting Potency of Food Supplements

The potency of food supplements on the positive list will also be limited, as the EFSD stipulates these nutrients will be subject to maximum "upper safe levels."

The U.K.'s Alliance for Natural Health (ANH) concluded that the "most effective option now left for the protection of the continued supply of safe, natural and effective advanced food supplements in the EU was to challenge the EFSD ban on non-positive list nutrients, in the courts."

Most fundamentally, says the ANH, the ban on vitamins and mineral forms excluded from the positive list is unconstitutional under EU law. Since the EFSD is the first part of a plan for the comprehensive regulation of food supplements at the EU level, it is critical that "this legal challenge be pursued, otherwise the prospects for a successful challenge to a second or subsequent directive" (such as herbals) will be greatly reduced.

It is also likely that the recently created FAO/WHO Nutrient Risk Assessment Project will have a strong impact on "upper levels" which are established for the EFSD.

"Risk" Assessment

As mentioned previously, the FAO/WHO recently announced plans to undertake a nutrient risk assessment project. The stated goal is to "define a scientifically-based and internationally applicable approach for nutrient risk assessment." Since the South African Codex delegation is heading up this project, it is believed that there will be opportunity for real discussion.

U.S. Positions

In talking with U.S. non-governmental organization (NGO) and observer delegates to Codex, the consensus is that the European Court of Justice (ECJ) will not overturn the EFSD but will clear the way for improvements to it, especially in the area of upper levels and possibly in restoring the banned 300 ingredients to the approved list.

What effect the ECJ rulings will have on the flotilla of dossiers about to be submitted to EFSA remains unclear. One delegate suggested that having an accepted dossier will give an ingredient a leg up on other competing ingredients without dossiers, regardless of what happens with the unapproved list.

Another delegate said that industry and consumer groups should not fail to recognize that with Codex this is "the first time a global, international body is declaring supplements are foods."

By James J. Gormley

Policy Advisor

Citizens for Health

Washington, D.C.

About the author:

James J. Gormley is an award-winning journalist, who was the editor-in-chief of Better Nutrition magazine from 1995 through 2002. Today Mr. Gormley is the policy advisor for Citizens for Health, as well as the scientific liaison for Purchase, N.Y.-based Nutrition 21. He can be reached at 914-701-4511; E-mail: [e-mail].