Europe: Codex and the European Food Supplements Directive (EFSD).
International trade agreements have caused a radical change in the nature of Codex. NAFTA NAFTA
in full North American Free Trade Agreement
Trade pact signed by Canada, the U.S., and Mexico in 1992, which took effect in 1994. Inspired by the success of the European Community in reducing trade barriers among its members, NAFTA created the world's and GATT See General Agreement on Tariffs and Trade.
See General Agreement on Tariffs and Trade (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."
Under the Uruguay Round Agreement on the Application of Sanitary and Phytosanitary Measures The Agreement on the Application of Sanitary and Phytosanitary Measures - also known as the SPS Agreement is an international treaty of the World Trade Organization. (SPS (Standby Power System) A UPS system that switches to battery backup upon detection of power failure. See UPS.
SPS - Symbolic Programming System. Assembly language for IBM 1620. 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 FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. standard or U.S. law (i.e., DSHEA DSHEA Dietary Supplement Health and Education Act of 1994 (US legislation) ) 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 The law of the United States was originally largely derived from the common law of the system of English law, which was in force at the time of the Revolutionary War. However, the supreme law of the land is the United States Constitution and, under the Constitution's Supremacy , 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 FDCA Food, Drug and Cosmetic Act
FdCA Federazione dei Comunisti Anarchici (Federation of Anarchist Communists, an Italian political organization)
FDCA Field Data Collection Automation (US Census) (Food Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act
a regulation in the United States which requires all drugs used in animals to be approved by the Food and Drug Administration. ) 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 EFSD European Foundation for the Study of Diabetes ). 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 The Food Standards Agency is a non-ministerial government department of the Government of the United Kingdom. It is responsible for protecting public health in relation to food throughout the United Kingdom and is led by an appointed board that is intended to act in the public (EFSA EFSA European Food Safety Authority
EFSA European Federation of Sea Anglers
EFSA European Food Safety Association ) 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 FAO/WHO Food and Agriculture Organization of the United Nations and the World Health Organisation Nutrient Risk Assessment Project will have a strong impact on "upper levels" which are established for the EFSD.
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.
In talking with U.S. non-governmental organization (NGO) and observer delegates to Codex, the consensus is that the European Court of Justice European Court of Justice, judicial branch of the European Union (EU). Located in Luxembourg, it was founded in 1958 as the joint court for the three treaty organizations that were consolidated into the European Community (the predecessor of the EU) in 1967. (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
Citizens for Health
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: firstname.lastname@example.org.