Robert V. Conover

The Codex Alimentarius Commission is the forum for setting international standards for food safety and quality. The deliberations of its various committees are very important, given the World Trade Organization’s recognition of Codex documents as “benchmarks” for resolving international trade disputes.

Labeling of foods derived from modern biotechnology (rDNA-biotechnology) is a substantial issue of tremendous scope and implication for international trade. It is one of the two hottest issues nutrition and health claims is the other) being addressed by the Codex Committee on Food Labeling (CCFL), with the goal of developing proposed draft guidelines. Biotech labeling also surfaces in discussions by other Codex committees, e.g., Methods of Analysis and Sampling (CCMAS) and General Principles (CCGP).

An indicator of the divergence of views and difficulty experienced by various governments and other organizations in dealing with biotech labeling is the length of time that the issue has been on Codex agendas, unresolved. The issue has been deliberated by Codex since 1991 and in CCFL meetings since 1993. Development of guidelines for labeling foods derived from modern biotechnology was at such an impasse last year that a special “Friends of the Chair” advisory working group was formed to propose a way to break through the stalemate.

One of the areas of debate and lack of consensus is the notion of “processed-based labeling, “ which goes beyond “end-product (composition, characteristic or nutrient-based) labeling.” The Institute of Food Technologists—as a nongovernmental organization (NGO) participating in Codex—has contributed substantively to the debate, stressing these key points:
Terminology used in labeling should convey information in an understandable, accurate, and non-misleading manner. To avoid a misleading presentation of the food, the label must reveal all material facts. If rDNA biotechnology is used in the development of a plant variety but the rDNA biotechnology-derived food is not significantly different from the conventional counterpart, there would be no material fact regarding the food to disclose. Thus, without significant differences, the fact that a food is rDNA biotechnology-derived is not itself a material fact.

Any labeling to distinguish rDNA biotechnology-derived foods from other foods would require monitoring tools sufficiently precise to meet the labeling objectives. Yet, reference samples are not readily available for validating analytical methods or assessing performance of methods and laboratories. As new rDNA biotech-derived crops are developed, new assays need to be developed, and neither internationally recognized sampling methods nor agreement on the appropriate sample number or size currently exist. Without reliable standardized analytical tests and sampling protocols, it is difficult, if not impossible, to verify the accuracy of label declarations.

These important analytical issues are being addressed by CCMAS, which is drafting guidelines on criteria for analytical methods and quality control measures for laboratories performing methods for detecting and identifying rDNA biotechnology-derived foods.

At the 32nd Session of CCFL, held in Montreal, Canada, on May 10–15, 2004, the Friends of the Chair working group presented options as to how to move forward in addressing biotech labeling, but no consensus was reached. The United States delegation and others expressed the view that there was a consensus on the need for mandatory labeling in cases where significant changes in product composition, characteristics, nutritional value, or end use exist. The U.S. delegation opposed the idea of labeling based solely on the method of production since it would be misleading, as any consumers would perceive it as a safety warning. The European Community delegation stressed that the purpose of labeling foods is to provide consumers with useful information, not only to draw attention to health and safety information.

The U.S. and other delegations proposed that another working group be formed to address these issues during the coming year. The EC and other delegations were opposed. As a result of a lack of consensus, no working group will be formed. Instead, CCFL agreed to devote one entire day to review all “biotech” labeling issues at its next meeting in May 2005.

This is only one of many crucial issues of international trade impact that is being debated in Codex. Other hot issues include traceability/product tracing, nutrition and health claims, the general standard for food additives (where information on technical functionality of additives is key), and principles of risk analysis. More information about these issues can be found on the Codex Web site at or the Web sites of Codex member governments, e.g., the U.S. at and Canada at

If you would like more information on scientific viewpoints contributed by IFT on such issues—or would like to add your input—contact me at [email protected] or Rosie Newsome, IFT’s Director of Science and Communications, at [email protected]. Also, contact Rosie Newsome if you would like to be added to an electronic distribution list for reports by IFT Codex delegates.

by Robert V. Conover, Chair of the IFT Committee on Global Regulations and Policy, is Assistant General Counsel, Kikkoman Foods, Inc., P.O. Box 69, Walworth, WI 53184.