Implications of Codex Standards for the Regulation of Genetically Modified Food

Judson O. Berkey
September 19, 2000
The Codex Alimentarius (Codex) is a commission jointly sponsored by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex adopts standards that may be used by its 162 participating governments to develop national regulations. Codex is currently developing a variety of international standards for the trade of genetically modified food (GMF).(1)
Codex has three committees that are considering various issues related to GMFs. These committees are the following: 1) Codex Committee on Food Labeling (CCFL); 2) Codex Committee on General Principles (CCGP); and 3) Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology (Task Force).
The CCFL currently is considering two different labeling options for GMFs. Under Option 1 (proposed by the U.S.), all foods derived from biotechnology or containing ingredients derived from biotechnology would be labeled as such only if the altered food differs from the original food in terms of composition, nutritional value, or intended use. Labeling would also be required if the genetic modification introduced a known allergen into the food. In order to implement this option, it will be necessary to determine the degree of “difference” that triggers the labeling requirement. The U.S. is on record as supporting a “differs significantly from” standard as opposed to a “is no longer equivalent to” standard.
Under Option 2 (proposed by the EU), all food composed of or containing ingredients with genetically modified material would have to labeled as such. In addition, labels would have to state the method of production for the GMF (e.g., “produced by genetic modification”). This option may or may not contain a threshold level to determine the minimum genetically modified content that triggers the labeling requirement. The EU has recently approved its own internal GMF labeling requirement with a 1% threshold level.
At its most recent annual meeting on May 9-12, 2000, the CCFL agreed to spend another year considering these initial two options and a third option proposed by Norway and India. This third option would require labeling of foods in which genetically modified material has been used at any time during the production process. The practical effect of this proposal would be to require labeling of refined oils (e.g., vegetable oil) that are made from genetically modified crops (e.g., soybeans) even though they no longer contain any genetically modified material in their final form. The next meeting of the CCFL will occur in April 2001.
The CCGP is currently considering the application of the “precautionary principle” in the process of risk analysis. The CCGP’s current draft document, Proposed Draft Codex Working Principles for Risk Analysis, contains a set of principles for risk analysis that are “intended for application in the framework of Codex Alimentarius and are also intended to provide advice to governments where applicable.” Thus, the working principles will be slightly different from the typical Codex Standard in that they will serve not only as a standard but also will govern the development of new Codex Standards as well.
The draft document currently contains two alternative precautionary principles. The two alternatives (emphasis added for comparison) are as follows:
Where relevant scientific evidence is insufficient, precaution can be exercised as an interim measure to protect the health of consumers. However, additional information for a more objective risk assessment should be sought and the measures taken reviewed accordingly within a reasonable time.
When relevant scientific evidence is insufficient to objectively and fully assess risk from a hazard in food, and where there is reasonable evidence to suggest that adverse effects on human health may occur, but it is difficult to evaluate their nature and extent, it may be appropriate for risk managers to apply precaution through interim measures to protect the health of consumers without awaiting additional scientific data and a full risk assessment, in accordance with the following criteria:
The most obvious difference between these two alternatives is that the first requires a review of any measures taken according to the precautionary principle while the second only states that any measures should be considered “interim” measures. A second notable difference is that while the second alternative provides some indication of what constitutes “insufficient” scientific evidence (i.e., that which is lacking, but would be necessary to “objectively and fully assess risk”), the first does not. The CCGP has formed a working group that will attempt to better define the precautionary principle by its next meeting in April 2001.
Task Force
At is most recent biennial meeting on June 28-July 3, 1999, the Codex Commission established the Ad Hoc Codex Intergovernmental Task Force on Foods Derived from Biotechology to “develop standards, guidelines, or recommendations, as appropriate, for foods derived from biotechnology or traits introduced into foods by biotechnology, on the basis of scientific evidence, risk analysis, and having regard, where appropriate, to other legitimate factors relevant to the health of consumers and the promotion of fair trade practices.” The intent was for the Task Force to develop GMF safety and nutrition standards while the CCFL addressed labeling issues and the CCGP considered the precautionary principle.
The Task Force met for the first time in on March 14-17, 2000. At the meeting, the Task Force agreed to develop a set of overarching principles for the application of risk analysis that would include the following elements:
science-based decision making;
premarket assessment;
post market monitoring; and
other legitimate factors as appropriate.
The Task Force also agreed to develop a set of guidelines for risk assessment that would include the following elements:
food safety and nutrition;
substantial equivalence;
potential long term health effects; and
non-intentional effects.
The Task Force is currently preparing discussion papers on the concepts of food ingredient traceability and familiarity for consideration at its second meeting in March 2001.
Relationship of Codex to the WTO
Two WTO agreements are relevant for Codex standards: 1) Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) and 2) Agreement on Technical Barriers on Trade (TBT Agreement). The SPS Agreement applies to those national laws designed to protect life and health from risks that arise from, among other things, additives, contaminants, toxins, diseases and pests. The TBT Agreement applies to all national technical regulations and standards governing product characteristics, labeling and packaging. These agreements provide the conditions under which national laws and regulations that may otherwise be considered to be trade restrictions can be justified.
Although it is not yet clear whether the SPS Agreement or the TBT Agreement will apply to GMF regulations, the particular agreement that does apply will make a material difference in how any disputes are treated under the WTO. The SPS Agreement requires national measures to “conform to” international standards including those developed by Codex. National measures may be more stringent than international standards (e.g., requiring GMF labels on foods with a lower threshold trigger level than that which may be set by Codex) only when there is “a scientific justification” for doing so, or, in the absence of adequate scientific evidence, when the member country adopts a measure based on “available pertinent information, including that from the relevant international organizations” and continues to seek information necessary for “a more objective assessment of risk...within a reasonable time.”
Under the TBT Agreement, on the other hand, national measures only need to be “in accordance” with international standards, which may or may not include Codex standards. This requirement in and of itself is weaker than that of “conformity” as required by the SPS Agreement. In addition, under the TBT Agreement, a national measure may be more stringent than an international standard when the standard would be an “ineffective or inappropriate means for the fulfillment of the legitimate objectives pursued, for instance because of fundamental climatic or geographic factors or fundamental technological problems.” This is definitely a weaker standard than the requirement of “scientific justification” under the SPS Agreement.
The full effect of Codex standards will ultimately depend on how the standards are treated within the WTO because the WTO provides the forum where any disputes over the trade effects of these standards will be settled. Thus, the development of Codex standards will still not provide complete clarity on the rules governing the trade of GMFs.
1. Information on Codex and Codex documents are available on the FAO website at The U.S. Delegation also publishes its summary reports from Codex meetings on its website at The OECD also has an active GMF work program that may result in international regulatory standards. Details on the OECD work can be found at 
2. No specific criteria are provided. However, paragraph 35 of the draft document (still in square brackets to indicate a lack of consensus on its acceptability) may be intended to provide the criteria. Paragraph 35 currently contains criteria that are very similar to those contained in the EU Communication on the Precautionary Principle released by the EU Commission on February 2, 2000 (IP/00/96, 2 February 2000).
About the Author: 
Judson O. Berkey is the Regulatory Policy Analyst at the Institute of International Finance, Inc. in Washington, D.C. He holds degrees from Harvard Law School (J.D., 1998) and the University of Virginia (B.A., 1995) and previously worked as an associate in the international trade department of a large Washington, D.C. law firm. He can be contacted at