John Fagan

The European Union’s new regulations on labeling and traceability of genetically modified food and feed became effective in October 2003. EC 1829/2003 and EC 1830/2003 will be fully enforced starting in April 2004, now that the EC has announced its system of unique identifiers for genetically modified organisms (GMOs).

Whether you see the regulations—which can be viewed online at — as a trade barrier, an attempt to placate overly worried EU consumers, or the result of a government exercising its right to label food according to the wishes of its citizens, they define the reality of a very important market for food and agricultural products from the United States. Europe is the U.S.’s biggest customer, with more than 400 million people.

Key components of the new EU regulations are traceability, labeling, and thresholds. The regulations mandate product traceability through documentation and implementation of identity preservation (IP) systems and procedures for the entire supply chain. Products containing GMOs must be labeled as such, even when undetectable by test. Products containing traces of GMOs below the appropriate regulatory tolerance thresholds are exempt from labeling, provided that compliant traceability systems are in place and the traces are adventitious and technically unavoidable. There is a 0.9% regulatory tolerance for EU-authorized GMOs and 0.5% for unauthorized GMOs that have already received a favorable EU risk assessment. Compliant traceability systems must be in place and must demonstrate that any traces of GMOs are adventitious and are technically unavoidable.

What is happening in the EU is just one example of what is happening almost everywhere else in the world. The new EU regulations serve as an interesting example of what food producers may expect to see emerging in various countries around the world in 2004 and beyond. With the exception of North America, virtually every center of economic influence around the world has implemented laws requiring that GM foods be labeled. These include all of Europe, Japan, Korea, China, Australia, New Zealand, and India. More than 35 countries have GMO regulations under consideration.

From a North American perspective, where GMOs are not a regulatory consideration, the regulatory and marketplace developments in the EU and elsewhere seem unnecessary and inconvenient. On the other hand, the new EU GMO traceability and labeling regulations can be viewed as an opportunity for North American food and ingredient producers to maintain or expand their EU market share. To benefit from this opportunity, existing quality assurance systems can in many cases be readily upgraded with non-GMO IP protocols.

Compliance with these new EU regulations requires (1) a properly documented traceability system demonstrating that all reasonable precautions and due diligence were taken to exclude GM material from the product and that any traces present are adventitious or technically unavoidable; and (2) GMO testing that is sensitive and accurate enough to confirm that levels of adventitious GMs are below the prescribed 0.9% and 0.5% thresholds.

Many U.S. producers have already designed and implemented non-GMO IP programs, often with the help of experts who make sure that the producer has covered all its bases with an economical, flexible, efficient, and market-oriented non-GMO IP program. In many cases, these producers have undertaken certification of their IP systems by an independent, third-party certification body. An Internet search for “non-GMO certification” or “non-GMO IP programs” or “non-GM IP Programs” will provide a list of links to third-party certifiers such as Cert ID, which can also be found directly at

This independent verification enhances the value of an IP system in the marketplace. It maximizes buyer confidence and enhances the producer’s ability to expand market share in the EU and in other markets where GMOs are an issue. Certified non-GM products are attractive to buyers, not only because they allow the buyers to meet their own product specifications, but also because it allows them to satisfy the needs and concerns of their customers. This will become increasingly important in 2004 and beyond as the EU begins to enforce the new regulations.

An effective non-GMO IP program will be flexible enough to meet the economic and other needs of a food or ingredient producer’s business while also effectively and reliably satisfying regulatory requirements and marketplace demands. It will do more than just satisfy the EU requirements but can be designed to ensure that a company’s systems and products satisfy non-GMO requirements worldwide.

It is well worth the price of implementing such programs for a company to know that its traceability systems and products will meet or exceed buyer expectations, consumer demands, and government regulations in any market where it does business.

by John Fagan
is Chief Scientific Officer,
Genetic ID Inc., 501 Dimick Dr.,
Fairfield, IA 52556,
[email protected].