The European Union (EU) has just adopted some of the world's most comprehensive regulations regarding labeling and traceability of genetically modified (GM) food and feed. Enforcement is scheduled to begin in April 2004.

Many food producers are wondering, “What does this mean for me? What do I need to do if I want to sell my products in the EU?” This article explains what food producers need to do to comply with the new EU regulations and maintain or expand market share and profitability in overseas markets where genetically modified organisms (GMOs) in food are regulated.

Two critical elements need to be put in place to ensure compliance with the new EU regulations:

1. A well documented traceability system that demonstrates that all reasonable precautions and due diligence were undertaken to exclude GM material from the product, and, thus, that any traces present are adventitious or technically unavoidable.

2. GMO testing to verify that levels of adventitious GM are below the relevant thresholds (0.9% and 0.5%).

Research Non-GMO Standards

A good way to begin that process is to examine some of the standards for identity preserved (IP) systems developed in recent years. A number of private companies, associations and certification agencies offer non-GMO IP programs. An Internet search for “non-GMO IP programs” or “Non-GM IP Programs” will provide you with links. You also can search for “non-GMO certification” and choose one of the third-party, non-GMO certifiers. These companies have a good understanding of the implications of the new EU regulations and can help streamline the process of developing, implementing and monitoring your non-GMO IP program.

It is important to understand the key elements of non-GMO IP systems. Upon examining a few non-GMO standards, you will find that comprehensive non-GMO IP standards have some common elements:

  • Segregation of non-GMO product(s) and input from any sources of GMO contamination.

  • Traceability for all input and a traceable chain of custody as products are moved from organization to organization within the food chain.

  • Selecting and training qualified personnel to operate the program.

  • A quality program that lets the QA staff verify the program is operating properly.

  • Complete documentation of the design and operation of the non-GMO IP system.

  • Ideally, independent third-party certification of the program.

    Examine your system in light of the basic principles and elements of IP. Once you understand the key elements of non-GMO IP systems, the next step will be to consider your own production system in light of these elements. A good way to do this is to create a flow chart that shows how product flows through your production system and the processes that take place within that system. Then, examine each step and process in your system using the non-GMO IP standard chosen. The outcome of this process should be a program that meets the core requirements of an IP system, yet is optimized for your production system and business objectives.

    Once a program is defined on paper, the next step is to audit the actual facilities against that plan. Bring in an outside inspector or auditor who has a background in assessing non-GMO IP systems, or use someone in-house who has the appropriate background. The goal is to identify inconsistencies between your plan and your actual production system.

    Implementing a Non-GMO IP Program

    The outcome of the audit will be an optimized IP plan. The next step will be to actually modify the production system and operational procedures to rectify the gaps between those systems and procedures and the optimized IP plan. This is the central and most critical part of IP program development. Once this is accomplished, the next step is to put the new production system into operation.

    Once the system is in operation, its performance needs to be monitored. This assessment should cover not only standard product specifications, but also the specifications relevant to the new IP program. This assessment may lead to refinements of the production system and operational procedures, and may also lead to revisions and refinements of the IP program.

    Many organizations find that it makes good business sense to contract with an independent third-party organization to verify or "certify" their non-GMO IP system. These certification organizations provide independent validation that the production system operates to a certain standard of performance in its ability to deliver non-GM products.

    Food and agricultural producers who have instituted non-GMO IP programs are finding ready customers in the EU market. A robust non-GMO IP program helps them and their EU customers rest assured that they are in compliance with the new EU GM Traceability and Labeling Regulations. This gives the food producer a competitive edge in the EU, and in other markets where GMOs are a concern for governments, buyers, retailers or consumers.

    Sidebar 1:
    On the Web: GMO Regulations

  • — Farmers are paid a premium for exported non-GMO foods
  • — A short history of the EU's ban on new GMOs
  • —Good background information on GMOs

    Sidebar 2:
    Key Components of the EU's New GM Food & Feed

    Regulations (Enforcement expected in early 2004)
    Traceability: Mandates product traceability through documentation and implementation of identity preservation systems and procedures for the entire supply chain.
    Labeling: 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 traces of GMOs are adventitious and technically unavoidable.
    Thresholds: 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.