Regulatory Issues: What do Europe’s GM regs require?

Sept. 22, 2004
A conscientious manufacturer will be at a disadvantage against unscrupulous competitors operating anywhere on the planet.
In April, the European Union’s latest set of regulations dealing with foods derived from genetically modified (GM) sources took effect. Now, foods marketed in Europe must be labeled to disclose the presence of any ingredient or additive derived from a genetically modified source. Manufacturers handling finished foods and food ingredients in Europe also must comply with the traceability requirements, meaning they must keep records regarding any foods, ingredients and additives derived from genetically modified sources: where they came from and where they went.The effective date of these regulations has focused much attention on their impracticality and lack of clarity. A few difficulties with the new regulatory scheme are discussed below.Traceability of food additivesMany food additives are derived in whole or in part from crops that might or might not be genetically modified, such as corn, soybeans and various oilseeds. Take sorbitol as just one example. Sorbitol is produced from sugar solutions containing glucose or fructose, both of which are often derived from corn. A manufacturer placing sorbitol on the market in the EU now has essentially three options: 1. market only non-GM derived product in Europe, if this can be done in a cost-effective way; 2. take great pains to learn the source of the fructose/glucose raw material if that is possible, and on a batch-by-batch basis inform customers in Europe that the finished product was or was not derived from GM raw materials; 3. disregard the source of the glucose or fructose raw material, assume that it is likely derived from GM corn, and communicate that the sorbitol is GM-derived to anyone who receives it in Europe.If the sorbitol supplier elects option 2 or 3, customers in Europe will likely reject the product and insist on a non-GM version so as to avoid the need to label a finished food as containing GM-derived sorbitol. Perhaps most regrettable under this scenario, a conscientious manufacturer will be at a disadvantage against competitors operating anywhere on the planet who may turn a blind eye to the EU requirements and market additives of unknown origin as if they were known to be non-GM.Approval of GM-derived additivesApart from the labeling and traceability concerns, a conscientious manufacturer of food additives also may spend time worrying about whether a GM-derived additive can be marketed in Europe in the first place. At least one passage in the EU regulations suggests — without any elaboration — that food additives derived from GM sources should be reviewed and approved. The exact meaning of this will probably be clarified in the future.In the meantime, however, one might ask: Does sorbitol derived from a particular variety of GM corn need to be specifically authorized in the EU? What if the GM corn in question has been approved for human consumption in the EU? What if the GM corn has not been approved for human consumption in the EU? What is the approval mechanism for GM-derived additives? There is currently a regrettable lack of transparency and clarity in this area.Of course, the European food industry could certainly find plenty of things to complain about in the U.S. Code of Federal Regulations, probably beginning with the facility registration and recordkeeping requirements under the Bioterrorism Act. Importantly, however, our regulations are adopted in accordance with notice and comment rulemaking procedures. FDA accepts and considers comments submitted from outside the United States and publishes final rules along with lengthy preambles. We may not like the European GMO regulations, no matter how clearly they are articulated, but it would be a big help if we could understand exactly what they require.David Joy is a partner at the Washington, D.C., law firm of Keller and Heckman LLP. He specializes in food and drug law, is a member of the District of Columbia Bar and holds a bachelor’s degree in chemistry. For more information about Keller and Heckman, visit the firm’s web site at

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