Regulatory Issues: E.U. issues new GMO regulations

Dec. 15, 2003
The new rules may represent a step forward -- and the most that any proponent of genetically modified foods can realistically hope for

Editor's Note: This article was originally published December 2003

The European Union recently issued two regulations dealing with the touchy subject of food and food ingredients derived from genetically modified sources. Both regulations have been pending for several years and have been largely opposed by the food industry in the United States.

The more substantial of the two regulations, E.U. Regulation No. 1829/2003, deals with pre-market authorization and labeling of genetically modified foods intended for humans and animals.

Regarding pre-market authorization, the new regulation consolidates and streamlines various provisions that already existed under E.U. law. Anyone wishing to market a new, genetically modified variety of corn, for example, must submit an application to one of the E.U. Member States. The application is then made available to the European Food Safety Authority (EFSA) and the other Member States. EFSA is expected to give its opinion on the application within a period of six months, after which the E.U. Commission will prepare a draft decision on the application (either consistent with EFSA's opinion or not).

The Commission is to take into consideration "the opinion of [EFSA], any relevant provision of Community law and other legitimate factors." The draft decision is then referred to the Standing Committee on the Food Chain and Animal Health, which is made up of experts from the Member States. If the Standing Committee approves the Commission's draft decision, the Commission may adopt the decision. If the Committee and the Commission disagree, the Commission may forward its draft decision to the European Parliament and the Council of Ministers for further consideration.

Importantly, this procedure involves more than a straightforward scientific evaluation of the safety of the genetically modified food. There is an opportunity for the Member States to block approvals of new genetically modified foods (as they have been doing for the past several years), and the regulation explicitly invites consideration of other legitimate factors, meaning factors other than food safety.

Even if a new genetically modified food is approved for marketing through this process, the authorization will only be good for a period of ten years. At the end of ten years, the applicant must submit an application for renewal.

Although the regulation clearly contains some elements that reflect European unease with genetically modified foods, it's important to acknowledge that this regulation may represent a step forward, and the most that any proponent of genetically modified foods can realistically hope for. Under this framework, the E.U. does have the ability to approve new genetically modified foods and do so in a way that may eventually lead to their de-stigmatization. That's the optimistic view anyway.

The regulation also deals with labeling of genetically modified foods. The new rule is fairly uncomplicated: If a food or a food ingredient is derived from a genetically modified source, that information must appear on the label. Hence, if corn oil is derived from genetically modified corn, and the corn oil is used in a processed food, the ingredient declaration on the label of the finished food must indicate the corn oil came from genetically modified corn. It no longer matters whether DNA or protein associated with the genetic modification can be detected in the corn oil or in the finished food. An "exception" is established whereby a food or food ingredient does not need to be labeled as genetically modified if it contains only a small amount, less than 0.9 percent, of a genetically modified variety, providing its presence is accidental and technically unavoidable.

This labeling exception will almost certainly be misinterpreted. It does not mean a food can contain up to 0.9 percent of a genetically modified ingredient and go unlabeled. The exemption only applies to a segregated, non-GM variety of food. If, despite the best efforts of the producer, this food is contaminated with a very small amount (less than 0.9 percent) of a genetically modified variety, the GM labeling requirement does not attach to the food or ingredients derived from it.

How will it be enforced?

You may wonder how the labeling requirement will be enforced if it applies to highly purified and processed food ingredients, such as corn oil, where it cannot be determined analytically that the ingredient was derived from a genetically modified source. This is where the other new regulation comes into play, Regulation No. 1830/2003. Essentially, the regulation requires anyone placing a genetically modified food on the market to inform the recipient of the food in writing that it was derived from a genetically modified source. Downstream recipients of the food must also be notified of its GM origin. Thus, if the first recipient of the food processes it into an ingredient and then markets that ingredient, recipients of the ingredient must also be informed in writing that it was derived from a genetically modified source. This creates a paper trail that is intended to be used for enforcement purposes.

Those who favor labeling of foods and food ingredients derived from genetically modified sources often emphasize that the consumer has every right to know what is present in his food. This is certainly a strong argument. However, those who oppose the labeling requirement will point out that in addition to being costly and impractical, special labeling unfairly stigmatizes genetically modified foods. Even if the information is presented in neutral terms, it carries a suggestion of warning that ultimately does consumers a disservice.

Opponents of GM labeling will also point out that we've been employing biotechnology to produce food since ancient times, when yeast was used to leaven bread and ferment wine. In the 19th century, we began breeding plants, including food crops, through cross-pollination. It's true that modern biotechnology allows us to take genetic material from one source and introduce it to an unrelated plant or animal species, but this is arguably just an extension of traditional methods. Historically, food labels have not given consumers information about the techniques used to develop new plant varieties, and today's genetically modified foods are more thoroughly tested for safety than foods produced in the past through random cross-breeding.

The E.U.'s new regulations side with the consumer's right to know while re-affirming that genetically modified foods must be labeled as such throughout Europe. (Europe, however, will not require foods produced with the aid of genetically modified organisms, such as wine and cheese, to be labeled as such.)

The U.S. is currently pursuing a World Trade Organization (WTO) complaint against the E. U. for its de facto refusal to authorize the marketing of new genetically modified foods over the past several years. The E.U.'s two new regulations will probably not contribute toward a resolution of the trade dispute, although they ostensibly provide a mechanism for new approvals. However the WTO dispute is resolved, it seems clear that consumer acceptance of genetically modified foods on both sides of the Atlantic is essential to their continued existence. A U.S. victory at the WTO may be a dubious achievement if it contributes to resentment rather than acceptance of these foods.

DAVID JOY is a partner at the Washington, D.C., law firm of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides, and medical devices. He 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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