European Union Safety Legislation and Term Paper

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1). Prior to market introduction of a GMO for commercial use in any part of the EU, notification must be sent to the competent member state authority where the GMO will be released (Council Directive 90/220/EEC, art. 11 (1)). Notification must include a risk assessment with information necessary for evaluating the foreseeable risks posed by the GMO to human health or the environment, to which the competent authority will evaluate and provide written consent as a prerequisite release. In addition, a Proposal for Labeling and Packaging must accompany the notification (Council Directive 90/220/EEC, art. 11).

In cases of successful applications, the Commission adopts the measures, whereas noncomplying proposals are forwarded to the Council for decision (See Council Directive 90/220/EEC, art. 21). GMOs approved by either the Commission or Council may be used without prohibition, restriction, or impediment in any member state.

Council Regulation 258/97: Novel Foods Regulation

Aimed at providing a uniform law for new foods throughout the member states, the Novel Foods Regulation applied to foods which have not been used for human consumption to a significant degrees within the community (Commission Regulation No. 258/97 art. 1(2)). These novel foods include GMO products within the meaning of the Direct Release Directive, foods produced by though not containing GMOs, and foods with a new or intentionally modified primary molecular structure (Commission Regulation No. 258/97 art. 1). Through an approval procedure, this legislation requires the submission of a proposed label for the product, including information as to how the product's characteristics differ from existing foods (Commission Regulation No. 258/97 art. 6(1), 8(1)(a)). Scientific assessment determines the novelty of the proposed food by comparing its equivalence to existing products, calculated to ultimately disclose through labels to consumers purchasing the product as to whether GMOs are present or may be present in the food (Commission Regulation No. 258/97 art. 8(1), 8(1)(d)).

Commission Directive 97/35/EC

This Directive placed additional requirements on labeling for products containing or made from GMOs (Commission Directive 97/35). Under this legislation, a label or accompanying document must be included on products approved under Directive 90/220 indicating whether the product consists of GMOs, and the possibility that GMOs may be present within the product. Although this placed stricter labeling requirements on new GMOs, segregation of GMO and non-GMO products is not required.

Council Regulation No. 1139/1998

In an effort to encompass certain genetically modified products not affected by the Novel Foods Regulation, such as genetically modified soybeans and genetically modified maize authorized under the Deliberate Release Directive, Council Regulation 1139/1998 attempted to apply uniform labeling requirements among the member states for such products. Foods made of and produced from genetically modified soybeans and genetically modified maize constituted no exception, and thus were made subject to these labeling requirements (Council Regulation No. 1139/1998, par. 9).

Legislative Trends and the Relation to Marketing

Thus, important legislative attempts by the EU reflect the trends underlying the previously described regulations, namely the strengthening of existing regulation to stringently monitor the approval and release of GMO products and an effort to disclose to the consumers the content of foods containing such GMO products. All of this legislation has furthered the regulation of the marketing of such food products and to establish a reliable system of identification and labeling of GMOs.

The effect that the above mentioned legislation will have on the method and manner in which companies market their products in the EU is significant. Since the legislation requires that GMOs be properly labeled, companies will have to comply with the laws and label their good appropriately. However, since the majority of the EU public is against the use of GMOs, companies will ultimately face difficulties in promoting their products. Marketing efforts will have to be changed to address and focus on the safety of such products to encourage the purchase and consumption by EU consumers. This is the only way in which companies will be able to promote their products to the public, because in accordance with the labeling requirements, it will be common knowledge that a product contains a GMO.

Thus, the best strategy that companies have to take in marketing products consisting of or derived from GMOs is to stress the safety of such items. Another possible route is to focus on their marketing efforts on non-GMO products, which are preferred by EU consumers anyway. One positive factor for such companies is that the labeling requirements do not address the issues of products that were derived from animals fed with GMOs. This is a loophole in the EU legislation which favors the marketing efforts of companies because they will not be required to disclose such facts on labels containing these products. Although this will not serve the EU public very well, it is in the companies' best marketing and financial interest not to disclose what is not necessary.

As a result, such companies will not need to greatly change their marketing efforts with regard to products derived from animals fed with GMOs. In other words, what they don't know, won't hurt them. At least these companies will have one "safety net," and can leave the labeling of GMOs to what exactly is mandated under law. It is predicted, however, that soon enough the EU public will be aware of such a loophole, and demand for more legislation in this area for their protection. Or perhaps the EU public will become complacent and supportive of biotechnology and the use of GMOs in their food consumption as more scientific information and experiments become available.


As indicated above, the marketing efforts of companies in the EU are significantly impacted by the existing legislation. However, the marketing efforts, although changed, will still likely be successful. If genetically modified foods are unsuccessful in the European market, the result will no doubt be attributable to consumer activity arising out of health and scientific concerns over food safety, not discriminatory government regulation designed to interfere with market forces. The labeling of GMOs on the products is not a factor unwelcome by the EU public. Instead, it is the consumption of GMOs that is unwelcome.

Disclosure and dissimulation of information remain essential for market efficiency, and such objectives are adequately addressed and accomplished through a mandatory labeling regime of GMO foods. The further labeling of non-GMOs may also serve to enhance the marketing efforts of companies. In this manner, consumers will be given numerous options and allowed to subjectively determine the success or failure of GMO foods in the European Market, on their own. Consumers in the EU will decide whether to purchase GMO products or non-GMO products through an examination of labels, and future studies and legislative efforts in this area will greatly contribute to this knowledge. Finally, on the basis of recent research, surveys and legislation, it seems likely that consumers will continue to demand a cautious approach to the marketing of genetically enhanced products and GMOs.


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