European Union safety legislation

European Union Safety Legislation and Its Effect on Marketing

In the past few years, it has become notable to citizens, policy makers and government officials that safety legislation enacted in the European Union (EU) has significantly impacted the manner and method in which companies market their products.

One of the most dramatically affected products involves the use of genetically modified organisms (GMOs). A genetically modified organism is a man-made organism created in a laboratory through the process of genetic engineering. Since many unanswered questions exist regarding the safety and ethical issues surrounding GMOs, the European Parliament has adopted the world's harshest rules on the labeling of GMOs, despite intensified pressure from the United States (Greenpeace, 2003). The legislation currently in place in the EU demands that all food and animal feed containing GMOs must be clearly labeled. This labeling requirement has different implications for the method and manner in which companies market their products in the EU. This paper will discuss how safety legislation and specific cases regarding GMOs has affected marketing in the EU.

There exist arguments in both in favor and against biotechnology and the use and production of GMOs. Supporters of GMOs and biotechnology assert several benefits arising from their use serving both environmental and economical means. Proponents base their arguments on the efficiency and productivity inherent in the transfer of favorable characteristics into new plants (Horsch, 1999). Through higher food production per acre of farmland, proponents believe GMOs will enable farmers to feed a growing population while the reducing the space farmlands occupy on scarce land (Horsch, 1999). In addition to environmental and economic benefits, GMOs are believed to offer varying health benefits through enriched food profiles and improved pharmaceutical development. Certain GMOs contain vaccines for diseases, enhanced vitamins and minerals, and less fatty acids (York, 2001).

On the other hand, opponents cite several threats associated with GMOs that merit further scientific investigation, such as the potential transfer of genes through a natural process of hybridization from pesticide- resistant crops to other wild or semi-domesticate relatives, spurring the creation of uncontrollable superweeds (Alteri, 1999). In addition, opponents attempt to undermine the benefit of pesticide reduction, citing the potential for insect pests to develop immunities to crops with engineered toxins (Alteri, 1999). Evidence supporting such an argument arises from laboratory and field tests where insects targeted by the toxins of Bt corn developed a resistance (Alteri, 1999). Further concerns exist over threats posed to beneficial insects, as well as the potential harm in human consumption, specifically relating to allergenic reactions and long-term toxic effects (Ferber, 1999). Opponents additionally argue that all technology is unnatural and unacceptable, while others express concerns over the inclusion of animal genes in GMOs, leading to disparities in moral and religious beliefs (Vogt & Parish, 1999).

The EU public has been massively opposed to genetically engineered food, since the first shipment of genetically enhanced soya arrived in Europe in 1996 (Greenpeace, 2003). An examination of the research indicates that European consumers are consistently rejecting genetically enhanced food. The EU maintains a comprehensive regulatory framework designed to ensure the protection of human health and the subsistence of a single European market for biotechnological products (Greenpeace, 2003). Through an evolving approach reflecting the diversity of political views and historical attitudes towards food alteration technology, the EU provides for a dual approach to biotech regulation, namely pre-marketing safety assessments. Previously, under the EU labeling rules, thousands of products, such as oil, starch, and animal feed, did not have to be labeled. Under the current legislation, such products do need to be labeled, although EU consumers will not be aware of whether meat or dairy products have come from animals fed with GMOs (Greenpeace, 2003).

Greenpeace's EU Advisor on genetic engineering has noted many concerns the EU public has regarding genetic contamination and the marketing and labeling of foods. According to Greenpeace, if nothing is done to protect conventional and organic crops from genetic contamination, the new labeling system will actually be at risk of becoming useless after a few years because it will be increasingly hard to secure GMO-free supplies (Greenpeace, 2003). Consumer antipathy towards GMOs remains entrenched in the EU, and a recent Greenpeace survey among food companies showed that 170 out of 216 companies asked for produce without any genetically enhanced ingredients (Greenpeace, 2003). The survey revealed that only 18 companies do not want to exclude genetically enhanced food, thus necessitating a higher standard for companies in their marketing of such food.

Furthermore, vigorous and effective public awareness campaigns have been conducted by non-governmental organizations in Europe (Brough, 2000).

Legislative History

The legislative background surrounding GMOs has stirred controversy between the EU and other countries such as the United States, which support and greatly advocates biotechnology and the use of GMOs. As stated by Justice Holmes in the historic dissenting opinion of Northern Securities Co. v. U.S., "these immediate interests exercise a kind of hydraulic pressure which makes what previously was clear seem doubtful, and before which eve well settled principles of law will bend (193 U.S. 197, 1904)." Historically, EU policy-makers have been faced with the challenge of developing and applying GMO legislation in light of continuing scientific uncertainty over potential adverse effects of GMOs on the environment and human health. This challenge has been accompanied by the simultaneous need to address international trade obligations, concerns over competitiveness of the European biotechnology industry, and growing public concern over potential risks posed by genetically enhanced crops and foods.

In the 1990's the EU Industry Ministers called for changes to European rules regulating the use and release of genetically modified organisms. For the biotechnology industry in Europe, product approval processes were one of the main causes of concern. As a result, product legislation in the EU increased, including issues such as the regulation of the contained use of GMOs, the authorization of deliberate releases of GMOs into the environment via field- testing and commercial growing, the authorization for market inclusion of GMOs and GMO products, and the labeling of GMOs and GMO products (Mackenzie & Franceson, 2000).

The regulation of GMOs in the EU differs from that in the United States. Under the authority of the Federal Food, Drug, and Cosmetic Act (FFDCA), the FDA maintains the responsibility to ensure the safety of most foods, including GMOs and GMFs (21 U.S.C. 301-395 (1994). The FDA regulates GMOs in the same way as traditional food products derived from normal breeding techniques. Although new additives in foods must be demonstrated safe before marketing, companies producing foods through biotech means need not obtain FDA approval to introduce such foods to the U.S. market, as U.S. And FDA policy recognize that such foods are like conventional foods and generally safe. While companies are given the option to consult with the FDA prior to marketing, companies customarily request such pre-marketing consultations. In the event the product raises health concerns during these consultations, the FFDCA empowers the FDA to require a pre-market review. In essence, the U.S. system places the burden on the producer to assure food safety (Francer, 2001).

As a result of the differences between the legislation in the EU and that of the United States, it is likely that many international legal cases will result. Currently litigation exists between the EU and U.S. which is being arbitrated by the World Trade Organization. Before the WTO, the European Commission has argued in the context of food safety measures that the precautionary principle is "a general customary rule of international law, or at least a general principle of law, the essence of which is that it applies not only in the management of risk, but also in the assessment thereof (Report of the Appellate Body, 1998)." The U.S. belief is that agricultural products enhanced through biotechnology do not significantly differ from their traditional counterparts, no general requirement exists for the labeling of agricultural products derived from or containing GMOs. In the U.S., though some circumstances may call for labeling, such as when the genetically modified food differs considerably from its conventional counterpart, labeling would likely be required to warn consumers of potential these potential threats.

However, the labeling of genetically modified foods may be an unconstitutional violation of free speech in the U.S., as demonstrated in a 1994 Vermont case challenging a law requiring the labeling of milk and milk products derived from cattle treated with recombinant bovine somatotropin.

In International Dairy Foods ass'n v. Amestoy, the court held that the labeling statute would probably be held unconstitutional given the state of Vermont's failure to show cognizable harm and that the First Amendment protects the rights of companies not to speak (898 F.Supp. 246 (D. Vt. 1995)). This ideology is not illustrated in any EU litigated court cases.

Council Directive 90/220/EEC: Deliberate Release Directive

Establishing the centerpiece of EU GMO legislation, the Deliberate Release Directive established a mandatory pre-market approval for GMOs (Council Directive 90/220/EEC, art. 1). The Directive sought to protect the health, safety, and environment and to approximate the laws of the EU member states regarding GMOs intended for environmental release (Council Directive 90/220/EEC, art. 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.