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2 GMO Products

The following sections will present an overview of the currently approved food products which either are or have been derived from GMOs. Special focus centres on genetically engineered agricultural crops as well as the genes and regulatory elements used to generate these transgenic plants.

2.1 Regulations

Since the end of the 1980s GMO regulatory processes have been developed in the United States and Western Europe. By now many countries have introduced legislation regulating the release and approval of GMOs (OECD, 1995; Screen Newsletter, 1995). In August 1996, the first gene regulatory body in Eastern Europe was established in Bulgaria, regulating the release of genetically modified higher plants for both, research and commercial purposes. The sections below briefly summarise existing regulations and name the competent authorities for Switzerland, the European Community, Germany and the United States dealing with GMOs.

2.1.1 Switzerland

The new ordinance on food stuffs ('Lebensmittelverordnung', LMV) that became effective in Switzerland on 1 July 1995, requires that all food stuffs, food additives and processing aids consisting of or derived from GMOs have premarket approval (Article 15, LMV) and that they have to be labelled as 'GVO-Erzeugnis' (Articles 22k and 23, LMV) (Pauli and Schwab, 1996). Only those products free of the GMO itself and which were purified from the (transgenic) DNA (e.g. chemically defined substances like sugar) may be exempt from the labelling requirement. The ordinance for the authorisation procedure for GMO food stuffs ('Verordnung über das Bewilligungsverfahren für GVO-Lebensmitel, GVO-Zusatzstoffe und GVO-Verarbeitungshilfsstoffe', VBGVO) has just recently been published (19 November 1996) and was enacted on 1 December 1996.

2.1.2 The European Community

The regulatory framework with respect to GMOs in the European Community is currently based on the European Commission Directives for deliberate release (90/220/EEC) and for contained use (90/219/EEC), each of which was published in 1990 (for a review on the regulations see: Schauzu [1996; 1997]). A new regulation on novel foods and food ingredients was adopted by the Council in December 1996 and by the European Parliament in January 1997. It has been decided that the novel food regulation will become effective ninety days after its publication; i.e. by end of April, 1997.

Directive 90/220/EEC of 23 April 1990 for deliberate release regulates the release of GMOs (both for research and commercial purposes) into the environment. It was amended by directive 94/15/EC. A simplified procedure for multi-site and repeat releases has been introduced for the most common types of genetically engineered plants (decisions 93/584/EEC and 94/730/EC). Several decisions related to directive 90/220/EEC are 91/596/EEC, 92/146/EEC, 93/572/EEC and 94/211/EC. For the commercialisation of GMO products in the EC member states Denmark, the United Kingdom and the Netherlands, apart from approval according 90/220/EEC, additional approval of GMO crops according to national legislation are currently required. Such national legislation is likely to be superseded by the novel food directive when this enters into force.

The novel food regulation that has been discussed within the EC commission will probably require labelling of GMO products if they can be distinguished from respective conventional products by scientific, analytical methods. In contrast to Swiss regulations, the novel food regulations will not include enzymes, vitamins or processing aids derived by GMOs (Pauli, 1997).

In addition to the directive 90/219/EEC of 23 April 1990 and 94/51/EC of 7 November 1994, regulating the contained use of genetically modified microorganisms, further EC-regulations may be relevant: (i) directives 90/679/EEC and 93/88/EEC on the protection of workers from risks related to exposure to biological agents at work; (ii) directive 93/41/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those of biotechnology; (iii) directive 93/114/EEC on additives in feeding stuffs, including additives containing or consisting of GMOs.

The use of herbicides (including the use on herbicide-tolerant plants) is regulated by directive 91/414/EEC of 15 July 1991 and several amendments. These regulations are currently still being implemented into national legislation of EC member states (e.g. in Germany). According to directive 91/414/EEC, only those applications of the respective herbicide that have been tested and registered will be approved. Directive 70/457/EEC (including several amendments) is relevant for the registration of food crop varieties. Varieties registered in any EC member state (e.g. in Germany by the 'Biologische Bundesanstalt für Land- und Forstwirtschaft' in Braunschweig) are combined in a common EC list of varieties for agricultural crops. Seeds of any variety registered in that list may be sold in any of the member states. So far, this list has not contained any transgenic varieties (Source: Bundessortenamt, Hannover; 30th of January 1997).

2.1.3 USA

In the United States three independent authorities are involved in the regulation of the release of genetically engineered plants and their use as food stuffs. In contrast to the European authorities, who use a process-oriented approach, the responsible federal agencies in the United States prefer a product-oriented approach for the regulation of genetically engineered products. This latter system does not categorise genetically engineered products on the basis of the technique by which they were developed, but solely on the actual plant characteristics.

1. APHIS (Animal and Plant Health Inspection Service) of the USDA (US Department of Agriculture). The APHIS authorises experimental field releases by issuing 'Field Test Permits'. Since 1993 a simplified procedure has been applicable under certain conditions for the approval of releases ('Notifications'). APHIS regulations under 7 CFR Part 340 pertain to the import, interstate movement or release of certain genetically engineered plants, including the deregulation for commercial release. The list of deregulated products can be accessed on the World Wide Web site of the Biotechnology, Biologics and Environmental Protection division (BBEP) of USDA-APHIS under: http://www.aphis.usda.gov/.
2. FDA (Food and Drug Administration). The FDA has the authority under the 'Federal Food, Drug and Cosmetic Act' to ensure the safety and wholesomeness of most food stuffs (except meat and poultry, which are regulated by the USDA, and agents with pesticidal characteristics falling under the jurisdiction of EPA [see below]). Although premarket approval of a product by the FDA is not formally required, all companies that applied for a new transgenic crop so far completed their consultations with FDA prior to the market introduction of the product. The FDA's policy statement on foods developed by biotechnology (including transgenic plants) can be accessed on the World Wide Web site http://www.fda.gov. The FDA does not require labelling of food consisting of or derived by genetically engineered organisms. Special labelling would be obligatory if the composition of a food developed through genetic engineering differed significantly from its conventional counterpart (e.g. if a product contained substances that were not constituents in the human diet before, or if the product contained an allergen that the consumer would not expect in that food).
3. EPA (Environmental Protection Agency). Only some GMOs require approval by the EPA. This federal agency regulates transgenic plants that contain pesticidal components, such as genes or gene products that confer resistance against insects (e.g. -endotoxins from Bacillus thuringiensis), and thus are considered pesticides themselves. Regulation of such crops by EPA is required only when field testing becomes large scale or the determination of a tolerance level or excemption from a tolerance is required. Aspects of plant health and environmental risks of such plants are assessed by the EPA. In addition, the EPA approves changes in the registration for herbicide use on (transgenic) crops but does not assess aspects of plant health or potential environmental risks of herbicide-tolerant crops.



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