The potential to exploit fully GM technologies is severely limited by constraints on the use of the technology itself, as well as in satisfying the legislation that exists on the pre-market approval of foods that have been produced by the technology, or are in some way novel. These constraints are so severe in Europe that in very few cases will any producer see a return on their investment if nutritional improvement is their goal. This market is also affected by the widespread addition of specific nutrients as additives to certain processed foods. Enhancement of any component considered to be beneficial is likely to be of market value only if positive claims can be made. Whenever possible 'conventional' plant breeding will be used.
There has been a de facto European Union moratorium on the approval of GMO products since October 1998. Eighteen products have already been approved under the general EU Directive (90/220/CEE) whilst 14 are pending approval. Five Member States have temporarily banned already approved GM products, which is permitted under the Directive. Two new EU labelling regulations have been drafted but have not been implemented because of a lack of testing methodologies, certifying labels and inspection procedures. The ultimate intention is to ensure that products can be labelled GM free to enable consumers to make an informed choice. It has been argued that products labelled as containing products derived from GM will convey negative messages to consumers. This is likely to be so in the absence of benefits that are clearly seen by consumers. This will occur if plants are used as factories for the production of vaccines and pharmaceutical products. However, it is unclear at present where these benefits will lie in the nutritional field other than for the developing world.
The lack of public confidence in the European food safety system is already causing harm to markets in the US and in developing nations where the technology is already embraced. This is likely to lead to major problems in international trade unless it is resolved.
No scientific development in food can ignore the very strict regulatory controls that exist before any new or 'novel' product or process can be applied in its production. Food plants produced by 'conventional' plant breeding techniques in general are not subject to any regulatory controls. In some countries voluntary codes of practice have been developed within the plant breeding sector when it was discovered that varieties of potatoes with good agronomic characteristics were found to contain high levels of toxic glycoalkaloids.35
At the present time, genetically-modified (GM) foods are regulated applying the concept of 'substantial equivalence'.36 This concept is applied as the basis from which to determine the extent of the requirements for food safety assessment. If a genetically modified food can be characterised as substantially equivalent, it can be assumed to pose no new health risks over its conventional counterpart and can be marketed without the need to undertake extensive toxi-cological and nutritional studies to determine its safety-in-use.
The principle of substantial equivalence was adopted into the EU Regulation on Novel Foods and Novel Food Ingredients.37 The Regulation excludes from its controls foods and food ingredients obtained through traditional propagating or breeding practices and which have a history of safe use. GM plants are considered as 'novel' under the terms of the Regulation. However, the detailed safety evaluation provisions of the Regulation do not apply to foods produced by genetic manipulation 'if on the basis of the scientific evidence available they are substantially equivalent to existing foods with regard to their composition, nutritional value, metabolism, intended use, and the level of undesirable substances present'. The Regulation regards food as 'novel' if the characteristics of the food differ from the conventional food regarding the accepted limits of natural variation of such characteristics. It is clear that most nutritionally enhanced plants would be caught under the definition of a 'novel' food.
The principle of substantial equivalence is vague and difficult to define in many cases. Consequently the whole issue of regulation of GM foods is under intensive debate. Meanwhile the EU has applied a de facto moratorium on GM plant introductions. The US attitude to regulation has so far been to regard safety as an issue that relates to the characteristic of the food and not to the process(es) that lead to it. Novel food products, of which products produced by GM are included in the definition, are not subject to any specific approval on safety ground if the constituents of the food are the same, or substantially similar, to substances currently found in other foods.
It is clear that it is never going to be possible to argue that a GM plant is safe any more than it is possible to argue that a plant produced by conventional plant breeding is safe. The very concept can be addressed only in the context of a history of safe use as a human food. Clearly, the overwhelming evidence supports the view that health benefits arise as a consequence of the regular consumption of a variety of fruits and vegetables, few if any of which have any close compositional relationship to the wild types from which they were bred. Similarly their production, storage and distribution has depended on the use of a wide range of chemical fertilisers and pesticides. These chemicals are extensively tested for safety before approval is given for their marketing and use but this has not removed the widely held view amongst consumers that 'organic products' are better for your health. There is no evidence to support this view and any adverse health effects that there might be as a consequence of the use of pesticides appear to be outweighed by the beneficial effects from the consumption of fruit and vegetables. What determines 'safety' is the overall effect of consumption over a period, not the effects of a specific chemical that might be present.
The issue of 'safety' in the context of the ability to market foods which are 'novel' is emotionally charged and without a solid scientific base. Consequently it is unlikely that any industry would want to take on these issues unless they had a product with a potentially large market.
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