Safety

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 containhigh 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 toxicological 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. [36] 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 grounds 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 anymore than to be able 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.