Approaches adopted by regulatory authorities to the safety assessment of novel
foods and novel food ingredients universally acknowledge the methodological difficulties arising from their often complex nature and, in some cases, their high levels of dietary incorporation. These are characteristics which novel foods and ingredients share with their traditional counterparts but the latter have not usually been the subject of systematic safety assessments. The safety of traditional foods and ingredients is usually
accepted on the basis of their history of use unless there are overt indications to the contrary. The introduction of novel foods and ingredients as a result of the increasing pace of developments in science and technology and in trade has prompted regulatory authorities to adopt a proactive approach to their safety assessment. There is a general consensus that, where possible, safety assessments should use traditional foods and ingredients as reference points and that the assessment process should focus on the differences between these and the novel foods and ingredients under assessment. Such an approach is based on the concept that there may be substantial equivalence between the novel food and a traditional counterpart whose safety is accepted. It requires a systematic comparison of the information available on the novel food and its relevant traditional counterpart, and the identification of any key additional information that
may be required to permit a conclusion as to the safety of the novel food. Several schemes, usually in the form of decision trees, have been developed to assist in structuring the comparison of information and in identifying requirements for data.
The objective of the present exercise is to suggest how such additional data might be generated within the methodological constraints imposed by the nature of the food components and their intended use, and how all of the information might subsequently be integrated to provide a focussed and scientifically valid assessment of safety.
The approach outlined draws together available best practices that currently provide a high level of safety assurance in relation to the use of novel foods and ingredients. Developing technologies, for example in the fields of genomics, transcriptomics, proteomics and metabolomics, may in the future complement existing methods to provide even greater power to resolve the toxicological and nutritional characteristics of novel foods, thereby adding to the level of confidence associated with assessment of their safety.
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