Guidelines on the assessment of novel foods and processes / Advisory Committee on Novel Foods and Processes.

  • Great Britain. Advisory Committee on Novel Foods and Processes.
Date:
1991
Catalogue details

Licence: Open Government Licence

Credit: Guidelines on the assessment of novel foods and processes / Advisory Committee on Novel Foods and Processes. Source: Wellcome Collection.

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    nature of foods there is a need to balance test and control diets for both major and minor components. (b) A food, once it has been adequately tested in appropriate animal and in vitro systems, may need to undergo tolerance testing, including monitoring for possible allergenicity (see paras 5.31—5.32). 5.24 The general principles of animal husbandry to be adopted when assessing the safety of foods are set out in the DHSS ‘Guidelines for the Testing of Chemicals for Toxicity’ (HMSO, 1982). This document should also be consulted for further details of the tests discussed below. 5.25 Before starting animal studies, it is desirable to investigate the nutritional properties and the palatability of the test diet in the test animals. If a palatability problem is encountered, it may be necessary to increase the amount of food to the required level gradually. Paired-feeding techniques should be used if the problem cannot be overcome. 5.26 As foods are usually complex mixtures of chemicals, studies on the metabolic fate of every constituent of the food would be impracticable. However, if it is suspected that contaminants or minor components are a cause of toxicity, the metabolism of the suspect chemicals should be investigated. It may be relevant in some situations to investigate the digestibility of the novel food material. Also, if a novel food, or a major component of it, consists of a new chemical compound which does not normally occur in the diet (eg a novel carbohydrate), studies of the metabolic fate after ingestion of the new compound will be appropriate. 5.27 Changes in normal excretory functions caused by a food may be relevant, and analysis of urine and faeces may give important information. For example, a novel food may alter the gut flora drastically, or may encourage preferential loss of a mineral or vitamin to the detriment of the good health of the study animals. 5.28 As a novel food will usually consist mostly of compounds unlikely to produce acute toxic effects (carbohydrates, lipids and proteins), acute toxicity studies will normally be inappropriate. 5.29 In most instances where some toxicological testing of a food is necessary, this will consist, at least initially, of a 90-day repeated dose study, normally in the rat, and a battery of in vitro mutagenicity screening tests. If the extent of human exposure to the food is likely to be widespread and the intake significant, then further toxicological studies will also be required, such as tests for chronic toxicity/carcinogenicity, embryotoxicity (including teratogenicity) and effects on reproduction. Details on the performance of such studies is given in the DHSS ‘Guidelines for the Testing of Chemicals for Toxicity’ (HMSO, 1982). There are problems in the interpretation of mutagenicity tests on foods, particularly in view of the presence of numerous mutagens in naturally-occurring foodstuffs. Nevertheless, such studies may be 16