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Nutritional assessment of novel foods
200
Information Section--Fd Chem. Toxic. Vol. 32, No. 2
in vivo it induced micronuclei in the bone marrow of mice exposed by inhalation, and gave some evidence of SCE induction in the bone marrow and DNA binding in the liver. No data were available on germ cell effects, but it would be prudent to assume it had the potential for producing heritable mutations. The CoC added that it ewas carcinogenic in the rat and mouse (particularly the latter species, in which it induced tumours at multiple sites at inhaled concentrations of 20ppm or more). There was also some evidence that occupational exposure increased haematopoietic/lymphopoietic malignancies, although further data, particularly on exposure levels, were needed to support a definite causal relationship. On present evidence it should be regarded as a potent genotoxic animal carcinogen and probable human carcinogen. Acrylamide was also concluded to be an in vivo mutagen in somatic and germ cells, and a recent rat study had strengthened the evidence of carcinogenicity obtained from a previous test. No long-term mouse studies were available, but it had been shown to initiate skin and lung turnouts in mice by several routes of administration. Two negative studies of occupationally exposed humans were limited by small numbers of subjects and sparse exposure data. The CoC recommended that the level of acrylamide monomer in polyacrylamide used for drinking water treatment should be reduced to the lowest practicable level, and requested information on possible replacements of this use of polyacrylamide, the present detection level of acrylamide, the possibility of developing a more sensitive method, and whether the polymer could degrade to monomer in water. An epidemiological study of the breast cancer risk from silicone breast implants (Berkel et aL, New England Journal o f Medicine 1992, 326, 1649) pro-
NUTRITIONAL
vided qualified assurance of safety, but information from larger numbers of women with adequate followup was considered necessary before definite conclusions could be drawn. Polyurethane coated implants had been reviewed in the last report (1991 Annual Report of the Committees on Toxicity, Mutagenicity, Carcinogenicity of Chemicals in Food, Consumer Products and the Environment. Doll. HMSO, London, 1992, pp. 60. £9.50). The Committees also gave advice on a number of general topics. These included principles for setting ADIs, the genotoxicity testing of quinoione antibiotics, mutagenicity testing strategies on new substances, the classification of chemicals on the basis of mutagenic properties, the value of the mouse spot test, the testing of natural toxins, peroxisome proliferators (the subject of a symposium held in January 1992), air quality guidelines for carcinogens, and the design of carcinogenicity tests in the light of large bioassays of two nitrosamines, in the last case the CoC found no reason to alter the design of conventional studies, but suggested that studies might be extended to the natural lifespan if there was interest in the dose response of a particular tumour, or started at an earlier age than usual. The greater Government openness that publication of this report signifies is to be welcomed. It is a shame that it does not extend to listing the scientific references on which the opinions are based, details of which are only available on direct application to Doll. [1992 Annual Report of the Committees on Toxicity, Mutagenicity, Carcinogenicity of Chemicals in Food, Consumer Products and the Environment. Department of Health. HMSO, London, 1993, pp. 72. £1 i.70.]
ASSESSMENT
At the request of the Committee on Medical Aspects of Food Policy, the Panel on Novel Foods has drawn up general principles and criteria for the nutritional assessment of novel foods and processes. The Panel recommends that novel foods should be at least as safe as comparable existing foods. Potential advantages and disadvantages from their introduction should be identified, taking account of their composition, likely contribution to the diet, and preparation or cooking requirements. A history of safe use elsewhere in the world should be taken into consideration, bearing in mind the adequacy of the database. They should be considered in the context of the whole diet and the response to that diet by humans, including potentially vulnerable groups such as children and pregnant or lactating women. Foods derived from genetically modified sources should be assessed in a similar manner to those produced by conventional techniques. If limited clearance is given for use
OF NOVEL FOODS
in a specified food product or range of products, a re-evaluation is needed ifa further use is subsequently proposed. Novel foods should not increase the likelihood of disease by direct metabolic or other actions on pathophysiological processes, or by affecting relationships and interactions between nutrients, or nutrients and known toxicants, likely to be present in the diet. Specific nutritional criteria should include the dietary significance of the novel food; the nutrient content of the diet containing it, and the content of anti-nutritional constituents (such as trypsin inhibitors) that may be introduced with the novel food; the bioavailahility of nutrients in the novel food, its possible effects on other dietary components such as minerals, and implications of possible changes in the gut microflora; and its quantitative effects and/or dose-response relationships on gut and systemic functions.
Information Section--Fd Chem. Toxic. Vol. 32, No. 2 The Panel proposes new terms of reference for itself to incorporate the above principles. Its function should be to advise on the implications of novel foods and food processes for public health, taking account of their impact on the nutritional safety of the diet; on human metabolic pathways and physiological functions that may have beneficial or adverse effects on the long-term health of the population and potentially vulnerable subgroups; and on the nutritional value of the diet in relation to current dietary recommendations and national targets. The report also discusses some specific examples of nutritional issues arising from novel foods and processes that have been submitted for evaluation to the Advisory Committee on Novel Foods and Processes. In the case of fat substitutes the Panel acknowledges that they might make a valuable contribution to a lower fat diet, but feels unable to endorse their use as an effective way of achieving a lifelong reduction in risk of diseases related to dietary fat. Their effect on absorption of fat soluble vitamins and on the overall composition of the diet should also be considered. Soluble sugar beet fibre has been proposed for addition to granulated sugar, but its effect on micronu-
trient uptake and intestinal function requires eludication. The Panel also questions the appropriateness of using a vehicle such as sugar, the consumption of which COMA had advised should fall, to increase fibre consumption. Other submissions still being evaluated include interesterified fats (restructured triglycerides), with a fatty acid profile resembling that of human breast milk fat, for use in pre-term infant formulae; fructo-oligosaccharides as sugar substitutes; and caprenin (caprocaprylobehenin) for replacing cocoa butter and confectionery fats. The potential nutritional significance of genetic modification to the food supply is at present uncertain, but the Panel notes that transgenesis (the introduction of DNA from one species into the genome of another) may produce food of significantly altered composition or quality, that should be monitored from a nutritional perspective. [The Nutritional Assessment of Novel Foods and Processes. Report of the Panel on Novel Foods of the Committee on Medical Aspects of Food Policy. Department of Health Report on Health and Social Subjects 44. HMSO, London, 1993, pp. vii + 22. £4.50.1
THE ETHICS OF GENETIC The Committee on the Ethics of Genetic Modification and Food Use, established last year, has published its conclusions. The Committee sees no overriding ethical objections to the use of organisms containing copy genes of human origin as food, subject to the necessary safety assessment. However, A C N F P (Advisory Committee on Novel Foods and Processes) guidelines should be expanded to discourage the use of all ethically sensitive genes in food organisms where alternatives are available. Organisms from genetic modification programmes that can be clearly demonstrated not to have been modified should also be allowed into the food chain without restrictions, beyond those that apply to other types of animals from experimental programmes. Because some people may object on ethical grounds to the consumption of organisms containing copy genes of human origin, or from animals that are the subject of religious dietary restrictions, and certain vegetarians may dislike consuming plants containing copy genes of animal origin, the Committee considers that all such food products should be labelled to allow these groups to make an informed choice. A de minimis principle should apply in recognition of the practicalities of the situation, and derived products of specific, non-genetic nature need
MODIFICATION
not be labelled. As labelling may not provide all the information desired by consumers, industry and Government should explore the prospects for additional means of informing the public on the modifications applied to particular foods. The Committee observes that the dilution of the original host DNA during its introduction into another organism, or the use of complementary DNA (synthesized using messenger RNA as a template, which means that the original DNA is not involved in the cloning procedure) results in transgenes losing their original status, in the sense that they are manufactured in vitro rather than derived directly from a donor organism. A number of ethical objections surrounding the use of introduced genes might also be removed if the genes were entirely synthetic. It recommends that these issues should be further debated, particularly within the religious communities, to see if they might offer a way forward. [Report of the Committee on the Ethics of Genetic Modification and Food Use. M A F F . HMSO, London, 1993, pp. vi + 43. £7.95.] The Government proposes to accept these recommendations, subject only to review of labelling issues by the FAC (MAFF New Release 307/93, 20 September 1993).
PESTICIDE POISONING Pesticides were implicated in 174 of the 655 animal poisoning incidents investigated by the English, Welsh and Scottish Agriculture Departments during
201
OF ANIMALS
1992. Of the pesticide-related incidents, 146 involved vertebrates, 15 involved beneficial insects (honey- and bumble-bees) and 13 involved suspected baits and
Information Section--Fd Chem. Toxic. Vol. 32, No. 2
in vivo it induced micronuclei in the bone marrow of mice exposed by inhalation, and gave some evidence of SCE induction in the bone marrow and DNA binding in the liver. No data were available on germ cell effects, but it would be prudent to assume it had the potential for producing heritable mutations. The CoC added that it ewas carcinogenic in the rat and mouse (particularly the latter species, in which it induced tumours at multiple sites at inhaled concentrations of 20ppm or more). There was also some evidence that occupational exposure increased haematopoietic/lymphopoietic malignancies, although further data, particularly on exposure levels, were needed to support a definite causal relationship. On present evidence it should be regarded as a potent genotoxic animal carcinogen and probable human carcinogen. Acrylamide was also concluded to be an in vivo mutagen in somatic and germ cells, and a recent rat study had strengthened the evidence of carcinogenicity obtained from a previous test. No long-term mouse studies were available, but it had been shown to initiate skin and lung turnouts in mice by several routes of administration. Two negative studies of occupationally exposed humans were limited by small numbers of subjects and sparse exposure data. The CoC recommended that the level of acrylamide monomer in polyacrylamide used for drinking water treatment should be reduced to the lowest practicable level, and requested information on possible replacements of this use of polyacrylamide, the present detection level of acrylamide, the possibility of developing a more sensitive method, and whether the polymer could degrade to monomer in water. An epidemiological study of the breast cancer risk from silicone breast implants (Berkel et aL, New England Journal o f Medicine 1992, 326, 1649) pro-
NUTRITIONAL
vided qualified assurance of safety, but information from larger numbers of women with adequate followup was considered necessary before definite conclusions could be drawn. Polyurethane coated implants had been reviewed in the last report (1991 Annual Report of the Committees on Toxicity, Mutagenicity, Carcinogenicity of Chemicals in Food, Consumer Products and the Environment. Doll. HMSO, London, 1992, pp. 60. £9.50). The Committees also gave advice on a number of general topics. These included principles for setting ADIs, the genotoxicity testing of quinoione antibiotics, mutagenicity testing strategies on new substances, the classification of chemicals on the basis of mutagenic properties, the value of the mouse spot test, the testing of natural toxins, peroxisome proliferators (the subject of a symposium held in January 1992), air quality guidelines for carcinogens, and the design of carcinogenicity tests in the light of large bioassays of two nitrosamines, in the last case the CoC found no reason to alter the design of conventional studies, but suggested that studies might be extended to the natural lifespan if there was interest in the dose response of a particular tumour, or started at an earlier age than usual. The greater Government openness that publication of this report signifies is to be welcomed. It is a shame that it does not extend to listing the scientific references on which the opinions are based, details of which are only available on direct application to Doll. [1992 Annual Report of the Committees on Toxicity, Mutagenicity, Carcinogenicity of Chemicals in Food, Consumer Products and the Environment. Department of Health. HMSO, London, 1993, pp. 72. £1 i.70.]
ASSESSMENT
At the request of the Committee on Medical Aspects of Food Policy, the Panel on Novel Foods has drawn up general principles and criteria for the nutritional assessment of novel foods and processes. The Panel recommends that novel foods should be at least as safe as comparable existing foods. Potential advantages and disadvantages from their introduction should be identified, taking account of their composition, likely contribution to the diet, and preparation or cooking requirements. A history of safe use elsewhere in the world should be taken into consideration, bearing in mind the adequacy of the database. They should be considered in the context of the whole diet and the response to that diet by humans, including potentially vulnerable groups such as children and pregnant or lactating women. Foods derived from genetically modified sources should be assessed in a similar manner to those produced by conventional techniques. If limited clearance is given for use
OF NOVEL FOODS
in a specified food product or range of products, a re-evaluation is needed ifa further use is subsequently proposed. Novel foods should not increase the likelihood of disease by direct metabolic or other actions on pathophysiological processes, or by affecting relationships and interactions between nutrients, or nutrients and known toxicants, likely to be present in the diet. Specific nutritional criteria should include the dietary significance of the novel food; the nutrient content of the diet containing it, and the content of anti-nutritional constituents (such as trypsin inhibitors) that may be introduced with the novel food; the bioavailahility of nutrients in the novel food, its possible effects on other dietary components such as minerals, and implications of possible changes in the gut microflora; and its quantitative effects and/or dose-response relationships on gut and systemic functions.
Information Section--Fd Chem. Toxic. Vol. 32, No. 2 The Panel proposes new terms of reference for itself to incorporate the above principles. Its function should be to advise on the implications of novel foods and food processes for public health, taking account of their impact on the nutritional safety of the diet; on human metabolic pathways and physiological functions that may have beneficial or adverse effects on the long-term health of the population and potentially vulnerable subgroups; and on the nutritional value of the diet in relation to current dietary recommendations and national targets. The report also discusses some specific examples of nutritional issues arising from novel foods and processes that have been submitted for evaluation to the Advisory Committee on Novel Foods and Processes. In the case of fat substitutes the Panel acknowledges that they might make a valuable contribution to a lower fat diet, but feels unable to endorse their use as an effective way of achieving a lifelong reduction in risk of diseases related to dietary fat. Their effect on absorption of fat soluble vitamins and on the overall composition of the diet should also be considered. Soluble sugar beet fibre has been proposed for addition to granulated sugar, but its effect on micronu-
trient uptake and intestinal function requires eludication. The Panel also questions the appropriateness of using a vehicle such as sugar, the consumption of which COMA had advised should fall, to increase fibre consumption. Other submissions still being evaluated include interesterified fats (restructured triglycerides), with a fatty acid profile resembling that of human breast milk fat, for use in pre-term infant formulae; fructo-oligosaccharides as sugar substitutes; and caprenin (caprocaprylobehenin) for replacing cocoa butter and confectionery fats. The potential nutritional significance of genetic modification to the food supply is at present uncertain, but the Panel notes that transgenesis (the introduction of DNA from one species into the genome of another) may produce food of significantly altered composition or quality, that should be monitored from a nutritional perspective. [The Nutritional Assessment of Novel Foods and Processes. Report of the Panel on Novel Foods of the Committee on Medical Aspects of Food Policy. Department of Health Report on Health and Social Subjects 44. HMSO, London, 1993, pp. vii + 22. £4.50.1
THE ETHICS OF GENETIC The Committee on the Ethics of Genetic Modification and Food Use, established last year, has published its conclusions. The Committee sees no overriding ethical objections to the use of organisms containing copy genes of human origin as food, subject to the necessary safety assessment. However, A C N F P (Advisory Committee on Novel Foods and Processes) guidelines should be expanded to discourage the use of all ethically sensitive genes in food organisms where alternatives are available. Organisms from genetic modification programmes that can be clearly demonstrated not to have been modified should also be allowed into the food chain without restrictions, beyond those that apply to other types of animals from experimental programmes. Because some people may object on ethical grounds to the consumption of organisms containing copy genes of human origin, or from animals that are the subject of religious dietary restrictions, and certain vegetarians may dislike consuming plants containing copy genes of animal origin, the Committee considers that all such food products should be labelled to allow these groups to make an informed choice. A de minimis principle should apply in recognition of the practicalities of the situation, and derived products of specific, non-genetic nature need
MODIFICATION
not be labelled. As labelling may not provide all the information desired by consumers, industry and Government should explore the prospects for additional means of informing the public on the modifications applied to particular foods. The Committee observes that the dilution of the original host DNA during its introduction into another organism, or the use of complementary DNA (synthesized using messenger RNA as a template, which means that the original DNA is not involved in the cloning procedure) results in transgenes losing their original status, in the sense that they are manufactured in vitro rather than derived directly from a donor organism. A number of ethical objections surrounding the use of introduced genes might also be removed if the genes were entirely synthetic. It recommends that these issues should be further debated, particularly within the religious communities, to see if they might offer a way forward. [Report of the Committee on the Ethics of Genetic Modification and Food Use. M A F F . HMSO, London, 1993, pp. vi + 43. £7.95.] The Government proposes to accept these recommendations, subject only to review of labelling issues by the FAC (MAFF New Release 307/93, 20 September 1993).
PESTICIDE POISONING Pesticides were implicated in 174 of the 655 animal poisoning incidents investigated by the English, Welsh and Scottish Agriculture Departments during
201
OF ANIMALS
1992. Of the pesticide-related incidents, 146 involved vertebrates, 15 involved beneficial insects (honey- and bumble-bees) and 13 involved suspected baits and