- Email: [email protected]
Control of novel, including genetically engineered, foods in the United Kingdom
Comment
member nations are to successfully communicate that its adopted food standards are scientifically based and its analyses technologically sound, participation must be broadened to a wider spectrum - including nay-sayers. As the clock ticks its way through the last decade towards the next lOO-year cycle, a revolution in technological advances can be envisaged. During the 1890s the wind down of the 19th century, the world experienced a scientific revolution, for it was during that decade that modern physics was born by the discovery of the X-ray. Four new chemical elements (helium, xenon, krypton and neon) and the electron were discovered. The approach of the year 2000 represents yet another time of scientific and technological discovery. In keeping with the Codex mission to provide for safe and wholesome foodstuffs to the world’s citizens through international trade, all of us involved in food and agriculture must be ready to accept the challenge of the exciting technological advances occurring due to the expansion of biotechnology and computer based diagnostic tools. I commend the CAC for its com-
mitment to continue the work begun a little over a quarter of a century ago. The Commission’s gallant efforts to harmonize and coordinate acceptance of international food standards, to protect consumers and to ensure fair food trade practices internationally, created the climate for developed and developing countries to come together and minimize technical barriers to trade through the control of chemicals in food. The Commission must remain vigilant and diligent in its efforts to realize this mission. The future holds great opportunity to assure the safety and wholesomeness of the world’s food supply through scientific and technological breakthroughs and I know that the CAC stand ready to accept tomorrow’s challenges.
References Daughaday, M.D. and Barbano, D.M. (1990)
Bovine somatotrophin supplementation of dairy cows - is the milk safe? 1. Am. Med. Assoc. 264, 1003-1005 Grnasman, C.J. (1990) Genetic engineering and the use of bovine somatotrophin. 1. Am. Med. Assoc. Justevkh,
J.J.
264
and Guycr,
Bovine growth hormone: safety evaluation. Science
C.G.
human
(1990) food
Control of novel, including genetically engineered, foods in the United Kingdom Professor Moseley outlines procedures the UK
for control in
Novel and genetically engineered foods are becoming increasingly common as new methodr of food processing and biotechnology develop. It was agreed in 1980 that manufacturers should notify the Ministry of Agriculture, Fisheries and Food before marketing a novel food, and as a result of this agreement several committees have been formed to assess the safety and advise on the labelling of novel foods.
As the result of an understanding reached with the Ministry of Agriculture, Fisheries and Food (MAFF) in 1980, the Food and Drink Industries Council recommended that members of its associations should notify MAFF before marketing a novel food, so that the Professor B.E.B. Moseley is Head of Laboratory at the AFRC Institute of Food Research, Reading Laboratory, Shinfield, Reading RG2 9AT, UK 0956-7135/91/040199-03 0
1991
nutritional and safety aspects of the food could be evaluated, in strict confidence, by independent experts. Subsequently the Advisory Committee on Irradiated and Novel Foods (ACINF) was set up in 1982 with a remit to advise Ministers both on the irradiation of food and on foods produced from novel processes. Most of its work is related to the evaluation of food irradiation and a report was issued on this topic in 1986 (ACINF, 1986).
Butterworth-HeinemannLtd
The main conclusion of this report was that ionizing radiation up to an average dose of lOkGy, correctly applied, provides an efficacious food preservation treatment which will not lead to a significant change in the natural radioactivity of the food or prejudice its safety and wholesomeness. ACINF, in addition to giving advice on certain food projects submitted by the food industry, also issued a memorandum which included guidelines for the testing of novel foods (ACINF, 1984). Following completion of the review of food irradiation by ACINF, and bearing in mind the recent food advances in significant biotechnology and, in particular, techniques for genetic modification, Ministers reconstituted the Committee as the Advisory Committee on Novel Foods and Processes (ACNFP) in 1988. The Committee’s new name better reflects its work, which includes the assessment of the safety of foods which are themselves genetically modified organisms, or which are produced in processes involving such organisms, although the Committee continues to advise as necessary on food irradiation and the safety of novel foods which are not the result of genetic modification. The membership of the Committee was increased to strengthen its expertise in biotechnology and genetic modification, while retaining its expertise in the more traditional areas of microbiological safety, nutrition, chemical toxicology and biophysics and radiobiology. In addition to giving advice to Ministers on submissions on individual novel foods and processes, the work of the ACNFP includes giving guidance to the food industry on the sort of information it would wish to see in any such submission. To fulfil this aspect of its work, the ACNFP has updated and revised the guidelines issued by ACINF in 1984 to take account of the wider range of novel food products now being submitted for assessment and the newer techniques of genetic modification (Department of Health, 1991). The working definition of novelty with respect to foods and processes is as follows: ‘Novel foods are foods or food ingredients which have not Food Control - October 1991
199
Comment
hitherto been used for human consumption to a significant degree in the United Kingdom and/ or which have been produced by extensively modified or entirely new food production processes.’ ‘A novel process is a process which has not hitherto been used in the processing of foods.’
Under current UK food law, companies must be satisfied of the safety of their products and should themselves evaluate whether foods or processes should be referred to the Committee for consideration. To provide guidance for those producing such foods or wishing to market them, the Committee has derived a decision tree scheme which, by answering a series of questions, will indicate the kind of information likely to be required in individual cases (Figure I). Working through the decision tree scheme will result in a novel food or process falling into one of 18 categories (A to R). Each of these categories has an information requirement which may vary from one item of information for category A to 11 items for categories Q and R. The information requirements in the scheme are shown in Table I. The Committee would then, in the light of the information provided, consider the safety of the novel food or process and inform the appropriate Ministers accordingly. It is the Minister’s prerogative, on the basis of the advice given by the ACNFP, to advise companies of his decision and all clearances are announced by press release. The ACNFP has now issued two annual reports covering its activities from its first meeting in October 1988 to the end of 1990 (ACNFP, 1989, 1990). In the 1989 annual report it was recorded that recommendations had been made to Ministers on the safety of genetically modified bakers yeast and on fructose syrup containing dextrans. The Committee’s advice on the safety of chymosin from a genetically modified source micro-organism was referred to the Food Advisory Committee (FAC) and its views on a particular novel fat replacer to the Committee on Medical Aspects of Food Policy. The Committee also 200
Novel food or pmcess
Naturally
occurring strain?
I
I Contains genetic material?
E
Uncooked seeds or live onanisms?
Uncooked seeds or live omanisms? Uncooked seedsw
i Figure 1 decision tree for assessing a novel food or process and the information required for the evaluation of its safety. Reproduced from Report on Health and Social Subjects No. 38 (Department of Health, 1991) with the permission of the Controller of her Majesty’s Stationery Office
commented on a Code of Practice for Taste Panels evaluating the acceptability of beers produced using genetically modified yeasts, and reviewed yet again the evidence on the suggestion that the consump-
tion of freshly irradiated wheat causes polyploidy in humans. It concluded that the overwhelming balance of evidence was in favour of the wheat not causing genetic damage. Food Control - October 199 7
Comment
Table 1 Information 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
requirements
for use in association with the decision tree
Instructions for use Evidence of previous human exposure Intake or extent of use Technical details of processing and product specification Nutritional studies History of organism Characterization of derived strain Toxicological assessment Human studies Assessment of a genetic modification procedure Effect of a genetic modification procedure on the known properties of the parent organism Genetic stability of a modified organism Site of expression of any novel genetic material Transfer of the novel genetic material Assessment of a modified organism for survivability, colonization, and replication or amplification in the human gut
The 1990 annual report recorded that other topics on which the Committee had completed its consideration included a second chymosin enzyme from a genetically modified source micro-organism for use in cheese manufacture; passion fruit seed oil for use in speciality foods; trehalose, a disaccharide of glucose, for use in dehydrated foods; syrups, powders and fibres from the enzyme hydrolysis of whole grain; taste trials for genetically modified tomatoes; the safety of consuming irradiated food shortly after treatment and the separate, but related, topic of the safety of using high energy X-ray surveillance equipment to examine consignments of food. Topics still under consideration are transgenic animals, ohmic heating, quinoa, honey containing polgenetically modified len from plants, and lupins. The Committee is of the view that the advice it gives and the reasoning behind that advice should be available to the general public. Thus, in addition to the publication of the annual reports, Agendas of the Committee are published in advance of meetings and copies of the Committee’s reports to Ministers are made available on request.
Food Control - October 199 1
Additionally the Committee is instituting a procedure for the deposition of data from toxicological and other safety evaluation studies considered in support of an application with the British Library. The ACNFP is, of course, only one of a number of independent Committees advising the UK Government on food or biotechnology matters. Some issues require consideration by more than one of these Committees and frequently the ACNFP refers to other Committees for input into particular cases. For example, the Committee on Toxicology provides expert advice on toxicological issues; the Advisory Committees on Genetic Modifications and Releases to the Environment advise on safety at work and environmental protection, respectively, with respect to genetically modified organisms. The FAC is responsible for advice on the labelling, composition and chemical safety of food, including food additives. It is in this context that the ACNFP passed on its recommendation on the safety of chymosin to the FAC and why the recently produced latter has ‘Guidelines for the Labelling of Foods Produced using Genetic Modification’ (Department of
Health, 1991; Appendix C). The FAC has designated four basic food categories as a primary screening mechanism to determine when specific food labelling is required. For ‘nature identical food products of genetically modified organisms (GMOs)’ and ‘food from intra-species GMOs’, special labelling would not be required, although each case is considered on its merits. However, for ‘novel food products of GMOs’ and ‘food from special GMOs’, trans-species labelling would probably be required with the statement ‘(contains) products of gene technology’ as part of the label. The clearance scheme for novel foods operates at present under voluntary arrangements, but the Food Safety Bill, which became law in 1991, contains provisions to put the voluntary scheme on a statutory basis. In addition, the European Commission is making proposals to regulate novel foods on a Community basis in the near future.
References Committee on Irradiated and Novel Foods (ACINF) (1986) Report on the Safety and Wholesomeness of Irradiated Food HMSO, London
Advisory
Advisory Committee on Irradiated and Novel Foods (ACINF) (1984) Memorandum on the Testing of Novel Foods Incorporating Guidelines for Testing Ministry of Agriculture, London
Fisheries and Food (MAFF),
Department of Health (1991) Guidelines on the Assessmenr of Novel Foods and Processes. Report on Health and Social Subjects No 38 HMSO, London Advisory Committee on Novel Foods and Processes (ACNFP) (1989) Annual Report 1989, Department of Health and Ministry of Agriculture, Food (MAFF), London
Fisheries
and
Advisory Committee on Novel Foods and Processes (ACNFP) (1989) Annual Report 1990, Department of Health and Ministry of Agriculture, Food (MAFF), London
Fisheries
and
201
member nations are to successfully communicate that its adopted food standards are scientifically based and its analyses technologically sound, participation must be broadened to a wider spectrum - including nay-sayers. As the clock ticks its way through the last decade towards the next lOO-year cycle, a revolution in technological advances can be envisaged. During the 1890s the wind down of the 19th century, the world experienced a scientific revolution, for it was during that decade that modern physics was born by the discovery of the X-ray. Four new chemical elements (helium, xenon, krypton and neon) and the electron were discovered. The approach of the year 2000 represents yet another time of scientific and technological discovery. In keeping with the Codex mission to provide for safe and wholesome foodstuffs to the world’s citizens through international trade, all of us involved in food and agriculture must be ready to accept the challenge of the exciting technological advances occurring due to the expansion of biotechnology and computer based diagnostic tools. I commend the CAC for its com-
mitment to continue the work begun a little over a quarter of a century ago. The Commission’s gallant efforts to harmonize and coordinate acceptance of international food standards, to protect consumers and to ensure fair food trade practices internationally, created the climate for developed and developing countries to come together and minimize technical barriers to trade through the control of chemicals in food. The Commission must remain vigilant and diligent in its efforts to realize this mission. The future holds great opportunity to assure the safety and wholesomeness of the world’s food supply through scientific and technological breakthroughs and I know that the CAC stand ready to accept tomorrow’s challenges.
References Daughaday, M.D. and Barbano, D.M. (1990)
Bovine somatotrophin supplementation of dairy cows - is the milk safe? 1. Am. Med. Assoc. 264, 1003-1005 Grnasman, C.J. (1990) Genetic engineering and the use of bovine somatotrophin. 1. Am. Med. Assoc. Justevkh,
J.J.
264
and Guycr,
Bovine growth hormone: safety evaluation. Science
C.G.
human
(1990) food
Control of novel, including genetically engineered, foods in the United Kingdom Professor Moseley outlines procedures the UK
for control in
Novel and genetically engineered foods are becoming increasingly common as new methodr of food processing and biotechnology develop. It was agreed in 1980 that manufacturers should notify the Ministry of Agriculture, Fisheries and Food before marketing a novel food, and as a result of this agreement several committees have been formed to assess the safety and advise on the labelling of novel foods.
As the result of an understanding reached with the Ministry of Agriculture, Fisheries and Food (MAFF) in 1980, the Food and Drink Industries Council recommended that members of its associations should notify MAFF before marketing a novel food, so that the Professor B.E.B. Moseley is Head of Laboratory at the AFRC Institute of Food Research, Reading Laboratory, Shinfield, Reading RG2 9AT, UK 0956-7135/91/040199-03 0
1991
nutritional and safety aspects of the food could be evaluated, in strict confidence, by independent experts. Subsequently the Advisory Committee on Irradiated and Novel Foods (ACINF) was set up in 1982 with a remit to advise Ministers both on the irradiation of food and on foods produced from novel processes. Most of its work is related to the evaluation of food irradiation and a report was issued on this topic in 1986 (ACINF, 1986).
Butterworth-HeinemannLtd
The main conclusion of this report was that ionizing radiation up to an average dose of lOkGy, correctly applied, provides an efficacious food preservation treatment which will not lead to a significant change in the natural radioactivity of the food or prejudice its safety and wholesomeness. ACINF, in addition to giving advice on certain food projects submitted by the food industry, also issued a memorandum which included guidelines for the testing of novel foods (ACINF, 1984). Following completion of the review of food irradiation by ACINF, and bearing in mind the recent food advances in significant biotechnology and, in particular, techniques for genetic modification, Ministers reconstituted the Committee as the Advisory Committee on Novel Foods and Processes (ACNFP) in 1988. The Committee’s new name better reflects its work, which includes the assessment of the safety of foods which are themselves genetically modified organisms, or which are produced in processes involving such organisms, although the Committee continues to advise as necessary on food irradiation and the safety of novel foods which are not the result of genetic modification. The membership of the Committee was increased to strengthen its expertise in biotechnology and genetic modification, while retaining its expertise in the more traditional areas of microbiological safety, nutrition, chemical toxicology and biophysics and radiobiology. In addition to giving advice to Ministers on submissions on individual novel foods and processes, the work of the ACNFP includes giving guidance to the food industry on the sort of information it would wish to see in any such submission. To fulfil this aspect of its work, the ACNFP has updated and revised the guidelines issued by ACINF in 1984 to take account of the wider range of novel food products now being submitted for assessment and the newer techniques of genetic modification (Department of Health, 1991). The working definition of novelty with respect to foods and processes is as follows: ‘Novel foods are foods or food ingredients which have not Food Control - October 1991
199
Comment
hitherto been used for human consumption to a significant degree in the United Kingdom and/ or which have been produced by extensively modified or entirely new food production processes.’ ‘A novel process is a process which has not hitherto been used in the processing of foods.’
Under current UK food law, companies must be satisfied of the safety of their products and should themselves evaluate whether foods or processes should be referred to the Committee for consideration. To provide guidance for those producing such foods or wishing to market them, the Committee has derived a decision tree scheme which, by answering a series of questions, will indicate the kind of information likely to be required in individual cases (Figure I). Working through the decision tree scheme will result in a novel food or process falling into one of 18 categories (A to R). Each of these categories has an information requirement which may vary from one item of information for category A to 11 items for categories Q and R. The information requirements in the scheme are shown in Table I. The Committee would then, in the light of the information provided, consider the safety of the novel food or process and inform the appropriate Ministers accordingly. It is the Minister’s prerogative, on the basis of the advice given by the ACNFP, to advise companies of his decision and all clearances are announced by press release. The ACNFP has now issued two annual reports covering its activities from its first meeting in October 1988 to the end of 1990 (ACNFP, 1989, 1990). In the 1989 annual report it was recorded that recommendations had been made to Ministers on the safety of genetically modified bakers yeast and on fructose syrup containing dextrans. The Committee’s advice on the safety of chymosin from a genetically modified source micro-organism was referred to the Food Advisory Committee (FAC) and its views on a particular novel fat replacer to the Committee on Medical Aspects of Food Policy. The Committee also 200
Novel food or pmcess
Naturally
occurring strain?
I
I Contains genetic material?
E
Uncooked seeds or live onanisms?
Uncooked seeds or live omanisms? Uncooked seedsw
i Figure 1 decision tree for assessing a novel food or process and the information required for the evaluation of its safety. Reproduced from Report on Health and Social Subjects No. 38 (Department of Health, 1991) with the permission of the Controller of her Majesty’s Stationery Office
commented on a Code of Practice for Taste Panels evaluating the acceptability of beers produced using genetically modified yeasts, and reviewed yet again the evidence on the suggestion that the consump-
tion of freshly irradiated wheat causes polyploidy in humans. It concluded that the overwhelming balance of evidence was in favour of the wheat not causing genetic damage. Food Control - October 199 7
Comment
Table 1 Information 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
requirements
for use in association with the decision tree
Instructions for use Evidence of previous human exposure Intake or extent of use Technical details of processing and product specification Nutritional studies History of organism Characterization of derived strain Toxicological assessment Human studies Assessment of a genetic modification procedure Effect of a genetic modification procedure on the known properties of the parent organism Genetic stability of a modified organism Site of expression of any novel genetic material Transfer of the novel genetic material Assessment of a modified organism for survivability, colonization, and replication or amplification in the human gut
The 1990 annual report recorded that other topics on which the Committee had completed its consideration included a second chymosin enzyme from a genetically modified source micro-organism for use in cheese manufacture; passion fruit seed oil for use in speciality foods; trehalose, a disaccharide of glucose, for use in dehydrated foods; syrups, powders and fibres from the enzyme hydrolysis of whole grain; taste trials for genetically modified tomatoes; the safety of consuming irradiated food shortly after treatment and the separate, but related, topic of the safety of using high energy X-ray surveillance equipment to examine consignments of food. Topics still under consideration are transgenic animals, ohmic heating, quinoa, honey containing polgenetically modified len from plants, and lupins. The Committee is of the view that the advice it gives and the reasoning behind that advice should be available to the general public. Thus, in addition to the publication of the annual reports, Agendas of the Committee are published in advance of meetings and copies of the Committee’s reports to Ministers are made available on request.
Food Control - October 199 1
Additionally the Committee is instituting a procedure for the deposition of data from toxicological and other safety evaluation studies considered in support of an application with the British Library. The ACNFP is, of course, only one of a number of independent Committees advising the UK Government on food or biotechnology matters. Some issues require consideration by more than one of these Committees and frequently the ACNFP refers to other Committees for input into particular cases. For example, the Committee on Toxicology provides expert advice on toxicological issues; the Advisory Committees on Genetic Modifications and Releases to the Environment advise on safety at work and environmental protection, respectively, with respect to genetically modified organisms. The FAC is responsible for advice on the labelling, composition and chemical safety of food, including food additives. It is in this context that the ACNFP passed on its recommendation on the safety of chymosin to the FAC and why the recently produced latter has ‘Guidelines for the Labelling of Foods Produced using Genetic Modification’ (Department of
Health, 1991; Appendix C). The FAC has designated four basic food categories as a primary screening mechanism to determine when specific food labelling is required. For ‘nature identical food products of genetically modified organisms (GMOs)’ and ‘food from intra-species GMOs’, special labelling would not be required, although each case is considered on its merits. However, for ‘novel food products of GMOs’ and ‘food from special GMOs’, trans-species labelling would probably be required with the statement ‘(contains) products of gene technology’ as part of the label. The clearance scheme for novel foods operates at present under voluntary arrangements, but the Food Safety Bill, which became law in 1991, contains provisions to put the voluntary scheme on a statutory basis. In addition, the European Commission is making proposals to regulate novel foods on a Community basis in the near future.
References Committee on Irradiated and Novel Foods (ACINF) (1986) Report on the Safety and Wholesomeness of Irradiated Food HMSO, London
Advisory
Advisory Committee on Irradiated and Novel Foods (ACINF) (1984) Memorandum on the Testing of Novel Foods Incorporating Guidelines for Testing Ministry of Agriculture, London
Fisheries and Food (MAFF),
Department of Health (1991) Guidelines on the Assessmenr of Novel Foods and Processes. Report on Health and Social Subjects No 38 HMSO, London Advisory Committee on Novel Foods and Processes (ACNFP) (1989) Annual Report 1989, Department of Health and Ministry of Agriculture, Food (MAFF), London
Fisheries
and
Advisory Committee on Novel Foods and Processes (ACNFP) (1989) Annual Report 1990, Department of Health and Ministry of Agriculture, Food (MAFF), London
Fisheries
and
201