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Salmonella Co-ordinating Unit

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have not shown any evidence of carcinogenicity. Reproduc- tive (rat), teratogenic (mouse, rat and rabbit) and mutagenic (rat) studies have revealed no evidence of embryotoxic, tera- togenic or mutagemc effects of Aspartame. L-aspartic acid, when administered at high dose levels to newborn rodents, has been shown to produce lesions in the hypothalamic region of the brain. Hypothalamic lesions also have been observed in neonatal rodents when Aspartame was administered at dose levels equal to or exceeding I gram! kilogram body weight. However, when infant mon- keys were given 2 gram! kilogram Aspartame, hypothalamic morphology remained normal at both the microscopic and ultra structural level. Thus, in contrast to the newborn rodent, the infant primate is able to cope either metaboli- cally or at the level of the blood-brain barrier with excessive amino acid loads. The morphologic and anatomic character- istics of the monkey brain resemble those of the human to a much greater extent than does the brain of rodents; thus, the finding in rodents of hypothalamic lesions with high doses of Aspartame is considered to be of limited toxicological significance. Clinical tolerance studies in normal, obese, diabetic and phenylketonuric heterozygous adult humans showed no untoward effects associated with the consumption of Aspar- tame. Persons with phenylketonuria, an inborn error in metabolism, must restrict their intake of L-phenylalanine from common foods, as well as from Aspartame. Based on the "no adverse effect level" of 4 grams! kilo- gram body weight! day from long-term animal studies and using the lOO-fold safety factor for transposing the results obtained in animals to man, an acceptable daily intake for Aspartame for man of 40 milligrams! kilogram body weight per day has been estimated. Based on estimated average levels of consumption of Aspartame this acceptable daily intake will permit all of the requested uses for which the Branch has been petitioned. Labelling The following labelling proposals for foods containing Aspartame have been designed to provide consumers with the nt:cessary information to enable them to make use of this new substance in an informed manner. It is proposed that the label of any tabletop sweetener containing Aspartame shall carry the following information: 1. an indication of the sweetness of a serving expressed in terms of the amount of sugar producing an equivalent degree of sweetness; 2. the quantity of protein, fat, carbohydrate and Aspartame expressed in grams per 100 grams or per 100 millilitres and per specified serving and the energy expressed in either calories or kilojoules or both per 100 grams or per 100 millilitres and per specified serving. Labels of individual serving-size packages would be required to carry the above information on a per serving basis only. It is also proposed that the Food and Drug Regulations be amended to permit tabletop sweeteners to carry a com- parative statement of the energy value of a specified serving and of a serving of sugar or equivalent sweetening power. In the case of a food sweetened with Aspartame, other than a tabletop sweetener, it is proposed that the label carry the following information: the quantity of protein, fat, car- bohydrate and Aspartame expressed in grams per 100 grams or per 100 millilitres and per specified serving and the energy value expressed in calories or kilojoules or both per 100 grams or 100 millilitres and per specified serving. Foods intended for special dietary use in which Aspar- tame is used must meet the requirements of Division 24 of the Food and Drug Regulations. No claims respecting a Can. Insl. Food Sci. Technol.1. Vol. 13, No. 4, October 1980 reduction in the carbohydrate and sugar content will be permitted for foods containing Aspartame which do not meet the requirements of Division 24. This will not preclude claims to the effect that the food has been sweetened with Aspartame either alone or with other sweeteners provided all sweeteners are named. Because it is recognized that persons with phenylketonu- ria must restrict their intake of the amino acid phenylala- nine, a suitable indication that Aspartame contains phenyl- alanine is considered to be necessary. It is proposed that the label of any food which contains Aspartame must carry on its principal display panel the statement "contains aspartic acid and phenylalanine" in letters at least the same size as those used for the net quantity declaration. Post-Market Surveillance Aspartame has the potential for extensive and escalating use in foods, beverages and as a tabletop sweetener. Esti- mates of potential intake indicate that if all refined sugar in the diet were replaced with Aspartame the acceptable daily intake would not be exceeded by the average consumer. Nevertheless, based on experience with other additives, including saccharin, the Branch is concerned that a certain proportion of consumers may exceed the acceptable daily intake. Detailed information on the use of Aspartame by popUlation sub-groups would be of considerable value in monitoring its safety under practical conditions of use. Thus, it is proposed that the use pattern and intake of Aspartame by high users be monitored by industries using this sweetener with a view to establishing levels of consump- tion of Aspartame from all sources. These post-market sur- veillance studies would be designed to provide data, satisfac- tory to the Branch, regarding the distribution of Aspartame intake, including mean and upper percentiles for high users. It also is proposed that these studies cover a long enough period of time to provide longitudinal data on consumption. A period of five years is suggested, provided that during that time use patterns and levels of consumption do not continue to escalate. It is further proposed that the user industries work cooperatively with the Branch to ensure that the design of these studies will meet stated objectives. The industry is requested to provide detailed comments on post-market surveillance of Aspartame in reply to this letter. In addressing this issue, industry may wish to take cog- nizance of the fact that the Branch is considering the advisa- bility of surveillance studies on certain other classes of chem- icals used in food production and processing. Conclusion It is the intention of the Health Protection Branch to recommend to the Minister of National Health and Welfare that the requested uses of Aspartame be approved, provided labelling and post-market surveillance requirements are met. Comments are invited from interested parties on the foregoing presentation within ninety days of the date of this letter. Comments should be addressed to: Advisor, Legisla- tive Policy (Food), Food Directorate, Room 200, Health Protection Branch Building, Department of National Health and Welfare, Tunney's Pasture, Ottawa, Ontario KlA OL2. Le Sous-ministre adjoint A.B. Morrison, Ph.D. Assistant Deputy Minister SALMONELLA CO-ORDINATING UNIT Agriculture Canada's Salmonella Co-ordinating Unit is drawing up a plan of action to reduce the incidence of salmonella contamination in Canadian poultry and meats. Institute Affairs/ A59
Transcript

have not shown any evidence of carcinogenicity. Reproduc­tive (rat), teratogenic (mouse, rat and rabbit) and mutagenic (rat) studies have revealed no evidence of embryotoxic, tera­togenic or mutagemc effects of Aspartame.

L-aspartic acid, when administered at high dose levels to newborn rodents, has been shown to produce lesions in the hypothalamic region of the brain. Hypothalamic lesions also have been observed in neonatal rodents when Aspartame was administered at dose levels equal to or exceeding I gram! kilogram body weight. However, when infant mon­keys were given 2 gram! kilogram Aspartame, hypothalamic morphology remained normal at both the microscopic and ultra structural level. Thus, in contrast to the newborn rodent, the infant primate is able to cope either metaboli­cally or at the level of the blood-brain barrier with excessive amino acid loads. The morphologic and anatomic character­istics of the monkey brain resemble those of the human to a much greater extent than does the brain of rodents; thus, the finding in rodents of hypothalamic lesions with high doses of Aspartame is considered to be of limited toxicological significance.

Clinical tolerance studies in normal, obese, diabetic and phenylketonuric heterozygous adult humans showed no untoward effects associated with the consumption of Aspar­tame. Persons with phenylketonuria, an inborn error in metabolism, must restrict their intake of L-phenylalanine from common foods, as well as from Aspartame.

Based on the "no adverse effect level" of 4 grams! kilo­gram body weight! day from long-term animal studies and using the lOO-fold safety factor for transposing the results obtained in animals to man, an acceptable daily intake for Aspartame for man of 40 milligrams! kilogram body weight per day has been estimated. Based on estimated average levels of consumption of Aspartame this acceptable daily intake will permit all of the requested uses for which the Branch has been petitioned.

Labelling The following labelling proposals for foods containing

Aspartame have been designed to provide consumers with the nt:cessary information to enable them to make use of this new substance in an informed manner.

It is proposed that the label of any tabletop sweetener containing Aspartame shall carry the following information: 1. an indication of the sweetness of a serving expressed in

terms of the amount of sugar producing an equivalent degree of sweetness;

2. the quantity of protein, fat, carbohydrate and Aspartame expressed in grams per 100 grams or per 100 millilitres and per specified serving and the energy expressed in either calories or kilojoules or both per 100 grams or per 100 millilitres and per specified serving. Labels of individual serving-size packages would be

required to carry the above information on a per serving basis only.

It is also proposed that the Food and Drug Regulations be amended to permit tabletop sweeteners to carry a com­parative statement of the energy value of a specified serving and of a serving of sugar or equivalent sweetening power.

In the case of a food sweetened with Aspartame, other than a tabletop sweetener, it is proposed that the label carry the following information: the quantity of protein, fat, car­bohydrate and Aspartame expressed in grams per 100 grams or per 100 millilitres and per specified serving and the energy value expressed in calories or kilojoules or both per 100 grams or 100 millilitres and per specified serving.

Foods intended for special dietary use in which Aspar­tame is used must meet the requirements of Division 24 of the Food and Drug Regulations. No claims respecting a

Can. Insl. Food Sci. Technol.1. Vol. 13, No. 4, October 1980

reduction in the carbohydrate and sugar content will be permitted for foods containing Aspartame which do not meet the requirements of Division 24. This will not preclude claims to the effect that the food has been sweetened with Aspartame either alone or with other sweeteners provided all sweeteners are named.

Because it is recognized that persons with phenylketonu­ria must restrict their intake of the amino acid phenylala­nine, a suitable indication that Aspartame contains phenyl­alanine is considered to be necessary. It is proposed that the label of any food which contains Aspartame must carry on its principal display panel the statement "contains aspartic acid and phenylalanine" in letters at least the same size as those used for the net quantity declaration.

Post-Market Surveillance Aspartame has the potential for extensive and escalating

use in foods, beverages and as a tabletop sweetener. Esti­mates of potential intake indicate that if all refined sugar in the diet were replaced with Aspartame the acceptable daily intake would not be exceeded by the average consumer. Nevertheless, based on experience with other additives, including saccharin, the Branch is concerned that a certain proportion of consumers may exceed the acceptable daily intake. Detailed information on the use of Aspartame by popUlation sub-groups would be of considerable value in monitoring its safety under practical conditions of use. Thus, it is proposed that the use pattern and intake of Aspartame by high users be monitored by industries using this sweetener with a view to establishing levels of consump­tion of Aspartame from all sources. These post-market sur­veillance studies would be designed to provide data, satisfac­tory to the Branch, regarding the distribution of Aspartame intake, including mean and upper percentiles for high users. It also is proposed that these studies cover a long enough period of time to provide longitudinal data on consumption. A period of five years is suggested, provided that during that time use patterns and levels of consumption do not continue to escalate. It is further proposed that the user industries work cooperatively with the Branch to ensure that the design of these studies will meet stated objectives. The industry is requested to provide detailed comments on post-market surveillance of Aspartame in reply to this letter.

In addressing this issue, industry may wish to take cog­nizance of the fact that the Branch is considering the advisa­bility of surveillance studies on certain other classes of chem­icals used in food production and processing.

Conclusion It is the intention of the Health Protection Branch to

recommend to the Minister of National Health and Welfare that the requested uses of Aspartame be approved, provided labelling and post-market surveillance requirements are met. Comments are invited from interested parties on the foregoing presentation within ninety days of the date of this letter. Comments should be addressed to: Advisor, Legisla­tive Policy (Food), Food Directorate, Room 200, Health Protection Branch Building, Department of National Health and Welfare, Tunney's Pasture, Ottawa, Ontario KlA OL2.

Le Sous-ministre adjoint A.B. Morrison, Ph.D.

Assistant Deputy Minister

SALMONELLA CO-ORDINATING UNIT Agriculture Canada's Salmonella Co-ordinating Unit is

drawing up a plan of action to reduce the incidence of salmonella contamination in Canadian poultry and meats.

Institute Affairs/ A59

Since the Vnit's formation in February 1980, the co­ordinators, Dr. J.R. Pettit and A.H. Bentley, have begun cross-country consultations with representatives of the poul­try industry, provincial and regional veterinarians and the regional directors of the Food Production and Inspection Branch.

On the basis of these discussions, recommendations will be made and pilot projects planned to test practical ways to reduce the numbers of salmonella bacteria now present in poultry products.

The first phase of the Salmonella Co-ordinating Vnit's work will continue until September of this year. If Agricul­ture Canada's Senior Management Committee accepts the V nit's report, the testing and analysis of the recommenda­tions will begin.

If test results are favorable, the cost of implementing the recommendations throughout Canada will be calculated. Assuming that costs are reasonable and that benefits out­weigh costs, implementation in the poultry industry would begin in early 1982.

The Salmonella Co-ordinating V nit is seeking volunteer organizations to participate in pilot projects to test recommendations.

If any organization is interested in working with the Salmonella Co-ordinating Vnit, or wants further informa­tion, the co-ordinators can be contacted by writing: The Salmonella Co-ordinating Vnit, Room 589, Sir John Carling Building, Ottawa, Ontario K I A OC5, or telephone (613) 995-5880.

HIGH FRUCTOSE CORN SYRUP FACILITY Canada's first high fructose corn syrup plant, in produc­

tion since the late summer of 1979, is expanding its basic production capacity by 25%.

Corn, the raw material from which High Fructose is made, has a history of price stability compared to sugar, and is an important Canadian agricultural product. The High Fructose Syrup produced will replace an equivalent amount of cane sugar made from imported raw material.

The Industrial Division of Canada Starch is marketing the product under the trade name INVER TOSE and by offering significant savings compared to sucrose it has been well accepted by the Canadian food and beverage industries.

Starch conversion is a multi-enzyme process reflecting the latest technology of the corn refining industry. The basic process modifies pure dextrose syrup converted from corn starch to a syrup containing a high percentage of fructose. The resulting syrup is essentially as sweet as sucrose and can be used as a partial or total replacement for cane or beet sugar in a wide range offood applications. Finished product quality, taste, eye appeal and other vital properties can be maintained at less cost with this sweet corn-derived syrup. Some of these applications are carbonated and non­carbonated beverages, baked goods, jams and jellies, pre­serves, condiments, pickles, ketchup, canned fruits and juices, wines, table syrup and frozen desserts.

The Canada Starch Company has been a major producer of products derived from corn since its establishment in 1858. Capacity has expanded steadily during the company's history reflecting the firms' dedication to meeting an increas­ing demand for corn-derived products in both the food and non-food manufacturing industries.

NEW BOOKS Editorial Note: All too often there is a long delay between the arrival of a new book and its review. In order to close the gap, this column will feature books related to Food Science and Technology which will be reviewed at a later date.

F.R.V.

A60/ Affaires de l'Institut

Food Processing Waste Management Green and Kramer AVI Publishing Company, Inc. (1980) $39.00.

Food Industry Energy Alternatives Ouellette, Lord and Cheremisinoff Food and Nutrition Press (1980) 135 pp. $22.00.

Rice: Production & Utilization Luh A VI Publishing Company, Inc. (1980) $39.00.

Standardization of Analytical Methodology for Feeds Pigden, Balch and Graham International Development Research Centre (1980) 128 pp. $ 10.00.

Food and Health: Science and Technology Birch and Parker Applied Science Publishers Ltd. (1980) 532 pp. $80.00 V.S.

Linking Research to Crop Production Staples and Kuhr Plenum Publishing Corporation (1980) 235 pp. $29.50.

Methods for Analysis of Musts and Wines Amerine and Ough John Wiley and Sons, Inc. (1980) 341 pp. $30.00.

Enzymes: The Interface Between Technology and Economics

Danehy and Wolnak Marcel Dekker, Inc. (1980) 204 pp. $25.00.

Nutritional and Safety Aspects of Food Processing Tannenbaum Marcel Dekker, Inc. (1979) 448 pp. $45.00.

Human Physical Growth and Maturation. Methodologies and Factors

J ohnston, Roche and Susanne Plenum Publishing Corporation (1980) 364 pp. $42.50 V.S.

Developments in Food Colours - 1 Walford Applied Science Publishers Ltd. (1980) 259 pp. $45.00 V.S.

Vitamin E. A Comprehensive Treatise Machlin Marcel Dekker, Inc. (1980) 660 pp. $79.50.

Fibrous Proteins: Scientific, Industrial and Medical Aspects. Volume 1

Parry and Creamer Academic Press Inc. (1979) 508 pp. $46.00.

Residue Reviews. Volume 73 Gunther and Gunther Springer-Verlag New York Inc. (1980) 130 pp. $21.80.

Human Nutrition. A Comprehensive Treatise. 3A - Nutrition and the Adult Macronutrients

Roslyn B. Alfin-Slater and David Kritchevsky Plenum Publishing Corporation (1980) 290 pp. $25.00 V.S.

1. Inst. Can. Set Technol. Aliment. Vcl. 13, r\o. 4, Octobre 1980


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