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Postmarketing surveillance of food additives.

Postmarketing surveillance of consumption and of anecdotal reports of adverse health effects has been recognized by a number of regulatory authorities as a potentially useful method to provide further assurance of the safety of new food additives. Surveillance of consumption is used to estimate more reliably actual consumption levels relative to the acceptable daily intake of a food additive. Surveillance of anecdotal reports of adverse health effects is used to determine the presence of infrequent idiosyncratic responses that may not be predictable from premarket evaluations. The high-intensity sweetner, aspartame, is a food additive that has been the subject of extensive evaluation during the postmarketing period and is thus used as an example to discuss postmarketing surveillance.

Aspartame↗

[Hygienic substantiation of using new antibiotic preparations, tylosin phosphate and vitagrin as food additives].

Hygienic regulation of the use of the agents studied in animal experiments as food additives has been validated with respect to the dose level, regimen of addition and the period of waiting for slaughter. It is recommended that tylosin-phosphate should be included into the animals' ration as a food additive in a dose of 60 mg/kg for a short time (2-3 days), the period of waiting for slaughter being not less than 6-7 days. Addition of vitagrin has been recommended for young growing animals in a dose of 400-500 g/ton of feed. The dose of vitagrin should be reduced to 200-300 g/ton of feed one-two months before slaughter, with a 10-day period of waiting for slaughter.

Animal Feed↗

The results of skin testing with food additives and the effect of an elimination diet in chronic and recurrent urticaria and recurrent angioedema.

Ninety-one subjects suffering from chronic or recurrent urticaria or recurrent angioedema of 2 months to 17 yr duration were skin-prick and scratch tested with 18 various food additives. Twenty-four of the subjects (26%) had at least one histamine equivalent skin test (ST) reaction. In contrast, only 24 (10%) of 247 non-urticaria control subjects showed comparable results. An oral provocation test with food additives was carried out on 10 of the 24 ST-positive subjects with urticaria or angioedema, but only one positive reaction, caused by benzoic acid, was recorded. All 91 subjects were advised to follow an additive-free diet. The effect of the diet was investigated with a retrospective postal survey. Twenty-three ST-positive subjects returned the questionnaire, 18 had followed the diet, and 16 (89%) of these 18 had experienced marked relief of their symptoms. Correspondingly, 42 of the 47 ST-negative subjects had followed the diet, and 17 (40%) had improved. The difference was significant (P less than 0.05). Our results suggest that skin tests with food additives can be used to measure skin hyperreactivity and that they may have a predictive value in identifying patients who will respond to an additive-free diet.

Adolescent↗

Detection of urticaria with food additives intolerance by means of diet.

A diet free of salicylates, benzoates and azo dyes was applied to 158 patients with chronic urticaria. On the basis of the results of this diet, 50 persons were recognized as 'sensitive' to food additives. Psychosomatic examination of the latter patients demonstrated that they do not differ significantly from the remaining ones as regards exacerbations of skin changes by psychological stress. On the other hand, the coexistence of a frustrating situation at the beginning of appearance of skin changes is markedly less frequent in persons 'sensitive' to food additives. Patients are described in whom intolerance to food additives occurred together with hypersensitivity to drugs or some kinds of food.

Aspirin↗

Combination of antagonistic yeasts with two food additives for control of brown rot caused by Monilinia fructicola on sweet cherry fruit.

AIMS: To evaluate beneficial effect of two food additives, ammonium molybdate (NH4-Mo) and sodium bicarbonate (NaBi), on antagonistic yeasts for control of brown rot caused by Monilinia fructicola in sweet cherry fruit under various storage conditions. The mechanisms of action by which food additives enhance the efficacy of antagonistic yeasts were also evaluated. METHODS AND RESULTS: Biocontrol activity of Pichia membranefaciens and Cryptococcus laurentii against brown rot in sweet cherry fruit was improved by addition of 5 mmol l(-1) NH4-Mo or 2% NaBi when stored in air at 20 and 0 degrees C, and in controlled atmosphere (CA) storage with 10% O2 + 10% CO2 at 0 degrees C. Population dynamics of P. membranefaciens in the wounds of fruit were inhibited by NH4-Mo at 20 degrees C after 1 day of incubation and growth of C. laurentii was inhibited by NH4-Mo at 0 degrees C in CA storage after 60 days. In contrast, NaBi did not significantly influence growth of the two yeasts in fruit wounds under various storage conditions except that the growth of P. membranefaciens was stimulated after storage for 45 days at 0 degrees C in CA storage. When used alone, the two additives showed effective control of brown rot in sweet cherry fruit and the efficacy was closely correlated with the concentrations used. The result of in vitro indicated that growth of M. fructicola was significantly inhibited by NH4-Mo and NaBi. CONCLUSION: Application of additives improved biocontrol of brown rot on sweet cherry fruit under various storage conditions. It is postulated that the enhancement of disease control is directly because of the inhibitory effects of additives on pathogen growth, and indirectly because of the relatively little influence of additives on the growth of antagonistic yeasts. SIGNIFICANCE AND IMPACT OF THE STUDY: The results obtained in this study suggest that an integration of NH4-Mo or NaBi with biocontrol agents has great potential in commercial management of postharvest diseases of fruit.

Ascomycota↗

An assessment of the safety of tocopherols as food additives.

This paper is a critical review of data relevant to the safety of tocopherols as food additives. Tocopherols are considered from the standpoint of their chemical-physical properties, occurrence in nature and use in commercial products. Dietary intake and kinetic and metabolic data, as well as biological activity and interactions with other vitamins, are also examined. The subjects discussed include acute, subchronic and chronic toxicity data, reproduction and teratogenesis studies, and observations in humans following high intakes of tocopherols. On the basis of the comprehensive experimental and clinical data available on alpha-tocopherol, the chemical and biological similarity of the alpha-, beta-, gamma- and delta-tocopherols and the information available on the levels of tocopherols used as food antioxidants, it is concluded that tocopherols are safe food additives.

Animals↗

[Evaluation of a food additive prepared from blood proteins].

The authors provide the data on the biological value of food additive manufactured from the slaughtered animals' blood upon its defibrinization . The biological value was determined from the effects of proteolytic enzymes on proteins and by the microbiological rapid method with the use of ciliary infusoria as test object. The relationship was found between the biological value of the food additive and the ratio in it of fibrin and coloring enzyme.

Animals↗

Evaluation of the antioxidant properties of Mediterranean and tropical fruits compared with common food additives.

Several Mediterranean and tropical fruits have been analyzed in order to assess their antioxidant activity compared with that of common food additives (butylated hydroxyanisole [BHA], butylated hydroxytoluene [BHT] and propyl gallate). Among Mediterranean fruits, red grape and plum were more effective (P < 0.05) scavengers of peroxyl radicals than BHA, BHT, and propyl gallate. Of the tropical fruits, banana was the most effective scavenger of peroxyl radicals. Mediterranean and tropical fruits showed very good scavenger activity against hydroxy radicals (OH*), protecting deoxyribose better than BHA and BHT. The HOCI scavenging ability of Mediterranean fruits tested was, in decreasing order, lemon > plum > apricot > white grape > melon > red grape > mandarin > watermelon > peach > medlar > apple > orange > cherry > strawberry. However, the four varieties of pear were poor scavengers (P < 0.05). Among tropical fruits, the order of efficiency as HOCI scavengers was passion fruit > lime > passiflora > kumquat > avocado > pineapple > physalis > papaya fruit > carambola > mango > banana. All Mediterranean fruits showed an effect on hydrogen peroxide except peach. Tropical fruits also had a strong effect on hydrogen peroxide except avocado, which had no effect. The effect of Mediterranean and tropical fruits on the protection factor of refined olive oil, analyzed by the Rancimat method and compared with common food additives, was clear. Watermelon conferred a significantly (P < 0.05) greater protection than the other Mediterranean fruits. Among tropical fruits, physalis had the most stabilizing effect.

Antioxidants↗

Adverse reactions to food additives.

There are thousands of additives used by the food industry for a variety of purposes in the foods we eat. However, only a small number have been implicated in causing adverse reactions in humans. Although there are reported cases of individuals who have reactions to single additives, most of the medical literature involves patients with asthma or chronic idiopathic urticaria/angioedema whose conditions are exacerbated after ingestion of food additives. Many of these reports are characterized by poorly controlled challenge procedures. Recent studies performed under properly controlled conditions imply that sensitivity to food additives in patients with chronic urticaria/angioedema is very uncommon.

Food Additives↗

Survey of residual solvents in natural food additives by standard addition head-space GC.

Residual levels of 12 solvents in 87 natural food additives (66 samples of food colours, 19 samples of natural antioxidants and two natural preservatives) collected between 1997 and 1999 were determined by automated head-space GC using FID, with a porous-polymer (PLOT) column. Calibration curves were prepared by the method of standard addition. Confirmation was by manually injected head-space GC using mass spectrometric detection. 1,2-Dichloroethane was found in turmeric colour (natural food colour) collected in 1997 at the concentrations of 8.6 microg g(-1), but was not found in samples collected in 1998 and 1999. Hexane was found in three samples of dunaliella carotene (11, 72 and 75 microg g(-1)), and in chlorophyll at 93 microg g(-1) (both natural food colours). Acetone was found in turmeric colour, annatto colour, dunaliella carotene, kaoliang colour, cacao colour at a concentration between 8.7 and 42 microg g(-1) (all natural food colours).

Antioxidants↗

[Hygienic aspects of the use of food additives].

The state of usage of food supplements was studies in Kiev and some Ukrainian regions. Remains of widely using food supplements were determined. The attempt to determine food supplements load on the person. The results of investigation have shown a possibility of food supplements consumption in amounts bordering upon permissible daily level or exceeding them.

Child↗

Efficacy of leukotriene receptor antagonist in chronic urticaria. A double-blind, placebo-controlled comparison of treatment with montelukast and cetirizine in patients with chronic urticaria with intolerance to food additive and/or acetylsalicylic acid.

BACKGROUND: The cause and pathogenesis of chronic urticaria are still poorly understood. IgE-independent reactions, are common in adult patients with chronic urticaria, who have daily spontaneous occurrence of weals. H(1)-receptor antagonists (antihistamines) are the major class of therapeutic agents used in the management of urticaria and angioedema. Nevertheless, chronic urticaria is often difficult to treat and may not be controlled by antihistamines alone. It has been postulated that mediators other than histamine, such as kinins, prostaglandin and leukotrienes, may be responsible for some of the symptoms in urticaria which are not controlled by antihistamines. In this study, which was randomized double-blind, placebo-controlled, we compare the clinical efficacy and safety of montelukast (MT) 10 mg given once a day and cetirizine (CET) 10 mg given once a day with placebo (PLA), in the treatment of patients with chronic urticaria who have positive challenge to acetylsalicylic acid (ASA) and/or food additives. PATIENTS AND METHODS: A group of 51 patients, ranging in age from 15 to 71 years, with chronic urticaria and positive challenge to food additives and/or ASA, participated in this study for a period of 4 weeks, starting from a 3-day run-in. The assessment of the efficacy was based on scores of daily urticaria symptoms. RESULTS: MT significantly increased the percentage of symptom-free days for hive and itch. Analysis of frequency distribution of urticaria scores for each symptom gave similar results (MT vs. CET and MT vs. PLA, P < 0.001). The interference with sleep due to their skin condition was also lower in the group treated with MT (P < 0.001). In addition, the median number of days without the rescue medication was significantly higher in the MT group (24 days) than both the CET and the PLA groups (18 days, P < 0.001, and 20 days, P < 0.001, respectively). Finally, a low incidence of adverse events was observed in this study. CONCLUSION: The results of this comparative study demonstrate that montelukast orally administered once a day is very effective for the treatment of cutaneous symptoms in patients with chronic urticaria due to food additives and/or ASA.

Acetates↗

Food additives intolerance: does it present as perennial rhinitis?

PURPOSE OF REVIEW: A case report published in 2001 raised the possibility that some patients with long-lasting 'nonallergic' perennial rhinitis might in effect have food additives intolerance. The recent literature published in English was reviewed to find controlled studies able to confirm this observation. RECENT FINDINGS: Two double-blind, placebo-controlled studies published between August 2002 and July 2003 confirmed the above observation. The prevalence of additives intolerance among individuals with 'nonallergic' perennial rhinitis is about 5%. The pathogenic mechanisms involved remain unclear. SUMMARY: Intolerance to food additives may sometimes present as perennial rhinitis. Clinicians should consider this possibility before they definitively dismiss patients as 'nonallergic'.

Clinical Trials as Topic↗

Influence of surface-active food additives on the integrity and permeability of rat intestinal mucosa.

The influence of two surface-active food additives on the integrity and permeability of rat ileal mucosa has been studied. We determined the activity of N-acetyl-beta-glucosaminidase, a lysosomal enzyme, in the rat intestinal lumen after deposition of polyoxyethylene (20) sorbitan monostearate (polysorbate 60; Tween 60) or polyoxyethylene (20) sorbitan monooleate (polysorbate 80; Tween 80) in a section of ligated, cannulated gut. We also determined the activities of N-acetyl-beta-glucosaminidase, alkaline phosphatase, 5'-nucleotidase and phospholipase A2 in mixtures of isolated mucosal cells and polysorbate 60 or polysorbate 80. The activity of N-acetyl-beta-glucosaminidase was increased in the luminal contents of the cannulated gut 15 min after deposition of either polysorbate 60 or polysorbate 80 (10 mg/ml fluid instilled into gut). It was also increased in mixtures of mucosal cells and polysorbate 60 or polysorbate 80 (0.1-10 mg/ml). In contrast, the activities of alkaline phosphatase and 5'-nucleotidase were unaffected and that of phospholipase A2 was decreased by the presence of either polysorbate. These findings indicated that polysorbate 60 and polysorbate 80 released lysosomal enzymes from the intestinal mucosal cells and that these agents might damage the intestinal mucosa and increase its permeability. We therefore determined the intestinal permeability to sodium fluorescein in the absence and presence of polysorbate 60 or 80 and found that the permeability was slightly increased in the presence of either of the compounds at concentrations of 10 mg/ml fluid instilled into gut. It is possible therefore that surface-active food additives might impair the function of the mucosal barrier and increase the permeability of the gut to potentially toxic and pathogenic molecules.

5'-Nucleotidase↗

Spectrophotometric determination of saponin in Yucca extract used as food additive.

A spectrophotometric method was developed for the determination of saponin in Yucca extract or its preparation for food additive use. A saponin fraction of Yucca extract was prepared by column chromatography with porous polymer, and hydrolyzed with a 2 mol/L mixture of hydrochloric acid-ethanol (1 + 1) to generate sapogenin. Sapogenin amounts were determined by measuring absorbance at 430 nm, based on the color reactions with anisaldehyde, sulfuric acid, and ethyl acetate. Recoveries from Yucca extracts were 91.5-95.1%, and the detection limit was 10 microg/kg. Commercial Yucca extracts for food additive use were composed of 5.6-6.4% (w/w) saponin, making it a minor component.

Food Additives↗

Attenuation of blood parameters in smokers and non-smokers after intake of a complex food additive.

This report describes an intervention study with healthy volunteers (20 smokers, 28 non-smokers) taking a food additive mainly containing vitamin C (ascorbic acid), vitamin E (alpha-tocopherol), ubiquinone (Q10), vitamin A and zinkoxide for four weeks in a double blind, randomized and placebo controlled manner. Before and after the intervention blood was withdrawn and general blood parameters were analyzed. In addition, lipid soluble antioxidants were analyzed in blood plasma by HPLC and the water soluble antioxidative properties were tested with the enzymic xanthin/xanthinoxidase-reaction. In summary the results show that the smoker-verum group exhibit a significant down regulation of the leukocyte counts. The test for antioxidants show the following significant differences after intervention: Smokers exhibit an increase of both vitamin E and coenzyme Q10 and an attenuation of their (before intervention) clearly increased water soluble-antioxidative potential, non-smokers showed only an increase of vitamin E and trends of an increase of Q10 and water soluble-antioxidative potential. These results may contribute to the discussion of the intrinsic deficiency brought about by smoking and the possible attenuation of part of these deficiency by increasing the intake of certain vitamins or food additives.

Ascorbic Acid↗