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PubMed1976

[Effects of technological additives and heating range on some chemical and physical changes in canned meat. 2. Changes in redox potentials and selected quality characteristics].

The influence of technological additives and the range of heating on the redox potential, as well as on some quality features of canned meat was examined. The experiments showed, that the time of storage and the degree of heating of model preserves of meat influence on the redox potential. The technological additions as polyphosphates, ascorbic acid, gelatine and mixtures of these substances influence less on the redox potential. The analysis of each experimental factor showed, that on the secretion of meat juice occurring during can pasteurization or sterilization influence all experimental factors, as the kind of heating, the time of storage as well as the kind and the quantity of technological additives. The highest secretion of meat juice was found in cans with addition of ascorbic acid. Cans with addition of gelatine had the smallest content of jelly and consequently the lowest secretion of meat juice. It was also found a certain relation between the level of redox potential and the tested quality features of the model meat preserves.

Ascorbic Acid↗
PubMed1985

FDA's priority-based assessment of food additives. II. General toxicity parameters.

We examine in greater depth some general toxicity parameters that have been compiled for food additives in the Priority-Based Assessment of Food Additives project. Correlations between chemical structure categories and basic parameters such as lowest effect level, highest no-effect level, and study duration indicate (among other things) trends in these parameters that are consistent in magnitude and direction with the Concern Level break points proposed in the FDA's Redbook. Certain data on the nature and extent of observed toxic effects of additives, when related to corresponding estimated levels of human intake, help to provide a profile of toxicological characteristics of a number of the regulated additives. The resulting breadth of such a profile reinforces the need for systematic priority setting in the allocation of resources to potential food additive safety concerns.

Animals↗
PubMed1986

FDA's priority-based assessment of food additives. III. Specific toxicity parameters.

In this third paper, we focus on a subset of 58 additives in the Priority-Based Assessment of Food Additives (PAFA) Project that have been associated in toxicity studies with specific toxic effects of inherently high concern. Additives producing these effects are assigned to categories based on chemical structure. A probability distribution of "R values" is calculated. We examine whether any apparent correlation exists between chemical structure category assignment and a tendency for compounds in a category to produce certain types of toxic response. Many chemical structure categories include additives having little or no toxicological data. Although this circumstance limits the scope of conclusions that may be drawn about structure-activity relationships, certain "trends" in the data appear to be worth additional future investigation.

Animals↗
PubMed1988

Monitoring adverse reactions to food additives in the U.S. Food and Drug Administration.

Technological advances in food science have resulted in the development of numerous food additives, most of which require premarket approval by the Food and Drug Administration (FDA). Concomitant with the benefits of these additives, such as extending the shelf life of certain food commodities, is the potential for various risks. These potential risks include the possibility of the consumer experiencing an adverse reaction to the additive. In order to ascertain the character and the gravity of alleged adverse reactions to food products which it regulates, the FDA's Center for Food Safety and Applied Nutrition has developed the Adverse Reaction Monitoring System (ARMS). This postmarketing surveillance system for food additives is designed to analyze consumer reports of adverse reactions in order to alert FDA officials about any potential public health hazard associated with an approved food additive, and to delineate specific syndromes which may lead to focused clinical investigations. To date, among the products routinely monitored in the ARMS, sulfiting agents and the artificial sweetener aspartame have generated the largest volume of consumer reports describing adverse reactions. An overview of the analyses of the sulfite and aspartame adverse reaction reports is presented, along with a description of the mechanics of the postmarketing surveillance system, and a detailed discussion of its limitations.

Aspartame↗
PubMed1975

[Toxicity by relay. II. A method for the asessment of safety to human consumers of carbadox, a growth-promoting additive to the feed of slaughter pigs].

A toxicity by relay. II. A method for the assessment of safety to human consumers of carbadox, a growth-promoting additive to the feed of slaughter pigs. A new methodology called "toxicity by relay" has been used to assess the potential hazard to humans of incorporating an additive into animal feeds. This methodology considers a farm-reared animal as a "relay" between the food additive and the human consumer, and employs laboratory animals as "pseudo-consumers". These laboratory animals are fed throughout their entire lives with the meat or organs of the "relay" animals which have been reared on feeds supplemented with various levels of the additive. In the present study, the toxicity of carbadox was assessed in this way. In pigs, where it is used as a growth promoter, carbadox is metabolised into serveal different products, and so an assessment of its safety using traditional methods of studying the toxicity of a substance and tis known metabolites, would perhaps be subject to error. A safety factor for man, in relation to the safety factors for rats and dogs, was calculated using (a) the comparative consumption of the laboratory animals and man; (b) an assessment of the highest dosage likely to be consumed in normal circumstances compared to the laboratory dosage, and (c) the consideration that in the laboratory there is no period of withdrawal from feeding before sacrifice as is the case with animals for slaughter. Pigs were used as "relays" in the present study by supplementing their feed with carbadox. The meat and/or livers of these animals were then fed daily to (a) rats for a period of 3 generations; (b) rats for 24-25 months, and (c) dogs for 60 months. No abnormalities were observed at the termination of the experiments. We may therefore conclude that there is no hazard for the human consumer from the use of carbadox as a pig-feed additive.

Animal Feed↗
PubMed2025

Costs and cost-effectiveness of returning secondary findings from genomic sequencing based on the return of additional findings in the 100,000 Genomes Project.

PURPOSE: To assess costs and cost-effectiveness of returning additional findings from genome sequencing using data from the 100,000 Genomes Project (100kGP). METHODS: A model-based cost-utility analysis combining yield, consent rates, and cost data from the 100kGP with published estimates of downstream costs and quality-adjusted life years expected to accrue over a lifetime, after the identification of a pathogenic variant. RESULTS: The cost of returning additional findings to participants in the 100kGP was £7.1m or £81 per participant, with a yield of 0.85% for consented participants. The estimated lifetime incremental cost per participant was £125 and quality-adjusted life years 0.004, giving an incremental cost-effectiveness ratio of £28,830. Implementing a policy of returning additional findings is unlikely to be cost-effective (ie, 13%) at a willingness-to-pay threshold of £20,000. A short-term cost of returning findings of £43 per participant or lower (compared with the base case of £81) would result in an incremental cost-effectiveness ratio of less than £20,000. Alternatively, cost-effectiveness may be improved by returning additional findings to younger patient populations. CONCLUSION: Return of additional findings following genome sequencing for this group of conditions may not be a cost-effective use of health care system resources. Our cost-effectiveness outcomes rely on published estimates and should be validated through long-term follow-up data.

Humans↗
PubMed1991

Feed additives.

Feed additives used to supplement dairy rations can increase daily feed cost from 2 to 65 per animal. The economic response (benefit to cost ratio) varies from $2.00 to $12.00 for each dollar invested in a specific additive. Knowledgeable dairy veterinarians must understand the role of each additive, when it will be beneficial, inclusion level, strategies and limitations associated with an additive, research and field recommendations, and measurable responses to monitor. Dairy additives and various methods to evaluate their role and economic response objectively are discussed.

Animal Feed↗
PubMed2005

New method of DNA isolation from two food additives suitable for authentication in polymerase chain reaction assays.

Locust bean gum and guar gum are galactomannans used as additives (E 410 and E 412, respectively) in the food industry as stabilizing agents. Analytical discrimination between the two additives in gums and foods is now feasible by molecular techniques. However, only complex and time-consuming DNA isolation protocols are available to date. We have developed simple improved protocols to obtain enough DNA suitable for PCR amplification from a few milligrams of commercial E 410 and E 412 additives (containing more than 75% polysaccharides). The suspension of additives in water or 10 mM Tris-HCl, pH 8.5, efficiently recovers DNA suitable for authentication in PCR assays. However, the Tris method was much more efficient for the extraction of DNA from E 410 than for E 412 additives. Conversely, the water method was the most suitable for detecting DNA extracted from E 412 or from E 410/E 412 mixtures. Combined with the use of the two specific ribosomal primer pairs previously designed, our methods are well-suited for a fast and simple high-throughput sample treatment of commercial gums for molecular certification.

DNA↗
PubMed2002

Urinary metabolites of histamine and leukotrienes before and after placebo-controlled challenge with ASA and food additives in chronic urticaria patients.

BACKGROUND: The recovery of mediator metabolites from urine has the potential to provide a rapid, safe, and easily available index of release of mediators. We aimed to determine urinary metabolites of both histamine and leukotrienes (LTs) in patients affected by chronic urticaria (CU). METHODS: Twenty patients with CU were studied. They were selected on the basis of double-blind placebo-controlled challenge (DBPC) with acetyl salicylic acid (ASA) and food additives. Ten patients (group B) were negative to both challenges. Ten patients (group C) presented urticaria and/or the appearance of angioedema during or 24 h after challenge, with reactions to ASA (five patients) or food additives (five patients). We recruited 15 healthy volunteers as controls (group A). During a second challenge, groups B and C were challenged double-blind with a single dose of ASA, or a specific food additive, or placebo. The healthy group was challenged only with a placebo (talc capsule). Patients in groups B and C were challenged twice: with placebo (as groups B1 and C1) and with ASA (groups B2 and C2) or food additives (C2). Four samples of urine were collected; one during the night before the specific or sham challenge (baseline), and three at 2, 6 and 24 h after the challenge. Urinary methylhistamine (N-MH) and LTE4 were analyzed and normalized for urinary creatinine. RESULTS: For urinary N-MH at baseline, there was a significant difference only between group A and groups B1, B2, C1 and C2 (A vs. B1, P < 0.0001; A vs. B2, P < 0.0001; A vs. C1, P < 0.0001; A vs. C2, P < 0.0001). We detected a significant variation in urinary methylhistamine excretion only in group C2 after 2 h, 6 h and 24 h (P < 0.0001). However, no variations were observed in N-MH excretion rate in the other groups (A, B1, C1) after challenge with placebo, and in B2 after challenge with ASA 20 mg. For urinary LTE4 at baseline no differences were found between the mean values for the different groups. After specific challenge, only C2 patients showed significantly increased excretion rates of urinary LTE4 compared with the other groups challenged with placebo (A, B1, C1), or ASA (B2) (P < 0.0001). No significant correlation was seen between urinary LTE4 and methylhistamine excretion rate in any patients. CONCLUSION: Our results show that urinary excretion of N-MH and LTE4 is different for CU patients without ASA or food hypersensitivity, compared to those with CU with ASA or food additive hypersensitivity after specific challenge.

Administration, Oral↗
PubMed2000

Clinical relevance of food additives in adult patients with atopic dermatitis.

BACKGROUND: Adverse reactions to food play an important role in the pathogenesis of atopic dermatitis (AD). In infancy and childhood, food allergies are observed in up to 30%, whereas nonallergic hypersensitivity reactions (pseudoallergic reactions) towards food additives have been reported to occur between 2 and 7%. By contrast, sensitizations towards food allergens are rarely of clinical relevance in adults and little data is available on nonallergic hypersensitivity reactions. To date the role of pseudoallergic reactions as an aggravating factor in AD of adult patients remains controversial. However, many adult patients report on food-related aggravation of the disease and nonallergic hypersensitivity reactions have been incriminated repeatedly. OBJECTIVE: To elucidate the relevance of food additives in adult patients suffering from AD. METHODS: Fifty patients were monitored over 4 weeks under regular diet followed by 6 weeks of a diet omitting known pseudoallergens. Skin status of patients was assessed every 2 weeks by a standardized scoring, and serum eosinophilic cationic protein (ECP) was determined before and after diet. RESULTS: Nine of fifty patients dropped out, 26 showed a significant improvement of the Costa-score by 57%. In 23/26 patients a corresponding reduction of serum ECP level by 52% on average was determined. Responder patients (24/26) were orally challenged with food rich in pseudoallergens followed by double-blind exposure to food additives (n = 15). A worsening of the eczema was seen in 19/24 patients after intake of pseudoallergen-rich food and in 6/15 patients after exposure to food additives. CONCLUSION: These results indicate that a subgroup of adult patients with AD clinically improve on low-pseudoallergen diet but only a small subgroup respond to oral provocation with food additives.

Adolescent↗
PubMedDate not supplied

Data-derived safety factors for the evaluation of food additives and environmental contaminants.

A safety factor of 100-fold is commonly applied to animal data to derive the acceptable daily intake (ADI) of food additives; other factors have been used in some cases and higher values are used more frequently for determining the tolerable daily intake (TDI) of environmental chemicals. The 100-fold factor is considered to represent the product of a 10-fold factor to allow for species differences between the test animal and humans and a 10-fold factor to allow for inter-individual differences. A scheme is proposed whereby data relevant to the safety assessment of a compound, e.g. species differences in toxicokinetics, can contribute quantitatively to the safety factor and therefore to the ADI or TDI. For this to be possible, it is necessary to subdivide each of the 10-fold factors into two separate factors to allow for differences in toxicokinetics and toxicodynamics. For any compound, data on one particular aspect may be used to derive a specific data-derived factor for that aspect. The overall safety factor will then be calculated as the product of the known data-derived factor(s) and default values for the remaining unknown factors. In this way the derivation of the safety factor would be clearly defined and the potential impact of additional data on other aspects identified. Additional safety factors (over and above the 100-fold or overall data-derived factor) are also proposed to allow for the nature or severity of the toxicity and the adequacy of the database. These factors are consistent with previous evaluations and will allow the logical derivation of factors greater than either 100 or the appropriate data-derived factor. These additional factors will be of greatest value in the derivation of safety factors for the calculation of the TDIs of environmental contaminants but may also be applied if necessary to the safety assessment of food additives. In such cases the rationale and logic for a safety factor in excess of 100 will be clearly defined.

Animals↗
PubMedDate not supplied

Estimation of food additive intake. Nordic approach.

Food additive intake has been estimated in Finland by means of a stepwise system using simultaneously two different methods. The first method, based on food consumption and food control analysis, can be classified into the group of Estimated Daily Intake methods (EDI). The second method, a questionnaire to food manufacturers concerning the use of food additives, has been employed five times. Estimates have been timed to reflect legislative changes and their influence on the intake. The intake of most food additives and sweeteners by Finnish diabetic adolescents was well below Acceptable Daily Intakes (ADIs). The average nitrite intake, especially by children and adolescents, was greater. Estimates of nitrite intake by children varied between 39% and 89% of ADIs depending on the method used and the new ADIs given by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Diabetic children's and the mothers' daily intake of nitrite was shown to be greater when compared with that of non-diabetics and the results of that other Finnish study gives support the evidence that dietary nitrites may be associated with the development of Type I diabetes. New estimates of additive intakes, based on a nationwide control project carried out in 1994, will be worked out. The results will reflect the situation in Finland before EU membership.

Finland↗
PubMedDate not supplied

Needs and methods for priority setting for estimating the intake of food additives.

Direct measurement of the intake of food additives is a complex, time-consuming and expensive process. Prioritization of intake surveys is important to focus initial attention on those additives of most concern. Intakes at or below the Acceptable Daily Intake (ADI) are not of concern, by definition, and therefore a high priority should be given to those additives for which simple, but conservative, theoretical estimates of potential intake indicate a probability of exceeding the ADI. Although ADI values for different additives are equivalent, because they are based on No-Observed-Adverse-Effect Levels (NOAELs), the risk associated with intakes above the ADI can only be determined by reference back to the data which are the basis for the ADI estimation. In consequence the nature and severity of toxic effects detected in animal experiments above the NOAEL should be taken into account in the prioritization of intake surveys. A scheme is proposed which incorporates both exposure estimation and toxicology in determining which food additives should be allocated a high priority for inclusion in intake surveys.

Diet Surveys↗
PubMedDate not supplied

Evaluation of the budget method for screening food additive intakes.

The Budget Method, originally developed for determining food additive use limits, has been proposed as a tool for screening food additive intakes to establish monitoring priorities. Theoretical Maximum Daily Intake (TMDI) estimates derived using the Budget Method rely on assumptions regarding physiological requirements for energy and liquid and on the energy density of food rather than on food consumption survey data. This report summarizes work performed to determine the validity of Budget Method assumptions and to assess the potential for error in assigning monitoring priority based on Budget Method results. Budget Method assumptions regarding energy and liquid intake were compared with data from UK, German and US nationwide food consumption surveys. It was found that the Budget Method assumptions of energy intake and liquid intake are higher than mean intakes reported in surveys. The Budget Method assumption regarding energy density of foods also was found to be a slight overestimate. Budget Method TMDIs for case study additives were in each case larger than survey-based 95th percentile per capita additive intake estimates. Based on these results, the Budget Method appears to be a suitably conservative screen for establishing additive monitoring priorities based on potential lifetime average intakes.

Beverages↗
PubMed1977

Physiological responses of human adults to foods containing phosphate additives.

An experiment was conducted to assess the physiological effects of a diet rich in foods cotaining phosphate additives. During a 4-week control period, eight adults were fed a balanced diet free of phosphate additives providing approximately 95 g protein 0.7 g Ca and 1.0 g P per day. During a subsequent 4-week period, food items containing phosphate additives were substituted for counterpart items devoid of added phosphates. This diet contained 0.7 g Ca and 2.1 g P per day. The introduction of foods containing phosphate additives was associated with intestinal distress, soft stools or mild diarrhea. These symptoms subsided in six subjects but occurred intermittently throughout the experimental period in the other two subjects. The high-phosphorus diet induced increases in serum phosphorus and urinary phosphorus and decreases in serum calcium and urinary calcium. Hydroxyproline excretion in the urine was increased and cyclic AMP excretion was elevated in six of the eight subjects. These changes are analogous to those seen in experimental animals fed high-phosphorus diets which were shown to be due to enhanced parathyroid activity (secondary hyperparathyroidism). The use of phosphate food additives is discussed with respect to their possible stimulating effect on adult bone resorption.

Adult↗
PubMed1980

In vitro stimulation of lymphocytes in patients with chronic urticaria induced by additives and food.

We studied the stimulation of lymphocytes in 258 patients with urticaria and/or angioedema using a series of food extracts and additives. Of this group, 238 revealed a positive response index (RI). There was a positive RI to additives in 18.4% of the cases, to food extracts in 35.2% and to both extracts and additives in 46.6% of the cases. A positive RI to both aspirin and tartrazine was revealed in 25% and to all the additives tested in 11% of the cases. Diets from which food extracts and additives were excluded achieved total remission in 159 (61.1%), partial remission in fifty-seven cases (22%) and no remission in forty-two (16.2).

Angioedema↗
PubMed1989

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↗
PubMed2005

Food-additive-induced urticaria: a survey of 838 patients with recurrent chronic idiopathic urticaria.

BACKGROUND: Recurrent chronic idiopathic urticaria (RCIU) is a common skin condition that affects 0.1-3% of the population in the USA and Europe and accounts for nearly 75% of all 'ordinary' chronic urticaria (CU) cases. METHODS: We studied 838 consecutive patients with RCIU referred to hospital between 1998 and 2003. Patients with known causes of CU were excluded. Clinical history, physical examination, and symptom diaries were evaluated during two periods, a diet-free period (1 week) and a food-additive-free diet (FAFD) period (4 weeks), respectively, and two double-blind placebo-controlled (DBPC) challenges of six food additives were administered. The first DBPC challenge included a mixture of the six food additives (DBPCmixed) given to all patients. The second DBPC challenge comprised the single food additives, administered at increasing doses (DBPCsingle) to patients with a positive DBPCmixed test and 105 patients with a negative DBPCmixed test, as a control. RESULTS: The DBPCmixed challenge was positive in 116 patients. None of the 105 control patients had a positive DBPCsingle test. Only 31 DBPCsingle tests were positive in patients with positive DBPCmixed challenge. Twenty-four of the 116 patients showing a positive DBPCmixed challenge also had a positive DBPCsingle result. CONCLUSIONS: Our results confirmed that food additive hypersensitivity reactions occurred in few RCIU patients using DBPCsingle challenge. The combination of the results of FAFD and DBPCmixed challenge seems to be of considerable practical interest for allergists, internists and dermatologists, rather than the data of clinical history and the results of DBPCsingle challenge, in patients with RCIU.

Adolescent↗