Food additive emulsifiers: a review of their role in foods, legislation and classifications, presence in food supply, dietary exposure, and safety assessment.

Recommended Dietary Allowances (RDAs) are allocated to each food article as published in the Denmark Budget Methods in the Codex Alimentalius of the WHO/FAO Joint Committee when standards of pollutants in food are needed. When daily intakes of Food Additives and Contaminants need to be calculated, the Theoretical Maximum Daily Intake. (TMDI) and the Estimated Maximum Daily Intake (EMDI) have been generally used. TMDI and EMDI are calculated using the formulae shown below: [formula: see text] i: food article (i = 1, ....., n) A: standard value for food additives and contaminants X: mean weight of food article consumed daily l: rate of residue after cooking Exposure assessment should be more exact in order to meet social health needs and to help avoid unnecessarily strict regulations. The U. S. Food and Drug Administration (FDA) is continually improving its estimates of the dietary intakes of pesticides and essential minerals, and comparing these intakes with established safe or recommended dietary intake levels. Dietary survey methods have also improved in parallel, with examples being the USDA's Household Food Consumption Survey (1955 and 1965) and National Health and Nutrition Examination Survey II (1976-1980). In Japan, TMDI and EMDI have received more attention as methods of estimating the daily intakes of food additives and contaminants than has the Total Diet Study, even though the former are not as exact as the latter. The Japanese National Nutrition Survey is one of the most respected nutrition surveys in the world, because it has continued nationwide yearly since 1946. Nevertheless, it is very unfortunate that no one utilizes the Household Food Consumption Survey data for the estimation of intakes of food additives and contaminants, because that is not the primary purpose of the Japanese National Nutrition Survey. Practically, there are neither foods which have an uniform of food additives and contaminants nor individuals who consume uniform amounts of each food item. In this report the authors propose a revised estimation method for the daily intake of food contaminants and additives, based on food consumption data of 159 female volunteers, without using the National Nutrition Survey data. The results obtained are as follows: 1) This method succeeded in making clear the intakes of food additives and contaminants. Mean, maximum and minimum values and distribution curves for the target population were obtained. 2) The suggested name for this method is "Estimated Ecological Daily Intake (EEDI)", which is processed in terms of the food consumption structure for calculation, and methodologically estimated by food ecology.

ABSTRACTFood additives such as antioxidants and color fixatives are substances used in food intentionally for technical effect, such as decolorizing or intensifying the color of food. Based on the necessity of re-evaluating food additives for safety and to improve consumer perception, we conducted safety assessments for food additives according to the Risk Assessment Guidelines of the Korean Ministry of Food and Drug Safety. These safety assessments evaluated new risk information based on toxicology data and estimates of dietary intake exposures to food additives in comparison with the acceptable daily intake (ADI). Estimated daily intakes (EDI) of food additives were calculated using food consumption data for the Korean population derived from the Korea National Health and Nutrition Examination Survey and monitoring data based on the analysis of food additives in food products. Unlike contaminants, antioxidants and color fixatives are purposely added as food additives, and they are largely consumed in processed foods. Therefore, EDI was compared with ADI to investigate the likelihood of potentially hazardous effects in humans. The risk likelihoods of food additives, evaluated by comparing the EDI with the ADI, were less than 2% in the total population. Thus, exposure levels to antioxidants and color fixatives do not exceed the ADI. Based on the safety assessments conducted in this study, we estimate exposure to food additives to be within safe limits for all population groups.

Food additives have been used throughout history to perform specific functions in foods. A comprehensive framework of legislation is in place within Europe to control the use of additives in the food supply and ensure they pose no risk to human health. Further to this, exposure assessments are regularly carried out to monitor population intakes and verify that intakes are not above acceptable levels (acceptable daily intakes). Young children may have a higher dietary exposure to chemicals than adults due to a combination of rapid growth rates and distinct food intake patterns. For this reason, exposure assessments are particularly important in this age group. The paper will review the use of additives and exposure assessment methods and examine factors that affect dietary exposure by young children. One of the most widely investigated unfavourable health effects associated with food additive intake in preschool-aged children are suggested adverse behavioural effects. Research that has examined this relationship has reported a variety of responses, with many noting an increase in hyperactivity as reported by parents but not when assessed using objective examiners. This review has examined the experimental approaches used in such studies and suggests that efforts are needed to standardise objective methods of measuring behaviour in preschool children. Further to this, a more holistic approach to examining food additive intakes by preschool children is advisable, where overall exposure is considered rather than focusing solely on behavioural effects and possibly examining intakes of food additives other than food colours.

BackgroundEmerging evidence showed that consumption of food additives, artificial sweeteners, contribute to gut dysbiosis and increase offspring’s harmful gut. Yet, there is limiting epidemiological studies focusing on the impact of...

The data currently available in the European Union in terms of food consumption and of food chemical and nutrient concentration data present many hnitations when used for estimating intake. The most refined techniques currently available were used within the European Union FP5 Monte Carlo project to estimate, as accurately as possible, the intake of food additives, pesticide residues and nutrients. Databases of ‘true’ intakes of food additives (based on brand level food consumption records and additive concentration data), pesticide residues (based on duplicate diet studies) and nutrients (based on biomarker studies) have thus been generated. These kind of estimates are rarely repeatable because the databases generated and used to calculate them require an extraordinary expenditure of time and resources. The databases created served the purpose of estimating as accurately as possible ‘true’ chemical intakes for assessing the validity of additive, nutrient and pesticide probabilistic models.

BackgroundEpidemiological evidence suggests health risks arise from intake of food additives. This study aims to investigate the mechanisms linking food additives to childhood asthma through a metabolomics strategy.MethodsA total of 120 children with asthma and 120 control subjects were recruited. Serum concentrations of ten food additives - including cyclamate, neotame, aspartame, sodium saccharin, acesulfame, sucralose, benzoic acid, dehydroacetic acid, sunset yellow, and ponceau 4R - were quantified using UPLC-MS/MS. The associations between food additives and asthma were evaluated by logistic regression and chi-square tests. Serum metabolic profiling was performed by UPLC-MS. Identified asthma-associated metabolites were subsequently analyzed for pathway enrichment and mediation effects. In murine studies, acesulfame, sodium saccharin, sodium benzoate, or their mixtures were co-administered with OVA to C57BL/6 mice. Airway inflammation, IgE, IL-4, IL-17A, immune cell differentiation, and CD4+ T cell metabolomics profiles were assessed.ResultsThe detection rates for dehydroacetic acid, benzoic acid and sodium cyclamate exceeded 60%. Benzoic acid, dehydroacetic acid and acesulfame were significantly associated with asthma. Mediation analysis identified fourteen metabolites as mediators in the relationship between benzoic acid and dehydroacetic acid, and childhood asthma, including PC(14:0/14:0), LysoPC(17:0), glycerophosphocholine, PC(18:1(9Z)e/2:0), PE(18:2(9Z,12Z)/14:0), glutamic acid, glutamine, GlcCer(d18:1/16:0), sphingosine, sphingosine-1-phosphate, spermine, spermidine, histidine, and acetylcholine. These metabolites were enriched in glycerophospholipid metabolism, β-alanine metabolism, glutathione metabolism, sphingolipid metabolism, arginine and proline metabolism, arginine biosynthesis, and histidine metabolism pathways. In murine models, food additives significantly exacerbated lung tissue inflammation and elevated levels of IgE, IL-4, and IL-17A in both BALF and serum, and also increased eosinophil percentages in BALF. Furthermore, flow cytometry showed significant alterations in Th1/Th2, Th17/Treg and allergic DC/tolerogenic DC balance within the mesenteric lymph node (MLN) and the lung tissue. Metabolomic profiling of CD4+ T-cells from the MLN demonstrated that food additives primarily disrupted phenylalanine, tyrosine, and tryptophan biosynthesis, and glycerophospholipid metabolism pathways. This disruption involved key metabolites including PC(36:4), platelet-activating factor, LysoPE(P-16:0), PS(14:0/5-iso PGF2VI), PE(14:1(9Z)/15:0), Na,Na-dimethylhistamine, docosadienoic acid, cyclohexaneundecanoic acid, L-acetylcarnitine, phosphorycholine, Cer(d18:2/20:0), DG(22:1n9/0:0/20:4n6), 5’-methylthioadenosine, L-tyrosine, and N-palmitoyl leucine.ConclusionFood additives may aggravate asthma by metabolically dysregulating the homeostasis of helper T-cells and antigen-presenting cells, thereby disrupting immune tolerance.

Safety and nutritional assessment of GM plants and derived food and feed: The role of animal feeding trials

BackgroundThe global increase in food additives consumption over recent decades raises concerns about its potential impact on maternal and child health. The cohort study aims to evaluate the relationship between...

EFSA has the mandate to collect data on the occurrence of chemicals in food and feed in relation to various domains (i.e. contaminants, food additives, pesticide residues and veterinary medicinal product residues (VMPRs)) at the level of the European Union. National food authorities, research institutions, academia, food business operators and other stakeholders submit data to EFSA in the SSD2 (Standard Sample Description version 2) format. A crucial prerequisite for reliable dietary exposure and risk assessments is that the occurrence data are harmonised and accurate. Quality issues, inconsistencies or incomplete information may have a considerable impact on the accuracy of the dietary exposure assessments carried out for EFSA’s scientific outputs, especially when these data have been collected from different countries and institutions. Considering that exposure assessment is a critical component of risk assessment, the present report proposes guidance for the resolution of the issues that affect the occurrence data. Although primarily intended for the use of EFSA exposure assessors dealing with cleaning and further adjustments of the occurrence data in relation to contaminants in food and feed, food additives and pesticides residues levels in food, it can be applied by any exposure assessor dealing with the assessment of dietary exposure to food chemicals. The following most commonly occurring issues that can affect the occurrence data used for dietary exposure assessments were identified: sampling strategy, pooled samples, country of origin, date of sampling, analytical method not available, issues related to limit of detection/quantification, data below detection capability, recovery, occurrence data expressed differently than on whole weight, qualitative occurrence data, conversion factors and occurrence data on ‘grains as crops’. The report is designed to introduce these issues and to provide practical instructions on an appropriate approach to address those that are identified during the cleaning and preparation of chemical occurrence data that are being used to estimate dietary exposure.

Probabilistic acute dietary exposure assessments to captan and tolylfluanid using several European food consumption and pesticide concentration databases

(1) Background: Developing countries have experienced a rapid recent rise in Inflammatory Bowel Disease (IBD) incidence and emerging evidence suggests processed foods and food additives may predispose one to the development and perpetuation of Crohn’s disease (CD). The aim of this study was to evaluate processed food and food additive intake in CD patients and controls, in Australia (high CD incidence), Hong Kong (intermediate incidence) and mainland China (emerging incidence). (2) Methods: In 274 CD patients (CD), 82 first-degree relatives (FDR), 83 household members (HM) and 92 healthy unrelated controls (HC) from Australia (n = 180), Hong Kong (HK) (n = 160) and mainland China (n = 191) we estimated early life (0–18 years), recent (12 months), and current processed and food additive intake, using validated questionnaires and a 3-day-food diary. (3) Results: Early life processed food intake: Combining all regions, CD were more likely to have consumed soft drinks and fast foods than HM, more likely to have consumed processed fruit and snacks than their FDR, and more likely to have consumed a range of processed foods than HC. HK and China CD patients were more likely to have consumed a range of processed foods than HC. Recent food-additive intake (12-months): Combining all regions, CD patients had significantly higher intakes of aspartame and sucralose, and polysorbate-80, than HC, and more total emulsifiers, artificial sweeteners, and titanium dioxide than FDR and HC. HK and China CD patients had a higher intake of almost all food additives than all controls. Current additive intake (3-days): Australian and HK CD patients had higher total food-additive intake than FDR, and HK CD patients had a higher intake of total food-additives and emulsifiers than HM. (4) Conclusions: CD patients have been exposed to more processed food and food additives than control groups, which may predispose them to CD development and ongoing inflammation.

The results of French intake estimates for 13 food additives prioritized by the methods proposed in the 2001 Report from the European Commission on Dietary Food Additive Intake in the European Union are reported. These 13 additives were selected using the first and second tiers of the three-tier approach. The first tier was based on theoretical food consumption data and the maximum permitted level of additives. The second tier used real individual food consumption data and the maximum permitted level of additives for the substances which exceeded the acceptable daily intakes (ADI) in the first tier. In the third tier reported in this study, intake estimates were calculated for the 13 additives (colours, preservatives, antioxidants, stabilizers, emulsifiers and sweeteners) according to two modelling assumptions corresponding to two different food habit scenarios (assumption 1: consumers consume foods that may or may not contain food additives, and assumption 2: consumers always consume foods that contain additives) when possible. In this approach, real individual food consumption data and the occurrence/use-level of food additives reported by the food industry were used. Overall, the results of the intake estimates are reassuring for the majority of additives studied since the risk of exceeding the ADI was low, except for nitrites, sulfites and annatto, whose ADIs were exceeded by either children or adult consumers or by both populations under one and/or two modelling assumptions. Under the first assumption, the ADI is exceeded for high consumers among adults for nitrites and sulfites (155 and 118.4%, respectively) and among children for nitrites (275%). Under the second assumption, the average nitrites dietary exposure in children exceeds the ADI (146.7%). For high consumers, adults exceed the nitrite and sulfite ADIs (223 and 156.4%, respectively) and children exceed the nitrite, annatto and sulfite ADIs (416.7, 124.6 and 130.6%, respectively).

Review of the state of the art of human biomonitoring for chemical substances and its application to human exposure assessment for food safety

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.

Today we have about 300 approved food additives on the European market and all of them have been evaluated for safety by the European Commission's expert advisory body - the Scientific Committee for Food (SCF). There are fundamental requirements for approval of a food additive. The additive has to be of value for the consumer or necessary for the handling and distribution of the food. In addition, it has to be toxicologically acceptable according to European Community regulatory requirements. For most additives, a numerical (mg/kg bw/day) ADI-value (Acceptable Daily Intake) has been determined that shows how much it is possible to consume each day during a life time without any appreciable risk of adverse effects. If no adverse effects have been demonstrated in the safety evaluation no numerical value for the AD1 is specified and the additive may be used according to the principles of Good Manufacturing Practice (quantum satis), i.e. the minimum amount necessary to produce the desired effects. When the intake of certain food additives can be assumed to be high in relation to the ADI, this should always trigger additional consideration and action. For such food additives it is important that continuous monitoring of use and intake is performed, that potentially sensitive groups and/or individuals are identified and that intake calculations are performed to ensure that the AD1 is not exceeded. Key words: Consumption, food additives, intake, regulatory requirements, safety assessment