scholarly journals Food allergens: threshold levels and methodologies for risk management

Food systems ◽  
2022 ◽  
Vol 4 (4) ◽  
pp. 246-254
Author(s):  
E. V. Kryuchenko ◽  
Yu. A. Kuzlyakina ◽  
I. M. Chernukha ◽  
V. S. Zamula
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Food Products ◽  
Food Allergies ◽  
Food Allergens ◽  
Probability Models ◽  
Food Ingredients ◽  
Threshold Levels ◽  
Adverse Effect Level ◽  
Effect Level

Food allergies and allergen management are important problems of the public health and food industry. The idea of determining allergen concentrations in food ingredients and food products that are capable of causing severe allergic reactions is of great interest for regulatory bodies as well as consumer associations and the industry all over the world. In this connection, scientists proposed different approaches to determining the basis for assessment of severity of risks of food allergens for health of patients suffering from food allergy similar to methods of risk assessment for other hazards associated with food products (for example, chemical, microbiological). To assess risk of allergens, three different approaches were proposed: i) traditional risk assessment using the no observed adverse effect level (NOAEL)) and uncertainty factors; (ii) approach based on the benchmark dose (BMD)) and margin of exposure (MoE)); and (iii) probability models. These approaches can be used in risk management in food production and in the development of warning marking about the presence of allergens. The reliability of risk assessment will depend on a type, quality and quantity of data used for determining both population threshold levels (or threshold distributions) and an impact of an allergenic product/ingredient on a particular individual.

scholarly journals Safety Assessment of Food Additives: Case Example With Myrcene, a Synthetic Flavoring Agent

2019 ◽  
Vol 47 (8) ◽  
pp. 1035-1037 ◽  
Author(s):  
Steven R. Mog ◽  
Yu Janet Zang
Keyword(s):  
Food Additives ◽  
Daily Intake ◽  
The United States ◽  
Pathological Effect ◽  
Food Ingredients ◽  
Toxicological Effect ◽  
Other Information ◽  
Adverse Effect Level ◽  
Effect Level ◽  
Flavoring Agent

In the United States, the Food and Drug Administration (FDA) regulates the safe use of food ingredients, including food additives. Food additives are subject to FDA premarket review and approval, a process conducted by FDA scientists to evaluate the additive’s safety for the intended conditions of use. Typically, an acceptable daily intake level is established by toxicologists based on the highest no observable adverse effect level for the most sensitive noncancer toxicity end point determined from a pivotal nonclinical study with application of an appropriate safety factor. Utilizing other information, including the additive’s use and exposure levels, a safety determination (reasonable certainty of no harm) is made. During ongoing safety assessments, pathologists are often consulted by toxicologists for case-specific reasons, which may include verifying that an observed pathological effect is treatment related and adverse, confirming the determination of the pivotal study, endorsing a mode of action, or evaluating the human relevance of a toxicological effect found in experimental animals. Last year, the FDA took regulatory action to no longer allow the use of the food additive myrcene, a synthetic flavoring agent, based on results from National Toxicology Program carcinogenicity studies. The cancer and noncancer end points from the rat studies are discussed.

ILSI Europe’s Food Allergy Task Force: From Defining the Hazard to Assessing the Risk from Food Allergens

2018 ◽  
Vol 101 (1) ◽  
pp. 91-95 ◽  
Author(s):  
René R W Crevel ◽  
Stefan Ronsmans ◽  
Cyril F M Marsaux ◽  
Diána Bánáti
Keyword(s):  
Risk Assessment ◽  
Food Allergy ◽  
Task Force ◽  
World Health ◽  
Health Concern ◽  
Food Allergies ◽  
Food Allergens ◽  
The European Union ◽  
Funded Project ◽  
The Impact

Abstract The International Life Sciences Institute (ILSI) Europe Food Allergy Task Force was founded in response to early public concerns about the growing impact of food allergies almost coincidentally with the publication of the 1995 Food and Agriculture Organization-World Health Organization Technical Consultation on Food Allergies. In line with ILSI principles aimed to foster collaboration between stakeholders to promote consensus on science-based approaches to food safety and nutrition, the task force has played a central role since then in the development of risk assessment for food allergens. This ranged from consideration of the criteria to be applied to identifying allergens of public health concern through methodologies to determine the relationship between dose and the proportion of allergic individuals reacting, as well as the nature of the observed responses. The task force also promoted the application of novel, probabilistic risk assessment methods to better delineate the impact of benchmarks, such as reference doses, and actively participated in major European food allergy projects, such as EUROPREVALL, the European Union (EU)-funded project “The prevalence, cost and basis of food allergy across Europe;” and iFAAM, “Integrated approaches to food allergen and allergy risk management,” also an EU-funded project. Over the years, the task force’s work has evolved as answers to initial questions raised further issues: Its current work program includes a review of analytical methods and how different ones can best be deployed given their strengths and limitations. Another activity, which has just commenced, aims to develop a framework for stakeholders to achieve consensus on acceptable risk.

Health effects of moniliformin: a poorly understood Fusarium mycotoxin

2010 ◽  
Vol 3 (4) ◽  
pp. 403-414 ◽  
Author(s):  
K. Peltonen ◽  
M. Jestoi ◽  
G. Eriksen
Keyword(s):  
Risk Assessment ◽  
Human Health ◽  
Daily Intake ◽  
Human Consumption ◽  
Limit Of Quantification ◽  
Major Species ◽  
Adverse Effect Level ◽  
Food And Feed ◽  
Effect Level ◽  
Fusarium Fungi

The contamination of the food and feed chain with mycotoxins and the subsequent threat to human health and animal welfare is evident. Today mycotoxin research is still strongly focused on mycotoxins such as aflatoxins, ochratoxin A and for Fusarium fungi mainly the trichothecenes deoxynivalenol (DON) and T-2 and HT-2 toxins. However, fungi of the Fusarium genus are clearly capable of synthesising other mycotoxins as well, including moniliformin (MON). The occurrence of MON is worldwide and the levels in grains vary from below the limit of quantification to the highest detected value in maize intended for human consumption being close to 20 mg/kg. In Finland and Norway, the reported levels are typically a few hundreds of micrograms per kilogram. The toxicology of MON is not well understood. It is characterised by major species differences but typically MON evokes myocardiac damage. For MON, No Observed Adverse Effect Level (NOAEL) has not been established and a provisional Tolerable Daily Intake (pTDI) value has not been proposed. In our risk assessment, we applied a NOAEL value of 10 mg/kg bw/day which is based on our unpublished subchronic exposure experiments. By applying this value in the risk assessment combined with the estimated intakes from food in Finland and Norway, it seems that MON per se does not pose a clear threat to human health at current levels. On the other hand, one needs to bear in mind the concurrent exposure to other mycotoxins and the fact that the risk assessment of mycotoxin mixtures are in their infancy.

scholarly journals Risk assessment. Principles and consequences

2000 ◽  
Vol 72 (6) ◽  
pp. 1051-1056 ◽  
Author(s):  
I. F. H. Purchase
Keyword(s):  
Risk Assessment ◽  
Safety Factor ◽  
Animal Experiments ◽  
Cumulative Risk ◽  
Exposure Data ◽  
Adverse Effect Level ◽  
Genotoxic Carcinogens ◽  
Effect Level ◽  
Unbiased Estimates ◽  
Risk Of Exposure

Risk assessment is an important tool in deciding how to allocate resources to controlling risks. In most cases it is based on hazard data derived from animal experiments and on exposure data from an assessment of the likely or actual exposure of the population of interest. Recent advances have improved the understanding of the use of the no adverse effect level (NOAEL) and safety factor for risk assessment by providing a scientific justification of the 100-fold safety factor. Concern about the risks of exposure by various routes simultaneously (aggregate exposure) and the risks of exposure to mixtures (cumulative risk assessment) have lead to new approaches to these issues. For many years, risk assessment of genotoxic carcinogens has relied on low-dose extrapolation using mathematical models. Recently, these methods are being reconsidered and, in some cases, replaced with the NOAEL/safety factor approach combined with all information on the mechanism of action and the magnitude of the response. It is vitally important to ensure that risk assessment provides accurate and unbiased estimates of risk of exposure so that appropriate measures can be taken to control the risks.

scholarly journals Food Production and Processing Considerations of Allergenic Food Ingredients: A Review

2012 ◽  
Vol 2012 ◽  
pp. 1-14 ◽  
Author(s):  
Pedro A. Alvarez ◽  
Joyce I. Boye
Keyword(s):  
Risk Management ◽  
Food Processing ◽  
Food Production ◽  
International Standards ◽  
Food Allergens ◽  
Policy Makers ◽  
Food Ingredients ◽  
Food Manufacturing ◽  
Prepackaged Foods ◽  
General Standard

Although most consumers show no adverse symptoms to food allergens, health consequences for sensitized individuals can be very serious. As a result, the Codex General Standard for the Labelling of Prepackaged Foods has specified a series of allergenic ingredients/substances requiring mandatory declaration when present in processed prepackaged food products. Countries adhering to international standards are required to observe this minimum of eight substances, but additional priority allergens are included in the list in some countries. Enforcement agencies have traditionally focused their effort on surveillance of prepackaged goods, but there is a growing need to apply a bottom-up approach to allergen risk management in food manufacturing starting from primary food processing operations in order to minimize the possibility of allergen contamination in finished products. The present paper aims to review food production considerations that impact allergen risk management, and it is directed mainly to food manufacturers and policy makers. Furthermore, a series of food ingredients and the allergenic fractions identified from them, as well as the current methodology used for detection of these allergenic foods, is provided.

scholarly journals Are adverse effects of cannabidiol (CBD) products caused by tetrahydrocannabinol (THC) contamination?

F1000Research ◽  
2021 ◽  
Vol 8 ◽  
pp. 1394
Author(s):  
Dirk W. Lachenmeier ◽  
Stephanie Habel ◽  
Berit Fischer ◽  
Frauke Herbi ◽  
Yvonne Zerbe ◽  
...  
Keyword(s):  
Adverse Effect ◽  
Adverse Effects ◽  
Mass Spectrometric ◽  
Dose Effect ◽  
German Market ◽  
Food Ingredients ◽  
Adverse Effect Level ◽  
Effect Level ◽  
Tandem Mass Spectrometric ◽  
Liquid Chromatographic

Cannabidiol (CBD)-containing products are widely marketed as over the counter products, mostly as food supplements. Adverse effects reported in anecdotal consumer reports or during clinical studies were first assumed to be due to hydrolytic conversion of CBD to psychotropic Δ9-tetrahydrocannabinol (Δ9-THC) in the stomach after oral consumption. However, research of pure CBD solutions stored in simulated gastric juice or subjected to various storage conditions such as heat and light with specific liquid chromatographic/tandem mass spectrometric (LC/MS/MS) and ultra-high pressure liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC-QTOF) analyses was unable to confirm THC formation. Another hypothesis for the  adverse effects of CBD products may be residual Δ9-THC concentrations in the products as contamination, because most of them are based on hemp extracts containing the full spectrum of cannabinoids besides CBD. Analyses of 181 food products of the German market (mostly CBD oils) confirmed this hypothesis: 21 products (12%) contained Δ9-THC above the lowest observed adverse effect level (2.5 mg/day). Inversely, CBD was present in the products below the no observed adverse effect level. Hence, it may be assumed that the adverse effects of some commercial CBD products are based on a low-dose effect of Δ9-THC and not due to effects of CBD itself. The safety, efficacy and purity of commercial CBD products is highly questionable, and all of the products in our sample collection showed various non-conformities to European food law such as unsafe Δ9-THC levels, hemp extracts or CBD isolates as non-approved novel food ingredients, non-approved health claims, and deficits in mandatory food labelling requirements. In view of the growing market for such lifestyle products, the effectiveness of the instrument of food business operators' own responsibility for product safety and regulatory compliance must obviously be challenged, and a strong regulatory framework for hemp products needs to be devised.

scholarly journals Is food allergen analysis flawed? Health and supply chain risks and a proposed framework to address urgent analytical needs

The Analyst ◽  
2016 ◽  
Vol 141 (1) ◽  
pp. 24-35 ◽  
Author(s):  
M. J. Walker ◽  
D. T. Burns ◽  
C. T. Elliott ◽  
M. H. Gowland ◽  
E. N. Clare Mills
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Food Allergy ◽  
International Unit ◽  
Food Allergens ◽  
Unit Of Measurement ◽  
Societal Challenge ◽  
Allergen Analysis ◽  
Supply Chain Risks ◽  
Current Risk

Food allergy is an increasing problem. If we fail to realise the promise of current risk assessment and risk management of food allergens through lack of ability to measure them reproducibly and with traceability to an international unit of measurement, the analytical community will have failed a significant societal challenge.

scholarly journals Re-evaluation of polihexanide use in wound antisepsis in order to clarify ambiguities of two animal studies

2019 ◽  
Vol 28 (4) ◽  
pp. 246-255 ◽  
Author(s):  
Axel Kramer ◽  
Thomas Eberlein ◽  
Gerald Müller ◽  
Joachim Dissemond ◽  
Ojan Assadian
Keyword(s):  
Risk Assessment ◽  
Animal Studies ◽  
Carcinogenic Risk ◽  
Epigenetic Effects ◽  
Benefit Risk Assessment ◽  
Endothelial Proliferation ◽  
Adverse Effect Level ◽  
Effect Level ◽  
High Concentrations ◽  
Rats And Mice

Objective: Due to classification of the agent polihexanide (PHMB) in category 2 ‘may cause cancer’ by the Committee for Risk Assessment of the European Chemicals Agency in 2011, the users of wound antiseptics may be highly confused. In 2017, this statement was updated, defining PHMB up to 0.1% as a preservative safe in all cosmetic products. In the interest of patient safety, a scientific clarification of the potential carcinogenicity of PHMB is necessary. Methods: A multidisciplinary team (MDT) of microbiologists, surgeons, dermatologists and biochemists conducted a benefit-risk assessment to clarify the hazard of antiseptic use of PHMB. Results: In two animal studies, from which the assessment of a carcinogenic risk was derived, PHMB was administered orally over two years in extremely high concentrations far above the NO(A)EL (no-observed-(adverse-) effect level) in rats and mice. Feeding in the NO(A)EL range resulted in no abnormal effects. In one male in the highest dose group of 4000ppm PHMB, an adenocarcinoma was found, which the author attributed to chronic inflammation of the colon with systemic atypical exposure. The increasing incidence of hemangiosarcomas highly probably resulted from increased endothelial proliferation, triggered by the exceedingly high dosage fed, because PHMB is not genotoxic and there is no evidence for epigenetic effects. Discussion: It is well known that PHMB is not absorbed when applied topically. Considering the absence of genotoxicity and epigenetic effects together with the interpretation of the animal studies, it is the consensus of the multidisciplinary experts that a carcinogenic risk from PHMB-use for wound antisepsis can be ruled out. Conclusion: On this basis and considering their effectiveness, tolerability and clinical evidence, the indications for PHMB based wound antiseptics are justified.

MODELLING AND CONTROLLING THE ENTERPRISE RISKS COMPLEX ASSESSMENT SYSTEMON THE BASIS OF RUSSIAN STATE STANDARD ISO 9001-2015 CONCERNING RISK-ORIENTED THINKING. GENERAL PROBLEMS AND WAYS OF SOLVING THEM

2020 ◽  
Vol 2020 (2) ◽  
pp. 33-41
Author(s):  
Irina Merzlyakova ◽  
Aleksandr Feofanov
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
State Standard ◽  
Control Model ◽  
Enterprise Risk Management ◽  
Iso 9001 ◽  
Management Procedure ◽  
Russian State Standard ◽  
Russian State ◽  
Enterprise Risk

The article considers general problems of implementing the enterprise risk management procedure. One of the ways to solve the problems arising when meeting Russian state standard ISO 9001-2015 requirements concerning risk-oriented thinking is presented. A risk assessment control model aimed at coordinating all kinds of the enterprise departments activities, forming a clear algorithm of risk management procedure implementation and attracting a greater number of employees towards this activity is offered.

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