Time filter

Source Type

Shane A.L.,Lee University | Cabana M.D.,International Life science Institute ILSI Europe | Vidry S.,Georgetown University | Merenstein D.,Erasmus Medical Center | And 7 more authors.
Gut Microbes | Year: 2010

The heterogeneity of human clinical trials to assess the efectiveness of probiotics presents challenges regarding interpretation and comparison. Evidence obtained from clinical trials among a population with a disease or specific risk factors may not be generalizable to healthy individuals. The evaluation of interventions in healthy persons requires careful selection of outcomes due to the absence of health indicators and the low incidence of preventable conditions. Given the tremendous resources invested in such trials, development of consistent approaches to assessing the efectiveness of probiotics would be benefcial. Furthermore, the reporting, presentation and communication of results may also afect the validity of the scientifc evidence obtained from a trial. This review outlines the challenges associated with the design, implementation, data analysis and interpretation of clinical trials in humans involving probiotics. Best practices related to their design are ofered along with recommendations for enhanced collaboration to advance research in this emerging feld. © 2010 Landes Bioscience.


Crevel R.W.R.,Unilever | Baumert J.L.,University of Nebraska - Lincoln | Luccioli S.,Center for Food Safety and Applied Nutrition | Baka A.,International Life science Institute ILSI Europe | And 6 more authors.
Food and Chemical Toxicology | Year: 2014

Risk assessment describes the impact of a particular hazard as a function of dose and exposure. It forms the foundation of risk management and contributes to the overall decision-making process, but is not its endpoint. This paper outlines a risk analysis framework to underpin decision-making in the area of allergen cross-contact. Specifically, it identifies challenges relevant to each component of the risk analysis: risk assessment (data gaps and output interpretation); risk management (clear and realistic objectives); and risk communication (clear articulation of risk and benefit). Translation of the outputs from risk assessment models into risk management measures must be informed by a clear understanding of the model outputs and their limitations. This will lead to feasible and achievable risk management objectives, grounded in a level of risk accepted by the different stakeholders, thereby avoiding potential unintended detrimental consequences. Clear, consistent and trustworthy communications actively involving all stakeholders underpin these objectives. The conclusions, integrating the perspectives of different stakeholders, offer a vision where clear, science-based benchmarks form the basis of allergen management and labelling, cutting through the current confusion and uncertainty. Finally, the paper recognises that the proposed framework must be adaptable to new and emerging evidence. © 2014 ILSI Europe.


PubMed | University Utrecht, Food Standards Agency, University of Nebraska - Lincoln, Imperial College London and 5 more.
Type: | Journal: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association | Year: 2016

Regulators and risk managers in general need to decide whether an allergenic food or ingredient is of such public health importance that it needs to be actively managed. There is therefore a need to scale the relative allergenicity of foods and ingredients according to the hazards they pose. Objective criteria increase transparency and trust in this decision-making process and its conclusions. This paper proposes a framework that allows categorisation and prioritisation of allergenic foods according to their public health importance. The challenge is to find a basis on which the allergenicity of foods can best be described and a method to combine the relevant measures of allergenicity into a scoring system that prioritises allergenic foods on the basis of their public health relevance. The framework is designed in accordance with the generic risk analysis principles used in food safety and can be used by regulators to decide whether or not a specific allergenic food or ingredient is of sufficient public health importance that it warrants regulation (i.e. mandatory labelling) when used in the production of food products.


PubMed | Nestlé, Coca Cola Services, Unilever, European Anaphylaxis Taskforce and Nederlands Anafylaxis Netwerk and 6 more.
Type: | Journal: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association | Year: 2014

Risk assessment describes the impact of a particular hazard as a function of dose and exposure. It forms the foundation of risk management and contributes to the overall decision-making process, but is not its endpoint. This paper outlines a risk analysis framework to underpin decision-making in the area of allergen cross-contact. Specifically, it identifies challenges relevant to each component of the risk analysis: risk assessment (data gaps and output interpretation); risk management (clear and realistic objectives); and risk communication (clear articulation of risk and benefit). Translation of the outputs from risk assessment models into risk management measures must be informed by a clear understanding of the model outputs and their limitations. This will lead to feasible and achievable risk management objectives, grounded in a level of risk accepted by the different stakeholders, thereby avoiding potential unintended detrimental consequences. Clear, consistent and trustworthy communications actively involving all stakeholders underpin these objectives. The conclusions, integrating the perspectives of different stakeholders, offer a vision where clear, science-based benchmarks form the basis of allergen management and labelling, cutting through the current confusion and uncertainty. Finally, the paper recognises that the proposed framework must be adaptable to new and emerging evidence.


PubMed | General Health Effects Toxicology Safety Food GETS, University of Natural Resources and Life Sciences, Vienna, University of Kaiserslautern, Cargill Inc. and 5 more.
Type: Review | Journal: Mycotoxin research | Year: 2016

Mycotoxins are fungal metabolites commonly occurring in food, which pose a health risk to the consumer. Maximum levels for major mycotoxins allowed in food have been established worldwide. Good agricultural practices, plant disease management, and adequate storage conditions limit mycotoxin levels in the food chain yet do not eliminate mycotoxins completely. Food processing can further reduce mycotoxin levels by physical removal and decontamination by chemical or enzymatic transformation of mycotoxins into less toxic products. Physical removal of mycotoxins is very efficient: manual sorting of grains, nuts, and fruits by farmers as well as automatic sorting by the industry significantly lowers the mean mycotoxin content. Further processing such as milling, steeping, and extrusion can also reduce mycotoxin content. Mycotoxins can be detoxified chemically by reacting with food components and technical aids; these reactions are facilitated by high temperature and alkaline or acidic conditions. Detoxification of mycotoxins can also be achieved enzymatically. Some enzymes able to transform mycotoxins naturally occur in food commodities or are produced during fermentation but more efficient detoxification can be achieved by deliberate introduction of purified enzymes. We recommend integrating evaluation of processing technologies for their impact on mycotoxins into risk management. Processing steps proven to mitigate mycotoxin contamination should be used whenever necessary. Development of detoxification technologies for high-risk commodities should be a priority for research. While physical techniques currently offer the most efficient post-harvest reduction of mycotoxin content in food, biotechnology possesses the largest potential for future developments.


van Bilsen J.H.M.,TNO | Ronsmans S.,Coca Cola Services | Crevel R.W.R.,Unilever | Rona R.J.,King's College London | And 3 more authors.
Regulatory Toxicology and Pharmacology | Year: 2011

Identification of allergenic foods of public health importance should be based on well-defined criteria. Björkstén et al. (2008) proposed that the criteria should assess the evidence for an IgE mechanism, the reaction, the potency and the severity of the effect of the food and its prevalence. This study evaluated the application of the proposed criteria based on published reports. Publications were selected from two databases to test whether the descriptions for ranking the level of evidence for each criterion were unambiguous and covered the full range of levels of evidence regarding seven foods, five known to be allergenic and two negative controls. The options available to rank the quality of evidence were appropriate but needed refinement to improve clarity and conceptual value. The criteria were helpful to assess known IgE-dependent allergens, and to exclude the non-allergenic substances. The criteria framework discriminated between papers with high, moderate and low quality of evidence. The advantage of using the proposed criteria is to make the decision-making process and rationale explicit. The framework helps to identify gaps in knowledge and to uncover the level of heterogeneity of the evidence thus guiding research and providing a basis for sound risk management decisions. © 2011 ILSI Europe.


PubMed | Tereos Syral, Mondelez International, University of Manchester, Bayer S.A.S. and 7 more.
Type: | Journal: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association | Year: 2015

Food processing can have many beneficial effects. However, processing may also alter the allergenic properties of food proteins. A wide variety of processing methods is available and their use depends largely on the food to be processed. In this review the impact of processing (heat and non-heat treatment) on the allergenic potential of proteins, and on the antigenic (IgG-binding) and allergenic (IgE-binding) properties of proteins has been considered. A variety of allergenic foods (peanuts, tree nuts, cows milk, hens eggs, soy, wheat and mustard) have been reviewed. The overall conclusion drawn is that processing does not completely abolish the allergenic potential of allergens. Currently, only fermentation and hydrolysis may have potential to reduce allergenicity to such an extent that symptoms will not be elicited, while other methods might be promising but need more data. Literature on the effect of processing on allergenic potential and the ability to induce sensitisation is scarce. This is an important issue since processing may impact on the ability of proteins to cause the acquisition of allergic sensitisation, and the subject should be a focus of future research. Also, there remains a need to develop robust and integrated methods for the risk assessment of food allergenicity.


Hattersley S.,UK Food Standards Agency | Ward R.,R. Ward Consultancy Ltd | Baka A.,International Life science Institute ILSI Europe | Crevel R.W.R.,Unilever
Food and Chemical Toxicology | Year: 2014

Food allergy is a relatively recent newcomer to the ranks of food safety issues, only being effectively recognised as such in the last 25-30. years. This recognition, allied with the near impossibility of avoiding the unintended presence of small, yet potentially dangerous residues of allergenic constituents, brought with it the need to assess and manage the resulting risk. This paper provides an overview of the development and current knowledge and thinking on risk assessment and its application to risk management of food allergens. It also discusses the associated challenges, in particular those around communicating meaningfully that risk to allergic consumers, including the use of precautionary labelling. The paper also provides an introductory context to the more detailed analyses of these issues in the following papers, based on the deliberations of a recent stakeholder workshop.The paper concludes that consistent risk management approaches using agreed quantitative action levels based on scientifically robust principles will provide optimal protection to allergic consumers. Growing amounts of data from oral food challenges along with the parallel development of risk assessment methodologies, such as probabilistic modelling, offer a realistic possibility of agreement among stakeholders on such levels in the near future. © 2014 ILSI Europe.


PubMed | Coca Cola Europe, Firmenich, Bayer CropScience, Food Chemical Risk Analysis and 5 more.
Type: | Journal: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association | Year: 2015

Uncertainty analysis is an important component of dietary exposure assessments in order to understand correctly the strength and limits of its results. Often, standard screening procedures are applied in a first step which results in conservative estimates. If through those screening procedures a potential exceedance of health-based guidance values is indicated, within the tiered approach more refined models are applied. However, the sources and types of uncertainties in deterministic and probabilistic models can vary or differ. A key objective of this work has been the mapping of different sources and types of uncertainties to better understand how to best use uncertainty analysis to generate more realistic comprehension of dietary exposure. In dietary exposure assessments, uncertainties can be introduced by knowledge gaps about the exposure scenario, parameter and the model itself. With this mapping, general and model-independent uncertainties have been identified and described, as well as those which can be introduced and influenced by the specific model during the tiered approach. This analysis identifies that there are general uncertainties common to point estimates (screening or deterministic methods) and probabilistic exposure assessment methods. To provide further clarity, general sources of uncertainty affecting many dietary exposure assessments should be separated from model-specific uncertainties.


Crevel R.W.R.,Unilever | Baumert J.L.,University of Nebraska - Lincoln | Baka A.,International Life science Institute ILSI Europe | Houben G.F.,Applied Scientific Research | And 5 more authors.
Food and Chemical Toxicology | Year: 2014

The need to assess the risk from food allergens derives directly from the need to manage effectively this food safety hazard. Work spanning the last two decades dispelled the initial thinking that food allergens were so unique that the risk they posed was not amenable to established risk assessment approaches and methodologies. Food allergens possess some unique characteristics, which make a simple safety assessment approach based on the establishment of absolute population thresholds inadequate. Dose distribution modelling of MEDs permitted the quantification of the risk of reaction at the population level and has been readily integrated with consumption and contamination data through probabilistic risk assessment approaches to generate quantitative risk predictions. This paper discusses the strengths and limitations of this approach and identifies important data gaps, which affect the outcomes of these predictions. These include consumption patterns among allergic individuals, analytical techniques and their application, severity-dose relationships, and the impact of extraneous factors which alter an individual's physiology, such as infection or exercise. Nevertheless, application of these models has provided valuable insights, leading to further refinements and generating testable hypotheses. Their application to estimate the risk posed by the concurrent consumption of two potentially contaminated foods illustrates their power. © 2014 ILSI Europe.

Loading International Life science Institute ILSI Europe collaborators
Loading International Life science Institute ILSI Europe collaborators