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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.

Houben G.,TNO | Burney P.,Imperial College London | Crevel R.,Unilever | Dubois A.,University of Groningen | And 5 more authors.
Food and Chemical Toxicology | 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. © 2016 The Authors.

van Bilsen J.H.M.,TNO | Ronsmans S.,Coca Cola Services | Crevel R.W.R.,Unilever | Rona R.J.,Kings 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.

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.

Kennedy M.,UK Environment Agency | McNamara C.,Creme Global | Oberdorfer R.,Bayer CropScience | O'Mahony C.,Creme Global | And 4 more authors.
Food and Chemical Toxicology | 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. © 2015 ILSI Europe.

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