The application of post-market monitoring to novel foods

Hepburn, Paul; Howlett, John; Boeing, Heiner; Cockburn, A.; Constable, Anne; Davi, A.; Jong, Nynke de; Moseley, Bevan; Oberdörfer, Regina; Robertson, Claire E.; Wal, Jean‐Michel; Samuels, Fiona

doi:10.1016/j.fct.2007.09.008

Cited by 57 publications

(30 citation statements)

References 39 publications

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“…In the absence of methodologies to determine sensitization potential and potency, a postlaunch monitoring exercise may be considered to provide an early warning of any undue allergenicity developing after introduction of a novel food into the market and thereby permit the initiation of risk management measures. Possibilities and limitations for such resource intensive post-launch monitoring in the context of novel foods and unintended health effects has been critically discussed (Hepburn et al, 2008) and the special case of allergenicity has been reviewed (Wal et al, 2003).…”

Section: Discussionmentioning

confidence: 99%

Approaches to assess IgE mediated allergy risks (sensitization and cross-reactivity) from new or modified dietary proteins

Remington¹,

Broekman

Blom³

et al. 2018

Food and Chemical Toxicology

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A B S T R A C TThe development and introduction of new dietary protein sources has the potential to improve food supply sustainability. Understanding the potential allergenicity of these new or modified proteins is crucial to ensure protection of public health. Exposure to new proteins may result in de novo sensitization, with or without clinical allergy, or clinical reactions through cross-reactivity.In this paper we review the potential of current methodologies (in silico, in vitro degradation, in vitro IgE binding, animal models and clinical studies) to address these outcomes for risk assessment purposes for new proteins, and especially to identify and characterise the risk of sensitization for IgE mediated allergy from oral exposure. Existing tools and tests are capable of assessing potential crossreactivity. However, there are few possibilities to assess the hazard due to de novo sensitization. The only methods available are in vivo models, but many limitations exist to use them for assessing risk. We conclude that there is a need to understand which criteria adequately define allergenicity for risk assessment purposes, and from these criteria develop a more suitable battery of tests to distinguish between proteins of high and low allergenicity, which can then be applied to assess new proteins with unknown risks.

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Section: Discussionmentioning

confidence: 99%

Approaches to assess IgE mediated allergy risks (sensitization and cross-reactivity) from new or modified dietary proteins

Remington¹,

Broekman

Blom³

et al. 2018

Food and Chemical Toxicology

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“…PMM, also known as post-launch monitoring (PLM) or post-market surveillance (PMS), is a concept that has not been specifically defined but has been used in the context of testing the conclusions drawn from the pre-market risk assessment, e.g. confirmation of the extent to which the product is being consumed by its target group and estimation of exposure in other population groups (Hepburn et al, 2008). The concept has received attention recently as a potential tool in the approaches available for evaluating the safety of novel foods and ingredients (EFSA GMO Panel, 2011;Hepburn et al, 2008).…”

Section: Figurementioning

confidence: 99%

“…confirmation of the extent to which the product is being consumed by its target group and estimation of exposure in other population groups (Hepburn et al, 2008). The concept has received attention recently as a potential tool in the approaches available for evaluating the safety of novel foods and ingredients (EFSA GMO Panel, 2011;Hepburn et al, 2008). In principle, however, the PMM methodology is applicable to all food groups.…”

Section: Figurementioning

confidence: 99%

“…According to (Hepburn et al, 2008), PMM (e.g. for novel food) may provide the means to evaluate the actual intake of a food by consumers and may increase the probability of detecting adverse effects in small, well characterised segments of the population deemed most at risk in the pre-market assessment, when they are exposed to the food during long periods of time under conditions of everyday life.…”

Section: Figurementioning

confidence: 99%

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

Choi¹,

Mørck²,

Polcher³

et al. 2015

EFS3

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Human biomonitoring (HBM) measures the levels of substances in body fluids and tissues. Many countries have conducted HBM studies, yet little is known about its application towards chemical risk assessment, particularly in relation to food safety. Therefore a literature search was performed in several databases and conference proceedings for 2002 -2014. Definitions of HBM and biomarkers, HBM techniques and requirements, and the possible application to the different steps of risk assessment were described. The usefulness of HBM for exposure assessment of chemical substances from food source, and for the implementation of a systematic Post Market Monitoring (PMM) approach for regulated chemical substances was evaluated. An inventory of HBM programmes provides detailed information about study design, analytical methods, reference values (RV) and biomarkers used. Environmental monitoring and associations between HBM values and food, as well as coverage of substances and remaining deficits are highlighted. The review of study results provides information on emerging chemicals, higher exposed and particularly vulnerable populations.Conclusions: HBM can bring added value for chemical risk assessment in food safety areas (namely exposure assessment), and for the implementation of a systematic PMM approach. But further work needs to be done to improve usability. Major deficits are the lack of HBM guidance values on a considerable number of substance groups, for which health based guidance values (HBGVs) have been developed, insufficient knowledge regarding exposure sources, and incomplete dietary intake assessment. Recommendations: We recommend to foster development of HBM based guidance values and validated analytical methods/BMs, stronger inclusion of substances of interest for EFSA in European surveys, expanded monitoring of highly exposed and vulnerable subgroups, uptake of EFSA guidance concerning dietary intake assessment, as well as biobanking, surveillance synergies and targeted research, and an EU wide collaborative approach to support the future use of HBM in PMM.©BiPRO GmbH, 2015 DISCLAIMERThe present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors. The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded foll...

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“…For several years now, important scientific conceptual and practical works have indeed been developed in several EU-MS along with reports from national committees in charge of GMO approvals (ACRE, 2004;Breckling and Reuter, 2006;Garcia-Alonso et al, 2006;Graef et al, 2005;Monkemeyer et al, 2006;Wilhelm et al, 2009;Wolt et al, 2010;Zughart et al, 2008). Most of these scientific works focused on environmental effects, while the effects on human health are roughly "delegated" by the consent holders to national health monitoring networks (Bakshi, 2003;Cellini et al, 2004;Covelli and Hohots, 2003;D'Agnolo, 2005;EFSA GMO panel, 2006b;Filip et al, 2004;Hepburn et al, 2008;Wal et al, 2003). To provide an example of EU-MS, in France, the "Sentinelles" network, ANSES 9 , and InVS 10 might form parts of such a general surveillance plan on human health in application of the WHO and European rules, directives, and regulations.…”

Section: General Surveillancementioning

confidence: 99%