Risk assessments are conducted to ensure that chemicals present in food do not compromise food safety. The safety assessment processes used to protect consumers should be robust and transparent, and based on the best available science. There is general agreement on the major steps involved in the risk assessment of chemicals in food.

 

The task force aims to improve methodologies and tools to assess the risk of food chemicals. This includes development of approaches that take into account variability and uncertainty, and integrate human data, animal in vivo data, and in vitro data. These tools can help advance and refine the risk assessment process, and thus contribute to ensuring the safety of foods.

 

As a natural extension of the risk assessment process the task force also aims to develop a structured approach to weigh possible health risks of chemicals in foods against health benefits resulting from the same or different substances found in a particular food item.

 

This task force critically reviews the risk assessment process in order to ensure the safety of chemicals in food, and examines the science base for new qualitative and quantitative methods to assess risks from components in the food chain (e.g. low molecular weight chemicals, micronutrients, macronutrients).

 

The members of the task force agreed to start two new activities, as illustrated below. One activity will begin in 2012 and the other in 2013; the order has still to be decided during the next task force meeting in April 2012.

 

The safety evaluation of feed is of obvious importance to ensure safe and healthy food to consumer. With regard to animal products this is of upmost importance because livestock animals may accumulate substances / contaminants present in their feed and / or metabolites thereof in the edible parts (milk, egg, fat, muscle, edible offals). Substances like plant protection products, veterinary drugs, or well-known contaminants such as dioxins / mycotoxins / heavy metals are well investigated.

 

However, there are other substances coming from cross-contamination via other sources, up to date unknown substances being present in feed, or other impurities coming from e.g. synthesis of veterinary drug actives, packaging materials or natural substances e.g. phytochemicals. Safety assessment of these substances requires investigation of their likely metabolites. One initial question could be whether or not food producing animals might produce a genotoxic metabolite which is not generated by laboratory animals used in safety testing.

 

The activity should provide a review document, e.g. an ILSI Europe Concise Monograph, on transformation pathways in livestock animals.

The European Funded project BRAFO developed a methodology whereby benefits and risks of foods or constituents of foods can be weighed one against the other to help inform risk management decisions. The methodology uses a tiered approach that characterises both the benefits and risks and a common metric: DALYs or QALYs. As the assessment progresses up the tiers, the data requirements increase as does the complexity of the assessment. In many scenarios, evidence of risk is derived from animal studies and there is no agreed approach how such data could be translated into metrics such as DALYs or QALYs.

 

Indeed there are many uncertainties in extrapolating from experimental animal data to human disease risk, e.g. time of onset of disease, disease severity, dose-response relationship in humans and relevance of the effect for humans. A programme of work looking at how health metrics or weights could be derived from/applied to experimental animal data would significantly add to the utility of the BRAFO approach in scenarios where health based guidance values e.g. TDI (Total Daily Intake), UL (upper limit) are exceeded and there is a need to further characterise the risk to human health posed by such exceedances and consider alongside potential health benefits. 

 

The overall aims of the activity are to build a science-based approach whereby results from experimental animal data can be used to derive human health-based metrics e.g. DALYs & QALYs for use in risk-benefit analysis, in particular to:

The outcome of the activity will be a scientific publication in a peer-reviewed journal.

 

In the context of mounting concern about food as a source of exposure to chemicals, it has to be realized that over five millions man-made chemicals are known, of which 70’000 are in use today. The application of continuously improving analytical methods has revealed that many of these chemicals can enter the food chain and result in measurable human exposure. Since for the vast majority of these chemicals, toxicological information is absent or limited, the assessment of their health significance is therefore difficult.

 

It appears likely that the food sector will increasingly face cases of emerging issues associated with chemicals for which no or little toxicological data are available. Because such cases may evolve into crises, triggering not only heavy management actions (e.g. public recalls) but also alarm resulting in loss of consumer confidence for the food supply, emerging chemical issues require to be managed properly. As a pre-requisite, management of chemicals in food requires the possibility to establish the levels of safety concern in order to ensure adequate consumer protection without undue over-conservatism. This is necessary even if toxicological data are inadequate or absent. Solutions to this general issue are not straightforward.

 

The focus of this activity is on food chemicals and does not consider allergenicity. The expert group will review the available toxicological models and integrate them into a tiered approach involving QSAR and grouping read-across methods.

 

The approach is expected to have broad applications in: 

The stepwise approach integrating all the selected tools will be developed and tested with appropriate case studies. The outcome of the activity will be submitted to a peer-reviewed journal. The possibility to develop training materials will be considered by the task force.

 

 

Background

Following the discovery and confirmation of relatively large amounts of 3-MCPD-esters in foods and food ingredients, a workshop was organised by ILSI-Europe in February 2009, in order to review all available data relevant for risk assessment. Significant knowledge gaps and research needs were identified. Recommendations on how best to address issues related to 3-MCPD esters and related compounds, i.e. 2-MCPD–esters and glycidyl-esters, in foods were formulated. This workshop triggered widespread activities on analytical challenges, mitigation and toxicology. It was decided to follow these scientific developments through a shared activity between the ILSI Europe Process-related and Natural Toxins and the Risk Assessment of Chemicals in Food task forces.

The progress was reviewed in a second workshop held in 2011 which focussed on the development of analytical methods, including the direct analysis of MCPDs, glycidol and their esters. An ILSI Europe expert group initiated a critical review of these methods in the context of their performance and applicability to address key issues such as occurrence in food, mechanism of formation, mitigation and toxicology. It is currently considered that several important analytical challenges encountered earlier could now be resolved. In addition, new evidence on mechanisms of formation and on possible application in mitigation approaches is emerging. The expert group prepared a working document targeting the following topics:

 

 

 

The Risk Assessment of Chemicals in Food Task Force had successfully applied for a Specific Support Action under the EC’s Sixth Framework Programme, Priority 5, Food Quality and Safety.

 

BRAFO was a logical follow-up to the EC projects FOSIE, FUFOSE and PASSCLAIM. FOSIE developed a risk assessment framework for chemicals in food whereas FUFOSE and PASSCLAIM addressed benefit assessment.

 

The aim of BRAFO was to develop a framework that allows a quantitative comparison of human health risks and benefits of foods and food compounds, using a common scale of measurement. It is based on the evaluation of changes in the quality and/or duration of life, and will allow weighing for data quality and severity of effect. For quantification purposes a DALY-like methodology is used. The framework took into account how risks and benefits relate to each other, and considers how these relate to the same and different sub-populations. The methodology developed and tested is sufficiently transparent to serve as a reference for the harmonisation of the evaluation methods used within the European Union and beyond.

 

BRAFO involved representatives from academia, regulatory agencies and the food industry with expertise in risk assessment, nutrition and risk/benefit analysis.

 

For more information on BRAFO: www.brafo.org

 

 

*Scientific Advisor

 

 

 

*Observer

 

 

*Observer

 

 

* Observer

 

C. Crews. Summary report of the workshop on MCPD and Glycidyl Esters in Food Products held in November 2011. ILSI Europe Report Series 2012: 1-24.

 

Summary report of the workshop on 3-MCPD Esters in Food Products published in the ILSI Europe Report Series 2009:1-32.

 

J.F. Borzelleca and H. Verhagen, Editors. Risk Characterisation of Chemicals in Food and Diet – Final part of Food Safety in Europe (FOSIE): Risk Assessment of Chemicals in Food and Diet. Food and Chemical Toxicology 2003;41(9):1205-1271.

 

S. Barlow et al., Guest Editors. Food Safety in Europe (FOSIE): Risk Assessment of Chemicals in Food and Diet. Food and Chemical Toxicology 2002;40(2/3):139-427.

 

To download the poster of the task force, please click here.

 

For more information, please contact info@ilsieurope.be.