Creme Global

What`s in the Package?

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What's in the Package?

Packaging Migrant Food Safety Assessment

What exactly is in your food's packaging? Migrants from food contact materials, often referred to as indirect food additives, have been shown to be present at low concentrations in food. As these migrants are hazards, their presence in food needs to be regulated. The new EU super directive aims to regulate all substances that may migrate from the food contact material into the food. These include all impurities, degradation products and aids to polymerisation that may be present in the finished food contact material.

However, it must be noted that not all hazards are risks. A substance may have harmful effects at certain doses but if it is not consumed at that dose it will never be a risk. 'All substances are poisons, there is none which is not a poison, but the right dose differentiates a poison and a remedy.' Paracelsus c. 1400.

Probabilistic - also known as statistical or realistic - exposure assessments have been used in a number of areas in recent years. For example, they have been used to deal with environmental issues, direct food additives, food contaminants as well as food contact materials.

The current regulations covering the exposure of chemicals migrating from food contact materials into food take an extremely conservative approach. The results generated are not realistic or helpful in actually understanding the risk to consumers.

The scientific and economic value of realistic exposure assessments has been well recognised by industry and academia. These assessments give not only the worst case conservative estimates, but also an accurate distribution of potential population exposure under multiple scenarios. The benefit of probabilistic modelling is in fact to take into account all possible scenarios and to understand the potential risk of each using validated methods and quantitative data.

The primary purpose of exposure assessment is to ascertain whether exposure to a chemical is below acceptable or tolerable levels for the ultimate protection of the consumer. It is also used to check compliance with the legislation and to monitor trends in food chemical intakes.

With probabilistic analysis of dietary exposure to chemicals, it is possible to use distributions for all inputs including food consumptions and chemical concentration data to characterise their variability (i.e. natural variation in the model that is irreducible) and/or uncertainty (i.e. lack of knowledge about the true values of a given model input, which may be reduced by further measurement). Thus, if all required input data is available and treated correctly, it is possible to generate validated results with confidence intervals.

These results are more informative to risk managers by giving them an actual understanding of point estimate approach, which is currently being used for estimating exposure to migrants from food contact materials and is essential to improve the comprehension of the consumer in risk communication (EU Scientific Steering Committee 2000).

In 2000 the European Commission funded the development of software to measure exposure to direct food chemicals (pesticides, additives and sweeteners) using probabilistic models in the Monte Carlo project. The funding of this project represented recognition of the importance placed by the Commission's risk assessment forum of the Scientific Steering Committee in exposure assessment and probabilistic risk assessment. In 2003 the software was further developed to allow estimation of migrants from food contact materials. The result of this research is the CREMe software solution.

So, what does the CREMe software actually do to help?

The CREMe software allows the risk assessor to combine large food consumption data sets with packaging migration data to produce a realistic estimate of exposure to the population of chemical migrants from packaging. CREMe can also calculate exposure to additives, pesticides, contaminants, novel and functional foods.

Exposure assessment to chemicals from food contact materials is calculated using large data sets on the food consumption habits of population samples and data sets on the chemical of concern. Market share information on different package types in the market is an important input data set for this analysis, which is readily available to industry.

The risk assessor uploads their own data sets to the software service and performs their analysis and downloads the results, statistics and graphs.

Advantages of CREMe

* Detailed exposure profile of consumers
* Web-delivered software system allowing online collaboration and eliminating requirement for local installation and maintenance
* On-demand High Performance Computing allowing full data sets to be analysed with a significant reduction in analysis times
* Efficient scenario analysis
* Rapid and reliable results

This all leads to a far better understanding of risks to consumers. Regulators can have more confidence in their results and thus avoid having to be super-conservative due to the lack of knowledge about the risks.

CREMe specialises in handling these issues for our clients which include government regulators, food and packaging manufacturers, consultants and researchers. With our state-of-the-art software service which utilises techniques that are used by the major financial institutions to manage financial risk we will provide the rapid and reliable results that you need.

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