Employing a “worst-case” approach to food package material testing
Food packaging products and materials are an important element in the overall effort to provide consumers worldwide with safe and nutritious food. However, packaging manufacturers must be prepared to deal with a complex global regulatory landscape, in which individual jurisdictions have adopted different regulatory frameworks for the review and approval of food packaging materials. In addition, the risk assessment and testing approach commonly used to evaluate the safety of food packaging material can add time and expense to the overall approval process.
Using European Union (EU) requirements applicable to plastic food packaging materials as an example, this article discusses how taking a “worst case” approach to package testing can demonstrate safety consistent with applicable regulations while reducing overall testing costs.
EU packaging regulation overview
In the EU, requirements applicable to food packaging materials are detailed in Framework Regulation (EC) No. 1935/2004, which establishes minimum requirements applicable to most types of food packaging. These requirements mandate that all packaging materials:
Do not transfer components or chemicals to food so as to endanger human health, change food composition or adversely affect food taste or odour;
Are produced consistent with good manufacturing practices, consistent with the requirements of Regulation (EC) No. 2023/2006;
Are traceable through the production chain;
Bear the EU’s ‘glass-and-fork” symbol or otherwise labelled to signify compliance with the requirements.
Under Regulation No. 1935/2004, packaging materials must be authorised by the European Food Safety Authority (EFSA) prior to being placed on the market. Food packaging materials that have been authorised are listed in a publically-available online database maintained by the EFSA.
Food packaging materials are also subject to the EU's Plastics Regulation (EU) No. 10/2011 that addresses the use of all plastic materials intended to come in contact with food. Importantly, Regulation No. 10/2011 establishes an overall migration limit (OML) for plastic products that come in contact with food, as well as specific migration limits (SMLs) and residual quantity in material (QM) limits for certain substances.
Risk assessment and testing
Compliance with the limits prescribed in Regulation No. 10/2011 is verified through a testing scheme described in the Regulation, and plastic food packaging materials are also subject to review and authorisation by the EFSA prior to be placed on the market. In essence, the testing is intended to demonstrate that the packaging material cannot transfer components into food in quantities that could endanger human health, change the composition of the food in an unacceptable way, or cause a deterioration in the taste or odour of the food.
Typically, food simulants that closely mirror specific characteristics of actual food products are used in food packaging testing. Regulation No. 10/2011 provides a list of food simulants, with individual simulants available for testing based on their hydrophilic character, acid content, alcohol content and lipophilic qualities, as well as simulants for dairy products and dry foods.
Package material testing is conducted by putting the material into direct contact with the simulant that most closely matches the food product intended for packaging. Specific testing conditions, for example, testing time and testing temperature, are based on the final anticipated use of the packaging material. In most cases, the actual testing time and testing temperature for a given material is based on the “worst-case” principle, that is, exposure to the most extreme temperature over the longest period of time anticipated under reasonably foreseeable use conditions.
Testing and risk assessment alternatives
Regulation No. 10/2011 explicitly states that, “As migration testing is complex costly and time consuming, it should be admissible that compliance can be demonstrated also by calculations, including modelling, other analysis, and scientific evidence or reasoning if these render results that are at least severe as the migration testing.” The Regulation further states that, “to screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants overestimate migration compared to the regulated food simulant.”
In practice, this means that package material testing can be reduced to an assessment of the material’s performance based on a single food simulant, if it can be scientifically demonstrated that the chosen simulant will produce the highest possible migration result (i.e., worst-case result). In most cases, the food simulant that has the highest solubility will produce the highest migration result, providing the basis for a worst-case analysis. Data regarding the solubility of various types of foods can be easily found in the available scientific literature, speeding the process of selecting a single appropriate food simulant for package material testing purposes.
This approach generally requires a preliminary study of the intended use of the food packaging material as well as extensive chemical expertise. For these reasons, the worst-case approach to food packaging testing is seldom employed by providers of food package material testing services. Yet, the worst-case approach provides a safe and scientifically-based assessment of packaging materials, while significantly reducing the costs associated with package material testing and associated quality control systems.
While following the worst-case approach in evaluating food packaging materials for suitable uses can streamline the overall material approval process, its effective application requires a thorough understanding of the regulations and standards applicable to packaging materials, as well as in-depth scientific knowledge of material chemistry in relation to the unique characteristics of the food targeted for packaging. Therefore, manufacturers of food packaging materials are well advised to seek the advice of a testing organisation with the requisite knowledge and expertise to ensure a prompt assessment of applicable requirements and the development of a cost-effective and efficient material testing plan.
 "Regulation (EC) No. 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come in contact with food and repealing Directives 80/590/EEC and 89/109/EEC," Official Journal of the European Union, November 13,2004. Available here (as of 25 February 2016).
 The “Food Contact Materials” database is available here (as of 25 February 2016).
 “Commission Regulation (EU) No. 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food,” Official Journal of the European Union, January 15, 2011. Available here (as of 25 February 2016).