TNO develops innovative approach, Safety assessment of food contact materials (FCM)Published: 03-02-2014
TNO and TNO Triskelion in collaboration have a wealth of experience and expertise in helping food companies comply with the myriad of regulations mandated by various governmental authorities. This experience includes both knowledge of traditional FCM assessment protocols as well as the development of highly innovative assessment techniques that are more efficient and can reduce the all-important “time-to-market” equation.
Traditional approach vs. timesaving innovations
As many readers of this article are aware, the traditional approach to the FCM assessment process is comprised of several stages:
Stage 1: A compliance check
Depending on the intended market, producers need to assess compliance with the different regulations. TNO Triskelion has broad experience in determining whether the food contact materials comply with the relevant regulations, and can advise and assist companies to evaluate compliance. The traditional approach for the compliance check of a food contact material involves the following steps:
- Collection of compositional data starting from the composition of the final food contact material and, if necessary, from all intermediates and raw materials that contribute to the total composition of the sample.
- Administrative verification as to whether the composition of the food contact material complies with the relevant regulation; i.e., the regulatory status of each individual substance within the material will be checked.
- Demonstration of compliance with the regulations through overall migration tests, specific migration tests and determinations of the residual content of relevant components; i.e., analytical check for the overall migration limit and of specific limits for individual substances.
- Determination of the residual content of relevant components.
- Extraction tests according to FDA legislation.
- Issuing of an analytical report and a declaration of compliance.
When using new substances in food contact materials, producers have to demonstrate that the substance is safe for use. Data on the food contact substance, migration data and toxicity data are needed, and a petition dossier has to be compiled and submitted to the authorities.
It is widely recognized that not all substances used in the manufacture of a food contact material will migrate into food products. For those substances that do migrate, many will appear in the food in the same chemical form in which they were incorporated into the food contact materials. Others will migrate partially or appear in another chemical form. Therefore, the safety evaluation also applies to transformation or reaction of products, further complicating the overall evaluation.
Stage 2: Safety evaluation of food contact materials
Depending on the outcome of the compliance check and the migration levels determined, a safety assessment may be required. Traditionally such a safety evaluation is performed for all identified components detected above certain migration limits. This safety assessment may include a toxicological literature review, but may also require genotoxicity experiments or animal feeding studies. However, a traditional safety evaluation is not always feasible given the increasing complexity of food contact materials and ever more stringent legislation.
For example, coatings and paperboard may contain a large number of unidentified substances, including non-intentionally added substances (NIAS). With the current Commission Regulation (EU) 10/2011, all of these components, including NIAS, should be evaluated for their toxicological safety. The risk of such unidentified components can only be assessed through a great deal of experimental work (analytical and toxicological). This is often very time- and animal-consuming. As a result, great improvements in the safety assessment of such complex products are needed to help the food industry succeed in the market introduction of its valuable product innovations.