Migration tests

The EU Framework Regulation 1935/2004 stipulates that packaging articles and materials may not release their constituents into food at levels harmful to human health or result in the deterioration of the organoleptic properties of the food.

Ever since the photoinitiator isopropylthioxanthone (ITX) was found in concentrations of up to 450 µg/kg in baby food in autumn 2005, both food surveillance authorities and consumers are aware of this issue.

The previously ignored components of printing inks used for food packaging have become the focus of interest. For all substances for which there is insufficient toxicological data and whose molecular weight is less than 1000 Da, 10 µg/kg (10 ppb) was set as the maximum specific migration limit.

Depending on the manufacturing process, components of the printing inks, in particular photoinitiators and acrylate monomers, can migrate into the filling material by set-off migration (contact) or through diffusion.

As part of their due diligence, both the suppliers of printing inks and the packaging manufacturers must have the migration potential of their products analysed.

To protect patients, manufacturers of pharmaceutical products must ensure that no harmful substances migrate from the primary packaging into medicinal products. This is why the packaging of pharmaceutical formulations is tested for extractables and leachables. The analysis begins with an examination of the packaging and the medicinal product packed in it. After the packaging material has been extracted under extreme conditions, the extractables contained in the extraction solution are analyzed. The components that can migrate from the packaging to the medicinal products under normal conditions (e.g., during a stability study) (leachables) are then quantified in the pharmaceutical formulations using specific analysis methods.

We are an experienced service provider for these studies. We design migration studies with realistic conditions using standardised migration cells and of course taking into account the relevant legislative regulations. By using GC-MS-MS, LC-MS-MS and the QTOF-MS, we are then able to determine almost all of the substances in question with high selectivity and sensitivity.

So far, we have developed methods for more than 200 ink components to determine their specific migration. We have also established an analytical method to determine overall migration.