Primary aromatic amines (PAA) may be present in food contact materials as, for example, residual- or by-products of the synthesis of azo colourants and other colour pigments. Besides, they may be formed by hydrolysis from residual isocyanates used in PU-adhesives or other polyurethanes in contact with aqueous food or food simulants. Thus, in food contact applications, these substances may migrate from the packaging material into the packed foodstuffs.
Compounds of this substance class are in the public focus because of their toxicological properties. Therefore, a risk assessment for the transfer of primary aromatic amines from a food contact material into the contacting food needs to be performed. Food contact plastic materials and articles are subject to the provisions of the European Plastics Regulation (EU) No 10/2011. The restrictions concerning the migration of primary aromatic amines have been tightened with the latest amendment, Regulation (EU) No 2020/1245. Primary aromatic amines listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 shall not be released from plastic materials and articles into food or food simulant applying a limit of detection of 0.002 mg/kg food(simulant) for each individual primary aromatic amine. The sum of the other primary aromatic amines shall not exceed 0.01 mg/kg in food(simulant).
The potential transfer of primary aromatic amines into food is evaluated based on migration tests using food simulants. The analysis is usually performed with aqueous-acidic food simulants applying the testing conditions as laid down in Regulation (EU) No 10/2011. However, internal studies have shown that certain primary aromatic amines are not stable at migration contact conditions in the food simulant. This may result in an underestimation of migration and food contact articles may be evaluated as compliant although migration of primary aromatic amines in real foodstuffs cannot be excluded. The scope of the project is a systematic stability analysis of selected primary aromatic amines at different migration or storage conditions. The project aims to optimize migration testing in food simulants with regard to a realistic representation and evaluation of migration of primary aromatic amines.