Primary aromatic amines (PAA) are chemicals present in a wide variety of situations, as they are used in the production of pesticides, pharmaceuticals, explosives, rubber, epoxy polymers, inks (azo).
PAA can be present and migrate from food contact materials, also as degradation products or impurities; they are used in the manufacture of certain colourants present as impurities in the finished pigments or they can derive from degradation of isocyanates in some kind of adhesives.
Many PAA are toxic compounds and/or suspected human carcinogens; for this reason they are substances of concern in food contact materials, toys and other consumer products (napkins). PAAs are among the substances to control in the control plan established by COMMISSION RECOMMENDATION (EU) 2019/794 of 15 May 2019.
The new draft of 15th amendment of the Plastic Regulation (EU) no. 10/2011 - proposed a different approach towards PAAs migration studies since it considers the primary aromatic amines listed at entry 43 to Appendix 8 of Annex XVII to the REACH, Regulation (EC) no. 1907/2006.
The only PAA with a specified migration limit in the positive list of Plastic Regulation is m-phenylenediamine (0.01 mg/kg). For other PAAs, the draft states:
- amines included in REACH Regulation shall not be detectable using analytical equipment with a limit of detection of 0.002 mg/kg per food or food simulant applied to each individual primary aromatic amine.
- concerning the excluded amines, their sum shall not exceed 0.01 mg/kg in food or food simulant.
Primary Aromatic Amines have been studied for many years: in 2011, JRC issued its Technical guidelines on testing the migration of primary aromatic amines from polyamide kitchenware, which has been a reference for Mérieux NutriSciences Lab.
If the draft amendment is approved as it is, there will be a list of 28 PAAs present in REACH, which will be of interest in the sector of food contact plastics.
Thanks to LC-MS analysis, Mérieux NutriSciences tests the migration of all these primary aromatic amines from packaging.