On September 26, 2019, the German Federal Institute for Risk Assessment (BfR) released a position statement regarding potential health risks posed by colorfully printed paper-based food contact materials (FCMs). The institute experimentally measured the migration of the four substances 3-hydroxy-2-naphthanilide (naphthol AS; CAS 92-77-3), 2′,4′-dimethylacetoacetanilide (NAAX; CAS 97-36-9), acetamide,N-(2-chloro-4-methylphenyl) (NDPA; CAS 2050-43-3), and 3-hydroxy-2-naphthoic acid (HNS; CAS 92-70-6) from paper-containing FCMs using water as a food simulant and a 24 hour contact time at room temperature. Each of the four substances could be present in the FCMs as either starting reactants, impurities, or degradation products of azo dyes used in the printing process.
Currently, no migration limits or health guidelines exist for any of the four substances. Using available toxicological data, consideration of substances with similar structures, and computer models, the BfR determined an acceptable intake level for HNS of 360 μg/day for a person weighing 60 kg. Migration results from the FCM samples tested show no expected risk for this substance. Significantly less data were found to be available for the other three substances, however available information combined with computer models predicts that these three substances or their degradation products could have, unlike HNS, mutagenic and carcinogenic properties. Using a threshold of toxicological concern (TTC) approach, the institute found that adverse human health effects are unlikely to occur below a maximum intake level of 0.15 μg/day for a person weighing 60 kg. However, the migration results from some of the tested FCM samples showed that this maximum level could be exceeded by many times. Packaging paper for bakery products were found to have contamination from several of the substances, while other sampling groups including straws, muffin dishes, and napkins were found to have lower levels. The BfR is advising that any materials that release these substances or their precursors should not be used in contact with food until enough toxicological data is generated to ensure the safety of these substances. Manufacturers are being encouraged to test their starting materials and final products and to switch to alternative materials as necessary.
BfR (September 26, 2019). “Buntbedruckte Bäckertüten, Servietten & Co. können gesundheitsgefährdende Stoffe freisetzen.” (in German) (pdf)