A novel safety assessment strategy for non-intentionally added substances (NIAS) in carton food contact materials

Abstract

One of the main challenges in food contact materials research is to prove that the presence of non-intentionally added substances (NIAS) is not a safety issue. Migration extracts may contain many unknown substances present at low concentrations. It is difficult and time-consuming to identify all these potential NIAS and concurrently to assess their health risk upon exposure, whereas the health relevance at low exposure levels might not even be an issue. This paper describes a scientifically based, but pragmatic safety assessment approach for unknown substances present at low exposure levels in food contact matrices. This complex mixture safety assessment strategy (CoMSAS) enables one to distinguish toxicologically relevant from toxicologically less relevant substances, when related to their respective levels of exposure, and allows one to focus on the substances of potential health concern. In particular, substances for which exposure will be below certain thresholds may be considered not of health relevance in case specific classes of substances are excluded. This can reduce the amount of work needed for identification, characterisation and evaluation of unknown substances at low concentration. The CoMSAS approach is presented in this paper using a safety assessment of unknown NIAS that may migrate from three carton samples.

Keywords:

• non-intentionally added substances
• NIAS
• food contact materials
• food matrix
• safety
• assessment
• evaluation
• complex mixture safety assessment strategy
• CoMSAS
• TTC
• threshold of toxicological concern

Acknowledgements

Wim Traag and Hans Mol from RIKILT are acknowledged for performing the dioxin analysis. Ajan Verhoef, Roel Engel, Suryati Sunarto, Joyce Bezemer, Elly Spies-Faber, Sandra Steegman and Yvonne Schouten from TNO Triskelion are acknowledged for their contribution to this paper. Michèle van den Wijngaard from TNO Triskelion and Mariska Gröllers-Mulderij from TNO are acknowledged for their work on the BlueScreen HC assay. Guidance in the definition of IAS and NIAS is currently being prepared by a working group of the European Branch of the International Life Sciences Institute (ILSI Europe) dealing with NIAS; the aim is for it to be available in 2014.