Prioritization before risk assessment: The viability of uncertain data on food contact materials

Abstract

The shortage of data on non-intentionally added substances (NIAS) present in food contact material (FCM) limits the ability to ensure food safety. Recent strategies in analytical method development permit NIAS investigation by using chemical exploration, but this has not been sufficiently investigated in risk assessment context. Here, exploration is utilized and followed by risk prioritization on chemical compounds that can potentially migrate to food from two paperboard FCM samples. Concentration estimates from exploration are converted to tentative exposure assessment, while predicted chemical structures are assessed using quantitative structure-activity relationships (QSAR) models for carcinogenicity, mutagenicity, and reproductive toxicity. A selection of 60 chemical compounds from two FCMs is assessed by four risk assessors to classify compounds based on probable risk. For almost 60% of cases, the assessors classified compounds as either high priority or low priority. Unclassified compounds are due to disagreements between experts (18%) or due to a perceived lack of data (23%). Among the high priority substances are high-concentration compounds, benzophenone derivatives, and dyes. The low priority compounds contained e.g. oligomers from plasticizers and linear alkane amides. The classification scheme provides valuable information based on tentative data and is able to prioritize discovered chemical compounds for pending risk assessment.

Evaluation of the presence of potential hazardous substances from plastic and textile fibre recycling

“…The TTC concept uses tentative exposure data to determine whether intake of a substance is below an acceptable threshold of no concern, defined by assigning a Cramer class based on the chemical structure or so-called structural alerts. TTC is a preliminary assessment tool that has been applied in strategies to detect and evaluate NIAS as described by Koster et al (2014) and Pieke et al (2018a).…”

“…Another approach is proposed by Pieke et al (2018a). They realized that a risk assessment of NIAS is most of the time not possible since much information is missing.…”

“…Most NIAS do not have assigned chemical structures, concentration data or characterization of hazards. In a recent series of publications Pieke et al (2017Pieke et al ( , 2018aPieke et al ( , 2018b described the use of explorative methods to determine NIAS in food contact materials and concluded that untargeted analytical strategies are useful to estimate the concentration and chemical structure of NIAS. However, a comprehensive analysis of all substances found via exploration is not realistic and therefore a risk prioritization is required to identify the substances that most likely have adverse health effects.…”

“…In silico tools are essentially computer models, able to make predictions for a non-evaluated substance based on knowledge extracted from a collection of structurally related substances with experimental toxicity data. Quantitative structure-activity relationship (QSAR) modelling of chemical hazard may provide substitute toxicity data if testing is prohibitive, which has successfully been applied to FCM for hazard-based assessment and prioritization by Van Bossuyt et al (2017) and by Pieke et al (2018a).…”

Review of analytical approaches for the identification of non-intentionally added substances in paper and board food contact materials

“…The TTC concept uses tentative exposure data to determine whether intake of a chemical is below an acceptable threshold of no concern, defined by assigning a Cramer class based on the chemical structure or so-called structural alerts. TTC is a preliminary assessment tool that has been applied in strategies to detect and evaluate NIAS as described by Koster et al (2014) and Pieke et al (2018a). Koster et al (2014) published an extensive report on a safety assessment strategy for detecting unknown NIAS in carton FCMs.…”