Recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials

Abstract

This Opinion describes recent developments in the safety assessment of chemicals in food and explores their potential impact on EFSA evaluation of food contact materials (FCM). It is not intended to be a guidance document. The draft opinion was subject to a public consultation and this final Opinion takes into account the scientific comments received. The Opinion will provide the European Commission with the scientific basis for a discussion among risk managers on possible implications for risk management. One major area to revisit is the estimation of consumer exposure. Four food consumption categories could be set. They are approximately 9, 5, 3 and 1.2 times higher than the current SCF default scenario, i.e. 17 g/kg bw per day, and so using them would afford a higher level of protection, particularly for infants and toddlers. Special exposure scenarios might be used if consumption were lower. The amount of toxicity data needed should be related to the expected human exposure. The tiered approach of the SCF is updated. For substances used in FCM, genotoxicity testing is always required, even if their migration leads to a low exposure. Beyond this, three threshold levels of human exposure, namely 1.5, 30 and 80 μg/kg bw per day, are proposed as triggers for the requirement for additional toxicity data. Regarding the identification and evaluation of migrating substances, experience has shown that more focus is needed on the finished materials and articles. Considering the non-intentionally added substances (NIAS), such as impurities of the substance along with reaction and degradation products including oligomers, the same approach as is used for authorised substances could, in principle, be applied for their toxicological assessment, as the same degree of safety should be warranted for all migrating substances. However, non-testing methods could have increased importance for the assessment of genotoxicity of NIAS.

Evaluation of the Suitability of Mammalian In Vitro Assays to Assess the Genotoxic Potential of Food Contact Materials

“…Direct-acting agents or their metabolites usually cause gene mutations, such as point mutations, insertions or deletions, or structural damage, including clastogenicity [24]. Due to the toxicological severity, these substances are treated in a non-threshold manner [4]. On the other hand, molecules/mixtures acting via an indirect MoA are those able to induce DNA-damage via other cellular mechanisms and are treated in a threshold manner.…”

“…Considering the lack of toxicological information to perform a risk assessment of FCM, the integration of a safe level concept into the approach is proposed. The European Food Safety Agency (EFSA) suggests applying the threshold of toxicological concern (TTC) concept for the assessment of FCM [4]. The TTC concept is a screening and prioritization approach for toxicological safety assessment, when there are limited toxicity data available or when hazard data are incomplete.…”

Optimization of mass spectrometry acquisition parameters for determination of polycarbonate additives, degradation products, and colorants migrating from food contact materials to chocolate

“…21 The resolving power of the Orbitrap mass analyzer diminishes as the square root of the m/z ratio. 2,5 Acquiring data at higher resolving power results in better mass accuracy, but the scan duration increases with increasing resolving power. Therefore, the best compromise between speed, accuracy, and identification rates has to be reached.…”

“…Moreover, the same approach used for authorized substances should be applied for the toxicological assessment of NIAS, as the same degree of safety should be warranted for all migrating substances. 5 Polycarbonates (PC) are linear polyesters of unstable carbonic acid that are produced by reacting phosgene with bisphenol A (BPA). PCs are used as components in containers exposed to hot filling or hot processing after filling.…”

Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal health

“…There are already several EFSA guidance documents that include the concept of the 'size' of substances, e.g. from the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) ('Guidance for the preparation of dossiers for sensory additives', EFSA FEEDAP Panel, 2012a) and from the Panel on Food Contact Materials (FCM), Enzymes, Flavourings and Processing aids (CEF Panel) (EFSA CEF Panel, 2016a). For polymers used in FCM, for instance, the general rule is that smaller sized additives migrate faster and at higher rates than those of larger sizes.…”