The objective of this study was to develop and test a procedure for the identification of chemicals registered under the REACH Regulation that are of potential health concern and are likely to occur in the food chain. For this purpose, 100 data-rich substances registered under REACH together with four positive controls were evaluated. The evaluation of the 104 substances took into account parameters related to exposure (tonnage, release, biodegradation and potential bioaccumulation) and toxicity (repeated dose toxicity, genotoxicity and reproductive toxicity) organised in six blocks. All substances were scored for each block. ACC-HUMANsteady software was used to evaluate the potential for bioaccumulation in eleven different food items using input data derived from QSAR predictions. The extraction of the relevant experimental data generated under REACH was successful, but encountered several problems in relation to the data extraction process and subsequent evaluation steps. Several weighting scenarios were tested to aggregate scores for the six blocks into a total score to enable a ranking of the 104 substances. Scenarios that assigned high total scores to chemicals that combined high scores in the exposure blocks with high scores in the toxicity blocks identified a set of substances of potential concern (including the positive controls). In addition, a Pivot table selection was implemented that can be used without weighting. Further analyses compared the scores derived from experimental data with those derived from predicted data. These analyses found a good agreement of scores for biodegradability, but considerable disagreement of scores for toxicity endpoints. In conclusion, a scoring and ranking procedure was developed for the identification of chemicals of potential concern in the food chain (potential emerging risks) that showed a good level of differentiation. The focus on (semi-)automated processes ensures that this procedure can be applied to all chemicals registered under the REACH Regulation. © European Food Safety Authority

This study applied a procedure for the identification of potential emerging chemical risks in the food chain to substances registered under the REACH Regulation that was previously developed and tested in an EFSA‐sponsored pilot study. The selection was limited to substances that (a) were registered with a full registration, (b) met eligibility criteria (e.g. availability of a CAS number and a SMILES notation) and (c) were considered to be inside the applicability domain of the models used in this study (excluding e.g. ionisable compounds and metals). This selection reduced the number of substances from about 15 000 to 2 336 substances that were subsequently assessed in four blocks: environmental releases (based on tonnage and use pattern), biodegradation (using BIOWIN predictions assessed in a battery approach), bioaccumulation in food/feed (using ACC‐HUMANsteady modelling) and toxicity (based on classification for carcinogenicity, mutagenicity, reprotoxicity and repeated dose toxicity). A scoring system was applied with a maximum score of 10 in each of the four blocks. The procedure showed a good degree of differentiation in each block. Two weighting scenarios and pivot table selections were applied to the scores in the four blocks. An evaluation of both approaches led to the prioritisation of substances for their potential to represent ‘emerging chemical risks’ in the food chain. Following additional curation steps, 212 ‘potential emerging risks’ were identified that are considered to (a) be released to the environment and/or poorly biodegraded, (b) bioaccumulate in food/feed and (c) represent a chronic human health hazard. In this study, in‐depth evaluations were performed for ten ‘potential emerging risks’ that so far have not been assessed by an EU regulatory body for their presence in food via the investigated exposure pathway. The selection of these ten substances does not imply that the remaining 202 potential emerging risks are of lower priority

The European Food Safety Authority (EFSA) is responsible for risk assessment of all aspects of food safety, including the establishment of procedures aimed at the identification of emerging risks to food safety. Here, a scoring system was developed for identifying chemicals registered under the European REACH Regulation that could be of potential concern in the food chain using the following parameters: (i) environmental release based on maximum aggregated tonnages and environmental release categories; (ii) biodegradation in the environment; (iii) bioaccumulation and in vivo and in vitro toxicity. The screening approach was tested on 100 data-rich chemicals registered under the REACH Regulation at aggregated volumes of at least 1000 tonnes per annum. The results show that substance-specific data generated under the REACH Regulation can be used to identify potential emerging risks in the food chain. After application of the screening procedure, priority chemicals can be identified as potentially emerging risk chemicals through the integration of exposure, environmental fate and toxicity. The default approach is to generate a single total score for each substance using a predefined weighting scenario. However, it is also possible to use a pivot table approach to combine the individual scores in different ways that reflect user-defined priorities, which enables a very flexible, iterative definition of screening criteria. Possible applications of the approaches are discussed using illustrative examples. Either approach can then be followed by in-depth evaluation of priority substances to ensure the identification of substances that present a real emerging chemical risk in the food chain.

A screening procedure for the identification of potential emerging chemical risks in the food and feed chain developed in a previous EFSA-sponsored study was applied to 15021 substances registered under the REACH regulation at the time of evaluation.

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