Final Report: Applying a tested procedure for the identification of potential emerging chemical risks in the food chain to the substances registered under REACH ‐ REACH 2

Abstract

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

Potential emerging chemical risks in the food chain associated with substances registered under REACH

“…The materials and methods for the multi-step procedure are described in detail elsewhere. 3,4,7 Briey, eligible substances were rst selected from among all substances registered under the REACH Regulation. These eligible substances were then evaluated with respect to environmental releases (block A), biodegradation (blocks B), bioaccumulation in food/feed (block C) and chronic toxicity, which involved scoring in each of the four blocks.…”

“…These procedures are described in detail elsewhere. 7 Substance selection for evaluation of the four blocks. All substances registered under the REACH Regulation were extracted from the website of the European Chemicals Agency (ECHA) 9 in January 2017 as a single spreadsheet le.…”

“…All the evaluation and curation steps in the substance selection process are described in detail elsewhere. 7 Evaluation of the four blocks (environmental releases, biodegradation, bioaccumulation and toxicity)…”

“…Full details of this approach and comparisons with experimental biodegradation data from REACH registration dossiers are described elsewhere. 3,7 Bioaccumulation in food feed (block C). Bioaccumulation was assessed on the basis of ACC-HUMANsteady 5,6 modelling as described previously.…”

“…3 This paper presents the results of the application of the rened methodology to a large set of substances registered under REACH in a second EFSA-sponsored study. While the methodology and detailed results have been published by EFSA in an external scientic report, 7 this paper presents key ndings and conclusions, with a focus on the substance selection, evaluation and prioritisation results in the overall workow, and reality checks carried out by additional analyses and evaluations.…”