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
The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.
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