Final report: Testing a procedure for the identification of emerging chemical risks in the food chain. External Scientific Report. OC/EFSA/SCER/2014/03

Abstract

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

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

“…Releases to the environment are assessed on the basis of the tonnage manufactured and/or imported in the EU and the uses of a substance with respect to potential releases to the environment. The latter is evaluated on the basis of Environmental Release Categories (ERCs) assigned in REACH registration dossiers to the specific uses of a substance (Bitsch et al, 2016).…”

“…The maximum score for both the Tonnage Score and the ERC Score is 5. The maximum Total Score A is therefore 10 (Bitsch et al, 2016).…”

EFSA's activities on emerging risks in 2017

“…The procedure was tested in a pilot study that was finalised at the end of 2016 (Bitsch et al, 2016). The procedure was tested in a pilot study that was finalised at the end of 2016 (Bitsch et al, 2016).…”

EFSA's Activities on Emerging Risks in 2016

“…The focus on (semi-)automated processes ensures that this procedure can be applied to all chemicals registered under the REACH Regulation. The project is concluded and a final report was published in June 2016 (Bitsch et al, 2016) A follow-up project is planned for 2017 where the proposed revised methodology is applied to the entire REACH database.…”

“…Ranking results from the two most suitable weighting scenarios (I and II) (adapted from Bitsch et al, 2016) 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.…”