Characterizing the Coverage of Critical Effects Relevant in the Safety Evaluation of Food Additives by AOPs

Adverse outcome pathways (AOPs) are often used by several chemical sectors to organize biological and toxicological information and assist in data interpretation and method development. However, this approach is rarely used in the food sector. Thus, during the present study, safety evaluation reports of 326 food additives (included in the Annex II of Regulation (EC) No 1333/2008 of the European Union) were screened to qualitatively and quantitatively characterize toxicity induced in laboratory animals. The results were then used to identify the critical adverse effects used for risk assessment and to investigate whether food additives share common AOPs. The analysis indicated that often such scrutiny of AOPs was not possible or necessary as for 69% of the food additives, the report did not document any adverse effects in studies based on which the safety evaluation was performed. For the remaining 31%, critical adverse effects and related points of departure could be identified, involving mainly effects on the liver, kidney, cardiovascular system, lymphatic system, central nervous system and reproductive system. The results also highlighted that AOPs for other adverse outcomes pertinent to food additives, including gastrointestinal irritation and corrosion are lacking and thus future studies should focus on developing AOPs for these particular endpoints.

The paper is available here as open access.

For more information please visit the New Approaches to Chemical Risk Assessment for Food and Food Ingredients Task Force webpage.