In an article published on March 25, 2019, the European Food Safety Authority (EFSA) announced that it has developed and published a guidance introducing a “harmonized framework to use across its scientific panels when evaluating the potential ‘combined effects’ of chemical mixtures in food and feed.” Also published is a technical document summarizing the outcomes of a public consultation on the draft guidance that was held in 2018 (FPF reported). The new guidance “gives . . . the tools to follow a mixtures approach when needed, which complements the current EU regulatory requirements for assessing single substances.”
EFSA explains that the proposed methodology “is based on the risk assessment steps (problem formulation, exposure assessment, hazard identification and characterization, and risk characterization including uncertainty analysis), with tiered and stepwise approaches for both whole mixture approaches and component-based approaches.” Further, the guidance gives “specific considerations. . . to component-based approaches including the grouping of chemicals into common assessment groups, the use of dose addition as a default assumption, approaches to integrate evidence of interactions and the refinement of assessment groups.” In addition, several case studies are presented “to explore the feasibility and spectrum of applications of the proposed methods and approaches for human and animal health and ecological risk assessment.” The EFSA’s Scientific Committee “considers that this Guidance is fit for purpose for risk assessments of combined exposure to multiple chemicals and should be applied in all relevant areas of EFSA’s work.”
On the same day, EFSA also published a survey-based research study that characterized “consumers’ understanding and views” on the topic of chemical mixtures and risk assessment. In a press release, EFSA summarized that this study showed “that overall in the EU awareness of chemical mixtures among the general public is quite low.” More precisely, however, the study’s findings have indicated “that consumer[s] are well-aware of man-made chemicals, but less so of naturally-occurring chemicals.” Further, consumers were found to “have low awareness of chemical mixtures and the risk assessment process,” but “their level of concern from being exposed to combined effects of chemicals in food is high.” The study also observed that the consumer perceptions of risk are “influenced by the general perception that chemicals are man-made and therefore pose a greater risk to human health than other substances or products considered natural.” In response, EFSA has developed an interactive multimedia tool aiming “to help people understand some of the main issues and concepts, such as ‘combined exposure’ and ‘combined toxicity.’”
EFSA (March 25, 2019). “Mixtures methodology equips EFSA for multiple chemicals.”
EFSA (2019). “When chemicals mix. Assessing the risks to humans, animals and the environment.” Interactive multimedia tool
Chemical Watch (March 28, 2019). “Efsa publishes final version of mixtures guidance.”
EFSA (March 25, 2019). “Guidance on harmonized methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals.” EFSA Journal 17:e05634.
EFSA (March 25, 2019). “Technical report on the public consultation on the draft ‘Guidance on harmonized risk assessment methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals.’” EFSA Supporting Publications 16:1589E.
EFSA (March 25, 2019). “EU Insights. Chemical mixtures awareness, understanding and risk perceptions.” EFSA Supporting Publications 16:1602E.