The European Food Safety Authority (EFSA) opinion on PFAS: Past and present
In 2008 the European Food Safety Authority (EFSA) established a Health Based Guidance Value (HBGV) for PFOS of 150 ng/kg bw/day based on changes in lipids and thyroid hormones in monkeys; and of 1500 ng/ kg bw/day for PFOA based on increased liver weights in rats. After that publication several European agencies published their own opinions on polyfluoroalkyl substances (PFAS) reaching slightly different conclusions. As an example, in 2016 the National Institute for Public Health and the Environment (RIVM), Netherlands, set a HBGV of 12.5 ng/kg bw/day for PFOA using the same critical study as EFSA in 2008. A new EFSA opinion was published in 2018 were increase in liver enzymes, serum lipids and immune suppression were identified as critical outcomes based on human studies. A HBGV of 13 ng/kg bw/week for PFOS and 6 ng/kg bw/week for PFOA was derived based on changes in serum lipids. These 100-1000-fold lower values are partly in line with the approach taken by the German Human Biomonitoring (HBM) Commission that derived HBM-I values for PFOA and PFOS in plasma of 2 ng/mL and 5 ng/mL using human studies. The EFSA 2018 opinion ended in a formal divergency process with several European agencies, which resulted in further revision of the opinion in late 2018. A draft revision was submitted for public consultation in February 2020. In that draft opinion a mixture approach was taken for the PFHxS, PFOS, PFOA and PFNA and where a tolerable weekly intake of 8 ng/kg bw per week for the sum of four substances was established. In this presentation the main points of friction and results from past opinions will be explained along with the results and conclusion from the EFSA 2020 opinion.