On April 16, 2020, the European Food Safety Authority (EFSA) published a technical report assessing new information on bisphenol S (BPS; CAS 80-09-1) submitted by registrants under the EU REACH regulation. BPS is currently authorized for use in food contact materials (FCMs) with a specific migration limit (SML) of 0.05 mg/kg food. The European Commission (EC) asked EFSA to assess the impact that these new studies could have on the current authorization of BPS in plastic FCMs (EFSA Question 2019-00299).
The technical report considered two newly published studies on BPS. The first is an Extended One Generation Reproductive Toxicity Study (EOGRTS) focusing on developmental neurotoxicity (DNT) and developmental immunotoxicity (DIT) cohorts (OECD test guideline (TG) 443). The second is a toxicokinetic (TK) study in rats performed according to OECD TG 417. The new kinetic data from the studies “support that BPS is rapidly metabolized and eliminated from rats.” Based on these two studies “EFSA concluded that the lowest NOAEL [No Observed Adverse Effect Level] of 20 mg/kg [body weight] per day from the EOGRTS neither affects the current SML for BPS of 0.05 mg/kg food nor BPS current authorization under Regulation (EU) No 10/2011.”
The agency acknowledges that other toxicological studies have been published meanwhile and therefore this report “does not take into consideration the full toxicological dataset available for this compound.” It recommends that data is collected on the use of BPS in plastic FCMs and on its occurrence in and migration into food. This should be done to determine its potential use as an alternative to bisphenol A (BPA; CAS 80-05-7).
Chemical Watch (April 22, 2020). “Efsa: BPS food contact authorisation unaffected by new REACH data.”