Assessment of new information on Bisphenol S (BPS) submitted in response to the Decision 1 under REACH Regulation (EC) No 1907/2006

First published in EFSA Supporting Publications
16 Abril 2020
Type
Technical Report

Abstract

Bisphenol S (BPS) is currently authorised under Regulation (EU) No 10/2011 to be used as a monomer in plastic food contact materials (FCM)with a Specific Migration Limit (SML) of 0.05 mg/kg food.The European Commission (EC) asked EFSA to assess the impact on the current authorisation of BPS in plastic FCM of the newly generated studies submitted by the Registrant(s)of BPS in response to the European Chemical Agency (ECHA)'s Decision on the substance evaluation under the REACH Regulation (EC) No 1907/2006.These studies include anExtended One Generation Reproductive Toxicity Study (EOGRTS), with developmental‐ neurotoxicity (DNT) and ‐immunotoxicity (DIT) cohorts(OECD test guideline (TG) 443), and a toxicokinetic (TK) study (OECD TG 417) in rats.The lowest NOAEL from the EOGRTSwas identified for developmental toxicity and developmental immunotoxicity at the lowest BPS dose tested of 20 mg/kg bw per day. The mid‐dose of 60 mg/kg bw per day was the NOAEL for general systemic toxicity, whereas developmental neurotoxicity, fertility and reproductive performance were not affected even at the highdose tested of 180 mg/kg bw per day.The new kinetic data support that BPS is rapidly metabolised and eliminated from rats.Based solely on the studies above, EFSA concluded that the lowest NOAEL of 20 mg/kg bw per day from the EOGRTS neither affects the current SML for BPS of 0.05 mg/kg food nor BPS current authorisation under Regulation (EU) No 10/2011. EFSA is nonetheless aware that other toxicological studies have been published since BPS authorisation.This report does not take into consideration the full toxicological dataset available for this compound.EFSA recommends the collection of data on the use of BPS in plastic FCM and on its occurrence and migration intofoodin the context of its possible use as an alternative to bisphenol A (BPA).

Contact
fip [at] efsa.europa.eu
doi
10.2903/sp.efsa.2020.EN-1844
Question Number
On request from
European Commission