The Parma-based agency announced earlier this month (Feb) that use of additive 3,9-bis[2-(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy)-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5,5]undecane posed no concern for human health as long as migration and its oxidation product does not exceed 0.05 mg/kg food.
The substance is intended for use as a stabilizer at a maximum content of 50 mg/kg polyolefins for contact with all kind of foodstuffs for short term contact at high temperatures and long term storage at/or below room temperature.
Efsa’s CEF panel of experts reviewed the substance after a referral from the German body, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, on behalf of Sumitomo Chemical Company Ltd.
No genotoxicity
The substance was evaluated the European Commission’s Scientific Committee of Food (SCF) in 1997 (EC, 1998).
It was classified in SCF List 7 due to the lack of data demonstrating absence of accumulation in vivo especially in liver and fat.
Under EC classification, List 7 substances are those for which some toxicological data exist, but for which an acceptable daily intake (ADI) or a tolerable daily intake (TDI) could not be established. The required additional information needs to be obtained, adds Brussels.
The Efsa panel confirmed that while no new toxicological tests had been submitted for this evaluation new migration tests had been carried out.
“Based on the lack of genotoxicity in three in vitro genotoxicity tests provided, the substance and its oxidation product are considered non-genotoxic,” said the safety watchdog.
The substance was also tested in a 90-day oral toxicity study in rats. The ‘no observable effects level (NOAEL) in this study was considered to be 100 mg/kg diet corresponding to 8 mg/kg bw/day based on a significant and dose related increase in absolute and relative liver and kidney weights.
The substance is highly lipophilic and no data demonstrating the absence of accumulation in man were provided, said the agency.
Based on the data the CEF Panel concluded that that the use of the substance is not of safety concern for the consumer if the sum of the migration of the substance and its oxidation product does not exceed 0.05 mg/kg food.
It also recommended that for enforcement purposes, the Fat (Consumption) Reduction Factor (FRF) may be applied to the migration
The application has CAS No 90498-90-1, REF. No 38565, and FCM substance No 858.
To read the full opinion click HERE