Scientific Opinion on the safety evaluation of the substance, 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt, CAS No. 128-44-9, for use in food contact materials


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2012;10(3):2640 [9 pp.].
Possible conflict of interest
One member of the Panel declared an interest as his laboratory carried out experimental migration testing used in the application. This was considered as a conflict of interest and he was asked to leave the room during discussion and vote.
Panel Members
Ulla Beckman Sundh, Mona-Lise Binderup, Leon Brimer, Laurence Castle, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean-Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Fidel Toldrá and Detlef Wölfle

The Panel wishes to thank the members of the Working Group on Food Contact Materials for the preparation of this opinion: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Eugenia Lampi, Jean-Claude Lhuguenot, Maria Rosaria Milana, Karla Pfaff, Fatima Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the support provided to this EFSA scientific output.

Opinion of the Scientific Committee/Scientific Panel
On request from
Bundesamt für Verbraucherschultz und Lebensmittelsicherheit, Germany
Question Number
22 March 2012
Published in the EFSA Journal
28 March 2012
European Food Safety Authority (EFSA), Parma, Italy

This scientific opinion of EFSA deals with the risk assessment of the additive 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (saccharin, sodium salt), with CAS No 128-44-9 and FCM Substance No 902, for use as a nucleating agent up to 0.1% w/w in polyesters. The substance has been evaluated by the SCF in 1995 which concluded that it is appropriate to set a full ADI for sodium saccharin of 0-5 mg/kg bw. Under the present evaluation, the CEF Panel concluded that the use of the substance, as additive in polyesters, is not of safety concern for the consumer. The substance should comply with the specific purity criteria as set in Directive 2008/60/EC.

1,2-Benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt; Saccharin, sodium salt; CAS number 128-44-9; FCM substance No 902; Food contact materials; Safety assessment; Evaluation
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