Time-temperature indicator system based on C. maltaromaticum and acid fuchsin

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Article
Time-temperature indicator system; Carnobacterium maltaromaticum; Acid fuchsin; FCM Substance No 01033; Food contact materials; Active and intelligent materials; Safety evaluation
First published in the EFSA Journal
25 July 2013
Adopted
4 July 2013
Type
Scientific Opinion
Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of a system based on Carnobacterium maltaromaticum and a colour change indicator, acid fuchsin (CAS number 3244-88-0, FCM Substance No 01033), used as a time-temperature indicator on the packaging of chilled food. The micro-organism, the indicator and a nutritive medium gel are incorporated in a multilayer plastic sachet glued onto the outer layer of the food package. All the substances constituting the system, with the exception of acid fuchsin, are authorised as food additives, food colorants or novel food ingredients, or are an enzymatic digest of edible protein sources and yeast edible extract. Specific migration of acid fuchsin was estimated to be less than 7 x 10-9 mg/kg food. Acid fuchsin elicited a positive response in a bacterial gene mutation assay and a negative response in an in vitro micronucleus assay. Given the lack of in vivo studies, the genotoxicity potential of acid fuchsin cannot be ruled out. However, the Panel noted that the layer of the plastic sachet in contact with food contact articles behaves as a barrier which prevents any release of its content (including acid fuchsin), and that the sachet is stuck onto the outer layer of the packaging, hence is not in contact with the food. Thus no exposure to the substances constituting the system from the consumption of the packed food is expected under the intended conditions of use. Therefore, the Panel concluded that the substances of the intelligent system, C. maltaromaticum and acid fuchsin, do not raise a safety concern for the consumer when used in a plastic sachet which prevents any migration from the system into food and which is stuck onto the outer layer of the packaging of chilled food.

Panel members at the time of adoption
Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq, Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá and Detlef Wölfle
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Contact
cef [at] efsa.europa.eu
doi
10.2903/j.efsa.2013.3307
EFSA Journal 2013;11(7):3307 [10 pp.].
Question Number
On request from
“Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes”, France
Print on demand
Number of Pages
10