The intelligent system is based on a non-pathogenic micro-organism C. maltaromaticum which is used together with a colour change indicator, acid fuchsin, and a gel made of a nutritive medium.
Depending on the time-temperature profile experienced by the system, C. maltaromaticum grows using the carbon source of the medium and releases substances that cause a change of pH and consecutively a change of the colour from green to red.
This change is used to monitor whether the cold chain has been maintained.
EFSA received an application from the Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes, France.
The application was submitted by Cryolog, France and was evaluated by EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF).
C. maltaromaticumis used together with a colour change indicator (acid fuchsin) and a nutritive medium gel.
The strain of C. maltaromaticum used in the intelligent system produces a biogenic amine (tyramine).
Fuchsin is not authorised as a food additive, colorants or novel ingredient, or an enzymatic digest of edible protein sources and yeast edible extract.
The micro-organism, colour indicator and gel are placed in a plastic sachet which is stuck onto the outer layer of the food package using a hot-melt adhesive so that the sachet and its contents are not in contact with the food.
Sachet prevents migration
The sachet is intended to act as a barrier to prevent any migration of the contents from the sachet and intended applications are for all types of chilled foods stored at temperatures between 2 °C and 12 °C for a few hours up to eight days.
Specific migration of acid fuchsin was estimated to be less than 7 x 10(-9) mg/kg food and elicited a positive response in a bacterial gene mutation assay and a negative response in anin vitromicronucleus assay, said the panel.
It said 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 and is not in contact with the food.
So no exposure to the substances constituting the system from the consumption of the packed food is expected under the intended conditions of use.
Although the genotoxicity potential of the colour change indicator acid fuchsin cannot be ruled out, the panel concluded that the substances of the intelligent system, C. maltaromaticum and acid fuchsin, do not raise a safety concern for the consumer.