Scientific Opinion on the safety evaluation of a time-temperature indicator system, based on Carnobacterium maltaromaticum and acid fuchsin for use in food contact materials

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.