EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Silano, Vittorio, Bolognesi, Claudia, Chipman, Kevin, Cravedi, Jean-Pierre, Engel, Karl‐Heinz, Fowler, Paul, Franz, Roland, Grob, Konrad, Gürtler, Rainer, Husøy, Trine, Kärenlampi, Sirpa, Mennes, Wim, Milana, Maria Rosaria, Pfaff, Karla, Riviere, Gilles, Srinivasan, Jannavi, Tavares Poças, Maria de Fátima, Tlustos, Christina, Wölfle, Detlef, Zorn, Holger, Kolf‐Clauw, Martine, Lampi, Eugenia, Svensson, Kettil, Lioupis, Alexandros, Castle, Laurence, ToxAlim (ToxAlim), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Ecole d'Ingénieurs de Purpan (INPT - EI Purpan), and Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Recherche Agronomique (INRA)
International audience; The substance isobutane is intended to be used as a foaming agent at max 4.5% to produce expanded polystyrene (EPS) to be used for packaging foods, such as fruits, vegetables, meat, fish and cheese, at room temperature or lower. Isobutane is approved in Europe as a food additive (E943b) to be used quantumsatis as a gas propellant only in vegetable oil pan spray (for professional use only) and water-based emulsion spray according to Regulation (EC) No1333/2008. The purity requirements for the use of isobutane as a food additive are described in Commission Regulation (EU) No231/2012. The substance is a gas at room temperature. It is a saturated hydrocarbon, obtained with a high level of purity, and is not expected to react under the processing conditions used to make foamed polystyrene materials and articles. Data on migration of isobutane from trays at 20 degrees C for 10days ranged from 0.2 to 0.4mg/kg food. Considering the intended applications, estimated exposure is extremely low based on migration data. In the absence of genotoxicity alerts and given the very low toxicity following repeated exposure with no observed adverse effect concentration (NOAEC) of several thousands of mg/m(3) by inhalation, it was considered that the use of isobutane as a foaming agent, at the expected exposure from food, does not raise a safety concern.