TY - JOUR
T1 - Safety assessment of the substance isobutane, for use in food contact materials
AU - EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
AU - Silano, Vittorio
AU - Bolognesi, Claudia
AU - Chipman, Kevin
AU - Cravedi, Jean Pierre
AU - Engel, Karl Heinz
AU - Fowler, Paul
AU - Franz, Roland
AU - Grob, Konrad
AU - Gürtler, Rainer
AU - Husøy, Trine
AU - Kärenlampi, Sirpa
AU - Mennes, Wim
AU - Milana, Maria Rosaria
AU - Pfaff, Karla
AU - Riviere, Gilles
AU - Srinivasan, Jannavi
AU - Poças, Maria de Fátima Tavares
AU - Tlustos, Christina
AU - Wölfle, Detlef
AU - Zorn, Holger
AU - Kolf-Clauw, Martine
AU - Lampi, Eugenia
AU - Svensson, Kettil
AU - Lioupis, Alexandros
AU - Castle, Laurence
PY - 2018/1
Y1 - 2018/1
N2 - 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 (E 943b) to be used quantum satis as a gas propellant only in vegetable oil pan spray (for professional use only) and water‐based emulsion spray according to Regulation (EC) No 1333/2008. The purity requirements for the use of isobutane as a food additive are described in Commission Regulation (EU) No 231/2012. 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°C for 10 days ranged from 0.2 to 0.4 mg/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/m3 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.
AB - 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 (E 943b) to be used quantum satis as a gas propellant only in vegetable oil pan spray (for professional use only) and water‐based emulsion spray according to Regulation (EC) No 1333/2008. The purity requirements for the use of isobutane as a food additive are described in Commission Regulation (EU) No 231/2012. 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°C for 10 days ranged from 0.2 to 0.4 mg/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/m3 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.
KW - CAS No 75-28-5
KW - E 943b
KW - FCM Substance No 1069
KW - Foaming agent
KW - Food contact materials
KW - Isobutane
KW - Polystyrene
KW - Safety assessment
UR - http://www.scopus.com/inward/record.url?scp=85062078435&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2018.5116
DO - 10.2903/j.efsa.2018.5116
M3 - Article
C2 - 32625667
AN - SCOPUS:85062078435
SN - 1831-4732
VL - 16
JO - EFSA Journal
JF - EFSA Journal
IS - 1
M1 - e05116
ER -