Open AccessAssessment of the impact of the IARC Monograph Vol. 121 on the safety of the substance styrene ( FCM No 193) for its use in plastic food contact materials
Author(s) -
Silano Vittorio,
Barat Baviera José Manuel,
Bolognesi Claudia,
Chesson Andrew,
Cocconcelli Pier Sandro,
Crebelli Riccardo,
Gott David Michael,
Grob Konrad,
Lambré Claude,
Lampi Evgenia,
Mengelers Marcel,
Mortensen Alicja,
Steffensen IngerLise,
Tlustos Christina,
Van Loveren Henk,
Vernis Laurence,
Zorn Holger,
Castle Laurence,
Di Consiglio Emma,
Franz Roland,
Hellwig Nicole,
Milana Maria Rosaria,
Pfaff Karla,
Carfi Maria,
Van Haver Ellen,
Rivière Gilles
Publication year - 2020
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2020.6247
Subject(s) - food contact materials , styrene , environmental health , european commission , inhalation exposure , food packaging , international agency , inhalation , population , exposure assessment , medicine , toxicology , occupational exposure , food science , chemistry , european union , cancer , biology , business , organic chemistry , anatomy , copolymer , economic policy , polymer
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids ( CEP ) was requested by the European Commission to re‐evaluate the safety of styrene ( FCM No 193) for use in plastic food contact materials ( FCM ) following the classification by the International Agency for Research on Cancer ( IARC ) as ‘probably carcinogenic to humans’. The IARC Monograph pertains to hazard identification, based on studies on high‐dose occupational exposures by inhalation and animal studies, also mainly by inhalation. The Panel considered that the IARC conclusions cannot be directly applied to the evaluation of risks for consumers from the oral exposure to styrene, but also concluded that, based on the data provided in the IARC Monograph and by the industry, a concern for genotoxicity associated with oral exposure to styrene cannot be excluded. The migration of styrene into foods packed in styrenic plastics is below 10 μg/kg for the majority of the foods, but up to 230 μg/kg was reported. Migration tends to be high for contact with fatty foods, and/or with high surface to volume ratios of the FCM . Dietary exposure of the consumers to styrene migrating from styrenic plastics was estimated in the order of 0.1 μg/kg body weight (bw) per day. It is in the same range as exposure from styrene present in foods as such. The dietary exposure (food component plus migration from styrenic plastics) is similar or lower than that by inhalation in the general population. Taking the human exposure data into account, the Panel concluded that a systematic review of genotoxicity and mechanistic data, comparative toxicokinetics and analysis of species differences is required for assessing the safety of styrene for its use in FCM .