Safety assessment of the substance dimethyl carbonate for use in food contact materials

Flavourings and Processing Aids (CEF) EFSA Panel on Food Contact Materials Enzymes, Vittorio Silano, Claudia Bolognesi, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn, Corina-Aurelia Zugravu & 5 others Martine Kolf-Clauw , Eugenia Lampi, Kettil Svensson, Cristina Croera, Laurence Castle

Research output: Contribution to specialist publicationArticle

6 Downloads (Pure)

Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of dimethyl carbonate used as monomer for making a polycarbonate prepolymer with 1,6-hexanediol and then reacted with 4,4′-methylenediphenyldiisocyanate (MDI) and diols, such as polypropylene glycol and 1,4-butanediol, to form a thermoplastic polyurethane containing 29% of the polycarbonate prepolymer. This polymer is intended for repeated use articles with short-term contact (≤ 30 min) at room temperature for types of food, simulated by 10% ethanol and 3% acetic acid. In the third migration test performed at 40°C during 30 min, overall migration was below 2 mg/dm2. Complete migration of the residual dimethyl carbonate would have amounted to less than 1.5 μg/kg food. The migration of two cyclic hexanediol carbonate oligomers was below 50 μg/kg food when determined by the third migration test; that of all others was below 1 μg/kg food. Three in vitro genotoxicity studies performed in accordance with OECD Guidelines and covering the three endpoints gene mutation, structural and numerical aberrations were provided and were considered negative by the CEF Panel. The oligomers detected by the migration tests are formed from dimethyl carbonate and 1,6-hexanediol (FCM ref No 1067) do not give rise to concern for genotoxicity. The CEF Panel concluded that the use of dimethyl carbonate does not raise safety concern in the application described above. It is aware that dimethyl carbonate may be used for other polycarbonates and/or under other conditions. These are likely to result in different migrates which need to be evaluated by the business operators. In such cases, the migration of dimethyl carbonate and the total polycarbonate oligomers below 1,000 Da is of no safety concern, if each of them does not exceed 0.05 mg/kg food.
Original languageEnglish
Pagese04901
Volume15
No.7
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
DOIs
Publication statusPublished - Jul 2017

Fingerprint

safety
carbonate
food
genotoxicity
OECD
material
acetic acid
ethanol
mutation
polymer
enzyme
gene
test
temperature

Keywords

  • dimethyl carbonate
  • CAS number 616-38-6
  • FCM materials No 1067
  • Food contact materials
  • Safety assessment

Cite this

EFSA Panel on Food Contact Materials Enzymes, F. A. P. A. CEF., Silano, V., Bolognesi, C., Cravedi, J-P., Engel, K-H., Fowler, P., ... Castle, L. (2017). Safety assessment of the substance dimethyl carbonate for use in food contact materials. EFSA Journal, 15(7), e04901. https://doi.org/10.2903/j.efsa.2017.4901

Safety assessment of the substance dimethyl carbonate for use in food contact materials. / EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF); Silano, Vittorio; Bolognesi, Claudia; Cravedi, Jean-Pierre; Engel, Karl-Heinz; Fowler, Paul; Franz, Roland; Grob, Konrad; Gürtler, Rainer; Husøy, Trine; Kärenlampi, Sirpa; Mennes, Wim; Milana, Maria Rosaria ; Penninks, André; Smith, Andrew; Tavares Poças, Maria de Fátima; Tlustos, Christina; Wölfle, Detlef; Zorn, Holger; Zugravu, Corina-Aurelia; Kolf-Clauw , Martine ; Lampi, Eugenia; Svensson, Kettil; Croera, Cristina; Castle, Laurence.

In: EFSA Journal, Vol. 15, No. 7, 07.2017, p. e04901.

Research output: Contribution to specialist publicationArticle

EFSA Panel on Food Contact Materials Enzymes, FAPACEF, Silano, V, Bolognesi, C, Cravedi, J-P, Engel, K-H, Fowler, P, Franz, R, Grob, K, Gürtler, R, Husøy, T, Kärenlampi, S, Mennes, W, Milana, MR, Penninks, A, Smith, A, Tavares Poças, MDF, Tlustos, C, Wölfle, D, Zorn, H, Zugravu, C-A, Kolf-Clauw , M, Lampi, E, Svensson, K, Croera, C & Castle, L 2017, 'Safety assessment of the substance dimethyl carbonate for use in food contact materials' EFSA Journal, vol. 15, no. 7, pp. e04901. https://doi.org/10.2903/j.efsa.2017.4901
EFSA Panel on Food Contact Materials Enzymes FAPACEF, Silano V, Bolognesi C, Cravedi J-P, Engel K-H, Fowler P et al. Safety assessment of the substance dimethyl carbonate for use in food contact materials. EFSA Journal. 2017 Jul;15(7):e04901. https://doi.org/10.2903/j.efsa.2017.4901
EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF) ; Silano, Vittorio ; Bolognesi, Claudia ; Cravedi, Jean-Pierre ; Engel, Karl-Heinz ; Fowler, Paul ; Franz, Roland ; Grob, Konrad ; Gürtler, Rainer ; Husøy, Trine ; Kärenlampi, Sirpa ; Mennes, Wim ; Milana, Maria Rosaria ; Penninks, André ; Smith, Andrew ; Tavares Poças, Maria de Fátima ; Tlustos, Christina ; Wölfle, Detlef ; Zorn, Holger ; Zugravu, Corina-Aurelia ; Kolf-Clauw , Martine ; Lampi, Eugenia ; Svensson, Kettil ; Croera, Cristina ; Castle, Laurence. / Safety assessment of the substance dimethyl carbonate for use in food contact materials. In: EFSA Journal. 2017 ; Vol. 15, No. 7. pp. e04901.
@misc{856291bc364348fdb9d73f070d512981,
title = "Safety assessment of the substance dimethyl carbonate for use in food contact materials",
abstract = "This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of dimethyl carbonate used as monomer for making a polycarbonate prepolymer with 1,6-hexanediol and then reacted with 4,4′-methylenediphenyldiisocyanate (MDI) and diols, such as polypropylene glycol and 1,4-butanediol, to form a thermoplastic polyurethane containing 29{\%} of the polycarbonate prepolymer. This polymer is intended for repeated use articles with short-term contact (≤ 30 min) at room temperature for types of food, simulated by 10{\%} ethanol and 3{\%} acetic acid. In the third migration test performed at 40°C during 30 min, overall migration was below 2 mg/dm2. Complete migration of the residual dimethyl carbonate would have amounted to less than 1.5 μg/kg food. The migration of two cyclic hexanediol carbonate oligomers was below 50 μg/kg food when determined by the third migration test; that of all others was below 1 μg/kg food. Three in vitro genotoxicity studies performed in accordance with OECD Guidelines and covering the three endpoints gene mutation, structural and numerical aberrations were provided and were considered negative by the CEF Panel. The oligomers detected by the migration tests are formed from dimethyl carbonate and 1,6-hexanediol (FCM ref No 1067) do not give rise to concern for genotoxicity. The CEF Panel concluded that the use of dimethyl carbonate does not raise safety concern in the application described above. It is aware that dimethyl carbonate may be used for other polycarbonates and/or under other conditions. These are likely to result in different migrates which need to be evaluated by the business operators. In such cases, the migration of dimethyl carbonate and the total polycarbonate oligomers below 1,000 Da is of no safety concern, if each of them does not exceed 0.05 mg/kg food.",
keywords = "dimethyl carbonate, CAS number 616-38-6, FCM materials No 1067, Food contact materials, Safety assessment",
author = "{EFSA Panel on Food Contact Materials Enzymes}, {Flavourings and Processing Aids (CEF)} and Vittorio Silano and Claudia Bolognesi and Jean-Pierre Cravedi and Karl-Heinz Engel and Paul Fowler and Roland Franz and Konrad Grob and Rainer G{\"u}rtler and Trine Hus{\o}y and Sirpa K{\"a}renlampi and Wim Mennes and Milana, {Maria Rosaria} and Andr{\'e} Penninks and Andrew Smith and {Tavares Po{\cc}as}, {Maria de F{\'a}tima} and Christina Tlustos and Detlef W{\"o}lfle and Holger Zorn and Corina-Aurelia Zugravu and Martine Kolf-Clauw and Eugenia Lampi and Kettil Svensson and Cristina Croera and Laurence Castle",
year = "2017",
month = "7",
doi = "10.2903/j.efsa.2017.4901",
language = "English",
volume = "15",
pages = "e04901",
journal = "EFSA Journal",
issn = "1831-4732",
publisher = "European Food Safety Authority (EFSA)",

}

TY - GEN

T1 - Safety assessment of the substance dimethyl carbonate 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 - 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 - Penninks, André

AU - Smith, Andrew

AU - Tavares Poças, Maria de Fátima

AU - Tlustos, Christina

AU - Wölfle, Detlef

AU - Zorn, Holger

AU - Zugravu, Corina-Aurelia

AU - Kolf-Clauw , Martine

AU - Lampi, Eugenia

AU - Svensson, Kettil

AU - Croera, Cristina

AU - Castle, Laurence

PY - 2017/7

Y1 - 2017/7

N2 - This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of dimethyl carbonate used as monomer for making a polycarbonate prepolymer with 1,6-hexanediol and then reacted with 4,4′-methylenediphenyldiisocyanate (MDI) and diols, such as polypropylene glycol and 1,4-butanediol, to form a thermoplastic polyurethane containing 29% of the polycarbonate prepolymer. This polymer is intended for repeated use articles with short-term contact (≤ 30 min) at room temperature for types of food, simulated by 10% ethanol and 3% acetic acid. In the third migration test performed at 40°C during 30 min, overall migration was below 2 mg/dm2. Complete migration of the residual dimethyl carbonate would have amounted to less than 1.5 μg/kg food. The migration of two cyclic hexanediol carbonate oligomers was below 50 μg/kg food when determined by the third migration test; that of all others was below 1 μg/kg food. Three in vitro genotoxicity studies performed in accordance with OECD Guidelines and covering the three endpoints gene mutation, structural and numerical aberrations were provided and were considered negative by the CEF Panel. The oligomers detected by the migration tests are formed from dimethyl carbonate and 1,6-hexanediol (FCM ref No 1067) do not give rise to concern for genotoxicity. The CEF Panel concluded that the use of dimethyl carbonate does not raise safety concern in the application described above. It is aware that dimethyl carbonate may be used for other polycarbonates and/or under other conditions. These are likely to result in different migrates which need to be evaluated by the business operators. In such cases, the migration of dimethyl carbonate and the total polycarbonate oligomers below 1,000 Da is of no safety concern, if each of them does not exceed 0.05 mg/kg food.

AB - This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of dimethyl carbonate used as monomer for making a polycarbonate prepolymer with 1,6-hexanediol and then reacted with 4,4′-methylenediphenyldiisocyanate (MDI) and diols, such as polypropylene glycol and 1,4-butanediol, to form a thermoplastic polyurethane containing 29% of the polycarbonate prepolymer. This polymer is intended for repeated use articles with short-term contact (≤ 30 min) at room temperature for types of food, simulated by 10% ethanol and 3% acetic acid. In the third migration test performed at 40°C during 30 min, overall migration was below 2 mg/dm2. Complete migration of the residual dimethyl carbonate would have amounted to less than 1.5 μg/kg food. The migration of two cyclic hexanediol carbonate oligomers was below 50 μg/kg food when determined by the third migration test; that of all others was below 1 μg/kg food. Three in vitro genotoxicity studies performed in accordance with OECD Guidelines and covering the three endpoints gene mutation, structural and numerical aberrations were provided and were considered negative by the CEF Panel. The oligomers detected by the migration tests are formed from dimethyl carbonate and 1,6-hexanediol (FCM ref No 1067) do not give rise to concern for genotoxicity. The CEF Panel concluded that the use of dimethyl carbonate does not raise safety concern in the application described above. It is aware that dimethyl carbonate may be used for other polycarbonates and/or under other conditions. These are likely to result in different migrates which need to be evaluated by the business operators. In such cases, the migration of dimethyl carbonate and the total polycarbonate oligomers below 1,000 Da is of no safety concern, if each of them does not exceed 0.05 mg/kg food.

KW - dimethyl carbonate

KW - CAS number 616-38-6

KW - FCM materials No 1067

KW - Food contact materials

KW - Safety assessment

U2 - 10.2903/j.efsa.2017.4901

DO - 10.2903/j.efsa.2017.4901

M3 - Article

VL - 15

SP - e04901

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

PB - European Food Safety Authority (EFSA)

ER -