Safety assessment of the substance (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate for use in food contact materials

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, Christina Tlustos, Detlef Wölfle , Holger Zorn, Corina-Aurelia Zugravu, Martine Kolf-Clauw, Eugenia Lampi, Kettil SvenssonEric Barthélemy, Laurence Castle, Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

Research output: Contribution to specialist publicationArticle

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Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety re-assessment of (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate for use at up to 40% w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA). Finished articles are intended for repeated contact at room temperature or below with aqueous, acidic and/or low alcoholic foodstuffs for less than 1 day and with dry foodstuffs for more than 1 day. The substance has a low molecular weight fraction (LMWF) below 1,000 Da up to 3.3%. It starts to thermally degrade at ca 230°C, below the maximum temperature of processing finished articles, 250°C. Among the substances released from the heated polymeric additive, four were detected to be released from the finished food contact material (FCM). Migration of oligomers and reaction products into 3% acetic acid and 20% ethanol from a SAN/PMMA material was found to decrease with repeated uses. After the third contact, cyclo-octatetraene, toluene and a hexanedioic acid related substance were detected by GC–MS analysis of the simulant samples, at approximately 5 μg/kg food. From analysis with headspace-GC–MS of heated plastic samples with and without the substance, four volatiles were (semi)quantified at ca 1 μg/6 dm2 or less. Considering that the substance is a polymeric additive without structural alert for genotoxicity, manufactured using authorised monomers and with limited potential migration of the LMWF, no toxicological data were requested. The CEF Panel concluded that the substance is not of safety concern for the consumer if it is used at up to 40% w/w in blends of SAN/PMMA repeat-use articles intended for contact at room temperature with aqueous, acidic and/or low alcoholic foodstuffs for less than 1 day and with dry foodstuffs without a time limit.
Original languageEnglish
Pagese04637
Volume14
Specialist publicationEFSA Journal
DOIs
Publication statusPublished - Nov 2016

Fingerprint

divinyl benzene
Styrene
Acrylonitrile
Polymethyl Methacrylate
Copolymers
Molecular weight
Toluene
Processing
Reaction products
Oligomers
Acetic Acid
Temperature
Ethanol
Monomers
Plastics
1,3-butylene glycol
Dakril 4B
1,3-butadiene
Enzymes

Keywords

  • (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate, CAS number 25101-28-4
  • FCM substance No. 856
  • food contact materials
  • safety assessment
  • evaluation

Cite this

Safety assessment of the substance (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate for use in food contact materials. / Silano, Vittorio; Bolognesi, Claudia; Cravedi, Jean-Pierre; Engel, Karl-Heinz; Fowler, Paul; Franz, Roland; Grob, Konrad; Gürtler, Rainer; Husøy, Trine; Kärenlampi, Sirpa; Mennes, Wim; Rosaria Milana, Maria; Penninks, André; Tlustos, Christina; Wölfle , Detlef; Zorn, Holger; Zugravu, Corina-Aurelia; Kolf-Clauw, Martine ; Lampi, Eugenia ; Svensson, Kettil; Barthélemy, Eric; Castle, Laurence; Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF).

In: EFSA Journal, Vol. 14, 11.2016, p. e04637.

Research output: Contribution to specialist publicationArticle

Silano, V, Bolognesi, C, Cravedi, J-P, Engel, K-H, Fowler, P, Franz, R, Grob, K, Gürtler, R, Husøy, T, Kärenlampi, S, Mennes, W, Rosaria Milana, M, Penninks, A, Tlustos, C, Wölfle , D, Zorn, H, Zugravu, C-A, Kolf-Clauw, M, Lampi, E, Svensson, K, Barthélemy, E, Castle, L & Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2016, 'Safety assessment of the substance (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate for use in food contact materials' EFSA Journal, vol. 14, pp. e04637. https://doi.org/10.2903/j.efsa.2016.4637
Silano, Vittorio ; Bolognesi, Claudia ; Cravedi, Jean-Pierre ; Engel, Karl-Heinz ; Fowler, Paul ; Franz, Roland ; Grob, Konrad ; Gürtler, Rainer ; Husøy, Trine ; Kärenlampi, Sirpa ; Mennes, Wim ; Rosaria Milana, Maria ; Penninks, André ; Tlustos, Christina ; Wölfle , Detlef ; Zorn, Holger ; Zugravu, Corina-Aurelia ; Kolf-Clauw, Martine ; Lampi, Eugenia ; Svensson, Kettil ; Barthélemy, Eric ; Castle, Laurence ; Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). / Safety assessment of the substance (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate for use in food contact materials. In: EFSA Journal. 2016 ; Vol. 14. pp. e04637.
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abstract = "This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety re-assessment of (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate for use at up to 40{\%} w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA). Finished articles are intended for repeated contact at room temperature or below with aqueous, acidic and/or low alcoholic foodstuffs for less than 1 day and with dry foodstuffs for more than 1 day. The substance has a low molecular weight fraction (LMWF) below 1,000 Da up to 3.3{\%}. It starts to thermally degrade at ca 230°C, below the maximum temperature of processing finished articles, 250°C. Among the substances released from the heated polymeric additive, four were detected to be released from the finished food contact material (FCM). Migration of oligomers and reaction products into 3{\%} acetic acid and 20{\%} ethanol from a SAN/PMMA material was found to decrease with repeated uses. After the third contact, cyclo-octatetraene, toluene and a hexanedioic acid related substance were detected by GC–MS analysis of the simulant samples, at approximately 5 μg/kg food. From analysis with headspace-GC–MS of heated plastic samples with and without the substance, four volatiles were (semi)quantified at ca 1 μg/6 dm2 or less. Considering that the substance is a polymeric additive without structural alert for genotoxicity, manufactured using authorised monomers and with limited potential migration of the LMWF, no toxicological data were requested. The CEF Panel concluded that the substance is not of safety concern for the consumer if it is used at up to 40{\%} w/w in blends of SAN/PMMA repeat-use articles intended for contact at room temperature with aqueous, acidic and/or low alcoholic foodstuffs for less than 1 day and with dry foodstuffs without a time limit.",
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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 - Rosaria Milana, Maria

AU - Penninks, André

AU - Smith, Andrew

AU - de Fátima Tavares Poças, Maria

AU - Tlustos, Christina

AU - Wölfle , Detlef

AU - Zorn, Holger

AU - Zugravu, Corina-Aurelia

AU - Kolf-Clauw, Martine

AU - Lampi, Eugenia

AU - Svensson, Kettil

AU - Barthélemy, Eric

AU - Castle, Laurence

AU - Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

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N2 - This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety re-assessment of (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate for use at up to 40% w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA). Finished articles are intended for repeated contact at room temperature or below with aqueous, acidic and/or low alcoholic foodstuffs for less than 1 day and with dry foodstuffs for more than 1 day. The substance has a low molecular weight fraction (LMWF) below 1,000 Da up to 3.3%. It starts to thermally degrade at ca 230°C, below the maximum temperature of processing finished articles, 250°C. Among the substances released from the heated polymeric additive, four were detected to be released from the finished food contact material (FCM). Migration of oligomers and reaction products into 3% acetic acid and 20% ethanol from a SAN/PMMA material was found to decrease with repeated uses. After the third contact, cyclo-octatetraene, toluene and a hexanedioic acid related substance were detected by GC–MS analysis of the simulant samples, at approximately 5 μg/kg food. From analysis with headspace-GC–MS of heated plastic samples with and without the substance, four volatiles were (semi)quantified at ca 1 μg/6 dm2 or less. Considering that the substance is a polymeric additive without structural alert for genotoxicity, manufactured using authorised monomers and with limited potential migration of the LMWF, no toxicological data were requested. The CEF Panel concluded that the substance is not of safety concern for the consumer if it is used at up to 40% w/w in blends of SAN/PMMA repeat-use articles intended for contact at room temperature with aqueous, acidic and/or low alcoholic foodstuffs for less than 1 day and with dry foodstuffs without a time limit.

AB - This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety re-assessment of (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate for use at up to 40% w/w in blends of styrene acrylonitrile copolymer (SAN)/poly(methyl methacrylate) (PMMA). Finished articles are intended for repeated contact at room temperature or below with aqueous, acidic and/or low alcoholic foodstuffs for less than 1 day and with dry foodstuffs for more than 1 day. The substance has a low molecular weight fraction (LMWF) below 1,000 Da up to 3.3%. It starts to thermally degrade at ca 230°C, below the maximum temperature of processing finished articles, 250°C. Among the substances released from the heated polymeric additive, four were detected to be released from the finished food contact material (FCM). Migration of oligomers and reaction products into 3% acetic acid and 20% ethanol from a SAN/PMMA material was found to decrease with repeated uses. After the third contact, cyclo-octatetraene, toluene and a hexanedioic acid related substance were detected by GC–MS analysis of the simulant samples, at approximately 5 μg/kg food. From analysis with headspace-GC–MS of heated plastic samples with and without the substance, four volatiles were (semi)quantified at ca 1 μg/6 dm2 or less. Considering that the substance is a polymeric additive without structural alert for genotoxicity, manufactured using authorised monomers and with limited potential migration of the LMWF, no toxicological data were requested. The CEF Panel concluded that the substance is not of safety concern for the consumer if it is used at up to 40% w/w in blends of SAN/PMMA repeat-use articles intended for contact at room temperature with aqueous, acidic and/or low alcoholic foodstuffs for less than 1 day and with dry foodstuffs without a time limit.

KW - (butadiene, styrene, methyl methacrylate, butyl acrylate) copolymer cross-linked with divinylbenzene or 1,3-butanediol dimethacrylate, CAS number 25101-28-4

KW - FCM substance No. 856

KW - food contact materials

KW - safety assessment

KW - evaluation

U2 - 10.2903/j.efsa.2016.4637

DO - 10.2903/j.efsa.2016.4637

M3 - Article

VL - 14

SP - e04637

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

ER -