SUPERSEDED: Safety assessment of the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Vittorio Silano; Claudia Bolognesi; Kevin Chipman; Jean-Pierre Cravedi; Karl-Heinz Engel; Paul Fowler; Roland Franz; Konrad Grob; Rainer Gürtler; Trine Husøy; Sirpa Kärenlampi; Wim Mennes; Maria Rosaria Milana; Karla Pfaff; Gilles Rivière; Jannavi Srinivasan; Maria de Fátima Tavares Poças; Christina Tlustos; Detlef Wölfle; Holger Zorn; Martine Kolf-Clauw; Eugenia Lampi; Kettil Svensson; Katharina Volk; Laurence Castle

doi:10.2903/j.efsa.2018.5326

SUPERSEDED: Safety assessment of the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Vittorio Silano, Claudia Bolognesi, Kevin Chipman, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Gilles Rivière, Jannavi Srinivasan, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef WölfleHolger Zorn, Martine Kolf-Clauw, Eugenia Lampi, Kettil Svensson, Katharina Volk, Laurence Castle

Research output: Contribution to specialist publication › Article

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Abstract

Abstract This opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate), Chemical Abstracts Service (CAS) No 147398-31-0 and food contact material (FCM) substance No 1059, for contact with dry/solid food. This biodegradable (co)polymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). No migration of oligomers into food simulant E (10 days at 40 and 60°C) was found at a detection limit per single oligomer of 5 μg/kg food. Migration of the degradation product crotonic acid was 8 and 25 μg/kg at the two test temperatures, respectively. The other migrating substances detected, ■■■■■, likely originated from or are related to the authorised substance (FCM No. 9) ‘palm oil and/or palm fatty acid distillate’ used as carbon source for the fermentation. At the migration levels reported, these migrants do not give rise to safety concern. No genotoxicity data are required for poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) because of its high molecular weight. The fraction below 1,000 Da is 0.5 3-hydroxybutyric acid, is an intermediate in fatty acid metabolism. The minor monomeric unit, 3-hydroxyhexanoic acid, tested negative for bacterial gene mutations. Degradation products, which may be present in the (co)polymer, are crotonic acid and (E)-2-hexenoic acid. Crotonic acid is authorised for use in FCM with a specific migration limit (SML) of 0.05 mg/kg food; for (E)-2-hexenoic acid, no indication for genotoxicity was identified by the EFSA CEF Panel in its 2010 group evaluation of flavouring substances in FGE.05Rev2. The CEF Panel concluded that the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) is not of safety concern if used alone or in blends with other polymers for contact with dry/solid food. If the SML of crotonic acid is met, migration of (E)-2-hexenoic acid will also not exceed 0.05 mg/kg food.

Original language	English
Pages	e05326
Volume	16
No.	7
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2018.5326
Publication status	Published - 20 Jul 2018

Keywords

CAS No 147398-31-0
Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate)
PHBH
food contact materials
FCM substance No 1059
dry/solid foods

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Silano_etal_EFSA_Safety_Assessment_Of_VoR
© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. https://creativecommons.org/licenses/by-nd/4.0/
Final published version, 1.24 MBLicence: CC BY-ND

Cite this

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Silano, V., Bolognesi, C., Chipman, K., Cravedi, J.-P., Engel, K.-H., Fowler, P., Franz, R., Grob, K., Gürtler, R., Husøy, T., Kärenlampi, S., Mennes, W., Milana, M. R., Pfaff, K., Rivière, G., Srinivasan, J., Tavares Poças, M. D. F., Tlustos, C., ... Castle, L. (2018). SUPERSEDED: Safety assessment of the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials. EFSA Journal, 16(7), e05326. https://doi.org/10.2903/j.efsa.2018.5326

SUPERSEDED: Safety assessment of the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials. / EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Silano, Vittorio; Bolognesi, Claudia et al.
In: EFSA Journal, Vol. 16, No. 7, 20.07.2018, p. e05326.

Research output: Contribution to specialist publication › Article

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Silano, V, Bolognesi, C, Chipman, K, Cravedi, J-P, Engel, K-H, Fowler, P, Franz, R, Grob, K, Gürtler, R, Husøy, T, Kärenlampi, S, Mennes, W, Milana, MR, Pfaff, K, Rivière, G, Srinivasan, J, Tavares Poças, MDF, Tlustos, C, Wölfle, D, Zorn, H, Kolf-Clauw, M, Lampi, E, Svensson, K, Volk, K & Castle, L 2018, 'SUPERSEDED: Safety assessment of the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials' EFSA Journal, vol. 16, no. 7, pp. e05326. https://doi.org/10.2903/j.efsa.2018.5326

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Silano V, Bolognesi C, Chipman K, Cravedi JP, Engel KH et al. SUPERSEDED: Safety assessment of the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials. EFSA Journal. 2018 Jul 20;16(7):e05326. Epub 2018 Jul 20. doi: 10.2903/j.efsa.2018.5326

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abstract = "Abstract This opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate), Chemical Abstracts Service (CAS) No 147398-31-0 and food contact material (FCM) substance No 1059, for contact with dry/solid food. This biodegradable (co)polymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). No migration of oligomers into food simulant E (10 days at 40 and 60°C) was found at a detection limit per single oligomer of 5 μg/kg food. Migration of the degradation product crotonic acid was 8 and 25 μg/kg at the two test temperatures, respectively. The other migrating substances detected, ■■■■■, likely originated from or are related to the authorised substance (FCM No. 9) {\textquoteleft}palm oil and/or palm fatty acid distillate{\textquoteright} used as carbon source for the fermentation. At the migration levels reported, these migrants do not give rise to safety concern. No genotoxicity data are required for poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) because of its high molecular weight. The fraction below 1,000 Da is 0.5 3-hydroxybutyric acid, is an intermediate in fatty acid metabolism. The minor monomeric unit, 3-hydroxyhexanoic acid, tested negative for bacterial gene mutations. Degradation products, which may be present in the (co)polymer, are crotonic acid and (E)-2-hexenoic acid. Crotonic acid is authorised for use in FCM with a specific migration limit (SML) of 0.05 mg/kg food; for (E)-2-hexenoic acid, no indication for genotoxicity was identified by the EFSA CEF Panel in its 2010 group evaluation of flavouring substances in FGE.05Rev2. The CEF Panel concluded that the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) is not of safety concern if used alone or in blends with other polymers for contact with dry/solid food. If the SML of crotonic acid is met, migration of (E)-2-hexenoic acid will also not exceed 0.05 mg/kg food.",

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doi = "10.2903/j.efsa.2018.5326",

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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

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AU - Srinivasan, Jannavi

AU - Tavares Poças, Maria de Fátima

AU - Tlustos, Christina

AU - Wölfle, Detlef

AU - Zorn, Holger

AU - Kolf-Clauw, Martine

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N2 - Abstract This opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate), Chemical Abstracts Service (CAS) No 147398-31-0 and food contact material (FCM) substance No 1059, for contact with dry/solid food. This biodegradable (co)polymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). No migration of oligomers into food simulant E (10 days at 40 and 60°C) was found at a detection limit per single oligomer of 5 μg/kg food. Migration of the degradation product crotonic acid was 8 and 25 μg/kg at the two test temperatures, respectively. The other migrating substances detected, ■■■■■, likely originated from or are related to the authorised substance (FCM No. 9) ‘palm oil and/or palm fatty acid distillate’ used as carbon source for the fermentation. At the migration levels reported, these migrants do not give rise to safety concern. No genotoxicity data are required for poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) because of its high molecular weight. The fraction below 1,000 Da is 0.5 3-hydroxybutyric acid, is an intermediate in fatty acid metabolism. The minor monomeric unit, 3-hydroxyhexanoic acid, tested negative for bacterial gene mutations. Degradation products, which may be present in the (co)polymer, are crotonic acid and (E)-2-hexenoic acid. Crotonic acid is authorised for use in FCM with a specific migration limit (SML) of 0.05 mg/kg food; for (E)-2-hexenoic acid, no indication for genotoxicity was identified by the EFSA CEF Panel in its 2010 group evaluation of flavouring substances in FGE.05Rev2. The CEF Panel concluded that the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) is not of safety concern if used alone or in blends with other polymers for contact with dry/solid food. If the SML of crotonic acid is met, migration of (E)-2-hexenoic acid will also not exceed 0.05 mg/kg food.

AB - Abstract This opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate), Chemical Abstracts Service (CAS) No 147398-31-0 and food contact material (FCM) substance No 1059, for contact with dry/solid food. This biodegradable (co)polymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). No migration of oligomers into food simulant E (10 days at 40 and 60°C) was found at a detection limit per single oligomer of 5 μg/kg food. Migration of the degradation product crotonic acid was 8 and 25 μg/kg at the two test temperatures, respectively. The other migrating substances detected, ■■■■■, likely originated from or are related to the authorised substance (FCM No. 9) ‘palm oil and/or palm fatty acid distillate’ used as carbon source for the fermentation. At the migration levels reported, these migrants do not give rise to safety concern. No genotoxicity data are required for poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) because of its high molecular weight. The fraction below 1,000 Da is 0.5 3-hydroxybutyric acid, is an intermediate in fatty acid metabolism. The minor monomeric unit, 3-hydroxyhexanoic acid, tested negative for bacterial gene mutations. Degradation products, which may be present in the (co)polymer, are crotonic acid and (E)-2-hexenoic acid. Crotonic acid is authorised for use in FCM with a specific migration limit (SML) of 0.05 mg/kg food; for (E)-2-hexenoic acid, no indication for genotoxicity was identified by the EFSA CEF Panel in its 2010 group evaluation of flavouring substances in FGE.05Rev2. The CEF Panel concluded that the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) is not of safety concern if used alone or in blends with other polymers for contact with dry/solid food. If the SML of crotonic acid is met, migration of (E)-2-hexenoic acid will also not exceed 0.05 mg/kg food.

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KW - food contact materials

KW - FCM substance No 1059

KW - dry/solid foods

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DO - 10.2903/j.efsa.2018.5326

M3 - Article

C2 - 32625967

SN - 1831-4732

VL - 16

SP - e05326

JO - EFSA Journal

JF - EFSA Journal

ER -

SUPERSEDED: Safety assessment of the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials

Abstract

Keywords

UN SDGs

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