Genotoxicity testing approaches for the safety assessment of substances used in food contact materials prior to their authorization in the European Union

Claudia Bolognesi, Anna F Castoldi, Riccardo Crebelli, Eric Barthélémy, Daniela Maurici, Detlef Wölfle, Katharina Volk, Laurence Castle

Research output: Contribution to journalReview article

9 Citations (Scopus)

Abstract

Food contact materials are all materials and articles intended to come directly or indirectly into contact with food. Before being included in the positive European "Union list" of authorized substances (monomers, other starting substances and additives) for plastic food contact materials, the European Food Safety Authority (EFSA) must assess their safety "in use". If relevant for risk, the safety of the main impurities, reaction and degradation products originating from the manufacturing process is also evaluated. Information on genotoxicity is always required irrespective of the extent of migration and the resulting human exposure, in view of the theoretical lack of threshold for genotoxic events. The 2008 EFSA approach, requiring the testing of food contact materials in three in vitro mutagenicity tests, though still acceptable, is now superseded by the 2011 EFSA Scientific Committee's recommendation for only two complementary tests including a bacterial gene mutation test and an in vitro micronucleus test, to detect two main genetic endpoints (i.e., gene mutations and chromosome aberrations). Follow-up of in vitro positive results depends on the type of genetic effect and on the substance's systemic availability. In this study, we provide an analysis of the data on genotoxicity testing gathered by EFSA on food contact materials for the period 1992-2015. We also illustrate practical examples of the approaches that EFSA took when evaluating "non standard" food contact chemicals (e.g., polymeric additives, oligomer or other reaction mixtures, and nanosubstances). Additionally, EFSA's experience gained from using non testing methods and/or future possibilities in this area are discussed. Environ. Mol. Mutagen. 58:361-374, 2017. © 2017 Wiley Periodicals, Inc.

Original languageEnglish
Pages (from-to)361-374
Number of pages14
JournalEnvironmental and Molecular Mutagenesis
Volume58
Issue number5
DOIs
Publication statusPublished - Jun 2017

Fingerprint

Food Safety
European Union
Safety
Food
Mutagenicity Tests
Bacterial Genes
Food Additives
Micronucleus Tests
Mutation
Mutagens
Chromosome Aberrations
Plastics
Genes
In Vitro Techniques

Keywords

  • Animals
  • European Union
  • Food Contamination/prevention & control
  • Humans
  • Mutagenicity Tests/methods
  • Risk Assessment/methods

Cite this

Genotoxicity testing approaches for the safety assessment of substances used in food contact materials prior to their authorization in the European Union. / Bolognesi, Claudia; Castoldi, Anna F; Crebelli, Riccardo; Barthélémy, Eric; Maurici, Daniela; Wölfle, Detlef; Volk, Katharina; Castle, Laurence.

In: Environmental and Molecular Mutagenesis, Vol. 58, No. 5, 06.2017, p. 361-374.

Research output: Contribution to journalReview article

Bolognesi, Claudia ; Castoldi, Anna F ; Crebelli, Riccardo ; Barthélémy, Eric ; Maurici, Daniela ; Wölfle, Detlef ; Volk, Katharina ; Castle, Laurence. / Genotoxicity testing approaches for the safety assessment of substances used in food contact materials prior to their authorization in the European Union. In: Environmental and Molecular Mutagenesis. 2017 ; Vol. 58, No. 5. pp. 361-374.
@article{f7cbcd19524f4191a469d521c6664dad,
title = "Genotoxicity testing approaches for the safety assessment of substances used in food contact materials prior to their authorization in the European Union",
abstract = "Food contact materials are all materials and articles intended to come directly or indirectly into contact with food. Before being included in the positive European {"}Union list{"} of authorized substances (monomers, other starting substances and additives) for plastic food contact materials, the European Food Safety Authority (EFSA) must assess their safety {"}in use{"}. If relevant for risk, the safety of the main impurities, reaction and degradation products originating from the manufacturing process is also evaluated. Information on genotoxicity is always required irrespective of the extent of migration and the resulting human exposure, in view of the theoretical lack of threshold for genotoxic events. The 2008 EFSA approach, requiring the testing of food contact materials in three in vitro mutagenicity tests, though still acceptable, is now superseded by the 2011 EFSA Scientific Committee's recommendation for only two complementary tests including a bacterial gene mutation test and an in vitro micronucleus test, to detect two main genetic endpoints (i.e., gene mutations and chromosome aberrations). Follow-up of in vitro positive results depends on the type of genetic effect and on the substance's systemic availability. In this study, we provide an analysis of the data on genotoxicity testing gathered by EFSA on food contact materials for the period 1992-2015. We also illustrate practical examples of the approaches that EFSA took when evaluating {"}non standard{"} food contact chemicals (e.g., polymeric additives, oligomer or other reaction mixtures, and nanosubstances). Additionally, EFSA's experience gained from using non testing methods and/or future possibilities in this area are discussed. Environ. Mol. Mutagen. 58:361-374, 2017. {\circledC} 2017 Wiley Periodicals, Inc.",
keywords = "Animals, European Union, Food Contamination/prevention & control, Humans, Mutagenicity Tests/methods, Risk Assessment/methods",
author = "Claudia Bolognesi and Castoldi, {Anna F} and Riccardo Crebelli and Eric Barth{\'e}l{\'e}my and Daniela Maurici and Detlef W{\"o}lfle and Katharina Volk and Laurence Castle",
note = "{\circledC} 2017 Wiley Periodicals, Inc.",
year = "2017",
month = "6",
doi = "10.1002/em.22094",
language = "English",
volume = "58",
pages = "361--374",
journal = "Environmental Mutagenesis",
issn = "0893-6692",
publisher = "Wiley-Liss Inc.",
number = "5",

}

TY - JOUR

T1 - Genotoxicity testing approaches for the safety assessment of substances used in food contact materials prior to their authorization in the European Union

AU - Bolognesi, Claudia

AU - Castoldi, Anna F

AU - Crebelli, Riccardo

AU - Barthélémy, Eric

AU - Maurici, Daniela

AU - Wölfle, Detlef

AU - Volk, Katharina

AU - Castle, Laurence

N1 - © 2017 Wiley Periodicals, Inc.

PY - 2017/6

Y1 - 2017/6

N2 - Food contact materials are all materials and articles intended to come directly or indirectly into contact with food. Before being included in the positive European "Union list" of authorized substances (monomers, other starting substances and additives) for plastic food contact materials, the European Food Safety Authority (EFSA) must assess their safety "in use". If relevant for risk, the safety of the main impurities, reaction and degradation products originating from the manufacturing process is also evaluated. Information on genotoxicity is always required irrespective of the extent of migration and the resulting human exposure, in view of the theoretical lack of threshold for genotoxic events. The 2008 EFSA approach, requiring the testing of food contact materials in three in vitro mutagenicity tests, though still acceptable, is now superseded by the 2011 EFSA Scientific Committee's recommendation for only two complementary tests including a bacterial gene mutation test and an in vitro micronucleus test, to detect two main genetic endpoints (i.e., gene mutations and chromosome aberrations). Follow-up of in vitro positive results depends on the type of genetic effect and on the substance's systemic availability. In this study, we provide an analysis of the data on genotoxicity testing gathered by EFSA on food contact materials for the period 1992-2015. We also illustrate practical examples of the approaches that EFSA took when evaluating "non standard" food contact chemicals (e.g., polymeric additives, oligomer or other reaction mixtures, and nanosubstances). Additionally, EFSA's experience gained from using non testing methods and/or future possibilities in this area are discussed. Environ. Mol. Mutagen. 58:361-374, 2017. © 2017 Wiley Periodicals, Inc.

AB - Food contact materials are all materials and articles intended to come directly or indirectly into contact with food. Before being included in the positive European "Union list" of authorized substances (monomers, other starting substances and additives) for plastic food contact materials, the European Food Safety Authority (EFSA) must assess their safety "in use". If relevant for risk, the safety of the main impurities, reaction and degradation products originating from the manufacturing process is also evaluated. Information on genotoxicity is always required irrespective of the extent of migration and the resulting human exposure, in view of the theoretical lack of threshold for genotoxic events. The 2008 EFSA approach, requiring the testing of food contact materials in three in vitro mutagenicity tests, though still acceptable, is now superseded by the 2011 EFSA Scientific Committee's recommendation for only two complementary tests including a bacterial gene mutation test and an in vitro micronucleus test, to detect two main genetic endpoints (i.e., gene mutations and chromosome aberrations). Follow-up of in vitro positive results depends on the type of genetic effect and on the substance's systemic availability. In this study, we provide an analysis of the data on genotoxicity testing gathered by EFSA on food contact materials for the period 1992-2015. We also illustrate practical examples of the approaches that EFSA took when evaluating "non standard" food contact chemicals (e.g., polymeric additives, oligomer or other reaction mixtures, and nanosubstances). Additionally, EFSA's experience gained from using non testing methods and/or future possibilities in this area are discussed. Environ. Mol. Mutagen. 58:361-374, 2017. © 2017 Wiley Periodicals, Inc.

KW - Animals

KW - European Union

KW - Food Contamination/prevention & control

KW - Humans

KW - Mutagenicity Tests/methods

KW - Risk Assessment/methods

U2 - 10.1002/em.22094

DO - 10.1002/em.22094

M3 - Review article

C2 - 28556235

VL - 58

SP - 361

EP - 374

JO - Environmental Mutagenesis

JF - Environmental Mutagenesis

SN - 0893-6692

IS - 5

ER -