TY - RPRT
T1 - EFSA Panel on Genetically Modified Organisms (GMO); Draft Scientific Opinion on the assessment of allergenicity of GM plants and microorganisms and derived food and feed
AU - EFSA Publication
AU - Sørensen, Ilona Kryspin
PY - 2010
Y1 - 2010
N2 - The weight-of-evidence, case-by-case approach is considered the most appropriate way of assessing
the allergenicity of genetically modified (GM) food and feed. This scientific opinion discusses various
aspects to increase the strength and accuracy of this approach, including the latest developments
pertaining to clinical aspects of allergic reactions, structural aspects of GM food and feed and in silico
approaches, as well as IgE binding studies and cell-based methods, profiling techniques and animal
models. In this context, conclusions and recommendations are provided to update and complement
current risk assessment strategies for the allergenicity assessment of newly expressed protein(s) and
whole GM food and feed. In summary, it is recommended that with regard to the search for sequence
homology and structural similarities, the local alignment method with a known allergen with a
threshold of 35% sequence identity over a window of at least 80 amino acids is considered a minimal
requirement. When IgE binding tests are considered necessary, e.g. when there is sequence homology
and/or structure similarity with known allergens, the use of individual sera from allergic individuals
rather than pooled sera is recommended. In addition to the pepsin resistance test, it is recommended
that the resistance to digestion of the newly expressed proteins is evaluated using other in vitro
digestibility tests mimicking physiological conditions of humans. Finally, when the recipient of the
introduced gene is allergenic, in order to compare the allergenicty of the whole GM plant with that of
its appropriate comparator(s), it is recommended that relevant characterised endogenous allergens are
included in the comparative compositional analysis of the GM plant and its appropriate comparator(s).
Proposals for the use of additional testing that may improve the weight-of-evidence approach and suggestions for further evaluation of new promising methods that are as yet in an early phase of
development are also addressed.
AB - The weight-of-evidence, case-by-case approach is considered the most appropriate way of assessing
the allergenicity of genetically modified (GM) food and feed. This scientific opinion discusses various
aspects to increase the strength and accuracy of this approach, including the latest developments
pertaining to clinical aspects of allergic reactions, structural aspects of GM food and feed and in silico
approaches, as well as IgE binding studies and cell-based methods, profiling techniques and animal
models. In this context, conclusions and recommendations are provided to update and complement
current risk assessment strategies for the allergenicity assessment of newly expressed protein(s) and
whole GM food and feed. In summary, it is recommended that with regard to the search for sequence
homology and structural similarities, the local alignment method with a known allergen with a
threshold of 35% sequence identity over a window of at least 80 amino acids is considered a minimal
requirement. When IgE binding tests are considered necessary, e.g. when there is sequence homology
and/or structure similarity with known allergens, the use of individual sera from allergic individuals
rather than pooled sera is recommended. In addition to the pepsin resistance test, it is recommended
that the resistance to digestion of the newly expressed proteins is evaluated using other in vitro
digestibility tests mimicking physiological conditions of humans. Finally, when the recipient of the
introduced gene is allergenic, in order to compare the allergenicty of the whole GM plant with that of
its appropriate comparator(s), it is recommended that relevant characterised endogenous allergens are
included in the comparative compositional analysis of the GM plant and its appropriate comparator(s).
Proposals for the use of additional testing that may improve the weight-of-evidence approach and suggestions for further evaluation of new promising methods that are as yet in an early phase of
development are also addressed.
KW - Feed
KW - Genetically modified organism
KW - Food
KW - Allergenicity
KW - Safety
KW - Weight-ofevidence approach
KW - Newly expressed protein
M3 - Report
T3 - the EFSA Journal
BT - EFSA Panel on Genetically Modified Organisms (GMO); Draft Scientific Opinion on the assessment of allergenicity of GM plants and microorganisms and derived food and feed
PB - European Food Safety Authority
ER -