EFSA has published supplementary guidance on allergenicity to further strengthen risk assessment of genetically modified (GM) plants. The document considers new scientific and regulatory developments, complementing recommendations in existing guidance and regulations.
What are the key points?
The new guidance relates to three particular areas.
Non-IgE-mediated adverse immune reactions to food comprise a large group of diseases, mostly occurring during childhood. Celiac disease is currently the best characterised of these diseases and therefore the only condition of this type covered by the guidance. The guidance provides detailed advice on how to assess the risk of novel proteins in GM plants causing celiac disease.
In vitro digestibility tests provide valuable information on how a newly created protein in a GM plant behaves during digestion, an important part of the overall safety assessment. The new guidance suggests refinements in the way current in vitro tests are conducted and proposes to evaluate their added value during a two-year interim period.
The assessment of endogenous allergenicity ensures the genetic modification does not adversely affect the levels of existing allergens in the GM plant compared to its conventional counterpart. This guidance document provides detailed additional information on how to address this requirement.
Successful conclusion of pilot project
The publication of this guidance document brings a two year-long pilot project to a successful conclusion. EFSA’s aim was to increase engagement with stakeholders in its scientific processes as part of the Open EFSA initiative.
An eight-member focus group acted as the consultative body throughout the development of this document. All parties involved agreed that the scientific process benefited from this inclusive approach.
- Guidance on allergenicity assessment of genetically modified plants
- Outcome of the public consultation on the draft guidance on allergenicity assessment of genetically modified plants
Immunoglobulin E (IgE) is a type of antibody produced by the immune system in response to an allergen. Non-IgE mediated immune reactions are those in which other mediators in the body are involved.