EU launched a public consultation on GM plant allergenicity guidance

The European Food Safety Authority (EFSA) has launched a public consultation on its draft guidance for the allergenicity assessment of genetically modified (GM) plants. Interested parties are invited to submit written comments by 25th of September 2016. 

The aim of this draft Guidance Document is to provide supplementary guidance on specific topics for the allergenicity risk assessment of GM plants to incorporate new developments in the area. The topics addressed are non-IgE-mediated immune adverse reactions to foods, in vitro protein digestibility tests and endogenous allergenicity.

This draft Guidance Document provides proposals supplementing the general recommendations published in the EFSA GMO Panel Guidance Document on the risk assessment of food and feed from GM plants and the Implementing Regulation (EU) No 503/2013.

Reflecting new scientific and regulatory developments

EFSA strives to include the latest scientific findings in its risk assessments and continuously monitors scientific developments to this end. The new guidance document on allergenicity reflects scientific advances as compared to the current guidance.

Updates in the guidance are based in part on extensive literature reviews, which revealed new methodologies that could be applied in allergenicity assessment. The new guidance also reflects recent EU legislation on GM food and feed by addressing new requirements for the authorisation of GM plants for the European market. These requirements refer to the inclusion of certain allergens in the compositional analysis of the allergenicity assessment of a GM plant.

EFSA decided to delay inclusion of guidance on in vitro digestibility studies for allergenicity assessment pending further evaluations.

Successful early stakeholder engagement – next steps

The draft guidance on allergenicity assessment of GM plants is a milestone in EFSA’s efforts to engage stakeholders in its scientific processes. An eight-member stakeholder focus group acted as a consultative body and contributed to the development of this guidance document from the start. This pilot project began with a workshop in June 2015. The involvement of the stakeholder focus group allowed EFSA to benefit from relevant expertise throughout the development of the guidance.

Efforts to engage with stakeholders will continue with a workshop on 23 November 2016 where feedback from the public consultation will be discussed. EFSA is organising this event in close collaboration with the focus group.

Submit comments (deadline: 25 September 2016)
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For more detailed information about this public consultation, please visit the original website: Public consultation on the draft Guidance Document on allergenicity assessment of genetically modified plants.