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The draft guidance on allergenicity assessment of GM plants is a milestone in EFSA’s efforts to engage stakeholders in its scientific processes.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.