EFSA and stakeholders discuss draft allergenicity guidance

EFSA has discussed input received during a public consultation on its draft guidance document on allergenicity of genetically modified (GM) plants with interested stakeholders. More than 60 scientific experts, representatives from Member States, NGOs, industry and patient groups as well as international partners, representatives of regulatory bodies and the European Commission had accepted EFSA’s invitation.

Reflecting new scientific findings

The assessment of potential allergenicity is an integral part of the overall risk assessment of GM plants that takes place before they can be authorised in the European Union. The supplementary guidance on allergenicity will reflect relevant technical advances and new scientific findings since the current guidance was published in 2011.

In response to over 200 comments received from the public, EFSA tabled three proposals on key issues of the guidance document – on in vitro Az élő szervezetekből kivont sejtek vagy szövetek tesztelését magában foglaló kutatási módszer digestibility assessment, endogenous allergenicity and Non-IgE adverse immune reaction. The lively discussion resulted in valuable input for the finalisation of the guidance document which is planned for May 2017.

Engagement with stakeholders

This recent meeting is a continuation of EFSA’s efforts to engage with stakeholders in its scientific processes as part of its Open EFSA initiative. In a pilot approach to boost transparency and openness, an eight member focus group was created to act as a consultative body throughout the development of the document. The first meeting with stakeholders was held in June 2015, when EFSA sought input for the document before the drafting process.

Representatives of the EFSA working group developing the document as well as stakeholder representatives of the focus group gave highly positive feedback about this approach. All agreed that the draft guidance document clearly benefited from the inclusive approach applied during the development phase.