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EFSA calls for comments on GM allergy guidance

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A public consultation has been launched by the European Food Safety Authority (EFSA) on its Draft Guidance on Allergenicity Assessment of Genetically Modified Plants.

The risk assessment document, drawn up by the authority’s Panel on Genetically Modified Organisms, provides supplementary guidance on the allergenicity risk assessment of GM plants, covering non-IgE-mediated immune adverse reactions to foods, in vitro protein digestibility tests and endogenous allergenicity.

The organisation is asking stakeholders and the general public to contribute written comments in order to “enhance its quality and clarity” and says that following the public consultation process, the document will be revised accordingly to take into consideration new developments in the area.

The consultation document states: “Concerning potential allergenicity of novel proteins in GMOs there is, however, in practice no way to ensure full certainty, as there is no single test or parameter that on its own can provide sufficient evidence to predict allergenicity of a protein or peptide.

“This is the case because it is only insufficiently understood what causes a protein or peptide to be allergenic, and development of allergic disease additionally depends on other factors like genetic predisposition of the individual or environmental factors. Still, a high degree of confidence in the safety of GMOs can be reached using a weight-of-evidence approach.”

“At any time, this approach must be based on the best and most up-to-date scientific knowledge and methodologies. The field of molecular biology is in rapid development, and regulations and guidance documents need to be updated frequently to take scientific advances on board and to reduce remaining uncertainty after a weight-of-evidence evaluation.”

The full document can be found here. http://www.efsa.europa.eu/sites/default/files/consultation/160726.pdf Written comments must be submitted by 25 September 2016 via the EFSA’s electronic template. http://registerofquestions.efsa.europa.eu/roqFrontend/consultation/doc/75

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