In line with its policy on openness and transparency it is seeking comments from the scientific community and all stakeholders and interested parties have until 25th September 2016 to submit their written comments via the Authority’s electronic template.
The aim of the draft document is to provide additional guidance on the allergenicity risk assessment of GM plants incorporating new developments in the area.
Specific topics addressed are non-IgE-mediated immune adverse reactions to foods, in vitro digestibility tests in the prediction of potential allergenicity of the newly expressed protein and quantification of endogenous allergens in the recipient plant.
"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," it said.
"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."
Following the public consultation an EFSA information session will be held with the final adoption of the guidance envisaged for spring 2017.
All comments will be published however comments submitted by individuals will be presented anonymously. Comments submitted on behalf of an organisation will appear with the name of the organisation.
Late submissions will not be accepted.
For the full accompanying document click here.