Public consultation on the draft Guidance Document on allergenicity assessment of genetically modified plants

25 September 2016
Document (4.11 MB)
Table C1 (409.42 KB)
Privacy Statement (220.84 KB)

EFSA has launched a public consultation on a draft Guidance Document on allergenicity assessment of genetically modified (GM) plants endorsed by the EFSA Panel on Genetically Modified Organisms.

The aim of this draft Guidance Document is to provide supplementary guidance on specific topics for the allergenicity risk assessment of GM plants to incorporate new developments in the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This draft Guidance Document provides proposals supplementing the general recommendations published in the EFSA GMO Panel Guidance Document on the risk assessment of food and feed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[1] and the Implementing Regulation (EU) No 503/2013[2].

In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments from the scientific community and all stakeholders, EFSA has launched a public consultation on the draft Guidance Document.

Interested parties are invited to submit written comments by 25th of September 2016. Please use exclusively the electronic template provided to submit comments and refer to the line and page numbers. Please note that after 2 hours of non-activity your working session will expire and comments submitted after that time will not be recorded and transmitted. Therefore, if the page is left inactive for more than 2 hours, please re-open it from the link before restarting to comment. If you would like to submit additional data to support your comments or file, send an email to: GMO.PublicConsult.75 [at]

Please note that comments will not be considered if they:

  • are submitted after the closing date of the public consultation 
  • are presented in any form other than what is provided for in the instructions and template
  • are not related to the contents of the document
  • contain complaints against institutions, personal accusations, irrelevant or offensive statements or material
  • are related to policy or risk management aspects, which is out of the scope of EFSA's activity.

EFSA will assess all comments from interested parties which are submitted in line with the criteria above. The comments will be further considered by the relevant EFSA Panel and taken into consideration if found to be relevant.

All comments submitted will be published. Comments submitted by individuals in a personal capacity will be presented anonymously. Comments submitted formally on behalf of an organisation will appear with the name of the organisation.

Submit comments (deadline: 25 September 2016)

[1] EFSA Panel on Genetically Modified Organisms (GMO); Scientific Opinion on Guidance for risk assessment of food and feed from genetically modified plants. EFSA Journal 2011; 9(5): 2150. [37 pp.] doi:10.2903/j.efsa.2011.2150.

[2] Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006. Official Journal of the European Union, L157:1–47.

26 July 2016