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Public consultation - Applicability of the EFSA opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis

EFSA's GMO Panel has launched an open consultation on its draft scientific opinion on the applicability of the EFSA opinion on site-directed nucleases type 3 (SDN-3) for the safety assessment of plants developed using site-directed nucleases type 1 and 2 (SDN-1 and SDN-2) and oligonucleotide-directed mutagenesis (ODM). In line with the mandate of the European Commission, this opinion takes into consideration section 4 and conclusions of the EFSA opinion on SDN-3 (EFSA GMO Panel, 2012) and evaluates the applicability of those sections for the risk assessment of plants produced via SDN-2, SDN-3, and ODM approaches.

Interested parties are invited to submit written comments by 4 June 2020 (extended deadline). Please use the electronic template provided to submit comments and refer to the line and page numbers. Kindly 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: GMOManagement [at]

Please note that comments will not be considered if they:

  • are submitted after the closing date of the 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 that are submitted in line with the criteria above. The comments will be further considered by EFSA’s GMO Panel and taken into consideration if found relevant.

Copyright-cleared contributions

Persons or organisations participating in a public consultation of EFSA are responsible for ensuring that they hold all the rights necessary for their submissions and consequent publication by EFSA. Comments should inter alia be copyright-cleared taking into account EFSA’s transparency policy and practice to publish all submissions. In case the submission reproduces third-party content in the form of charts, graphs or images, the required prior permissions of the right holder(s) should have been obtained by the public consultation respondent.

Publication of contributions

Contributions will be published (as part of an EFSA report published together with the final scientific opinion) and may be re-used by EFSA in a different context. It should be noted that contributions submitted by individuals in a personal capacity will be published as such, indicating the author’s first and family name, unless a substantial justification for protection is provided by the respondent. Contributions submitted on behalf of an organisation are also made publicly available and attributed to the organisation in question.

Reference documents

EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2012. Scientific opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease 3 and other Site-Directed Nucleases with similar function. EFSA Journal 2012;10(10):2943