SNIF (Summary Notification Information Format ) B Form
An application for the release into the environment of GMOs under Directive 2001/18/EC (Part B) is always accompanied by a public summary, the ‘Summary Notification and Information Form’, or SNIF. The SNIF must be completed under the European notification procedure. Article 11 of Directive 2001/18/EC provides for information exchange between the competent authorities and the European Commission. This means that the competent authorities must send a summary of the application form (SNIF form) to the Commission. The SNIF form is published on the European Commission's website (GMO registers (europa.eu)). Other member states can respond to it within 30 days. A copy of the complete dossier can also be requested by a member state upon request.
Until October 2022, the national authority ensured that the SNIF was submitted to the European Commission (EC). With the Transparency Regulation ( EU/2019/1381) coming into force, this procedure has changed.
From 3 October 2022, you must submit the SNIF directly through the EC's E-Submission Food Chain Platform (ESFC) and the national authority must process the SNIF within the ESFC platform.
So you no longer need to send the SNIF with your application.
NB. A sponsor cannot apply for Part A of the gene therapy application form. Only the legal entity with ultimate responsibility for the work to be performed can act as an applicant for a licence. In most cases, the applicant is the Board of Directors (management) of the hospital (institution) where the study will be conducted.
More information
More information on this amendment can be found on the EC website.
Bureau GMO (Genetically Modified Organism )(Genetically Modified Organism) would also like to remind you that the user guide (User guide pp. 77-79) for using the ESFC platform has been updated for the SNIF submission.
Questions?
If you have any questions about accessing or using the ESFC platform, please contact the EC at the e-mail address: sante-consult-E3@ec.europa.eu.