Submission of the summary form concerning field trials changes

Submission of the summary form concerning field trials changes

The preparation of applications for field tests, i.e. activities under Part B of Directive 2001/18/EC, will change as of 3 October 2022 across the European Union. In addition to conventional field trials, the amendment also applies to those clinical trials with medicinal products containing genetically modified organisms that do not meet the criteria for contained use.

In future, the operator must submit the summary form of its application (so-called B-SNIF form) to the E-submission Food Chain Platform (ESFC). However, the actual application shall be submitted to the national competent authority in the country where the field trial takes place. In Finland, the application documents are submitted to the Board for Gene Technology.

Information on the procedure will be provided on the Commission’s website. The ESFC user guide provides instructions on how to submit the SNIF form to the system.