Monitoring plans and reports

Monitoring plans and reports

Applications for GMOs and GM food/feed products must contain a monitoring plan which is part of the authorisation decision.

Depending on the scope of the application, there are several kinds of monitoring.

For the applications for GMO cultivation, post-market environmental monitoring plan (PMEM) must satisfy the requirements of Annex VII of Directive 2001/18/EC and comprise:

  • General surveillance for unanticipated adverse effects

  • Case-specific monitoring to detect direct and indirect effects which have been identified in the environmental risk assessment

For the applications for GM food and feed, post-market environmental monitoring plan (PMEM) must satisfy the requirements of Annex VII of Directive 2001/18/EC and comprise:

  • General surveillance for unanticipated adverse effects

  • Case-specific monitoring to detect direct and indirect effects which have been identified in the environmental risk assessment

In addition, post-market monitoring plan (PMM) regarding the use of the GM food/feed for human/animal consumption is requested in cases where it is appropriate to verify that the conditions of use are properly applied and to monitor the consumption of the product.

Once an authorisation is given, the applicant must implement the monitoring plan(s) and report on it regularly.

Post-market environmental monitoring reports of GMO cultivation can be found here.