Monitoring plans and reports

About monitoring plans and reports

Post-market environmental monitoring (PMEM) plan

Applications for the deliberate release into the environment of GMOs and for the placing on the market of food or feed products containing or consisting of GMOs must contain a PMEM plan, which becomes part of the consent or the authorisation decision.

The PMEM plan must satisfy the requirements of Annex VII of Directive 2001/18/EC and comprise general surveillance for unanticipated adverse effects and, depending on the outcome of the environmental risk assessment, case-specific monitoring to detect direct and indirect effects which have been identified in the environmental risk assessment.

As regards the placing on the market of food and feed containing or consisting of certain GM agricultural crops (cotton, maize, oilseed rape and soybean), a template for the PMEM plans has been developed in cooperation with operators to ensure a harmonised implementation of such plans.

This template has been complemented with an annex, endorsed on 11 April 2025 by the Standing Committee on Plants, Animals, Food and Feed - Section Genetically Modified Food and Feed and Environmental Risks. The new annex is relevant for future applications for authorisation and renewal of authorisations, but also for the monitoring of already authorised GMOs, as it provides complementary information on the usual methodologies and measures applied by operators to implement the general surveillance of PMEM plans.

Post-market monitoring (PMM) plan for GM food and feed

A PMM plan regarding the use of the GM food/feed for human/animal consumption may be 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 granted, the applicant must carry out the monitoring and report on it according to the conditions specified in the consent or authorisation decision.

PMEM reports for GM food and feed

General surveillance and Case-specific monitoring reports

PMEM reports for GMO cultivation

General surveillance and Case-specific monitoring reports

PMEM reports for GMO for ornamental purposes

General surveillance and Case-specific monitoring reports

PMM reports for GM food and feed