Strategy support for the Post-Market Monitoring (PMM) of GM plants: Review of existing PMM strategies developed for the safety assessment of human and animal health
The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.
Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified (GM) food and feed legalised the requirement for a Post-Market Monitoring (PMM) plan if the outcome of the risk assessment identifies a need to do so. This report provided a systematic review of existing monitoring programmes for food, feed, human and animal health and an inventory of data collection sources that may be useful for PMM of GM food and feed. Under the legislative requirements PMM should confirm that specific recommendations of use are followed by the consumer/animal owner, qualify the predicted consumption of GM food and feed and further characterise any intended or unintended effects highlighted during the pre-market risk assessment. The largest barriers to conducting PMM of GM food and feed in the EU were found to be the ‘unrecognisable’ nature of GM traits further down the food and feed supply chain after processing, and the lack of appropriate consumption data at the branded/product level. EU legislation on traceability and labelling of GMOs requires products to carry a ‘unique identifier’, however, this information is lost once the product is further processed to become a product ‘produced from a GMO’. Consumption data held at a product level by retailers or market research agencies was shown to be more useful for PMM of GM food or feed than that held at the national level by public bodies. The project concludes that several changes would be required in order to conduct comprehensive PMM of GM food and feed in the EU, namely; greater detail on traceability requirements of GMOs, a database of which food and feed products contain which GM traits at specific quantities, consumption data at the branded/product level and a system for reporting the relevance and intensity of effects and unintended effects.