GMO applications – guidance documents

EFSA has prepared several guidance documents for the risk assessment of GMOs and derived food and feed. These documents detail the type of scientific data that applicants must include in GMO applications and outline the approach followed by the GMO Panel in the evaluation of the risk assessment. EFSA regularly updates its guidance documents and therefore applicants are reminded to ensure that they use the latest version of these documents.

There are seven main guidance documents that should be used by applicants when compiling technical dossiers in support of GMO applications to be submitted to EFSA:

• Risk assessment of food and feed from GM plants (2011)
• Environmental risk assessment of GM plants (2010)
• Guidance on the submission of applications for authorisation of GM food and feed and GM plants for food and feed (2011)
• Risk assessment of GM microorganisms and their products intended for food and feed use (2011)
• Risk assessment of GM plants used for non-food or non-feed purposes (2009)
• Renewal of authorisations of existing GMO products (2006)
• Risk assessment of food and feed from GM animals and on animal health and welfare aspects (2012)

The first two documents, compiling all relevant information from earlier EFSA documents on different aspects of GMO risk assessment, provide a comprehensive overview of the principles and data requirements for food and/or feed and environmental risk assessment, respectively. The third document – submission guidance – provides instructions to applicants on how to prepare and present data in an application to be submitted to EFSA.

The above main guidance documents replace the following previous documents:

• Working document GM plants and plant protection products interplay (2008)
• Guidance document on stacked transformation events (2007)
• Guidance on risk assessment of GM plants and derived food and feed (2006)
• Risk assessment of GM microorganisms and their derived products intended for food and feed use (2006)

In addition, EFSA has published several other documents which support the current guidance documents and/or provide additional information.

• Guidance on the selection of comparators (2011)
• Opinion on statistical considerations including field trials (2010)
• Opinion on the assessment of allergenicity of GM plants and microorganisms (2010)
• Opinion on potential impacts on non-target organisms (2010)
• Report on animal feeding trials (2008)
• Guidance on Post-market environmental monitoring (PMEM) of GM plants (2011)