This guidance document describes the principles to be followed when conducting risk assessments of genetically modified microorganisms (GMMOs), as well as the scientific information required in applications for authorisation to be evaluated by the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel).
9 June 2011: The European Food Safety Authority (EFSA) has released an updated guidance document for the risk assessment of genetically modified microorganisms (GMMOs) and their derived products intended for food and feed use.
The updated guidance covers: scope of the document; principles and strategies for GMMO risk assessment; and information required in applications for GMMOs and/or their products.
The section on scope explains the relevance of different EU Directives, including requirements for environmental risk assessments for the deliberate release of the GMMOs into the environment. The section on principles describes the strategy, steps to be taken, and issues to be considered when carrying out a comprehensive risk characterization. It notes that the objective of risk assessment is to identify and evaluate potential adverse effects of the GMMO, either direct or indirect, immediate or delayed, on human and animal health and the environment, linked to placing GMMOs and/or their products for food and feed use on the market.
The final section describes the scientific information that should be provided in applications, and requirements for the risk assessment by the EFSA’s Scientific Panel on Genetically Modified Organisms (GMOs). Such information includes: information on identification and characterization of hazards, including potential impacts on the environment; information relating to identification and assessment of environmental risks; and information on post-market environmental monitoring. [Publication: Scientific Opinion: Guidance on the Risk Assessment of GMMOs and their Products Intended for Food and Feed Use]