GM plants used for non-food or non-feed purposes – EFSA specifies requirements for safety assessment
In its opinion on “Guidance for the risk assessment of genetically modified plants used for non-food or non-feed purposes”, EFSA’s Panel on Genetically Modified Organisms (GMO) discusses risk assessment issues and defines the specific requirements that applicants need to follow to allow efficient risk assessment of GM plants used for other purposes than food or feed. This will complement EFSA’s existing “Guidance on the safety evaluation of GM plants”, initially conceived for the assessment of GM plants used for food and feed purposes.
GM plants developed for non-food or non-feed purposes are plants which may be used for a wide range of applications such as the production of: industrial enzymes; raw materials for bio-fuels, paper and starch; medicinal products (such as vaccines and antibodies); as well as other uses which can range from energy production to helping to address environmental issues (for instance the take-up of contaminants present in soil through phytoremediation).
In its opinion, the GMO Panel advocates – as for GM plants used for food and feed - a comparative approach whilst highlighting that it should be applied carefully. The Panel considered that existing guidance for environmental risk assessment is adequate but that additional emphasis should be given to issues such as gene transfer and the exposure of non-target organisms, particularly wildlife feeding on these GM plants. When in certain cases the applicant proposes confinement strategies to reduce exposure of humans, animals or the environment, the GMO Panel has specified the information requirements needed to carry out the exposure assessment. Where new potential GM plant risks are identified, the plants are likely to require more specific risk management conditions.
The Guidance benefited from the contribution of selected experts in the field of GM plants for non-food or non-feed purposes and in the field of risk assessment of pharmaceutical products. Legal advice was also given by the European Commission and the European Medicines Agency (EMEA). EFSA received comments during a 3-month public consultation which have been taken into account in finalising the opinion.
EFSA’s role is to evaluate the safety of GM plants for human and animal health and the environment. Guidance documents aim at ensuring that applications for marketing GM plants contain all information and data required to support a comprehensive risk assessment, so that applications can be efficiently evaluated by EFSA and other competent authorities in Europe.