GMO applications: frequently asked questions

EFSA provides scientific advice on the safety evaluation of genetically modified organisms (GMOs) and their use as food or feed and/or for cultivation. This includes GM plants, GM microorganisms and GM animals.

Frequently Asked Questions

Some general questions that we often receive are available in our Connect.EFSA portal dedicated FAQ page

1. Are the requirements for applicants the same for all GMO A genetically modified organism (GMO) is an organism which contains genetic material that has been deliberately altered and which does not occur naturally through breeding or selection evaluations?

No. The requirements for applicants differ depending on a number of factors, including a) whether the application concerns a GM micro- organism A living thing such as humans, animals, plants and microbes (e.g. bacteria, viruses) (GMM), a GM plant or a GM animal, b) whether the GMO contains a single event or stacked events, and c) on the type of species A subdivision of the genus, a species is a group of closely related and similar-looking organisms; for example, in the case of Homo sapiens (humans), the second part of the name (sapiens) represents the species and the intended use of the GMO, determining the possible routes of exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time for humans, animals and the environment. All specific requirements for applicants can be found in the Commission Implementing Regulation EU No 503/2013 on applications for authorisation of genetically modified food and feed and in the relevant EFSA scientific guidance documents.

2. I am an applicant wanting to use data held in the European Food Consumption Database for an exposure assessment One of the key steps in risk assessment, this relates to a thorough evaluation of who, or what, has been exposed to a hazard and a quantification of the amounts involved as part of my application. Where can I find these data?

EFSA provides summary statistics of human consumption data for food categories from certain crops of interest for GMO risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. These data are designed to complement the exposure assessment in applications for authorisation of genetically modified plants. In using the data, it is strongly recommended that applicants follow the associated EFSA Guidance document. Both the available data and the associated Guidance document are accessible through the EFSA website.

3. Short cuts for applicants