Modern biotechnology has many applications in the pharmaceutical and agri-food industries. One example is the use of GMOs in the food production chain. GMOs are organisms such as plants, animals and micro-organisms (bacteria, viruses, etc.), the genetic characteristics of which have been modified artificially in order to give them a new property (a plant's resistance to a disease or insect, improvement of a food's quality or nutritional value, increased crop productivity, a plant's tolerance of a herbicide, etc.). In order to ensure that this development of modern biotechnology, and more specifically of GMOs, takes place in complete safety, the European Union has established a legal framework comprising various acts:

• The contained use of genetically modified micro-organisms, e.g. laboratory research (in a confined environment), is regulated by Directive 90/219/EC on the contained use of genetically modified micro-organisms;



• The experimental release of GMOs into the environment, in other words the introduction of GMOs into the environment for experimental purposes (e.g. for field testing), is governed by Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (mainly Part B thereof);



• The placing on the market of GMOs (products containing or consisting of GMOs), e.g. for cultivation, import or processing into industrial products, is subject to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (mainly Part C thereof);



• The placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs is governed by Regulation (EC) 1829/2003 on genetically modified food and feed. Where a food product contains or consists of GMOs, the applicant has a choice: either the application as a whole is subject solely to Regulation (EC) 1829/2003, in application of the principle of "one door, one key", in order to obtain authorisation for the deliberate release of a GMO into the environment - in accordance with the criteria laid down by Directive 2001/18/EC - and for the use of this GMO in food products - in accordance with the criteria laid down by Regulation (EC) 1829/2003; or the application - or part of it - is subject both to Directive 2001/18/EC and to Regulation (EC) 1829/2003.



• Unintentional movements of GMOs between Member States and exports of GMOs to third countries are governed by Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms.

The above legislation establishes the conditions under which a party may develop, use or market a GMO or a food product derived from GMOs.

GMOs and food products derived from GMOs placed on the market must also comply with labelling and traceability requirements. These requirements are found in Regulation (EC) 1829/2003 and in Regulation (EC) 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC.