Plants may serve as new hosts for the production of recombinant nutraceuticals and pharmaceuticals. Nutraceuticals and pharmaceuticals can be distinguished at best on the basis of their aim. Nutraceuticals on the one hand aim to maintain the health situation of principally healthy humans or animals. They are single compounds that are naturally present in, or (purified) added to foods for daily consumption. Such foods are called 'functional foods' (and in the case of animal application: 'functional feed'). They can be supplied with a health claim. Pharmaceuticals on the other hand aim to cure (human, animal) patients, to mitigate, or to serve in diagnostics. They are purified, well defined medicinal and/or therapeutic preparations that have passed the clinical tests and that are supplied with a medicinal claim. Plants, transgenically producing nutraceuticals or pharmaceuticals, should meet the general requirements for genetically modified organisms, and, additionally, the specific requirements related to the production of the specific medicinal or health compounds. To guarantee safety, to proper regulate the production processes, and for the sake of consumers trust, in the EU and USA, an extensive variety of (often regionspecific) guidelines and regulations encircle both categories of activities, the GM technology, and the production of health foods and medicinal articles: For the cultivation, import, marketing and animal feeding of a genetically modified crop approval must be sought from the EU. A distinction is made by Dutch legislation between the in-doors- and out-doors- cultivation of genetically modified plants. The in-doors cultivation, will require a less elaborate risk assessment than the out-doors cultivation. Production of pharmaceuticals and nutraceuticals in GMOs in greenhouses is bound by special rules related to the transgenic status of the plants and should occur according to the guidelines for 'good agricultural practice' (GAP). GAP guidelines apply to the production of all plant materials used in the food, feed , medicinal , flavoring and perfume industries. GAP conditions must also be met concerning processing of the harvested transgenic plant material. The type of greenhouse (PK-I, PK-II or PK-III) that needs to be used depends on the the specific case and is related to the characteristics of the inserted gene, the biological and agronomic characteristics, and the treatments of the crop plant involved. Food applications include whole foods and food ingredients on one side and food additives on the other side. Both categories are differently regulated. In the EU, genetically modified organisms are regulated as a specific category for use as novel foods or novel- food ingredients but not for use as food additives, colourants, or flavourings.