Botanicals: a comparison between Italian and German legislations in the light of the EU regulatory framework

Natural substances derived from plant products, algae, fungi and lichens, called botanicals or botanical preparations, recall a rising popularity in Europe and its countries. These botanicals are variously processed and sold as natural food products through different channels in the EU. Their use can be very diverse, ranging from medicinal herbal products that promise beneficial effects on, for example, digestion, sleep or the immune system, to cosmetic benefits such as better skin and thick hair. In general, they promote general health and positive effects on health, a preventive effect on diseases as well as cosmetical effects. They are processed into capsules, tablets, essential oils, powders, teas and similar foods. In the European Union, botanicals, depending on the produced product, either fall under food law or medicinal law. There are no harmonized rules yet, to when which regulatory framework applies to the product. This decision is to be done by the Member States individually. If botanicals are considered food, they will be regulated by the General Food Law. If botanicals are considered non-food or medicinal products, they will be subjects to other specific provisions. The general food law lays down the general principles and requirements of food law, including fundamental principles of food law such as risk assessment, protection of consumer health, transparency of food businesses and the precautionary principle. It lacks rules on common procedures for risk assessment, characterization and consumer information, or specific guidelines on botanicals. As a result, Member States are allowed to set their own rules for botanicals, resulting in differences from country to country. This comparative thesis aims to analyze and clarify the differences and commonalities of the regulatory frameworks of two Member States and their legal predispositions for the admission of botanical preparations, focusing on a comparison between Italy and Germany. It also discusses the legal history of botanicals and the aims of the EU to implement harmonized legislation, how this situation has arisen and why harmonized rules are necessary in the future.