It has become quite usual to encounter the substance in the most diverse constellations as a concrete regulatory object, be it by means of limit values (e. g. in food legislation), as a subject to certain bans (just think of certain narcotics) but also as a subject of explicit permissions (like under the authorisation scheme of the prominent EU REACH regulation).
In addition, a number of items are legally defined as a substance. These are, among others, cosmetic products , medicinal products , narcotics , plant protection products , biocidal products  and partly also food . Thus, a new field of law, the substances law, arose.
Beyond this area of law, which only began to form properly after the end of the Second World War, the substance has long played a major role in the context of intellectual property rights. The substance patents created here also established a separate area within the patent system. In German, this is called "Stoffschutz" (substance protection). In US American law, its history can be traced back to the end of the 18th century.
But what exactly does the term substance mean in law?
Following the usual legal approach, various legislators have tried in different fields of law to define the term substance for its part, too. An analysis of these legal definitions showed that the term substance most commonly was defined as the chemical elements and their compounds. This refers to the central theoretical framework of the natural science of chemistry, namely the periodic table. This table contains all chemical elements and, among other sciences, chemistry assumes that no less than everything that exists is composed of these elements.
What are the implications of this definition? Can it fulfill its central function, the delimitation of the term substance? And, if not, how can we then deal with the many and varied stipulations of substance law and the IP rights granted directly to substances?
Stefanie Merenyi's legal thesis The Concept of Substance in Law (so far only in German: Der Stoffbegriff im Recht) tries to give first answers to these and further questions.
|||Art. 2 s. 1 lit. a) Regulation (EC) Nr.1223/2009|
|||Art. 1 No. 2 Directive 2001/83/EC|
|||§ 1 s. 1 German Narcotics Law (BtMG)|
|||Art. 2 s. 1 Regulation (EC) Nr.1107/2009|
|||Art. 3 s. 1 lit. a) Regulation (EU) Nr.528/2012|
|||Art. 2 Regulation (EC) Nr.178/2002|