Biotechnologically produced chitosan for nanoscale products. A legal analysis

Conventionally, chitosans are derived from shrimp and other crustacean shells. Biotechnology offers an alternative route to produce chitosans and more importantly, specific chitosan structures tailored to the needs of a diversity of industries. However, for biotech chitosans and products thereof to be commercialised, legislation should not create a burden. Here, the requirements of the EU regulatory framework have been analysed for the entire chain from research to development and production of several potential applications including nanomaterials. The animal or biotechnological origin leads to specific requirements in production of the raw material. No EU legislation dedicated to nanomaterials has been adopted. Instead, products are governed under the respective existing product legislation subject to extra requirements for safety assessment. While a knowledge gap exists on hazards related to nanomaterials in general, there is a need to establish realistic regulatory study designs to assess the safety of specific products. Furthermore, as many of the existing chitosan applications are not considered nanomaterials, it would be discriminatory to treat biotechnology derived products differently.