Users guide to European regulation in Biotechnology


EU Commission

The Users Guide to European Regulation in Biotechnology aims to provide a basic overview of the Community regulatory system for biotechnology, and guidance as to how it operates from a user's perspective. It helps companies identify routes to regulatory compliance for their products and processes, reducing uncertainty as it clarifies which regulations are applicable and what the basic regulatory procedures are. This should reduce the costs of compliance. At the same time, the Guide promotes understanding of the way regulation balances the benefits, risks and ethical issues arising from biotechnology.

Key legislative requirements are indicated by the Guide, but the focus is on providing access to more specific Community sources of information. The Guide does not aim to interpret legal documents, and should not be read as legally binding. National (Member State) legislation is not covered, but, where relevant, lists of national authorities are provided.