Wide-ranging regulations control all aspects of the production of serum and other animal derived products and their subsequent use. The European Union and the United States are major users of these materials with Japan, India and China emerging as major players. The main cattle producing countries are the United States and Canada, Australia and New Zealand and several South American nations. Animal health and welfare, slaughter conditions, hygiene and all subsequent treatments and processes are highly regulated and supervised by national veterinary authorities according to both national laws and the laws of the importing nations.
The animal by-products framework is defined by Regulation (EC) No 1069/2009 and the implementing Regulation (EU) No 142/2011. These regulations are intended to simplify requirements and reduce the administrative burden on Industry, with a particular focus on achieving a more risk-based approach in handling of those animal by-products destined for the manufacture of technical products and which are not intended to enter the food or feed chain. Regulation (EU) No 294/2013 has recently been added.
These regulations cover the importation, certification, handling and transportation requirements for ‘raw’ animal by-products, derived products, blood derived products and Intermediate Products and define when devices or products have reached their end point and/or are otherwise outside the scope of Regulation (EC) No 1069/2009.
The ISIA (International Serum Industry Association) has played an active role in discussion with various regulatory bodies in the evolution of these and other regulations.