USP Proposes Standards for Probiotic Food Ingredients

January 9, 2012

By Riëtte van Laack

On January 3, 2012, the U.S. Pharmacopeial Convention (“USP”), a scientific organization that publishes the Food Chemical Codex (“FCC”), an international compendium of quality specifications for food ingredients, announced proposed standards for probiotic food ingredients. The proposed standards will be included as new Appendix XV. 

The latest FCC Forum, the free-access on-line publication of proposed FCC standards, proposes standards to be included as new FCC Appendix XV, titled “Microbial Food Cultures Including Probiotics.”  The proposed standards provide a broad description of microbial food cultures (“MFCs”).  Taxonomically and functionally diverse, MFCs include species of a broad range of bacteria, yeasts and fungi.  The proposed FCC standards divide MFCs into two categories: MFCs with a technological role, e.g., starter cultures, and MFCs with a functional role, i.e., those that impart a health benefit.  The proposed FCC standards employ the FAO/WHO definition of probiotics, i.e., “live microorganisms, which when administered in adequate amounts confer a health benefit on the host.”

The proposed quality specifications include identification and enumeration, intended use in food, safety, regulatory status, and purity.  Under the proposed standards probiotics must be identified at the strain level (in contrast starter cultures may be identified at the genus or species level, depending on the requirements of their use).  USP asserts that this level of specification is important for safety (e.g., presence of transferable antibiotic resistance traits) and in supporting health claims. 

Although enumeration of probiotics cannot be generalized, probiotic activity typically relies on the number of live microorganisms and viability is essential at the time of consumption.  Thus, viability through the end of the shelf life in the food matrix is an important characteristic.

The proposed standards are general and applicable to all probiotics.  Future standards development work by USP may include individual standards for specific probiotic strains.