Methods of Manufacture That Remove Contaminants From Fish Oils: information compiled through the GRAS (generally recognized as safe) notification program
A. J. Edwards, E. Garcia, C. A.. Hendrickson, CFSAN, FDA, College Park, MD
Introduction: Through the GRAS notification program (62 FR 18938; April 17, 1997), a manufacturer or individual may voluntarily notify FDA of their determination that an ingredient such as fish oil is GRAS for its intended use in foods. FDA has received several GRAS notices for fish oils obtained from a variety of fish species. Fish oils are of interest in human health as rich dietary sources of omega-3 and omega-6 fatty acids; however, they are also potential dietary sources of environmental contaminants. Published literature and information contained in GRAS notices show evidence of contamination of fish with heavy metals, pesticides, polycyclic aromatic hydrocarbons (PAHs), polybrominated diphenyl ethers (PBDEs), polychlorinated biphenyls (PCBs), dioxins, and dioxin-like compounds.
Method/Results: On a case-by-case basis, the GRAS notices for fish oil have addressed chemistry issues relevant to the safety of these ingredients, including source, estimated dietary exposure, method of manufacture, fatty acid composition, analyses for contaminants, and quality assurance specifications. OFAS has compiled data from the published literature regarding the removal of environmental contaminants through various oil refining steps and additional purification processes. For purposes of reference, this compilation includes safety assessment information from both national and international government agencies and other expert bodies.
Conclusion: This poster presents an overview of chemistry issues regarding the safety of fish oils as ingredients in foods and the role of purification processes used during manufacturing to remove contaminants from fish oils.