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- W293353108 abstract "Safety refers to a “reasonable certainty of no harm” based on an intellectual concept, not an inherent property of a substance. Tolerability refers to the capacity a subject has to consume a substance without the occurrence of an adverse event or the appearance of an increased sensitivity to the substance. Three processes are often used when considering the safety or tolerability of Single Cell Oils (SCOs). The first involves risk assessment, and the second and third processes involve risk management (regulation and control) and risk communication. This chapter discusses the general aspects of the safety and tolerability of SCOs. Safety evaluation of food ingredients, including SCOs, is based on a reasonable assumption that such ingredients do not cause any harm. The FDA Redbook was prepared to assist in the design of protocols for animal studies conducted to test the safety of food ingredients and includes detailed guidelines for testing the effects of food ingredients. The chapter also discusses the regulatory pathway for obtaining pre-market clearance of SCOs for use as food ingredients in the U.S. and as novel food ingredients in the EU, Australia, New Zealand, and Canada, citing some of the more recent published approvals for the oils." @default.
- W293353108 created "2016-06-24" @default.
- W293353108 creator A5007181258 @default.
- W293353108 creator A5029958756 @default.
- W293353108 creator A5040827356 @default.
- W293353108 date "2010-01-01" @default.
- W293353108 modified "2023-09-23" @default.
- W293353108 title "Safety Evaluation of Single Cell Oils and the Regulatory Requirements for Use as Food Ingredients" @default.
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- W293353108 doi "https://doi.org/10.1016/b978-1-893997-73-8.50019-0" @default.
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