Is Potassium Sorbate banned?
Potassium Sorbate is permitted by the US FDA. Several countries restrict, warning-label, or have reviewed it for safety concerns. The US has more lenient additive rules than the EU, UK, Canada, and Japan, which is why this ingredient remains widely used here.
Why Potassium Sorbate is flagged
Potassium sorbate has a generally good safety profile compared to other synthetic preservatives. EFSA's 2015 re-evaluation maintained the ADI at 3 mg/kg body weight, finding no significant carcinogenicity or genotoxicity. However, some human and in vitro studies have documented concerns. A 2010 study in Toxicology in Vitro found potassium sorbate was genotoxic (caused DNA strand breaks) in human blood cells at concentrations achievable in food. The study found it damaged peripheral blood lymphocytes. A 2014 study in Food and Chemical Toxicology found potassium sorbate caused DNA damage in human lymphocytes at food use concentrations. Contact dermatitis and allergic reactions from topical use are documented. At very high doses in animal studies, liver and kidney effects have been observed. The general regulatory consensus is that potassium sorbate is one of the safer food preservatives, but the in vitro genotoxicity findings deserve attention.
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