EFSA to consider limits for kaurenoic acid, an impurity found in stevia

EUROPE – The European Food Safety Authority (EFSA) is considering a recommendation to the European Union to set limits for the kaurenoic acid (KA), an impurity found in stevia, a sweetener and sugar substitute.

Last month, EFSA held a technical meeting with representatives from Cargill, International Stevia Council (ISC), Pure Circle, Coca Cola, Sweegen and Intertek to deliberate on the impurity kaurenoic acid in stevia sweeteners.

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This came with a series of controversies regarding the health implications of kaurenoic acid on human health in regards to genotoxic potential.

However, a recent study by Cano et al (2017) reported a lack of KA genotoxicity when tested at non-cytotoxic concentrations.

Other findings predicted a lack of bacterial mutagenicity and mammalian genotoxicity potential.

Based on the data evidence provided by DSM, Cargill, PureCircle and Sweegen on the KA Genotoxicity, EFSA indicated that there were no safety concerns based upon a lack of KA in the commercial products and that KA is shown to be non-mutagenic at non-cytotoxic concentrations.

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It further concluded that there is no need to change the current EU SG specification.

“Consequently, no limits for kaurenoic acid are currently included in the specifications for the food additives steviol glycosides according to Regulation (EU) No. 231/2012.

“EFSA will be finalising the assessment on the new production process by fermentation for the food additive steviol glycosides (E 960).

Based on all the information available, EFSA may recommend adding limits for kaurenoic acid to the specifications for E960,” said Camilla Smeraldi, senior scientic officer at EFSA’s food ingredients and packaging unit.

Speaking on the matter to FoodNavigator, Maria Teresa Scardigli, executive director of the International Stevia Council, the trade association that represents the stevia industry said, “Kaurenoic acid is a precursor in the formation of steviol glycosides in the leaf and steviol glycosides are the sweet compounds naturally found in the leaf of the stevia plant.

“In addition, kaurenoic acid is naturally found in a fruit, cherimoya, which is grown, sold and consumed in markets such as Spain and Portugal.”

She said ISC was preparing to submit detailed data to EFSA to show the absence of kaurenoic acid in steviol glycosides in high purity stevia leaf extracts.

DSM which last year took the first regulatory steps to bring fermented steviol glycosides to the European market said it has “no doubts” about the safety of kaurenoic acid.

“We are happy to provide additional safety data to EFSA, and should EFSA deem it desirable to apply any limit, will ensure that KA levels are below that,” said a DSM spokesperson.

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