Vice president and head of global scientific and regulatory affairs at PureCircle Dr Sidd Purkayastha said the opinions reflected “typical dialogue” with global regulatory bodies.
“We are in the process of collecting all of the necessary documentation for both opinions, and will be resubmitting the petitions. We always appreciate the opportunity to work with and learn from regulatory bodies around the world.”
Major headache for minor molecules?
So far EFSA has approved 11 steviol glycosides extracted from the plant: Reb A, B, C, D, E, F, M, stevioside, rubusoside, steviolbioside and dulcoside A.
In the first case, PureCircle had asked the food safety authority to extend the existing EU specifications for stevia to include both major and minor glycosides. According to the Kuala Lumpur-headquartered firm, blends of major and minor glycosides improve the flavour.
“Where these minor glycosides are approved in US, Australia, New Zealand and Canada, we’ve seen a lot of success in using tailored blends of various stevia leaf ingredients, including the minor glycosides,” Purkayastha told FoodNavigator.
However, in an opinion published last week EFSA’s panel on food additive safety concluded that “the available information was not sufficient to assess the safety of the proposed amendment.
“The conclusions on the previous assessments on steviol glycosides cannot be extrapolated to any other mixture of steviol glycosides […] extracted from S. rebaudiana Bertoni leaves.
“Therefore, the panel concluded that the submitted data were insufficient to assess the safety of proposed amendment of the specifications of the food additive steviol glycosides (E 960).
PureCircle also requested an EFSA opinion for glucosylated stevia last year, aiming to bring the sweetener to the European market in 2018. The Malaysian manufacturer already markets glucosylated stevia under the brand name Zeta-LE, which has been approved for the US, Japan, Malaysia and South Korea.
Glucosylated stevia is manufactured by adding between one and twenty additional glucose units to steviol glycosides, resulting in a sweetener that has less bitterness and astringency and is said to be around 167 times sweeter than sucrose.
However, the scientists said in their February opinion that PureCircle had not provided any toxicological studies on the sweetener, concluding that: “the submitted data are insufficient to assess the safety of the glucosylated steviol glycoside preparations to be used as a new food additive”.
Purkayastha said: "The EFSA opinion is just looking for further technical data to better understand on [how] glucosylated stevia is metabolized. Once we provide additional documentation, we believe the regulatory approval process will progress."