In approving draft regulations on the matter, FSANZ established two main criteria for a generic classification that won the support of major players in the area such as Unilever, Kraft and Raisio, which lodged the application for the generic novel foods status in March, 2009.
These were that safety and efficacy could only be proven if the plant sterol in question contained 95 per cent desmethyl sterols - the common forms of plant sterols contained in, “current commercial and well-studied preparations.”
The other related to placing limits on the use of solvents.
FSANZ determined these two elements were required in addition to criteria drawn from a 2008 monograph produced by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
Currently, specific types of plant sterols taken from vegetable or tall oil sources may be added to four approved food categories: low-fat milk, certain types of breakfast cereals, edible oil spreads and low-fat yoghurt.
“The weight of evidence supports the safety of plant sterols at present levels of consumption irrespective of the combination or proportion used of the individual phytosterol or phytostanol components used or their source,” FSANZ said.
“FSANZ concludes that phytosterols, phytostanols and their esters are bioequivalent in terms of their food safety properties.”
Others to support the amendments included the Food Technology Association of Australia; Arboris; the Australian Food and Grocery Council; Cognis Australia; Forbes Medi-Tech; the Dietitians Association of Australia and the National Heart Foundation of Australia.
However Raisio had reservations. It suggested the solvent limit should be 1000ppm not 50pppm, as this was unachievable for many suppliers. But Cognis said the opposite recommending 50ppm.
Raisio also stated there should be no requirement for a fresh application for reduced fat cheese to be included as one of the approved food matrixes.