Coke Applies for Phytosterol Use in Juice in Australia

Phytosterol esters and non-esterified phytosterols have been permitted in edible oil spreads and margarines since 2001. In November 2006, permission was given for the addition of phytosterol esters to breakfast cereals, low-fat milk and low-fat yoghurt.

17/12/08 Coca-Cola South Pacific Pty Ltd has made an Application to FSANZ seeking approval for the use of phytosterols derived from vegetable oils as a novel food ingredient in fruit juice and fruit juice drinks with a minimum 20% juice. In the Australia New Zealand Food Standards Code (the Code) Standard 1.5.1 – Novel foods, requires that novel foods undergo a safety assessment before being permitted in the food supply. If approved, the novel food is listed in the Table to the Standard and must comply with any special conditions of use also listed in the Table. The products will be specifically marketed to adult consumers, generally over the age of 40, with concerns about their blood cholesterol level (the ‘target consumers’).

Phytosterol esters (derived from vegetable oils) and non-esterified phytosterols (derived from a tall-oil source) have been permitted in edible oil spreads and margarines since 2001. In November 2006, permission was given for the addition of phytosterol esters to breakfast cereals, low-fat milk and low-fat yoghurt. Non-esterified phytosterols derived from a tall oil source are also permitted in low-fat milk. However, there is currently no permission in Australia and New Zealand to use non-esterified vegetable oil-derived phytosterols.

In assessing this Application, FSANZ will have regard to the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) policy guideline on Addition to Food of Substances other than Vitamins and Minerals (the Guideline). This provides general guidance to assist FSANZ determine the appropriate circumstances under which substances should be permitted for addition to foods.

In order to assess the merits of this Application, data on the cholesterol lowering effects, nutritional effects and safety of phytosterols when added to fruit juice and fruit juice drinks will be taken into consideration. The Applicant has supplied details of a clinical study and additional scientific information relevant to a safety assessment supporting the extended use of phytosterols in fruit juice and fruit juice drinks. FSANZ will consider the studies submitted by the Applicant as well as a wide range of other evidence, including published studies. FSANZ will consider the Acceptable Daily Intake (ADI) recently established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and the potential dietary impact of a broader range of products containing phytosterols on target and non-target consumers.

At Initial Assessment, FSANZ has identified a number of issues that will need to be considered at Draft Assessment. These include:

• The possibility for cumulative intakes of phytosterols (including current permissions for tall oil phytosterols and phytosterol esters) to exceed the ADI, especially among children, once they are permitted in a broader range of foods.

• The potential for increased juice and juice drink consumption by the target consumers, and concerns around increased energy intakes related to this.

• That in the future, food manufacturers may wish to make health claims on products containing phytosterols.

This Initial Assessment Report is not an assessment of the merits of this Application, but rather is an appraisal of whether the Application warrants further consideration according to criteria laid down in the Food Standards Australia New Zealand Act 1991 (FSANZ Act).