Friday, 1 June 2001

Food Standards Ministers Approve plant sterol esters as a novel food ingredient in edible oil spreads

The Food Standards Ministerial Council of Australia and New Zealand today approved vegetable oil-derived plant sterol esters as a novel food ingredient in edible oil spreads (margarines).

The Ministerial Council accepted the advice of the Australia New Zealand Food Authority (ANZFA) that plant sterol esters should be allowed in edible oil spreads, and that the product must carry an advisory statement. The advisory statement will recommend that these products are not appropriate for infants, children and pregnant and lactating women and that people using cholesterol reducing medication should seek medical advice before using the spreads.

This followed a safety assessment by ANZFA of plant sterol esters as novel food ingredients that concluded that there is sufficient data to demonstrate their safety at the level of intake which would be achieved from their use in edible oil spreads. In relation to the use of plant sterol esters in other foods, manufacturers had not supplied ANZFA with sufficient data to show that plant sterol esters are safe at the higher levels of intake which might be expected if there was permission to use these ingredients in a broader range of foods.

On 16 June 2001 the new Novel Foods Standard comes into effect in Australia and New Zealand. Novel foods are new foods for which there is insufficient knowledge in the community to ensure that the likely total levels of consumption will be safe. Novel foods and novel food ingredients will not be permitted after 16 June 2001 unless they have passed a rigorous pre-market safety assessment by ANZFA and been approved by the Ministerial Council. This process is similar to the pre-market safety assessment of food additives and processing aids.

Ministers noted ANZFA's advice that industry has commissioned further research to test the safety of plant sterol esters when consumed at much higher levels. The results are expected to be available late this year.

In the meanwhile, it will not be legal to sell after 16 June 2001, foods other than edible oil spreads which have been fortified with plant sterol esters.

Regulators in other western countries are examining the same issue. The European Commission permits only edible oil spreads containing plant sterol esters. In the US, spreads, salad dressings, snack bars and a yoghurt containing plant sterol esters have 'generally recognised as safe' status but have not been through a pre-market safety assessment by a government agency. In Canada, plant sterol esters are currently considered to be therapeutic products and there is no permission for marketing them as foods.

The manufacturers are fully co-operating with the phase out of the products by 16 June 2001. The products are a yoghurt, a breakfast bar, a salad dressing, a mayonnaise and a milk.

New Zealand note: Edible oil spreads (margarines) are the only products containing plant sterol esters currently available in New Zealand therefore no products will be need to be removed from the shelves.

www.foodstandards.gov.au or www.foodstandards.govt.nz