The opinion, published last week, says genetically modified ice structuring protein (ISP) is safe for use as a food ingredient at levels no exceeding 0.01 per cent by weight – the level specified by the international food manufacturer.
EFSA's opinion has now been passed to the Commission. A decision will now be made through Standing Committee on whether the product can be approved.
ISPs occur naturally in nature and are present in organisms such as cold water fish, vegetables, grains, lichens and bacteria.
They bind to ice and help protect the organisms in very cold environments by lowering the temperatures at which the ice crystals form and altering their size and shape to prevent tissue damage.
Unilever found the qualities of ISPs could also provide textual benefits for low-fat ice cream, as well as providing pH stability in frozen products.
There is increasing demand for low-fat products that do not compromise on quality or taste, as health conscious consumers seek healthy yet indulgent treats.
Unilever carried out tests using type III ISPs from ocean pout (Macrozoarces americanus). However, because it is not economical, practical or sustainable to rely on ocean pout for the ISPs, it developed a fermentation process using GM baker’s yeast carrying the synthetic gene encoding for the ISP. The protein produced does not contain any residual modified yeast cells or detectable recombinant DNA, the company says.
Between 2003 and 2007, more than 470m edible ice products containing ISP were sold in the USA, and 47,000 litres of ice cream made using ISPs were purchased in Australian and New Zealand.
There have been no reports of safety issues but it has not yet been authorised in Europe and concerns have been raised in Europe about the potential reactions against yeast allergens.
Unilever supplied details of a 13-week gavage study in rats using a maximum dose of ISP type III. No relevant differences between the control and the test groups were observed.
EFSA said: “The Panels found no evidence of genotoxic activity in a variety of trials. Based on a range of test results, the risk of an allergic reaction in fish-allergic people or the population at large is considered very unlikely, as is the possibility that allergic reactions to yeast allergens could occur due to eating the ISP-containing products."
Background to application
Unilever submitted its request for approval for its ISP ingredient under the Novel Food Regulation to the UK authorities in 2006.
At that time, anti-GM campaigners such as the Independent Science Panel said there was no evidence that the transgenic ice-structuring protein developed by Unilever was identical to the protein produced in ocean pout. They called for further comprehensive tests.
However, in 2007, the UK Food Standards Agency (FSA) concluded that the ISP preparation was acceptable, but thought consumers should be made aware that the products are made using ISPs, even though the GM yeast cells are removed from the final product, a move that could deter many consumers as GM remains a controversial process.
The initial report was then passed on to the European Commission and shown to member states, which raised concerns about the possibility of allergic reactions and issues concerning labelling.
While EFSA has drawn conclusions on the safety aspects, the Commission and member states must now decide on how products containing ISPs are labelled, should the ingredient receive approval.