EFSA News item, 8 August 2008
EFSA's NDA and GMO Panels have issued a joint opinion on the safety of ice structuring proteins (ISPs) for use in foods. ISPs are naturally produced by a variety of living organisms – including certain fish, plants and vegetables - to help them cope with very cold environments by lowering the temperature at which ice crystals form.
A technique has been developed to add ISPs to ice cream in order to control the formation of ice crystals during manufacture permitting a creamy consistency with lower fat content. The technique involves production of the isolated proteins using a genetically modified strain of baker's yeast – a system common in the production of vitamins and enzymes. The protein produced does not contain any residual modified yeast cells or detectable recombinant DNA.
A food manufacturer has submitted an application under the Novel Food Regulation to use ISPs as a food ingredient by applying this technique. The European Commission asked EFSA to review the evidence regarding the safety of ISPs including scientific arguments raised by Member States during the regulatory commenting period.
EFSA's NDA and GMO Panels concluded that the proposed use of ISPs – in ice cream at no more than 0.01% of weight - is safe subject to the specification and production practices described by the applicant. 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.
Ice structuring proteins are already consumed as part of the human diet - they have been found in common foods such as oats, rye, wheat, barley, carrot, potato and cold water fish. No safety issues have been reported either from consuming natural dietary sources or through the addition of ISPs to foods, which is authorised in countries including the United States, Australia and New Zealand. If added to ice cream, expected EU consumer intake through this source would be well within the current estimated levels of dietary exposure.