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[SANET-MG] GM Protein for Ice Cream Not Ready for Commercial Use
ISIS Press Release 16/04/07
GM Protein for Ice Cream Not Ready for Commercial Use
The advisory committee has made considerable effort towards assuring the
safety of a genetically modified ice-structuring protein intended for
use in edible ices, but large gaps still remain
Prof. Joe Cummins and Dr. Mae-Wan Ho
This report has been submitted to the Food Standards Agency on behalf of
the Institute of Science in Society. Please circulate widely
The Advisory committee on Novel Foods and Processes (ACNFP) of UK?s Food
Standards Agency prepared a draft opinion on an ice-structuring
structuring protein Type III HPLC 12) derived from fermented genetically
modified baker?s yeast as a food ingredient  following the 2006
application from Unilever Corporation for the preparation to be used in
edible ices .
The ice-structuring protein was derived from a polar fish, ocean pout,
and is intended for making ice cream smoother and creamier. The GM
protein, produced in transgenic bakers? yeast prevents large ice
crystals forming in ice cream and other frozen foods.
The initial application was put out for public comment, and the
Independent Science Panel submitted a report recommending rejection of
the application until comprehensive, long term studies have been carried
out  (GM Protein in Ice Cream, SiS 31).
Unilever responded to the comments with information from a new study
published in 2007 , which has been incorporated into ACNFP?s draft
opinion. The study found no immune or allergic response in human
volunteers given an oral dose of the ice structuring preparation.
However, the single-blind placebo-controlled trial left a lot to be
desired, and a number of important questions remain unanswered.
· The trial involved only a small number of healthy human volunteers, 23
in the test group, and nine in the control group.
· The preparation used was not purified ISP, but a crude isolate
containing an unknown assemblage of yeast proteins and sugars, which
would be expected to complicate the immune response, particularly as
seven in the test group and four in the control group had predisposition
· A low dose of the ice-structuring preparation, equivalent to 16.3 mg
of ice structuring protein (ISP) was given daily for five days a week
over a short period of just eight weeks, which may well not be
sufficient to fully expose the immunogenic potential of the ISP.
· The preparation was given orally in a ?flavoured drink? instead of in
ice cream, where the use of ISP was intended. This was a serious
oversight, as the complex of ISP and microscopic ice crystals was known
to elicit immune response distinct from the ISP; antibodies to the
complex, but not the protein was found in the ISP?s natural host
species, the ocean pout, as well as the Atlantic herring .
Despite these serious shortcomings, ACNFP?s Draft Opinion  indicated
that there was no need for a fuller study in an animal model.
There are other considerations that need to be taken into account.
Even if the study had been properly conducted, and no immune response
could be demonstrated as the result of oral ingestion, that would not
rule out an immune response from other routes of exposure. Children
tend to ?wear? ice cream by spilling it on themselves. Open sores,
bruises, or cuts provide one avenue of exposure; and dried ice cream on
skin or clothing can be inhaled into the respiratory tract as ice cream
dust. These other routes of exposure are realistic, but there no
published reports on the injection of ISP into experimental animals. The
Unilever report  and the 2006 report on ISP by Food Standards
Australia & New Zealand  both describe experiments using monoclonal
antibodies to ISP as analytical tools, indicating that the protein
itself is indeed immunogenic.
A full investigation should be carried out on the immune response to ISP
following exposure by injection, topical application and inhalation. The
inflammatory potential of the commercial ISP preparation was dismissed
 even though no routes of exposure to the ISP other than the oral
were studied. The ACNFP further concluded that using cod allergic
individuals in assessing the allergic potential of the ISP preparation
is representative of the fish allergic population. That conclusion is
irrational and unscientific. Cod allergy is caused by parvalbumin; ISP
is unrelated to parvalbumin and has no similarity to the protein. Study
of ISP allergy in individuals with cod allergy makes no sense at all.
Assurances from such meaningless experiments are simply misleading the
Similarly, long-term studies should be done on the immunogenicity of the
ice-structuring preparation in micro ice-crystal complex.
The commercial ISP preparation appears to be made up of 60 percent
un-glycosylated ISP and 40 percent gkycosylated ISP. Only the
un-glycosylated form is active in forming micro ice crystal complex,
while the glycosylated form is non-functional . Purification of the
un-glycosylated away from the glycosylated form and other contaminants
should be a priority.
The committee?s recommendation that products containing the ISP
preparation should be labelled as having been derived from yeast  is
not sufficient; it should be labelled as having been derived from
genetically modified yeast.
Nevertheless, the Draft Opinion  has gone a considerable way towards
assuring the safety of ISP and we hope that such efforts will continue.
1. Lidner N. DRAFT OPINION ON AN APPLICATION UNDER THE NOVEL FOODS
REGULATION FOR ICE STRUCTURING PREPARATION DERIVED FROM FERMENTED
GENETICALLY MODIFIED BAKER?S YEAST Saccharomyces cerevisiae AS A FOOD
INGREDIENT Draft issued for public comment, 2April 2007 ADVISORY
COMMITTEE FOR NOVEL FOODS AND PROCESSES,
2. Lewis S. Application for the Approval of Ice Structuring Protein Type
III HPLC preparation for use in Edible Ices. Safety and Environmental
Assurances Centre Unilever Colworth 2006,
3. Cummins. J, Ho MW and Hooper M. GM protein in ice cream Science in
Society 31 , 9, 2006.
4. Crevel RW, Cooper KJ, Poulsen LK, Hummelshoj L, Bindslev-Jensen C,
Burks AW and Sampson HA. Lack of immunogenicity of ice structuring
protein type III HPLC12 preparation administered by the oral route to
human volunteers. Food Chem Toxicol. 2007, 45(1),:79-87.
5. Verdier JM, Ewart KV, Griffith M and Hew CL. An immune response to
ice crystals in North Atlantic fishes. Eur J Biochem. 1996, 241(3), 740-3.
6. Food Standards Australia New Zealand A Safety Assessment Report Ice
Structuring Protein as a processing aid for ice cream and edible ices,
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