The main problem appears to be the the colour and flavour of Puratein, which is aimed to appeal to the mass market.
"The samples that were sent to ADM for the regulatory work were darker in colour than we had normally been producing," said Michael Kirwan, senior vice president of corporate development at Burcon. "A lighter colour of product will have much wider market appeal."
He added that the estimated extended period is in the range of four months, but "the time frame may get pushed out for a number of reasons, including positive developments on the process that they want to explore further."
Burcon last year signed a contract with Archer Daniels Midland (ADM) to commercialize the proteins, and stressed that the length of the new development time will ultimately be the decision of the US agri-giant.
However, Kirwan said that Burcon did not expect this development to add any extra costs to the monthly ougoings.
"We will attempt to defer any non time sensitive expenses to stay on budget and, as stated in our last quarterly report, we have enough funds to take us through to September 2005," said Kirwan.
Moroever, he noted that researchers were under the impression that any problems relating to colour and flavour were connected and were not actually due to the protein itself.
"The colour and flavour likely come from the remaining phenolics, glucosinolates, chlorophyll, or a combination there of," he said. "There is also the possibility that the process creates a byproduct that would add colour."
According to Kirwan, ADM believe that Puratein could function in food products now, but problems with colour and flavour would limit the ingredient's appeal to health food gurus. Instead they want to conquer the mass market and target those "consumers that would buy a canola hotdogs or mayonnaise because it looks and tastes like a regular hotdog or mayonnaise". Hence, the need for further research.
This will most certainly delay the regulatory process as the samples that are used for regulatory work must be made from the exact process that will be used in final production process.
"ADM's regulatory people felt it was prudent to wait and see if the modification to the process would be considered significant by regulatory standard," said Kirwan. "ADM did have laboratory space booked to start feeding trials in December, but that date will be cancelled and rescheduled by them."
The proteins will eventually be produced in Europe, a major canola grower, in plants in Germany and the Netherlands, to guarantee GM-free status. However, the first products containing the proteins will most likely be sold in the US as only a GRAS dossier will need to be compiled to gain access to the US food market, while in Europe the products would have to go through the novel foods process.
Burcon NutraScience and the Fraunhofer Institute concluded the first phase of their investigations into the potential health benefits of the canola proteins, Supertein and Puratein, at the beginning of the month and found that the anti-oxidant results were "remarkable".
Protein ingredients are used in a wide variety of foods and personal care products. The protein ingredient industry is currently experiencing rapid growth and estimates place the global market in excess of $10 billion.