The decision comes off the back of a positive scientific opinion by The European Food and Safety Authority (EFSA), which could find no safety concerns with the ingredient.
“Now the approval is formally in place and we can start to act fully on the market in Europe,” says Torsten Helsing, CEO of aXichem.
“We have known that a publication would occur, but not exactly when. I am very happy that this formal part is now complete as well.”
The entry into the NF catalogue specifies a maximum phenylcapsaicin level of 2.5 milligrams per day (mg/day) for food supplements and special medical purpose foods for the general population.
This excludes foods for infants, young children and children under the age of 11 years and supplements not suitable for children under the age of 11 years
Additional requirements require labelling to make clear the foodstuff contains ‘phenylcapsaicin’.
In February 2018 aXichem submitted an application for approval for the product aXiphen that in August of that year, EFSA announced that the application was considered complete.
On May 16 this year, the company announced the application had reached the third and final phase before approval, setting up this latest announcement, which now opens the door for full commercialisation in the European market.
Only this week, aXichem revealed details of a SEK 2.5m (€240,000) agreement with Danish Chr. Olesen Synthesis, part of Chr. Olesen Group, to increase the manufacturing capabilities of phenylcapsaicin.
aXichem already has an agreement in place with Chr. Olesen Group to distribute and market aXichem's aXiphen product in Europe and Latin America.
“Together with Chr. Olesen Synthesis, we have worked on transferring and testing our manufacturing method for phenylcapsacin to their plant in Denmark,” says Helsing.
“Some practical work remains, but during the first half of 2020 everything should be in place for large-scale production. This collaboration provides an important complement to the production that is made in China.
‘High quality guarantee’
Thomas Moestrup, managing director at Chr. Olesen Synthesis adds that after careful preliminary work, Chr. Olesen Synthesis is “able to offer this relatively advanced production of phenylcapsaicin”.
“We see that our extensive expertise in synthetic production and our modern production facility will guarantee high quality in collaboration with aXichem,” he says.
Phenylcapsaicin’s role in food supplements is primarily that of a bioenhancer of active ingredients, making the ingredient suitable for the pharmaceutical industry.
Genotoxic studies confirm an absence of any mutagenic, clastogenic/aneugenic (chromosome-disrupting) properties.