Its scientific opinion states that phenylcapsaicin, intended for use in supplements and special medical purpose foods, does not pose a threat to the general population above 11 years old at a maximum level of 2.5 milligrams per day (mg/day).
This level corresponds to 36 micrograms per kilogram (μg/kg) body weight (bw) per day for adults (considering an average bodyweight of 70 kg) and 58 μg/kg bw per day for adolescents aged 10–14 years (considering an average bodyweight of 43.4 kg).
The Authority wrote in its opinion: “The Panel considers that phenylcapsaicin does not have a nutritionally relevant role in the diet and that the consumption of the NF is not nutritionally disadvantageous.”
‘No nutrition disadvantage’
The decision is good news for the applicant aXichem, a Swedish-based ingredients supplier, who began the process back in Feb 2018, filing an application for approval of its phenylcapsaicin product aXiphen.
In that same year, the ingredient received Generally Recognized As Safe (GRAS) approval and hence permission to market and sell phenylcapsaicin in the US.
“We are therefore very pleased with EFSA's statement,” says Torsten Helsing, CEO of aXichem. “We now consider that the most difficult part of the process is behind us.
“EFSA's statement is indicative of the member states and I see no reason why this should not be developed as we please.
“When in time this happens depends on how fast the countries are in their handling, but I mean that we largely keep the expected schedule."
Pharma applications
Phenylcapsaicin’s role in food supplements is primarily that of a bioenhancer of active ingredients, making the ingredient suitable for the pharmaceutical industry.
In EFSA’s examination, its Panel confirmed the ingredient posed no concern regarding the NF’s genotoxicity with studies confirming an absence any mutagenic, clastogenic/aneugenic (chromosome-disrupting) properties.
Notably, EFSA’s conclusions did not take into account any human studies, which were unavailable when assessing the NF’s safety.
EFSA added that since phenylcapsaicin is not naturally present in foods, the combined intake from the NF and other sources would not be considered in its final assessment.