aXichem will submit additional data to the Commission as EFSA publishes an “Inconclusive Scientific Opinion” for the company’s ongoing Feed Additive application regarding aXiphen
aXichem AB (publ), which develops and markets natural analogue industrial chemicals, announces, that EFSA has published an “Inconclusive Scientific Opinion” for aXichem’s ongoing Feed Additive application regarding phenylcapsaicin (aXiphen®). EFSA’s opinion concludes that there are a few data gaps in the areas of environmental safety, consumer safety, and efficacy, in the submitted application. aXichem will immediately start the process to produce the data required to fill the gaps and when ready submit the complementary information to the European Commission for final processing and approval. aXichem estimates that the company needs approximately six months to produce the required information. Phenylcapsaicin is since 2019 approved to be used in food in the EU, according to the Novel Food regulation.
“I am positive that we can provide the data required for the defined areas. We will inform EFSA and the Commission of our intent to submit the complementary information. Our team has already initiated the work and we estimate that it will take approximately six months to produce and provide the data, where major part of the activities will be related to the gap in environmental safety and efficacy. Some of the submitted efficacy data did not fully meet EFSA’s guidelines for some specific endpoints and were thus not included in EFSA’s evaluation. We will bridge this gap with complementary data which will be submitted to the European Commission, who will take it into account when they draft their regulation or, if necessary, EFSA will be asked to re-evaluate the data and issue a new scientific opinion”, says Torsten Helsing, CEO of aXichem.
The scientific opinion from EFSA will be available at: https://efsa.onlinelibrary.wiley.com/journal/18314732
About phenylcapsaicin and aXiphen
The health benefits of chili, with its active ingredient capsaicin have been known for centuries. aXichem’s proprietary molecule, phenylcapsaicin, combines the naturally occurring phenyl group with capsaicin, bridged by a triple bond. The result is an innovative natural analogue capsaicin with high purity, where the pungency is greatly reduced.
Production tests and studies have proven the effectiveness of aXiphen® (phenylcapsaicin) as an ingredient in poultry feed. A production test on on-floor salmonella prevalence, following the inclusion of 15 ppm phenylcapsaicin in a regular starter diet, was carried out in a full-scale commercial broiler production trial under farming conditions. The production test included about 1.6 million broiler chickens. The trial concluded that under the conditions of the test, the inclusion of 15 ppm phenylcapsaicin in broiler chicken feed statistically significantly reduced the number of farms with salmonella-positive floor boot swabs. The European model for production efficiency, EPEF, showed that breeding efficiency increased by 14% compared to traditional feeding.
This information is such that aXichem AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted, through the care of the contact person below, for publication on 14 December 2023, at 11:50 CET.
Torsten Helsing, CEO, aXichem, Ph+46 70 686 33 55. Email: torsten.helsing@axichem.se
About aXichem
aXichem develops, patents and markets natural analogue industrial chemicals, i.e., synthetically produced substances that have similar and comparable properties to natural substances. The company's first product is phenylcapsaicin, which the company commercializes under two brands, aXiphen® and aXivite®, as an ingredient in animal feed and dietary supplements, respectively. The business is divided into three market areas with different applications for phenylcapsaicin: as an ingredient in feed for poultry, such as chicken and turkey; as an ingredient in food supplements for gut health, weight control and sports and exercise; and as an ingredient in food supplements for the bio-enhancement of curcumin and melatonin. aXichem is listed on the Nasdaq First North Growth Market. Västra Hamnen Corporate Finance AB is Certified Adviser. More information is available at www.axichem.com.