The claim is for the Lyon-based company’s Condensyl brand, which is a mix of B vitamins, vitamin E, zinc, betalain, quercetin L-cysteine and the herbal extract of prickly pear (Opuntia ficus-indica).
The proposed article 14 claim reads: “Condensyl decreases sperm DNA damage (sperm nuclear decondensation index and DNA fragmentation index). High sperm DNA damage (sperm nuclear decondensation index and DNA fragmentation index) is a risk factor for male subfertility/infertility.”
According to a French survey conducted in the 80s and still referenced today, about 15% of couples are unable to conceive after one year of unprotected sex.
The men in these couples were ‘solely responsible’ for the infertility in about 20% of the cases and a contributory factor in another 30-40%.
Five month deadline
EFSA has five months to complete its evaluation once the application is considered complete.
To date EFSA has received 268 applications for article 14 claims, which refer to the reduction of disease risk or to children's development or health.
Yet only 75 scientific opinions have so far been adopted.
There has been mounting evidence for antioxidants as a potential strategy against male infertility.
“The cellular damage in the semen is a result of an improper balance between ROS [reactive oxygen species] generation and scavenging activities. Therefore, numerous antioxidants such as vitamin C, vitamin E, glutathione, and coenzyme Q10, have proven beneficial effects in treating male infertility,” a 2005 review published in the journal Current Drug Metabolism.
“A multi-faceted therapeutic approach to improve male fertility involves identifying harmful environmental and occupational risk factors, while correcting underlying nutritional imbalances to encourage optimal sperm production and function.”
However historically there hasn’t been a great success rate with fertility claims.
EFSA has only ever approved one claim on the topic for selenium and normal spermatogenesis, or production of sperm.
Others for the likes of L/arginine, L-carnitine and docosahexaenoic acid (DHA) have all been rejected.