Autophagy is the process of natural degradation within the cell, which removes unnecessary or dysfunctional components through a regulated mechanism dependent on the lysosome. In this way, the body’s cells eliminate everything that is not needed or damaged to facilitate the recycling of necessary nutrients for vital functions, homeostasis, aging, and development. This system promotes the elimination of potentially harmful waste and also provides energy to the cells.

Defects in the autophagic process have been linked to various human diseases, including neurodegeneration and cancer, and the interest in modulating autophagy as a potential treatment for these diseases has grown rapidly. It has been demonstrated that viruses belonging to the Coronavirus family are capable of blocking cellular autophagic processes to avoid their own degradation. In fact, there exists a complex and concomitant interaction between Coronaviruses and autophagy, as these viruses exploit the molecular mechanism of autophagy while avoiding protective apoptotic drift and activation of innate cellular immune responses. They do not utilize the typical biosynthetic secretory pathway used by viruses to exit infected cells but instead exploit lysosomal trafficking, inhibit the autophagic mechanism, and employ unconventional cellular exocytosis.

Eugedin Complex® contains Clove Essential Oil, Wheat Germ as a source of Spermidine, and Vitamin D. The recommended daily dose of this particular raw material for supplements is 2 g/day. Clove Essential Oil is classified as GRAS (Generally Recognized As Safe) by the FDA and is commonly used as a flavoring agent. Clinical studies suggest that there are no known side effects of Spermidine.
Regulation (EU) 2018/1023 of the European Commission dated 23 July 2018 specifies that the maximum dosage of Spermidine in a food supplement intended for the adult population, excluding pregnant and breastfeeding women, is 6 mg/day. Therefore, the recommended dose of Spermidine in the mixture (16 μg) is much lower than the maximum dose set by Regulation (EU) 2018/1023. The use of Eugedin Complex® at the recommended dose is considered safe.

There is a comprehensive European regulatory framework covering the ingredients of the product. The General Food Law Regulation (EC Regulation 178/2002 of the European Parliament and the Council) established the principle and foresaw the creation of an independent body called the European Food Safety Authority (EFSA) with the specific task of providing scientific opinions based on the assessment of the beneficial effects on health and the risks associated with food consumption. The ingredients of the Eugedin Complex® product, particularly spermidine and Clove Essential Oil, fall under two broad categories of EU laws that regulate their use and specifications. Spermidine is considered a novel food and is therefore regulated by the series of EU regulations and implementing regulations on novel foods. Clove Essential Oil is regulated by regulations on botanicals referring to Annex 1 to DM 10 August 2018. However, regarding spermidine and Clove Essential Oil in particular, the European Commission has adopted two regulations:
Commission Implementing Regulation (EU) No. 141/2014, of February 13, 2014, amending Implementing Regulation (EU) No. 540/2011 as regards the conditions of approval of the active substance plant oils/clove oil.
Commission Implementing Regulation (EU) 2020/443, of March 25, 2020, authorizing the amendment of the specifications of the new food extract of wheat germ rich in spermidine (Triticum aestivum) under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470.