Business
Regulatory update
Regulatory update.
About this update from Eden Research Plc
[{"type":"text","content":"\n \n \n 10 May 2022\n \n \n \n Eden Research Plc\n \n \n \n (\"Eden\" or \"Company\")\n \n \n \n Regulatory update: Progress towards EPA approval and further authorisation in Italy\n \n \n \n Eden Research plc (AIM: EDEN), the AIM-quoted company focused on sustainable biopesticides and a plastic-free formulation technology for use in global crop protection, animal health and consumer products industries, announces that it has passed a key milestone in the US for the approval of its products, Mevalone® and Cedroz\n Ô\n . In addition, Eden's biofungicide, Mevalone®, has received authorisation for use on new crops in Italy for the control of the disease Botrytis cinerea, a destructive fungal pathogen affecting many plant species, as well as authorisation for use against additional fungal pathogens Powdery Mildew and Sclerotinia.\n \n \n \n \n \n \n Progress towards EPA approval\n \n \n \n \n \n \n The United States Environmental Protection Agency (EPA) has confirmed that it has granted Eden's plastic-free, microencapsulation technology, Sustaine®, an exemption from the requirement of a tolerance for residues in pesticide formulations in pre-harvest applications to crops. This is a key milestone with Eden now in the final stages of a process which should result in its three active ingredients (eugenol, geraniol and thymol) and two formulated products (Mevalone and Cedroz) receiving authorisation in the US in 2022.\n \n \n \n \n \n The addressable markets in the US, based on the products' current labels, are approximately €94m for Mevalone and €189m for Cedroz. With the demand for biopesticides such as these increasing significantly in the US due to rising regulatory restrictions for conventional chemicals, the tolerance exemption and subsequent approvals will present a significant opportunity for Eden.\n \n \n \n \n \n \n Further Mevalone authorisation in Italy\n \n \n \n \n \n \n Mevalone is sold exclusively in Italy by Eden's commercial partner, Sipcam Oxon SpA (\"Sipcam\"), under the brand name \"3logy®\".\n \n \n \n \n \n Eden announces that it has been granted a label extension for 3logy in Italy, which authorises 3logy to be used against two new fungal pathogens and adds a number of new crop types to the label including berry fruits, tomato, watermelon, salad leaves, herbs, auber...