US EPA registration for Mevalone Delta

Eden BioSolutions plc (AIM: EDEN), a leader in sustainable biopesticide and biocontrol technologies, announces that the United States Environmental Protection Agency ("EPA") has granted an unconditional registration under the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA") for Mevalone Delta, an optimised biofungicide formulation based upon Eden’s registered active ingredients and microencapsulation technology, Sustaine® (EPA Reg. No. 92331-6).

Registration covers a variety of fungal diseases on a wide range of high-value crops

The crops covered by the approved label had a combined US farm-gate value of c. $33 billion in 2024

Total addressable market for Mevalone Delta in the US estimated to be in the region of $144 million

Significant opportunity to grow sales across North America

The registration

This registration covers the control of a range of fungal diseases on a broad list of high-value crops, including grapes (table, wine and raisin), almonds, strawberries, and other berries. Target diseases on the approved label include grey mould (Botrytis cinerea), powdery mildew, Sclerotinia (white mould), brown rot blossom blight (Monilinia) and chocolate spot (Botrytis fabae). This registration is required before a pesticide can be sold or distributed in the United States and Mevalone Delta will now undergo state-level review and registration, which is expected to take between one and twelve months, depending upon the state.

Mevalone Delta contains the same three naturally derived active ingredients as Mevalone® – eugenol, geraniol and thymol – and is classified by the Fungicide Resistance Action Committee ("FRAC") as a Group BM01 fungicide with multiple modes of action. It is therefore suitable for use in integrated pest management programmes and to delay or prevent the development of resistance to single-site fungicides. The label permits application up to three days before harvest, giving growers flexibility to protect crops late in the season. This optimised formulation allows us to position the product for a wider overall segment, competing in more cost sensitive segments whilst still delivering high levels of efficacy.

The US market opportunity

The United States is one of the world's largest markets for crop protection products, and the crops on the Mevalone Delta label are among the most valuable grown in the country. Based on USDA data, the crops covered by the approved label had a combined US farm-gate value of approximately $33 billion in 2024. This includes grapes (approximately $6.2 billion), almonds ($5.7 billion), leafy vegetables including lettuce, spinach and celery ($5.5 billion), and strawberries ($4.0 billion). Growers of these crops face increasing pressure from retailers, export markets and regulators to reduce chemical residues, supporting demand for effective biological alternatives.

The Company estimates the total addressable market for Mevalone Delta in the US to be in the region of $144 million, with an expectation of achieving a market share of around 3% at the point of peak sales.

Mevalone Delta will be distributed in the US by Sipcam Agro USA, Inc. ("Sipcam"), Eden's existing US commercial partner for Mevalone.

Sean Smith, Chief Executive Officer of Eden BioSolutions plc, commented: “The registration of Mevalone Delta is another significant milestone for Eden in the United States, one of the world’s largest markets for crop protection products. The breadth of the label, spanning a wide range of high-value crops worth more than $30 billion annually at the farm gate, gives Eden and our partner, Sipcam, a significant opportunity to grow sales across North America.

“Mevalone Delta offers growers an effective, residue-friendly disease control tool with multiple modes of action, which fits well in resistance management programmes and can be used almost up to harvest. As state registrations are secured over the coming months, we look forward to working with Sipcam to bring Mevalone Delta to growers and to providing further updates on its commercial progress.”

Brent Marek, Chief Executive Officer of Sipcam Agro USA, commented: “We are delighted to add Mevalone Delta to our portfolio, following its registration by the EPA. Growers of high-value fruit, vegetable and speciality crops continue to look for effective and sustainable biological solutions that help manage resistance and residues without compromising performance, and Mevalone Delta's broad label and short pre-harvest interval make it a valuable tool for them. We look forward to building on our successful partnership with Eden.”