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MBI announces The Netherlands as new rapporteur member state for Sakalia biofungicideqrcode

−− Move taken in response to Brexit

Feb. 21, 2018

Favorites Print Feb. 21, 2018
Marrone Bio Innovations, Inc. (NASDAQ:MBII) (MBI) recently announced that the Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) has agreed to serve as the new European Union (EU) Rapporteur Member State for Sakalia™, a novel biofungicide that is derived from Giant Knotweed (Reynoutria sachalinensis), a plant native to Asia, where is it commonly sold and consumed as food.  Giant Knotweed is also ubiquitous to Europe and North America, where it was introduced for fodder and ornamental uses and where extracts are sold and consumed as dietary supplements.

In response to recent guidance from the European Commission that applicants for the approval of plant protection products should consider the impact of pending BREXIT negotiations, MBI announced today that the Netherlands has agreed to serve as the Rapporteur Member State (RMS) for the review and approval of Sakalia for European market entry.  As RMS, Ctgb will provide guidance and advice to MBI on addressing EU approval for plant protection products.

“The Netherlands has an established and respected expertise specifically in helping companies, like MBI, with biologically-based pest management products to successfully navigate an EU regulatory process that is not tailored to unique characteristics of plant-extract based and microbially-based pesticides.   Currently, MBI is working with Ctgb as RMS for Grandevo®, our Chromobacterium subtsugae-based microbial insecticide, miticide and nematicide, and we look forward to further guidance and collaboration with the Netherlands on pursuing the approval of Sakalia in the European Union,” stated Keith Pitts, Chief Sustainability Officer of Marrone Bio Innovations.

Previously, the United Kingdom’s Chemicals Review Directorate (CRD) had served at the RMS for Sakalia. However, expected deadlines for the United Kingdom’s exit from the European Union necessitated ending the current CRD-supported submission and submitting Sakalia to the EU review process with support from a new European Union member state.  MBI requested a voluntary withdrawal of the pending UK-sponsored dossier. The voluntary withdrawal was approved via European Commission administrative action in late January.  MBI will be working closely with CRD, which has previously recommended Sakalia for approval in the EU, to secure market entry in the United Kingdom.

In European field trials, Sakalia has demonstrated efficacy against several diseases on a wide variety of crops, including:
- Cucurbitaceae(cucumber, melon, zucchini): powdery mildew (Erysiphe cichoracearum, Leveillula taurica, Podosphaera xanthii, Sphaerotheca fuliginea), downy mildew (Pseudoperonospora cubensis).
- Solanaceae (Tomato, pepper, aubergine): powdery mildew (Oidium neolycopersici, Leveillula taurica), grey mould (Botrytis cinerea), late blight (Phytophthora infestans).
- Lettuce: downy mildew (Bremia lactucae), grey mould (Botrytis cinerea).
- Strawberry: powdery mildew (Podosphaera macularis).
- Grape: grey mould (Botrytis cinerea), powdery mildew (Erysiphe necator).
- Stone fruit(apricot, peach):Monilinia spp. (Monilinia laxa, Monilinia fructigena), powdery mildew (Podosphaera leucotricha, Sphaerotheca pannosa).
- Pome fruit(apple, pear): powdery mildew (Podosphaera leucotricha).

Sakalia has a novel, multifaceted “Induced Systemic Resistance Response” mode of action (a unique P5 FRAC code) that makes this biofungicide an excellent resistance management and integrated disease management tool for growers.  The formulation is also USDA National Organic Program, OMRI (US and Canada) and Control Union certified for use in organic farming, making Sakalia an excellent tool for both conventional and organic farmers.   EcoCert certification is anticipated upon product approval in the European Union.

Syngenta is the exclusive distributor of Sakalia in Europe and holds ownership of the Sakalia product name. In other markets, the formulation is marketed as Regalia® Maxx. The formulation is registered in more than 25 countries, including major agricultural markets in the United States, Canada, Mexico, Brazil, Chile, South Africa, Turkey, Morocco and Tunisia.  In countries where approved, Regalia Maxx has received “minimal risk” to humans and the environment designations, including MRL (pesticide residue) exempt status, zero day pre-harvest intervals and minimally-restricted worker re-entry intervals. New application efforts are also underway in Australia, New Zealand, the Philippines, China, Vietnam and Kenya.  On average, approvals for Regalia Maxx have taken 18 months in countries where it is now marketed and sold.

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