Regulatory Status

The process

Before a plant protection product, like those being developed by Eden Research, can be used, sold, supplied, advertised or stored, they must be approved for use. These approvals are granted in the UK by the Chemicals Regulation Directorate (CRD) under a range of specific (UK and EU) pesticide related legislation. Similar national authorization is required worldwide.

In the European Community, the dominant regulation is directive 1107/2009 (which replaced 91/414). This requires that a pesticide's safety and efficacy is proven. This process involves three stages:

  • Assessment of the safety profile of each active ingredient - in the case of Eden's product 3AEY, this represents three terpenes;
  • Assessment of the safety profile of the formulation - in 3AEY's case an encapsulated aqueous matrix containing three terpenes encapsulated in yeast glucan particles; and
  • Assessment of a set required number of high quality trials data justifying claims about the efficacy of the formulation and its safety when applied against a specific pest or disease on a specific crop(s).

This last stage often has to be repeated in each EU registration zone (South, Central and North zones) and in some cases specific trials are required in each member state to address local concerns and specific agro-climatic conditions. Certain strategically important agricultural sectors may then require testing to be even more comprehensive (e.g. the French wine grape industry) and further highly prescriptive tests have to be undertaken.

Progressing 3AEY

A summary of the work completed on Eden's first commercial product, 3AEY, is as follows:

  • A suite of standard tests to assess the safety profile of each active ingredient and its metabolites has been completed successfully. This, with relevant public domain literature, forms the evidence supporting three submissions (in early February 2008) to the regulatory authority; in this case the CRD, which agreed to evaluate the substance in 2007.
  • Concurrently, a similar suite of tests was conducted to confirm the safety of the formulation (3AEY). The formulation dossier was presented alongside the active ingredient submissions.
  • The CRD, as the relevant national regulatory authority, once satisfied that the active ingredients and the formulation do not present an unacceptable risk to humans and the environment, then submits a Draft Assessment Report (DAR) to the 26 other EU regulatory authorities and pan-European organizations such as the European Food Safety Authority. They review the report and confirm that, in their view, the materials are safe. The DAR was submitted in April 2010.
  • In May 2013, the three active ingredients that are used in 3AEY were approved for use in plant protection products by the European Commission under Regulation No. 1107/2009 within the European Union. These approvals represent the successful outcome of a process which has taken over seven years to complete.
  • Eden's efficacy and crop safety trials conducted to European regulatory standards have been on-going since 2005. Once provisional approval has been granted, the results from these trials, together with further work being conducted by commercial partners, will enable national approval for use to be given. The same data has also enabled Eden management to market the product to prospective partners.
  • 3AEY has received authorisation for 3AEY in Albania, Bulgaria, Cyprus, France, Greece, Italy, Kenya, Malta and Spain

Future benefits

Although the process to achieve regulatory approval is slow and expensive, Eden has had the advantage of progressing its regulatory dossiers under the CRD's "Biopesticides" scheme for low risk biological crop protection products. This streamlined scheme reduces the sum of evidence and, therefore, the time and cost of compiling the evidence required by the regulators. Fees for evaluation are significantly lower and arguments can be made and accepted for many tests to be waived, with public domain data and reasoned scientific arguments used to justify this.

As a result, there are a number of benefits that will accrue as we move forward:

The data created from the testing programmes has further significant value. As Eden is the sole organization obtaining approval for field application of the active ingredients used in its products, the route to market will be shorter and the cost of future submissions lower for new formulations containing any of the ingredients used in 3AEY. This will make other products in our development pipeline more attractive and less costly to bring to market.

As the testing programme was conducted to a variety of international standards, we also anticipate our commercial partners being able to use the same supporting data and the opinions of the EU's regulators, to accelerate approval in many new important markets such as the USA, Japan, Australasia, and South America. These regions/countries comprise over half of the world market for agricultural chemicals, and we foresee limited expenditure being required by Eden to obtain approval to sell products in these locations.

For further detailed information on Eden's products, please contact Eden at info@edenresearch.com

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