Protection & nutrition

Biopesticides Active substances

While there is no official definition for biopesticides, their active substances include natural products (plant extracts and botanical active substances), microorganisms and semiochemicals.

Our experts help you obtain approval for new active substances under Regulation (EC) N° 1107/2009 and to renew the approval of existing ones by following the same procedure as for traditional active substances (via DG Health and Food Safety).

We also check to make sure that the active substance is on the positive list of plant protection products approved for organic production (Annex II to Regulation (EU) 889/2008 and its amendments) and, where necessary, we take the steps to get it registered (via DG for Agriculture and Rural Development & EGTOP).

Our offer

Strategic analysis and regulatory consulting

Compare application with regulatory requirements to advise the best possible procedure / opportunity. We monitor the specific requirements for microorganisms (defined in part B of the annex to Reg 283/2013) and also take their metabolites into consideration (SANCO/2020/12258).

In the case of botanicals, the challenge is to adapt the requirements applicable to pure chemical substances (defined in part A of the annex to Reg. 283/2013), to the specific characteristics set out in the guide to botanicals (SANCO/11470/2012-rev.8).

Exploration of “low-risk” avenues (Regulation 2017/1432) and LMR exemption (SANCO/11188/2013 rev.2).

Stewardship (preparation and participation) for pre-application meetings

This type of meeting is essential insofar as it represents an opportunity to present the product and proposed strategy and, above all, to speak directly with the authorities who will evaluate the application.

Support in conducting and monitoring of laboratory studies

Laboratory choice is vital. Knowledge of the substance being tested and of the test principle is important for its proper design and to anticipate any potential pitfall. We take specific parameters into account such as the notion of ‘major components’ for botanicals and pathogenicity and infectivity for microorganisms.

Help with setting up efficacy and residue trials

These trials are conducted in different countries depending on the specificities of your adjuvants; either through our company Redebel for trials in Belgium or through our Rhizome network for European projects.

Completion of the approval application (first or renewal) of the active substance of a plant protection product

Our team prepares the active substance and representative product application adhering to the latest requirements and technical guidelines to ensure full compliance while anticipating all potential issues.

Drafting of all different sections (including risk assessments for representative uses and risk characterisation according to CLP):

Identity and mode of action, physico-chemical aspects, analytical methods, toxicology, environmental fate, ecotoxicology, residue (if necessary) and efficacy.

Submission of the active substance and representative product application to the relevant authorities in the proper format

Submission of the MRL application or exemption request to EFSA

Efficient monitoring of the evaluation process and interactions with relevant authorities

Our job does not end when the file is submitted. We remain available to respond to any requests for further information.

Our experts guide you through the different phases of drafting, submission and evaluation of your approval application for plant protection products based on microorganisms, botanicals and semiochemicals.

RRA is at the heart of the deliberation process that will enable you to find the best strategy and achieve your goal.

Contact

RRA Redebel Regulatory Affairs

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