Protection & nutrition

Biopesticides Formulated products

Our experts stand by you at all stages of the process of placing biopesticides affected by Regulation (EC) No 1107/2009 on the market, and provide support in renewing the authorisation of existing products and extending their use following the same process as for conventional plant protection products.

Our teams check national requirements so that the plant protection product can be authorised in all EU Member States and also so that it can be used in organic farming and is included on national catalogues.

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 preparations based on microorganisms (defined in part B of the annex to Reg 284/2013) and also take their metabolites into consideration (SANCO/2020/12258).

In the case of botanicals, the challenge is to adapt the requirements applicable to chemical plant protection product (defined in part A of the annex to Reg. 284/2013), to the specific characteristics set out in the guide to botanicals (SANCO/11470/2012-rev.8).

Following are the possible ways to achieve this:

Application for new authorisation by zone, use extension (minor and/or major) and authorisation renewal

Mutual recognition for new authorisations and authorisation renewals

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 laboratory studies

Laboratory choice is vital. Knowledge of the product 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.

Technical equivalence

Our team can assist you in these steps to get approval for your new source of active substance and to demonstrate its equivalence with respect to the reference source.

Drafting of the authorisation application (first, renewal, and use extension) and administrative documents

Our team prepares the 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 and risk characterisation according to CLP)

Physico-chemical aspects, analytical methods, toxicology, enviromental fate, ecotoxicology, residue (if necessary), national and European biological dossiers (BAD).

Management of access to active substance data (LoA and DMT)

Submission of the application to the relevant authorities in the proper format

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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