Protection & nutrition

Plant protection Formulated products

Our experts help you obtain authorisation for new plant protection products, to renew the authorisation of existing products and to broaden their uses.

Our teams monitor national requirements so that the protection product can be authorised in all member states of the European Union.

Our offer

Strategic analysis and regulatory consulting

Compare application with regulatory requirements to advise the best possible procedure / opportunity. We monitor the requirements applicable to chemical plant protection products (defined in part A of the annex to Reg 284/2013).

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 of 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.

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 Rhizome 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.

Completion of the approval application (first or renewal) of the active substance of a plant protection product and of the representative formulation application 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 registration dossier to 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.

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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