Protection & nutrition

Plant protection Active substances

Our experts help you obtain approval for new active substances and to renew the approval of existing ones.

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 active substances (defined in part A of the annex to Reg 283/2013).

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.

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.

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 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 active substances.

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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