Harnessing the power of microbial genomics for market authorisation of bioinputs.

In the face of today’s sustainable development challenges and the growing demand to consume more natural and healthy products, the agricultural inputs industry is increasingly focusing on biointrants such as biofertiliser and biocontrol products. These biological solutions enhance soil fertility, improve plant health, and increase crop yields, while minimising adverse environmental impacts compared to more conventional chemical inputs.

Bioinputs are composed of either microorganisms as active substance, or theirby-products. In France, all microorganisms must undergo a rigorous safety evaluation process conducted by the Agence Nationale de Sécurité Sanitaire de l’Alimentation, de l’Environnement et du Travail (ANSES). Applicants are required to compile a dossier substantiating the safety of their product and submit it to ANSES for approval.

By leveraging the power of natural organisms and processes, bioinputs support biodiversity, soil health, and long-term agricultural productivity.They are a vital component of modern, sustainable agriculture, driving progress towards a more resilient and environmentally friendly agricultural future.

Challenges of ANSES Market Authorisation

Navigating the ANSES safety evaluation process presents significant challenges. The procedure is extensive and complex due to the volume of analyses required and the rigorous expectations. Applicants must meticulously compile and present comprehensive data on the safety of the microorganisms used.

This includes detailed scientific evidence, risk assessments, and adherence to strict regulatory standards. The substantial documentation and rigorous scrutiny can be daunting, demanding time, expertise, and resources. Successfully navigating this process is crucial for market approval and ensuring the safety of biofertiliser and biocontrol products.

Pricing

Our Offer: Characterisation and effects of the microbial bioinputs

Genomic characterisation of the production strain

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• Whole Genome Sequencing (WGS)

Using a hybrid approach combining Long-read and Short-read Sequencing, high-quality sequences are recovered to meet or exceed regulatory bodies expectations (e.g. ANSES).

• Data analysis

De novo assembly is performed on the generated data by a specialised Bioinformatics team, generating a complete and precise genome sequence and enabling detailed characterisation of the production strain.

Search for genes of concern in the production strain

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• Toxins factors

The presence of toxins genes is tested by comparing the strain genomic data to various and up-to-date databases. Searches are also conducted in literature to demonstrate the absence of safety concerns in the microorganisms used.

Natural occurrence study in soils

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• Metagenomic testing

Using metagenomics, we study the microbiodiversity of soils and give proofs whether the strain occurs naturally or not in soils, as required by the ANSES.

Kinetic study of the strain

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• Kinetic study

The strain presence in soil is followed using qPCR from its application to the return to the natural/inherent equilibrium state.

For prokaryotes strains

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• Antimicrobial Resistance (AMR) Genes

The presence of AMR genes is tested by comparing the strain genomic data to various and up-to-date databases.

Dossier redaction

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• Comprehensive documentation

All the above analyses are delivered in a “ready to publish” format, containing all necessary details on results and analyses.

• Compliance with ANSES guidelines

The dossier follows ANSES guidelines to meet their expectations, providing supporting data in the required format.

Advantages of our Offer

Content

Quality and Compliance

Advanced Technology

Utilisation of the most advanced technology available to meet or exceed regulatory bodies expectations.

Rigorous Standards

Adherence to the highest standards of quality and regulatory compliance, ensuring all analyses and documentation align with ANSES guidelines.

Accurate and Reliable Results

Commitment to delivering precise and dependable data, which is critical for the evaluation process.

Proven Success in Regulatory Approvals

Detailed Dossier Preparation

Expertise in compiling comprehensive, ANSES-compliant dossiers that facilitate a smoother approval process.

Comprehensive Services

End-to-End Solutions

Offering a full suite of services from genomic characterisation to dossier preparation, ensuring a seamless and integrated approach to meeting ANSES requirements.

Tailored Support

Customised services to meet the specific needs of each client’s production process and product features.

Avoid Costly Rejections

Navigate regulatory landscape efficiently & effectively

The stringent requirements set by the ANSES and the extensive analyses needed for market authorisation make the process challenging, often resulting in considerable loss of time and money. Partnering with an experienced company like GenoScreen can minimise preventable errors and increase approval success rates.

top-tier genomic expertise

dedicated team

advanced technologies

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Biofertiliser & biocontrol

Challenges of ANSES Market Authorisation

Advantages of our Offer

Get our catalogue