Today’s industrial Food production relies on the use of enzymes and additives in order to optimise the production process or to improve the properties of the final product.


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These vital components are often derived from microorganisms. Indeed, microorganisms can produce various enzymes through fermentation processes, which can then be isolated and incorporated into processes as catalysts, or into food formulations to improve digestibility and nutrient utilisation by consumers.

Additionally, certain microorganisms themselves, or their by-products, can be directly used as food additives to confer specific health or performance benefits to consumers.

In Europe, these microorganisms can be genetically modified (then called GMM) to be used as improved production microorganisms. Regardless of their origin or modification status, all microorganisms must undergo a rigorous safety and efficacy evaluation process conducted by the European Food Safety Authority (EFSA).

To do so, the applicants are required to compile a dossier substantiating the safety of their product and submit it to the EFSA.



Challenges of EFSA Safety Evaluation

Navigating the EFSA safety evaluation process presents significant challenges. The procedure is extensive and complex, often creating uncertainty due to the sheer volume of required analyses and stringent prerequisites. Applicants must meticulously compile and present comprehensive data on the safety and efficacy of the microorganisms used.

Site feed

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


Our offfer

Our Offer: Identity and characterisation of the strain

Genomic characterisation of the production strain

• Whole Genome Sequencing (WGS)
  1. Utilising a hybrid approach that combines Long-read and Short-read Sequencing, high-quality sequences are recovered to meet or exceed EFSA expectations.
• Data analysis
  1. 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

• Antimicrobial Resistance (AMR) Genes
  1. The presence of AMR genes is tested by comparing the strain genomic data to various and up-to-date databases.
• Virulence factors and toxin
  1. Similarly, searches are conducted both in databases and literature for virulence factors and toxin production genes to demonstrate the absence of safety concerns in the microorganisms used.

Absence of DNA from the production strain in final product

• DNA quantification
  1. Using qPCR, the presence of DNA from the production strain in the feed product is tested and quantified as required by EFSA, to prove its absence.

For Genetically Modified Microorganisms strains

• Sequence comparison
  1. The sequence of the strain of interest is compared with the parental or recipient strain to identify variants.
• Insert stability verification
  1. The stability of the gene of interest insert in the GMM strain is verified through PCR on the inserted region.

For QPS (Qualified Presumption of Safety) strains

• AMR gene determination
  1. Determination of AMR “intrinsic” and “acquired” genes in the production strain by comparing and analysing WGS data.

Dossier redaction

• Comprehensive documentation
  1. All the above analyses are delivered in a “ready to publish” format, containing all necessary results and analyses.
• Compliance with EFSA guidelines
  1. The dossier follows EFSA guidelines to meet their expectations, and data are provided in a standardised format.


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Advantages of our Offer

Quality and Compliance

Rigorous Standards

Adherence to the highest standards of quality and regulatory compliance, ensuring that all analyses and documentation meet EFSA guidelines.

Accurate and Reliable Results

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

Proven Success in Regulatory Approvals

Successful Track Record

Demonstrated success in helping clients achieve regulatory approvals, highlighting the effectiveness of GenoScreen’s services in navigating the complex EFSA evaluation process.

Detailed Dossier Preparation

Expertise in preparing comprehensive, EFSA-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 EFSA requirements.

Tailored Support

Customised services to meet the specific needs of each client, whether for GMM strains, QPS strains, or standard production strains.

Avoid Costly Rejections

Navigate regulatory landscape efficiently & effectively

During the first semester of 2024, 50% of new Food Additive requests involving microorganisms were rejected by the EFSA, often causing significant time and money losses. Partnering with an experienced company like GenoScreen can minimize preventable errors and increase approval success rates.

top-tier genomic expertise

dedicated team

advanced technologies


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