With the growing demand for high-quality animal products, the optimisation of feed formulations through the use of additives and enzymes has become a cornerstone of modern industrial feed production practices.
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 feed formulations to improve digestibility and nutrient utilisation by animals.
Additionally, certain microorganisms themselves, or their by-products, can be directly used as feed additives to confer specific health or performance benefits to animals.
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.
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 feed products.
Advantages of our Offer
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.
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.
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.
Navigate regulatory landscape efficiently & effectively
In 2023, 40% of new feed additive applications involving micro-organisms have been rejected by EFSA. These rejections were due to strain characterization problems, often resulting in considerable loss of time and money. 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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