Genomic information at the service of human health and its environment
Markets
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.
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.
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.
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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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) if necessary. 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
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
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
Get our catalogue
Fill in the form below
Microbial related products are found everywhere, from the feed given to the animals, to the food, or directly to the biofertilizers used in the soils of our farms. And as safety comes first, in the fields of life sciences and biotechnology, regulatory compliance goes beyond administrative formalities.
Regulatory dossiers stands as a cornerstone for ensuring the safety, efficacy, and quality of your products, while also fostering trust among consumers and regulatory authorities alike. In this ever-evolving and intricate landscape, the compilation and submission of regulatory dossiers become pivotal steps in the obtention of market authorizations.
Navigating the regulatory landscape can be daunting, with complexities and nuances that demand meticulous attention to detail. As such, partnering with an expert in the field becomes not just advantageous but essential.
Our regulatory offer applies to several cases, listed later, and offers several advantages:
Improving Success Odds
Using our deep expertise and regulatory knowledge, we help you create thorough, compliant dossiers to improve your chances of getting product authorizations
Saving time
Our efficient methods and proven expertise speed up dossier submissions, helping you enter the market faster and seize commercial opportunities
Relieving Regulatory Burden
Delegate
your genomic regulatory tasks
to GenoScreen, freeing you to focus on your core business while we handle analysis,
data interpretation and dossier compilation
for you
your genomic regulatory tasks
to GenoScreen, freeing you to focus on your core business while we handle analysis,
data interpretation and dossier compilation
for you
Expertise in microbial regulatory services
Throughout the years, GenoScreen developed its expertise in regulatory affairs to help its clients and prospects comply with the expectations of the regulatory bodies. We run dossiers compliant testing including genomic characterization of microbial strains and efficacy testing such as impact studies for microbiome related products, and then we analyse the results and compile them in a “ready to publish” format, encompassing all necessary information with utmost transparency about methodology required for regulatory bodies such as EFSA, FDA or ANSES.
You will be provided with
compliant methodologies and pipelines fulfilling the regulatory expectations
reports that can directly be integrated into regulatory dossier
a dedicated regulatory contact to guide you through the submission process
Contact us for any further information
Feed Additives & Enzymes
For our clients producing thanks to microorganisms Enzymes or Additives for the Feed industries, in order to obtain European market authorisation, they require to go through a Safety (and Efficacy) evaluation process by the European Food Safety Authority (EFSA). We help them by accompanying them in giving proofs of safety and writing in the rightful way their report.
Food Enzymes & Additives
Food industry uses Enzymes and Additives in their production process. In Europe, these products are under the EFSA regulation to ensure their safety and efficacy. We accompany biotech companies eager to fill in dossiers when it comes to microbiological analyses by providing them EFSA compliant microbiological reports.
Probiotics
Food Industry is increasingly using Probiotics in their food products as we understand further day after day the impact of the microbiomes on health, and the importance to keep healthy microbiomes. We support our clients in their quest of obtaining a market authorisation for their probiotic strains.
Biofertiliser & Biocontrol
We help our clients eager to access the French biofertilizer/biocontrol market to perform analyses as intended by the ANSES authority (Agence Nationale de Sécurité Sanitaire de l’Alimentation, de l’Environnement et du Travail). We provide all the expected analyses and prerequisites regarding microbiological safety to our client, to maximise their chances to obtain market authorisation.
Novel Food
Novel Food is officially described by EFSA as “food that had not been consumed to a significant degree by humans in the EU before 15 May 1997”. It needs of course an authorisation before being available for consumption in Europe, once again, it is granted by the EFSA. Our analyses fill all the prerequisites asked for the biological part of the dossier.
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Genomics enables the development of a new form of agriculture, adopting a more holistic approach that focuses on the interactions between plants and micro-organisms.
Microbiological quality of soils
It specifically allows us to highlight the interactions that soil bacteria, yeasts and fungi can have with different crops, whether they are annual or perennial.
GenoScreen has established its expertise in this field by contributing, in a pioneering position, in national projects such as BIMM-SOL and GenoSol, which focused on the microbiological quality of soils.
GenoScreen’s offer to understand the microbiological component of soils
GenoScreen helps you to identify the microbiological composition of soils, reveal their properties and act on them, either by using inputs or by modifying your farming practices. Our services and solutions include:
- Study of the microbiological component of soils: taxonomy of the microorganisms presents and measurement of the fungal/bacterial balance
- Identification and characterisation of bioinputs (biostimulants and biopesticides) along with studying their impact on soil microbiological quality
- Analysis of the microbiological composition of soils at different times and under various conditions (crops, ploughing, inputs, climate, etc.)
- Support for research, particularly in the development of new inputs
Soil study techniques and methods
Our analysis solutions are based on the latest techniques available (Illumina, PacBio and ONT sequencers), and include a wide range of methods:
- NGS (Next-Generation Sequencing): Genome studies using the latest sequencing technologies
- Molecular metabarcoding: Taxonomic study of microbial populations
- Metagenomics or environmental genomics: Study of the genetic content of samples within an ecosystem to reveal both taxonomy and putative functions
- Metatranscriptomics: Study of all active microbial genes and pathways in a sample (the transcriptome)
- qPCR (Quantitative Polymerase Chain Reaction): Quantification of microorganisms of interest present in a sample
These analyses, along with the conclusions and solutions they provide, require the ability to access repositories of characterised genomic data. Such data repositories can be found in databases of varying degrees of specialisation and documentation. In this regard, our expertise led us to select the best databases and to develop our own, as well as the ability to utilise them effectively.
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Genomics, and above all metagenomics, constitute the sharpest method for studying interaction between skin and its microbiota, and analysis the entirety of the microorganism communities present on the epidermis.
Genomics for Cosmetics
Advances in science allow us to explore the genes and molecular interactions that influence the health and appearance of our skin. Explore the genomic solutions that are transforming the way we understand and treat dermatological needs, opening up new innovations for Beauty Care and strong assets for new products development.
Applications of genomics for skincare
Genomics provides breakthrough innovation and technological inputs in the cosmetics and skin care sector :
Microbiome
- Skin microbiome impact studies of dermocosmetics product or active ingredient
- Clinical studies in dermatology to measure treatments effects on skin diseases
- Analysis of dysbiosis in the microbiota of interest
- Virulent strains genomic characterization of certain bacterial or fungal species of interest
Science added-value
- Claim substantiation and scientific added-value for new dermocosmetics products, formulations, active ingredients.
- Prebiotics, probiotics and postbiotics evaluation to assess their efficiency
- Nutricosmetics and Cosmeceuticals assay through gut-skin axis study
Industry
- Optimized production processes for cosmetic ingredients (biotechnology and fermenters)
- Quality control, microbiological monitoring and contaminants detection in Cosmetics production processes
Our analytical solutions for dermocosmetics
As a true scientific partner, GenoScreen provides the beauty and skin care sector with tailor-made solutions and high-performance tools that boost innovation :
- Skin Microbiota :
- GenoBiome Skin, our all-in-one offer for analysing cutaneous microorganism communities
- Microbiome friendly testing
- Metagenomics with several adaptable technologies to shape your own projects : targeted metagenomics 16S (bacteria), 18S/ITS (fungi) in short read and long read, shotgun metagenomics from skin swab samples.
- Strain-specific solutions :
- Genomic tools for identifying, sequencing, annotating and comparing microbial genomes.
- Genotyping strains of interest (virulence detection)
- Bacterial/fungal genes differential expression under varying conditions (with or without application of an active ingredient, for example), using Transcriptomics (RNA-Seq)
- Microorganism strains quantification through qPCR approach
- Expertise and know-how :
- Bioinformatics : customized pipeline developed by GenoScreen, interactive and comprehensive reports
- Support from experts : from experimental protocol design to results interpretation, our team of microbiologists will provide you answers to you initial biological questions.
- Skincare claims validation and Regulatory dossiers fulfillment.
GenoScreen’s commitment : To provide an exceptional customer experience for your sequencing needs.
Support: Dedicated technical and scientific team, available to understand your needs and provide the proper solution.
Adaptability: Adapted methods and customized solutions fitting your project.
Expertise: More than 20 years of research and study on microorganisms and molecular microbiology : DNA is our DNA.
Reactivity: our teams are mobilized to respond as quickly as possible to your needs, and to provide you with the support you need even after the results have been delivered.
Transparency : From clear, detailed quotations to the provision of "materials and methods", you will have everything you need for your scientific publications.
Examples of GenoScreen involvement in R&D projects for Skin Care:
Ionescu M-A, Tatu AL, Busila C, Axente ER, Badalato N, Feuilloley MGJ, Asquier E, Martínez JD, Lefeuvre L. Microbiome Modulation in Acne Patients and Clinical Correlations. Life. 2024; 14(6):688. https://doi.org/10.3390/life14060688
Callejon, S., Giraud, F., Larue, F., Buisson, A., Matéos, L., Grare, L., Guyoux, A., Perrier, E., Ardiet, N., & Trompezinski, S. (2020). Respect of Skin Microbiome with Different Types of Leave-on Skincare Products, an Ecobiological Approach. Preprints. https://doi.org/10.20944/preprints202005.0500.v1
Bianchi, P., Theunis, J., Casas, C., Villeneuve, C., Patrizi, A., Phulpin, C., Bacquey, A., Redoulès, D., Mengeaud, V., & Schmitt, A. M. (2016). Effects of a New Emollient-Based Treatment on Skin Microflora Balance and Barrier Function in Children with Mild Atopic Dermatitis. Pediatric dermatology, 33(2), 165–171. https://doi.org/10.1111/pde.12786
Blanchet-Réthoré S, Bourdès V, Mercenier A, Haddar CH, Verhoeven PO, Andres P. Effect of a lotion containing the heat-treated probiotic strain Lactobacillus johnsonii NCC 533 on Staphylococcus aureus colonization in atopic dermatitis. Clin Cosmet Investig Dermatol. 2017;10:249-257. https://doi.org/10.2147/CCID.S135529
Hilaire, P., Landemaine, L., Contreras, S., Blanquart-Goudezeune, H., Siguier, P., Cornet, F., Chiapello, H., Loux, V., Clavaud, C., & Morand, S. C. (2021). Complete Genome Sequence of Staphylococcus epidermidis PH1-28, Isolated from the Forehead of a Hyperseborrheic Donor. Microbiology resource announcements, 10(9), e00165-21. https://doi.org/10.1128/MRA.00165-21
Landemaine, L., Da Costa, G., Fissier, E., Francis, C., Morand, S., Verbeke, J., Michel, M. L., Briandet, R., Sokol, H., Gueniche, A., Bernard, D., Chatel, J. M., Aguilar, L., Langella, P., Clavaud, C., & Richard, M. L. (2023). Staphylococcus epidermidis isolates from atopic or healthy skin have opposite effect on skin cells: potential implication of the AHR pathway modulation. Frontiers in immunology, 14, 1098160. https://doi.org/10.3389/fimmu.2023.1098160
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GenoScreen provides biotech companies with access to high-level, flexible, agile genomics services that match perfectly to their needs in innovative R&D groups.
Access to cutting-edge genomics facilities
For start-ups, GenoScreen provides guaranteed access to cutting-edge technical facilities that have been designed for research and innovation in genomics.
Our facilities were equipped to address the demands of the pharmaceutical and agrifood sectors, and are structured to deliver irreproachable, high-quality results.
Our services cover the full range of needs in genomics and metagenomics :
Your partner in innovation
As specialists in innovation, GenoScreen’s scientific staff can get involved in high-level collaborative projects and add their valuable experience to your research efforts. Our organizational structure ensures full confidentiality and the protection of your intellectual property rights.
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Ever since its foundation, GenoScreen has worked with groups from academia, research centers and public-sector healthcare institutions.
Our team’s expertise and experience have always met the quality requirements of these complex projects.
GenoScreen works alongside academic groups in many public-sector and mixed private-/public-sector research projects worldwide. GenoScreen provides to these market players a high-level technological platform enabling the completion of the most complex analyses and a focus on customer care. Beyond these criteria, GenoScreen can respond effectively to time constraints thanks to its flexibility and its staff effectiveness.”
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News
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How to preserve the skin microbiota?
The skin microbiota plays a vital role in maintaining the skin's integrity and functionality. It contributes to the proper regulation of organisms and organs, allowing the skin to perform its essential functions, including acting as a barrier. See our latest article "Why preservce the skin...
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GenoScreen bioinformatics training courses 2024
As a training organization, GenoScreen is offering bioinformatics training courses for professionals in 2024. Whether you are a novice or an expert, our training courses will give you the skills you need to master the analysis of NGS data and gain...
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Why preserve the skin microbiota?
The skin serves as the first line of interaction with the external environment and as a defence mechanism against the physical, chemical, or biological stresses and challenges it encounters. The skin microbiota plays a key role in these interactions and defence functions. Formerly known as "skin...