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How to successfully navigate in the midst of EFSA requirements?

How to successfully navigate in the midst of EFSA requirements?

You have discovered a new microorganism that you plan to use as a feed additive or in any food product. And you have downloaded the EFSA Guidance on the characterization of microorganisms used as feed additives or as production organisms.
It is a good start, but I am convinced that you may feel, at times, lost with the next steps.

At this point in time, Biosafe would be an excellent resource for cooperation, to turn to and seek guidance from. We are a Contract Research Organization (CRO) specialized in helping our clients to fulfill all microorganism-related requirements by the European Food Safety Authorities (EFSA).

Our pipeline of cooperation

Cooperation starts usually with discussions through e-mail or online meeting, during which we’ll ask for background information of the microorganism that you have developed. We are especially interested in the intended use of the strain and other properties, such as whether it is genetically modified or has some antibiotic resistance. Based on the preliminary evaluation and discussion, we shall guide our client as regards the specific tests that are needed for the microorganism in question. For that, we have a collection of services developed specifically to meet EFSA requirements. We do most analyses in-house, but we also have a network of service providers to meet various needs.

As a result of our first discussions, you shall receive an offer. This process is a journey of a minimum of two weeks, but when a series of tests and analyses need to be conducted, several months of actual cooperation begins.

Mailing, testing, and analyzing

Jenny Makkonen
Project Manager, Ph.D

Testing is subject to Biosafe first receiving a parcel consisting of the living microorganism in question, and product samples when the strain is a production organism. We are aware that our clients sometimes feel insecure about sending the living microbial strain. However, many analyses require fresh microbial cultures. This is the only accountable way to confirm that testing goes smoothly from now on.

Upon receiving the microorganism for bioinformatic analyses, we first isolate its DNA and confirm that its quality and quantity meet the requirements for further testing. The DNA sequencing takes place in one of our trusted partner organizations’ laboratories, and our own bioinformatics team will analyse the genome sequence. Other analyses, such as characterizing the antimicrobial susceptibility or presence of cells or DNA in the final product, takes place in our own wet lab.

Budgeting wisely

There are several alternatives to get the microbial genome sequenced. Budget-wise, there may be an inexpensive and a more costly testing alternative available for the same procedure. We might suggest a PacBio sequencing method for a genetically modified microorganism, while a cheaper option might work for other microbes. However, I would like to seize the opportunity to emphasize that thinking of a short-term saving and thus using a cheap alternative does not necessarily provide the customer with results that are thorough enough to answer the study question in full or are not compliant with regulations in the first place.

Boosting up the schedule

The more we know about our customer’s microbe or the final product, the better we can plan ahead. One key aspect to remember is to follow the sampling instructions that we provide. In the sample collection phase, the amount and quality of samples are important for the success and compliance of the tests.

There are a couple of aspects regarding the acceleration of the process. First, the earlier one proceeds with the preparations for any foreseen testing needs, the faster we will be able to reach the submission date of your EFSA dossier.

Second, if you wish to become even more effective and save both time and costs, we also offer our consulting services to you during your R&D phase. This is how we could, together, identify the best microbial strains early on.

All reports that we provide our clients with are designed to meet EFSA requirements and can be read easily. We like to see our set of services and expertise as a one-stop shop destination—there is no need for our clients to look any further. We know how to guide you through the various options and requirements of testing, and help you avoid any unnecessary steps or costs.

Jenny Makkonen

Contact us here for your safety assessment needs: https://www.biosafe.fi/en/contact