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 novel food guidance or even the EFSA Guidance on the characterization of microorganisms used as feed additives or as production organisms. It is a good start, but you may at times feel lost with what next steps to take to get your novel food in the market.
Biosafe is an excellent resource to turn to for advice and cooperation with European food safety regulation. We are a Contract Research Organization (CRO) specialized in helping our clients fulfill all microorganism-related requirements of the European Food Safety Authority (EFSA).
Our pipeline of cooperation
Cooperation starts usually with discussions via e-mail or online meetings, 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 guide our client to the specific tests that are needed for the microorganism in question. 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 begin.
Mailing, testing, and analyzing
Testing is subject to us first receiving a parcel consisting of the living microorganism in question, and product samples if the strain is a production organism. We are aware that our clients sometimes feel insecure about sending a living microbial strain. However, many analyses require fresh microbial cultures. It is the only accountable way to confirm that testing proceeds accurately and it's completely safe.
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. DNA sequencing takes place in one of our trusted partner laboratories. Our own bioinformatics team analyses the genome sequence. Other analyses, such as characterising the antimicrobial susceptibility or presence of cells or DNA in the final product, takes place in our own wet lab.
There are several alternatives to get the microbial genome sequenced. Budget-wise, there are both inexpensive and more costly testing methods available for the same procedure. PacBio sequencing method are recommended for genetically modified microorganisms, while cheaper options are just as feasible for other microbes. However, getting short-term savings from cheaper testing alternatives won't necessarily pay off: you might not get results that are thorough enough to answer your study question in full or the method might not be compliant with regulations in the first place. We have plenty of experience of people coming to ask us what the proper testing method would be after rounds of redundant testing.
Stepping up the schedule
The more we know about your microbe or your final novel 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.
If you need to accelerate the process, there are two things to keep in mind.
First, the earlier you proceed 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 money, we can also provide consulting services during your R&D phase. This is how we can, together, identify the most feasible microbial strains early on.
All reports that we provide our clients are designed to meet EFSA requirements right away and they are easily readible. We like to call our set of services and expertise a one-stop shop: 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 we can help you avoid any pitfalls of unnecessary steps or costs.