Consumer safety in first place
Throughout history, microorganisms have played a pivotal role in food production, shaping culinary traditions and advancing human civilisation. From the fermentation of grains to the creation of dairy products and beyond, the utilisation of these tiny organisms has transformed raw ingredients into food substances daily consumed by the population.
Ensuring the safety of microorganisms in food production is paramount for safeguarding public health. Indeed, microorganisms are able to produce toxins or metabolites, carry antibiotic-resistant genes or virulence factors, and possess allergenic properties that can pose risks to consumers.
This is why the European Food Safety Authority (EFSA) asks applicants who put on the market such new microorganism-produced food substances to deeply characterise the producer microorganism.
Scientific Requirements from the Authorities
Guidance on the characterisation of microorganisms used as feed additives or as production organisms, published in 2018, gives a detailed description of the data required for authorising the food product and ensuring total consumer safety. More information can also be found on the Guidance on enzyme and Novel food.
The first mandatory requirement is performing a Whole Genome Sequence (WGS) analysis that, besides unambiguously identifying the microorganisms, provides insight into potential functional traits of concern (e.g. virulence factors, production of or resistance to antimicrobials of clinical relevance, production of known toxic metabolites). Of course, this should be accompanied by the taxonomic information (genus, species and strain name) of the microorganism under assessment.
GMOs under the magnifying glass
If a genetically modified microorganism (GMO) has been used, the WGS analysis is required for both the parental and the producer strains. Indeed, this kind of analysis is able to provide comprehensive information on the structure of the genetic modification induced.
It also asked applicants to describe traits and changes in phenotype and metabolism the genetic modification has resulted in.
Finally, according to the Guidance above, the absence of microorganism cells in the finished food product should be proven by performing ad hoc analysis, such as DNA residues and viable cell tests.
Traceability as a paramount prerequisite
The organism under assessment should be deposited in an internationally recognised culture collection, having acquired the status of International Depositary Authority under the Budapest Treaty (preferably in the European Union) and maintained by the culture collection for the authorised period of the food substance. A valid certificate of deposition from the collection should then be provided.
Chemsafe can assist you in collecting all the relevant information and data and help you submit all the requirements to the EC/EFSA.
