by Julie MacKinnon, Microbiome Services Manager
There is a growing interest in the use of microorganisms within the food chain, and this can be attributed to a number of different factors. For example, knowledge and understanding of the gut microbiome and its role in human health has led to an interest in fermented foods and supplements containing bacteria associated with gut health. There is also an interest in microorganisms as a more environmentally friendly alternative to chemical pesticides used in agriculture, and for the production of food additives such as flavourings or colourings. Production of novel foods such as alternative protein sources has been another active area of research and development in recent years.
As you might expect, The National Collection of Industrial, Food and Marine Bacteria includes many food related strains, as well as strains that may have potential for use in animal feed and crop protection. These strains could have potential applications within the biotech and food sectors, but what are the steps in place to ensure that these microorganisms are safe for use in the food chain?
Qualified Presumption of Safety: a simplified approach
Within the European Union, the European Food Safety Authority (EFSA) receives applications for market authorisation of feed additives, food additives, food enzymes, food flavourings, novel foods and plant protection products.
To simplify this process, a system of assigning a qualified presumption of safety to taxonomic units (for example, species) that meet certain criteria was implemented in 2007.
The QPS assessment process is triggered by EFSA following receipt of an application for market authorisation. During the QPS assessment taxonomic identity, body of knowledge and any potential safety concerns, including knowledge of relevant acquired antimicrobial resistance, are assessed. If a hazard related to a taxonomic unit that can be tested at the strain or product level is identified, a qualification to exclude that hazard may be established during the QPS assessment.
Strains from species granted QPS status still require a simplified safety assessment
In summary, EFSA uses existing knowledge about the safety of specific microbes proposed for use in the food chain, to differentiate those which are not of concern (and can be given QPS status) from those which may represent a risk and should be subject to a full safety assessment. Some biological groups are excluded from QPS assessment based on ambiguous taxonomic position, or the possession of potentially harmful traits.
However, it is important to remember that although QPS assessment was introduced to simplify the authorisation process, using a strain that has been granted QPS status does not necessarily guarantee market authorisation. For species granted QPS status, a simplified assessment may be carried out and NCIMB offers a range of services to assist with this.
Safety assessment is required at the strain level
The QPS status is granted through assessment at the species level for bacteria and yeasts, but safety assessment of microorganisms included in applications for market authorisation is done at strain level. According to the EFSA website, assessment required includes:
- confirmation of taxonomic identity
- confirmation that the QPS qualifications assigned during the QPS assessment, e.g. absence of acquired antimicrobial resistance genes are met.
- For genetically modified microorganisms, a confirmation of the safety of the genetic modification.
- A safety assessment based on a specific data package as requested by the Regulation and EFSA guidance documents for the application areas of the requested product authorisation.
Browse NCIMB strains from species on the QPS list
Because strains from species that have already been granted QPS status may be of interest for our customers working within the food or feed sectors, we have created a listing of strains within our culture collection that are from species on the QPS list. This will make it easier to browse find the strains that may require a simplified assessment. You can browse the list on our QPS and strains for food feed and crop protection page. Note that strains occasionally undergo reclassification and synonyms are referenced where this had been highlighted.
“For species granted QPS status, a simplified assessment may be carried out and NCIMB offers a range of services to assist with this.”