Regulatory Assessments

A. Risk Assessments

Due to the ever increasing stringency with which EFSA is imposing on the industry there is a growing realisation that the safety of a bacterial strain needs to be defined at the level of the genome.

SporeGen® has successfully conducted a number of genomic assessments on behalf of major industry in the food and feed sector. In some cases these assessments have been used in self-affirmed GRAS dossiers in the USA.

Either you or SporeGen® will sequence the bacterial strain and this is then assessed gene-by-gene for potential coding sequences that might be of concern. For example, an analysis of this kind will reveal all genes involved in antimicrobial resistance, heavy metal resistance etc. It is important to realise that this assessment is a risk assessment and does not necessarily preclude use of the bacterium in a food or feed product. On the contrary, due diligence on behalf of the owner can be considered good practice and awareness of the need to ‘define a product’.

Our previous studies have taken the form of 70-120 page dossiers that describe relevant genes and in most cases demonstrate that the risk these genes pose is minimal to neglible.

B. EFSA compliant testing

We have successfully conducted a number of tests that are required by EFSA for determining the safety of strains for use as food supplements. This includes:

  1. determination of antibiotic MICs in comparison to reference strains,
  2. characterisation of cellular cytotoxicity,
  3. identification of enterotoxin genes by PCR.