Vitamin B2 80% from Bacillus subtilis
To: All Operators placing Vitamin B2 80% from Bacillus subtilis in the market and Certification Bodies
FAMI-QS would like to call the attention of all Members placing Vitamin B2 80% from Bacillus subtilis in the market for the below described situation.
Vitamin B2 80% is a feed additive produced by fermentation of a genetically modified Bacillus subtilis strain.
In order not to pose any safety concern regarding to the genetic modification of the production strain, EU legislation requires that neither the bacteria's production strain nor its recombinant DNA be detectable in the final vitamin B2 80% feed grade product. This shall not apply to traces of authorised GMOs in a proportion no higher than 0,9% or lower thresholds established in the legislation, provided that these traces are adventitious or technically unavoidable.
Considering the above, in case the finished vitamin B2 80% contains DNA belonging to the production strain, including the genetic modification, or contains viable cells from the production strain, the product poses a risk for the spread of viable cells and DNA of a genetically modified strain-harbouring genes coding for resistance to antimicrobials.
That being said, we would like to kindly ask all Members for a statement, covering:
- Evidence of compliance with the current EU legislation (absence of bacteria's production strain and its recombinant DNA in the finished product);
- Precautionary actions to ensure that the finished product is free of the production strains, genetic modified DNA and recombinant DNA.
Please send the statement to email@example.com, until 30 May 2018.
In addition, auditors carrying out audits in sites where Vitamin B2 80% from Bacillus subtilis is produced or traded, shall consider the traceability of the strain used.
Thank you for your proactive cooperation.