Interested parties have until 15 September 2017 to submit written comments.
The Authority said the draft guidance combines all the requirements for the safety assessment of feed additives containing or obtained from microorganisms. The latter group includes genetically modified microorganisms.
“Advances in scientific knowledge and technology enable the development of new risk assessment methodologies and this guidance combines these developments and establishes assessment criteria based on the best available science,” a spokesperson for the EU food and feed risk assessor told us:
The publication outlines methodologies for investigating the possible presence of DNA of the microorganism used in the production process in the final product and reflects current EFSA practice for the assessment of such additives.
The guidance document is meant to help applicants in the preparation and presentation of applications for authorization.
“In the frame of EFSA’s commitment to transparency, accountability, high scientific quality and efficiency, the FEED Unit took the decision, in collaboration with the FEEDAP Panel, to run a public consultation for all the guidance documents subject to update or revision as well as for the new ones,” added the spokesperson.
Antimicrobial susceptibility
When asked whether antimicrobial resistance (AMR) is the big issue in relation to these type of feed additives, she said:
“AMR is a global problem and does represent one important aspect for additives containing viable microorganisms. It is also of relevance for additives obtained from microorganisms, but is not the only one. As reported in table 1 of the draft, there are different requirements for scientific information according to the type of product and all of them need to be covered.”
The section of the guidance on AMR includes a statement that microbial feed additives should not add to the pool of antimicrobial resistance (AMR) genes already present in the gut bacterial population or otherwise increase the risk of transfer of AMR.
“Antimicrobials considered are those relevant to their use in humans and animals (critically important antimicrobials (CIAs) or highly important antimicrobials (HIAs), last revision WHO, 2016).
“The possibility of transfer of resistance from viable microorganisms to other microorganisms is related to the genetic basis of the resistance and is considered to be most plausible when the resistance is mediated by added/acquired genes.
“For this, two sets of data should be provided:
- Phenotypic testing based on determination of a minimum inhibitory concentration (MIC) for a selected group of antimicrobials
- A search of the whole genome sequence WGS for the presence of known AMR genes.”
The full guidance document can be read here.