1. Fertilizers WG meeting 2017-11-13
Safety of microorganisms used in fertilizing products: a criteria-based approach
Fertilizers WG meeting

2. Our topics for today
Developing a criteria-based approach to evaluation of microorganisms The future Expert Group on Microorganisms
Fertilizers WG

3. Added value of a criteria-based approach
Increases the capacity of the system to keep up with fast-paced and accelerating R&D related to microbial products
Can neutralize questions of data protection when applied by Notified Bodies: sensitive data would be covered by the confidentiality of the NB-client relationship
Allows for useful strains to be incorporated into CE- Marked products even when other strains in the same taxonomic group are not desirable (either for safety or effect reasons)
Fertilizers WG

4. EBIC's proposal: how to amend CMC 7 (safety evaluation of microorganisms)
N.B.: this only addresses the safety of the microorganism (as efficacy is evaluated at the product level)
Fertilizers WG

5. Proposed identity criteria
Name, taxonomic classification and identification method of the microorganism are known at strain level (*) The microorganism species does not belong to WHO risk groups 3 or 4 as defined by EU Dir 2000/54 The microorganism is susceptible to at least two distinct antimicrobial substances defined by WHO as a critically important antimicrobial (CIA) or highly important antimicrobial (HIA). These two should be representing different antimicrobial classes (*) A representative sample is stored in a reputable culture collection, i.e. a collection which is ISO 9001 certified for accession, control, preservation, storage and supply of biological material The environmental origin of where the microorganism was originally sourced is known An SDS is available (*) Standards to be developed
Fertilizers WG

6. Proposed human safety criteria
Fertilizers WG

7. Proposed environmental safety criteria
Fertilizers WG

8. Outstanding questions regarding the expert group on microorganisms
Mandate and deliverables
Establishing guidelines?
Populating the positive list at species/strain level?
Modus operandi
Sources and criteria for declaring a taxonomic group "safe"?
Timeline for evaluations?
How will the expert group's decisions translate into regulation? At what frequency?
Participation
How will industry participants be selected?
Need to prevent potential conflicts of interest for industry
Fertilizers WG