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EU - EFSA approaches to risk assessment in the area of antimicrobial resistance, with an emphasis on commensal microorganisms

The scientific secretariat staff in the BIOHAZ, FEED, GMO, Pesticides and BIOMO Units have collaborated in drafting a technical report covering the following topics: (i) Mapping of the activities carried out in all the relevant areas of antimicrobial resistance in EFSA; (ii) Identification of purposes of use for commensal microorganisms in specific areas under the remit of EFSA. Review of the legislative background within these areas; (iii) definition of the taxonomic unit of commensal microorganisms (genus, species and strains) where EFSA has already conducted risk assessments; (iv) Definition (type, and interpretative criteria) of antimicrobial resistance in these commensal microorganisms; and (v) summary of the main considerations on horizontal transfer of antimicrobial resistance, and review of the approaches undertaken in the different EFSA units/panels to carry out antimicrobial risk assessments for these microorganisms

November 2, 2011


The scientific secretariat staff in the BIOHAZ, FEED, GMO, Pesticides and BIOMO Units have collaborated in drafting a technical report covering the following topics: (i) Mapping of the activities carried out in all the relevant areas of antimicrobial resistance in EFSA; (ii) Identification of purposes of use for commensal microorganisms in specific areas under the remit of EFSA. Review of the legislative background within these areas; (iii) definition of the taxonomic unit of commensal microorganisms (genus, species and strains) where EFSA has already conducted risk assessments; (iv) Definition (type, and interpretative criteria) of antimicrobial resistance in these commensal microorganisms; and (v) summary of the main considerations on horizontal transfer of antimicrobial resistance, and review of the approaches undertaken in the different EFSA units/panels to carry out antimicrobial risk assessments for these microorganisms. The information has been summarised below for the purpose of being presented to the EFSA Scientific Committee. The main conclusions of this review are that for EFSA as a whole, the use of interpretative criteria and methods to define and monitor antimicrobial resistance have been harmonized and are reflected in EFSA’s guidance documents. The use of harmonized methods and epidemiological cut-off values ensures the comparability of data over time at country level, and also facilitates the comparison of the occurrence of resistance between MSs.
 
A synergy has been identified between the approaches for risk assessment of antimicrobial resistance of the FEEDAP and GMO Panels. Both the requirements and the evaluation of phenotypic AMR follow the same criteria in the assessment performed by the FEEDAP and GMO Panels. This is underpinned and complemented by the supporting information in the BIOHAZ QPS opinions which both scientific Panels apply and use as a basis for their risk assessments. Applications for feed additives produced with GMMs submitted under Regulation (EC) No 1831/2003 and biomasses for feed containing GMMs submitted under Regulation (EC) No 1829/2003 are assessed with an integrated approach that includes cross-reference to each Panel’s guidance document and the scientific opinion is adopted by both Panels. Finally, no EFSA guidance document has been developed on the area of microbial plant protection products, and an approach on a case-by-case basis has been used in this area by EFSA.

Download the full report from the link below (PDF)

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