Scientific Opinion on the removal of a maximum dose from the authorisation of microbial products assessed using the Qualified Presumption of Safety approach

The European Commission has received requests for a modification of the authorisations of certain microbial products, all based on species considered by EFSA as suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment. Applicants are seeking the removal of the maximum dose specified in the current authorisation on the basis that such a dose is not consistent with the QPS approach. Therefore, EFSA has been requested to provide an opinion on the implications of the deletion of the maximum dose currently applied to those authorised microbial products for which safety was assessed using the QPS approach and, more generally, in the case of all microorganisms for which this approach is used. Since the QPS assessment is not related to a specific purpose but has to take account of any reasonable use of the organism under consideration, no restrictions on the amount of the organism used for any particular application are made. Although, in principle, such a provision could be included as a “qualification” this has not proved necessary to date. Consequently, all pre-assessments made by EFSA for the microorganisms currently listed as suitable for QPS have been made independent of dose. As a consequence, unless a specific provision relating to dose is included in the “qualification” for a given taxonomic unit, safety is presumed at any reasonable dose. In such cases the setting of a maximum dose in an authorisation does not offer any additional degree of safety for target animals, consumers or the environment and, in the view of the FEEDAP Panel, is unnecessary.