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The EMA guideline [9] also suggested that if avoidance was not possible, then residues of any mutagenic materials to be used should be removed to a level that was “as low as reasonably practicable” (the so‐called ALARP concept). This concept too sounds immediately reasonable, especially in the context of the original request to control to as low as technically feasible, but is flawed when one begins to consider aspects of its implementation. Consider a case when an applicant has developed a process to deliver an active ingredient that contains a measurable, but low, level of a potentially MI. The applicant has established a control strategy in accordance with a TTC‐based limit. Should the assessor approve this application or require the applicant to further modify the process to lower the residual level yet further? How much more work would be required to be considered “reasonably practicable”? Can such a judgment be consistently applied, by all assessors, to all applicants? Will some applicants or assessors expect more to be done than others? All such considerations could introduce inconsistencies in what needs to be a level regulatory landscape. Given the conservative nature of the guideline, there should simply be no need to further improve quality if a TTC‐based control strategy has been established. After all the TTC is considered a virtually safe dose.