What are the regulatory requirements regarding updating HBEL monographs?

As indicated in the PIC/S "QUESTIONS AND ANSWERS ON IMPLEMENTATION OF RISK-BASED PREVENTION OF CROSS CONTAMINATION IN PRODUCTION AND ‘GUIDELINE ON SETTING HEALTH-BASED EXPOSURE LIMITS FOR USE IN RISK IDENTIFICATION IN THE MANUFACTURE OF DIFFERENT MEDICINAL PRODUCTS IN SHARED FACILITIES’ the toxicological or pharmacological data, on which the HBEL calculation relies, requires periodical re-assessment throughout a product's lifecycle. See below.

This is additionally reinforced in Q13.

It should be noted, the the EMA requirements and PIC/S requirements are almost identical.