In October 2018, the ICH Management committee issued Revisoin 7 of ICH Q3C Guideline for Residual Solvents.  The only change is an error correction of the Permitted Daily Exposure (PDE) for ethyleneglycol.  The corrected value (3.1 mg/day) was originally published in Pharmeuropa, Vol. 9, No. 1, Supplement, April 1997 S36.  This value is tighter than the PDE included in the previous revision of ICH Q3C (6.2 mg/day in Rev 6).

EMA and Health Canada have already adopted Revision 7 into local legislation –


Health Canada –

Additionally, the ICH Management committee approved the publication of Support Documents 1, 2 and 3, which include the summaries of the toxicity data from which PDEs were derived (

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