Pharmeuropa Draft for Ph. Eur. 2.8.13 Pesticide Residues

A revised version of Ph. Eur. chapter 2.8.13. Pesticide Residues has been published in Pharmeuropa Issue 38.3. The comment deadline is 30 September 2026.

The general Ph. Eur. chapter 2.8.13. (last substantially updated in Ph. Eur. Supplement 6.2) is being revised because agricultural/collection practices and available residue data have changed over the past 18 years. The revision clarifies how to determine applicable pesticide residue limits, adds flowcharts (e.g., decision trees for the determination of limits to be applied to pesticides in herbal drugs/herbal drug preparations), and updates the limit-setting approach.

Clearer ADI-Based Limits and Revised Analytical Section

In particular, the 100-factor has been deleted from the expression used to calculate limits with the ADI concept, as ADI values (Acceptable Daily Intake Level) already include a safety factor. Moreover, limits for pesticide residues in herbal drug preparations can now be determined using the ADI concept for all substances for which an ADI value is available, without referring to the limits given in Table 2.8.13.-1 or those laid down in Regulation (EC) No 396/2005. Lastly, a risk assessment is now prescribed for situations where a limit is not available or cannot be calculated.

In addition, Table 2.8.13.-1 (List of pesticides commonly detected in herbal drugs and their maximum residue limits (MRLs)) is updated using recent manufacturer batch data, still applying a 90th-percentile approach, with a default 0.01 ppm proposed for very toxic/persistent pesticides where percentile data are lacking, and terminology is harmonised with EU texts. New general principles specify whether testing applies to the herbal drug or its preparation and allow use of herbal drugs exceeding limits if the final preparation complies. The analytical section is aligned with SANTE/11312/2021 v2026 (replacing SANCO/10232/2006), stresses matrix-group validation for quantitative methods (similar to the approach described in Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids), and addresses unavoidable multiple-source substances with guidance and proposed limits for result interpretation.

More information is available in Pharmeuropa online.