HMPC Q&A Document on Herbal Medicines revised

Recommendation
10/11 September 2025
EMA's HMPC (Committee on Herbal Medicinal Products) has revised the questions & answers document on (traditional) herbal medicines.
With revision 5 the following question was added to the Q&A document as compared to the previous version number 4 from August 2014.
Is testing of benzene (class 1 solvent) for herbal preparations necessary?
Some solvents used for extraction, purification or during manufacture of a herbal preparation may contain benzene as an impurity. As a consequence, there might be benzene residues in herbal preparations.
The most commonly used solvents for the manufacture of herbal preparations are ethanol and water or combinations thereof. Ethanol of chemical origin may contain benzene as an impurity whereas ethanol obtained from fermentation does not normally contain any benzene. Therefore the production process of ethanol used in herbal preparations should be taken into account.
Ethanol, methanol and acetone complying with their European Pharmacopoeia monographs should not exceed 2 ppm of benzene, which is the ICH limit. Therefore, the content of benzene in other solvents should not exceed the ICH limit of 2 ppm either. Where solvents exceeding the ICH limit are used, potential benzene residues should be identified and quantified.
You can find the further explanations on this question on the testing of benzene under question 10 on page 7/19.
To get more details please see the complete Q&A document "Questions & answers on quality of herbal medicinal products/traditional herbal medicinal products".
Related GMP News
16.07.2025Inadequate Sampling and Component Testing Highlighted in FDA Warning Letter
16.07.2025EMA publishes new Product-Specific Bioequivalence Guidance
16.07.2025Revision of USP Chapter <1039> Chemometrics Published for Comments
16.07.2025Proposal for new USP Chapter <318> NMR Monomer Ratio Determination for Lactide-Glycolide Polymers
16.07.2025New USP Chapter <1221> on Ongoing Procedure Performance Verification (OPPV) Published for Comment
02.07.2025FDA Warning Letter: Missing Testing, No Stability Data, and Inadequate Raw Material Controls