Ph. Eur. Draft for Comment: 2.8.18. Determination of Aflatoxin B1 in Herbal Drugs

A revised draft of chapter 2.8.18 of the European Pharmacopoeia (Ph. Eur.), Determination of Aflatoxin B1 in Herbal Drugs, has been published in Pharmeuropa 38.4 for public consultation. The deadline for comments is 31 December 2026.

According to the briefing note, the proposal concerns the section entitled post-column derivatisation with photochemical reactor (PHRED). The reactor is fitted with a low-pressure mercury bulb that emits ultraviolet (UV) light at 254 nanometres. As the procedure is believed to be no longer in use, the European Directorate for the Quality of Medicines & HealthCare (EDQM) proposes deleting it from the chapter, thereby avoiding the need to specify mercury bulbs.

The briefing note places this proposal in the wider context of efforts to reduce the use of mercury. The Minamata Convention on Mercury is a global treaty to protect human health and the environment from the adverse effects of mercury. It was adopted in 2013 and entered into force on 16 August 2017. In the European Union (EU), Regulation (EU) No 847/2012 restricts the use of mercury in certain measuring devices, including thermometers, barometers, hygrometers and manometers.

The note also points out that several Ph. Eur. texts have already been revised to remove references to mercury in thermometers and other measuring devices, such as calomel electrodes. Where possible, revisions have also sought to avoid the use of mercury-containing reagents in analytical procedures.

The EDQM invites readers to provide information if they are aware of laboratories that still perform PHRED-based column derivatisation using suitable alternative reactors that do not rely on mercury bulbs.

To view the full draft, please go to Pharmeuropa online.