During its 181st session in March 2025, the European Pharmacopoeia Commission (EPC) adopted general chapter 2.6.7. Mycoplasmas and 11 monographs referring to it, all of which have been revised to reflect the new European Pharmacopoeia (Ph. Eur.) approach to the detection of mycoplasma contaminants. These revised texts now describe a less prescriptive testing strategy based on a risk assessment.

The revised general chapter specifies that both the culture method and the indicator cell culture method (or, alternatively, a NAT method) should be used conjointly to ensure the detection of both “cultivable” and “non-cultivable” mycoplasmas, unless otherwise prescribed in a monograph or unless justified by a risk assessment and authorised by the competent authority. It has also been clarified that, whenever possible, the samples should contain both cells and supernatant. Furthermore, the text now states that suitable strains may be selected from the proposed list and additional strains can be used, based on a risk assessment, taking into account the type of product and manufacturing process.

The section on Nucleic acid amplification techniques (NAT) has been extensively revised to reflect the state of the art in science and technology. A limit of less than 10 is now proposed as the acceptance criterion for the GC/CFU ratio of reference preparations, unless otherwise justified.

As a result of the changes made to general chapter 2.6.7, 11 monographs have been revised to remove specific instructions on the method to be applied or the volume to be used for the mycoplasma test. Two individual monographs on vaccines for human use (Smallpox vaccine (live) (0164) and Yellow fever vaccine (0537)) now indicate that the test is carried out on the single harvest. With the agreement of the competent authority, the test may alternatively be carried out on the pooled harvests.

The texts will be published in Issue 12.2 of the Ph. Eur. in October 2025 and will enter into force on 01 April 2026.