Changes to the list of microorganisms and toxins in article L5139-1 of the French Public Health Code

On May 28, two decrees on applicable regulations regarding the microorganisms and toxins (MOTs) listed in article L5139-1 of the French Public Health Code were published. These decrees respectively establish the new list of MOTs and parts of MOTs, and the maximum doses and concentrations of MOTs and parts of MOTs:

• Decree of April 26, 2023 establishing the list of microorganisms and toxins provided in article L. 5139 1 of the Public Health Code;

• Decree of April 26, 2023 establishing the maximum doses and concentrations of the microorganisms and toxins in the list provided in article L.5139 1, in application of article R.5139 20 of the Public Health Code.

In the new list, some microorganisms and toxins have been removed, some have been added, and the parts of MOTs have been adapted.

Particular attention needs to be paid to the updated list of toxins, as some have been newly added and/or the notion of a maximum level of 1mg per holder no longer applies, especially for SEB and saxitoxin, for which the MOT regulations now apply.

If you have in your possession a microorganism or toxin that has been added to the list, a technical application for authorization to possess and use the product must be submitted to the French National Agency for the Safety of Medicines and Health Products (ANSM) no more than 6 months after the publication of the new decree establishing the list of MOTs (in other words by November 27, 2023 at the latest).

If an application is not submitted within six months, the microorganisms and toxins may no longer be kept and must be destroyed and eliminated by this deadline in accordance with applicable regulations.

The Risk Prevention Department (mot@pasteur.fr) is available to answer any questions and assess the impact of these changes on your work.