As part of the “France Expérimentation” initiative, Council of State Decree  No. 2026-162 of March 4, 2026, allows for exemptions from the provisions of the Public Health Code in order to authorize pilot projects involving the reuse of primary packaging for waste from healthcare activities involving infectious risks and similar activities (DASRIA) and the recovery or recycling of such waste.

The draft order, referred to in Article 9 of the decree and submitted to the HCSP for review, concerns the oversight of trials, the content of applications for trial authorization, the annual monitoring reports for authorized trials, and the comprehensive trial evaluation report submitted by the authorization holder. These elements are intended to ensure the safety and security of reused packaging and recovered or recycled DASRIA.

After reviewing the draft order, the HCSP makes the following recommendations:

a) One of the general recommendations regarding the monitoring of the pilot program:

• The monitoring of the pilot program, as specified in Article 3, should include, in particular, the continuous recording of disinfection parameters for packaging or DASRIA intended for recovery or recycling, traceability of operations involving the reuse of packaging or the recovery or recycling of DASRIA, as well as verification of the effectiveness of disinfection through microbiological testing conducted on reused packaging or DASRIA intended for recovery or recycling. The nature and frequency of this monitoring should be tailored to the characteristics of the pilot project and specified in the order authorizing the pilot project;
• The proposed monthly frequency for monitoring the experiment, as set forth in Article 3, does not appear adequate for tracking the operational parameters of a disinfection process to detect potential deviations, for ensuring the traceability of operations in the packaging reuse, waste recovery, or recycling systems, and for microbiological testing, which depends on the nature and conditions of the pilot program. To be determined, these elements require a comprehensive analysis of the application for authorization of the pilot program.

b) The proposed editorial changes are presented below directly in the draft order (the corrections appear in strikethrough and bold).