France Grants 180-Day Biocide Derogation For Hospital Isolators

France has authorised a temporary derogation for the biocide sold as PROXITANE 5LDR and MDI. Supply and use are permitted exclusively for hospital-isolator biodecontamination in France for 180 days, starting when the order takes effect on 16 November 2026.

The order of 5 November, published on 15 November, follows requests from several hospitals. Its preamble explains that PROXITANE 5LDR is also distributed under the name MDI.

Products And Permitted Use

The derogation covers product-type 2 disinfectants containing peracetic acid and hydrogen peroxide as active substances. Article 1 limits the permission to biodecontaminating hospital isolators. Article 2 requires users to follow the manufacturer's conditions of use.

The order describes isolators used to prepare cancer chemotherapy treatments and parenteral nutrition. It does not grant a general permission for other disinfection uses.

Why The Derogation Was Issued

According to the order's preamble, SOLVAY CHEMICALS INTERNATIONAL amended its authorisation application in March 2026. The application no longer covers the use addressed by this derogation. The ministry says a halt in supply would exhaust available stocks during December 2026.

The preamble identifies alternative products but says hospitals need compatibility studies, technical adaptations and microbiological validation before using them. Those steps take several months and must be staggered to maintain hospital-pharmacy activity.

Temporary Public-Health Measure

The order invokes Article 55(1) of the EU Biocidal Products Regulation and the corresponding French Environmental Code provisions. Its stated purpose is to maintain continuity of care while alternatives are introduced. The 180-day authorisation remains restricted to the specified products and hospital-isolator use.