Commission Implementing Regulation (EU) 2026/1410 grants a Union-wide authorisation for the biocidal product family ‘Prisman Händedesinfektion’. This regulation allows the product to be made available on the market and used across all European Union Member States for human hygiene purposes (Product-Type 1). The authorisation is based on the assessment that the product meets the safety and efficacy conditions required by Regulation (EU) No 528/2012.
### Structure and Main Provisions
The act is structured into two primary articles and a comprehensive Annex detailing the Summary of Product Characteristics (SPC).
* **Article 1:** Formally grants the Union authorisation to Schuelke & Mayr GmbH, assigning the authorisation number EU-0034420-0000. It specifies the validity period from 6 August 2026 until 30 September 2035.
* **Article 2:** Sets the entry into force for the twentieth day following its publication.
* **The Annex:** This is the core technical component, divided into multiple “Meta SPCs” (1 through 12). Each Meta SPC defines specific compositions, target organisms (bacteria, yeasts, mycobacteria, viruses, etc.), application rates, and user categories (general public, professional, and industrial).
Compared to individual national authorisations, this Union authorisation provides a harmonized regulatory status, ensuring consistent safety and efficacy standards across the EU.
### Key Provisions for Use
For those utilizing or distributing this product, the following provisions are critical:
* **Active Substance:** The product family relies on propan-2-ol as the active substance, with concentrations varying by specific product formulation (ranging from 63.1% to 75% w/w).
* **User Restrictions:** The regulation strictly defines the category of users for each specific use case. Some uses are restricted to “professional” or “industrial” users, while others are permitted for the “general public.”
* **Application Protocols:** The Annex provides precise instructions for hygienic and surgical hand rubs, including required contact times (e.g., 30 seconds for hygienic, 45–180 seconds for surgical) and application volumes (3ml to 10ml depending on the specific use).
* **Safety and Risk Mitigation:** The regulation mandates specific hazard statements (e.g., H225: Highly flammable liquid and vapour) and precautionary measures (e.g., P210: Keep away from heat/sparks; P305+P351+P338: First aid for eye contact).
* **Refilling Requirements:** For professional and industrial users, the regulation sets strict labeling requirements for any containers or dispensers used for refilling, ensuring that the authorization number, trade name, and active ingredient information remain visible.
**:** This regulation has direct implications for the supply chain and health safety standards in all Member States, including those with significant humanitarian or medical needs, as it standardizes the use of this disinfectant for both domestic and clinical settings.
