Disinfecting laboratories with vaporised hydrogen peroxide: Union authorisation for OXTERIL 350 VHP — 1,092 mg/m³ (780 ppm) for at least 4 hours, microbiological validation and re-entry only below 1.25 mg/m³
Commission Implementing Regulation (EU) 2026/2042, published on 14 September 2026, grants Evonik Operations GmbH Union authorisation EU-0035928-0000 for the product OXTERIL 350 VHP (35% hydrogen peroxide) for disinfecting dry surfaces by vaporisation — in product-type 2 in laboratories and hospital rooms, among others, and in product-type 4 in food and feed areas. The authorisation applies from 4 October 2026 to 31 October 2033.
- It is a “same product” as the “Evonik’s Hydrogen Peroxide Product Family” authorised under EU-0028964-0000 (Regulation 2023/2183) — according to the ECHA opinion of 29 October 2025 the differences are limited to information that can be subject to administrative changes, and the expiry date was aligned with the reference family. The application was submitted on 30 September 2025.
- Conditions of use: room volume 30–150 m³, initial temperature 20 ± 2 °C, relative humidity 40–80%, diffusion rate 1.5–20 g of product per minute. The VHP generator maintains a hydrogen peroxide concentration of 1,092 mg/m³ (780 ppm) for at least 4 hours, and the concentration is monitored; target organisms are bacteria and yeasts, with at most 3 applications per day. The summary of product characteristics of the reference family from 2023 contains the same description of use.
- The user always carries out a microbiological validation of the disinfection in the rooms concerned (or in a suitable “standard room”) with the devices to be used and draws up a protocol on that basis. Where methods for chemically monitoring the active substance in air or on surfaces are available, a chemical validation is performed besides the biological one, for example with test strips or a device measuring ppm of hydrogen peroxide in air; for a “standard room” with an existing protocol, chemical validation is sufficient.
- Before entry the room is aerated to below 1.25 mg/m³ (or a lower national reference value), which must be checked, for example with test strips; the whole cycle takes 5–8 hours. While the generator is running or in the event of a failure, entry is only possible with a chemical protective suit and respiratory protective equipment (APF = 10) at a concentration of no more than 12.5 mg/m³.