Commission Implementing Regulation (EU) 2026/2028 grants a Union-wide authorisation for the biocidal product “ELOCLEAR,” an in-situ generated disinfectant based on active chlorine. This regulation formalizes the product’s market access across the European Union for specific professional uses in industrial, healthcare, and food-processing environments. It establishes strict operational parameters, safety protocols, and technical requirements to ensure the product is used effectively and safely. The authorisation is valid for a ten-year period, concluding on 30 September 2036.
### Structure and Provisions
The act is structured into two main articles and two detailed annexes:
* **Articles 1 & 2:** These define the scope of the authorisation, granting it to Arrow Regulatory (Ireland) Ltd, and set the legal validity period and entry into force.
* **Annex I:** Contains a specific compliance condition requiring the authorisation holder to submit additional analytical data regarding the accuracy of the active substance measurement by 1 April 2027.
* **Annex II (Summary of Product Characteristics – SPC):** This is the core technical document. It outlines the product composition (0.2% active chlorine), identifies the target organisms (bacteria, fungi, viruses, etc.), and provides mandatory instructions for use, risk mitigation, and storage.
Compared to standard national authorisations, this Union authorisation provides a harmonized regulatory status, allowing the product to be marketed across all EU Member States without requiring separate national approvals, provided the conditions in the SPC are met.
### Key Provisions for Practical Use
For professional users and stakeholders, the following provisions are critical:
1. **In-Situ Generation:** ELOCLEAR is not a pre-packaged chemical; it is generated on-site via electrolysis using specific devices (ELOCUBE or ELOSYSTEM). Users must strictly adhere to the technical parameters provided in Section 5.1, such as current density and precursor quality (food-grade salt).
2. **Authorised Use Cases:** The product is strictly limited to professional use for:
* Hard surface disinfection (spraying, mopping, or wiping) in industrial and healthcare settings.
* Disinfection of inner surfaces in food processing (Cleaning in Place – CIP).
3. **Risk Mitigation:** When applying the product via spraying, professionals are mandated to use specific respiratory protective equipment (EN 140/143/14387 standards). Furthermore, bystanders must be excluded from the area until the concentration of active chlorine in the air drops below 0.5 mg/m³.
4. **Food Safety Compliance:** When used in food areas, users must ensure that chlorate residues do not exceed the Maximum Residue Levels (MRLs) established by Regulation (EU) 2020/749.
5. **Storage and Stability:** The generated solution has a limited shelf life and must be used or stored on-site for a maximum of 7 days in HDPE containers under controlled temperature conditions (below 20°C).
**:** This regulation is relevant to Ukraine’s alignment with the EU acquis in the context of the European integration process. As Ukraine works toward harmonizing its chemical safety and biocidal product legislation with the EU’s Regulation (EU) No 528/2012, the technical standards and risk mitigation measures outlined in this act serve as a benchmark for the professional use of in-situ generated disinfectants in the Ukrainian market.
