SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT
ANNEX IISupplementary provisions
ANNEX II SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT ELOCLEAR Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Authorisation number: EU-0035839-0000 R4BP asset number: EU-0035839-0000 1. ADMINISTRATIVE INFORMATION 1.1. Trade name(s) of the product Trade name(s) ELOCLEAR 1.2. Authorisation holder Name and address of the authorisation holder Name Arrow Regulatory (Ireland) Ltd Address The Black Church St. Mary’s Place D07 P4AX Dublin IE Authorisation number EU-0035839-0000 R4BP asset number EU-0035839-0000 Date of the authorisation 1 October 2026 Expiry date of the authorisation 30 September 2036 1.3. Manufacturer(s) of the product Name of manufacturer Irrelevant since the in situ generated biocidal product is “manufactured” at the site of use Address of manufacturer Location of manufacturing sites Irrelevant since the in situ generated biocidal product is “manufactured” at the site of use 1.4. Manufacturer(s) of the active substance(s) Active substance Active chlorine generated from sodium chloride by electrolysis Name of manufacturer Irrelevant since the in situ generated Active Substance is “manufactured” at the site of use Address of manufacturer Location of manufacturing sites Irrelevant since the in situ generated Active Substance is “manufactured” at the site of use 2. PRODUCT COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the product Common name IUPAC name Function CAS number EC number Content (%) Active chlorine generated from sodium chloride by electrolysis Active substance 0,2 % (w/w) 2.2. Type(s) of formulation AL- Other liquids to be applied undiluted 3. HAZARD AND PRECAUTIONARY STATEMENTS Hazard statements H290: May be corrosive to metals. Precautionary statements P406: Store in a corrosion resistant container with a resistant inner liner. P234: Keep only in original packaging. P390: Absorb spillage to prevent material damage. 4. AUTHORISED USE(S) 4.1. Use description Table 1 Use 1: Hard surface disinfection by spraying Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Scientific name: bacteria Common name: bacteria Development stage: all Scientific name: fungi Common name: fungi Development stage: all Scientific name: yeasts Common name: yeasts Development stage: all Scientific name: viruses Common name: viruses Development stage: all Scientific name: bacterial spores Common name: bacterial spores Development stage: all Scientific name: mycobacteriaceae Common name: mycobacteria Development stage: all Scientific name: bacteriophages Common name: bacteriophages Development stage: all Field(s) of use indoor use Hard surface disinfection in industrial and healthcare facilities, in food processing industries (including dairy, meat industries, slaughterhouses and brewing industries) Application method(s) Method: spraying Detailed description: By spraying (trigger spraying, low pressure compression spraying 1-3 bars or medium pressure compression spraying up to 7 bars) Application rate(s) and frequency Application Rate: Apply 0,15 l/m 2 of product to the surfaces Dilution (%): 0 Ready to use solution (2000 mg/l available Chlorine (av CL)) Number and timing of application: PT2, at room temperature: For general surface disinfection, for a contact time of 5 minutes against bacteria, yeast, fungi, virus and bacterial spores. For surface disinfection (healthcare), for a contact time of 5 minutes against bacteria, yeast, virus bacterial spores and mycobacteria; for a contact time of 15 minutes against fungi. PT2, at temperatures of at least 10 o C and up to room temperature: For general surface disinfection, for a contact time of 5 minutes against bacteria and yeast. PT4, at room temperature: For general surface disinfection including meat industry and for surface disinfection in breweries, for a contact time of 5 minutes against bacteria, yeast, fungi, virus and bacterial spores. For surface disinfection of slaughterhouses, for a contact time of 5 minutes against bacteria, yeast and virus. PT4, at temperatures of at least 10 o C and up to room temperature: For general surface disinfection including meat industry, for surface disinfection in dairy industries and slaughterhouses against bacteria and yeast for a contact of 5 minutes and against bacteriophages for dairy industry only. Frequency: Apply as necessary Category(ies) of users professional Pack sizes and packaging material Not applicable 4.1.1. Use-specific instructions for use — Apply directly a 2000 mg/l av Cl solution generated by electrolysis from sodium chloride onto the surface using trigger spraying, low pressure spraying (1-3 bars) or medium pressure spraying (up to 7 bars). — Apply only on non-porous surfaces. — Only use on pre-cleaned surfaces. — Apply the product uniformly on the surface to be treated in sufficient quantity to wet the surface completely. — After contact time, rinse with water. 4.1.2. Use-specific risk mitigation measures — During disinfection process by low or medium pressure compression spraying 1-3 bars and up to 7 bars and during rinsing, Wear a respiratory protective equipment (RPE) protecting against combination of gases and particles with an assigned protection factor (APF) of at least 4. At least a device half/quarter mask (EN 140 or equivalent) with combination filter gas/P3: particle filter P3 according to the norm EN 143 and gas filter according to the norm EN 14387. This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to this act. — Bystanders and general public must not be present during disinfection process by compression sprayer (low and medium pressure) and until the aerial concentration of active chlorine is below the acceptable exposure concentration (AEC) of 0,5 mg/m 3 or lower national reference value. Professional bystanders must wear the same RPE as the professional user if it is necessary to be present. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment - 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging - 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage - 4.2. Use description Table 2 Use 2: Hard surface disinfection by mopping and wiping Product type PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Scientific name: bacteria Common name: bacteria Development stage: all Scientific name: yeasts Common name: yeasts Development stage: all Scientific name: fungi Common name: fungi Development stage: all Scientific name: viruses Common name: viruses Development stage: all Scientific name: bacterial spores Common name: bacterial spores Development stage: all Scientific name: mycobacteriaceae Common name: mycobacteria Development stage: all Scientific name: bacteriophages Common name: bacteriophages Development stage: all Field(s) of use indoor use Hard surface disinfection in industrial and healthcare facilities, in food processing industries (including dairy, meat industries, slaughterhouses and brewing industries) Application method(s) Method: mopping/wiping Detailed description: Application by mopping/wiping Application rate(s) and frequency Application Rate: Apply 0,15 l/m 2 of product to the surface Dilution (%): 0 Ready to use solution (2000 mg/l available Chlorine (av CL)) Number and timing of application: PT2, at room temperature: For general surface disinfection, for a contact time of 5 minutes against bacteria, yeast, fungi, virus and bacterial spores. For surface disinfection (healthcare), for a contact time of 5 minutes against bacteria, yeast, virus, bacterial spores and mycobacteria; for a contact time of 15 minutes, against fungi. PT2, at temperatures of at least 10 o C and up to room temperature: For general surface disinfection, for a contact time of 5 minutes against bacteria and yeast. PT4, at room temperature: For general surface disinfection including meat industry and for surface disinfection in breweries, for a contact time of 5 minutes against bacteria, yeast, fungi, virus and bacterial spores. For surface disinfection of slaughterhouses, for a contact time of 5 minutes against bacteria, yeast and virus. PT4, at temperatures of at least 10 o C and up to room temperature: For general surface disinfection including meat industry, for surface disinfection in dairy industries and slaughterhouses against bacteria and yeast for a contact of 5 minutes and against bacteriophages for dairy industry only. Frequency: Apply as necessary Category(ies) of users professional Pack sizes and packaging material Not applicable 4.2.1. Use-specific instructions for use — Immerse mop or cloth into a bucket containing a 2000 mg/l av Cl solution generated by electrolysis from sodium chloride. Ensure thorough wetting of the surface. — Apply only on non-porous surfaces. — Only use on pre-cleaned surfaces. — Apply the product uniformly on the surface to be treated in sufficient quantity to wet the surface completely. — After contact time, rinse with water. 4.2.2. Use-specific risk mitigation measures - 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment - 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging - 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage - 4.3. Use description Table 3 Use 3: Disinfection of inner surfaces (cleaning in place) Product type PT04: Food and feed area Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Scientific name: bacteria Common name: bacteria Development stage: all Scientific name: yeasts Common name: yeasts Development stage: all Scientific name: fungi Common name: fungi Development stage: all Scientific name: viruses Common name: viruses Development stage: all Scientific name: bacterial spores Common name: bacterial spores Development stage: all Scientific name: bacteriophages Common name: bacteriophages Development stage: all Field(s) of use indoor use Disinfection of inner surface in food processing industries (general disinfection including meat industry and specific industries (dairy industry, slaughterhouses and brewing industries). Application method(s) Method: Cleaning in place (CIP) with or without recirculation Detailed description: Application rate(s) and frequency Application rates: Apply 0,15 l/m 2 of product to the surface Dilution (%): 0 Ready to use solution (2000 mg/l av CL (av CL)) Number and timing of application: PT4, at room temperature: For general surface disinfection including meat industry and for surface disinfection in breweries, for a contact time of 5 minutes against bacteria, yeast, fungi, virus and bacterial spores. For surface disinfection of slaughterhouses, for a contact time of 5 minutes against bacteria, yeast and virus. PT4, at temperatures of at least 10 o C and up to room temperature : For general surface disinfection including meat industry, for surface disinfection in dairy industries and slaughterhouses against bacteria and yeast for a contact of 5 minutes and against bacteriophages for dairy industry only. Frequency: After each cleaning step in the process. Category(ies) of users professional Pack sizes and packaging material Not applicable 4.3.1. Use-specific instructions for use — Dose directly into the system a 2000 mg/l av Cl solution generated by electrolysis in the system to be disinfected. Disinfection is carried out with or without recirculation — Rinse treated surfaces with drinking water after application. — Only use on pre-cleaned surfaces. Disinfection of inner surfaces is performed after each cleaning step in the process. 4.3.2. Use-specific risk mitigation measures - 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment - 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging - 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage - 5. GENERAL DIRECTIONS FOR USE ( 1 ) 5.1. Instructions for use Instructions for device supplier: Technical parameters of IGS to generate in situ AS concentration 2000 mg/l: Technical device name: ELOCUBE or ELOSYSTEM Precursor: Food grade PDV salt compliant with BS 998:1990 Precursor pH:6 - 8 Salt delivery is either by bulk salt with automated delivery or manual application of salt to form the brine Applied current density: 122,3 A/m 2 Precursor inlet flow rate was 11,2 l/min/m 2 Inlet precursor temperature: 18,6 – 19,0°C Devices are fitted with a water softener Water hardness: ≤1.0 °dH Any other relevant operating conditions: Titanium anode coated with 100 % ruthenium or a blend of ruthenium and iridium (<20%) Instructions for the end user: In case support is needed, consult the device manual of ELOCUBE/ELOSYSTEM or contact the device supplier. 5.2. Risk mitigation measures For manual mixing and loading: During the loading of the precursor, avoid contact with skin and eyes and wash hands after use. Ensure that application is carried out in well-ventilated areas. For food commodities, ensure that the concentration of chlorate present in food does not exceed the MRL values set in Regulation 2020/749. Rinse the surfaces after application of the product. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment F INHALED: If symptoms occur call a POISON CENTRE or a doctor. IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. 5.4. Instructions for safe disposal of the product and its packaging — Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains. — Dispose of unused product and all other waste, in accordance with local regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage — Store the produced in-situ product in a cool, frost-free place out of direct sunlight and below 20°C. — The in-situ product can be stored on site for a maximum of 7 days at room temperature after in situ generation. 6. OTHER INFORMATION — Inform the authorisation holder if the treatment is ineffective. — The product is stable up to 7 days when stored at room temperature in HDPE — With respect to the “Category(ies) of user(s)”: “Professionals (including industrial users)” means trained professionals if this is required by national legislation. — Full titles of the EN standard mentioned in section 4.1.2: — EN 140 - Respiratory protective devices - Half masks and quarter masks - Requirements, testing, marking — EN 143 - Respiratory protective devices - Particle filters - Requirements, testing, marking — EN 14387 - Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking — Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) OJ L 131, 5.5.1998, pp. 11 ELI: http://data.europa.eu/eli/dir/1998/24/oj — Commission Regulation (EU) 2020/749 of 4 June 2020 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorate in or on certain products OJ L 178, 8.6.2020, pp. 7 ELI: http://data.europa.eu/eli/reg/2020/749/oj ( 1 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.