Commission Implementing Regulation (EU) 2026/2028 of 10 September 2026 granting a Union authorisation for the single biocidal product ELOCLEAR in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Official Journal EN of the European Union L series 2026/2028 11.9.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/2028 of 10 September 2026 granting a Union authorisation for the single biocidal product ‘ELOCLEAR’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products(1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:

(1) On 29 June 2022, Arrow Regulatory (Ireland) Ltd submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a single biocidal product named ELOCLEAR of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-HD078032-58 in the Register for Biocidal Products.

(2) ELOCLEAR contains active chlorine generated from sodium chloride by electrolysis as the active substance included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.

(3) On 11 March 2025, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation

(EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

(4) On 2 October 2025, the Agency submitted to the Commission its opinion(2), the draft summary of the product characteristics (‘SPC’) of ELOCLEAR and the final assessment report on the single biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that ELOCLEAR is a single biocidal product within the meaning of Article 3(1), point (r), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft summary of the SPC, it meets the conditions laid down in Article 19(1) of that Regulation.

(6) On 20 October 2025, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the single biocidal product ‘ELOCLEAR’.

(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2) ECHA opinion of 10 September 2025 on the Union authorisation of the single biocidal product ELOCLEAR (ECHA/BPC/492/2025),

https://echa.europa.eu/opinions-on-union-authorisation.

ELI: http://data.europa.eu/eli/reg_impl/2026/2028/oj 1/12EN OJ L, 11.9.2026

(8) In its opinion, the Agency identified data gap on the analytical method used for the analysis of the active substance in the product and recommends that the authorisation holder provides recovery data for the analytical method for the active substance or a justification for waiving such data, as a condition in the authorisation. The Commission agrees with that recommendation and considers that the authorisation holder should determine the accuracy of the proposed method by providing recovery data on the active substance, or a justification waiving such data, as a condition relating to the making available on the market and use of the biocidal product pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point

(d), of that Regulation based on existing data.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1 A Union authorisation with authorisation number EU-0035839-0000 is hereby granted to Arrow Regulatory (Ireland) Ltd for the making available on the market and use of the single biocidal product ‘ELOCLEAR’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the product characteristics set out in Annex II.

The Union authorisation is valid from 1 October 2026 until 30 September 2036.

Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 10 September 2026.

For the Commission The President Ursula VON DER LEYEN 2/12 ELI: http://data.europa.eu/eli/reg_impl/2026/2028/ojEN OJ L, 11.9.2026 ANNEX I Terms and conditions (EU-0035839-0000) By 1 April 2027 the authorisation holder shall submit to the Agency recovery data for the analytical method used for the analysis of the active substance in the product, or a justification for waiving such data, to demonstrate the accuracy of the method.

ELI: http://data.europa.eu/eli/reg_impl/2026/2028/oj 3/12EN OJ L, 11.9.2026 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 4/12 ELI: http://data.europa.eu/eli/reg_impl/2026/2028/ojEN OJ L, 11.9.2026

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 Active 0,2 % (w/w) generated from substance sodium chloride by electrolysis

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 Scientific name: bacteria stage) 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

ELI: http://data.europa.eu/eli/reg_impl/2026/2028/oj 5/12EN OJ L, 11.9.2026 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/m2of 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 10oC 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 10oC 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.

6/12 ELI: http://data.europa.eu/eli/reg_impl/2026/2028/ojEN OJ L, 11.9.2026

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/m3or 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 Scientific name: bacteria stage) 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

ELI: http://data.europa.eu/eli/reg_impl/2026/2028/oj 7/12EN OJ L, 11.9.2026 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/m2of 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 10oC 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 10oC 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 - 8/12 ELI: http://data.europa.eu/eli/reg_impl/2026/2028/ojEN OJ L, 11.9.2026

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 Scientific name: bacteria stage) 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/m2of 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.

ELI: http://data.europa.eu/eli/reg_impl/2026/2028/oj 9/12EN OJ L, 11.9.2026 PT4, at temperatures of at least 10oC 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/m2

(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.

10/12 ELI: http://data.europa.eu/eli/reg_impl/2026/2028/ojEN OJ L, 11.9.2026 Precursor inlet flow rate was 11,2 l/min/m2

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.

ELI: http://data.europa.eu/eli/reg_impl/2026/2028/oj 11/12EN OJ L, 11.9.2026 — 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 12/12 ELI: http://data.europa.eu/eli/reg_impl/2026/2028/oj