Commission Implementing Regulation (EU) 2024/772 of 4 March 2024 granting a Union authorisation for the single biocidal product AEROCLEAN in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
A Union authorisation with authorisation number EU-0031391-0000 is granted to HUVEPHARMA SA for the making available on the market and use of the single biocidal product ‘AEROCLEAN’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 25 March 2024 to 28 February 2034.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX Summary of product characteristics for a biocidal product AEROCLEAN Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Product type 3 – Veterinary hygiene (Disinfectants) Product type 4 – Food and feed area (Disinfectants) Authorisation number: EU-0031391-0000 R4BP asset number: EU-0031391-0000 1. ADMINISTRATIVE INFORMATION 1.1. Trade name(s) of the product Trade name(s) AIRNAPUR EGGOA FUMICLEAN FOGAIR ASEPTOL AIR SEPTOKAIR NEBULAIR OXIR KLEANSAIR AEROCLEAN 1.2. Authorisation holder Name and address of the authorisation holder Name HUVEPHARMA SA Address 34, rue Jean Monnet ZI d’Étriché – Segré, 49500 Segré-en-Anjou Bleu France Authorisation number EU-0031391-0000 R4BP asset number EU-0031391-0000 Date of the authorisation 25 March 2024 Expiry date of the authorisation 28 February 2034 1.3. Manufacturer(s) of the product Name of manufacturer HUVEPHARMA SA Address of manufacturer 12, rue de Malacussy, 42100 Saint-Etienne France Location of manufacturing sites 12, rue de Malacussy, 42100 Saint-Etienne France 1.4. Manufacturer(s) of the active substance(s) Active substance L-(+)-lactic acid Name of manufacturer PURAC BIOCHEM Address of manufacturer Arkelseddijk 46, 4206 AC Gorinchem, P.O. Box 21, 4200 AA GORINCHEM Netherlands Location of manufacturing sites Arkelseddijk 46, 4206 AC Gorinchem, P.O. Box 21, 4200 AA GORINCHEM Netherlands Active substance L-(+)-lactic acid Name of manufacturer Jungbunzlauer SA Address of manufacturer Z.I. et Portuaire, BP 32, 67390 Mackolsheim France Location of manufacturing sites Z.I. et Portuaire, BP 32, 67390 Mackolsheim France Active substance Hydrogen peroxide Name of manufacturer ARKEMA France Address of manufacturer 420 rue d’Estienne dOrves, 92705 Colombes France Location of manufacturing sites RN85, BP1, 38560 Jarrie France 2. PRODUCT COMPOSITION AND FORMATION 2.1. Qualitative and quantitative information on the composition of the product Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 6,25 Hydrogen peroxide Active Substance 7722-84-1 231-765-0 15,0 2.2. Type of formulation SL – Soluble concentrate 3. HAZARD AND PRECAUTIONARY STATEMENTS Hazard statements Causes severe skin burns and eye damage. May be corrosive to metals. Corrosive to the respiratory tract. Precautionary statements Wear protective gloves. Wear protective clothing. Wear eye protection. Wear face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER. Immediately call a doctor. Dispose of contents to in accordance with local regulation. Dispose of container to in accordance with local regulation. Do not breathe vapours. Do not breathe spray. Wash hands thoroughly after handling. IF SWALLOWED:Rinse mouth.Do NOT induce vomiting. IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water. Specific treatment (see instructions on this label). Wash contaminated clothing before reuse. Store locked up. IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with shower. Keep only in original packaging. Immediately call a POISON CENTER. Immediately call a doctor. IF INHALED:Remove person to fresh air and keep comfortable for breathing. Absorb spillage to prevent material damage. Store in a corrosion-resistant container/container with a resistant inner liner. 4. AUTHORISED USES(S) 4.1. Use description Table 1. Use # 1 – Airborne disinfection of empty greenhouses and empty material shelters Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Common name: Bacteria Development stage: Common name: Yeasts Development stage: Common name: Enveloped viruses Development stage: Common name: Fungi Development stage: Field(s) of use Indoor Disinfection of non-porous surfaces of empty visibly clean greenhouses and empty material shelters. Application method(s) Method: Cold nebulization in large enclosures (> 4 m 3 up to 300m 3 ) Detailed description: Temperature: room temperature Minimum contact time: 1 hour Range of median droplet diameters: 7 to 30 μm Application rate(s) and frequency Application Rate: Dose of pure product to be used: • Bacteria, yeasts: 5 ml/m 3 • Enveloped viruses: 5,2 ml/m 3 • Fungi: 10 ml/m 3 Dilution (%): Before application, the product needs to be diluted in water at a concentration ranged from 25 % to 100 % v/v of pure AEROCLEAN depending on the volume to be treated. To reach the required dose (e.g. 5 ml pure product/m 3 for bacteria and yeasts), the 'application rate of the diluted product has to be adapted according to the dilution factor (e.g. for a solution of 25 %v/v AEROCLEAN, 20 ml of diluted product/m 3 have to be applied against bacteria and yeast). Biological validation shall be performed for each room to be disinfected (or in a suitable "standard" room in a facility, if applicable) with the devices to be used after which a protocol for disinfection of these rooms can be made and used thereafter. Number and timing of application: One application to be done at each sanitation period of empty buildings. Category(ies) of users Professional Pack sizes and packaging material HDPE (High Density Polyethylene) can of 1 litre with degassing cap HDPE can of 5 litres with degassing cap HDPE can of 20 litres with degassing cap HDPE drum of 200 litres with degassing cap 4.1.1. Use-specific instructions for use The product shall only be used on visually clean surfaces when applied in greenhouses. The contact time starts when the required total volume of pure product (see application rate) is nebulized. Apply only on non-porous surfaces. As an example, the product has been demonstrated as efficacious against fungi (via efficacy studies performed according to the EN17272 standard) with a flow rate of 293,3 ml/minute (i.e. 17,6 litre/hour) and at 38,8 ml diluted product (at 25 % v/v) per cubic meter of room volume at room temperature. 4.1.2. Use-specific risk mitigation measures — 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 – Airborne disinfection of empty eggs storage rooms (not intended for human consumption) Product type PT03 – Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Common name: Yeasts Development stage: Common name: Bacteria Development stage: Common name: Fungi Development stage: Common name: Viruses Development stage: Field(s) of use Indoor Disinfection of non-porous surfaces of empty eggs storage rooms (not intended for human consumption) Application method(s) Method: Cold nebulization in large enclosure (> 4 m 3 up to 150m 3 ) Detailed description: Minimum contact time: 1 hour Temperature: room temperature Range of median droplet diameters: 7 to 30 μm Application rate(s) and frequency Application Rate: Dose of pure product to be used: Bacteria, yeasts, fungi, viruses: 13,2 ml/m 3 Dilution (%): Before application, the product needs to be diluted in water at a concentration of 33 % v/v of pure AEROCLEAN in order to apply 40 ml of diluted product/m 3 . Biological validation shall be performed for each room to be disinfected (or in a suitable "standard" room in a facility, if applicable) with the devices to be used after which a protocol for disinfection of these rooms can be made and used thereafter. Number and timing of application: Repeat before each new egg arrival in the room. Category(ies) of users Professional Pack sizes and packaging material HDPE can of 1 litre with degassing cap HDPE can of 5 litres with degassing cap HDPE can of 20 litres with degassing cap HDPE drum of 200 litres with degassing cap 4.2.1. Use-specific instructions for use Apply only on non-porous surfaces. The product is not intended to disinfect eggs. Treatment only in absence of eggs. The contact time starts when the required total volume of pure product (see application rate) is nebulized. As an example, the product has been demonstrated as efficacious against fungi (via efficacy studies performed according to the EN17272 standard) with a flow rate of 298,8 ml/minute (i.e. 17,93 litre/hour) and at 40 ml diluted product (at 33 % v/v) per cubic meter of room volume at room temperature. 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 – Airborne disinfection of empty buildings (livestock buildings, veterinary clinic and adjoining animal rooms) and materials Product type PT03 – Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Common name: Yeasts Development stage: Common name: Fungi Development stage: Common name: Bacteria Development stage: Common name: Viruses Development stage: Field(s) of use Indoor Disinfection of non-porous surfaces of empty buildings (livestock buildings, veterinary clinic, adjoining animal rooms) and materials. Application method(s) Method: Cold nebulization in large enclosures (> 4 m 3 up to 300m 3 ) Detailed description: Minimum contact time: 1 hour Temperature: room temperature Range of median droplet diameters: 7 to 30 μm Application rate(s) and frequency Application Rate: Dose of pure product to be used: • Bacteria and yeasts: 5 ml/m 3 • Viruses: 5,2 ml/m 3 • Fungi: 10 ml/m 3 Dilution (%): Before application, the product needs to be diluted in water at a concentration ranged from 25 % to 100 % v/v of pure AEROCLEAN depending on the volume to be treated. To reach the required dose (e.g. 5 ml pure product/m 3 for bacteria and yeasts) the application rate of the diluted product has to be adapted according to the dilution factor (e.g. for a solution of 25 % v/v AEROCLEAN, 20 ml diluted product/m 3 have to be applied against bacteria and yeast). Biological validation shall be performed for each room to be disinfected (or in a suitable "standard" room in a facility, if applicable) with the devices to be used after which a protocol for disinfection of these rooms can be made and used thereafter. Number and timing of application: One application to be done at each sanitation period of empty buildings. Category(ies) of users Professional Pack sizes and packaging material HDPE can of 1 litre with degassing cap HDPE can of 5 litres with degassing cap HDPE can of 20 litres with degassing cap HDPE drum of 200 litres with degassing cap 4.3.1. Use-specific instructions for use Apply only on non-porous surfaces. Clean surfaces before disinfection. The contact time starts when the required total volume of pure product (see application rate) is nebulized. As an example, the product has been demonstrated as efficacious against fungi (via efficacy studies performed according to the EN17272 standard) with a flow rate of 293,3 ml/minute (i.e. 17,07 litre/hour) and at 40 ml diluted product (at 25 % v/v) per cubic meter of room volume at room temperature. Treatment only use in empty animal housing. 4.3.2. Use-specific risk mitigation measures Re-entry is only permitted for animals once the hydrogen peroxide air concentration has dropped below 0,9 ppm (1,25 mg/m 3 ) or the corresponding national reference value. 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 — 4.4. Use description Table 4. Use # 4 – Airborne disinfection of empty buildings and materials on surfaces in contact with food or feed Product type PT04 – Food and feed area (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Common name: Bacteria Development stage: Common name: Yeasts Development stage: Common name: Fungi Development stage: Common name: Enveloped viruses Development stage: Field(s) of use Indoor Disinfection of non-porous surfaces of empty buildings and materials in feed or food industries Application method(s) Method: Cold nebulization in large enclosures (> 4 m 3 up to 300m 3 ) Detailed description: Minimum contact time: 1 hour Temperature: room temperature Range of median droplet diameters: 7 to 30 μm Application rate(s) and frequency Application Rate: Dose of pure product to be used: • Bacteria, yeasts: 5 ml/m 3 • Enveloped viruses: 5,2 ml/m 3 •Fungi: 10 ml/m 3 Dilution (%): Before application, the product needs to be diluted in water at a concentration ranged from 25 % to 100 % v/v of pure AEROCLEAN depending on the volume to be treated. To reach the required dose (e.g. 5 ml pure product/m 3 for bacteria and yeasts) the application rate of the diluted product has to be adapted according to the dilution factor (e.g. for a solution of 25 % v/v AEROCLEAN, 20 ml diluted product/m 3 have to be applied against bacteria and yeast). Biological validation shall be performed for each room to be disinfected (or in a suitable "standard" room in a facility, if applicable) with the devices to be used after which a protocol for disinfection of these rooms can be made and used thereafter. Number and timing of application: One application to be done at each sanitation period of empty buildings. Category(ies) of users Professional Pack sizes and packaging material HDPE can of 1 litre with degassing cap HDPE can of 5 litres with degassing cap HDPE can of 20 litres with degassing cap HDPE drum of 200 litres with degassing cap 4.4.1. Use-specific instructions for use Apply only on non-porous urfaes. The contact time starts when the required total volume of pure product (see application rate) is nebulized. As an example, the product has been demonstrated as efficacious against fungi (via efficacy studies performed according to the EN17272 standard) with a flow rate of 293,3 ml/minute (i.e. 17,6 litre/hour) and at 38,8 ml diluted product (at 25 % v/v) per cubic meter of room volume at room temperature. 4.4.2. Use-specific risk mitigation measures — 4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment — 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging — 4.4.5. 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 Follow the instructions of the equipment suppliers to obtain a sufficient diffusion time. The users shall inform and report to the authorisation holder immediately if the treatment is ineffective. The product has been demonstrated as efficacious (via efficacy studies performed according to the EN17272 standard) with a flow rate of 268,3 to 340 ml/minute (i.e. 16,1-20,4 litre/hour). Biological validation shall be performed for each room to be disinfected (or in a suitable "standard" room in a facility, if applicable) with the devices to be used after which a protocol for disinfection of these rooms can be made and used thereafter. 5.2. Risk mitigation measures To apply the product, use only automated nebulizer. Seal the treatment enclosure (e.g. with tape) to ensure that hydrogen peroxide levels outside the enclosure are kept at acceptable levels (below 0,9 ppm (1,25 mg/m 3 ) or the corresponding national reference value). During mixing and loading and cleaning of the device, the user shall wear gloves consistent with European Standard EN ISO 374 or equivalent, coverall consistent with at least category III type 4, EN 14605 or equivalent and goggles consistent with European Standard EN ISO 16321 or equivalent. During the nebulization (treatment time), contact time (one hour) and during ventilation time, no person (operator, by-stander etc.) is allowed to be present within the treated area. After nebulisation and contact time, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period shall be established by measurement with suitable measurement equipment. Re-entry is only permitted once the hydrogen peroxide air concentration has dropped below 0,9ppm (1,25 mg/m 3 ) or the corresponding national reference value. Use a calibrated sensor to confirm the hydrogen peroxide air concentration is below 0,9 ppm (1,25 mg/m 3 ) or below the corresponding national reference value prior to re-entry. The professional user may only enter the room in emergency situations or to reactivate the ventilation wearing respiratory protective equipment (RPE)with assigned protection factor (APF) 40 against vapour consitent with EN 14387 or equivalent (Type of RPE to be specified by the authorisation holder within the product information). The re-entry with the RPE in emergency situations or to reactivate the ventilation is therefore only allowed when the hydrogen peroxide level has dropped below 36 ppm (50 mg/m 3 ) or below 40 times the corresponding national reference value. Do not touch surfaces until they are dry. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. In case of impaired consciousness place in recovery position and seek medical advice immediately. 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, its packaging 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 Protect from direct sunlight Do not store above 25 °C Shelf life: 17 months 6. OTHER INFORMATION Foaming product: Do not agitate during mixing and loading to avoid foaming. Full titles of EN standards and legislation referred to in section 5.2: EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms. EN 14605 – Protective clothing against liquid chemicals – Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]) EN ISO 16321 – Eye and face protection for occupational use EN 14387 – Respiratory protective devices – Gas filter(s) and combined filter(s) – Requirements, testing, marking ( 1 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
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