Commission Implementing Regulation (EU) 2024/2587 of 2 October 2024 granting a Union authorisation for the biocidal product family Divosan PAA products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Name | Divosan PAA products |
Product type(s) |
Name and address of the authorisation holder | Name | Diversey Europe Operations B.V. |
Address | ||
Authorisation number | EU-0032463-0000 | |
EU-0032463-0000 | ||
Date of the authorisation | ||
Expiry date of the authorisation |
Name of manufacturer | Airedale Chemical Company Ltd |
Address of manufacturer | |
Location of manufacturing sites |
Name of manufacturer | Diversey Europe Operations B.V. |
Address of manufacturer | |
Location of manufacturing sites |
Active substance | Peracetic acid |
Name of manufacturer | Airedale Chemical Company Ltd |
Address of manufacturer | |
Location of manufacturing sites |
Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
---|---|---|---|---|---|
Peracetic acid | active substance | 79-21-0 | 201-186-8 | ||
Hydrogen peroxide | Hydrogen Peroxide | Non-Active substance | 7722-84-1 | 231-765-0 | |
Acetic Acid | Acetic Acid | Non-Active substance | 64-19-7 | 200-580-7 | |
HEDP | etidronic acid | Non-Active substance | 2809-21-4 | 220-552-8 |
Formulation type(s) | SL Soluble concentrate |
Identifier | Meta SPC: Peracetic Acid 5% |
Number | 1-1 |
Product type(s) |
Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
---|---|---|---|---|---|
Peracetic acid | active substance | 79-21-0 | 201-186-8 | ||
Hydrogen peroxide | Hydrogen Peroxide | Non-Active substance | 7722-84-1 | 231-765-0 | |
Acetic Acid | Acetic Acid | Non-Active substance | 64-19-7 | 200-580-7 | |
HEDP | etidronic acid | Non-Active substance | 2809-21-4 | 220-552-8 |
Formulation type(s) | SL Soluble concentrate |
Hazard statements | |
Precautionary statements |
Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
Product type | PT03: Veterinary hygiene |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
Product type | PT03: Veterinary hygiene |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
Product type | PT04: Food and feed area |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
Product type | PT04: Food and feed area |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
Product type | PT04: Food and feed area |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
the surfaces to be disinfected must be cleaned before the disinfection procedure, and the user must thoroughly clean, rinse and drain the cleaning liquids from the surfaces to be disinfected; products must be diluted in potable water before use.
Disinfection procedures by CIP: final rinsing step (with potable water).
Disinfection procedures by dipping: the solution shall not be re-used.
Disinfection procedures by spraying: wet the surface completely
(application rate > 20 ml/m 2 but maximum 100ml/m2 ) in order to keep the surface wet during the required contact time.do not use equipment until product is completely absorbed to the surface or air dried.
do not use equipment and surfaces or allow animals/poultry to enter the treated area until product is completely absorbed to the surface or air dried. the products shall not be used for the disinfection of animal transport vehicles.
Wear chemical goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, and chemical resistant gloves classified under European Standard EN 374 or equivalent. Goggles, protective clothing and glove material (preferably butyl rubber) to be specified by the authorisation holder within the product information. 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 titles of the EN standards and legislation. Use with adequate ventilation: Use engineering controls to maintain airborne level below exposure limit requirements or guidelines. Atmospheric levels shall be maintained below the exposure guideline. For all wiping and spraying application, a ventilation rate of at least 10 air changes/hour is required in the rooms where the application takes place. When respiratory protection is required (that is when the concentration of PAA and/or hydrogen peroxide are above their respective Acute Exposure Concentration (AEC)inhalation (0,5 mg/m3 and 1,25 mg/m3 respectively), use an approved air-purifying or positive-pressure supplied-air respirator depending on the potential airborne concentration. Do not use equipment and surfaces or allow animals/poultry to enter the treated area until product is completely absorbed to the surface or air dried. Keep out of reach of children and non-target animals and pets. Re-entrance into treated area is only allowed once the levels of peracetic acid and hydrogen peroxide in the air are below the AEC inhalation (respectively 0,5 mg/m3 for PAA & 1,25 mg/m3 for hydrogen peroxide) No bystanders are allowed in treated area during the application phase. Animals shall be removed before treatment takes place.
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 ON SKIN: Immediately wash skin with plenty of water. Take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. After washing the skin: Call 112/ambulance for medical assistance. Information to healthcare personnel/doctor: Initiate life support measures, thereafter call a POISON CENTRE 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. Information to healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Immediately call 112/ambulance for medical assistance. Information to healthcare personnel/doctor: Immediately initiate life support measures, thereafter call a POISON CENTRE. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
This biocidal product, when being disposed of in its unused and uncontaminated state, should be treated as a hazardous waste in accordance with Directive 2008/98/EC. Any disposal practices must be in compliance with all national and provincial laws and any municipal or local by-laws governing hazardous waste. Do not dump into any sewers, on the ground, or into any body of water. Avoid release to the environment. High-temperature incineration is an acceptable practice. Containers are non-refillable. Do not reuse or refill the containers. Containers should be triple or pressure rinsed with water promptly after they are emptied. They can then be offered for recycling or reconditioning for biocidal products, or they can be punctured and disposed of in a sanitary landfill or by other procedures approved by national and local authorities. Send waste liquid from rinsing of used containers to an approved waste handling facility.
Store between 0 °C and 30 °C Store in dark conditions Keep in a well-ventilated place. Keep this product in the original container when not in use. Container must be stored and transported in an upright position to prevent spilling the contents through the vent, where fitted. Do not store in and avoid contact with aluminium, carbon steel, copper, mild steel, iron. Avoid contact with amines, ammonia, strong acids, strong bases, strong oxidizers. Shelf-life: Meta-SPC 2 (5 % PAA): 6 months
Trade name(s) | Divosan Noble VT100 | Market area: EU | |||||
Authorisation number | EU-0032463-0001 1-1 | ||||||
Common name | IUPAC name | Function | CAS number | EC number | Content (%) | ||
Peracetic acid | active substance | 79-21-0 | 201-186-8 | 5 % (w/w) | |||
Hydrogen peroxide | Hydrogen Peroxide | Non-Active substance | 7722-84-1 | 231-765-0 | 23,513 % (w/w) | ||
Acetic Acid | Acetic Acid | Non-Active substance | 64-19-7 | 200-580-7 | 8,453 % (w/w) | ||
HEDP | etidronic acid | Non-Active substance | 2809-21-4 | 220-552-8 | 0,99 % (w/w) |
Identifier | Meta SPC: Peracetic Acid 15 % |
Number | 1-2 |
Product type(s) |
Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
---|---|---|---|---|---|
Peracetic acid | active substance | 79-21-0 | 201-186-8 | ||
Hydrogen peroxide | Hydrogen Peroxide | Non-Active substance | 7722-84-1 | 231-765-0 | |
Acetic Acid | Acetic Acid | Non-Active substance | 64-19-7 | 200-580-7 | |
HEDP | etidronic acid | Non-Active substance | 2809-21-4 | 220-552-8 |
Formulation type(s) | SL Soluble concentrate |
Hazard statements | |
Precautionary statements |
Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
Product type | PT03: Veterinary hygiene |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
Product type | PT03: Veterinary hygiene |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
Product type | PT04: Food and feed area |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
Product type | PT04: Food and feed area |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
Product type | PT04: Food and feed area |
Where relevant, an exact description of the authorised use | - |
Target organism(s) (including development stage) | |
Field(s) of use | |
Application method(s) | |
Application rate(s) and frequency | |
Category(ies) of users | industrial ; professional |
Pack sizes and packaging material |
the surfaces to be disinfected must be cleaned before the disinfection procedure, and the user must thoroughly clean, rinse and drain the cleaning liquids from the surfaces to be disinfected; products must be diluted in potable water before use.
Disinfection procedures by CIP: final rinsing step (with potable water).
Disinfection procedures by dipping: the solution shall not be re-used.
Disinfection procedures by spraying: wet the surface completely (application rate > 20 ml/m 2 but maximum 100ml/m2 ) in order to keep the surface wet during the required contact time.do not use equipment until product is completely absorbed to the surface or air dried.
do not use equipment and surfaces or allow animals/poultry to enter the treated area until product is completely absorbed to the surface or air dried. the products shall not be used for the disinfection of animal transport vehicles.
Wear chemical goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, and chemical resistant gloves classified under European Standard EN 374 or equivalent. Goggles, protective clothing and glove material (preferably butyl rubber) to be specified by the authorisation holder within the product information. 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 titles of the EN standards and legislation. Use with adequate ventilation: Use engineering controls to maintain airborne level below exposure limit requirements or guidelines. Atmospheric levels shall be maintained below the exposure guideline. For all wiping and spraying application, a ventilation rate of at least 10 air changes/hour is required in the rooms where the application takes place. When respiratory protection is required (that is when the concentration of PAA and/or hydrogen peroxide are above their respective Acute Exposure Concentration (AEC)inhalation (0,5 mg/m3 and 1,25 mg/m3 respectively), use an approved air-purifying or positive-pressure supplied-air respirator depending on the potential airborne concentration. Do not use equipment and surfaces or allow animals/poultry to enter the treated area until product is completely absorbed to the surface or air dried. Keep out of reach of children and non-target animals and pets. Re-entrance into treated area is only allowed once the levels of peracetic acid and hydrogen peroxide in the air are below the AEC inhalation (respectively 0,5 mg/m3 for PAA & 1,25 mg/m3 for hydrogen peroxide) No bystanders are allowed in treated area during the application phase. Animals shall be removed before treatment takes place.
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 ON SKIN: Immediately wash skin with plenty of water. Take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. After washing the skin: Call 112/ambulance for medical assistance. Information to healthcare personnel/doctor: Initiate life support measures, thereafter call a POISON CENTRE 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. Information to healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid. IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Immediately call 112/ambulance for medical assistance. Information to healthcare personnel/doctor: Immediately initiate life support measures, thereafter call a POISON CENTRE. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
This biocidal product, when being disposed of in its unused and uncontaminated state, should be treated as a hazardous waste in accordance with Directive 2008/98/EC. Any disposal practices must be in compliance with all national and provincial laws and any municipal or local by-laws governing hazardous waste. Do not dump into any sewers, on the ground, or into any body of water. Avoid release to the environment. High-temperature incineration is an acceptable practice. Containers are non-refillable. Do not reuse or refill the containers. Containers should be triple or pressure rinsed with water promptly after they are emptied. They can then be offered for recycling or reconditioning for biocidal products, or they can be punctured and disposed of in a sanitary landfill or by other procedures approved by national and local authorities. Send waste liquid from rinsing of used containers to an approved waste handling facility.
Store between 0 °C and 30 °C Store in dark conditions Keep in a well-ventilated place. Keep this product in the original container when not in use. Container must be stored and transported in an upright position to prevent spilling the contents through the vent, where fitted. Do not store in and avoid contact with aluminium, carbon steel, copper, mild steel, iron. Avoid contact with amines, ammonia, strong acids, strong bases, strong oxidizers. Shelf-life: Meta-SPC 3 (15 % PAA): 12 months
Trade name(s) | Divosan Splendid VT99 | Market area: EU | |||||
Authorisation number | EU-0032463-0002 1-2 | ||||||
Common name | IUPAC name | Function | CAS number | EC number | Content (%) | ||
Peracetic acid | active substance | 79-21-0 | 201-186-8 | 15 % (w/w) | |||
Hydrogen peroxide | Hydrogen Peroxide | Non-Active substance | 7722-84-1 | 231-765-0 | 25,109 % (w/w) | ||
Acetic Acid | Acetic Acid | Non-Active substance | 64-19-7 | 200-580-7 | 15,07 % (w/w) | ||
HEDP | etidronic acid | Non-Active substance | 2809-21-4 | 220-552-8 | 0,99 % (w/w) |