Commission Implementing Regulation (EU) 2025/2221 of 31 October 2025 amending Implementing Regulation (EU) 2023/364 as regards administrative changes to the Union authorisation of the biocidal product family IPA Family 1

ANNEXSummary of product characteristics for a biocidal product family
ANNEX
Summary of product characteristics for a biocidal product family
IPA Family 1
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
Authorisation number EU-0028425-0000
R4BP asset number EU-0028425-0000
PART I
FIRST INFORMATION LEVEL
1.    ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
IPA Family 1
1.2.    Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
Ecolab Deutschland GmbH
Address
Ecolab Allee 1 40789 Monheim am Rhein Germany
Authorisation number
EU-0028425-0000
R4BP asset number
EU-0028425-0000
Date of the authorisation
9.3.2023
Expiry date of the authorisation
28.2.2033
1.4.    Manufacturer(s) of the product
Name of manufacturer
Ecolab Europe GmbH
Address of manufacturer
Richtistrasse, 7 8304 Walliselen Switzerland
Location of manufacturing sites
Ecolab Europe GmbH site 1 Richtistrasse, 7 8304 Walliselen Switzerland
Name of manufacturer
Ecolab Limited
Address of manufacturer
Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
Ecolab Limited site 1 Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom of Great Britain and Northern Ireland (the)
Name of manufacturer
Ecolab Leeds
Address of manufacturer
Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
Ecolab Leeds site 1 Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)
Name of manufacturer
Esoform S.p.A.
Address of manufacturer
Viale del Lavoro 10, 45100 Rovigo Italy
Location of manufacturing sites
Esoform S.p.A. site 1 Viale del Lavoro 10, 45100 Rovigo Italy
Name of manufacturer
Nalco Deutschland Manufacturing GmbH und Co.KG
Address of manufacturer
Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany
Location of manufacturing sites
Nalco Deutschland Manufacturing GmbH und Co.KG site 1 Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany
Name of manufacturer
Ecolab NETHERLANDS BV
Address of manufacturer
Brugwal 11, 3432NZ Nieuwegein Netherlands (the)
Location of manufacturing sites
Ecolab NETHERLANDS BV site 1 Brugwal 11, 3432NZ Nieuwegein Netherlands (the)
Name of manufacturer
Ecolab Weavergate
Address of manufacturer
Winnington Avenue CW8 3AA Northwich Cheshire United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
Ecolab Weavergate site 1 Winnington Avenue CW8 3AA Northwich Cheshire United Kingdom of Great Britain and Northern Ireland (the)
Name of manufacturer
Ecolab Mullingar, Ireland
Address of manufacturer
Forest Park, Zone C Mullingar Ind. Estate, - Mullingar, Co. Westmeath, Ireland
Location of manufacturing sites
Ecolab Mullingar, Ireland site 1 Forest Park, Zone C Mullingar Ind. Estate, - Mullingar, Co. Westmeath, Ireland
Name of manufacturer
Ecolab d.o.o.
Address of manufacturer
Vajngerlova 4 2000 Maribor Slovenia
Location of manufacturing sites
Ecolab d.o.o. site 1 Vajngerlova 4 2000 Maribor Slovenia
Name of manufacturer
Ecolab Rozzano, Italy
Address of manufacturer
Via A. Grandi 9/11, 20089 Rozzano (MI) Italy
Location of manufacturing sites
Ecolab Rozzano, Italy site 1 Via A. Grandi 9/11, 20089 Rozzano (MI) Italy
Name of manufacturer
Ecolab B.V.B.A
Address of manufacturer
Havenlaan 4 3980 Tessenderlo Belgium
Location of manufacturing sites
Ecolab B.V.B.A site 1 Havenlaan 4 3980 Tessenderlo Belgium
Name of manufacturer
Nalco Española Manufacturing, SLU
Address of manufacturer
C/Tramuntana s/n Polígono Industrial de Celrà 17460 Celrà Spain
Location of manufacturing sites
Nalco Española Manufacturing, SLU site 1 C/Tramuntana s/n Polígono Industrial de Celrà 17460 Celrà Spain
Name of manufacturer
Ecolab production France SAS
Address of manufacturer
BP509, Avenue de Général Patton 51006 Châlons-en-Champagne France
Location of manufacturing sites
Ecolab production France SAS site 1 BP509, Avenue de Général Patton 51006 Châlons-en-Champagne France
Name of manufacturer
Ecolab Mandra, Greece
Address of manufacturer
25km Old National Road Athens- Theve, - Mandra Attica Greece
Location of manufacturing sites
Ecolab Mandra, Greece site 1 25km Old National Road Athens- Theve, - Mandra Attica Greece
Name of manufacturer
NALCO FINLAND MANUFACTURING OY
Address of manufacturer
Kivikummuntie 1, FIN-07955 Tesjoki Finland
Location of manufacturing sites
NALCO FINLAND MANUFACTURING OY site 1 Kivikummuntie 1, FIN-07955 Tesjoki Finland
Name of manufacturer
Manufacturing Plant Cisterna Nalco
Address of manufacturer
Via Ninfina II 4012 Cisterna Di Latina, Italy
Location of manufacturing sites
Manufacturing Plant Cisterna Nalco site 1 Via Ninfina II 4012 Cisterna Di Latina Italy
Name of manufacturer
Manufacturing Plant Fawley Nalco
Address of manufacturer
One buisness center 1180 SO45 3NP Hardley Hants United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
Manufacturing Plant Fawley Nalco site 1 One buisness center 1180 SO45 3NP Hardley Hants United Kingdom of Great Britain and Northern Ireland (the)
Name of manufacturer
Nalco Champion Plant, Tooling Plant, Aberdeen Nalco
Address of manufacturer
Minto Avenue, Alten Industrial Estate AB12 3JZ Aberdeen United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
Nalco Champion Plant, Tooling Plant, Aberdeen Nalco site 1 Minto Avenue, Alten Industrial Estate AB12 3JZ Aberdeen United Kingdom of Great Britain and Northern Ireland (the)
Name of manufacturer
Microtek Medical B.V.
Address of manufacturer
Hekkehorst, 24 7207 BN Zutphen Netherlands (the)
Location of manufacturing sites
Microtek Medical B.V. site 1 Hekkehorst, 24 7207 BN Zutphen Netherlands (the)
Name of manufacturer
Microtek Medical Malta Ltd.
Address of manufacturer
Sorbonne Centre F20 Mosta Technopark MST 3000 Mosta Malta
Location of manufacturing sites
Microtek Medical Malta Ltd. site 1 Sorbonne Centre F20 Mosta Technopark MST 3000 Mosta Malta
Name of manufacturer
Innovate GmbH
Address of manufacturer
Am Hohen Stein, 11 06618 Naumburg Germany
Location of manufacturing sites
Innovate GmbH site 1 Am Hohen Stein, 11 06618 Naumburg Germany
Name of manufacturer
CHRISTEYNS FRANCE S.A.
Address of manufacturer
31 rue de la Maladrie 44120 Vertou France
Location of manufacturing sites
CHRISTEYNS FRANCE S.A. site 1 54 avenue de la Plaine - ZI 13106 Rousset France
Name of manufacturer
Techtex
Address of manufacturer
Units 7 &amp; 8, Rhodes Business Park, Silbum Way M24 4NE Middelton, Manchester United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
Techtex site 1 Units 7 & 8, Rhodes Business Park, Silbum Way M24 4NE Middelton, Manchester United Kingdom of Great Britain and Northern Ireland (the)
Name of manufacturer
Technical Textile Services Ltd
Address of manufacturer
Unit 4, Rhodes Business Park, Silburn Way M24 4NE Middleton, Manchester United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
Technical Textile Services Ltd Unit 4, Rhodes Business Park, Silburn Way M24 4NE Middleton, Manchester United Kingdom of Great Britain and Northern Ireland (the)
Name of manufacturer
Pal International Limited
Address of manufacturer
Unit 3 Mountpark, Victoria Road LE67 1FA Ellistown, Coalville United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
Pal International Limited Unit 3 Mountpark, Victoria Road LE67 1FA Ellistown, Coalville United Kingdom of Great Britain and Northern Ireland (the)
Name of manufacturer
CID LINES NV
Address of manufacturer
Waterpoortstraat 2 8900 Ieper Belgium
Location of manufacturing sites
CID LINES NV Waterpoortstraat 2 8900 Ieper Belgium
Name of manufacturer
LABORATOIRES ANIOS
Address of manufacturer
3330 Rue de Lille 59262 Sainghin-en-Mélantois France
Location of manufacturing sites
LABORATOIRES ANIOS 3330 Rue de Lille 59262 Sainghin-en-Mélantois France
1.5.    Manufacturer(s) of the active substance(s)
Active substance
Propan-2-ol
Name of manufacturer
Ineos Solvents Germany GmbH
Address of manufacturer
Römerstrasse 733, D-47443 Moers Germany
Location of manufacturing sites
Ineos Solvents Germany GmbH site 1 Shamrockstrasse 88 D-44623 Herne Germany
Ineos Solvents Germany GmbH site 2 Romestrasse, 733, D-47443 Moers Germany
Active substance
Propan-2-ol
Name of manufacturer
Shell Chemicals Europe B.V.
Address of manufacturer
Postbus 2334 3000 CH Rotterdam Netherlands (the)
Location of manufacturing sites
Shell Chemicals Europe B.V. site 1 Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis, Netherlands (the)
Active substance
Propan-2-ol
Name of manufacturer
ExxonMobil Chemical Europe
Address of manufacturer
Hermeslaan 2 1831 Machelen Belgium
Location of manufacturing sites
ExxonMobil Chemical Europe site 1 Fawley Refinery and Petrochemical Plant, Fawley SO45 1TX Southampton United Kingdom of Great Britain and Northern Ireland (the)
ExxonMobil Chemical Europe site 2 Baton Rouge Chemical Plant 4999 Scenic Highway 70805-3359 LA United States (the)
Active substance
Propan-2-ol
Name of manufacturer
Brenntag N.V.
Address of manufacturer
Nijverheidslaan, 38 8540 Deerlijk Belgium
Location of manufacturing sites
Shell Energy and Chemicals Park Rotterdam Shell Nederland Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the)
ExxonMobil Baton Rouge Refinery 4045 Scenic Highway Baton Rouge 70805 LA United States (the)
Active substance
Propan-2-ol
Name of manufacturer
UNIVAR
Address of manufacturer
Steuber Drive M44 5AL Manchester United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
ExxonMobil Chemicals Fawley Refinery and Petrochemical Plant, Fawley SO45 1TX Southampton United Kingdom of Great Britain and Northern Ireland (the)
2.    PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1.    Qualitative and quantitative information on the composition of the family
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
30,3 - 65,66 % (w/w)
2.2.    Type(s) of formulation
Formulation type(s)
AE Aerosol dispenser
AL Any other liquid
XX – Ready to use wipe impregnated with water based liquid
PART II
SECOND INFORMATION LEVEL META SPC(S)
1.    META SPC 1 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 1 identifier
Identifier
Meta SPC: Meta-SPC 1.1
1.2.    Suffix to the authorisation number
Number
1-1
1.3.    Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
2.    META SPC 1 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
60,61 - 65,66 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 1
Formulation type(s)
AL Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P280: Wear eye protection.
P280: Wear face protection.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 1.1 – Disinfection of surfaces in cleanrooms by spraying or mopping.
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)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: fungi
Development stage: no data
Scientific name: no data
Common name: Enveloped viruses
Development stage: no data
Field(s) of use
indoor use
Disinfection of cleanroom hard non-porous surfaces in life sciences industry.
Application method(s)
Method: Trigger spraying or mopping
Detailed description:
Direct application onto surfaces by trigger spraying followed by wiping with a dry wipe for distribution or mopping.
Application rate(s) and frequency
Application Rate:
c.a. 18 ml/m 2
ready to use product
Number and timing of application:
As required
Category(ies) of users
professional
Pack sizes and packaging material
0,5 liter - 10 liters Polyvinylpyrrolidone (PVP) or (High density polyetheylene (HDPE) bottle / container (with and without trigger spray)
4.1.1.    Use-specific instructions for use
Clean and dry surfaces prior to disinfection.
Application by trigger spraying directly onto the surface: Open the nozzle before use. For optimum results hold bottle upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (18 ml/m 2 , corresponding to 20 strokes/m 2 ) followed by wiping with a dry wipe for distribution. Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. Always close the nozzle after use. Do not transfer the product to a trigger sprayer, but apply from a package delivered with trigger sprayer.
Application on surfaces by Mopping: Impregnate the clean mop with the liquid using a mop bucket and apply to the surface to be disinfected. Ensure complete wetting of the surface (18 mL/m 2 ). Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. No additional wiping necessary.
Do not mix product with other products. Do not pour any unused product back into the original container.
4.1.2.    Use-specific risk mitigation measures
Avoid contact with eyes.
Gloves, eye protection and respiratory protection equipment (RPE) of protection factor of 10 should be worn during mopping. Unprotected personnel should not be present in the room during disinfection by mopping.
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
Potential Health Effects
Eyes – Causes serious eye irritation.
Skin  – Health injuries are not known or expected under normal use.
Ingestion  – Health injuries are not known or expected under normal use.
Inhalation – Inhalation may cause central nervous system effects.
Chronic Exposure  - Health injuries are not known or expected under normal use.
First Aid Measures
IF IN EYES  : Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
IF SWALLOWED  : Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
IF INHALED  : Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use (5.4).
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use (5.5).
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1.    Instructions for use
Please refer to specific instructions for use for meta-SPC 1
5.2.    Risk mitigation measures
Please refer to specific Risk mitigation measures for meta-SPC 1
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Please refer to specific information for meta-SPC 1
5.4.    Instructions for safe disposal of the product and its packaging
Product
Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.
Contaminated packaging
Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national, and/or international regulations.
Product residues
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
Store away from direct sunlight and at temperature between 0°C to 25°C
Shelf life: 24 months
6.    OTHER INFORMATION
Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg body weight (bw)/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report on Propan-2-ol in PT2 – Germany – (January 2015).
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Klercide 70/30 IPA
Market area: EU
Klercide non-sterile 70/30 IPA
Market area: EU
Klercide 70/30 IPA non-sterile
Market area: EU
Authorisation number
EU-0028425-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
63,27 % (w/w)
1.    META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
Meta SPC: Meta-SPC 1.2
1.2.    Suffix to the authorisation number
Number
1-2
1.3.    Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
2.    META SPC 2 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
60,61 - 65,66 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 2
Formulation type(s)
XX – Ready to use wipe impregnated with water based liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 2.1 – Disinfection of surfaces in cleanroom by wiping
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)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: fungi
Development stage: no data
Scientific name: no data
Common name: Enveloped viruses
Development stage: no data
Field(s) of use
indoor use
Disinfection of cleanroom hard non-porous surfaces in life sciences industry by wiping.
Application method(s)
Method: Wiping
Detailed description:
Direct application onto surfaces by wiping with pre-wetted wipes.
Application rate(s) and frequency
Application Rate:
c.a. 10 ml/m 2
ready to use product
Number and timing of application:
Tub (200 wipes/pack, 230×200, Synthetic/cellulose blend): c.a. 0,13 m 2 can be disinfected with 1 wipe
Tub (100 wipes/pack, 200×230, Synthetic/cellulose blend): c.a. 0,23 m 2 can be disinfected with 1 wipe
Mop (10 wipes/pack, 420×250, Polyester/cellulose): c.a. 1,1 m 2 can be disinfected with 1 wipe
Pouch (15 wipes/pack, 200×200, Polyester/cellulose): c.a. 0,33 m 2 can be disinfected with 1 wipe
Pouch (10 wipes/pack, 200×200, 100% polyester): c.a. 0,51 m 2  can be disinfected with 1 wipe
Pouch (15 wipes/pack, 300×300, Polyester/cellulose): c.a. 0,47 m 2 can be disinfected with 1 wipe
Pouch (10 wipes/pack, 300×300, 100% polyester): c.a. 0,73 m 2  can be disinfected with 1 wipe
Category(ies) of users
professional
Pack sizes and packaging material
Tub (HDPE) (100-200 wipes/pack, 200×230, Synthetic/cellulose blend)
Pouch (10-30 wipes/pack, 200×200, Polyester/cellulose, 100% polyester)
Pouch (10-30 wipes/pack, 300×300, Polyester/cellulose, 100% polyester)
Mop wipe (10-30 wipes/pack, 420×250, Polyester/cellulose)
4.1.1.    Use-specific instructions for use
Clean and dry surfaces prior to disinfection.
Wiping: Wipe surface to be disinfected. Use wipe once. Ensure complete wetting of the surface (10 ml/m 2 ).
About 0,13-1,1 m 2 can be disinfected with 1 wipe depending on the wipe.
Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. Dispose of the wipes in the appropriate closed waste bin immediately after use. No additional wiping necessary.
For multipack wipes, close the package after opening.
Do not mix with other products.
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
Potential Health Effects
Eyes – Causes serious eye irritation.
Skin  – Health injuries are not known or expected under normal use.
Ingestion  – Health injuries are not known or expected under normal use.
Inhalation – Inhalation may cause central nervous system effects.
Chronic Exposure  – Health injuries are not known or expected under normal use.
First Aid Measures
IF IN EYES  : Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
IF SWALLOWED  : Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
IF INHALED  : Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use (5.4).
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use (5.5).
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1.    Instructions for use
Please refer to specific instructions for use for meta-SPC 2
5.2.    Risk mitigation measures
Please refer to specific risk mitigation measures for meta-SPC 2
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Please refer to specific information for meta-SPC 2
5.4.    Instructions for safe disposal of the product and its packaging
Product
Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.
Contaminated packaging
Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.
Product residues
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
Store away from direct sunlight and at temperature between 0°C to 25°C
Shelf life: 24 months
6.    OTHER INFORMATION
Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 Germany – (January 2015).
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Klerwipe 70/30 IPA
Market area: EU
Klerwipe non-sterile 70/30 IPA
Market area: EU
Klerwipe 70/30 IPA non-sterile
Market area: EU
Authorisation number
EU-0028425-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
63,27 % (w/w)
1.    META SPC 3 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 3 identifier
Identifier
Meta SPC: Meta-SPC 1.3
1.2.    Suffix to the authorisation number
Number
1-3
1.3.    Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
2.    META SPC 3 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
60,61 - 65,66 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 3
Formulation type(s)
AE Aerosol dispenser
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
Hazard statements
H222 : Extremely flammable aerosol.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
H229: Pressurised container: May burst if heated
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P280: Wear eye protection.
P280: Wear face protection.
P211: Do not spray on an open flame or other ignition source.
P251: Do not pierce or burn, even after use.
P410+P412: Protect from sunlight. Do no expose to temperatures exceeding 50°C/ 122°F.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 3.1 – Disinfection of surfaces in cleanroom by aerosols
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)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: fungi
Development stage: no data
Scientific name: no data
Common name: Enveloped viruses
Development stage: no data
Field(s) of use
indoor use
Disinfection of cleanroom hard non-porous surfaces in life sciences industry.
Application method(s)
Method: Aerosol spraying
Detailed description:
Direct application onto surfaces by aerosol spraying followed by wiping with a dry wipe for distribution.
Application rate(s) and frequency
Application Rate:
c.a. 18 ml/m 2
ready to use product
Number and timing of application:
As required
Category(ies) of users
professional
Pack sizes and packaging material
0,2 liter – 0,5 liter aluminium can
4.1.1.    Use-specific instructions for use
Clean and dry surfaces prior to disinfection.
Application by aerosol spraying: For optimum results hold can upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (18 ml/m 2 , corresponding to 7,2 seconds/m 2 spraying) followed by wiping with a dry wipe for distribution. Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi.
Do not mix product with other products.
4.1.2.    Use-specific risk mitigation measures
Avoid contact with eyes.
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
Potential Health Effects
Eyes – Causes serious eye irritation.
Skin  – Health injuries are not known or expected under normal use.
Ingestion  – Health injuries are not known or expected under normal use.
Inhalation – Inhalation may cause central nervous system effects. Intentional misuse by deliberate inhalation may be harmful or fatal.
Chronic Exposure  – Health injuries are not known or expected under normal use.
First Aid Measures
IF IN EYES  : Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
IF SWALLOWED  : Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
IF INHALED  : Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use (5.4).
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use (5.5).
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1.    Instructions for use
Please refer to specific instructions of use for meta-SPC 3
5.2.    Risk mitigation measures
Please refer to specific risk mitigation measures for meta-SPC 3
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Please refer to specific information for meta-SPC 3
5.4.    Instructions for safe disposal of the product and its packaging
Product
Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.
Contaminated packaging
Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.
Product residues
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
Store away from direct sunlight and at temperature between 0°C to 25°C
Shelf life: 24 months
6.    OTHER INFORMATION
Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015).
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Klercide 70/30 IPA Aerosol
Market area: EU
Authorisation number
EU-0028425-0003 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
63,269 % (w/w)
1.    META SPC 4 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 4 identifier
Identifier
Meta SPC: Meta-SPC 1.4
1.2.    Suffix to the authorisation number
Number
1-4
1.3.    Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
2.    META SPC 4 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
30,3 - 30,3 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 4
Formulation type(s)
XX - Ready to use wipe impregnated with water based liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
Hazard statements
H226: Flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 4.1 – Disinfection of non-food and food contact surfaces by pre-wetted wipes
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: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use
indoor use
Disinfection of food contact and non-food contact hard non-porous surfaces in: Commercial kitchens, Catering, Food processing and Food Retail, Canteen, Bathrooms and Restrooms in hotels, restaurants, stores, schools, offices.
Application method(s)
Method: Wiping
Detailed description:
Direct application onto hard non-porous surfaces by wiping.
Application rate(s) and frequency
Application Rate:
c.a. 10 ml/m 2 at room temperature
ready to use product
Number and timing of application:
Wiping with two superposed wipes.
About 0,074-0,222 m 2 can be disinfected with two superposed wipes depending on the size of wipe used.
Category(ies) of users
professional
Pack sizes and packaging material
Container (PP) (100 wipes 130×210)
Container (HDPE) (150 wipes 180×300)
Bucket (PP) (1500 wipes 150×210)
Pouch (PET/PE) (200 wipes 130×210)
Wipe material (all packagings): blend of Pulp, Polyester, Binder
4.1.1.    Use-specific instructions for use
Wiping: Clean and dry surfaces prior to disinfection.
Wipe surface to be disinfected with two superposed wipes. Use the wipes once. For optimum results ensure complete wetting of the surface (10 ml/m 2  ), about 0,074-0,222 m 2 can be disinfected with two superposed wipes depending on the size of wipe used. Allow to take effect for 15 minutes for bacteria and yeast. Dispose the wipes in the appropriate closed waste bin immediately after use. No additional wiping necessary.
For multipack wipes, close the package after opening.
Do not mix product with other products.
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
Potential Health Effects
Eyes  – Causes serious eye irritation.
Skin  – Health injuries are not known or expected under normal use.
Ingestion  – Health injuries are not known or expected under normal use.
Inhalation – Inhalation may cause central nervous system effects.
Chronic Exposure  – Health injuries are not known or expected under normal use.
First Aid Measures
IF IN EYES  : Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
IF SWALLOWED  : Rinse mouth. Give something to drink, if exposed person isable to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
IF INHALED  : Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use (5.4).
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use (5.5).
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 4
5.1.    Instructions for use
Please refer to specific instructions of use for meta-SPC 4
5.2.    Risk mitigation measures
Please refer to specific risk mitigation measures for meta-SPC 4
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Please refer to specific information for meta-SPC 4
5.4.    Instructions for safe disposal of the product and its packaging
Product
Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.
Contaminated packaging
Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.
Product residues
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
Store away from direct sunlight and at temperature between 0°C to 25°C
Shelf life: 24 months
6.    OTHER INFORMATION
Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015).
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Eco-Bac Wipes
Market area: EU
Sirafan Bac Wipes
Market area: EU
Authorisation number
EU-0028425-0004 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
30,3 % (w/w)
1.    META SPC 5 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 5 identifier
Identifier
Meta SPC: Meta-SPC 1.5
1.2.    Suffix to the authorisation number
Number
1-5
1.3.    Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
2.    META SPC 5 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 5
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
30,3 - 30,3 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 5
Formulation type(s)
AL Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
Hazard statements
H226: Flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P280: Wear eye protection.
P280: Wear face protection.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 5.1 – Disinfection of non-food and food contact surfaces by trigger spray
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: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use
indoor use
Disinfection of food contact and non-food contact hard non-porous surfaces in: Commercial kitchens, Catering, Food processing and Food Retail, Canteen, Bathrooms and Restrooms in hotels, restaurants, stores, schools, offices.
Application method(s)
Method: Trigger spraying
Detailed description:
Direct application onto hard non-porous surfaces by trigger spraying.
Application rate(s) and frequency
Application Rate:
c.a. 18 ml/m 2 at room temperature
ready to use product
Number and timing of application:
As required
Category(ies) of users
professional
Pack sizes and packaging material
0,5 liter – 10 liter HDPE container (with trigger spray)
4.1.1.    Use-specific instructions for use
Application by trigger spraying: Open the nozzle before use. For optimum results hold bottle upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (18 ml/m 2 , corresponding to 29 strokes/m 2 ). Allow to take effect for 30 seconds for bacteria and yeast. Always close the nozzle after use.
Do not mix product with other products. Do not pour any unused product back into the original container.
4.1.2.    Use-specific risk mitigation measures
Avoid contact with eyes.
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
Potential Health Effects
Eyes  – Causes serious eye irritation.
Skin  – Health injuries are not known or expected under normal use.
Ingestion  – Health injuries are not known or expected under normal use.
Inhalation – Inhalation may cause central nervous system effects.
Chronic Exposure  – Health injuries are not known or expected under normal use.
First Aid Measures
IF IN EYES  : Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
IF SWALLOWED  : Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
IF INHALED  : Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use (5.4).
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use (5.5).
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 5
5.1.    Instructions for use
Please refer to specific instructions of use for meta-SPC 5
5.2.    Risk mitigation measures
Please refer to specific risk mitigation measures for meta-SPC 5
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Please refer to specific information for meta-SPC 5
5.4.    Instructions for safe disposal of the product and its packaging
Product
Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.
Contaminated packaging
Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.
Product residues
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
Store away from direct sunlight and at temperature between 0°C to 25°C
Shelf life: 24 months
6.    OTHER INFORMATION
Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015).
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Sirafan Speed-FR
Market area: EU
Authorisation number
EU-0028425-0005 1-5
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
30,3 % (w/w)
Commission Implementing Regulation (EU) 2025/2221 of 31 October 2025 amending Implementing Regulation (EU) 2023/364 as regards administrative changes to the Union authorisation of the biocidal product family IPA Family 1

Schedules & Appendices

Cite this act
