Commission Implementing Regulation (EU) 2023/364 of 16 February 2023 granting a Union authorisation for the biocidal product family ‘IPA Family 1’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

ANNEX II
ANNEX II
Summary of product characteristics for a biocidal product family
IPA Family 1
Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 – Food and feed area (Disinfectants)
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 (Disinfectants)
PT04 – Food and feed area (Disinfectants)
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 March 2023
Expiry date of the authorisation
28 February 2033
1.4.    Manufacturer(s) of the biocidal products
Name of manufacturer
Ecolab Europe GmbH
Address of manufacturer
Richtistrasse, 7, 8304 Walliselen Switzerland
Location of manufacturing sites
Richtistrasse, 7, 8304 Walliselen Switzerland
Name of manufacturer
Ecolab Limited
Address of manufacturer
Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom
Location of manufacturing sites
Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom
Name of manufacturer
Laboratoires Prodene Klint
Address of manufacturer
Rue Denis Papin, 2 Z.I. Mitry Compans, F-77290 Mitry Mory France
Location of manufacturing sites
Rue Denis Papin, 2 Z.I. Mitry Compans, F-77290 Mitry Mory France
Name of manufacturer
Ecolab Leeds
Address of manufacturer
Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom
Location of manufacturing sites
Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom
Name of manufacturer
Esoform S.p.A.
Address of manufacturer
Viale del Lavoro 10, 45100 Rovigo Italy
Location of manufacturing sites
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
Justus-von-Liebig-Str. 11, D-64584 Biebesheim Germany
Name of manufacturer
Ecolab NETHERLANDS BV
Address of manufacturer
Brugwal 11, 3432NZ Nieuwegein Netherlands
Location of manufacturing sites
Brugwal 11, 3432NZ Nieuwegein Netherlands
Name of manufacturer
Ecolab Weavergate
Address of manufacturer
Winnington Avenue, CW8 3AA Northwich Cheshire United Kingdom
Location of manufacturing sites
Winnington Avenue, CW8 3AA Northwich Cheshire United Kingdom
Name of manufacturer
Ecolab Mullingar, Ireland
Address of manufacturer
Forest Park, Zone C Mullingar Ind. Estate, – Mullingar, Co. Westmeath, Ireland
Location of manufacturing sites
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
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
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
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
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
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
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
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
Via Ninfina II, 4012 Cisterna Di Latina Italy
Name of manufacturer
Manufacturing Plant Fawley Nalco
Address of manufacturer
One business center 1180, SO45 3NP Hardley Hants United Kingdom
Location of manufacturing sites
One business center 1180, SO45 3NP Hardley Hants United Kingdom
Name of manufacturer
Nalco Champion Plant, Tooling Plant, Aberdeen Nalco
Address of manufacturer
Minto Avenue, Alten Industrial Estate, AB12 3JZ Aberdeen United Kingdom
Location of manufacturing sites
Minto Avenue, Alten Industrial Estate, AB12 3JZ Aberdeen United Kingdom
Name of manufacturer
Microtek Medical B.V.
Address of manufacturer
Hekkehorst, 24, 7207 BN Zutphen Netherlands
Location of manufacturing sites
Hekkehorst, 24, 7207 BN Zutphen Netherlands
Name of manufacturer
Microtek Medical Malta Ltd.
Address of manufacturer
Sorbonne Centre F20 Mosta Technopark, MST 3000 Mosta Malta
Location of manufacturing sites
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
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
54 avenue de la Plaine – ZI, 13106 Rousset France
Name of manufacturer
Techtex
Address of manufacturer
Units 7 & 8, Rhodes Business Park, Silbum Way, M24 4NE Middelton, Manchester United Kingdom
Location of manufacturing sites
Units 7 & 8, Rhodes Business Park, Silbum Way, M24 4NE Middelton, Manchester United Kingdom
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, 47443 Moers Germany
Location of manufacturing sites
Shamrockstrasse 88, D-44623 Herne Germany
Romestrasse, 733, D-47443, 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
Location of manufacturing sites
Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis, Netherlands
Active substance
Propan-2-ol
Name of manufacturer
ExxonMobil Chemical Europe
Address of manufacturer
Hermeslaan 2, 1831 Machelen, Belgium
Location of manufacturing sites
Fawley Refinery and Petrochemical Plant, Fawley, SO45 1TX Southampton United Kingdom
Baton Rouge Chemical Plant 4999 Scenic Highway, 70805-3359 LA United States
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
30,3
65,66
2.2.    Type(s) of formulation
Formulation(s)
AL – Any other liquid
AE – Aerosol dispenser
XX – Ready to use wipe impregnated with water based liquid
PART II
SECOND INFORMATION LEVEL – META SPC(S)
META SPC 1
1.   META SPC 1 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 1 identifier
Identifier
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 (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
60,61
65,66
2.2.    Type(s) of formulation of the meta SPC 1
Formulation(s)
AL – Any other liquid
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Wear eye protection.
Wear face protection.
4.   AUTHORISED USE(S) OF THE META SPC 1
4.1.    Use description
Table 1. Use # 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 (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 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
Dilution (%): 0
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 (max. 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 (max. 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  ( 1 ) 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
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
META SPC 2
1.   META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
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 (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
60,61
65,66
2.2.    Type(s) of formulation of the meta SPC 2
Formulation(s)
XX – Ready to use wipe impregnated with water based liquid
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
4.   AUTHORISED USE(S) OF THE META SPC 2
4.1.    Use description
Table 2. Use # 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 (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 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
Dilution (%): 0
Number and timing of application:
Tub (200 wipes/pack, 230x200, Synthetic/cellulose blend): c.a. 0,13 m 2 can be disinfected with 1 wipe
Tub (100 wipes/pack, 200x230, Synthetic/cellulose blend): c.a. 0,23 m 2 can be disinfected with 1 wipe
Mop (10 wipes/pack, 420x250, Polyester/cellulose): c.a. 1,1 m 2 can be disinfected with 1 wipe
Pouch (15 wipes/pack, 200x200, Polyester/cellulose): c.a. 0,33 m 2 can be disinfected with 1 wipe
Pouch (10 wipes/pack, 200x200, 100 % polyester): c.a. 0,51 m 2 can be disinfected with 1 wipe
Pouch (15 wipes/pack, 300x300, Polyester/cellulose): c.a. 0,47 m 2 can be disinfected with 1 wipe
Pouch (10 wipes/pack, 300x300, 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, 200x230, Synthetic/cellulose blend)
Pouch (10-30 wipes/pack, 200x200, Polyester/cellulose, 100 % polyester)
Pouch (10-30 wipes/pack, 300x300, Polyester/cellulose, 100 % polyester)
Mop wipe (10-30 wipes/pack, 420x250, 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 (max. 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  ( 2 ) 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
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
META SPC 3
1.   META SPC 3 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 3 identifier
Identifier
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 (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
60,61
65,66
2.2.    Type(s) of formulation of the meta SPC 3
Formulation(s)
AE – Aerosol dispenser
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
Hazard statements
Extremely flammable aerosol.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Pressurised container: May burst if heated
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Wear eye protection.
Wear face protection.
Do not spray on an open flame or other ignition source.
Do not pierce or burn, even after use.
Protect from sunlight. Do not expose at temperatures exceeding 50 °C/122 °F.
4.   AUTHORISED USE(S) OF THE META SPC 3
4.1.    Use description
Table 3. Use # 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 (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 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
Dilution (%): 0
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 (max. 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  ( 3 ) 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
META SPC 4
1.   META SPC 4 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 4 identifier
Identifier
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 (Disinfectants)
PT04 – Food and feed area (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
30,3
30,3
2.2.    Type(s) of formulation of the meta SPC 4
Formulation(s)
XX – Ready to use wipe impregnated with water based liquid
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
Hazard statements
Flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
4.   AUTHORISED USE(S) OF THE META SPC 4
4.1.    Use description
Table 4. Use # 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 (Disinfectants)
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:
Field(s) of use
Indoor
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
Dilution (%): 0
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 130x210)
Container (HDPE) (150 wipes 180x300)
Bucket (PP) (1 500 wipes 150x210)
Pouch (PET/PE) (200 wipes 130x210)
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 (max. 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 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  ( 4 ) 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
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
META SPC 5
1.   META SPC 5 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 5 identifier
Identifier
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 (Disinfectants)
PT04 – Food and feed area (Disinfectants)
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 (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
30,3
30,3
2.2.    Type(s) of formulation of the meta SPC 5
Formulation(s)
AL – Any other liquid
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
Hazard statements
Flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Wear eye protection.
Wear face protection.
4.   AUTHORISED USE(S) OF THE META SPC 5
4.1.    Use description
Table 5. Use # 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 (Disinfectants)
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:
Field(s) of use
Indoor
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
Dilution (%): 0
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 (max. 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  ( 5 ) 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
( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.
( 2 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.
( 3 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.
( 4 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.
( 5 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.
Commission Implementing Regulation (EU) 2023/364 of 16 February 2023 granting a Union authorisation for the biocidal product family ‘IPA Family 1’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

Schedules & Appendices

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