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Commission Implementing Regulation (EU) 2024/2194 of 4 September 2024 amending Implementing Regulation (EU) 2020/1991 as regards administrative and minor changes to the Union authorisation for the biocidal product family perform-IPA

Type Implementing Regulation
Publication 2024-09-05
State In force
Text As published
Department European Commission, SANTE
Source EUR-Lex
articles 2

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

Reform history JSON API

1.1.   Meta SPC 5 identifier
Identifier meta SPC 5 kodan wipes IPA pro

1.2.   Suffix to the authorisation number
Number 1-5

1.3.   Product type(s)
Product type(s) PT04 - Food and feed area (Disinfectants) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (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 (%) Content (%)
Common name IUPAC name Function CAS number EC number Min Max
Propan-2-ol Active Substance 67-63-0 200-661-7 63,1 63,1

2.2.   Type(s) of formulation of the meta SPC 5
Formulation(s) Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
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. Keep container tightly closed. Ground and bond container and receiving equipment. Use explosion-proof electrical/ventilating/lighting equipment. Use non-sparking tools. Take action to prevent static discharges. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. Wear eye protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER or doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to /container to an approved waste disposal plant.

4. AUTHORISED USE(S) OF THE META SPC 5

4.1.   Use description

Table 13
Use # 1 – Disinfection of surfaces - 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) Scientific name: Bacteria including Mycobacterium tuberculosis Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: viruses (limited spectrum virucidal activity) Common name: - Development stage: -
Field(s) of use Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s) Method: Wiping Detailed description: Product will be wiped directly on the surface.
Application rate(s) and frequency Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application: -
Category(ies) of users Industrial Professional
Pack sizes and packaging material Soft pack: 1-200 wipes Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP Pouch: 10-200 wipes Packaging material: LDPE/PET Tube: 50-200 wipes Packaging material: HDPE closure material is either PP, PE3385
4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 14
Use # 2 – Disinfection of surfaces with food and feed contact - wiping
Product type PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use -
Target organism(s) (including development stage) Scientific name: Bacteria including Mycobacterium tuberculosis Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: -
Field(s) of use Indoor Disinfection of clean non-porous surfaces in kitchens and food industry
Application method(s) Method: Wiping Detailed description: Product will be wiped directly on the surface.
Application rate(s) and frequency Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application: -
Category(ies) of users Industrial Professional
Pack sizes and packaging material Soft pack: 1-200 wipes Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP Pouch: 10-200 wipes Packaging material: LDPE/PET Tube: 50-200 wipes Packaging material: HDPE closure material is either PP, PE3385
4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5. GENERAL DIRECTIONS FOR USE 10

OF THE META SPC 5

5.1.   Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6. OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

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) kodan® wipes pure kodan® wipes pure Market area: EU Market area: EU Market area: EU Market area: EU
schülke® classic wipes schülke® classic wipes Market area: EU Market area: EU Market area: EU Market area: EU
Authorisation number EU-0023656-0005 1-5 EU-0023656-0005 1-5 EU-0023656-0005 1-5 EU-0023656-0005 1-5 EU-0023656-0005 1-5 EU-0023656-0005 1-5
Common name IUPAC name Function Function CAS number EC number Content (%)
Propan-2-ol Active Substance Active Substance 67-63-0 200-661-7 63,1

META SPC 6

1. META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier
Identifier meta SPC 6 kodan wipes IPA

1.2.   Suffix to the authorisation number
Number 1-6

1.3.   Product type(s)
Product type(s) PT04 - Food and feed area (Disinfectants) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2. META SPC 6 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 6

Common name IUPAC name Function CAS number EC number Content (%) Content (%)
Common name IUPAC name Function CAS number EC number Min Max
Propan-2-ol Active Substance 67-63-0 200-661-7 63,1 63,1

2.2.   Type(s) of formulation of the meta SPC 6
Formulation(s) Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
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 If medical advice is needed, have product container or label at hand. Keep out of reach of children. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Keep container tightly closed. Ground and bond container and receiving equipment. Use explosion-proof electrical/ventilating/lighting equipment. Use non-sparking tools. Take action to prevent static discharges. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER or doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to /container to an approved waste disposal plant.

4. AUTHORISED USE(S) OF THE META SPC 6

4.1.   Use description

Table 15
Use # 1 – Disinfection of surfaces - 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) Scientific name: Bacteria including Mycobacterium tuberculosis Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: viruses (limited spectrum virucidal activity) Common name: - Development stage: -
Field(s) of use Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s) Method: Wiping Detailed description: Product will be wiped directly on the surface.
Application rate(s) and frequency Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application: -
Category(ies) of users Industrial Professional General public (non-professional)
Pack sizes and packaging material Soft pack: 1-200 wipes Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP Pouch: 10-200 wipes Packaging material: LDPE/PET Tube: 50-200 wipes Packaging material: HDPE closure material is either PP, PE3385
4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 16
Use # 2 – Disinfection of surfaces with food and feed contact - wiping
Product type PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use -
Target organism(s) (including development stage) Scientific name: Bacteria including Mycobacterium tuberculosis Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: -
Field(s) of use Indoor Disinfection of clean non-porous surfaces in kitchens and food industry
Application method(s) Method: Wiping Detailed description: Product will be wiped directly on the surface.
Application rate(s) and frequency Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application: -
Category(ies) of users Industrial Professional General public (non-professional)
Pack sizes and packaging material Soft pack: 1-200 wipes Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP Pouch: 10-200 wipes Packaging material: LDPE/PET Tube: 50-200 wipes Packaging material: HDPE closure material is either PP, PE3385
4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5. GENERAL DIRECTIONS FOR USE 11

OF THE META SPC 6

5.1.   Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Keep out of the reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6. OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

7.1.   Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) schülke Hygiene-Tücher schülke Hygiene-Tücher Market area: EU Market area: EU Market area: EU Market area: EU
SOS Desinfizierende Feuchttücher SOS Desinfizierende Feuchttücher Market area: EU Market area: EU Market area: EU Market area: EU
SOS Hygiene-Tücher SOS Hygiene-Tücher Market area: EU Market area: EU Market area: EU Market area: EU
kodan® clean comfort wipes kodan® clean comfort wipes Market area: EU Market area: EU Market area: EU Market area: EU
schülke clean comfort wipes schülke clean comfort wipes Market area: EU Market area: EU Market area: EU Market area: EU
Hygiene-Tücher Hygiene-Tücher Market area: EU Market area: EU Market area: EU Market area: EU
Desinfizierende Feuchttücher Desinfizierende Feuchttücher Market area: EU Market area: EU Market area: EU Market area: EU
Desinfektionstücher Desinfektionstücher Market area: EU Market area: EU Market area: EU Market area: EU
clean comfort wipes clean comfort wipes Market area: EU Market area: EU Market area: EU Market area: EU
disinfecting wipes disinfecting wipes Market area: EU Market area: EU Market area: EU Market area: EU
Authorisation number EU-0023656-0006 1-6 EU-0023656-0006 1-6 EU-0023656-0006 1-6 EU-0023656-0006 1-6 EU-0023656-0006 1-6 EU-0023656-0006 1-6
Common name IUPAC name Function Function CAS number EC number Content (%)
Propan-2-ol Active Substance Active Substance 67-63-0 200-661-7 63,1

META SPC 7

1. META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier
Identifier meta SPC 7 AntiLy SD

1.2.   Suffix to the authorisation number
Number 1-7

1.3.   Product type(s)
Product type(s) PT04 - Food and feed area (Disinfectants) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2. META SPC 7 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 7

Common name IUPAC name Function CAS number EC number Content (%) Content (%)
Common name IUPAC name Function CAS number EC number Min Max
Propan-2-ol Active Substance 67-63-0 200-661-7 63,1 63,1

2.2.   Type(s) of formulation of the meta SPC 7
Formulation(s) Any other liquid (AL), ready-to-use

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
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. Keep container tightly closed. Ground and bond container and receiving equipment. Use explosion-proof electrical/ventilating/lighting equipment. Use non-sparking tools. Take action to prevent static discharges. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. Wear eye protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER or doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to /container to an approved waste disposal plant.

4. AUTHORISED USE(S) OF THE META SPC 7

4.1.   Use description

Table 17
Use # 1 – Disinfection of surfaces - spraying
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) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: -
Field(s) of use Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
Application method(s) Method: Spraying Detailed description: Product will be sprayed directly on the surface.
Application rate(s) and frequency Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: -
Category(ies) of users Industrial Professional
Pack sizes and packaging material Bottle: 125-1000 ml packaging material: HDPE Clack cap material: PP; Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel); Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
4.1.1.   Use-specific instructions for use

Spray ready-to-use product onto the surfaces and allow to take effect for at least 1 minute at room temperature (20±2 °C).

4.1.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

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

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 18
Use # 2 – Disinfection of surfaces - 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) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: -
Field(s) of use Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
Application method(s) Method: Wiping Detailed description: Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping).
Application rate(s) and frequency Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: -
Category(ies) of users Industrial Professional
Pack sizes and packaging material Bottle: 125-1000 ml packaging material: HDPE Clack cap material: PP Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel); Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil) Canister: 5-30 litre packaging material: HDPE closure material: HDPE
4.2.1.   Use-specific instructions for use

Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20±2 °C).

4.2.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.3.   Use description

Table 19
Use # 3 – Disinfection of surfaces with food and feed contact - spraying
Product type PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use -
Target organism(s) (including development stage) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: -
Field(s) of use Indoor Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s) Method: Spraying Detailed description: Product will be sprayed directly on the surface.
Application rate(s) and frequency Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: -
Category(ies) of users Industrial Professional
Pack sizes and packaging material Bottle: 125-1000 ml packaging material: HDPE Clack cap material: PP Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
4.3.1.   Use-specific instructions for use

Spray ready-to-use product onto the surface and allow to take effect at room temperature (20 ± 2 °C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).

4.3.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.4.   Use description

Table 20
Use # 4 – Disinfection of surfaces with food and feed contact - wiping
Product type PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use -
Target organism(s) (including development stage) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: -
Field(s) of use Indoor Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s) Method: Wiping Detailed description: Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping).
Application rate(s) and frequency Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: -
Category(ies) of users Industrial Professional
Pack sizes and packaging material Bottle: 125-1000 ml packaging material: HDPE Clack cap material: PP Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil) Canister: 5-30 litre packaging material: HDPE closure material: HDPE
4.4.1.   Use-specific instructions for use

Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20 ±2°C).

4.4.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5. GENERAL DIRECTIONS FOR USE 12

OF THE META SPC 7

5.1.   Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Do not apply more than 25 ml/m2.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Apply a funnel for refilling.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 36 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6. OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7

7.1.   Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) AntiLy 5 AntiLy 5 Market area: EU Market area: EU Market area: EU Market area: EU
Authorisation number EU-0023656-0007 1-7 EU-0023656-0007 1-7 EU-0023656-0007 1-7 EU-0023656-0007 1-7 EU-0023656-0007 1-7 EU-0023656-0007 1-7
Common name IUPAC name Function Function CAS number EC number Content (%)
Propan-2-ol Active Substance Active Substance 67-63-0 200-661-7 63,1

7.2.   Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) AntiLy 6 AntiLy 6 Market area: EU Market area: EU Market area: EU Market area: EU
Authorisation number EU-0023656-0008 1-7 EU-0023656-0008 1-7 EU-0023656-0008 1-7 EU-0023656-0008 1-7 EU-0023656-0008 1-7 EU-0023656-0008 1-7
Common name IUPAC name Function Function CAS number EC number Content (%)
Propan-2-ol Active Substance Active Substance 67-63-0 200-661-7 63,1

META SPC 8

1. META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier
Identifier meta SPC 8 AntiLy SD wipes

1.2.   Suffix to the authorisation number
Number 1-8

1.3.   Product type(s)
Product type(s) PT04 - Food and feed area (Disinfectants) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2. META SPC 8 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 8

Common name IUPAC name Function CAS number EC number Content (%) Content (%)
Common name IUPAC name Function CAS number EC number Min Max
Propan-2-ol Active Substance 67-63-0 200-661-7 63,1 63,1

2.2.   Type(s) of formulation of the meta SPC 8
Formulation(s) Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
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. Keep container tightly closed. Ground and bond container and receiving equipment. Use explosion-proof electrical/ventilating/lighting equipment. Use non-sparking tools. Take action to prevent static discharges. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. Wear eye protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER or doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to /container to an approved waste disposal plant.

4. AUTHORISED USE(S) OF THE META SPC 8

4.1.   Use description

Table 21
Use # 1 – Disinfection of surfaces - 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) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: -
Field(s) of use Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
Application method(s) Method: Wiping Detailed description: Product will be wiped directly on the surface.
Application rate(s) and frequency Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application: -
Category(ies) of users Industrial Professional
Pack sizes and packaging material Can: 100-150 wipes Packaging: HDPE Closure material: HDPE Pack: 100-150 wipes Packaging: PET/PE
4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 22
Use # 2 – Disinfection of surfaces with food and feed contact - wiping
Product type PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use -
Target organism(s) (including development stage) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Viruses Common name: - Development stage: -
Field(s) of use Indoor Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s) Method: Wiping Detailed description: Product will be wiped directly on the surface.
Application rate(s) and frequency Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application: -
Category(ies) of users Industrial Professional
Pack sizes and packaging material Can: 100-150 wipes Packaging: HDPE Closure material: HDPE Pack: 100-150 wipes Packaging: PET/PE
4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5. GENERAL DIRECTIONS FOR USE 13

OF THE META SPC 8

5.1.   Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6. OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s) AntiLy 5 wipes AntiLy 5 wipes Market area: EU Market area: EU Market area: EU Market area: EU
Authorisation number EU-0023656-0009 1-8 EU-0023656-0009 1-8 EU-0023656-0009 1-8 EU-0023656-0009 1-8 EU-0023656-0009 1-8 EU-0023656-0009 1-8
Common name IUPAC name Function Function CAS number EC number Content (%)
Propan-2-ol Active Substance Active Substance 67-63-0 200-661-7 63,1

7.2.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s) AntiLy 6 wipes AntiLy 6 wipes Market area: EU Market area: EU Market area: EU Market area: EU
Authorisation number EU-0023656-0010 1-8 EU-0023656-0010 1-8 EU-0023656-0010 1-8 EU-0023656-0010 1-8 EU-0023656-0010 1-8 EU-0023656-0010 1-8
Common name IUPAC name Function Function CAS number EC number Content (%)
Propan-2-ol Active Substance Active Substance 67-63-0 200-661-7 63,1
6

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.

7

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.

8

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.

9

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.

10

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.

11

Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.

12

Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.

13

Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.

ELI: http://data.europa.eu/eli/reg_impl/2024/2194/oj

ISSN 1977-0677 (electronic edition)

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