LegalizeCommission Implementing Regulation (EU) 2022/1282 of 8 July 2022 granting a Union authorisation for the biocidal product family ‘Knieler & Team Propanol Family’ (Text with EEA relevance)
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.
Use # 2 – hard non-porous small surface disinfection RTU liquid
| Product type | PT04 - Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: |
| Field(s) of use | Indoor Health care facilities and in food industry, for example food preparation and handling in kitchens/restaurants: disinfection of small hard/non-porous surfaces. For professional use only. |
| Application method(s) | Method: Manual application Detailed description: Ready-to-use surface disinfectant at room temperature (20±2 °C). The entire surface to be disinfected is wetted by pouring or spraying from a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2) to keep the surface wet during the contact time. |
| Application rate(s) and frequency | Application Rate: Minimum exposure time: for the control of bacteria and yeasts at 20°C: 60 sec Dilution (%): Ready-to-use product Number and timing of application: The products can be used as often as necessary. A reasonable frequency in kitchens is 1-2 per day. No safety intervals need to be considered between the application phases. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | 100, 500, 750 and 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head); 5 000 ml transparent/white HDPE canister with HDPE screwed cap. |
4.2.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 6
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 of meta SPC 6
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 6
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 of meta SPC 6
5. GENERAL DIRECTIONS FOR USE 8 OF THE META SPC 6
5.1. Instructions for use
For professional use only.
5.2. Risk mitigation measures
The use of eye protection during handling of the product is mandatory.
Keep out of reach of children
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures: Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking. Prevent entry to sewers and public waters. Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
6. OTHER INFORMATION
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) | F-FDL | F-FDL | Market area: EU | Market area: EU | Market area: EU |
|---|---|---|---|---|---|
| Authorisation number | EU-0027467-0012 1-6 | EU-0027467-0012 1-6 | EU-0027467-0012 1-6 | EU-0027467-0012 1-6 | EU-0027467-0012 1-6 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-1-ol | Active Substance | 71-23-8 | 200-746-9 | 25,0 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 30,0 |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | A-FDL | A-FDL | Market area: EU | Market area: EU | Market area: EU |
|---|---|---|---|---|---|
| Authorisation number | EU-0027467-0013 1-6 | EU-0027467-0013 1-6 | EU-0027467-0013 1-6 | EU-0027467-0013 1-6 | EU-0027467-0013 1-6 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-1-ol | Active Substance | 71-23-8 | 200-746-9 | 35,0 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 35,0 |
7.3. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | C-FDL | C-FDL | Market area: EU | Market area: EU | Market area: EU |
|---|---|---|---|---|---|
| Authorisation number | EU-0027467-0014 1-6 | EU-0027467-0014 1-6 | EU-0027467-0014 1-6 | EU-0027467-0014 1-6 | EU-0027467-0014 1-6 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-1-ol | Active Substance | 71-23-8 | 200-746-9 | 30,0 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 40,0 |
7.4. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | E-FDL | E-FDL | Market area: EU | Market area: EU | Market area: EU |
|---|---|---|---|---|---|
| Authorisation number | EU-0027467-0015 1-6 | EU-0027467-0015 1-6 | EU-0027467-0015 1-6 | EU-0027467-0015 1-6 | EU-0027467-0015 1-6 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-1-ol | Active Substance | 71-23-8 | 200-746-9 | 25,0 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 40,0 |
META SPC 7
1. META SPC 7 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 7 identifier
| Identifier | meta SPC 7 |
1.2. Suffix to the authorisation number
| Number | 1-7 |
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 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-1-ol | Active Substance | 71-23-8 | 200-746-9 | 14,3 | 14,925 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 44,73 | 63,14 |
2.2. Type(s) of formulation of the meta SPC 7
| Formulation(s) | AL - Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
| Hazard statements | Highly flammable liquid and vapour. Causes serious eye damage. 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. Avoid breathing vapours. Use only outdoors or in a well-ventilated area. Wear eye protection. Immediately call a POISON CENTER/doctor. 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. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of container to an authorised waste collection point. |
4. AUTHORISED USE(S) OF THE META SPC 7
4.1. Use description
Table 13
Use # 1 – hard non-porous small surface disinfection RTU liquid
| 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 | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: Enveloped viruses Development stage: |
| Field(s) of use | Indoor Health care facilities and pharmaceutical and cosmetic industry, for example in patient-near surrounding, working areas/desks, general equipment (excluding food contact surfaces): disinfection of small hard/non-porous surfaces. For professional use only. |
| Application method(s) | Method: Manual application Detailed description: Ready-to-use surface disinfectant at room temperature (20±2 °C). The entire surface to be disinfected is wetted by pouring or spraying from short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2) to keep the surface wet during the contact time. |
| Application rate(s) and frequency | Application Rate: Minimum exposure time: • for the control of bacteria,yeasts and enveloped viruses: 60 sec Dilution (%): Ready-to-use product Number and timing of application: A reasonable frequency of disinfection in a patient’s room is 1-2 per day. Maximum number of applications is 6 per day. No safety intervals need to be considered between the application phases. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | 125, 150, 500, 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head); 5 000 ml transparent/white HDPE canister with HDPE screwed cap. |
4.1.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 7
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 of meta SPC 7
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 7
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 of meta SPC 7
4.2. Use description
Table 14
Use # 2 – hard non-porous small surface disinfection RTU liquid
| Product type | PT04 - Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: |
| Field(s) of use | Indoor Health care facilities and in food industry, for example food preparation and handling in kitchens/restaurants): disinfection of small hard/non-porous surfaces. For professional use only. |
| Application method(s) | Method: Manual application Detailed description: Ready-to-use surface disinfectant at room temperature (20±2 °C). The entire surface to be disinfected is wetted by pouring or spraying from short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2) to keep the surface wet during the contact time. |
| Application rate(s) and frequency | Application Rate: Minimum exposure time: for the control of bacteria and yeasts at 20°C: 60 sec Dilution (%): Ready-to-use product Number and timing of application: The products can be used as often as necessary. A reasonable frequency in kitchens is 1-2 per day. No safety intervals need to be considered between the application phases. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | 125, 150, 500, 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head); 5 000 ml transparent/white HDPE canister with HDPE screwed cap. |
4.2.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 7
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 of meta SPC 7
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 7
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 of meta SPC 7
5. GENERAL DIRECTIONS FOR USE 9 OF THE META SPC 7
5.1. Instructions for use
For professional use only.
5.2. Risk mitigation measures
The use of eye protection during handling of the product is mandatory.
Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures:Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.Prevent entry to sewers and public waters.Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
6. OTHER INFORMATION
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) | D-FDL | D-FDL | Market area: EU | Market area: EU | Market area: EU |
|---|---|---|---|---|---|
| Authorisation number | EU-0027467-0016 1-7 | EU-0027467-0016 1-7 | EU-0027467-0016 1-7 | EU-0027467-0016 1-7 | EU-0027467-0016 1-7 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-1-ol | Active Substance | 71-23-8 | 200-746-9 | 14,925 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 44,73 |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | B-FDL | B-FDL | Market area: EU | Market area: EU | Market area: EU |
|---|---|---|---|---|---|
| Authorisation number | EU-0027467-0017 1-7 | EU-0027467-0017 1-7 | EU-0027467-0017 1-7 | EU-0027467-0017 1-7 | EU-0027467-0017 1-7 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-1-ol | Active Substance | 71-23-8 | 200-746-9 | 14,3 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 63,14 |
META SPC 8
1. META SPC 8 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 8 identifier
| Identifier | meta SPC 8 |
1.2. Suffix to the authorisation number
| Number | 1-8 |
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 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-1-ol | Active Substance | 71-23-8 | 200-746-9 | 25,0 | 30,0 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 30,0 | 40,0 |
2.2. Type(s) of formulation of the meta SPC 8
| Formulation(s) | AL - Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
| Hazard statements | Flammable liquid and vapour. Causes serious eye damage. 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. Avoid breathing vapours. 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. Immediately call a POISON CENTER or doctor/physician. Store in a well-ventilated place. Keep cool. Store locked up. Dispose of container to an authorised waste collection point. |
4. AUTHORISED USE(S) OF THE META SPC 8
4.1. Use description
Table 15
Use # 1 – hard non-porous small surface disinfection RTU wipes
| 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 | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: viruses (limited spectrum virucidal activity) Development stage: |
| Field(s) of use | Indoor Health care facilities and pharmaceutical and cosmetic industry, for example patient-near surrounding, working areas/desks, general equipment (excluding food contact surfaces): disinfection of small hard/non-porous surfaces. For professional use only. |
| Application method(s) | Method: Manual application Detailed description: Ready-to-use disinfectant wipes at room temperature (20±2 °C). The surface to be disinfected is wiped and wetted with a sufficient amount of the product, ensuring complete coverage. |
| Application rate(s) and frequency | Application Rate: Minimum exposure time: • for the control of bacteria, yeasts and enveloped viruses: 60 sec • for the control of viruses (limited spectrum virucidal activity): 5 min; Make the surface completely wet. Dilution (%): Ready-to-use product Number and timing of application: A reasonable frequency of disinfection in a patient’s room is 1-2 per day. Maximum number of applications is 6 per day. No safety intervals need to be considered between the application phases. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Flow-pack of white polyethylene (PE)-composite foil with polypropylene (PP) Flap cover, containing 40 30% Viscose and 70% Polyethylene Terephtalate (VIS/PET) wipes. Exclusively for C-FDT (product 8.2): Transparent high-density polyethylene (HDPE) Canister with PP screwed cap, containing 30 PET wipes; Dispenser bag of white PE composite foil, containing 30 or 90 PET wipes used with dispenser box. |
4.1.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 8.
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 of meta SPC 8.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 8
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 of meta SPC 8
4.2. Use description
Table 16
Use # 2 – hard non-porous small surface disinfection RTU wipes
| Product type | PT04 - Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: |
| Field(s) of use | Indoor Health care facilities and food industry, for example food preparation and handling in kitchens/restaurants): disinfection of small hard/non-porous surfaces. For professional use only. |
| Application method(s) | Method: Manual application Detailed description: Ready-to-use disinfectant wipes at room temperature (20±2 °C). The surface to be disinfected is wiped and wetted with a sufficient amount of the product by wiping, ensuring complete coverage. |
| Application rate(s) and frequency | Application Rate: Minimum exposure time: • for the control of bacteria and yeasts at 20°C: 60 sec; Make the surface completely wet Dilution (%): Ready-to-use product Number and timing of application: The product can be used as often as necessary. A reasonable frequency of disinfection in kitchens is 1-2 per day. No safety intervals need to be considered between the application phases. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Flow-pack of white polyethylene (PE)-composite foil with polypropylene (PP) Flap cover, containing 40 30% viscose and 70% polyethylene terephtalate (VIS/PET) wipes. Exclusively for C-FDT (product 8.2): Transparent high-density polyethylene (HDPE) Canister with PP screwed cap, containing 30 PET wipes; Dispenser bag of white PE composite foil, containing 30 or 90 PET wipes used with dispenser box. |
4.2.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 8
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 of meta SPC 8
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 8
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 of meta SPC 8
5. GENERAL DIRECTIONS FOR USE 10 OF THE META SPC 8
5.1. Instructions for use
For professional use only.
For wipes reseal the package after opening.
5.2. Risk mitigation measures
Avoid contact with eyes.
Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.
Prevent entry to sewers and public waters.
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
6. OTHER INFORMATION
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) | F-FDT | F-FDT | Market area: EU | Market area: EU | Market area: EU |
|---|---|---|---|---|---|
| Authorisation number | EU-0027467-0018 1-8 | EU-0027467-0018 1-8 | EU-0027467-0018 1-8 | EU-0027467-0018 1-8 | EU-0027467-0018 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-1-ol | Active Substance | 71-23-8 | 200-746-9 | 25,0 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 30,0 |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | C-FDT | C-FDT | Market area: EU | Market area: EU | Market area: EU |
|---|---|---|---|---|---|
| Authorisation number | EU-0027467-0019 1-8 | EU-0027467-0019 1-8 | EU-0027467-0019 1-8 | EU-0027467-0019 1-8 | EU-0027467-0019 1-8 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-1-ol | Active Substance | 71-23-8 | 200-746-9 | 30,0 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 40,0 |
META SPC 9
1. META SPC 9 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 9 identifier
| Identifier | meta SPC 9 |
1.2. Suffix to the authorisation number
| Number | 1-9 |
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 9 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 9
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| Propan-1-ol | Active Substance | 71-23-8 | 200-746-9 | 14,3 | 14,925 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 44,73 | 63,14 |
2.2. Type(s) of formulation of the meta SPC 9
| Formulation(s) | AL - Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9
| Hazard statements | Highly flammable liquid and vapour. Causes serious eye damage. 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. Avoid breathing vapours. 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. Immediately call a POISON CENTER/doctor. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to an authorised waste collection point. |
4. AUTHORISED USE(S) OF THE META SPC 9
4.1. Use description
Table 17
Use # 1 – hard non-porous small surface disinfection RTU wipes
| 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 | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: Enveloped viruses Development stage: |
| Field(s) of use | Indoor Health care facilities and pharmaceutical and cosmetic industry, for example patient-near surrounding, working areas/desks, general equipment (excluding food contact surfaces): disinfection of small hard/non-porous surfaces For professional use only. |
| Application method(s) | Method: Manual application Detailed description: Ready-to-use disinfectant wipes at room temperature (20±2 °C). The surface to be disinfected is wiped and wetted with a sufficient amount of the product, ensuring complete Coverage. |
| Application rate(s) and frequency | Application Rate: Minimum exposure time: for the control of bacteria, yeasts and enveloped viruses: 60 sec; Make the surface completely wet. Dilution (%): Ready-to-use product Number and timing of application: A reasonable frequency of disinfection in a patient’s room is 1-2 per day. Maximum number of applications is 6 per day. No safety intervals need to be considered between the application phases. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Flow-pack of polyethylene (PE) composite foil with high-density polyethylene (HDPE) Flap cover, containing 80 Cellulose wipes; Dispenser bag of PE composite foil, containing 70 Cellulose wipes used with dispenser box Exclusively for B-FDT (product 9.2): Dispenser of PE composite foil with screwed-in PE cap, containing 100 PP/PE wipes. |
4.1.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 9
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 of meta SPC 9
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 9
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 of meta SPC 9
4.2. Use description
Table 18
Use # 2 – hard non-porous small surface disinfection RTU wipes
| Product type | PT04 - Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: |
| Field(s) of use | Indoor Health care facilities and food industry, for example patient-near surrounding, food preparation and handling in kitchens/restaurants): disinfection of small hard/non-porous surfaces. For professional use only. |
| Application method(s) | Method: Manual application Detailed description: Ready-to-use disinfectant wipes at room temperature (20±2 °C). The surface to be disinfected is wetted with a sufficient amount of the product by wiping, ensuring complete coverage. |
| Application rate(s) and frequency | Application Rate: Minimum exposure time: for the control of bacteria and yeasts at 20°C: 60 sec; Make the surface completely wet. Dilution (%): Ready-to-use product Number and timing of application: The product can be used as often as necessary. A reasonable frequency of disinfection in kitchens is 1-2 per day. No safety intervals need to be considered between the application phases. |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Flow-pack of polyethylene (PE) composite foil with high-density polyethylene (HDPE) Flap cover, containing 80 Cellulose wipes; Dispenser bag of PE composite foil, containing 70 Cellulose wipes used with dispenser box Exclusively for B-FDT (product 9.2): Dispenser of PE composite foil with screwed-in PE cap, containing 100 PP/PE wipes. |
4.2.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 9
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 of meta SPC 9
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 9
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
ee general directions for use of meta SPC 9
5. GENERAL DIRECTIONS FOR USE 11 OF THE META SPC 9
5.1. Instructions for use
For professional use only.
For wipes reseal the package after opening.
5.2. Risk mitigation measures
Avoid contact with eyes.
Keep out of reach of children
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures:Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.Prevent entry to sewers and public waters.Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feeding stuff. Keep away from combustible material.
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | D-FDT | D-FDT | Market area: EU | Market area: EU | Market area: EU |
|---|---|---|---|---|---|
| Authorisation number | EU-0027467-0020 1-9 | EU-0027467-0020 1-9 | EU-0027467-0020 1-9 | EU-0027467-0020 1-9 | EU-0027467-0020 1-9 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-1-ol | Active Substance | 71-23-8 | 200-746-9 | 14,925 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 44,73 |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | B-FDT | B-FDT | Market area: EU | Market area: EU | Market area: EU |
|---|---|---|---|---|---|
| Authorisation number | EU-0027467-0021 1-9 | EU-0027467-0021 1-9 | EU-0027467-0021 1-9 | EU-0027467-0021 1-9 | EU-0027467-0021 1-9 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-1-ol | Active Substance | 71-23-8 | 200-746-9 | 14,3 | |
| Propan-2-ol | Active Substance | 67-63-0 | 200-661-7 | 63,14 |
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.
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.
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.
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.
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.
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.
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.
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.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 9.
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.
This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence.
EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.