LegalizeCommission Implementing Regulation (EU) 2025/2074 of 16 October 2025 granting a Union authorisation for the biocidal product family B. Braun Medical Propanol Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
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.
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: Mycobacteria Common name: enveloped viruses Common name: viruses (limited spectrum virucidal activity) |
| Field(s) of use | indoor use The product is applied by foaming followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other health care institutions such as in patient-near surrounding, ambulances, surgeries and nursing homes, e.g. incl. home-care of patients (excluding food contact surfaces). |
| Application method(s) | Method: foaming followed by wiping Detailed description: The ready-to-use product is applied by foaming followed by wiping. |
| Application rate(s) and frequency | undiluted; ready-to-use product Number and timing of application: Application rate: Use sufficient product to ensure complete coverage. 18 -21 ml per m2 of surface. For foam spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2. Frequency: Typical application frequency in a patient room: 1-2 times per day. |
| Category(ies) of users | professional |
| Pack sizes and packaging material | pigmented/transparent HDPE bottle with screwed foam head of pigmented PP Sizes: 750 ml pigmented/transparent HDPE canister with screwed caps of pigmented HDPE. Sizes: 5 000 ml |
4.1.1. Use-specific instructions for use
It is a ready-to-use surface disinfectant.
Surfaces should be visibly clean prior to disinfection. For limited spectrum virucidal activity the surfaces should be cleaned before using the product and excessive amount of water should be removed prior to disinfection.
The entire surface to be disinfected is wetted with a sufficient amount of the product by spraying from short distance with a pump spray head and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (20°C):
- — for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 1 minute
- — limited spectrum virucidal activity: 5 minutes
Do not apply more than 21 ml per m2.
4.1.2. Use-specific risk mitigation measures
For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces.
The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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
Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 5.
4.2. Use description
Table 2
Surface disinfection RTU foam
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts |
| Field(s) of use | indoor use The product is applied by foaming followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces in food contact (disinfection in the presence of soiling) in hospitals and other healthcare institutions, incl. hospital canteens and large kitchens (e.g. food processing, preparation and handling). |
| Application method(s) | Method: foaming followed by wiping Detailed description: The ready-to-use product is applied by foaming followed by wiping. |
| Application rate(s) and frequency | undiluted; ready-to-use product Number and timing of application: Application rate: Use sufficient product to ensure complete coverage. 18-21 ml per m2 of surface. For foam spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2. Frequency: Typical application frequency in a kitchen: 1-2 times per day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | pigmented/transparent HDPE bottle with screwed foam head of pigmented PP Sizes: 750 ml pigmented/transparent HDPE canister with screwed caps of pigmented HDPE. Sizes: 5 000 ml |
4.2.1. Use-specific instructions for use
It is a ready-to-use surface disinfectant.
Surfaces should be visibly clean prior to disinfection.
The entire surface to be disinfected is wetted with a sufficient amount of the product by spraying from short distance with a pump spray head and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (20°C):
- — for the control of bacteria and yeasts: 1 minute
Do not apply more than 21 ml per m2.
4.2.2. Use-specific risk mitigation measures
For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces (up to 1 m2).
The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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
Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 5.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
5.1. Instructions for use
See use-specific instructions for use.
5.2. Risk mitigation measures
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
See use-specific instructions and measures.
5.4. Instructions for safe disposal of the product and its packaging
See use-specific instructions.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months.
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store below 40°C.
6. OTHER INFORMATION
Please be aware of the European reference value of 129,28 mg/m3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicalst.
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) | Trade name(s) | Trade name(s) | Meliseptol Pro foam | Meliseptol Pro foam | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0033840-0007 1-5 | EU-0033840-0007 1-5 | EU-0033840-0007 1-5 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-1-ol | Active substance | Active substance | 71-23-8 | 71-23-8 | 200-746-9 | 20 % (w/w) | |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 10 % (w/w) |
1. META SPC 6 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 6 identifier
| Identifier | Meta SPC: meta SPC 6 |
1.2. Suffix to the authorisation number
| Number | 1-6 |
1.3. Product type(s)
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
2. META SPC 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 (%) |
|---|---|---|---|---|---|
| Propan-1-ol | Active substance | 71-23-8 | 200-746-9 | 20 - 20 % (w/w) | |
| Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 10 - 10 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 6
| Formulation type(s) | Impregnated wipes |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
| Hazard statements | H226: Flammable liquid and vapour. H318: Causes serious eye damage. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye/face protection. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTER/doctor if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P310: Immediately call a POISON CENTER/doctor. P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Surface disinfection RTU wipes
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: Mycobacteria Common name: enveloped viruses Common name: viruses (limited spectrum virucidal activity) |
| Field(s) of use | indoor use The product is applied by wipe disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other health care institutions such as in patient-near surrounding, ambulances, surgeries and nursing homes, e.g. incl. home-care of patients (excluding food contact surfaces). |
| Application method(s) | Method: wiping Detailed description: The ready-to-use product is applied by wiping. |
| Application rate(s) and frequency | undiluted; ready-to-use product Number and timing of application: Application rate: Use sufficient product to ensure complete coverage. 18,0 × 20,0 cm wipe – 2-4 wipes per m2 24,0 × 30,0 cm wipe – 1-2 wipe per m2 Frequency: reasonable application frequency in a patient room: 1-2 times per day. |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE Dispenser box with PP closure including a polyethylene terephthalate/ polyethylene (PET/PE) flow pack with 60 PET wipes (with refill pack) PET/PE Flow-pack with 100 PET wipes and PP flap cover PET/PE Flow-pack XL with 42 PET wipes and PP flap cover |
4.1.1. Use-specific instructions for use
It is a ready-to-use pre-soaked disinfectant wipe. Surfaces should be visibly clean prior to disinfection. For limited spectrum virucidal activity the surfaces should be cleaned before using the product and excessive amount of water should be removed prior to disinfection.
The surface to be disinfected is wetted with a sufficient amount of wipes to completely wet the surface during the indicated exposure time. Only wet wipes shall be used.
Minimum exposure time (20°C):
- — for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 1 minute
- — limited spectrum virucidal activity: 5 minutes
18,0 × 20,0 cm wipe – 2-4 wipes per m2
24,0 × 30,0 cm wipe – 1-2 wipe per m2
4.1.2. Use-specific risk mitigation measures
For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces.
The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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
Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 6.
4.2. Use description
Table 2
Surface disinfection RTU wipes
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts |
| Field(s) of use | indoor use The product is intended to be used for the control of bacteria and yeasts. The product is applied for wipe disinfection of alcohol-resistant small hard non-porous surfaces in food contact (disinfection in the presence of soiling) in hospitals and other healthcare institutions, incl. hospital canteens and large kitchens (e.g. food processing, preparation and handling). |
| Application method(s) | Method: wiping Detailed description: The ready-to-use product is applied by wiping. |
| Application rate(s) and frequency | undiluted; ready-to-use product Number and timing of application: Application rate: Use sufficient product to ensure complete coverage. 18,0 × 20,0 cm wipe – 2-4 wipes per m2 24,0 × 30,0 cm wipe – 1-4 wipe per m2 Frequency: Typical application frequency in a kitchen: 1-2 times per day. |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE Dispenser box with PP closure including a PET/PE flow pack with 60 PET wipes (with refill pack) PET/PE Flow-pack with 100 PET wipes and PP flap cover PET/PE Flow-pack XL with 42 PET wipes and PP flap cover |
4.2.1. Use-specific instructions for use
It is a ready-to-use pre-soaked disinfectant wipe. Surfaces should be visibly clean prior to disinfection. The surface to be disinfected is wetted with a sufficient amount of wipes to completely wet the surface during the indicated exposure time. Only wet wipes shall be used.
Minimum exposure time (20°C):
— for the control of bacteria and yeasts: 1 minute
18,0 × 20,0 cm wipe – 2-4 wipes per m2
24,0 × 30,0 cm wipe – 1-2 wipes per m2
4.2.2. Use-specific risk mitigation measures
For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces (up to 1m2).
The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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
Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 OF THE META SPC 6
5.1. Instructions for use
See use-specific instructions for use.
5.2. Risk mitigation measures
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
See use-specific instructions and measures.
5.4. Instructions for safe disposal of the product and its packaging
See use-specific instructions.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months.
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store below 40°C.
6. OTHER INFORMATION
Please be aware of the European reference value of 129,28 mg/m3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicals
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) | Trade name(s) | Trade name(s) | Meliseptol Pro wipes | Meliseptol Pro wipes | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0033840-0008 1-6 | EU-0033840-0008 1-6 | EU-0033840-0008 1-6 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-1-ol | Active substance | Active substance | 71-23-8 | 71-23-8 | 200-746-9 | 20 % (w/w) | |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 10 % (w/w) |
1. META SPC 7 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 7 identifier
| Identifier | Meta SPC: 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 PT04: Food and feed area |
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 (%) |
|---|---|---|---|---|---|
| Propan-1-ol | Active substance | 71-23-8 | 200-746-9 | 25 - 25 % (w/w) | |
| Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 20 - 20 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 7
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
| Hazard statements | H226: Flammable liquid and vapour. H318: Causes serious eye damage. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye/face protection. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTER/doctor if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Surface disinfection RTU liquid
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: Mycobacteria Common name: enveloped viruses Common name: viruses (limited spectrum virucidal activity) |
| Field(s) of use | indoor use The product is applied by spraying or pouring followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other health care institutions such as in patient-near surrounding, ambulances, surgeries and nursing homes, e.g. incl. home-care of patients (excluding food contact surfaces). |
| Application method(s) | Method: spraying or pouring followed by wiping Detailed description: The ready-to-use product is applied by pouring or trigger spraying followed by wiping. |
| Application rate(s) and frequency | undiluted; ready-to-use product Number and timing of application: Application rate: Use sufficient product to ensure complete coverage. 18-21 ml per m2 of surface. For trigger spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2. Frequency: Typical application frequency in a patient room: 1-2 times per day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | pigmented/transparent HDPE bottles, closed with screwed flip top caps of pigmented PP. Sizes: 250/500/1 000 ml (accessory: PP spray head) pigmented/transparent HDPE canister with screwed caps of pigmented HDPE. Sizes: 5 000 ml |
4.1.1. Use-specific instructions for use
It is a ready-to-use surface disinfectant. Surfaces should be visibly clean prior to disinfection. For limited spectrum virucidal activity the surfaces should be cleaned before using the product and excessive amount of water should be removed prior to disinfection. The entire surface to be disinfected is wetted with a sufficient amount of the product by pouring or spraying from short distance with a pump spray head as a possible application aid and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (20°C):
- — for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 1 minute
- — limited spectrum virucidal activity: 2 minutes
Do not apply more than 21 ml per m2.
4.1.2. Use-specific risk mitigation measures
For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces.
The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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
Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 2
Surface disinfection RTU liquid
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts |
| Field(s) of use | indoor use The product is applied by spraying or pouring followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other healthcare institutions, incl. hospital canteens and large kitchens (e.g. food processing, preparation and handling). |
| Application method(s) | Method: spraying or pouring followed by wiping Detailed description: The ready-to-use product is applied by pouring or trigger spraying followed by wiping. |
| Application rate(s) and frequency | undiluted; ready-to-use product Number and timing of application: Application rate: Use sufficient product to ensure complete coverage. 18-21 ml per m2 of surface. For trigger spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2. Frequency: Typical application frequency in a kitchen: 1-2 times per day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | pigmented/transparent HDPE bottles, closed with screwed flip top caps of pigmented PP. Sizes: 250/500/1 000 ml (accessory: PP spray head) pigmented/transparent HDPE canister with screwed caps of pigmented HDPE. Sizes: 5 000 ml |
4.2.1. Use-specific instructions for use
It is a ready-to-use surface disinfectant. Surfaces should be visibly clean prior to disinfection. The entire surface to be disinfected is wetted with a sufficient amount of the product by pouring or spraying from short distance with a pump spray head as a possible application aid and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (4°C, 10°C, 20°C):
- — for the control of bacteria and yeasts: 1 minute
Do not apply more than 21 ml per m2.
4.2.2. Use-specific risk mitigation measures
For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces (up to 1 m2).
The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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
Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 OF THE META SPC 7
5.1. Instructions for use
See use-specific instructions for use.
5.2. Risk mitigation measures
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
See use-specific instructions and measures.
5.4. Instructions for safe disposal of the product and its packaging
See use-specific instructions.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months.
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store below 40°C.
6. OTHER INFORMATION
Please be aware of the European reference value of 129,28 mg/m3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicals
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) | Trade name(s) | Trade name(s) | Meliseptol Pro rapid | Meliseptol Pro rapid | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0033840-0009 1-7 | EU-0033840-0009 1-7 | EU-0033840-0009 1-7 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-1-ol | Active substance | Active substance | 71-23-8 | 71-23-8 | 200-746-9 | 25 % (w/w) | |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 20 % (w/w) |
1. META SPC 8 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 8 identifier
| Identifier | Meta SPC: 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 PT04: Food and feed area |
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 (%) |
|---|---|---|---|---|---|
| Propan-1-ol | Active substance | 71-23-8 | 200-746-9 | 25 - 25 % (w/w) | |
| Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 20 - 20 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 8
| Formulation type(s) | impregnated wipes |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
| Hazard statements | H226: Flammable liquid and vapour. H318: Causes serious eye damage. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye/face. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTER/doctor if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P310: Immediately call a POISON CENTER/doctor. P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Surface disinfection RTU wipes
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: Mycobacteria Common name: enveloped viruses Common name: viruses (limited spectrum virucidal activity) |
| Field(s) of use | indoor use The product is applied by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other health care institutions such as in patient-near surrounding, ambulances, surgeries and nursing homes, e.g. incl. home-care of patients (excluding food contact surfaces). |
| Application method(s) | Method: wiping Detailed description: The ready-to-use product is applied by wiping. |
| Application rate(s) and frequency | undiluted; ready-to-use product Number and timing of application: Application rate: Use sufficient product to ensure complete coverage. 18,0 × 20,0 cm wipe – 2-4 wipes per m2 24,0 × 30,0 cm wipe – 1-2 wipe per m2 Frequency: Typical application frequency in a patient room: 1-2 times per day. |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE Dispenser box with PP closure including a PET/PE flow pack with 60 PET wipes (with refill pack) PET/PE Flow-pack with 100 PET wipes and PP flap cover PET/PE Flow-pack XL with 42 PET wipes and PP flap cover |
4.1.1. Use-specific instructions for use
It is a ready-to-use pre-soaked disinfectant wipe. Surfaces should be visibly clean prior to disinfection. For limited spectrum virucidal activity the surfaces should be cleaned before using the product and excessive amount of water should be removed prior to disinfection.The surface to be disinfected is wetted with a sufficient amount of wipes to completely wet the surface during the indicated exposure time. Only wet wipes shall be used.
Minimum exposure time (20°C):
- — for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 1 minute
- — limited spectrum virucidal activity: 2 minutes
18,0 × 20,0 cm – 2-4 wipes per m2
24,0 × 30,0 cm wipe – 1-2 wipe per m2
4.1.2. Use-specific risk mitigation measures
For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces.
The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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
Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 2
Surface disinfection RTU wipes
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts |
| Field(s) of use | indoor use The product is applied by wiping for disinfection of alcohol-resistant small hard non-porous surfaces in food contact (disinfection in the presence of soiling) in hospitals and other healthcare institutions, incl. hospital canteens and large kitchens (e.g. food processing, preparation and handling). |
| Application method(s) | Method: wiping Detailed description: The ready-to-use product is applied by wiping. |
| Application rate(s) and frequency | undiluted; ready-to-use product Number and timing of application: Application rate: Use sufficient product to ensure complete coverage. 18,0 × 20,0 cm – 2-4 wipes per m2 24,0 × 30,0 cm wipe – 1-2 wipe per m2 Frequency: Typical application frequency in a kitchen: 1-2 times per day. |
| Category(ies) of users | professional |
| Pack sizes and packaging material | HDPE Dispenser box with PP closure including a PET/PE flow pack with 60 PET wipes (with refill pack) PET/PE Flow-pack with 100 PET wipes and PP flap cover PET/PE Flow-pack XL with 42 PET wipes and PP flap cover |
4.2.1. Use-specific instructions for use
It is a ready-to-use pre-soaked disinfectant wipe. Surfaces should be visibly clean prior to disinfection.The surface to be disinfected is wetted with a sufficient amount of wipes to completely wet the surface during the indicated exposure time. Only wet wipes shall be used.
Minimum exposure time (4°C, 10°C, 20°C):
- — for the control of bacteria and yeasts: 1 minute
18,0 × 20,0 cm – 2-4 wipes per m2
24,0 × 30,0 cm wipe – 1-2 wipe per m2
4.2.2. Use-specific risk mitigation measures
For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces (up to 1 m2).
The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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
Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 OF THE META SPC 8
5.1. Instructions for use
See use-specific instructions for use.
5.2. Risk mitigation measures
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
See use-specific instructions and measures.
5.4. Instructions for safe disposal of the product and its packaging
See use-specific instructions.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months.
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store below 40°C.
6. OTHER INFORMATION
Please be aware of the European reference value of 129,28 mg/m3 for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicals
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) | Trade name(s) | Trade name(s) | Meliseptol Pro wipes rapid | Meliseptol Pro wipes rapid | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0033840-0010 1-8 | EU-0033840-0010 1-8 | EU-0033840-0010 1-8 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-1-ol | Active substance | Active substance | 71-23-8 | 71-23-8 | 200-746-9 | 25 % (w/w) | |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 20 % (w/w) |
1. META SPC 9 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 9 identifier
| Identifier | Meta SPC: 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 PT04: Food and feed area |
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 (%) |
|---|---|---|---|---|---|
| Propan-1-ol | Active substance | 71-23-8 | 200-746-9 | 30 - 30 % (w/w) | |
| Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 45 - 45 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 9
| Formulation type(s) | AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9
| Hazard statements | H226: Flammable liquid and vapour. H318: Causes serious eye damage. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye/face protection. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTER/doctor if you feel unwell. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations. P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Surface disinfection RTU liquid
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: bacteria Common name: yeasts Common name: Mycobacteria Common name: enveloped viruses |
| Field(s) of use | indoor use The product is applied by spraying or pouring followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other health care institutions such as in patient-near surrounding, ambulances, surgeries and nursing homes, e.g. incl. home-care of patients (excluding food contact surfaces). |
| Application method(s) | Method: spraying or pouring followed by wiping Detailed description: The ready-to-use product is applied by pouring or trigger spraying followed by wiping. |
| Application rate(s) and frequency | undiluted; ready-to-use product Number and timing of application: Application rate: Use sufficient product to ensure complete coverage. 18-21 ml per m2 of surface. For trigger spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2. Frequency: Typical application frequency in a patient room: 1-2 times per day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | pigmented/transparent HDPE bottles, closed with screwed flip top caps of pigmented PP. Sizes: 250/500/1 000 ml (accessory: PP spray head) pigmented/transparent HDPE canister with screwed caps of pigmented HDPE. Sizes: 5 000 ml |
4.1.1. Use-specific instructions for use
It is a ready-to-use surface disinfectant.
Surfaces should be visibly clean prior to disinfection.
The entire surface to be disinfected is wetted with a sufficient amount of the product by pouring or spraying from short distance with a pump spray head as a possible application aid and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (20°C):
- — for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 1 minute
Do not apply more than 21 ml per m2
4.1.2. Use-specific risk mitigation measures
For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces.
The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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
Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 2
Surface disinfection RTU liquid
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Common name: yeasts Common name: bacteria |
| Field(s) of use | indoor use The product is applied by spraying or pouring followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other healthcare institutions, incl. hospital canteens and large kitchens (e.g. food processing, preparation and handling). |
| Application method(s) | Method: spraying or pouring followed by wiping Detailed description: The ready-to-use product is applied by pouring or trigger spraying followed by wiping. |
| Application rate(s) and frequency | undiluted; ready-to-use product Number and timing of application: Application rate: Use sufficient product to ensure complete coverage. 18-21 ml per m2 of surface. For trigger spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2. Frequency: Typical application frequency in a kitchen: 1-2 times per day |
| Category(ies) of users | professional |
| Pack sizes and packaging material | pigmented/transparent HDPE bottles, closed with screwed flip top caps of pigmented PP. Sizes: 250/500/1 000 ml (accessory: PP spray head) pigmented/transparent HDPE canister with screwed caps of pigmented HDPE. Sizes: 5 000 ml |
4.2.1. Use-specific instructions for use
It is a ready-to-use surface disinfectant.
Surfaces should be visibly clean prior to disinfection.
The entire surface to be disinfected is wetted with a sufficient amount of the product by pouring or spraying from short distance with a pump spray head as a possible application aid and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (4°C, 10°C and 20°C):
- — for the control of bacteria and yeasts: 2 minutes
Do not apply more than:
- — 21 ml per m2
4.2.2. Use-specific risk mitigation measures
For professional use only.
Avoid contact with eyes.
Only for treatment of small surfaces (up to 1 m2).
The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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
Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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 ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
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.
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.
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