LegalizeCommission Implementing Regulation (EU) 2025/1905 of 11 September 2025 granting a Union authorisation for the biocidal product family desmanol pure 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.
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
4.4.2. Use-specific risk mitigation measures
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.5. Use description
Table 5
Use #71 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable |
| Field(s) of use | Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- |
| Application rate(s) and frequency | Application Rate: Against bacteria, yeasts, mycobacteria and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: As required (typically 3 applications per day) |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.5.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
The product is restricted to adult use only.
4.5.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.6. Use description
Table 6
Use #72 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable |
| Field(s) of use | Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- |
| Application rate(s) and frequency | Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Number and timing of application: Frequency: as required (typically 3 applications per day) |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.6.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
The product is restricted to adult use only.
4.6.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.7. Use description
Table 7
Use #73 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable |
| Field(s) of use | Indoor use Use #73.1 .: (professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry Use #73.2 .: (professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- |
| Application rate(s) and frequency | Application Rate: Use #73.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #73.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Frequency: Use #73.1.: as required (typically 25 applications per day) Use #73.2.: as required (typically 4 applications per day) Number and timing of application: Frequency: Use #73.1.: as required (typically 25 applications per day) Use #73.2.: as required (typically 4 applications per day) |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.7.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump 3 ml (a palmful) into the palm (1-2 pump strokes). Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) (2-4 pump strokes) of the product into the palm or else pump 5 ml (a cupped hand) into the palm. Rub your hands and forearms for at least 45 seconds. Repeat that step (pouring, rubbing) one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.7.2. Use-specific risk mitigation measures
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.8. Use description
Table 8
Use #74 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable |
| Field(s) of use | Indoor use Use #74.1.: (Professional, industrial): Ready-to-use product for disinfection by hygienic hand rub in health care related areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice, cosmetic studios, elderly care, and in industrial areas like pharma or food production industry. Use #74.2.: (Professional): Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- |
| Application rate(s) and frequency | Application Rate: Use #74.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #74.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #74.1.: as required (typically 25 applications per day) Use #74.2.: as required (typically 4 applications per day) |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.8.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.8.2. Use-specific risk mitigation measures
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.9. Use description
Table 9
Use #75 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells |
| Field(s) of use | Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- |
| Application rate(s) and frequency | Application Rate: Against bacteria and yeasts: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.9.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.9.2. Use-specific risk mitigation measures
4.9.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.9.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.9.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.10. Use description
Table 10
Use #76 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses, viruses (limited spectrum virucidal activity) - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: not applicable |
| Field(s) of use | Indoor use Use #76.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) Use #76.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards), doctor or dental practice |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: --- |
| Application rate(s) and frequency | Application Rate: Use #76.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Use #76.2.: Against bacteria, yeasts, mycobacteria, enveloped viruses, and viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: Use #76.1.: as required (typically 25 applications per day) Use #76.2.: as required (typically 4 applications per day) |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.10.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (incl. activity against enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds.
Surgical hand rub disinfection (incl. activity against viruses (limited spectrum virucidal activity)): Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.10.2. Use-specific risk mitigation measures
4.10.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.10.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.10.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 8
5.1. Instructions for use
Application technique:
- Step 1: Apply the disinfectant and rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
- Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
- Step 3: Open fingers and rub the finger webs. Reverse and repeat action.
- Step 4: Rub palm to palm with fingers interlocked (5 times).
- Step 5: Rub thumb of each hand using a rotating movement.
- Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Do not use the product together with other products.
Always read the label or leaflet before use and follow all the instructions provided.
Keep out of reach of children and non-target animals/pets.
Avoid contact to eyes.
Do not eat, drink or smoke when using this product.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
5.2. Risk mitigation measures
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Particulars of likely direct or indirect effects:
None.
First aid instructions:
General information
Take persons to a safe place. Observe self-protection for first aid. Take off contaminated clothing and shoes immediately. Get medical attention if symptoms occur.
If medical advice is needed, have product container or label at hand.
IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.
Information to Healthcare personnel/doctor: Initiate life support measures if needed,
Most important symptoms and effects, both acute and delayed
Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Vapours have a narcotic effect and may cause headache, fatigue, dizziness and nausea. Coughing. Shortness of breath thereafter call a POISON CENTRE.
Emergency measures to protect the environment:
Avoid spillage of concentrates to soil, surface water or groundwater e.g. through collection pans
Collect escaping product by means of a suitable material (e.g. earth, sand, diatomaceous earth, vermiculite, universal binding agents).
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
In case of contamination of soil or water bodies notify the competent authorities.
Beware of the explosion danger.
Vapours are heavier than air and will spread along ground and collect in low or confined areas (sewers, basements, tanks).
Use non-sparking tools and explosion-proof equipment.
Take precautionary measures against static discharge.
Ensure electrical continuity by bonding and grounding (earthing) all equipment.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of contents/container to a special waste collection point in accordance with local/national/international requirements.
Product residues must be collected and disposed of in accordance with the national waste disposal legislation and any regional and/or local authority requirements.
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Do not empty into drains.
Dilute spills with water and mop up.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
Recommendation for professional use:
P280 Wear eye protection
Please be aware of the European reference value of 129.2 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment of the biocidal product family.
With respect to the “Category (ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
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) | desmanol® pure | desmanol® pure | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Septoderm® liquid | Septoderm® liquid | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Wrights alcohol hand rub | Wrights alcohol hand rub | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Rely alcohol hand rub | Rely alcohol hand rub | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HS Handisinfection liquid | HS Handisinfection liquid | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Profect Hand disinfection liquid | Profect Hand disinfection liquid | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | desmanol® hand disinfection | desmanol® hand disinfection | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | sensiva® hand disinfection liquid | sensiva® hand disinfection liquid | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | desmanol® N hand disinfection | desmanol® N hand disinfection | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | unodent hand disinfection | unodent hand disinfection | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | eurosept hand disinfection | eurosept hand disinfection | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Innocid Händedesinfektion | Innocid Händedesinfektion | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | desmanol® pure pro | desmanol® pure pro | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | desmanol® pure expert | desmanol® pure expert | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | desmanol® pure clever | desmanol® pure clever | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | desmanol® pure universal | desmanol® pure universal | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | desmanol® pure pocket | desmanol® pure pocket | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | desmanol® pure client | desmanol® pure client | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | microshield® hand rub | microshield® hand rub | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | microshield® pure | microshield® pure | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Halasept 792 | Halasept 792 | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0033833-0008 1-8 | EU-0033833-0008 1-8 | EU-0033833-0008 1-8 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 75 % (w/w) |
| 1-Tetradecanol | Tetradecan-1-ol | Non-active substance | Non-active substance | 112-72-1 | 112-72-1 | 204-000-3 | 0,5 % (w/w) |
1. META SPC 9 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 9 identifier
| Identifier | desmanol pure meta SPC9 |
1.2. Suffix to the authorisation number
| Number | 1-9 |
1.3. Product type(s)
| Product type(s) | PT01: Human hygiene |
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-2-ol | Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 75 - 75 % (w/w) |
| 1-Tetradecanol | Tetradecan-1-ol | Non-active substance | 112-72-1 | 204-000-3 | 0,25 - 0,5 % (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 | H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H412: Harmful to aquatic life with long lasting effects. EUH066: Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements | P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical attention. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use #77 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable |
| Field(s) of use | Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - |
| Application rate(s) and frequency | Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.1.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
The product is restricted to adult use only.
4.1.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
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
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.2. Use description
Table 2
Use #78 Hygienic hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable |
| Field(s) of use | Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - |
| Application rate(s) and frequency | Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.2.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm (1-2 pump strokes) or else pump it into the palm. Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
4.2.2. Use-specific risk mitigation measures
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
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.3. Use description
Table 3
Use #79 Surgical hand rub - professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable |
| Field(s) of use | Indoor use Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - |
| Application rate(s) and frequency | Application Rate: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: As required (typically 4 applications per day) |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.3.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product. Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.3.2. Use-specific risk mitigation measures
4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.4. Use description
Table 4
Use #80 Hygienic hand rub - industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable |
| Field(s) of use | Indoor use Ready-to-use product for disinfection by hygienic hand rub in industrial areas, e.g. pharma or food production industry |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - |
| Application rate(s) and frequency | Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 25 applications per day) |
| Category(ies) of users | Industrial |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.4.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
4.4.2. Use-specific risk mitigation measures
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.5. Use description
Table 5
Use #81 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable |
| Field(s) of use | Indoor use Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases) |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - |
| Application rate(s) and frequency | Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: As required (typically 3 applications per day) |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.5.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
The product is restricted to adult use only.
4.5.2. Use-specific risk mitigation measures
Ensure adequate ventilation during and after product application by opening windows or switch on mechanical ventilation at bathroom/kitchen area.
Do not use near domestic animals.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.6. Use description
Table 6
Use #82 Hygienic hand rub - non-professional user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable |
| Field(s) of use | Indoor use Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio). |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - |
| Application rate(s) and frequency | Application Rate: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Number and timing of application: Frequency: as required (typically 3 applications per day) |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.6.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
The product is restricted to adult use only.
4.6.2. Use-specific risk mitigation measures
In case of skin dryness, use appropriate skin care lotion.
4.6.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE) and bag/sachet (PE): 6 days
4.7. Use description
Table 7
Use #83 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable |
| Field(s) of use | Indoor use #Use 83.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) or in industrial areas, e.g. pharma or food production industry #Use 83.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in medical areas like hospitals (including ICU/intensive care unit, pediatric wards etc.), doctor or dental practice |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - |
| Application rate(s) and frequency | Application Rate: #Use 83.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) #Use 83.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: #Use 83.1.: as required (typically 25 applications per day) #Use 83.2.: as required (typically 4 applications per day) |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.7.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
Surgical hand rub disinfection: Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.7.2. Use-specific risk mitigation measures
4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.8. Use description
Table 8
Use #84 Hygienic/surgical hand rub - professional, industrial user - bacteria, yeasts, mycobacteria, enveloped viruses - pouring or pumping - indoor
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: bacteria Development stage: vegetative cells Scientific name: Yeasts Common name: yeasts Development stage: vegetative cells Scientific name: Mycobacteria Common name: Mycobacteria Development stage: vegetative cells Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: not applicable |
| Field(s) of use | Indoor use Use #84.1.: Ready-to-use product for disinfection by hygienic hand rub in health care related areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices, elderly care, cosmetic studio) and in industrial areas, e.g. pharma or food production industry. Use #84.2.: Ready-to-use product for disinfection by surgical hand rub for hand disinfection in health care areas (e.g. hospital, ICU/intensive care unit, pediatric wards, medical practices) |
| Application method(s) | Method: Pouring or pumping (dispenser specification: drop pump/output: drip) Detailed description: - |
| Application rate(s) and frequency | Application Rate: Use #84.1.: Against bacteria, yeasts, and enveloped viruses: 3 ml per disinfection, corresponding to 1.9 g a.s. Contact time: 30 sec. Against mycobacteria: 2 x 3 ml per disinfection, corresponding to 2 x 1.9 g a.s. Contact time: 60 sec. (in total) Use #84.2.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 2 x 5 ml per disinfection, corresponding to 2 x 3.16 g a.s. Contact time: 90 sec. (in total) Number and timing of application: Frequency: #Use 84.1.: as required (typically 25 applications per day) #Use 84.2.: as required (typically 4 applications per day) |
| Category(ies) of users | Industrial Professional |
| Pack sizes and packaging material | Bottle: 50, 60, 75, 95, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials bag/sachet: 40, 50, 90, 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 750, 800, 950, 1 000 ml Packaging: PET/ALU/PE, PET/PE or PET-SiO/PE Closure: PP, PC, PE, HDPE, LDPE or a combination of these materials ; Pump device: PP, PC, PE, HDPE, LDPE, EVA, POM, PBT, stainless steel, silicone, silica gel, NBR, TPE, glass or a combination of these materials Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), PC (polycarbonate), PE (polyethylene), LDPE (low-density polyethylene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate), PET (polyethylene terephthalate), NBR (nitrile butadiene rubber), TPE (thermoplastic elastomer), ALU (aluminium) |
4.8.1. Use-specific instructions for use
The product is ready-to-use. Apply the product only on intact human skin surface. Wash and dry your hands before using the product.
Hygienic hand rub (efficacy against bacteria, yeasts and enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes). Rub for at least 30 seconds. For additional mycobactericidal activity repeat that step one more time.
Surgical hand rub disinfection:
Pour 5 ml (a cupped hand) of the product into the palm or else pump it into the palm (2-4 pump strokes) and rub the hands and forearms. Rub for at least 45 seconds. Repeat that step one more time. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
4.8.2. Use-specific risk mitigation measures
--
4.8.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.8.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
4.8.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Protect from direct sunlight.
Store at room temperature in the original container.
Shelf life:
Bottle (PE), bag/sachet (PE): 6 days
4.9. Use description
Table 9
Use #85 Surgical hand rub - professional user - bacteria, yeasts - pouring or pumping - indoor
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.