Commission Implementing Regulation (EU) 2026/1429 of 30 June 2026 granting a Union authorisation for the biocidal product family Lyso IPA Hand Disinfection in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2026-06-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval, pharmaceutical product








L_202601429EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/1429


22.7.2026







            COMMISSION IMPLEMENTING REGULATION (EU) 2026/1429
of 30 June 2026
         
granting a Union authorisation for the biocidal product family ‘Lyso IPA Hand Disinfection’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:







(1)


On 22 June 2016, Schuelke & Mayr GmbH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘Lyso IPA Hand Disinfection’, of product-type 1, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-VT025199-03 in the Register for Biocidal Products. The application referred to the biocidal product family ‘desmanol pure’ authorised by Commission Implementing Regulation (EU) 2025/1905 (3), with authorisation number EU-0033833-0000.












(2)


The biocidal product family ‘Lyso IPA Hand Disinfection’ contains propan-2-ol as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 1.












(3)


On 11 February 2025, the Agency submitted to the Commission its opinion (4) and the draft summary of product characteristics (‘SPC’), in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.












(4)


In the opinion, the Agency concludes that the proposed differences between the biocidal product family ‘Lyso IPA Hand Disinfection’ and the related reference biocidal product family ‘desmanol pure’ are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (5), and that based on the assessment of the related reference biocidal product family ‘desmanol pure’ and subject to compliance with the draft SPC, the same biocidal product family ‘Lyso IPA Hand Disinfection’ meets the conditions laid down in Article 19(6) of Regulation (EU) No 528/2012.












(5)


On 13 November 2025, the Agency transmitted to the Commission the revised draft SPC of the biocidal product family ‘Lyso IPA Hand Disinfection’ in all the official languages of the Union, in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(6)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family ‘Lyso IPA Hand Disinfection’.












(7)


The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference biocidal product family ‘desmanol pure’.












(8)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0034272-0000 is hereby granted to Schuelke & Mayr GmbH for the making available on the market and use of the same biocidal product family ‘Lyso IPA Hand Disinfection’ in accordance with the summary of the product characteristics set out in the Annex.
The Union authorisation is valid from 11 August 2026 until 30 September 2035.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 June 2026.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj).

(3)  Commission 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 (OJ L, 2025/1905, 3.10.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/1905/oj).

(4)  European Chemicals Agency opinion of 11 February 2025 on the Union authorisation of the same biocidal product family ‘Lyso IPA Hand Disinfection’, UBP-C-1793933-11-00/F, https://echa.europa.eu/fr/opinions-on-applications-for-union-authorisation.

(5)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).




ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
Lyso IPA Hand Disinfection

Product type(s)

PT01: Human hygiene

Authorisation number: EU-0034272-0000

R4BP asset number: EU-0034272-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION
1.1.   Family name







Name


Lyso IPA Hand Disinfection




1.2.   Product type(s)







Product type(s)


PT01: Human hygiene




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Schuelke & Mayr GmbH




Address


Robert-Koch-Str. 2 22851 Norderstedt DE




Authorisation number


 


EU-0034272-0000





R4BP asset number



 


EU-0034272-0000




Date of the authorisation


 


11 August 2026




Expiry date of the authorisation


 


30 September 2035




1.4.   Manufacturer(s) of the product







Name of manufacturer


A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH




Address of manufacturer


Otto-Brenner-Straße 16 21337 Lüneburg Germany




Location of manufacturing sites


A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH site 1 Otto-Brenner-Straße 16 21337 Lüneburg Germany













Name of manufacturer


Lysoform Dr. Hans Rosemann GmbH




Address of manufacturer


Kaiser-Wilhelm-Straße 133 12247 Berlin Germany




Location of manufacturing sites


Lysoform Dr. Hans Rosemann GmbH site 1 Kaiser-Wilhelm-Straße 133 12247 Berlin Germany













Name of manufacturer


Sterisol AB




Address of manufacturer


Kronoängsgatan 3 592 23 Vadstena Sweden




Location of manufacturing sites


Sterisol AB site 1 Kronoängsgatan 3 592 23 Vadstena Sweden













Name of manufacturer


Rudolf Dankwardt GmbH - Jessenitz




Address of manufacturer


Lagerstr. 15 19249 Jessenitz - Werk / Lübtheen Germany




Location of manufacturing sites


Rudolf Dankwardt GmbH - Jessenitz site 1 Lagerstr. 15 19249 Jessenitz - Werk / Lübtheen Germany




1.5.   Manufacturer(s) of the active substance(s)







Active substance


Propan-2-ol




Name of manufacturer


Ineos Solvents Germany GmbH (formerly Sasol)




Address of manufacturer


Römerstraße 733 47443 Moers Germany




Location of manufacturing sites







Ineos Solvents Germany GmbH (formerly Sasol) site 1 Römerstraße 733 47443 Moers Germany




Ineos Solvents Germany GmbH (formerly Sasol) site 2 Shamrockstr. 88 44623 Herne Germany

















Active substance


Propan-2-ol




Name of manufacturer


Shell Chemicals Europe B.V.




Address of manufacturer


Postbus 2334 3000 CH Rotterdam Netherlands (the)




Location of manufacturing sites


Shell Chemicals Europe B.V. site 1 BV/Shell Nederland Raffinaderij B.V. Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the)




2.   PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1.   Qualitative and quantitative information on the composition of the family











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,1 - 75 % (w/w)




1-Tetradecanol


Tetradecan-1-ol


Non-active substance


112-72-1


204-000-3


0 - 0,5 % (w/w)




2.2.   Type(s) of formulation







Formulation type(s)


AL Any other liquid




PART II

SECOND INFORMATION LEVEL META SPC(S)

1.   META SPC 1 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 1 identifier







Identifier


desmanol pure meta SPC1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT01: Human hygiene




2.   META SPC 1 COMPOSITION
2.1.   Qualitative and quantitative information on the composition of the meta SPC 1











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




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 1







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1






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 in accordance with local and national regulations.
P501: Dispose of container in accordance with local and national regulations.




4.   AUTHORISED USE(S) OF THE META SPC
4.1.   Use description


Table 1


Use #1 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: HDPE
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. 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.
4.1.2.   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 (HDPE): 36 months
4.2.   Use description


Table 2


Use #2 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, 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 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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. 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.3.   Use description


Table 3


Use #3 Surgical hand rub – professional user – bacteria, yeasts, mycobacteria, 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
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 viruses (limited spectrum 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:
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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 5 ml (a cupped hand) into the palm (2-4 pump strokes). Rub your hands and forearms for at least 45 seconds. Repeat the 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 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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.4.   Use description


Table 4


Use #4 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, 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 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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. 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.5.   Use description


Table 5


Use #5 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: HDPE
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 (HDPE): 36 months
4.6.   Use description


Table 6


Use #6 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: HDPE
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.
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 (HDPE): 36 months
4.7.   Use description


Table 7


Use #7 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 #7.1.: (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 #7.2.: (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 #7.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #7.2.: 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 #7.1.: as required (typically 25 applications per day)
Use #7.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.8.   Use description


Table 8


Use #8 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 #8.1.: (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 #8.2.: (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 #8.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #8.2.: 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 #8.1.: as required (typically 25 applications per day)
Use #8.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.9.   Use description


Table 9


Use #9 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.10.   Use description


Table 10


Use #10 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 #10.1.: 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 # 10.2.: 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 #10.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #10.2.: 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 #10.1.: as required (typically 25 applications per day)
Use #10.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1
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 1
7.1.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


Schülke® 1


 




Authorisation number


 


EU-0034272-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


75 % (w/w)




1-Tetradecanol


Tetradecan-1-ol


Non-active substance


112-72-1


204-000-3


0,5 % (w/w)




1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


desmanol pure meta SPC2




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT01: Human hygiene




2.   META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




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 2







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







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 in accordance with local and national regulations.
P501: Dispose of container in accordance with local and national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use #11 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: HDPE
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 (HDPE): 36 months
4.2.   Use description


Table 2


Use #12 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.3.   Use description


Table 3


Use #13 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.4.   Use description


Table 4


Use #14 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.5.   Use description


Table 5


Use #15 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: HDPE
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 (HDPE): 36 months
4.6.   Use description


Table 6


Use #16 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: HDPE
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 (HDPE): 36 months
4.7.   Use description


Table 7


Use #17 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
Field of use description:
#Use 17.1.: 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 17.2.: 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 17.1.: 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 17.2.: 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 17.1.: as required (typically 25 applications per day)
#Use 17.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.8.   Use description


Table 8


Use #18 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 #18.1.: 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 #18.2.: 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 #18.1.: 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 #18.2.: 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 18.1.: as required (typically 25 applications per day)
#Use 18.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.9.   Use description


Table 9


Use #19 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 (2-4 pump strokes) it into the palm 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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.10.   Use description


Table 10


Use #20 Hygienic/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
Use #20.1.: 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 #20.2.: 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 #20.1.: 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 #20.2.: 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 #20.1.: as required (typically 25 applications per day)
Use #20.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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: Efficacy against bacteria, yeasts and enveloped viruses: Pour 3 ml 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 (2-4 pump strokes) it into the palm 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.11.   Use description


Table 11


Use #21 Hygienic hand rub – non-professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
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 (in case of special cases, e.g. conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 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: HDPE
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)




4.11.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.11.2.   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.
Avoid disinfection in the presence of children < 6 years.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.11.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.11.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.11.5.   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 (HDPE): 36 months
4.12.   Use description


Table 12


Use #22 Hygienic hand rub – professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable




Field(s) of use


indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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)




4.12.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




4.12.2.   Use-specific risk mitigation measures

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

—
4.12.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.12.5.   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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.13.   Use description


Table 13


Use #23 Hygienic hand rub – non-professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable




Field(s) of use


indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 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: HDPE
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)




4.13.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.13.2.   Use-specific risk mitigation measures

In case of skin dryness, use appropriate skin care lotion.
4.13.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.13.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.13.5.   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 (HDPE): 36 months
4.14.   Use description


Table 14


Use #24 Hygienic hand rub – professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable




Field(s) of use


indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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)




4.14.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




4.14.2.   Use-specific risk mitigation measures

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

—
4.14.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.14.5.   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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2

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 2

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













Trade name(s)


Schülke® 2


 




Authorisation number


 


EU-0034272-0002 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


75 % (w/w)




1-Tetradecanol


Tetradecan-1-ol


Non-active substance


112-72-1


204-000-3


0,5 % (w/w)




1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


desmanol pure meta SPC3




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT01: Human hygiene




2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


75 - 75 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 3







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
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.
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 in accordance with local and national regulations.
P501: Dispose of container in accordance with local and national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use #25 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: HDPE
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. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
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 (HDPE): 36 months
4.2.   Use description


Table 2


Use #26 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, 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 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.3.   Use description


Table 3


Use #27 Surgical hand rub – professional user – bacteria, yeasts, mycobacteria, 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
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 viruses (limited spectrum 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:
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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 (2-4 pump strokes) it into the palm 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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.4.   Use description


Table 4


Use #28 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, 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 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.5.   Use description


Table 5


Use #29 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: HDPE
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 it into the palm (1-2 pump strokes) and rub the hands. 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 (HDPE): 36 months
4.6.   Use description


Table 6


Use #30 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: HDPE
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 it into the palm (1-2 pump strokes) and rub the hands. 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 (HDPE): 36 months
4.7.   Use description


Table 7


Use #31 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 #31.1.: (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 #31.2.: (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 #31.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #31.2.: 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 #31.1.: as required (typically 25 applications per day)
Use #31.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 it into the palm (1-2 pump strokes) and rub the hands. 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 (2-4 pump strokes) it into the palm 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.8.   Use description


Table 8


Use #32 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 #32.1.: 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 #32.2.: 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 #32.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #32.2.: 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 #32.1: as required (typically 25 applications per day)
Use #32.2: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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) and rub the hands. 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 (2-4 pump strokes) it into the palm 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.9.   Use description


Table 9


Use #33 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 (2-4 pump strokes) it into the palm 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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.10.   Use description


Table 10


Use #34 Hygienic/surgical hand rub – professional 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 #34.1.: 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 #34.2.: 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 #34.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #34.2.: 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 #34.1.: as required (typically 25 applications per day)
Use #34.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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) and rub the hands. 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 (2-4 pump strokes) it into the palm 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 3

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 3

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













Trade name(s)


Schülke® 3


 




Authorisation number


 


EU-0034272-0003 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


75 % (w/w)




1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier







Identifier


desmanol pure meta SPC4




1.2.   Suffix to the authorisation number







Number


1-4




1.3.   Product type(s)







Product type(s)


PT01: Human hygiene




2.   META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


75 - 75 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 4







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4







Hazard statements


H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
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.
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 in accordance with local and national regulations.
P501: Dispose of container in accordance with local and national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use #35 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: HDPE
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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 (HDPE): 36 months
4.2.   Use description


Table 2


Use #36 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.3.   Use description


Table 3


Use #37 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 (2-4 pump strokes) it into the palm and rub the hands. 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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.4.   Use description


Table 4


Use #38 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.5.   Use description


Table 5


Use #39 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: HDPE
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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 (HDPE): 36 months
4.6.   Use description


Table 6


Use #40 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: HDPE
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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 (HDPE): 36 months
4.7.   Use description


Table 7


Use #41 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 #41.1.: 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 #41.2.: 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 #41.1.: 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 #41.2.: 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 41.1.: as required (typically 25 applications per day)
#Use 41.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 (2-4 pump strokes) it into the palm 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.8.   Use description


Table 8


Use #42 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 #42.1.: 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 #42.2.: 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 #42.1.: 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 #42.2.: 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 #42.1.: as required (typically 25 applications per day)
Use #42.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 (2-4 pump strokes) it into the palm 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.9.   Use description


Table 9


Use #43 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 (2-4 pump strokes) it into the palm 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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.10.   Use description


Table 10


Use #44 Hygienic/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
Use #44.1.: 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 #44.2.: 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 #44.1.: 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 #44.2.: 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 #44.1.: as required (typically 25 applications per day)
Use #44.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 (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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 (2-4 pump strokes) it into the palm 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.11.   Use description


Table 11


Use #45 Hygienic hand rub – non-professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
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/special case: conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 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: HDPE
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)




4.11.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.11.2.   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.
Avoid disinfection in the presence of children < 6 years.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.11.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.11.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.11.5.   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 (HDPE): 36 months
4.12.   Use description


Table 12


Use #46 Hygienic hand rub – non-professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable




Field(s) of use


indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 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: HDPE
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)




4.12.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.12.2.   Use-specific risk mitigation measures

In case of skin dryness, use appropriate skin care lotion.
4.12.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.12.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.12.5.   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 (HDPE): 36 months
4.13.   Use description


Table 13


Use #47 Hygienic hand rub – professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable




Field(s) of use


indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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)




4.13.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




4.13.2.   Use-specific risk mitigation measures

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

—
4.13.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.13.5.   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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.14.   Use description


Table 14


Use #48 Hygienic hand rub – non-professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
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/special case: conjunctivitis).




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 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: HDPE
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)




4.14.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.14.2.   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.
Avoid disinfection in the presence of children < 6 years.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.14.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.14.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.14.5.   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 (HDPE): 36 months
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 4

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 4

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













Trade name(s)


Schülke® 4


 




Authorisation number


 


EU-0034272-0004 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


75 % (w/w)




1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier







Identifier


desmanol pure meta SPC5




1.2.   Suffix to the authorisation number







Number


1-5




1.3.   Product type(s)







Product type(s)


PT01: Human hygiene




2.   META SPC 5 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 5











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,1 - 63,1 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 5







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5







Hazard statements


H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
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.
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 in accordance with local and national regulations.
P501: Dispose of container in accordance with local and national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use #49 Hygienic hand rub – non-professional user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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
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: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 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: HDPE
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, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy 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 (HDPE): 36 months
4.2.   Use description


Table 2


Use #50 Hygienic hand rub – professional user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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
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: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.3.   Use description


Table 3


Use #51 Surgical hand rub – professional user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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
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: 2 x 5 mL per disinfection, corresponding to 2 x 2,76 g a.s. Contact time 180 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.4.   Use description


Table 4


Use #52 Hygienic hand rub – industrial user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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
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: Bactericidal, yeasticidal, virucidal activity against enveloped viruses,: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.5.   Use description


Table 5


Use #53 Hygienic hand rub – non-professional user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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
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: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 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: HDPE
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 (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy 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 (HDPE): 36 months
4.6.   Use description


Table 6


Use #54 Hygienic hand rub – non-professional user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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
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: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 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: HDPE
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: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy 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 (HDPE): 36 months
4.7.   Use description


Table 7


Use #55 Hygienic/surgical hand rub – professional, industrial user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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 #55.1.: 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 like pharma or food production industry.
Use #55.2.: 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 #55.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Use #55.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
Use #55.1.: as required (typically 25 applications per day)
Use #55.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy 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 (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.8.   Use description


Table 8


Use #56 Hygienic/surgical hand rub – professional, industrial user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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 #56.1.: 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 like pharma or food production industry.
Use #56.2.: 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 #56.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Use #56.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
Use #56.1.: as required (typically 25 applications per day)
Use #56.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
Surgical hand rub:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.9.   Use description


Table 9


Use #57 Surgical hand rub – professional user – bacteria, yeasts, fungi – 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: Fungi
Common name: fungi
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: Bactericide, yeasticide, fungicide: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
4.10.   Use description


Table 10


Use #58 Hygienic/surgical hand rub – professional user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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 #58.1.: 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 #58.2.: 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 #58.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Use #58.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
Use #58.1.: as required (typically 25 applications per day)
Use #58.2.: 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: HDPE
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
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP 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 (efficacy against bacteria, yeasts, enveloped viruses): Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
Surgical hand rub:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 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.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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 (HDPE), canister (HDPE), drum (HDPE), IBC (HDPE with steel frame): 36 months
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 5

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 5

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













Trade name(s)


Schülke® 5


 




Authorisation number


 


EU-0034272-0005 1-5




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,1 % (w/w)




1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier







Identifier


desmanol pure meta SPC6




1.2.   Suffix to the authorisation number







Number


1-6




1.3.   Product type(s)







Product type(s)


PT01: Human hygiene




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-2-ol


 


Active substance


67-63-0


200-661-7


63,14 - 63,14 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 6







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6







Hazard statements


H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
EUH208: Contains Isoeugenol. May produce an allergic reaction.




Precautionary statements


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.
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 in accordance with local and national regulations.
P501: Dispose of container in accordance with local and national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use #59 Hygienic hand rub – professional user – bacteria, yeasts, tuberculosis bacteria, 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: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2,76 g a.s. Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 25 applications per day)




Category(ies) of users


professional




Pack sizes and packaging material


Bottle: 125, 500, 1 000  ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)




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. Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




4.1.2.   Use-specific risk mitigation measures

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

—
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: 36 months
4.2.   Use description


Table 2


Use #60 Surgical hand rub – professional user – bacteria, yeasts, tuberculosis bacteria, 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: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 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: 125, 500, 1 000  ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)




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. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
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: 36 months
4.3.   Use description


Table 3


Use #61 Hygienic/surgical hand rub – professional user – bacteria, yeasts, tuberculosis bacteria, 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: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable




Field(s) of use


indoor use
Use #61.1.: 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 #61.2.: 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 #61.1.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2,76 g a.s. Contact time: 30 sec. Use #61.2.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
Use #61.1.: as required (typically 25 applications per day)
Use #61.2.: as required (typically 4 applications per day)




Category(ies) of users


professional




Pack sizes and packaging material


Bottle: 125, 500, 1 000  ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)




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.
Hygienic hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds.
Surgical hand rub: Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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: 36 months
4.4.   Use description


Table 4


Use #62 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 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 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: 125, 500, 1 000  ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)




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. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
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: 36 months
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 6

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 6

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













Trade name(s)


Manorapid® r.f.u.


 




 


Neoseptin r.f.u.


 




 


Novosept r.f.u.


 




 


Novoseptin r.f.u.


 




 


Lyorthol r.f.u.


 




 


Desocid r.f.u.


 




 


Cosmo r.f.u.


 




 


Fordesin r.f.u.


 




 


Skin-Des r.f.u.


 




 


Dermorapid r.f.u.


 




 


Dermoguard r.f.u.


 




 


Aldovet r.f.u.


 




 


Vetfarm r.f.u.


 




 


MDI r.f.u.


 




 


Antiseptica r.f.u.


 




 


Saltero r.f.u.


 




 


Prop70 r.f.u.


 




 


Sterisol Isoprop


 




 


MENNO® DERM I-PA


 




 


Actoderm


 




Authorisation number


 


EU-0034272-0006 1-6




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,14 % (w/w)




1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier







Identifier


desmanol pure meta SPC7




1.2.   Suffix to the authorisation number







Number


1-7




1.3.   Product type(s)







Product type(s)


PT01: Human hygiene




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-2-ol


 


Active substance


67-63-0


200-661-7


63,14 - 63,14 % (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


H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
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.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
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 in accordance with local and national regulations.
P501: Dispose of container in accordance with local and national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use #63 Hygienic hand rub – professional user – bacteria, yeasts, tuberculosis bacteria, 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: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2,76 g a.s. Contact time: 30 sec.
Number and timing of application:
Frequency:
As required (typically 25 applications per day)




Category(ies) of users


professional




Pack sizes and packaging material


Bottle: 125, 500, 1 000  ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)




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. Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




4.1.2.   Use-specific risk mitigation measures

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

—
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: 36 months
4.2.   Use description


Table 2


Use #64 Surgical hand rub – professional user – bacteria, yeasts, tuberculosis bacteria, 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: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 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: 125, 500, 1 000  ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)




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. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
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: 36 months
4.3.   Use description


Table 3


Use #65 Hygienic/surgical hand rub – professional user – bacteria, yeasts, tuberculosis bacteria, 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: Tuberculosis bacteria
Common name: Tuberculosis bacteria
Development stage: vegetative cells
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: not applicable




Field(s) of use


indoor use
Use #65.1.: 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 #65.2.: 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 #65.1.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 5 ml per disinfection, corresponding to 2,76 g a.s. Contact time: 30 sec. Use #65.2.: Against bacteria, yeasts, tuberculosis bacteria, and enveloped viruses: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total)
Number and timing of application:
Frequency:
Use #65.1.: as required (typically 25 applications per day)
Use #65.2.: as required (typically 4 applications per day)




Category(ies) of users


professional




Pack sizes and packaging material


Bottle: 125, 500, 1 000  ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)




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.
Hygienic hand rub: Pour 5 ml (a cupped hand) of the product into the palm or else pump it (2-4 pump strokes) into the palm. Rub for at least 30 seconds.
Surgical hand rub: Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.
5-30 l canister, 220 l drum, 1 000 l container: Refill or transfer to other containers/devices as needed.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number;










—


The trade name of the biocidal product;










—


The identity and content of each active ingredient;










—


The instructions for use, including the incorporation time required for the biocidal action;










—


The information according to CLP.




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: 36 months
4.4.   Use description


Table 4


Use #66 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 disinfection product 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 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 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: 125, 500, 1 000  ml
Packaging: HDPE
Closure: Clack cap: PP or Pump device: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Canister: 5, 10, 20, 30 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
Drum: 220 l
Packaging: HDPE
Closure: HDPE, LDPE, PP or a combination of these materials
IBC: 1 000  l
Packaging: HDPE with steel frame
Closure: HDPE, LDPE, PP or a combination of these materials
Abbreviations: HDPE (high-density polyethylene), PP (polypropylene), LDPE, PE-LD (low-density polyethlene), EVA (ethylene vinyl acetate), POM (polyoxymethylene), PBT (polybutylene terephthalate)




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. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands and forearms. Rub for at least 30 seconds. Repeat that step one more time.
Decanting/refilling of the biocidal product for surgical hand rub use should only be done under aseptic conditions.
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: 36 months
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 7

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 7

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













Trade name(s)


Manorapid® pure


 




 


Desocid pure


 




 


Neoseptin pure


 




 


Novosept pure


 




 


Novoseptin pure


 




 


Lyorthol pure


 




 


Cosmo pure


 




 


Fordesin pure


 




 


Saltero pure


 




 


Prop70 pure


 




 


Skin-Des pure


 




 


Dermorapid pure


 




 


Dermoguard pure


 




 


Aldovet pure


 




 


Vetfarm pure


 




 


MDI pure


 




 


Antiseptica pure


 




 


Sterisol Isoprop pure


 




 


Des HD


 




 


MENNO® DERM I-P


 




 


Plurasept HD


 




 


Opynol


 




Authorisation number


 


EU-0034272-0007 1-7




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,14 % (w/w)




1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier







Identifier


desmanol pure meta SPC8




1.2.   Suffix to the authorisation number







Number


1-8




1.3.   Product type(s)







Product type(s)


PT01: Human hygiene




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-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 8







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8







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 in accordance with local and national regulations.
P501: Dispose of container in accordance with local and national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use #67 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)




4.1.1.   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. 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.
4.1.2.   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 #68 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, 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 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. 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.
4.2.2.   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 #69 Surgical hand rub – professional user – bacteria, yeasts, mycobacteria, 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
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 viruses (limited spectrum 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:
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 5 ml (a cupped hand) into the palm (2-4 pump strokes). Rub your hands and forearms for at least 45 seconds. Repeat the 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.
4.3.2.   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 #70 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, 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 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. 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)


Schülke® 1


 




Authorisation number


 


EU-0034272-0008 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


75 % (w/w)




1-Tetradecanol


Tetradecan-1-ol


Non-active substance


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


 


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 in accordance with local and national regulations.
P501: Dispose of container 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







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 (2-4 pump strokes) it into the palm 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 #86 Hygienic/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
Use #86.1.: 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 #86.2.: 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 #86.1.: 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 #86.2.: 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 #86.1.: as required (typically 25 applications per day)
Use #86.2.: 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)




4.10.1.   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 (efficacy against bacteria, yeasts and enveloped viruses):
Pour 3 ml 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 (2-4 pump strokes) it into the palm 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
4.11.   Use description


Table 11


Use #87 Hygienic hand rub – non-professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
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 (in case of special cases, e.g. conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 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)




4.11.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.11.2.   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.
Avoid disinfection in the presence of children < 6 years.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.11.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.11.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.11.5.   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
4.12.   Use description


Table 12


Use #88 Hygienic hand rub – professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable




Field(s) of use


indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 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)




4.12.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
4.12.2.   Use-specific risk mitigation measures

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

—
4.12.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.12.5.   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
4.13.   Use description


Table 13


Use #89 Hygienic hand rub – non-professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable




Field(s) of use


indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 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)




4.13.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.13.2.   Use-specific risk mitigation measures

In case of skin dryness, use appropriate skin care lotion.
4.13.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.13.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.13.5.   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
4.14.   Use description


Table 14


Use #90 Hygienic hand rub – professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable




Field(s) of use


indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 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)




4.14.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
4.14.2.   Use-specific risk mitigation measures

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

—
4.14.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.14.5.   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 9

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 9

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













Trade name(s)


Schülke® 2


 




Authorisation number


 


EU-0034272-0009 1-9




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


75 % (w/w)




1-Tetradecanol


Tetradecan-1-ol


Non-active substance


112-72-1


204-000-3


0,5 % (w/w)




1.   META SPC 10 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 10 identifier







Identifier


desmanol pure meta SPC10




1.2.   Suffix to the authorisation number







Number


1-10




1.3.   Product type(s)







Product type(s)


PT01: Human hygiene




2.   META SPC 10 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 10











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


75 - 75 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 10







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10







Hazard statements


H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
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.
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 in accordance with local and national regulations.
P501: Dispose of container in accordance with local and national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use #91 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: Ready-to-use product for disinfection by hygienic hand rub in private area/health care in domestic areas (e.g. in case of diseases)
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)




4.1.1.   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. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
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 #92 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, 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 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. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds.
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 #93 Surgical hand rub – professional user – bacteria, yeasts, mycobacteria, 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
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 limited spectrum 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:
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 (2-4 pump strokes) it into the palm 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 #94 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


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, 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 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. Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. 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 #95 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 it into the palm (1-2 pump strokes) and rub the hands. 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) and bag/sachet (PE): 6 days
4.6.   Use description


Table 6


Use #96 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 it into the palm (1-2 pump strokes) and rub the hands. 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) and bag/sachet (PE): 6 days
4.7.   Use description


Table 7


Use #97 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 #97.1.: (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 #97.2.: (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 #97.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #97.2.: 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 #97.1.: as required (typically 25 applications per day)
Use #97.2.: 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 it into the palm (1-2 pump strokes) and rub the hands. 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 (2-4 pump strokes) it into the palm 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 #98 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 #98.1.: 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 #98.2.: 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 #98.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #98.2.: 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 #98.1: as required (typically 25 applications per day)
Use #98.2: 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) and rub the hands. 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 (2-4 pump strokes) it into the palm 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 #99 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 (2-4 pump strokes) it into the palm 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 #100 Hygienic/surgical hand rub – professional 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 #100.1.: 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 #100.2.: 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 #100.1.: Against bacteria, yeasts, mycobacteria, and enveloped viruses: 3 ml per disinfection, corresponding to 1,9 g a.s. Contact time: 30 sec. Use #100.2.: 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 #100.1.: as required (typically 25 applications per day)
Use #100.2.: 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)




4.10.1.   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) and rub the hands. 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 (2-4 pump strokes) it into the palm 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 10

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 10

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













Trade name(s)


Schülke® 3


 




Authorisation number


 


EU-0034272-0010 1-10




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


75 % (w/w)




1.   META SPC 11 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 11 identifier







Identifier


desmanol pure meta SPC11




1.2.   Suffix to the authorisation number







Number


1-11




1.3.   Product type(s)







Product type(s)


PT01: Human hygiene




2.   META SPC 11 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 11











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


75 - 75 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 11







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11







Hazard statements


H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
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.
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 in accordance with local and national regulations.
P501: Dispose of container in accordance with local and national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use #101 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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 #102 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 or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 #103 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 (2-4 pump strokes) it into the palm 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 #104 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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 #105 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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 #106 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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 #107 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 #107.1.: 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 #107.2.: 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 #107.1.: 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 #107.2.: 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 107.1.: as required (typically 25 applications per day)
#Use 107.2.: 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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 (2-4 pump strokes) it into the palm 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 #108 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 #108.1.: 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 #108.2.: 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 #108.1.: 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 #108.2.: 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 #108.1.: as required (typically 25 applications per day)
Use #108.2.: 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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 (2-4 pump strokes) it into the palm 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 #109 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 (2-4 pump strokes) it into the palm 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 #110 Hygienic/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
Use #110.1.: 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 #110.2.: 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 #110.1.: 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 #110.2.: 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 #110.1.: as required (typically 25 applications per day)
Use #110.2.: 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)




4.10.1.   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 (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) and rub the hands. Rub for at least 30 seconds. For additional mycobactericidal efficacy 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 (2-4 pump strokes) it into the palm 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
4.11.   Use description


Table 11


Use #111 Hygienic hand rub – non-professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
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/special case: conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 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)




4.11.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.11.2.   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.
Avoid disinfection in the presence of children < 6 years.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.11.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.11.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.11.5.   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
4.12.   Use description


Table 12


Use #112 Hygienic hand rub – non-professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable




Field(s) of use


indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 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)




4.12.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.12.2.   Use-specific risk mitigation measures

In case of skin dryness, use appropriate skin care lotion.
4.12.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.12.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.12.5.   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
4.13.   Use description


Table 13


Use #113 Hygienic hand rub – professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
Development stage: not applicable




Field(s) of use


indoor use
Ready-to-use product for disinfection by hygienic hand rub in health care areas like medical practices (only in special cases, e.g. conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 sec. (in total)
Number and timing of application:
Frequency:
As required (typically 3 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)




4.13.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
4.13.2.   Use-specific risk mitigation measures

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

—
4.13.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.13.5.   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
4.14.   Use description


Table 14


Use #114 Hygienic hand rub – non-professional user – 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: Viruses (limited spectrum virucidal activity)
Common name: Viruses (limited spectrum virucidal activity)
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/special case: conjunctivitis)




Application method(s)


Method: Pouring or pumping (dispenser specification: drop pump/output: drip)
Detailed description:
—




Application rate(s) and frequency


Application Rate: Against viruses (limited spectrum of virucidal activity): 2 x 5 ml per disinfection, corresponding to 2 x 3,16 g a.s. Contact time: 120 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)




4.14.1.   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 (2-4 pump strokes) it into the palm and rub the hands. Rub for at least 60 seconds. Repeat that step one more time.
The product is restricted to adult use only.
4.14.2.   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.
Avoid disinfection in the presence of children < 6 years.
In case of skin dryness, use appropriate skin care lotion.
Use is restricted for adults only.
4.14.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—
4.14.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

—
4.14.5.   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
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 11

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 11

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













Trade name(s)


Schülke® 4


 




Authorisation number


 


EU-0034272-0011 1-11




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


75 % (w/w)




1.   META SPC 12 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 12 identifier







Identifier


desmanol pure meta SPC12




1.2.   Suffix to the authorisation number







Number


1-12




1.3.   Product type(s)







Product type(s)


PT01: Human hygiene




2.   META SPC 12 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 12











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,1 - 63,1 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 12







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12







Hazard statements


H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
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.
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 in accordance with local and national regulations.
P501: Dispose of container in accordance with local and national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use #115 Hygienic hand rub – non-professional user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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
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: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 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, enveloped viruses:
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy 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 #116 Hygienic hand rub – professional user – bacteria, yeasts, fungi, tuberculosis bacteria, enveloped viruses, viruses (limited spectrum virucidal activit)y – 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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
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: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 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, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy 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 #117 Surgical hand rub – professional user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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
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: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time 180 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. Make sure that your hands and forearms are kept moist by the product for the entire application time.
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 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 #118 Hygienic hand rub – industrial user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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
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: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 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, enveloped viruses: Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy 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 #119 Hygienic hand rub – non-professional user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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
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: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 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.
Hygienic hand rub (efficacy against bacteria, yeasts, enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy 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

—
4.6.   Use description


Table 6


Use #120 Hygienic hand rub – non-professional user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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
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: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 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.
Hygienic hand rub:
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy 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 #121 Hygienic/surgical hand rub – professional, industrial user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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 #121.1.: 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 like pharma or food production industry.
Use #121.2.: 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 #121.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Use #121.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
Use #121.1.: as required (typically 25 applications per day)
Use #121.2.: 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:
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy 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 (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 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 #122 Hygienic/surgical hand rub – professional, industrial user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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 #122.1.: 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 like pharma or food production industry.
Use #122.2.: 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 #122.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Use #122.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
Use #122.1.: as required (typically 25 applications per day)
Use #122.2.: 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, enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
Surgical hand rub:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 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 #123 Surgical hand rub – professional user – bacteria, yeasts, fungi – 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: Fungi
Common name: fungi
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: Bactericide, yeasticide, fungicide: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 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 (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 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 #124 Hygienic/surgical hand rub – professional user – bacteria, yeasts, fungi, tuberculosis bacteria, 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: Fungi
Common name: fungi
Development stage: vegetative cells
Scientific name: Tuberculosis bacteria
Common name: Tuberculosis bacteria
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 #124.1.: 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 #124.2.: 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:
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Application rate(s) and frequency


Application Rate: Use #124.1.: Bactericidal, yeasticidal, virucidal activity against enveloped viruses: 3 ml per disinfection, corresponding to 1,65 g a.s. Contact time: 30 sec. Limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy: 2 x 3 ml per disinfection, corresponding to 2 x 1,65 g a.s. Contact time: 60 sec. (in total) Use #124.2.: 2 x 5 ml per disinfection, corresponding to 2 x 2,76 g a.s. Contact time: 180 sec. (in total)
Number and timing of application:
Frequency:
Use #124.1.: as required (typically 25 applications per day)
Use #124.2.: 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)




4.10.1.   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 (efficacy against bacteria, yeasts, enveloped viruses):
Pour 3 ml (a palmful) of the product into the palm or else pump it into the palm (1-2 pump strokes) and rub the hands. Rub for at least 30 seconds. For additional limited spectrum virucidal activity, fungicidal and tuberculocidal efficacy repeat that step one more time.
Surgical hand rub:
Pour 5 ml (a cupped hand) of the product into the palm or else pump (2-4 pump strokes) it into the palm and rub the hands and forearms. Rub for at least 90 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

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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

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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 12

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

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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

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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 12

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













Trade name(s)


Schülke® 5


 




Authorisation number


 


EU-0034272-0012 1-12




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,1 % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2026/1429/oj
ISSN 1977-0677 (electronic edition)