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

Image omitted; see official source	Official Journal of the European Union	EN L series
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	2025/1905	3.10.2025

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 [^ntr1-L_202501905EN.000101-E0001], and in particular Article 44(5), first subparagraph, thereof,

Whereas:

• (1) On 19 April 2016, Schülke & Mayr GmbH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘desmanol pure’ of product-type 1, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Austria had agreed to evaluate the application. The application was recorded under case number BC-GA023097-64 in the Register for Biocidal Products.

• (2) ‘desmanol pure’ 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 13 June 2024, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

• (4) On 13 December 2024, the Agency submitted to the Commission its opinion [^ntr2-L_202501905EN.000101-E0002], the draft summary of the biocidal product characteristics (‘SPC’) of ‘desmanol pure’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

• (5) The opinion concludes that ‘desmanol pure’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(6) of that Regulation.

• (6) On 8 January 2025, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

• (7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the 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-0033833-0000 is granted to Schülke & Mayr GmbH for the making available on the market and use of the biocidal product family ‘desmanol pure’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 23 October 2025 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, 11 September 2025.

For the Commission

The President

Ursula VON DER LEYEN

[^ntr1-L_202501905EN.000101-E0001]: OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

[^ntr2-L_202501905EN.000101-E0002]: Opinion of 28 November 2024 on the Union authorisation of the biocidal product family ‘desmanol pure’ (ECHA/BPC/455/2024), https://echa.europa.eu/opinions-on-union-authorisation.

ANNEX

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

Desmanol pure

Product type(s)

PT01: Human hygiene

Authorisation number: EU-0033833-0000

R4BP asset number: EU-0033833-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	desmanol pure

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
Name and address of the authorisation holder	Address	Robert-Koch-Str. 2 22851 Norderstedt DE
Authorisation number		EU-0033833-0000
R4BP asset number		EU-0033833-0000
Date of the authorisation		23 October 2025
Expiry date of the authorisation		30 September 2035

1.4.   Manufacturer(s) of the product

Name of manufacturer	Schülke & Mayr GmbH
Address of manufacturer	Robert-Koch-Str. 2 22851 Norderstedt Germany
Location of manufacturing sites	Schülke & Mayr GmbH site 1 Robert-Koch-Str. 2 22851 Norderstedt Germany
---	---
Name of manufacturer	BOCHEMIE a.s.
Address of manufacturer	Lidická 326 735 95 Bohumín Czechia
Location of manufacturing sites	BOCHEMIE a.s. site 1 Lidická 326 735 95 Bohumín Czechia
---	---
Name of manufacturer	Prisman Chemie GmbH
Address of manufacturer	Otto-Hahn-Ring 6-18 64653 Lorsch Germany
Location of manufacturing sites	Prisman Chemie GmbH site 1 Otto-Hahn-Ring 6-18 64653 Lorsch Germany
---	---
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
Address of manufacturer	Gutenbergring 50-52 22848 Norderstedt Germany
Location of manufacturing sites	Rudolf Dankwardt GmbH site 1 Gutenbergring 50-52 22848 Norderstedt Germany
---	---
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 44643 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	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	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 to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Use #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)	Trade name(s)	Trade name(s)	desmanol® pure	desmanol® pure	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Septoderm® liquid	Septoderm® liquid	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Wrights alcohol hand rub	Wrights alcohol hand rub	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Rely alcohol hand rub	Rely alcohol hand rub	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	HS Handisinfection liquid	HS Handisinfection liquid	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Profect Hand disinfection liquid	Profect Hand disinfection liquid	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	desmanol® hand disinfection	desmanol® hand disinfection	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	sensiva® hand disinfection liquid	sensiva® hand disinfection liquid	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	desmanol® N hand disinfection	desmanol® N hand disinfection	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	unodent hand disinfection	unodent hand disinfection	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	eurosept hand disinfection	eurosept hand disinfection	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Innocid Händedesinfektion	Innocid Händedesinfektion	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	desmanol® pure pro	desmanol® pure pro	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	desmanol® pure expert	desmanol® pure expert	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	desmanol® pure clever	desmanol® pure clever	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	desmanol® pure universal	desmanol® pure universal	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	desmanol® pure pocket	desmanol® pure pocket	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	desmanol® pure client	desmanol® pure client	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	microshield® hand rub	microshield® hand rub	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	microshield® pure	microshield® pure	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Halasept 792	Halasept 792	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0033833-0001 1-1	EU-0033833-0001 1-1	EU-0033833-0001 1-1
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Propan-2-ol	Propan-2-ol	Active substance	Active substance	67-63-0	67-63-0	200-661-7	75 % (w/w)
1-Tetradecanol	Tetradecan-1-ol	Non-active substance	Non-active substance	112-72-1	112-72-1	204-000-3	0,5 % (w/w)

1. META SPC 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	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 to in accordance with local and national regulations. P501: Dispose of container to in accordance with local and national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Use #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

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

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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

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