Commission Implementing Regulation (EU) 2025/2200 of 21 October 2025 amending Implementing Regulation (EU) 2022/1186 as regards administrative changes to the Union authorisation of the biocidal product family L+R Propanol PT1 Family

ANNEXSUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
Propanol PT1 Family
Product type(s)
PT01: Human hygiene
Authorisation number : EU-0027466-00
R4BP asset number : EU-0027466-0000
PART I
FIRST INFORMATION LEVEL
1.   ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
Propanol PT1 Family
1.2.    Product type(s)
Product type(s)
PT01: Human hygiene
1.3.    Authorisation holder
1.4.
Manufacturer(s) of the product
Name and address of the authorisation holder
Name
Schülke & Mayr GmbH
Address
Robert-Koch-Str. 2 22851 Norderstedt Germany
Authorisation number
EU-0027466-00
R4BP asset number
EU-0027466-0000
Date of the authorisation
31.7.2022
Expiry date of the authorisation
30.6.2032
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
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
1.5.    Manufacturer(s) of the active substance(s)
Active substance
Propan-2-ol
Name of manufacturer
INEOS Solvent Germany GmbH
Address of manufacturer
Römerstrasse 733 47443 Moers Germany
Location of manufacturing sites
INEOS Solvent Germany GmbH site 1 INEOS Solvent Germany GmbH, Römerstrasse 733 47443 Moers Germany
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 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)
Active substance
Propan-1-ol
Name of manufacturer
OQ Chemicals GmbH (formerly OXEA)
Address of manufacturer
Rheinpromenade 4a 40789 Monheim am Rhein Germany
Location of manufacturing sites
OQ Chemicals GmbH (formerly OXEA) site 1 OQ Chemicals Corporation, 2001 FM 3057 (formerly OXEA Corporation) TX 77414-2968 Bay City United States (the)
Active substance
Propan-1-ol
Name of manufacturer
Sasol Chemie GmbH & Co. KG
Address of manufacturer
Secunda Chemical Operations, Sasol Place, 50 Katherine Street 2090 Sandton South Africa
Location of manufacturing sites
Sasol Chemie GmbH & Co. KG site 1 Secunda Chemical Operations, PDP Kruger Street 2302 Secunda South Africa
Active substance
Propan-1-ol
Name of manufacturer
BASF SE
Address of manufacturer
Carl-Bosch-Str. 38 67056 Ludwigshafen Germany
Location of manufacturing sites
BASF SE site 1 BASF SE, Carl-Bosch-Str. 38 67056 Ludwigshafen Germany
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
45 - 45 % (w/w)
Propan-1-ol
Active substance
71-23-8
200-746-9
30 - 30 % (w/w)
Tetradecanol
Myristil alcohol
Non-active substance
112-72-1
204-000-3
0 - 0,95 % (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
Meta SPC: meta SPC 1
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
45 - 45 % (w/w)
Propan-1-ol
Active substance
71-23-8
200-746-9
30 - 30 % (w/w)
Tetradecanol
Myristil alcohol
Non-active substance
112-72-1
204-000-3
0,95 - 0,95 % (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
H226: Flammable liquid and vapour.
H318: Causes serious eye damage.
H412: Harmful to aquatic life with long lasting effects.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P261: Avoid breathing vapours.
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.
P310: Immediately call a POISON CENTER / doctor.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of container to an approved waste disposal plant.
4.   AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Hygienic handrub
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant.
Target organism(s) (including development stage)
Scientific name: other
Common name: Bacteria
Development stage: no data
Scientific name: other
Common name: Yeasts
Development stage: no data
Scientific name: other
Common name: Mycobacteria
Development stage: no data
Scientific name: other
Common name: viruses (limited spectrum of virucidal activity)
Development stage: no data
Field(s) of use
indoor use
—
hospitals and other health care institutions, ambulances, surgeries, nursing homes (including home-care of patients),
—
hospital canteens, large kitchens, pharmaceutical industries, production sites, laboratories: hygienic handrub onto visibly clean and dry hands.
—
for professional use only.
Application method(s)
Method: manual application
Detailed description:
Rubbing
Application rate(s) and frequency
Application Rate:
Dosage: At least 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Minimum contact time: 30 sec
ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users
industrial
professional
Pack sizes and packaging material
100 ml, 500 ml and 1 000  ml in transparent HDPE bottles with PP flip top cap.
4.1.1.    Use-specific instructions for use
The products can be applied directly, or the products can be used in a dispenser or with a pump.
For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.
4.1.2.    Use-specific risk mitigation measures
See general directions for use of meta SPC 1
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 1
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 1
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use of meta SPC 1
4.2.    Use description
Table 2
Surgical handrub
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant.
Target organism(s) (including development stage)
Scientific name: other
Common name: Bacteria
Development stage: no data
Scientific name: other
Common name: Yeasts
Development stage: no data
Scientific name: other
Common name: Mycobacteria
Development stage: no data
Scientific name: other
Common name: viruses (limited spectrum of virucidal activity)
Development stage: no data
Field(s) of use
indoor use
hospitals and other health care institutions: surgical handrub onto visibly clean and dry hands and forearms.
For professional use only.
Application method(s)
Method: manual application
Detailed description:
Rubbing
Application rate(s) and frequency
Application Rate:
Dosage: in portions of 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Minimum exposure time: 90s
ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users
professional
Pack sizes and packaging material
100 ml, 500 ml and 1 000  ml in transparent HDPE bottles with PP flip top cap.
4.2.1.    Use-specific instructions for use
The products can be applied directly or the products can be used in a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
4.2.2.    Use-specific risk mitigation measures
See general directions for use of meta SPC 1
4.2.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 1
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 1
4.2.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use of meta SPC 1
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1.    Instructions for use
For professional use only.
5.2.    Risk mitigation measures
Avoid contact with eyes.
Keep out of reach of children.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water. for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
After spilling: Take up with absorbent material (for example sand, kieselgur, universal binder). When picked up, treat material as prescribed under “Disposal considerations”.
5.4.    Instructions for safe disposal of the product and its packaging
Residuals must be removed from packaging and when emptied completely disposed of in accordance with the regulations for waste removal.
Incompletely emptied packaging must be disposed of in the form of disposal specified by the regional disposer.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Technical measures and storage conditions:
Shelf-life: 36 months
Keep container tightly closed and dry in a cool, well-ventilated place. Protect from direct sunlight.
Recommended storage temperature: 0-30°C
Requirements for storage rooms and vessels:
Containers which are opened must be carefully closed and kept upright to prevent leakage. Always keep in containers of same material as the original one.
Advice on storage assembly:
Do not store together with: oxidizing substances; spontaneously combusting substances.
6.   OTHER INFORMATION
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)
desmanol protect
Market area: EU
desmanol plus
Market area: EU
desmanol pro
Market area: EU
desmanol ultra
Market area: EU
desmanol clinpure
Market area: EU
desmanol advanced
Market area: EU
desmanol ethanolfree
Market area: EU
desmanol pro pure
Market area: EU
sensiva protect
Market area: EU
virusept protect
Market area: EU
septoderm
Market area: EU
microshield
Market area: EU
Halasept 710
Market area: EU
Authorisation number
EU-0027466-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
45 % (w/w)
Propan-1-ol
Active substance
71-23-8
200-746-9
30 % (w/w)
Tetradecanol
Myristil alcohol
Non-active substance
112-72-1
204-000-3
0,95 % (w/w)
1.   META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
Meta SPC: meta SPC 2
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
45 - 45 % (w/w)
Propan-1-ol
Active substance
71-23-8
200-746-9
30 - 30 % (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
H226: Flammable liquid and vapour.
H318: Causes serious eye damage.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P261: Avoid breathing vapours.
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.
P310: Immediately call a POISON CENTER/doctor.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of container to an approved waste disposal plant.
4.   AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Hygienic handrub
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: other
Common name: Bacteria
Development stage: no data
Scientific name: other
Common name: Yeasts
Development stage: no data
Scientific name: other
Common name: Mycobacteria
Development stage: no data
Scientific name: other
Common name: viruses (limited spectrum of virucidal activity)
Development stage: no data
Field(s) of use
indoor use
—
hospitals and other health care institutions, ambulances, surgeries, nursing homes (including home-care of patients),
—
hospital canteens, large kitchens, pharmaceutical industries, production sites, laboratories: hygienic handrub onto visibly clean and dry hands.
—
for professional use only.
Application method(s)
Method: manual application
Detailed description:
Rubbing
Application rate(s) and frequency
Application Rate:
Dosage: At least 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per= 3 ml). Minimum exposure time: 30s
ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users
industrial
professional
Pack sizes and packaging material
100 ml, 500 ml and 1 000  ml in transparent HDPE bottles with PP flip top cap.
4.1.1.    Use-specific instructions for use
The products can be applied directly or the products can be used with a dispenser or with a pump.
For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.
4.1.2.    Use-specific risk mitigation measures
See general directions for use of meta SPC 2
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 2
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 2
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use of meta SPC 2
4.2.    Use description
Table 2
Surgical handrub
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Not relevant.
Target organism(s) (including development stage)
Scientific name: other
Common name: Bacteria
Development stage: no data
Scientific name: other
Common name: Yeasts
Development stage: no data
Scientific name: other
Common name: Mycobacteria
Development stage: no data
Scientific name: other
Common name: viruses (limited spectrum of virucidal activity)
Development stage: no data
Field(s) of use
indoor use
Hospitals and other health care institutions: surgical handrub onto visibly clean and dry hands and forearms.
For professional use only.
Application method(s)
Method: manual application
Detailed description:
Rubbing
Application rate(s) and frequency
Application Rate:
Dosage: in portions of 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Minimum exposure time: 90s
ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users
professional
Pack sizes and packaging material
100 ml, 500 ml and 1 000  ml in transparent HDPE bottles with PP flip top cap.
4.2.1.    Use-specific instructions for use
The products can be applied directly or the products can be used with a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
4.2.2.    Use-specific risk mitigation measures
See general directions for use of meta SPC 2.
4.2.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use of meta SPC 2.
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use of meta SPC 2.
4.2.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use of meta SPC 2.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1.    Instructions for use
For professional use only
5.2.    Risk mitigation measures
Avoid contact with eyes.
Keep out of reach of children.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water. for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
After spilling: Take up with absorbent material (for example sand, kieselgur, universal binder). When picked up, treat material as prescribed under “Disposal considerations”.
5.4.    Instructions for safe disposal of the product and its packaging
Residuals must be removed from packaging and when emptied completely disposed of in accordance with the regulations for waste removal.
Incompletely emptied packaging must be disposed of in the form of disposal specified by the regional disposer.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Technical measures and storage conditions:
Shelf-life: 36 months
Keep container tightly closed and dry in a cool, well-ventilated place. Protect from direct sunlight.
Recommended storage temperature: 0-30°C
Requirements for storage rooms and vessels:
Containers which are opened must be carefully closed and kept upright to prevent
leakage. Always keep in containers of same material as the original one.
Advice on storage assembly:
Do not store together with: oxidizing substances; spontaneously combusting substances
6.   OTHER INFORMATION
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)
desmanol pure protect
Market area: EU
desmanol pure+
Market area: EU
desmanol pure pro
Market area: EU
desmanol pure guard
Market area: EU
desmanol expert
Market area: EU
desmanol pure ultra
Market area: EU
desmanol EF
Market area: EU
desmanol clear
Market area: EU
sensiva pure
Market area: EU
virusept pure
Market area: EU
septoderm pure
Market area: EU
microshield pure
Market area: EU
Halasept 720
Market area: EU
Authorisation number
EU-0027466-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
45 % (w/w)
Propan-1-ol
Active substance
71-23-8
200-746-9
30 % (w/w)
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
desmanol pure universal
Market area: EU
desmanol pure plus
Market area: EU
desmanol pure expert
Market area: EU
desmanol proshield
Market area: EU
desmanol healthcare
Market area: EU
desmanol duo
Market area: EU
desmanol EtOH-free
Market area: EU
desmanol zero
Market area: EU
sensiva pure+
Market area: EU
virusept expert
Market area: EU
septoderm pure+
Market area: EU
microshield pure+
Market area: EU
Halasept 740
Market area: EU
Authorisation number
EU-0027466-0003 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
45 % (w/w)
Propan-1-ol
Active substance
71-23-8
200-746-9
30 % (w/w)
Commission Implementing Regulation (EU) 2025/2200 of 21 October 2025 amending Implementing Regulation (EU) 2022/1186 as regards administrative changes to the Union authorisation of the biocidal product family L+R Propanol PT1 Family

Schedules & Appendices

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