Commission Implementing Regulation (EU) 2025/1885 of 11 September 2025 granting a Union authorisation for the biocidal product family BPF Propan-2-ol Dr Deppe in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

ANNEXSUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
BPF Propan-2-ol Dr Deppe
Product type(s)
PT01: Human hygiene
Authorisation number : EU-0033834-0000
R4BP asset number : EU-0033834-0000
PART I
FIRST INFORMATION LEVEL
1.   ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
BPF Propan-2-ol Dr Deppe
1.2.    Product type(s)
Product type(s)
PT01: Human hygiene
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
Laboratorium Dr. Deppe GmbH
Address
Hooghe Weg 35 47906 Kempen DE
Authorisation number
EU-0033834-0000
R4BP asset number
EU-0033834-0000
Date of the authorisation
9 October 2025
Expiry date of the authorisation
30 September 2035
1.4.    Manufacturer(s) of the product
Name of manufacturer
Laboratorium Dr. Deppe GmbH
Address of manufacturer
Hooghe Weg 35 47906 Kempen Germany
Location of manufacturing sites
Laboratorium Dr. Deppe GmbH site 1
Laboratorium Dr. Deppe GmbH, Hooghe Weg 35 47906 Kempen Germany
Laboratorium Dr. Deppe GmbH site 2
Laboratorium Dr. Deppe GmbH, Am Selder 35 47906 Kempen Germany
1.5.    Manufacturer(s) of the active substance(s)
Active substance
Propan-2-ol
Name of manufacturer
Brenntag GmbH
Address of manufacturer
Stinnes-Platz 1 45472 Muelheim an der Ruhr Germany
Location of manufacturing sites
Brenntag GmbH site 1
Shell Nederland Raffinaderij B.V., Vondelingenweg 601, Vondelingenplaat 3196KK Rotterdam Netherlands (the)
Brenntag GmbH site 2
Exxon Mobil Chemical Plant, 4999 Scenic Highway LA 70805 Baton Rouge United States (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
63,14 -64 % (w/w)
2.2.    Type(s) of formulation
Formulation type(s)
AL Any other liquid
XX: wipes impregnated with liquid, ready-to-use
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
63,14 -64 % (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.
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.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical, ventilating, lighting equipment.
P243: Take actions to prevent static discharges.
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.
P312: Call a POISON CENTER / doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P370+P378: In case of fire: Use CO 2 , dry chemical, or foam to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to conform with local / regional / national / international regulations.
4.   AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use # 1.1 – Hygienic Handrub, General – BP01
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
n/a
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Tuberculosis bacteria
Common name: Yeasts
Common name: Enveloped viruses
Field(s) of use
Indoor use
In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.:
—
Domestic use
—
Recreational areas
Application method(s)
Method: Handrub (hygienic), liquid dispensing onto hands
Detailed description:
The product is ready to use (RTU).
Application rate(s) and frequency
Application Rate:
Adults and children of 12 years and above: 3 ml. The amount of liquid shall resemble the size of a large-sized coin (The number of pumps with the dosing system equivalent to 3 ml of the product to be specified by the authorisation holder within the product information).
Children under 12 years: 1,5 ml (The number of pumps with the dosing system equivalent to 1,5 ml of the product to be specified by the authorisation holder within the product information).
RTU
Number and timing of application:
Frequency:
Adults and children of 12 years and above: Up to 10 × per day
Children under 12 years: Up to 3 × per day
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
—
1 000  ml bottle – high density polyethylene (HDPE) + polypropylene (PP) screw cap (with and without low density polyethylene (LDPE) nozzle)
—
500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)
—
250 ml bottle – HDPE + PP screw flip top cap
—
150 ml bottle – HDPE + PP screw flip top cap
—
100 ml bottle – HDPE + PP screw flip top cap
Abbreviations:
HDPE: high density polyethylene
LDPE: low density polyethylene
PP: polypropylene
4.1.1.    Use-specific instructions for use
The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.
The product is ready-to-use. The product shall be either applied directly or used in a dispenser or with a pump.
Step 1: Apply the following amount of disinfectant:
—
Adults and children of 12 years and above: 3 ml
—
Children under 12 years: 1,5 ml
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.
Keep wet for 30 seconds against bacteria, yeast, tuberculosis bacteria and enveloped viruses.
Do not rinse.
Repeat if renewed hand disinfection is required.
Adults and children of 12 years and above: up to 10 × per day
Children under 12 years: up to 3 × per day
4.1.2.    Use-specific risk mitigation measures
Use for children (age > 1 year) only under supervision of an adult.
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
Use #1.2 – Hygienic Handrub, Professional – BP01
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
n/a
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Tuberculosis bacteria
Common name: Yeasts
Common name: Enveloped viruses
Field(s) of use
Indoor use
In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.:
—
Domestic use (home care etc.);
—
Institutional use (research etc.);
—
Industrial applications, e.g. food, cosmetic, pharmaceutical industry etc.;
—
Restaurants and large-scale/canteen kitchens;
—
Recreational areas.
Application method(s)
Method: Handrub (hygienic), liquid dispensing onto hands
Detailed description:
The product is ready to use (RTU).
Application rate(s) and frequency
Application Rate:
Adult: 3 ml. The amount of liquid shall resemble the size of a large-sized coin (The number of pumps with the dosing system equivalent to 3 ml of the product to be specified by the authorisation holder within the product information).
RTU
Number and timing of application:
Frequency: Adult: Up to 25 × per day
Category(ies) of users
Professional
Pack sizes and packaging material
—
5 000  ml canister - HDPE + HDPE screw cap
—
1 000  ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)
—
500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)
—
250 ml bottle – HDPE + PP screw flip top cap
—
150 ml bottle – HDPE + PP screw flip top cap
—
100 ml bottle – HDPE + PP screw flip top cap
4.2.1.    Use-specific instructions for use
The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.
The product is ready-to-use. The product shall be either applied directly or used in a dispenser or with a pump.
Step 1: Apply the following amount of disinfectant:
—
Adult: 3 ml
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.
Keep wet for 30 seconds against bacteria, yeast, tuberculosis bacteria and enveloped viruses.
Do not rinse.
Repeat if renewed hand disinfection is required (Adult: Up to 25 × per day).
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.
Transferring the content of larger packages to e.g. dispenser vessels is possible as far as hygienic requirements for the ambient conditions and for the materials used are met and contamination of the product can be safely excluded.
The canister must be equipped with canister pump dispenser or canister valve. The smaller vessel shall be fitted with a funnel.
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
See general directions for use of Meta SPC1.
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.
4.3.    Use description
Table 3
Use #1.3 – Surgical Handrub – BP01
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
n/a
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Tuberculosis bacteria
Common name: Yeasts
Common name: Enveloped viruses
Field(s) of use
Indoor use
Surgical handrub
Application method(s)
Method: Handrub (surgical), liquid dispensing onto hands and lower arms
Detailed description:
The product is ready to use (RTU).
Application rate(s) and frequency
Application Rate:
6-12 ml for 90 seconds contact time
RTU
Number and timing of application:
Frequency: Up to 4 × per day.
Category(ies) of users
Professional
Pack sizes and packaging material
—
5 000  ml canister – HDPE + HDPE screw cap
—
1 000  ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)
—
500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)
—
250 ml bottle – HDPE + PP screw flip top cap
—
150 ml bottle – HDPE + PP screw flip top cap
—
100 ml bottle – HDPE + PP screw flip top cap
4.3.1.    Use-specific instructions for use
The product shall be used on visibly clean hands and lower arms. If hands are dirty, wash with soap and water, rinse and dry before applying the product.
Rub undiluted solution on skin to keep hands and lower arms moist for 90 seconds.
Use sufficient product to ensure complete coverage during contact time. This may vary with hand size and skin condition.
Approximately 6-12 ml are needed for 90 seconds contact time.
Refilling/decanting of the product shall only be done under aseptic conditions.
The canister must be equipped with canister pump dispenser or canister valve.
The smaller vessel shall be fitted with a funnel.
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
See general directions for use of Meta SPC 1.
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
See general directions for use of Meta SPC 1.
4.3.4.    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.
4.3.5.    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
See use-specific instructions for each use.
Comply with the instructions for use.
5.2.    Risk mitigation measures
All handling shall only take place in well-ventilated areas.
In case of skin dryness, use appropriate skin care lotion.
Avoid contact with eyes.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
If medical advice is needed, have product container or label at hand.
In case of fire: Use CO 2 , dry chemical, or foam to extinguish.
Dispose of contents/container according to local / regional / national / international regulations.
First aid:
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.
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.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Waste disposal code: 070604
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children and non-target animals/pets.
Store in the dark. Keep cool. Do not store at temperatures exceeding 35 °C.
Shelf life: 3 years
6.   OTHER INFORMATION
Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No: 67-63-0) which was used for the risk assessment of the biocidal product family.
Professionals (including industrial, professionals) mean trained professional 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)
OP Sept Color
Market area: EU
Op Sept Blau
Market area: EU
Teva Sept Skin poly-alkoholos bőrfertőtlenítő (színezett)
Market area: EU
Authorisation number
EU-0033834-0001 1-1
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)
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
OP Sept residue-free
Market area: EU
Curacid HD-sept
Market area: EU
Manorapid pure
Market area: EU
Op Sept pur
Market area: EU
Op Sept pure
Market area: EU
Authorisation number
EU-0033834-0002 1-1
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)
7.3.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
OP Sept Classic
Market area: EU
Camed HD-Plus
Market area: EU
Curacid Poly
Market area: EU
Dezodent HW
Market area: EU
Dr. Desi Händedesinfektion
Market area: EU
Kühn Händedesinfektion
Market area: EU
Kühn Händedesinfektion
Market area: EU
Maimed Clean
Market area: EU
Manorapid Basic
Market area: EU
Manorapid r.f.u.
Market area: EU
Op Derm
Market area: EU
Op Derm Medical
Market area: EU
Op Sept
Market area: EU
OPSept
Market area: EU
OP-Sept
Market area: EU
Septomed
Market area: EU
Teva Sept Hand
Market area: EU
Teva Sept Hand
Market area: EU
Teva Sept Skin poly-alkoholos bőrfertőtlenítő és sebészi bemosakodó (színezetlen)
Market area: EU
Alcoman
Market area: EU
Alcoman +
Market area: EU
Alcoman Optima
Market area: EU
Alcoman Plus
Market area: EU
Hand Antiseptic
Market area: EU
Hand Disinfection
Market area: EU
Hände Antiseptikum
Market area: EU
Händedesinfektion
Market area: EU
MyClean IP-Sept
Market area: EU
MyClean OP-Sept
Market area: EU
Sicu Sept
Market area: EU
Actoderm
Market area: EU
OP Sept perfume-free
Market area: EU
OpSeptClassic - parfumfrei
Market area: EU
Authorisation number
EU-0033834-0003 1-1
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 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
63,14 -64 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 2
Formulation type(s)
XX: wipes impregnated with liquid, ready-to-use
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.
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.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical, ventilating, lighting equipment.
P243: Take actions to prevent static discharges.
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.
P312: Call a POISON CENTER / doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P370+P378: In case of fire: Use CO 2 , dry chemical, or foam to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to conform with local / regional / national / international regulations.
4.   AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use #2.1 – Hygienic Handrub, General – BP02
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
n/a
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Tuberculosis bacteria
Common name: Yeasts
Common name: Enveloped viruses
Field(s) of use
Indoor use
In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.:
—
Domestic use (home care etc.);
—
Recreational areas.
Application method(s)
Method: Handrub (hygienic), Wiping
Detailed description:
Ready to use (RTU) wipes.
Application rate(s) and frequency
Application Rate:
Use one wipe to disinfect hands.
RTU wipes
Number and timing of application:
Frequency: Up to 9 wipes per day.
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Small wipes:
Pack sizes: 6 / 12 / 15 / 30 / 48 / 60 / 72 / or 84 wipes per package
Total volume of biocide in package: 51,38 / 102,75 / 128,44 / 256,88 / 411,01 / 513,76 / 616,51 / or 719,26 ml
Package material: Polyethylene terephthalate/aluminium/low density polyethylene (PET/Alu/LDPE) laminated foil
Wipe material: 100 % Lyocell (white fabric, a fiber regenerated from 100 % wood cellulose)
Wipe size: 20 × 15 cm
Wipe weight: 1,5 g (per wipe)
Impregnation liquid weight: 7,5 g (per wipe)
Large wipes:
Pack sizes: 30 / 42 / 60 / 80 or 84 wipes per package
Total volume of biocide in package: 513,76 / 719,26 / 1 027,51 / 1 370,02 or 1 438,52  ml
Package material: PET/Alu/LDPE laminated foil
Wipe material: 100 % Lyocell (white fabric, a fiber regenerated from 100 % wood cellulose)
Wipe size: 20 × 30 cm
Wipe weight: 3 g (per wipe)
Impregnation liquid weight: 15 g (per wipe)
4.1.1.    Use-specific instructions for use
See general directions for use of Meta SPC 2.
4.1.2.    Use-specific risk mitigation measures
Use for children (age > 1 year) only under supervision of an adult.
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 direction 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
Use #2.2 – Hygienic Handrub, Professional – BP02
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
n/a
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Tuberculosis bacteria
Common name: Yeasts
Common name: Enveloped viruses
Field(s) of use
Indoor use
In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.:
—
Domestic use (home care etc.);
—
Institutional use (research etc.);
—
Industrial applications, e.g. food, cosmetic, pharmaceutical industry etc.;
—
Restaurants and large-scale/canteen kitchens;
—
Recreational areas.
Application method(s)
Method: Handrub (hygienic), Wiping
Detailed description:
Ready to use (RTU) wipes.
Application rate(s) and frequency
Application Rate:
Use one wipe to disinfect hands.
RTU wipes
Number and timing of application:
Frequency: Typically 25 applications per day
Category(ies) of users
Professional
Pack sizes and packaging material
Small wipes:
Pack sizes: 6 / 12 / 15 / 30 / 48 / 60 / 72 / or 84 wipes per package
Total volume of biocide in package: 51,38 / 102,75 / 128,44 / 256,88 / 411,01 / 513,76 / 616,51 / or 719,26 ml
Package material: PET/Alu/LDPE laminated foil
Wipe material: 100 % Lyocell (white fabric, a fiber regenerated from 100 % wood cellulose)
Wipe size: 20 × 15 cm
Wipe weight: 1,5 g (per wipe)
Impregnation liquid weight: 7,5 g (per wipe)
Large wipes:
Pack sizes: 30 / 42 / 60 / 80 / or 84 wipes per package
Total volume of biocide in package: 513,76 / 719,26 / 1 027,51 / 1 370,02 / or 1 438,52  ml
Package material: Polyethylene terephthalate (PET)/Alu/LDPE laminated foil
Wipe material: 100 % Lyocell (white fabric, a fiber regenerated from 100% wood cellulose)
Wipe size: 20 × 30 cm
Wipe weight: 3 g (per wipe)
Impregnation liquid weight: 15 g (per wipe)
4.2.1.    Use-specific instructions for use
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.
See the general use instructions of Meta SPC 2.
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
Comply with the instructions for use.
The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.
The wipes are ready-to-use. Only wet wipes are efficacious, dried wipes are to be discarded. Rub hands evenly with one wipe to keep hands moist for 30 seconds.
Please ensure that also all spaces between the fingers, the fingernail angles and skin folds are moistened completely and over the entire exposure time.
5.2.    Risk mitigation measures
All handling shall only take place in well-ventilated areas.
Used wipes must be disposed in a closed container.
In case of skin dryness, use appropriate skin care lotion.
Avoid contact with eyes.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
If medical advice is needed, have product container or label at hand.
In case of fire: Use CO 2 , dry chemical, or foam to extinguish.
Dispose of contents/container according to local / regional / national / international regulations.
Keep out of reach of children and non-target animals/pets.
First aid:
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, thereafter call a POISON CENTRE.
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.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements
Waste disposal code: 070604
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children and non-target animals/pets.
Store in the dark. Keep cool. Do not store at temperatures exceeding 40 °C.
Shelf life: 1 year
6.   OTHER INFORMATION
Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No: 67-63-0) which was used for the risk assessment of the biocidal product family.
Professionals (including industrial, professionals) mean trained professional 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)
OPSept Medical
Market area: EU
Alcohol Wipes
Market area: EU
Alcoman Tücher
Market area: EU
Alcoman Wipes
Market area: EU
Chucky Wipes
Market area: EU
Deppe Wipes
Market area: EU
Desi Wipes
Market area: EU
IP-Wipes
Market area: EU
Op Sept Medical
Market area: EU
Op Sept Wipes
Market area: EU
OPSept medical perfume-free
Market area: EU
Authorisation number
EU-0033834-0004 1-2
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 3 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 3 identifier
Identifier
Meta SPC: meta SPC 3
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
64 -64 % (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.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical, ventilating, lighting equipment.
P243: Take actions to pevent static discharges.
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.
P312: Call a POISON CENTER / doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical POISON CENTER / doctor.
P370+P378: In case of fire: Use CO 2 , dry chemical, or foam to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to conform with local / regional / national / international regulations.
4.   AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
Use #3.1 – Hygienic Handrub, General – BP03
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
n/a
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Enveloped viruses
Field(s) of use
Indoor use
In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.:
—
Domestic use (home care etc.);
—
Recreational areas.
Application method(s)
Method: Handrub (hygienic), gel dispensing onto hands
Detailed description:
The product is ready to use (RTU).
Application rate(s) and frequency
Application Rate:
Adults and children of 12 years and above: 3 ml. The amount of gel shall resemble the size of a large-sized coin (The number of pumps with the dosing system equivalent to 3 ml of the product to be specified by the authorisation holder within the product information).
Children under 12 years: 1,5 ml (The number of pumps with the dosing system equivalent to 1,5 ml of the product to be specified by the authorisation holder within the product information).
RTU
Number and timing of application:
Frequency:
Adults and children of 12 years and above: Up to 10 × per day
Children under 12 years: Up to 3 × per day
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
—
1 000  ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)
—
1 000  ml bottle – HDPE + PP/PE dosing cap
—
500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)
—
150 ml bottle – HDPE + PP screw flip top cap
—
100 ml bottle – HDPE+ PP screw flip top cap
4.1.1.    Use-specific instructions for use
The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.
The product is ready-to-use.
Step 1: Apply the following amount of disinfectant:
—
Adult and children of 12 years and above: 3 ml
—
Child under 12 years: 1,5 ml
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.
Keep wet for 30 sec against bacteria, yeast and enveloped viruses.
Do not rinse.
Repeat if renewed hand disinfection is required.
Adults and children of 12 years and above: up to 10 × per day
Children under 12 years: up to 3 × per day
4.1.2.    Use-specific risk mitigation measures
Use for children (age > 1 year) only under supervision of an adult.
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 3.
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 3.
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 3.
4.2.    Use description
Table 2
Use #3.2 – Hygienic Handrub, Professional – BP03
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
n/a
Target organism(s) (including development stage)
Common name: Bacteria
Common name: Yeasts
Common name: Enveloped viruses
Field(s) of use
Indoor use
In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.:
—
Domestic use (home care etc.);
—
Institutional use (research etc.);
—
Industrial applications, e.g. food, cosmetic, pharmaceutical industry etc.;
—
Restaurants and large-scale/canteen kitchens;
—
Recreational areas.
Application method(s)
Method: Handrub (hygienic), gel dispensing onto hands
Detailed description:
The product is ready to use (RTU).
Application rate(s) and frequency
Application Rate:
Adult: 3 ml. The amount of gel shall resemble the size of a large-sized coin (The number of pumps with the dosing system equivalent to 3 ml of the product to be specified by the authorisation holder within the product information).
RTU
Number and timing of application:
Frequency:
Adult: Typically 25 applications per day.
Category(ies) of users
Professional
Pack sizes and packaging material
—
1 000  ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)
—
1 000  ml bottle – HDPE + PP/PE dosing cap
—
500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)
—
150 ml bottle – HDPE + PP screw flip top cap
—
100 ml bottle – HDPE + PP screw flip top
4.2.1.    Use-specific instructions for use
The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.
The product is ready-to-use. The product shall be either applied directly or used in a dispenser or with a pump.
Step 1: Apply the following amount of disinfectant:
—
Adult: 3 ml
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.
Keep wet for 30 sec against bacteria, yeast and enveloped viruses.
Do not rinse.
Repeat if renewed hand disinfection is required.
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.
4.2.2.    Use-specific risk mitigation measures
See general directions for use of Meta SPC 3.
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 3.
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 3.
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 3.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1.    Instructions for use
See use-specific instructions for each use.
Comply with the instructions for use.
5.2.    Risk mitigation measures
All handling shall only take place in well-ventilated areas.
In case of skin dryness, use appropriate skin care lotion.
Avoid contact with eyes.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
If medical advice is needed, have product container or label at hand.
In case of fire: Use CO 2 , dry chemical, or foam to extinguish.
Dispose of contents/container according to local / regional / national / international regulations.
First aid:
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, thereafter call a POISON CENTRE.
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.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements
Waste disposal code: 070604
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children and non-target animals/pets.
Store in the dark. Keep cool. Do not store at temperatures exceeding 35 °C.
Shelf life: 3 years
6.   OTHER INFORMATION
Please be aware of the European reference value of 129,2 mg/m 3 for the active substance propan-2-ol (CAS No: 67-63-0) which was used for the risk assessment of the biocidal product family.
Professionals (including industrial, professionals) mean trained professional 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)
Lotio Sept Gel
Market area: EU
Alco Gel
Market area: EU
Care Sept Gel
Market area: EU
Lotio-Sept-Gel
Market area: EU
Manorapid gel
Market area: EU
Op Sept Gel
Market area: EU
SeptoMed Gel
Market area: EU
Sicu Gel
Market area: EU
Sicu Sept Gel
Market area: EU
Teva Lotio Sept Gel
Market area: EU
Tork Alcohol Gel
Market area: EU
Alcohol Gel
Market area: EU
Alcoman-Gel
Market area: EU
Alkohol Gel
Market area: EU
antiseptic gel
Market area: EU
Deppe Gel
Market area: EU
Desinfektionsgel
Market area: EU
desinfizierendes Handgel
Market area: EU
Händedesinfektionsgel
Market area: EU
Handgel
Market area: EU
Hygienegel
Market area: EU
Hygienic Hand Gel
Market area: EU
Actoderm Gel
Market area: EU
Lotio Sept Gel perfume-free
Market area: EU
Lotio Sept Gel pur
Market area: EU
Lotio Sept Gel pure
Market area: EU
Manorapid gel pure
Market area: EU
Authorisation number
EU-0033834-0005 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
64 % (w/w)
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Lotio Sept Gel Color
Market area: EU
Lotio Sept Gel blau
Market area: EU
Lotio Sept Gel blue
Market area: EU
OP Sept Gel Color
Market area: EU
Authorisation number
EU-0033834-0006 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active substance
67-63-0
200-661-7
64 % (w/w)
Commission Implementing Regulation (EU) 2025/1885 of 11 September 2025 granting a Union authorisation for the biocidal product family BPF Propan-2-ol Dr Deppe in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Schedules & Appendices

Cite this act
